News


Life Science | 2018-12-10
Kuros receives FDA 510(k) clearance for extending commercial indications of MagnetOs Putty in the United States

-        US Food and Drug Administration (FDA) clearance granted for extending the use of MagnetOs Putty as a stand-alone bone graft in extremities and pelvis

-        Paves way for commercial expansion into more clinical indications in orthopedic surgery

Schlieren (Zurich), Switzerland, December 10, 2018 – Kuros Biosciences (SIX: KURN) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for extending MagnetOs Putty indications to use as a stand-alone bone graft in extremities and pelvis. This is in addition to the existing clearance for use of MagnetOs Granules and MagnetOs Putty as an autograft extender in posterolateral spine.

Joost de Bruijn, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us as it allows Kuros to expand the commercial reach of MagnetOs into new orthopedic applications such as reconstructive surgery. It also consolidates Kuros’ strategy to expand into indications in which MagnetOs is utilized as a replacement for, rather than supplement to, autologous bone graft”.

Several studies have shown that MagnetOs leads to progressive bone formation comparable to the current gold standard autograft. The search for suitable alternatives to autograft could give the Company the opportunity to become a leading player in the area of total bone graft substitutes, with products that can compete in the majority of the markets growing to an estimated US $3.4 billion by 2030.,

For further information, please contact:

Kuros Biosciences AG     Media & Investors

Michael Grau     Hans Herklots

Chief Financial Officer    LifeSci Advisors

Tel +41 44 733 47 47    +41 79 598 7149

michael.grau@kurosbio.com

hherklots@lifesciadvisors.com

 

About MagnetOs

The MagnetOs product family is based on a unique and proprietary synthetic surface science technology. These products are based on calcium phosphate and have an advanced submicron surface topography that aims to direct bone formation and greatly enhance their ability to promote local bone formation. The surface topography has been demonstrated to stimulate the body to form bone in a safe, localized and accelerated manner.  A substantial number of clinically relevant and predictive preclinical studies in small and large animals have demonstrated that the MagnetOs bone graft substitute leads to progressive bone formation and implant resorption that is equivalent to the current gold standard autograft.

. MagnetOs is available as granules and as a putty formulation.

 

Previous US FDA clearance

MagnetOs granules have also obtained US FDA 510k clearance as an autograft extender in posterolateral spine early 2017. MagnetOs putty obtained US FDA 510k clearance in August 2017 as an autograft extender in posterolateral spine.

 

New US indications statement in FDA 510(k) clearance

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.

 

About Kuros Biosciences AG

Kuros Biosciences (SIX: KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



Life Science | 2018-12-06
Kuros reports publication of MagnetOs data demonstrating equivalence to autologous bone in spinal fusion

 

-        Study should further enhance competitive positioning of MagnetOs

-     Sheep animal model is one of the most relevant preclinical model and believed to be predictive of outcomes in humans

-     12 week fusion rate with MagnetOs granules & putty 92% & 83% versus autograft 75%

Schlieren (Zurich), Switzerland, December 6, 2018 – Kuros Biosciences (SIX: KURN) today announced the publication of data from a clinically-relevant preclinical model comparing MagnetOs with autologous bone in instrumented posterolateral spinal fusion in sheep. Utilizing multiple assessments for fusion, the study concluded that MagnetOs is a suitable alternative to autograft when used as a standalone graft.

The publication, which is entitled "Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion” was included in the December issue JOR Spine, an open-access Orthopaedic Research Society (ORS) journal.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “This latest study demonstrates early bone healing and physiologically-appropriate graft resorption for MagnetOs in this clinically-relevant model of posterolateral spinal fusion and adds to the growing body of evidence proving that MagnetOs is a reliable alternative to autologous bone graft.”

Professor Bill Walsh, University of New South Wales, Australia, who was principal investigator of the study said: “I’ve investigated many of the leading synthetic bone grafts in this model and, in my experience, MagnetOs leads to the most compelling fusion outcomes of all the grafts I’ve tested.”

About the study

MagnetOs Granules and MagnetOs Putty were implanted standalone and compared to autograft bone. Twenty-five adult, female Merino sheep underwent posterolateral spinal fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. Similarly, the three treatment groups showed a statistically significant decrease in lateral bending at the fusion levels at 12 weeks and 26 weeks compared to the 6-week time-point, which further confirmed spinal fusion. No significant differences in range of motion were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for autograft, MagnetOs Granules and MagnetOs Putty, respectively. The fusion rates were further increased 26 weeks post-implantation. Similar trends of bone growth were observed by histomorphometry.

Citation

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jsp2.1039

 

For further information, please contact:

Kuros Biosciences AG     Media & Investors

Michael Grau     Hans Herklots

Chief Financial Officer    LifeSci Advisors

Tel +41 44 733 47 47    +41 79 598 7149

michael.grau@kurosbio.com

hherklots@lifesciadvisors.com

 

About MagnetOs

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

 

US indications statement

MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

 

EU indications statement

MagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices.

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

 



Silver Economie | 2018-11-21
Stilla Technologies completes €16 Million ($18 Million) Series A

 

  • Objective: financing to commercialize its novel digital PCR system and develop clinical applications.

Paris, November 20th, 2018. Stilla Technologies, the European provider of pioneering digital PCR solutions for high precision genetic analysis, announced today the successful completion of a Series A financing round of 16 million euros ($18 Million) led by Illumina Ventures, with participation from Kurma Partners, LBO France, BNP Paribas Développement, Paris Saclay Seeds & Idinvest Partners. As part of the financing, Nick Naclerio (Illumina Ventures), Philippe Peltier (Kurma Partners) and Philippe Chambon (LBO France) have joined the board of directors, replacing the seed investors.

Since 2016, Stilla Technologies has been providing research organizations specialized in molecular biology and genetic analysis with its Naica System, a ground-breaking digital PCR solution that enables scientists to detect and quantify DNA mutations with unrivalled precision.

“With our Naica System, researchers worldwide are building a new generation of high-precision genetic tests, in various fields of applications such as liquid biopsy tests for cancer diagnostics, pre-natal testing or GMO detection” commented Rémi Dangla, CEO and co-founder of Stilla Technologies.”The additional financing will enable Stilla to accelerate the sales of the Naica System,  , launch our 2nd generation solution, and begin clinically validating panels to be run on the system with an initial focus in the field of oncology.”

“We are very excited to be working with Stilla and such a deep syndicate of European investors added Nick Naclerio, Founding Partner of Illumina Ventures. “The Stilla team has done an amazing job developing and launching the Naica system in Europe and Asia with a very limited amount of seed financing. With these additional resources, we believe that Stilla Technologies can become a global leader in digital PCR and the lowest cost platform for liquid biopsies.”

Stilla Technologies will be presenting its latest products and developments in the field of digital PCR at the upcoming annual 4BIO Summit – Europe in Rotterdam, Netherlands on the 27th and 28th of November 2018.

 

 

 

 

 



IT | 2018-10-29
Voluntis and AstraZeneca win prestigious Prix Galien MedStartUp Award for ‘Best Patient Engagement Technologies’ for eCO

Paris, France, October 29, 2018, 7:00 am CET – Voluntis (Euronext Paris, Ticker: VTX - ISIN: FR0004183960), a company specialized in digital therapeutics, and AstraZeneca (NYSE: AZN) announced that they have been awarded the 2018 Prix Galien – MedS¬tartUp Award for Best Patient Engagement Technology for eCO. The award recognizes outstanding partnerships between French and North American entities to improve health care. It was presented at a ceremony in New York City on October 25, 2018.

Pierre Leurent, CEO of Voluntis: “We are honored to receive this prestigious award, which recognizes eCO as a significant achievement in improving patients’ lives. It is also an acknowledgement of the strength of our partnership with AstraZeneca and the National Cancer Institute. We have been delighted to work with them in developing eCO as we bring our respective expertise and passion for patients. As they say at Prix Galien, ‘Actors win Oscars, innovators win the Prix Galien.’”

eCO is a companion digital therapeutic developed by Voluntis, in partnership with AstraZeneca and the National Cancer Institute, for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of Cediranib plus Olaparib. It aims to help these women manage symptoms sometimes associated with their treatment in collaboration with their care teams via a patient app and clinician web portal. In a feasibility study, published in the Journal of Clinical Oncology (JCO®) Clinical Cancer Informatics, patients had statistically significant, positive responses to the use of the eCO application. Patients indicated that using eCO made them feel more involved in their care and better connected to their healthcare team.

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.

For further information: http://www.voluntis.com

Diabeo® is a registered trademark of Sanofi. Insulia® is a registered trademark of Voluntis.

www.voluntis.com/fr

 

 

 



Silver Economie | 2018-10-25
Les Dr. Jan Berger et Roberta Herman rejoignent le Conseil d’Administration de Voluntis

Voluntis renforce l’expertise américaine, payeur et médicale de son Conseil d’Administration

 

Paris, France, le 25 octobre 2018, 17H45 CEST – Voluntis (Euronext Paris, Mnemo : VTX - ISIN : FR0004183960), société spécialisée dans les thérapies digitales, annonce aujourd’hui les nominations de Jan Berger et Roberta Herman en tant qu’administratrices de Voluntis. Les Dr. Herman et Berger ont chacune plus de 30 ans d’expérience dans le domaine de la santé, en particulier auprès des payeurs et des professionnels de santé américains.

