Bone Therapeutics SA and Asahi Kasei sign exclusive license agreement for PREOB® in Japan

Gosselies, Belgium, 22 September 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation (Tokyo: 3407). The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB®, in Japan.

Under the terms of the agreement, Asahi Kasei will obtain exclusive rights to develop, register and commercialise PREOB® for the treatment of osteonecrosis of the hip with the potential for other orthopaedic and bone applications in Japan. Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of stem cells into bone-forming cells in preparation for continued clinical development by Asahi Kasei in Japan. In addition, Bone Therapeutics has also granted Asahi Kasei an option to negotiate an exclusive license for the development and commercialization of PREOB® in Korea, China and Taiwan.

Bone Therapeutics will receive an upfront payment of €1.7 million from Asahi Kasei and is eligible to receive up to €7.5 million from development and commercial milestone payments, as well as tiered royalties based on annual net sales of PREOB® in Japan.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “This agreement is an important additional validator of our innovative regenerative technology in the field of orthopaedics and bone diseases and of its global, commercial potential. With its world-class research and development capabilities, its strong network and specific knowledge of the Japanese market, we believe Asahi Kasei is the ideal partner to develop and commercialize PREOB® in Japan and bring this promising therapy to patients in Asia. We look forward to working with the team at Asahi Kasei as we bring our platform closer towards commercialisation.

Hideki Kobori, President & Representative Director of Asahi Kasei Corporation, said: “We are delighted to be collaborating with Bone Therapeutics to develop and commercialize its unique autologous cell therapy product, PREOB®, in Japan. The field of orthopaedics is a major area of focus for Asahi Kasei and we believe PREOB® has the potential to add significant value to our current pipeline and has the potential to be a first-in-class treatment for patients suffering from debilitating bone conditions, such as osteonecrosis of the hip.

About PREOB®:

PREOB® is Bone Therapeutics’ cell-based medicinal product derived from autologous (derived from the patient) bone marrow mesenchymal stem cells. The active part of the product comprises human autologous osteoblastic cells, which are specialized cells that have the ability to restore a healthy bone environment and promote bone regeneration. Local implantation of these biologically active osteoblasts at the bone defect site is intended to mimic the natural process of bone formation and repair.

Today, PREOB® is being developed as a first in-line conservative treatment for early stages of osteonecrosis of the hip. Based on the promising results from an earlier Phase IIB study, which have shown clinically and radiologically relevant benefits, PREOB® is currently being evaluated in a pivotal Phase III study in Europe in the treatment of this debilitating disease. Key interim efficacy results are expected in Q3 2018 and could lead to a premature termination of patient recruitment.

About Asahi Kasei Corporation:

Asahi Kasei, headquartered in Tokyo, Japan, is one of Japan’s leading industrial companies, with a combined revenue of €15 billion and more than 33,000 employees, and a global leader in a diverse range of markets, including pharmaceuticals, medical devices and bioprocess consumables. Through its pharmaceutical core operating company, Asahi Kasei Pharma, the group is growing as a specialty pharmaceutical firm with a global presence by focusing on the development of new world-class drugs in the fields of orthopaedics, circulatory, urology, the immune system, and the central nervous system. For more information, please visit the company’s website at www.asahi-kasei.co.jp/asahi/en/.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Integra LifeSciences Announces First Patient Enrolled in Cadence® Total Ankle System Post-Market Study

PLAINSBORO, N.J., Sept. 21, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced the first Cadence® Total Ankle System has been implanted by Dr. David Pedowitz with the Rothman Institute in Philadelphia, Pennsylvania in the Cadence Total Ankle System non-randomized, prospective, multi-center post-market study.

“While this patient represents only one of many who have already benefited from the Cadence Total Ankle System, she is the first of my patients who will be a part of this important study, documenting the unique benefits of this new system in terms of ease of use, patient satisfaction, and survivability,” said Dr. David Pedowitz.

The primary objective of the study is to evaluate 2-year implant survivorship in subjects who received the Cadence Total Ankle System for primary ankle arthroplasty. Implant survivorship will further be evaluated at 5 and 10 years post-operatively. All patients in the study will receive the Cadence Total Ankle System.

