Orthobiologics Market Worth 6.06 Billion USD by 2022

PUNE, IndiaSeptember 27, 2017 /PRNewswire/ —

According to a new market research report Orthobiologics Market by Product (Viscosupplementation, Synthetic Orthobiologics, DBM, BMP, PRP, BMAC, Allograft), Application (Fracture Recovery, Osteoarthritis, Spinal Fusion, Soft Tissue), End User (Hospitals, ASCs, Academia) – Global Forecast to 2022, published by MarketsandMarkets™, the market is projected to reach USD 6.06 Billion by 2022 from USD 4.66 Billion in 2017, at a CAGR of 5.4% during the forecast period.

Browse 60 Market Data Tables and 38 Figures spread through 159 Pages and in-depth TOC on “Orthobiologics Market

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The report analyzes and studies the major drivers, restraints, opportunities, and challenges of the Orthobiologics Market in North AmericaEuropeAsia Pacific, and the Rest of the World (RoW). Factors such as rising burden of orthopedic injuries; increasing incidence of sports injuries and road accidents; increasing incidence of spinal fusion surgeries; risk factors associated with increasing aging population, obesity rate, & high incidence of musculoskeletal disorders; and growing patient preference for minimally invasive procedures are driving the Orthobiologics Market. However, high cost pertaining to orthobiologics based treatment is the major factor restraining the market growth to a certain extent.

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Based on product, the viscosupplementation products segment is estimated account for the largest segment of the market in 2017

On the basis of product, the Orthobiologics Market is segmented into allografts, synthetic orthobiologics, plasma-rich protein (PRP), bone marrow aspirate concentrate (BMAC), demineralized bone matrices (DBM), bone morphogenic protein (BMP), and viscosupplementation products. The viscosupplementation products segment is expected to account for largest share of the Orthobiologics Market in 2017. The large share of this segment can be attributed to the increasing incidence of osteoarthritis of the knee and hip joints among the baby boomer population and lower cost of viscosupplementations.

Based on application, the osteoarthritis and degenerative arthritis segment expected to account for the largest share of the market in 2017

Based on application, the Orthobiologics Market is segmented into fracture recovery, osteoarthritis & degenerative arthritis, spinal fusion, soft tissue injuries, and maxillofacial & dental applications. The osteoarthritis and degenerative arthritis segment is estimated to command the largest share of the global Orthobiologics Market in 2017. The large share of this segment is mainly due to factors such as the significant rise in target patient population across major markets, rising public awareness related to clinical side effects associated with oral medications for pain management, clinical advancements in OA management methodologies, robust healthcare infrastructure & facilities for specific joint replacement surgeries across major markets, and growing clinical evidence validating the efficacy of biologics in OA treatment.

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In 2017, North America is expected to account for the largest share of the Orthobiologics Market

Geographically, the Orthobiologics Market is segmented into North AmericaEuropeAsia Pacific, and the Rest of the World. North America is expected to account for the largest share of the global Orthobiologics Market in 2017. The growth of this region is attributed to rising incidence of orthopedic and spinal disorders; increasing geriatric population coupled with obesity; growing population exposure to key risk factors; rising number of spinal fusion surgeries and rising patient preference for minimally invasive orthopedic therapies over invasive grafting procedures; and growing physician and patient awareness about the newly introduced treatment procedures and technologies.

The major players in the market are DePuy Synthes, Medtronic, Stryker, Zimmer Biomet, Harvest Technologies, Globus Medical, Orthofix International, RTI Surgical, K2M Group, Kuros Biosciences, Bioventus, NuVasive, SeaSpine, Arthrex, and Xtant Medical.

Browse Related Reports:

Bone Growth Stimulator Market by Product (Device, Bone Morphogenetic Protein, PRP), Application (Spinal Fusion, Delay Union & Non-union Bone Fracture, Oral-maxillofacial), End User (Hospitals, Home Care, Academia, CROs) – Global Forecasts to 2022

http://www.marketsandmarkets.com/Market-Reports/bone-growth-stimulator-market-82341383.html

Spine Biologics Market by Product Type (Bone Graft, Bone Graft Substitute, Platelet Rich Plasma, BMAC), Surgery Type (Anterior Cervical Discectomy and Fusion, Posterior Lumbar Interbody Fusion), End User, and Geography-Global Forecast to 2020

http://www.marketsandmarkets.com/Market-Reports/spine-biologics-market-67680943.html

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LifeLink Tissue Bank Announces New Taiwan Distribution Partnership

Tampa, FL – (September 23, 2017) – LifeLink Tissue Bank, a division of LifeLink Foundation, Inc. headquartered in Tampa, FL, announced a new partnership with Taiwan-based HCT Regenerative, in which LifeLink will provide allografts for patients suffering from sports, orthopedic and/or spine injuries.