Jan Berger a occupé des fonctions exécutives au cours des 30 dernières années dans des groupes de santé privés et publics. En 2009, le Dr. Berger a fondé Health Intelligence Partners, un cabinet de conseil au service d’organisations et des ministères de santé dans 14 pays. Auparavant, elle était Senior Vice President, Chief Clinical Officer et Innovation Officer de CVS Health / Caremark. Actuellement, elle siège au Conseil d’Administration de Cambia Health Solutions (assureur multi-Etats Blue Cross Blue Shield), de GNS Healthcare (analyse de données de santé), Tabula Rasa (services de gestion et sécurité des médicaments) et Accent Care (santé à domicile et soins palliatifs). Le Dr. Berger est professeur adjoint à l’école de médecine et l’école de communication de Northwestern University à Chicago, Illinois. C’est une experte renommée dans l’engagement des patients et l’adhérence aux médicaments, ayant publié quatre livres et de nombreux articles sur ces sujets. Elle est titulaire d’un Doctorat en Médecine et d’un Master en Droit de l’Université de Loyola University (Chicago, USA).

Roberta Herman est actuellement Directeur exécutif de la Group Insurance Commission de l’Etat du Massachusetts, qu’elle est chargée de moderniser grâce à des initiatives innovantes visant à mieux assurer les soins des fonctionnaires et retraités de l’Etat. Elle codirigeait, auparavant, la practice stratégie payer / provider value transformation du cabinet Navigant Consulting. Jusqu’en 2013, elle était Chief Operating Officer et Chief Medical Officer d’Harvard Pilgrim Health Care, un assureur santé comptant 1,2 million d’adhérents des segments Commercial et Medicare dans trois Etats. Elle est membre du Conseil d’Administration du Joslin Diabetes Center. Le Dr. Herman enseigne depuis plus de 30 ans à l’école de médecine de Harvard University et est conférencière à la Harvard School of Public Health. Elle est diplômée de l’école de médecine de McGill University (Montréal, Canada).

Eric Elliott, Président du Conseil d’Administration de Voluntis, commente : « Nous sommes très heureux d’accueillir Jan Berger et Roberta Herman au sein de notre Conseil, seulement quelques mois après Viviane Monges qui nous apporte une expérience de premier plan de l’industrie des sciences de la vie. Leur profonde expertise des secteurs des payeurs et des fournisseurs de soins américains sera un réel atout à un moment clé pour Voluntis, focalisé sur l’extension du déploiement de ses solutions aux États-Unis et de leur remboursement par les organismes payeurs. »

Dr. Berger et Dr. Herman rejoindront les réunions du Conseil d’Administration à partir de novembre 2018. Mme. Émilie Lidome de CM-CIC Investissement quittera le Conseil suite à la fin de son mandat en octobre 2018. Eric Elliott déclare : « Je tiens également à remercier Émilie Lidome pour son engagement et sa contribution au développement de Voluntis ces dernières années et lui souhaite une très bonne continuation. »

 

A propos de Voluntis

Voluntis développe des thérapies digitales pour aider les patients atteints de maladies chroniques à mieux gérer leur traitement au quotidien afin d’en améliorer l’efficacité. Composées d'applications mobile et web, les solutions de Voluntis délivrent instantanément des recommandations personnalisées au patient et à son équipe soignante afin, par exemple, d'ajuster le dosage d'un traitement, d'en gérer les effets secondaires ou de surveiller des symptômes, tout en permettant un suivi du patient à distance. Ces recommandations sont générées grâce à des algorithmes médicaux digitalisés. Exploitant sa plateforme Theraxium, Voluntis a développé́ des thérapies digitales pour la gestion du diabète, comme Insulia® et Diabeo®, et du cancer, comme Zemy et eCO. Voluntis est partenaire, notamment, de Roche, AstraZeneca, Sanofi et Onduo. Basé à Paris et Boston, Voluntis est membre fondateur de la Digital Therapeutics Alliance.

Pour en savoir plus : http : //www.voluntis.com

Diabeo® est une marque déposée de Sanofi. Insulia® est une marque déposée de Voluntis.

 

www.voluntis.com/fr

 

 



Life Science | 2018-10-22
Kuros Biosciences obtains US patent covering a method for producing osteoinductive materials

Schlieren (Zurich), Switzerland, October 22, 2018 – Kuros Biosciences AG (SIX: KURN) announced today that its Dutch subsidiary, Kuros Biosciences BV, has recently been granted the US patent, US 10’064’892, entitled “Method for producing an osteoinductive calcium phosphate and products thus obtained” by the United States Patent and Trademark Office (USPTO).

The patent covers Kuros’ advanced technology for the production of osteoinductive calcium phosphates, which are endowed with a unique surface topography that instructs the body’s own stem cells and osteoprogenitor cells to differentiate into bone forming cells. Kuros is putting in place a portfolio of patents and patent applications to protect its MagnetOs product family.

“The grant of this patent by the USPTO demonstrates our innovative approach to bone graft materials and further reinforces our already considerable intellectual property estate in the U.S., Europe, and Australia around our advanced family of MagnetOs products, which are commercially available in the EU and US since June this year” said Joost de Bruijn, CEO of Kuros.

About MagnetOs

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:

Kuros Biosciences AG     Media & Investors

Michael Grau     Hans Herklots

Chief Financial Officer    LifeSci Advisors

Tel +41 44 733 47 47    +41 79 598 71 49

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



IT | 2018-10-19
63 M€ de chiffre d’affaires à l’issue des neuf premiers mois de l’exercice 2018 Accélération de la croissance pro forma au 3ème trimestre à +32%

PARIS, le 17 octobre 2018 - EKINOPS (Euronext Paris - FR0011466069 – EKI), fournisseur leader de solutions de télécommunications dédiées aux opérateurs de télécommunications, publie son chiffre d’affaires consolidé au titre du 3ème trimestre 2018. OneAccess et ses filiales sont consolidées par intégration globale depuis le 1er octobre 2017 dans les comptes du groupe.

 

En M€ - Normes IFR

Données non auditées    2017    2018    Variation        Variation

                                                                       Pro forma

 

Chiffre d’affaires

1er trimestre                 4,40     18,71     +325%              +1%

Chiffre d’affaires

2ème trimestre             6,24     23,38     +275%              +17%

Chiffre d’affaires

3ème trimestre             4,22     20,93     +395%              +32%

Chiffre d’affaires

9 mois                       14,85     63,02    +324%            +16%

 

Au 3ème trimestre 2018, Ekinops a enregistré un chiffre d’affaires consolidé de 20,93 M€, contre 4,22 M€ au 3ème trimestre du précédent exercice, soit une progression de +395% en données consolidées. En données pro forma, en intégrant OneAccess et ses filiales au 1er janvier 2017, la croissance trimestrielle du groupe s’établit à +32%.

A l’issue des neuf premiers mois de l’exercice, le chiffre d’affaires consolidé d’Ekinops s’établit désormais à 63,02 M€, contre 14,85 M€ un an plus tôt, en progression totale de +324%. En données pro forma, la croissance s’élève à +16% sur les neuf premiers mois de l’exercice 2018.

Dans le sillage de la 1ère moitié de l’année, la dynamique commerciale est particulièrement soutenue sur les grands clients, avec une croissance de +34% sur le Top 10 clients sur les neufs premiers mois de l’exercice 2018 (vs. 9 mois 2017 en données pro forma). Sur les 9 premiers mois de l’exercice 2018, le Top 10 clients représente ainsi 60% de l’activité du groupe.

Sur le plan géographique, la France et la zone EMEA (Europe - hors France -, Moyen-Orient & Afrique) demeurent le centre de gravité du groupe, représentant respectivement 44% et 37% des ventes depuis le début de l’année. Les Amériques totalisent 12% des ventes à neuf mois et l’Asie Pacifique 7%.

Confirmation des objectifs financiers annuels relevés fin septembre

Le 3ème trimestre témoigne de la poursuite de la bonne dynamique commerciale du Groupe sur toutes les zones géographiques.

Dans ce contexte, les objectifs financiers annuels 2018, relevés fin septembre à l’occasion de la publication des résultats semestriels, sont pleinement confirmés : un chiffre d’affaires annuel consolidé supérieur à 82 M€ (contre un chiffre d’affaires 2017 pro forma de 73,8 M€), accompagné d’une marge d’EBITDA d’au moins 5%, tenant compte des tensions actuelles sur les prix de certains composants électroniques et des investissements humains prévus en R&D au 2nd semestre 2018 pour préparer les futurs développements.

Agenda financier 2018

Date                                                                            Publication

Mercredi 23 janvier 2019                         Chiffre d’affaires annuel 2018 (non audité)

 

Toutes les publications interviendront après la clôture du marché d’Euronext Paris.

A propos d’EKINOPS

Ekinops est un fournisseur leader de solutions de télécommunications, ouvertes et interopérables, destinées aux fournisseurs de services (opérateurs de télécommunications et entreprises) à travers le monde.

Les solutions Ekinops, hautement programmables et évolutives, permettent le déploiement rapide et de manière flexible de nouveaux services de transport optique, haut débit et haute vitesse, ainsi que des services d'entreprise, notamment à travers la virtualisation des réseaux. Le portefeuille de solutions se compose de deux ensembles de produits parfaitement complémentaires :

▪ la plateforme Ekinops 360, afin de répondre aux besoins des réseaux métropolitains, régionaux et longue distance, à partir d’une architecture simple et très intégrée, pour la couche 1 (transport) des réseaux ;

▪ les solutions OneAccess, afin de proposer un large choix d'options de déploiement, physiques et virtualisées, pour les couches 2 et 3 (liaison et réseau).

À mesure que les fournisseurs de services adoptent les modèles de déploiement SDN (Software Defined Networking) et NFV (Network Functions Virtualization), les solutions Ekinops leur permettent ainsi de migrer, de manière transparente, vers des architectures ouvertes et virtualisées.

Ekinops dispose d’une organisation mondiale qui lui permet d’opérer globalement. Ekinops est coté sur Euronext à Paris.