About Cadence
Cadence Total Ankle System, is a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto, Toronto, Canada), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pennsylvania), Dr. Selene Parekh (Duke University, Durham, North Carolina) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio). To date, more than 350 Cadence total ankle procedures have been successfully performed in seven countries.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique. Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedures. Key implant features include:

  • Side-specific, anatomical tibial components, designed to avoid fibular impingement.
  • Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
  • Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Integra LifeSciences Holdings Corporation

Investor Relations Contact:

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media Contact:

Laurene Isip
609-750-7984
Laurene.isip@integralife.com

Paragon 28® launches 5th metatarsal fracture specific plating system, expanding the Baby Gorilla™ Mini Plating System offering

ENGLEWOOD, Colo.Sept. 21, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The Baby Gorilla™ 5th Metatarsal Plating System includes multiple styles of hook plates as well as non-hooked compression style plates specifically designed to fit the unique anatomy and fracture patterns of the 5th Metatarsal.

The Jones Fracture Hook Plates contain sharp hooks that seat into the bone of the 5th metatarsal and are intended to be utilized for zone 1 and 2 fractures. These plates are ideal for when a revision may be necessary or as a means of additional fixation. The Jones Fracture Compression Plates are sized and contoured to match the anatomic curvature of the 5th Metatarsal and are intended to be used in zone 2 and 3 fractures. Additionally, 5th Metatarsal Fracture Hook Plates (Avulsion Plates) are available and specifically designed to capture and secure fragments for avulsion type fracture patterns.

The 5th Metatarsal Plate System includes procedure specific instrumentation including plate templates and tamps to allow for optimal plate placement and to ensure hooks are seated securely in the bone. A drill guide included in the set is designed to allow a crossing screw to pass in-between the hooks of the 5th Metatarsal Fracture Hook Plates (Avulsion Plates) while avoiding screws in the construct and allowing the screw to cross the fracture site for additional stability.

This modularity of the Baby Gorilla™ Mini Plating System allows the 5th Metatarsal Plating system to utilize the same screws and instrumentation used by all other Baby Gorilla™ plates. All plates are designed to accept both 2.0 mm and 2.5 mm locking and non-locking variable angle plate screws. Additionally, the Baby Gorilla™ system includes a robust assortment of foot and ankle specific instrumentation including curettes, reduction clamps, osteotomies, as well as small pin compression and distraction devices.

For more information, contact: Jim Edson, Director of Product Marketing and Management, jedson@paragon28.com

Website:
http://www.Paragon28.com

 

SOURCE Paragon 28

SpinalCyte, LLC Announces New Australian Patent

September 20, 2017

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the issuance of Australian Patent No. 2015202319, “Methods And Compositions For Repair of Cartilage Using An In Vivo Bioreactor.”

The technology described in the patent involves producing chondrocytes or chondrocyte-like cells using fibroblasts in vivo with mechanical stress and low oxygen tension.

“This Australian patent covers our core technology and provides the foundation for our intellectual property protection internationally. It solidifies our scientific basis and protects our technology in an extremely important market,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte.

With this addition, SpinalCyte’s portfolio now includes 24 U.S. and foreign patents issued and directly owned by the company, along with 45 patents pending.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 24 U.S. and international issued patents and has filed for an additional 45 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

SpinalCyte, LLC
Investor Contact:
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com

Relievant Medsystems Names Kevin Hykes Chief Executive Officer

SUNNYVALE, Calif., Sept. 19, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, announced today that Kevin Hykes has been appointed President and Chief Executive Officer as well as a member of the Board of Directors, effective immediately. Alex DiNello, the Company’s CEO since 2011, will remain an integral member of the management team as Chief Operating Officer.