Plus d’informations sur www.ekinops.net



Life Science | 2018-09-28
Kuros reports first patient treated in randomized controlled trial of MagnetOs in spinal fusion

         Kuros commercial activity focused on MagnetOs in spinal fusion

         Study should further enhance competitive positioning of MagnetOs

Schlieren (Zurich), Switzerland, September 27, 2018 – Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study, which is entitled "A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion". UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “It is gratifying to see this important trial get underway in spinal fusion, as this area of great medical need is the focus of our commercial activities. The study is expected to generate important data that can help further differentiate MagnetOs and improve outcomes for patients.”

The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “It is a privilege to be leading this investigation of MagnetOs. MagnetOs is supported by some fantastic scientific evidence and is a treatment which has the potential to significantly improve patients’ lives. Patients own bone remains the gold standard against which all other grafts should be measured, yet very few studies have investigated synthetic alternatives side by side with autograft in a clinical setting. This study is poised to provide a level of definitive clinical evidence that surgeons have been crying out for.”

About the study

The study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will enrolled in this study. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

 

For further information, please contact:

Kuros Biosciences AG     Media & Investors

Michael Grau                 Hans Herklots

Chief Financial Officer    LifeSci Advisors

Tel +41 44 733 47 47    +41 79 598 7149

michael.grau@kurosbio.com

hherklots@lifesciadvisors.com

 

About MagnetOs

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



IT | 2018-09-27
EKINOPS : Amélioration significative des marges opérationnelles au 1er semestre 2018 Relèvement des objectifs de croissance et de rentabilité

 

Lien vers le communiqué



Silver Economie | 2018-09-20
Voluntis – First-half 2018: expanded and strengthened abilities to pursue future growth

•Developed direct commercial relationships with US payers and healthcare providers as well as extended collaboration with pharmaceutical industry

•Significant acceleration in investment to:

O strengthen organization and commercial capabilities, in line with increased interest in Voluntis’ digital therapeutics

O pursue technological developments

•H1 2018 revenue of €2.2 million, reflecting the evolution of the revenue structure, and EBIT of -€7.9 million due to an increase in staff costs

•Successful initial public offering, establishing cash of €28.6 million at end-June 2018

Paris, France, September 20, 2018, 5:40 pm CEST – Voluntis (Euronext Paris, ticker: VTX - ISIN: FR0004183960), a digital biotech specialized in digital therapeutics, announces its revenue and results for the first half of 2018, closed as of 30 June 2018.

Pierre Leurent, Chief Executive Officer of Voluntis, commented: "Following our successful IPO, which enabled us to finance our future development, we have continued to invest, in particular to strengthen our operational teams, mainly in the United States. In addition to strengthening our organization, we have also signed a contract with a US payer, a key stage in our development in this market, consolidated our product portfolio and extended our partnerships in oncology. In diabetes, we are planning to sign contracts with other payers in the United States and to expand our innovative solutions to other European countries."

Key events of the first half

•As it executes the strategy announced at the time of the IPO, Voluntis has focused its investments: 

            O In diabetes, to consolidate the organization and strengthen its commercial capabilities. During the first semester, these efforts led to:

O Signing an agreement in the United States with a payer, WellDyneRx, and continuing to deploy Insulia in healthcare centers.

O Extending the sales network through a distribution partnership with Monarch, thanks to its inpatient presence, and extending the product offering through a partnership with WellDoc, which aims to combine its coaching platform with Insulia.

O Launching a new version of Insulia, now available in Spanish and with enhanced user experience.

O Supporting the promotion of Insulia and Diabeo in France.

O Preparing the launch of Insulia in Canada, for which Insulia received regulatory clearance by Health Canada.

• In oncology, to continue technological, clinical and regulatory developments. Recently, Voluntis has:

O Strengthened its partnership with Roche, aiming to expand the indications covered by the Zemy app, and initiating a clinical study to evaluate the use of Zemy in breast cancer.

O Extended its agreement with AstraZeneca to implement a new clinical evaluation phase of the eCO digital therapy.

O Announced the publication of clinical results in the eCO (eCediranib-Olaparib) feasibility study, developed in partnership with AstraZeneca and the National Cancer Institute, in the Journal of Clinical Oncology (JCO®) Clinical Cancer Informatics.

O Enhanced its Theraxium Oncology digital platform, dedicated to cancer treatments.

H1 2018 revenue of €2.2 million, reflecting the evolution of Voluntis’ revenue structure, and EBIT of -€7.9 million due to an increase in staff costs

• Application of IFRS 15, the new revenue recognition standard: Voluntis has applied the standard since January 1, 2018, with no prior period restatement. A major evolution in the revenue recognition standard, the transition to this new model has nonetheless had a minor impact on the semester’s revenue, specifically less than €0.1 million.

• Variation in milestone payments: Voluntis reported first-half revenue of €2.2 million versus €5.7 million in first-half 2017, which benefited from €3.5 million of milestone payments compared with €0.1 million this year.

• Evolution of the revenue structure: The total revenue reduction reflects, per management expectations, the transition to a revenue model based more on recurring revenue from product sales and less on pre-launch revenue related to product development and approval. In the first semester, direct sales to payers and providers have yet to affect revenue.

In parallel, Voluntis continued to bolster its teams, particularly in the United States, to support the marketing and deployment of Insulia. The €1.5 million increase in operating expenses to €9.8 million was therefore due to growth in staff costs, which amounted to €6.7 million, including a €0.5 million impact related to IFRS 15. This new standard also takes into account the costs of contract execution with clients, of which a large part was recognized in personnel costs this semester.

On that basis, EBITDA came to -€7.0 million and EBIT to -€7.9 million.

After the IPO on Euronext Paris and the resulting capital increase, free cash amounted to €28.6 million on June 30, 2018 versus €1.8 million on December 31, 2017. Voluntis also issued a €4.0 million bond to Kreos during the period.

Outlook

Voluntis will continue to invest during the second half to support its growth.

Initiatives already underway include:

          Stepping up sales and marketing actions in the United States to extend the deployment of Insulia

          Finalizing the development of a proprietary multi-cancer solution in oncology

          Continuing to strengthen its teams by bringing in new skills, in particular new experts in the US market

Furthermore, the company foresees further strengthening its Board of Directors with additional well-known and deeply experienced US healthcare executives.

Medium-term targets unchanged

Voluntis has not changed its medium-term target of €50 million in revenue in 2021 after achieving breakeven at EBITDA level in 2020.

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.

For further information: http://www.voluntis.com

Diabeo® is a registered trademark of Sanofi. Insulia® is a registered trademark of Voluntis.

www.voluntis.com/fr

Voluntis                                  NewCap                                  NewCap

Matthieu Plessis                        Marc Willaume / Tristan             Nicolas Merigeau

CFO                                         Roquet Montégon                      Media Relations

Phone nb : 01 41 38 39 20         Investor relations                      Phone nb.: 01 44 71 94 98

Email:                                      Phone nb.: 01 44 71 94 94         Email: voluntis@newcap.eu

investisseurs@voluntis.com        Email: voluntis@newcap.eu



Life Science | 2018-09-14
Kuros Biosciences to Host Key Opinion Leader Meeting on Establishing the New Gold Standard in Bone Regeneration

Schlieren (Zurich), Switzerland, September 14, 2018 – Kuros Biosciences, (SWX: KURN) a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration, announced today that it will host a Key Opinion Leader (KOL) luncheon on establishing the new gold standard in bone regeneration on Thursday, September 20 at the Hotel Richemond in Geneva, Switzerland.

The KOL event will feature presentations by KOLs John Sutcliffe MBChB FRCS(Ed) FRCS(SN), from the London Spine Clinic, and Andrew A. Sama, MD, from the Hospital for Special Surgery, Weill Cornell Medical College, who will discuss the scientific rationale of Kuros’s lead programs, Fibrin/PTH and MagnetOS, as well the overall treatment landscape in both Europe and the United States, and the commercial potential of Kuros’s innovative portfolio in bone regeneration.

Kuros’s CEO Joost de Bruijn will give a short investor presentation highlighting the Company’s progress to date and upcoming milestones.

John Sutcliffe is Triage Consultant Spinal Neurosurgeon & Lead Clinician, London Spine Clinic, having trained in Edinburgh and qualifying in 1983. He was appointed as a consultant neurosurgeon in 1993 and has since concentrated exclusively in the management of patients with spinal disorders. He pioneered the concept of the multi-disciplinary team approach to spinal disorders, setting up the London Spine Clinic in 1997, the first hospital of its kind in the UK at the time. He resigned from the NHS in 2000 but remains an Emeritus Consultant at Barts' and the London NHS Trust. As training director in the NHS and at the London Spine Clinic and London Clinic Hospital, Mr. Sutcliffe has trained many young spinal surgeons in his 25 years as a consultant.

Dr. Andrew Sama serves as Director of Spine Surgery Fellowship at Hospital for Special Surgery & Associate Professor of Clinical Orthopaedic Surgery, Orthopaedic Surgery, Weill Cornell Medical College. Dr. Andrew Sama specializes in the management of all traumatic, degenerative, and deformity-related conditions of the cervical, thoracic, and lumbosacral spine. He has received a number of research grants, including funding from the National Institutes of Health. Dr. Sama is involved in product development and has helped design several orthopedic implant devices. He has published articles in numerous peer-reviewed medical journals and co-edited a textbook titled "Lateral Access Minimally Invasive Spine Surgery." He is on the editorial board of Current Reviews in Musculoskeletal Medicine and serves as a reviewer for the journals Spine and Clinical Orthopaedics and Related Research.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited.  A live webcast and replay will be accessible via the link here.  If you would like to ask a question during the live Q&A, please submit your request via email.

For further information, please contact:

Kuros Biosciences AG     LifeSci Advisors

Michael Grau     Hans Herklots

Chief Financial Officer    Media & Investors

Tel +41 44 733 47 47    +41 79 598 7149

michael.grau@kurosbio.com   

hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

 



Life Science | 2018-09-05
Kuros Biosciences Reports Results for First Half 2018

(Corrected Version, including link to Half Year Report)

http://kuros.ch/uploads/Reports_and_Presentations/2018HY1.pdf

Financial highlights

         CHF 9.7 million cash at June 30

         Operating expenses decreased to CHF 6.0 million

 

Operational highlights

         First U.S. & European sales of MagnetOs

         Commercial rollout in the U.S. and Europe on track

         Preparation for Phase II clinical study of Fibrin-PTH in spine on track

 

Schlieren (Zurich), Switzerland,

September 5, 2018 – Kuros Biosciences has delivered on its targets in the first half of 2018, confirming its successful transition into a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. Kuros has recorded first sales of MagnetOs in the U.S. and in Europe, and commercial rollout continues apace in both regions.

Joost de Bruijn, Chief Executive Officer, said: “We have successfully pursued the new course for Kuros in the first half of 2018, progressing on all fronts. We have realized the first sales from MagnetOs, an important milestone as we focus on the commercial opportunity of cutting-edge orthobiologics, and the commercial rollout is advancing on both sides of the Atlantic. Furthermore, we are driving forward the exciting clinical program with Fibrin-PTH in spinal fusion, which represents a huge commercial opportunity.

Financial position

Cash and cash equivalents (including financial assets and trade and other receivables) as per June 30, 2018, amounted to CHF 9.7 million, compared with CHF 21.4 million as per June 30, 2017.

Operating expenses decreased to CHF 6.0 million (first half 2017: CHF 7.5 million) primarily due to lower non-cash expenses in connection with share-based payments. Expenses for research and development of CHF 3.1 million (CHF 2.2 million in the first half 2017) are mainly external costs for the preparation of the Phase II study (spine indication) of fibrin PTH, personnel expenses and depreciation of tangible assets. Expenses for general and administrative of CHF 4.1 million contained costs for personnel and other expenses for maintenance and administration. Revenues amounted to CHF 0.3 million (first half 2017: CHF 0.5 million) and originated primarily from a milestone payment related to the agreement with Checkmate. Furthermore, the commercial rollout of MagnetOs recognized its first sales. Other income was CHF 1.1 million (first half 2017: CHF 1.5 million) and mainly consisted of proceeds from sub-lease agreements.

The net loss as per June 30, 2018 amounts to CHF 5.2 million, compared to CHF 7.0 million in the corresponding period in the first half of 2017. The primary reason for the substantial decrease of CHF 1.7 million are a substantial reduction in expenses for share-based payment and income tax effects.

Key figures                                           H1 2018           H1 2017

In TCHF, IFRS                           

Revenue                                              274                  534

Research and development                   (3,058)             (2,211)                             

General and administrative                   (4,112)             (6,777)

Other income                                       1,125                1,522

Net operating costs                               (6,045)             (7,466)

Operating income/(loss)                        (5,787)             (6,932)

Net financial income/(loss)                    (4)                   (247)

Net income/(loss)                                 (5,247)             (6,970)

Net income/(loss) per share (in CHF)      (0.63)               (1.11)

 

Cash and cash equivalents, financial

assets and trade and other receivables    9,650                21,417

 

Events after the reporting period

Kuros will issue 370,000 shares to former Xpand Biotechnology shareholders, a milestone related to the merger and triggered by the important CE mark certification in Europe for MagnetOs Putty, which today allows Kuros to commercialize MagnetOs Putty across Europe.

 

Outlook

Kuros’s products are advancing according to plan with MagnetOs Putty having received clearance for commercialization in the United States and recently having received CE mark in Europe followed by first commercial sales in the United States and Europe, in June 2018. Kuros is financed to initiate the commercialization of MagnetOs in the US and to prepare for the phase II clinical study of Fibrin-PTH in spine.

 

For further information, please contact:

Kuros Biosciences AG     LifeSci Advisors

Michael Grau                 Hans Herklots

Chief Financial Officer    Media & Investors

Tel +41 44 733 47 47    41 79 598 71 49

michael.grau@kurosbio.com

hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

 

 

 

 

 

 



Life Science | 2018-08-23
Kuros Biosciences appoints Pascal Longlade as Chief Medical Officer

Schlieren (Zurich), Switzerland, August 23, 2018 Kuros Biosciences AG (SIX: KURN) announced today the appointment of Pascal Longlade as Chief Medical Officer, effective September 1.

Pascal Longlade, MD, has more than 20 years international experience in clinical research and development with leading pharmaceutical, biotech and medical device companies, most recently as Director Medical Affairs, Head of Regulatory Affairs and Head of Pharmacovigilance at D&A Pharma in Paris. He replaces Virginia Jamieson, who has continued to work for Kuros as a consultant since her retirement in May.

“I’m delighted to welcome Pascal on board at Kuros and am very much looking forward to working with him,” said CEO Joost de Bruijn. “Pascal brings with him a wealth of experience and has previously built strong relationships with key opinion leaders, which will support the development of our clinical development pipeline and of the company.”

During his career, Pascal spent 10 years in clinical medicine and he has experience in managing large teams. He has previously served as Chief Medical Officer of Trophos SA, as Director of Clinical Research at Nicox SA and as Director Clinical Affairs EMEA at Abbott Vascular Devices.  Mr. Longlade holds a MD from Lariboisière-Saint-Louis Medical School, Paris, France.  He will be based at our site in Bilthoven, in the Netherlands.

“I am very excited to be joining Kuros at such an interesting point in its history, with several products going through clinical development and/or being launched in the US and EU as well as extensive opportunities to further develop the portfolio of innovative products in tissue repair and regeneration,” said Pascal Longlade.

For further information, please contact:

Kuros Biosciences AG     LifeSci Advisors

Michael Grau     Hans Herklots

Chief Financial Officer    Media & Investors

Tel +41 44 733 47 47    +41 79 598 7149

michael.grau@kurosbio.com   

hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

 



Silver Economie | 2018-08-16
Voluntis releases upgraded version of Insulia to improve user experience, including Spanish

Paris, France, August 16, 2018 – 6:00 pm CEST. Voluntis (Euronext Paris - ticker: VTX - ISIN Code: FR 0004183960), a digital biotech specialized in digital therapeutics, announces the release of an upgraded version of Insulia that improves user experience and makes Insulia available in Spanish.

“Over the past year, we’ve worked closely with the medical community and people with diabetes using Insulia to understand how we can further help meet their needs,” said Ellie Strock, Vice President of US Medical Affairs at Voluntis. “The beauty of digital therapeutics like Insulia is that we can use this feedback to continuously improve them, making insulin management ever easier.”

The addition of Spanish will allow providers and payers to expand the reach of Insulia for their at-risk diabetes population. The diabetes prevalence among Hispanics is 43% higher than the national average in the United States.1 In a recent study, 52% of Hispanics had poor glycemic control and were at higher risk for cardiometabolic abnormalities than non-Hispanic whites.2

Voluntis will be presenting the upgraded Insulia digital therapeutic at the AADE conference at booth #451 on the exhibition floor. In addition, attendees can come see our poster entitled “Smart Phones, Smart Coaches, Smart Patients: How to Use Digital Coaching in Type 2 Diabetes Management” (#P827).

About Insulia®

Insulia® provides automated basal insulin dose recommendations and coaching messages for people with type 2 diabetes while enabling the health care team to remotely monitor progress. A healthcare practitioner prescribes Insulia using their dedicated web portal and sets up the treatment plan rules that will adjust basal insulin dosing based on the person’s specific needs. The user then receives an activation code to get started with their personalized app. Once downloaded, the app uses blood glucose readings and any hypo symptoms to recommend doses in real-time. These are constantly updated using clinical algorithms built into the application. Data is automatically shared with the health care team, who can remotely monitor the patient’s progress toward their goal thanks to tailored notifications. This enables providers to deliver tailored telemedicine services, a practice increasingly supported by payers worldwide. Insulia is available for people using any brand of basal insulin including Lantus®, Levemir®, Toujeo®, Tresiba® (U-100) and Basaglar®.

For further information: http://www.insulia.com

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia® and Diabeo® in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.

Insulia® is a registered trademark of Voluntis.

For further information: http://www.voluntis.com

1 https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

2 http://www.diabetes.org/newsroom/press-releases/2014/diabetes-among-hispanics-all-are-not-equal.html

 



Silver Economie | 2018-07-31
Voluntis announces the launch of Theraxium Oncology, an innovative digital platform for symptom management

Paris, France, July 31, 2018 – Voluntis, a digital biotech specialized in digital therapeutics, announces the launch its Theraxium Oncology offer, a breakthrough technology that leverages digital therapeutics to empower patients so they can self-manage their symptoms, experienced when receiving cancer treatments, in coordination with care teams.

Theraxium Oncology takes advantage of over four years of research and development by Voluntis in partnership with life science partners and cancer institutes as well as user feedback from patients and multiple US cancer centers. It aims to deliver an improved patient journey by supporting self-management of symptoms and enhance decision-making and prioritization for care teams by providing them with patient-reported information. Initiated in ovarian and breast cancers, the new technology is designed to target the main cancer types, involving a wide range of treatments and mechanisms of action.

Symptom management, or supportive care, is essential to cancer care with a mean of 14 symptoms experienced per patient and frequency ranging between 11-91% depending on the symptom.[i] Treatment-related symptoms are known as the major reason for suboptimal adherence or treatment discontinuation.[ii] Severe symptoms often lead to unscheduled hospitalizations, since almost 80% of cancer hospitalizations are due to uncontrolled symptoms.[iii] Managing symptoms is therefore incredibly important for clinical practice, yet care teams are only partly aware of patient symptoms [iv] because they have few tools to monitor symptoms in a timely and effective manner and have limited time per patient.

“Providing and receiving supportive care can be a trying experience, both for patients and care teams,” says Romain Marmot, Chief Operations Officer at Voluntis. “Using evidence-based algorithms, digital therapeutics can empower patients to self-manage symptoms while allowing healthcare professionals to intervene at the right time, with the right data. The result is improved patient quality of life, reduced discontinuation rates and, ultimately increased survival.”