Mr. Hykes joins Relievant from Metavention, a clinical-stage medical device company developing interventional therapies for the treatment of type 2 diabetes, where he was Chairman and CEO as well as an Operating Partner at Versant Ventures. He is remaining as Chairman of the Board of Directors at Metavention. Mr. Hykes was previously President and CEO of Cameron Health, developer of the first subcutaneous implantable defibrillator, until its acquisition by Boston Scientific in 2012. Prior to Cameron Health, he was the Chief Commercial Officer of Visiogen, Inc., a privately held ophthalmology company which was acquired by Abbott Medical Optics in 2009. Previously, Mr. Hykes spent sixteen years at Medtronic, where he held leadership positions in the Cardiac Rhythm Management (CRM), Neurological, Heart Valve, and Cardiac Surgery businesses in the U.S. and Europe.

“Kevin is a highly respected industry veteran with an exceptional track record of building and leading strong teams, rapidly growing businesses, and developing markets for groundbreaking, PMA-class devices. Kevin’s experience and track record commercializing medical technologies around the world will be a significant asset as he leads Relievant into the next phase of its growth,” said Richard Mott, Executive Board Chairman of Relievant. “On behalf of the entire Board of Directors, we thank Alex for his contributions which have created a solid foundation for the company’s future success. We look forward to his continued leadership as our Chief Operating Officer.”

“I am thrilled to join Relievant and am impressed by what the company has accomplished to date.  The results of the SMART Trial, the medical device industry’s first successful Level 1, randomized sham-controlled trial for chronic low back pain, demonstrate the significant potential for the Intracept Procedure to fill a critical gap in the treatment continuum for chronic low back pain, and to provide physicians and patients with a much-needed new solution,” said Kevin Hykes. “I look forward to working with the Relievant team to deliver on our mission to improve the quality of lives for millions of patients suffering from this disabling condition.”

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN).  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com

BONESUPPORT™ Data Presented at EORS Highlights Cerament® Bone Void Filler’s Ability to Elute Drugs With Potential to Enhance Bone Growth

20-Sep-2017

Lund, Sweden, 08.00 CEST, 20 September 2017 – BONESUPPORT an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT platform announces that a pre-clinical  study evaluating the in-vivo release kinetics of radio-labelled bone morphogenic protein (rhBMP-2) and zoledronic acid (ZA) from CERAMENT BONE VOID FILLER (BVF) was presented at the European Orthopaedic Research Society (EORS) in Munich on 15th  September. The presentation was given by Mr Deepak Raina, Department of Orthopaedics, Medical Faculty, Lund University, Sweden.

In his presentation, Mr Raina, outlined data showing that CERAMENT BVF achieved co-delivery of both rhBMP-2 and ZA in-vivo measured over a period of four weeks. After 4 weeks, CERAMENT BVF had eluted 57% of rhBMP-2 and 23% of ZA. This is an important finding since the constant availability of rhBMP-2 over a long period could give osteo-inductive properties to CERAMENT BVF while at the same time the presence of ZA locally prevents bone resorption. 

These data suggest that by using CERAMENT BVF to elute BMPs it could be possible to overcome the problems of local delivery of BMPs using currently available approaches.  

Another pre-clinical study, which demonstrated in vivo that CERAMENT loaded with a combination of rhBMP-2 and ZA in very low doses was able to quantitatively and qualitatively generate a high amount of mineralized bone volume was covered in a paper published in Nature Scientific Reports (Raina, D et al, reference below). The study showed that the mineralized volume was significantly higher when CERAMENT was combined with rhBMP-2 and ZA compared to CERAMENT in combination with just rhBMP-2.

Mr Deepak Raina, commenting on his presentation said: “The important findings that we presented at EORS suggest that by capitalizing on CERAMENT BVF’s elution characteristics it could be possible to overcome the current problems associated with the local delivery of BMP to promote bone growth. The growing body of data that our research group is generating with CERAMENT BVF provides greater confidence that this novel approach could lead to a commercially available product able to enhance bone growth.” 

Richard Davies, CEO of BONESUPPORT, commented: “We are pleased that these in vivo data on CERAMENT BVF combined with bone morphogenic protein and zoledronic acid have been presented at this prestigious scientific conference. These data provide further support to our product pipeline strategy which is focused on developing new CERAMENT products that are able to enhance bone growth.”

Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports  http://bit.ly/22xgU84

For more information contact:

Richard Davies, CEO

Tel: +46 (0) 46 286 53 71

Björn Westberg, CFO

Tel: +46 (0) 46 286 53 60

Email: ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedr.co.uk

Notes to Editors

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT®BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

Bone Therapeutics SA : Announces all Patients Meet Primary Endpoint in ALLOB® Phase I/IIA Delayed-Union Study Interim Analysis

Gosselies, Belgium, 20 September 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces positive interim efficacy results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB® in 16 patients. Based on the evaluation of these interim data post a six-month follow-up, the Data and Safety Monitoring Board (DSMB) has recommended stopping the trial early due to the strong efficacy data. These interim data, combined with recently announced results for ALLOB® in spinal fusion, establish ALLOB® as a strong product candidate, representing a significant advance in Bone Therapeutics’ pipeline and building a foundation for future value creation.

The Phase I/IIA study was a six-month open-label trial to evaluate the safety and efficacy of ALLOB® in the treatment of delayed-union fractures of long bones. 16 patients with a fracture that had failed to consolidate after a minimum of three and a maximum of seven months received a single percutaneous administration of ALLOB® directly into the fracture site and completed the six-month follow-up. Fracture healing of ALLOB®-treated patients was assessed using clinical evaluation (e.g. health status and pain) and radiological evaluation (based on CT-scan).

At six months post administration, 100% of patients met the primary endpoint, defined as an increase of at least 2 points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of the clinical Global Disease Evaluation (GDE) score.

From a radiological perspective, the patients improved by on average 4 points on the TUS score (statistically significant), twice the required increase of 2 points. This minimum 2-point increase was achieved by 13 out of 16 patients (81%).

From a clinical perspective, the health status of patients, as measured by the GDE score, improved by on average 48% (statistically significant). The minimum 25% improvement was achieved by 12 out of 16 patients (75%). Pain at the fracture site, an important secondary endpoint, was reduced by on average 59% (statistically significant).

Overall, ALLOB® was shown to be well tolerated. In one patient, a hypersensitivity reaction without any established cause was reported 4 weeks after administration, with full recovery. In the context of a clinical trial, an association with ALLOB® cannot be excluded. As previously described in the literature covering clinical studies with allogeneic mesenchymal stem cells or their derivatives, it was observed that blood samples of about half of the patients contained donor-specific antibodies, either pre-existing or developed after administration.

Following the positive recommendation of the Data and Safety Monitoring Board based on the positive efficacy results observed in this study, the Company will stop the study recruitment immediately and prepare for the next clinical phase.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “Following on from the recently reported strong results for our allogeneic product in spinal fusion, the early conclusion of this study in delayed-union fractures allows us to accelerate the development of our allogeneic platform and brings us a step closer to the commercialisation of a potentially game-changing treatment in these large and growing markets.

Miguel Forte, Chief Medical Officer of Bone Therapeutics, added: “These strong data for ALLOB® demonstrate a significant improvement in delayed-union fracture patients whose only current option is either to wait and see or to undergo painful surgery with significant disease burden and long recovery times. The fact that the DSMB has recommended stopping this study points to the safety and efficacy of ALLOB®and to its feasibility in this large and promising indication.

The strong Phase IIA interim results for the allogeneic ALLOB® study in delayed-union fractures will lead Bone Therapeutics to further develop ALLOB® in difficult fractures. Given the close relationship between the delayed-union and non-union indications, the Company is stopping the recruitment in the non-union trial with its autologous product PREOB® to focus resources in the allogeneic platform and provide optimal value for patients.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Biogennix Bone Graft Substitute Materials Used to Treat 6000th Patient

September 20, 2017

IRVINE, Calif.–(BUSINESS WIRE)–Irvine, California-based Biogennix, an osteobiologic company which develops, manufactures, and distributes proprietary bone graft substitutes used for bone fusion procedures, announced today that its products have now been used in more than 6000 patients.