Voluntis’ technology combines a prescription mobile app and cloud-based solution for patients with a web portal for care teams. Patients enter symptom data in the app, either manually or by connecting to wireless sensors, to receive actionable recommendations personalized to their current condition. Leveraging embedded clinical algorithms, the app can help patients identify and qualify their symptoms, take treatment action in real time, gain knowledge about their disease and report their symptoms to their care teams.

Care teams follow the progress of their entire patient population in real-time from their desks thanks to their web portal, accessible without any download. Healthcare professionals can thus access the narrative of patient’s symptoms. This enables them to triage patients according to priority, take action to modify the treatment and coordinate better with all care team members and patients. The result is more responsive treatment management, improved patient engagement and care coordination, in view of improving both the quality and cost of care.

For more information about Theraxium Oncology: http://www.voluntis.com/oncology

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self-manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team that so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics. These include Insulia and Diabeo in diabetes as well as eCO and ZEMY in oncology. Voluntis has long-standing partnerships with leading life science companies such as Roche, AstraZeneca, Sanofi and Onduo. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance.

For further information: http://www.voluntis.com

[i] Stark et al. “The Symptom Experience of Patients with Cancer.” J Hosp Palliat Nurs. 2012 Jan-Feb; 14(1): 61–70.

[ii] Kidwell et al. “Patient-reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy.” Cancer. 2014 Aug 15;120(16);2403-11.

[iii] Numico et al. “Hospital Admission of Cancer Patients: Avoidable Practice or Necessary Care?” PLoS One. 2015; 10(3): e0120827.

[iv] Rha et al. “Gaps exist between patients' experience and clinicians' awareness of symptoms after chemotherapy: CINV and accompanying symptoms.” Support Care Cancer. 2016 Nov;24(11):4559-66.

 



Silver Economie | 2018-07-16
Publication des résultats de l’étude eCO dans la revue JCO® Clinical Cancer Informatics

Cambridge, MA, le 16 juillet 2018 à 18h00 – Voluntis (la « Société » ou « Voluntis » - mnémonique : VTX - ISIN : FR 0004183960), société spécialisée dans les logiciels thérapeutiques (digital therapeutics), annonce aujourd’hui que les résultats de l’étude eCO, la solution digitale d’accompagnement des femmes atteintes d’un cancer de l’ovaire, développée en partenariat avec AstraZeneca et le National Cancer Institute, ont été publiés dans la revue JCO® Clinical Cancer Informatics.

L’étude, publiée sous le titre « Technology APPlications: Use of digital health technology to enable drug development, » permettait d’étudier la faisabilité, la facilité d’utilisation et la satisfaction perçue des patientes utilisant eCO (eCediranib-Olaparib), une application mobile permettant d’assurer le suivi et la notification des effets secondaires chez les femmes atteintes d’un cancer de l’ovaire récidivant. La solution eCO a été spécifiquement conçue pour faciliter la prise en charge d’événements liés au traitement, tels que l’hypertension et la diarrhée, le plus souvent associés à l’arrêt du traitement, la nécessité d’un « congé thérapeutique » ou un arrêt/une modification des doses. Au cours de cet essai, les utilisatrices ont saisi leurs données et ont reçu en temps réel des recommandations de traitement pour mieux gérer leurs symptômes. Leurs données étaient aussi envoyées simultanément à leur équipe soignante pour que celle-ci puisse suivre l’évolution de leur traitement via un portail Web.

La solution eCO a permis aux prestataires de soins de répondre rapidement aux symptômes rapportés par les patientes, offrant à celles-ci une expérience générale positive. L’analyse de l’enquête a montré que les réponses des patientes concernant l’utilisation de l’application eCO étaient positives et statistiquement significatives. Les patientes ont indiqué que l’utilisation d’eCO leur donnait le sentiment de participer davantage à leurs soins et d’être mieux connectées à leur équipe soignante.

« La publication de ces résultats cliniques positifs dans la revue JCO® Clinical Cancer Informatics suggère qu’il existe un intérêt grandissant pour les solutions digitales d’accompagnement des patients en oncologie » déclare Pierre Leurent, Directeur Général de Voluntis. « Nous concevons des solutions pour aider les personnes atteintes d’un cancer à améliorer la prise en charge des effets secondaires de leur traitement, tout en restant connectées avec leur équipe soignante. Nous sommes certains que les thérapies digitales feront un jour partie des pratiques standards en oncologie clinique. »

AstraZeneca et Voluntis ont conclu un partenariat en 2015, en collaboration avec le National Cancer Institute, pour développer une solution digitale innovante destinée à accompagner les femmes suivant un traitement pour un cancer de l’ovaire platino-sensible récidivant de haut grade dans le cadre d’études cliniques sur l’association thérapeutique cediranib plus olaparib.

A propos de Voluntis

Voluntis développe des thérapies digitales pour aider les patients atteints de maladies chroniques à mieux gérer leur traitement au quotidien afin d’en améliorer l’efficacité. Composées d'applications mobile et web, les solutions de Voluntis délivrent instantanément des recommandations personnalisées au patient et à son équipe soignante afin, par exemple, d'ajuster le dosage d'un traitement, d'en gérer les effets secondaires ou de surveiller des symptômes, tout en permettant un suivi du patient à distance. Ces recommandations sont générées grâce à des algorithmes médicaux digitalisés. Exploitant sa plateforme Theraxium, Voluntis a développé́ des thérapies digitales pour la gestion du diabète, comme Insulia® et Diabeo®, et du cancer, comme Zemy et eCO. Voluntis est partenaire, notamment, de Roche, AstraZeneca, Sanofi et Onduo. Basé à Paris et Boston, Voluntis est membre fondateur de la Digital Therapeutics Alliance. Pour en savoir plus : http : //www.voluntis.com

Diabeo® est une marque déposée de Sanofi. Insulia® est une marque déposée de Voluntis.

 



IT | 2018-06-27
Teem Photonics appoints Pascal Langlois as new Chairman of the Supervisory Board

June 27, 2018, Meylan, France

Teem Photonics, the leader in Passively Q-Switched Microlasers as well as Photonics Integrated Circuits based on the ioNext technology, has appointed Pascal Langlois as Chairman of the supervisory board.

With more than 25 years in senior management positions in the industry, Mr. Langlois brings extensive executive experience in leading international businesses with proven track record in corporate transformations as well as of developing, managing and growing international high technology businesses in various industry segments, including automotive, wireless communication, consumer and industrial across the globe.

Most recently, Langlois was President and CEO of Tronics Microsystems a Mems company he has successfully introduced on Euronext Stock market in February 2015 and which was acquired by TDK Group end of 2016. Prior to that he was Chief Sales and Marketing Officer at ST-Ericsson and from 2006, Founder of NXP and part of the executive management team responsible for global commercial operations. He was previously with Philips Semiconductors BV, where he served in various capacities, including Senior Vice President of Sales and Marketing for multimarket products and Vice President/General Manager of the automotive global market segment. He also worked with National Semiconductors, and VLSI Technology, where he was last General Manager of Asia Pacific, Europe & Japan Operations.

We are delighted to bring onboard as Chairman, someone of the caliber of Pascal Langlois. He has the experience we need to take advantage of the current photonics and laser market opportunities and support Teem Photonicsto the next level of corporate transformation,said Antoine Kevorkian CEO and Founder of Teem Photonics.

Pascal brings to Teem Photonicsgreat experience in the fast-moving technology sector just as the company starts a new venture and expands its businesses. We were fortunate to find someone with his combination of talents to lead the company supervisory board in the next phase of company development,added Jean Marc Bally Managing Partner at Aster Capital.

Teem Photonicshas been very successfully repositioned in the past few years and I look forward to support further developing its next steps and technological leadership, engineering expertise, and manufacturing capabilities,said Langlois. The industrial, Life science, Lidar and Datacoms market segments Teem Photonicsis addressing based on its unique set of technologies are growing very fast and there are numerous opportunities to further grow the company .

Teem Photonicsis a privately-held company based near Grenoble, France. Spun off from the GeeO consortium and founded in 1998, Teem Photonicsis the leader in passively Q-switched microlasers as well as Photonics Integrated Circuits based on ion exchange technology.

 

 

 

 

 



Life Science | 2018-06-19
Kuros Biosciences to present promising clinical case studies with MagnetOs at leading spine surgery conference

Schlieren (Zurich), Switzerland, June 19, 2018 Kuros Biosciences will this week present results from several investigator-led clinical case studies of MagnetOs Granules at the 15thannual State of Spine Surgery Think Tank, a leading conference uniquely dedicated to innovation in spinal surgery.

 

The case studies, in which MagnetOs Granules were implanted in the spine, were performed by Alwyn Jones MB ChB, BSc, MSc, FRCS, FRSC (Orth), Consultant Orthopaedic Spinal Surgeon at Spire Cardiff Hospital in the UK.

 

The key clinical outcomes at six months were improved back and leg pain. The most important fusion outcomes were good incorporation of MagnetOs in the posterior fusion bed, graft resorption and remodelling to bone, and progression towards fusion.

 

Key takeaways from the case studies were:

  • MagnetOs Granules were welltolerated and no device related adverse events were reported in the small cohort of patients requiring spinal fusion
  • MagnetOs Granules were easy to apply as a standalone graft or when mixed with bone marrow aspirate (BMA) or local bone
  • Resorption and remodelling of MagnetOs Granules was evident from as early as 3 months postimplantation
  • MagnetOs Granules promoted spinal fusion in a mixed cohort of patients when implanted using 5 different surgical approaches

 

Alwyn Jones said: "I implanted MagnetOs in a cohort of five patients requiring spinal fusion in 2017 and I’m very pleased with their progress. In all cases, my radiographic data indicated remodelling of MagnetOs and progression towards a fusion. All five patients had a reduction in pain, improvement in disability index and improved clinical symptoms compared to their pre-surgical assessment. This initial experience has encouraged me to use MagnetOs in my broader clinical practice."

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “The results from these investigator-led clinical case studies with MagnetOs are very gratifying and underline the interest of the clinical research community in our CE marked product. The MagnetOs Granules were easy to apply and showed clear clinical benefits for patients, giving them an improved quality of life with less pain.”

 

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

 

The State of Spine Surgery Think Tank, formerly known as the Cabo Meeting, takes place June 21-13 in Aruba.

 

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



Life Science | 2018-06-12
Kuros Biosciences announces start of of randomized controlled trial of MagnetOs in spinal fusion

Study should further enhance competitive positioning of MagnetOs

Kuros announced today that the University Medical Center Utrecht (UMCU) in the Netherlands has obtained approval from its ethical committee to start an investigator-led multicenter study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The study is entitled "A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion", with UMCU as principal investigator. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world. The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion. The first patients are expected to be enrolled in H2 2018. 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “Spinal fusion is the focus of Kuros’s commercial activity, and this study is expected to generate valuable data to help further differentiate MagnetOs in the bone graft substitute market. It is part of the Kuros philosophy ‘proof what you claim’ and should enhance our competitive positioning.”

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “We are excited about the prospects of MagnetOs in this study as the solid science underlying MagnetOs has already shown powerful bone generating properties of calcium phosphates with a submicron topography. Replacing patient-own bone with a product like MagnetOs would provide a real clinical benefit.”

Spinal fusion is currently performed by using large amounts of autologous bone graft. A substitute for a patient’s own bone would eliminate the graft harvesting morbidity and associated pain that is one of the main disadvantages of this approach.

About the study

This study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will be recruited and enrolled in this study. Primary endpoint is  posterior spinal fusion rate after one year based on CT-scans.

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:

Kuros Biosciences AG                            Media & Investors

Michael Grau                                         Hans Herklots

Chief Financial Officer                            LifeSci Advisors

Tel +41 44 733 47 47                           +41 79 598 7149

michael.grau@kurosbio.com                   hherklots@lifesciadvisors.com

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

 

 



Life Science | 2018-06-04
Kuros Biosciences to propose appointment of new Board Members at AGM

Schlieren (Zurich), Switzerland, May 31, 2018 – Kuros Biosciences (SIX: KURN) will propose the appointment of CEO Joost de Bruijn, as well as three new independent non-executive directors at its 2018 Annual General Meeting (AGM) on 14 June.

 

Shareholder approval will be sought for the appointment of Joost de Bruijn, Chief Executive Officer of Kuros. Dr. de Bruijn has more than 28 years of experience in academia and the life science industry. He was the founder and CEO of Progentix Orthobiology and more recently of Xpand Biotechnology. He is Professor of Biomaterials at Queen Mary University of London, UK, and Professor of Regenerative Medicine and Entrepreneurship at Twente University, The Netherlands.

 

Jason Hannon, Chief Executive Officer and Member of the Board of Directors of Mainstay Medical SA, is proposed to replace Didier Cowling, who will not stand for reelection. Mr. Hannon has extensive experience in the healthcare and medical devices industry, particularly related to commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management, and the building of a high-performance culture. Mr. Hannon previously served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a medical device company focused on the spine market.

 

Scott P. Bruder, MD, PhD, would replace Frank-Jan van der Velden who will not stand for reelection. Dr. Bruder is an expert in orthobiology and is a seasoned senior executive with a track record spanning more than 25 years at industry leaders such as DePuy Biologics (now Depuy Synthes), Johnson & Johnson Regenerative Therapeutics, LLC, Becton, Dickinson and Company (now BD), and Stryker Corporation.

 

Oliver Walker would replace Harry Welten who will not stand for reelection. Mr. Walker is a finance executive with more than 20 years of experience covering all aspects of finance including M&A, capital market transactions, treasury, reporting and fundraising. Has was CFO of a number of leading healthcare companies, such as Nobel Biocare, Sonova, and Stratec. Oliver has an MSC in Business Administration & Economics at the University of Berne.

 

Furthermore, the Board of Directors proposes the re-election of Clemens van Blitterswijk as member, and the election as chairman of the Board of Directors and the re-election of Christian Itin, Leanna Caron, Giacomo Di Nepi and Gerhard Ries as members of the Board of Directors, each for the term until the next Annual Shareholders Meeting.

 

Documents for the AGM, including the Information Notice with a full agenda, will be made available online on June 1 at: http://www.kuros.ch/investors

 

For further information, please contact:

Kuros Biosciences                                  AG Media & Investors

Michael Grau                                         LifeSci Advisors

Chief Financial Officer                Hans Herklots

Tel +41 44 733 47 47                           +41 79 598 7149

michael.grau@kurosbio.com                   hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



Silver Economie | 2018-05-30
Voluntis réussit avec succès son introduction en bourse et lève 30,1 M€ sur le marché réglementé d’Euronext à Paris

Première introduction en bourse dans le secteur des thérapies digitales en Europe

Près de 70% de la demande institutionnelle provenant de l’Allemagne, du Royaume-Uni et de la Suède

Prix de l’offre fixé à 14,0 € par action

Capitalisation boursière de 105,9 M€

Titres admis à la cotation le 1er juin 2018

Paris, France, le 29 mai 2018 – 21h45 : Voluntis (la « Société » ou « Voluntis » - mnémonique : VTX - ISIN : FR 0004183960), société spécialisée dans les logiciels thérapeutiques (digital therapeutics), annonce aujourd’hui le succès de son introduction en bourse sur le compartiment C du marché réglementé d’Euronext à Paris.

« Je suis très heureux d’annoncer le succès de notre introduction en bourse sur Euronext Paris, étape structurante dans le développement de Voluntis. Cette opération favorisera notre croissance, notamment aux Etats-Unis où le dispositif commercial sera sensiblement étendu. Elle permet également de consolider notre portefeuille de thérapies digitales, en particulier avec la poursuite du développement de notre solution multi-cancer propriétaire. Ces moyens renforcent notre capacité à déployer à grande échelle des solutions de santé de nouvelle génération qui personnalisent les traitements et accompagnent, au quotidien, le patient dans la gestion de sa maladie » déclare Pierre Leurent, directeur général et co-fondateur de Voluntis. « Nous tenons à remercier nos actionnaires historiques, notre partenaire Sanofi ainsi que nos nouveaux actionnaires pour leur participation à cette levée de fonds. »

L’introduction en bourse, réalisée dans le cadre d’une offre globale (l’« Offre ») comprenant une offre au public en France réalisée sous la forme d’une offre à prix ouvert (« OPO ») et un placement global principalement destiné aux investisseurs institutionnels en France et dans certains pays (« Placement Global »), permet à la Société de lever 30,1 M€ par voie d’augmentation de capital.

Le prix applicable au Placement Global et à l’OPO a été fixé à 14,0 € par action, correspondant au bas de la fourchette indicative de prix resserrée de l’Offre, telle qu’annoncée dans le communiqué de presse de la Société en date du 28 mai 2018.

Sur la base du prix d’introduction de 14,0 € par action, la capitalisation boursière de Voluntis s’élèvera à environ 105,9 M€ à l’issue de l’opération.

Les actions seront tout d’abord négociées sous la forme de promesses d’actions sur le marché réglementé d’Euronext à Paris dès le 30 mai jusqu’au 31 mai 2018 inclus. Elles seront ensuite négociées sur le compartiment C du marché réglementé Euronext Paris sur une ligne de cotation unique intitulée « Voluntis » (code ISIN : FR0004183960 ; code mnémonique : VTX) dès l’ouverture des négociations le 1er juin 2018.

L’option de surallocation n’ayant pas été allouée, il ne sera pas mis en oeuvre d’opération de stabilisation.

Rappel des raisons de l’offre

Le produit net des fonds levés dans le cadre de l’Offre, soit 27,4 M€, sera utilisé selon la répartition suivante :

à hauteur de 60% afin de renforcer le dispositif commercial du groupe Voluntis en Amérique du Nord et en Europe, via :

o la poursuite de la constitution de l’équipe commerciale, marketing et médicale en charge de la commercialisation directe des logiciels thérapeutiques en diabétologie auprès des organismes payeurs ; et

o la croissance des équipes d’opérations terrain et de support (« field operations »), en charge du soutien au déploiement local des solutions du groupe Voluntis dans les différents pays ciblés,

à hauteur de 20% afin de poursuivre les développements technologiques, cliniques et réglementaires de la solution multi-cancer propriétaire, en vue de son homologation réglementaire préalablement à sa commercialisation, et

à hauteur du solde, soit 20%, afin de consolider l’organisation du groupe Voluntis, à travers notamment la croissance de la filiale américaine de la Société et la poursuite des investissements dans la plateforme technologique du groupe Voluntis.

Le produit de l’Offre permettra également à la Société d’accroître sa notoriété en France et à l’international.

Modalités de l’offre

Prix de l’Offre

Le prix de l’OPO et du Placement Global est fixé à 14,0 € par action.

Ce prix fait ressortir une capitalisation boursière de Voluntis d’environ 105,9 M€ post augmentation de capital.

Taille de l’Offre et produit brut de l’opération

2.150.000 actions nouvelles ont été émises dans le cadre de l’OPO et du Placement Global.

Le produit brut de l’émission s’élève à 30,1 M€.

Le produit net de l’émission s’élève à environ 27,4 M€.

Répartition des actions souscrites dans le cadre de l’Offre

Placement Global : 1.991.767 actions nouvelles (soit près de 27,9 M€ et environ 93% du nombre total de titres alloués).

OPO : 158.233 actions nouvelles au public (soit près de 2,2 M€ et environ 7% du nombre total des titres offerts).