The company’s novel bone graft substitutes, osteoSPAN™ and Morpheus™ are resorbable, osteoconductive scaffolds ideally suited for bone regeneration and optimal handling by surgeons. Biogennix’s composites of calcium phosphate and calcium carbonate have complete interconnected porosity and the optimal pore diameter for bone reconstruction. Available in strips, granules and moldable putty, the products are indicated for orthopedic applications including the posterolateral spine, long bone and pelvis.

“We’re proud that our osteoSPAN and Morpheus bone graft products have been so well received by the clinician and patient communities and that we’ve been able to contribute to such positive post-op outcomes for more than 6000 spine surgery patients,” said Dr. Edwin Shors, President of Biogennix. “It’s come to the point where we receive positive feedback from surgeons on a regular basis. We firmly believe that our products are fast becoming the new standard of effectiveness and ease of use when it comes to bone graft substitutes.”

The osteoSPAN bone graft substitute is available in either granular form (1-4mm) or in blocks, called “Fusion Kits.” The granules and blocks serve as bone graft substitutes and they are mixable with autograft for use as a bone graft extender in the posterolateral spine. Handling characteristics favored by surgeons include the product’s compressive strength, wettability, and easy integration with autogenous bone.

Morpheus is a moldable variation of the original osteoSPAN product. The 1-2mm osteoSPAN granules are combined with an organic binder which provides improved intraoperative handling and is packaged in a syringe-like dispenser to facilitate placement and containment of the implant. The binder dissolves quickly, and does not interfere with the osteoconductive properties of the granules. The granules are gradually resorbed and remodeled by bone over the next 6-12 months.

Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration. Biogennix designs, manufactures and distributes all of its products from its Irvine facilities.

Biogennix is a fully-integrated osteobiologic company headquartered in Irvine which develops, manufactures, and distributes proprietary bone graft substitutes used in bone fusion procedures. Learn more at biogennix.com.

Contacts

For Biogennix
Paul Williams, 310-569-0023
paul@medialinecommunications.com

Spine Surgeon in Thailand Successfully Completes First International Mazor Robotics PROlat™ Case

ORLANDO, Fla. – September 18, 2017 – Mazor Robotics, a pioneer and leader in the field of surgical guidance systems, announced that the first international PROlat case was performed by Assoc. Prof. Wicharn Yingsakmongkol, MD in Bangkok, Thailand. PROlat is a single-position solution for placing pedicle screws and other spinal hardware in the lateral decubitus position with the Renaissance® Guidance System.

“Lateral approaches have been gaining acceptance in Asia, as we have an aging population that benefits highly from minimally invasive procedures,” said Prof. Yingsakmongkol.  “I perform a high volume of lateral procedures each year, so the PROlat application was something that made a lot of sense to me as a way to enjoy the benefits of the Renaissance technology while the patient remains in a single lateral position.  We were able to save 30-40 minutes by not flipping the patient, which is less time for the patient to be under anesthesia, and less cost for the hospital.”

Mazor also recently fulfilled orders for the PROlat application in Spain and Australia and continues to see a lot of interest for this procedural solution in the international markets.

 

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Mazor Robotics Announces CE Mark Approval for the Mazor X Surgical Assurance Platform

September 20, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, announced today CE Mark approval for its Mazor X Surgical Assurance Platform. The CE Mark allows Mazor and its commercial partner, Medtronic, to market the Mazor X in the European Union, as well as other countries that recognize the CE Mark.

“Receipt of the CE Mark is an important step in our plan to expand the patient, surgeon and hospital benefits of the Mazor X Surgical Assurance Platform to the European market,” said Ori Hadomi, Mazor’s Chief Executive Officer. “Our commercial partner for the Mazor X, Medtronic, will be responsible for marketing and selling the system in Europe and we look forward to working with them to ensure a successful launch.”

The Mazor X will be displayed in Medtronic’s booth (F10) at EUROSPINE, which is being held from October 11-13, 2017 in Dublin, Ireland.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of CE Mark approval, statements regarding the marketing and selling of the system in Europe, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

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