Dans le cadre de l’OPO, les ordres A1 et A2 seront servis à 100%.

Engagement d’abstention de la Société

A compter de la signature du contrat de placement et de garantie et pendant 180 jours calendaires suivant la date de règlement-livraison, sous réserve de certaines exceptions usuelles.

Engagement de conservation des actionnaires représentant 99,57% du capital social de la Société

A compter de la date du visa de l’AMF sur le prospectus et jusqu’à 360 jours calendaires suivant la date de règlement-livraison des actions de la Société, pour 100% de leurs actions, sous réserve de certaines exceptions usuelles ; étant précisé que cet engagement porte sur l’ensemble des actions de la Société qu’ils détiennent au jour de l’introduction en bourse (mais non celles qu’ils viendraient à détenir, le cas échéant, dans le cadre de ou postérieurement à l’introduction en bourse).

Répartition du capital à l’issue de l’Offre

A la suite de la réalisation de l’augmentation de capital dans le cadre de l’introduction en bourse, le capital social de

Voluntis s’élèvera à 756.766,10 euros, divisé en 7.567.661 actions ordinaires.

Chacun des engagements de souscription tels que décrits dans la note d’opération visée par l’AMF en date du 14 mai 2018 a été servi à hauteur de 100%.

 

Calendrier de l’opération

30 mai 2018 : Début des négociations des actions de la Société sous la forme de promesses d’actions sur le marché

réglementé d’Euronext à Paris (jusqu’au 31 mai 2018 inclus)

 

 

31 mai 2018 : Règlement livraison de l’OPO et du placement global

 

 

1 juin 2018 : Début des négociations des actions de la Société sur le marché réglementé d’Euronext à Paris sur une ligne de cotation intitulée « Voluntis »

 

Codes d’identification des titres Voluntis

 Libellé : Voluntis

 Code ISIN : FR0004183960

 Mnémonique : VTX

 Compartiment : Euronext Paris (Compartiment C)

 Secteur d’activité : 9537 - Software

 

Intermédiaires financiers / Chefs de File et Teneurs de Livre Associés

BRYAN, GARNIER & CO                 ODDO BHF 

 

Informations accessibles au public

Des exemplaires du prospectus visé par l’AMF le 14 mai 2018 sous le numéro 18-169, composé du document de base enregistré le 17 avril 2018 sous le numéro I.18-016 et d’une note d’opération (incluant le résumé du prospectus), sont disponibles sans frais et sur simple demande auprès de la société Voluntis, 58 avenue de Wagram, 75017 Paris, France - ainsi que sur les sites Internet de Voluntis (www.voluntis.com) et de l’AMF (www.amf-france.org).

 

Facteurs de risques

Voluntis attire l’attention des investisseurs sur le chapitre 4 « Facteurs de risques » du document de base enregistré auprès de l’AMF et sur le chapitre 2 « Facteurs de risques liés à l’offre » de la note d’opération et notamment sur son risque de liquidité, la Société estimant être en mesure de faire face à ses engagements jusqu’en septembre 2018 (sans tenir compte du produit net de la présente offre).

 

À propos de Voluntis

Voluntis développe des thérapies digitales pour aider les patients atteints de maladies chroniques à mieux gérer leur traitement au quotidien afin d’en améliorer l’efficacité. Composées d'applications mobile et web, les solutions de Voluntis délivrent instantanément des recommandations personnalisées au patient et à son équipe soignante afin, par exemple, d'ajuster le dosage d'un traitement, d'en gérer les effets secondaires ou de surveiller des symptômes, tout en permettant un suivi du patient à distance. Ces recommandations sont générées grâce à des algorithmes médicaux digitalisés. Exploitant sa plateforme Theraxium, Voluntis a développé́ des thérapies digitales pour la gestion du diabète, comme Insulia® et Diabeo®, et du cancer, comme Zemy et eCO. Voluntis est partenaire, notamment, de Roche, AstraZeneca, Sanofi et Onduo. Basé à Paris et Boston, Voluntis est membre fondateur de la Digital Therapeutics Alliance.

Pour en savoir plus : http : //www.voluntis.com

Diabeo® est une marque déposée de Sanofi. Insulia® est une marque déposée de Voluntis.

 

 

Avertissement

Aucune communication, ni aucune information relative à l’émission par Voluntis des actions (les « Actions ») ne peut être diffusée au public dans un pays dans lequel une obligation d’enregistrement ou d’approbation est requise. Aucune démarche n’a été entreprise (ni ne sera entreprise) en dehors de France, dans un quelconque pays dans lequel de telles démarches seraient requises. L’émission ou la souscription des Actions peuvent faire l’objet dans certains pays de restrictions légales ou réglementaires spécifiques. Voluntis n’assume aucune responsabilité au titre d’une violation par une quelconque personne de ces restrictions.

 

Le présent communiqué ne constitue pas un prospectus au sens de la Directive 2003/71/CE du parlement européen et du conseil du 4 novembre 2003 telle que modifiée, notamment par la Directive 2010/73/UE du Parlement européen et du Conseil du 24 novembre 2010, telle que modifiée et telle que transposée dans chacun des Etats membres de l’Espace Economique Européen (la « Directive Prospectus »).

 

S’agissant des Etats membres de l’Espace Economique Européen autres que la France (les « États membres ») ayant transposé la Directive Prospectus, aucune action n’a été entreprise et ne sera entreprise à l’effet de permettre une offre au public des titres rendant nécessaire la publication d’un prospectus dans l’un ou l’autre des Etats membres. En conséquence, les Actions peuvent être offertes dans les Etats membres uniquement : (a) à des personnes morales qui sont des investisseurs qualifiés tels que définis dans la Directive Prospectus ; ou (b) dans les autres cas ne nécessitant pas la publication par Voluntis d’un prospectus au titre de l’article 3(2) de la Directive Prospectus.

 

Pour les besoins du présent paragraphe, la notion d’« offre au public d’Actions » dans chacun des États membres se définit comme toute communication adressée à des personnes, sous quelque forme et par quelque moyen que ce soit, et présentant une information suffisante sur les conditions de l’offre et sur les Actions objet de l’offre, pour permettre à un investisseur de décider d’acheter ou de souscrire ces Actions, telle que cette notion a été, le cas échéant, modifiée dans l’État membre considéré dans le cadre de la transposition de la Directive Prospectus.

 

Cette restriction de placement s’ajoute aux autres restrictions de placement applicables dans les Etats membres.

La diffusion du présent communiqué n’est pas effectuée par et n’a pas été approuvée par une personne autorisée (« authorised person ») au sens de l’article 21(1) du Financial Services and Markets Act 2000. En conséquence, le présent communiqué est adressé et destiné uniquement (i) aux personnes situées en dehors du Royaume-Uni, (ii) aux professionnels en matière d’investissement au sens de l’article 19(5) du Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (l’« Ordonnance »), (iii) aux personnes visées par l’article 49(2) (a) à (d) (sociétés à capitaux propres élevés, associations non-immatriculées, etc.) de l’Ordonnance ou (iv) à toute autre personne à qui le présent communiqué pourrait être adressé conformément à la loi (les personnes mentionnées aux paragraphes (i), (ii), (iii) et (iv) étant ensemble désignées comme les « Personnes Habilitées »). Les titres sont uniquement destinés aux Personnes Habilitées et toute invitation, offre ou tout contrat relatif à la souscription, l’achat ou l’acquisition des titres ne peut être adressé ou conclu qu’avec des Personnes Habilitées. Toute personne autre qu’une Personne Habilitée doit s’abstenir d’utiliser ou de se fonder sur le présent communiqué et les informations qu’il contient. Le présent communiqué ne constitue pas un prospectus approuvé par la Financial Services Authority ou par toute autre autorité de régulation du Royaume-Uni au sens de la Section 85 du Financial Services and Markets Act 2000.

 

Le présent communiqué ne constitue pas une offre de valeurs mobilières ou une quelconque sollicitation d’achat ou de souscription de valeurs mobilières ni une quelconque sollicitation de vente de valeurs mobilières aux Etats-Unis. Les valeurs mobilières objet du présent communiqué n’ont pas été et ne seront pas enregistrées au sens du U.S. Securities Act de 1933, tel que modifié (le « U.S. Securities Act ») et ne pourront être offertes ou vendues aux Etats-Unis sans enregistrement ou exemption à l’obligation d’enregistrement en application du U.S. Securities Act. Voluntis n’a pas l’intention d’enregistrer l’offre mentionnée dans le présent communiqué ou une partie de cette offre aux Etats-Unis ni d’effectuer une quelconque offre publique aux Etats-Unis. 

La diffusion du présent communiqué dans certains pays peut constituer une violation des dispositions légales en vigueur. Les informations contenues dans le présent communiqué ne constituent pas une offre de valeurs mobilières aux Etats-Unis, au Canada, en Australie ou au Japon. 

Le présent communiqué ne doit pas être publié, transmis ou distribué, directement ou indirectement, sur le territoire des Etats-Unis, du Canada, de l’Australie ou du Japon. 

Le prospectus visé par l’Autorité des marchés financiers contient des déclarations prospectives. Aucune garantie ne peut être donnée quant à la réalisation de ces déclarations prospectives qui sont soumises à des risques tels que, notamment, ceux décrits dans le prospectus de la Société, et à l’évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels Voluntis est présente.

 

Schlieren (Zurich), Switzerland, May 29th , 2018 – Kuros Biosciences (SIX: KURN) announced today the start of an investigator-led study at University Medical Center (UMC) Utrecht, using MagnetOs Granules for maxillary sinus floor elevation with two-stage implant placement. Sinus floor elevation is performed to allow placement of dental implants in the maxilla, or upper jaw. It is most commonly performed when the floor of the sinus is too close to an area where dental implants are to be inserted.

 

The prospective clinical trial will compare MagnetOs Granules to autologous bone (autograft), harvested from the patient's own body, which is the current gold standard treatment. It is being conducted at the Department of Oral and Maxillofacial Surgery & Special Dentistry, UMC Utrecht and is designed as a controlled open-label, randomized non-inferiority trial with 30 patients. The primary outcome is assessment of effectiveness after 4-6 months. The first patients have already been treated.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are very pleased to be taking part in this investigator-led study with the world-renowned Department of Oral and Maxillofacial Surgery at UMC Utrecht. There is a lot of interest from the clinical research community to study a variety of exciting applications in which our CE marked MagnetOs product can promote bone formation. These investigatorled studies expand the clinical evidence base of MagnetOs, and potentially support its positioning in additional therapeutic areas.

 

” Prof. Toine Rosenberg of the Dept. of Oral and Maxillofacial Surgery at UMC Utrecht, who is leading the study, said: “This is a valuable opportunity to assess promising osteoinductive granules that promote local bone formation, which could help make the delicate task of inserting dental implants easier and more successful. Success in this trial could have implications for multiple other potential applications.”

 

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

 

For further information, please contact: Kuros Biosciences AG Michael Grau Chief Financial Officer Tel +41 44 733 47 47 michael.grau@kurosbio.com Media & Investors Hans Herklots LifeSci Advisors +41 79 598 7149 hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



IT | 2018-05-15
Voluntis lance son introduction en bourse sur le marché réglementé d’Euronext à Paris

www.voluntis-finance.com/images/PDF/docs/fr/Voluntis_CP_20180515_Lancement_VF_77223.pdf



Life Science | 2018-05-14
OMNI Appoints Rick Epstein as Chief Executive Officer

RAYNHAM, Mass., May 14, 2018 /PRNewswire/ -- OMNIlife science, Inc. ("OMNI"), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, reported today that Rick Epstein has joined OMNI as CEO.  Before joining OMNI, Mr. Epstein served as President and CEO of Sonoma Orthopedic Products for 5 years. Prior to Sonoma, Rick held several executive leadership positions in prominent organizations including Baxter International and Cardinal Health.

 

"We are pleased that Rick is joining the OMNI team as our CEO and member of our Board of Directors," commented Guy Mayer, Executive Chairman of OMNI.  "Rick's experience successfully leading medical device companies through new product introductions will bring great value as we begin launching our new OMNIBotics® Active Spacer™ technology for robotically balancing the ligaments in a total knee replacement surgery."

 

"I'm looking forward to leading OMNI through an exciting growth stage as surgeons, hospitals and surgery centers begin to experience the benefits OMNI's products and services will bring to them," Mr. Epstein stated. "The recent FDA clearance of OMNI's Active Spacer along with the OMNIBotics surgical robot and OMNI's knee implants provide surgeons with the most advanced tools available for balancing soft tissue, implanting total knees and ultimately providing the best possible outcomes for their total knee patients."

 

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon's ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.


FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms "plans," "believes" or similar expressions are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management's current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI's markets, decrease in the demand for OMNI's products, delays in OMNI's product research and development cycles, decreases in the use of OMNI's principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI's current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI's current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI's sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI's products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

 

CONTACT

cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com



Life Science | 2018-05-03
Kuros Biosciences Receives European Clearance for MagnetOs Putty and Prepares for Commercial Roll-Out in the U.S. and Europe

SCHLIEREN (ZURICH), Switzerland, May 02, 2018 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX:KURN) announced today that it has received the CE Mark for MagnetOs Putty indicated for use as an osteoconductive and osteoinductive bone void filler in the skeletal system (i.e. spine, extremities, pelvis, cranium, mandible and maxilla). This market clearance allows commercialization of MagnetOs Putty in Europe, and complements the existing clearance for MagnetOs Granules, and the 510K clearance for both formulations from the U.S. Food and Drug Administration as an autograft extender in the posterolateral spine. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to autograft (patient’s own bone), the current gold standard.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “MagnetOs Putty and MagnetOs Granules have now been cleared in our main target markets. We are gearing up for the commercial roll-out later this year in the U.S. and selected geographies in Europe, as we are executing on our strategy to build a leading orthobiologics company.”

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.



Life Science | 2018-04-30
Kuros Biosciences Reports Full-Year 2017 Results

Financial highlights

  • CHF 17.0 million cash at year-end
  • CHF 16.9 million equity raise in June 2017
  • Standby equity facility established in November 2017 to increase financial flexibility

Operational highlights

  • Successful completion of merger with Xpand Biotechnology creating a leader in orthobiologics
  • FDA approvals for MagnetOs Granules & Putty
  • Prepared for U.S. launch of MagnetOs by end of June 2018
  • Clinical development of Fibrin-PTH for spinal fusion on track

SCHLIEREN (Zurich), Switzerland, April 30, 2018 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX:KURN) reported today its Full-Year 2017 Results, and the publication of its annual report.

2017 has been a transformative year for Kuros Biosciences, which successfully transitioned into a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. MagnetOs Granules and MagnetOs Putty have been cleared by the U.S. Food and Drug Administration, and the Company is gearing up for their U.S. commercial launch in 2018.

As a technology leader in synthetic and drug-based bone regeneration, Kuros is well-positioned to capture the commercial opportunity in the orthobiologics market, which is estimated to grow to more than $3 billion by 2030. Kuros intends to initially focus on spinal fusion, which represents 50% of the total orthobiologics market.

Joost de Bruijn, Chief Executive Officer, said: “During 2017 we successfully set Kuros on a new course – one that is focused on cutting-edge orthobiologics, an important commercial opportunity. Our international team has responded with verve to our ongoing commercial transition, embracing their new challenges. As a result, we are well-positioned to execute on the commercial roll-out plan for MagnetOs in the U.S. and drive forward our exciting clinical program with Fibrin-PTH in spinal fusion, which represents a huge opportunity.”

Financial position

Cash and cash equivalents (including financial assets and trade and other receivables) as per December 31, 2017, amounted to CHF 17.0 million, compared with CHF 13.0 million as per December 31, 2016. The increase is mainly due to capital increases which off-set net operating cash. In 2017, Kuros received a milestone payment of TCHF 534 (TCHF 997 in 2016) from a collaboration partner. Operating costs for 2017 amounted to CHF 16.8 million, compared with CHF 22.4 million in the previous year. Research and development expenses decreased from CHF 7.9 million in 2016 to CHF 4.5 million in 2017. General and administrative expenses decreased from CHF 17.1 million in 2016 to CHF 15.2 million in 2017.

During 2017, Kuros raised CHF 16.9 million in equity, and put a CHF 30 million equity financing facility in place to provide the Company with more financial flexibility. 

Key figures

 

2017

2016

In TCHF, IFRS

 

 

 

Revenue

 

534

1,061

Research and development

 

(4,470)

(7,909)

General and administration

 

(15,242)

(17,070)

Other income

 

2,935

2,572

Net operating costs

 

(16,777)

(22,407)

Operating income/(loss)

 

(16,243)

(21,346)

Net financial income/(loss)

 

(350)

1,069

Net income/(loss)

 

(16,484)

(19,744)

Net income/(loss) per share (in CHF)

 

(2.32)

(3.95)

Cash and cash equivalents, financial assets

And trade and other receivables

 

17,024

13,034

Outlook
In 2018, the Company aims to capitalize on the restructuring as it executes on its renewed focus on orthobiologics. This includes setting-up a U.S. commercial infrastructure to support the U.S. launch of MagnetOs, as well as the preparation of a Phase 2 clinical study for our drug-based Fibrin-PTH product candidate KUR-113 for spinal indications.

Annual report
The annual report of Kuros Biosciences is available online at
www.kuros.ch/investors/reports-presentations.html.

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

 

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

 



IT | 2018-03-28
Résultats semestriels 2017/18 ▪ 9,2% de marge d’EBITDA retraité à taux de change constants ▪ Premiers effets bénéfiques de la réorganisation industrielle au 2nd semestre 2017/18

Confirmation des objectifs du plan de développement : 250 M EUR et 10% de marge d'EBITDA à horizon 2021

Paragon ID (Euronext Paris - FR0011980077 - PID), champion européen des solutions d'identification dédiées aux marchés de l'e.ID, du Transport & Smart Cities, et de la Traçabilité & Protection des marques, publie ses comptes semestriels consolidés condensés de l'exercice 2017/18 (période du 1er juillet au 31 décembre 2017). Ces comptes ont été approuvés par le Conseil d'administration du 27 mars 2018 et ont fait l'objet d'un examen limité de la part des commissaires aux comptes.

Il est rappelé que le 1er semestre 2016/17 présente les chiffres historiques de la division Identification de Paragon Group., et à ce titre n'inclut ni les comptes de la filiale Bemrose Booth Paragon qui a rejoint la division au 1er mars 2017, ni les comptes de Paragon ID et de ses filiales qui sont intégrées au périmètre de consolidation à compter du 1er mai 2017. Le 1er semestre 2017/18 est en revanche un semestre où l'intégralité des filiales sont présentes et contributives et constitue, à ce titre, un semestre de référence.

Données consolidées au 31/12 (en M€) – Normes IFRSExamen limité

1er semestre 2017/18

1er semestre 2016/17

Chiffre d'affaires

51,6

23,8

EBITDA retraité1 à taux de change fixes2

4,7

2,3

Marge d'EBITDA retraité1 à taux de change fixes2

9,2%

9,6%

EBITDA retraité1

4,3

2,3

Marge d'EBITDA retraité1

8,3%

9,6%

Dotations aux amortissements et provisions

-2,6

-0,6

Résultat opérationnel courant

1,7

1,7

Marge opérationnelle courante

3,3%

7,2%

Autres produits et charges non courants

-1,7

-0,5

Résultat opérationnel

0,0

1,2

Résultat financier

-1,0

-0,1

Résultat net des activités poursuivies