HCT Regenerative was established in July 2016, and is the first company in Taiwan to focus on processing human tissue to produce regenerative biomaterials for clinical use. LifeLink will procure and provide to HCT certain bone and tissue for HCT’s use in its operations, while both parties will collaborate to assist HCT in the growth and development of its operations.

Jean Davis, President and CEO of LifeLink Foundation, Inc. said, “LifeLink is pleased to work with HCT Regenerative, which will provide tissue for reconstructive procedures to save and heal lives, and increase donation opportunities for donors and their families. This is a great opportunity for LifeLink to make an impact in Taiwan and across Asia.”

James Tsai, Ph.D., HCT cofounder and Managing Director, said, “It is a great honor to partner with LifeLink Foundation.  Together we are dedicated to providing high quality allografts to improve patients’ quality of life in the Asia-Pacific region.”

About LifeLink:

LifeLink Foundation, an independent, non-profit community service organization is dedicated to the recovery and transplantation of organs and tissue.  The Foundation is made up of five divisions:  LifeLink Tissue Bank, which recovers and processes tissue for patients in need, LifeLink of Florida, LifeLink of Georgia, and LifeLink of Puerto Rico, three federally-certified organ procurement organizations; and LifeLink Transplantation Immunology Laboratory, which supports 15 organ-specific transplant programs.  Additionally, the LifeLink Legacy Fund supports the LifeLink Foundation mission through transplant patient assistance, research and programmatic grants to improve organ and tissue donation, and transplantation. Learn more about LifeLink Foundation at www.LifeLinkFoundation.org, or LifeLink Tissue Bank at www.LifeLinkTB.org.

About HCT Regenerative:

HCT Regenerative is devoted to developing advanced human cellular and tissue based products (HCT/Ps) to improve patients’ quality of life.  The company aims to cultivate relationships with American tissue banks as well as hospitals and medical device companies in Taiwan to help achieve the goals.  Additionally, HCT Regenerative will develop and manufacture high quality tissue allografts for surgeons throughout the Taiwanese market to benefit patients in need. For more information visit www.HCTRegenerative.com.

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.

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

Bone Solutions Inc. Launches OsteoCrete® Magnesium-Based Bone Void Filler

Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, TX, announces the launch of its magnesium-based orthopedic medical device, OsteoCrete®. OsteoCrete® bone void filler is designed to assist with bone repair and generation, and it’s the first in the U.S. to incorporate magnesium, a critical property for bone health and development.

“We’re excited to bring this important orthopedic technological advancement to the market,” says BSI president and CEO, Drew Diaz. “OsteoCrete® provides surgeons a much-needed option currently not available, as it’s the only bone-repair product made with magnesium.”

“Many modern devices used for bone repair or replacement are calcium-based and do not exhibit a combination of compressive strength and expandability necessary for optimal binding quality,” Diaz stated. OsteoCrete® is also resorbable, or capable of being assimilated back into the body, as it is replaced with bone as the patient heals. OsteoCrete® is also injectable, moldable, and biocompatible.

Magnesium contains high specific strength and an elastic modulus that closely resembles human bone. Most of the magnesium in the body (60%) is stored in bone and helps to preserve and develop bone structure by working with Vitamin D and calcium. Its effectiveness was a key component of BSI’s approach to developing its OsteoCrete® technology.

The FDA has cleared this orthopedic platform technology for use in bone-related surgical procedures ranging from complex sport-related injuries to all musculoskeletal extremities trauma cases.

“We’ve been fortunate to have surgeons test OsteoCrete® in various studies, and they were impressed about its positive effects and performance. It’s an incredible development for both patients and surgeons,” Diaz stated.

OsteoCrete® is currently being distributed to clinics and surgical centers around the country for immediate use.

About Bone Solutions Inc. 
Bone Solutions Inc. (‘BSI’) (http://www.bonesolutionsinc.com) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.

Media Contact:
Bone Solutions Inc.:
Drew Diaz
President/CEO
817-809-8850
diaz(at)bonesolutions.net

Organogenesis Names New Chief Commercial Officer and Chief Operating Officer

CANTON, Mass.Sept. 19, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine with a portfolio of advanced and next-generation bioactive and acellular biomaterials products in the advanced wound care and surgical biologics markets, has elevated two industry veterans and longtime company employees, Brian Grow and Patrick Bilbo, to Chief Commercial Officer and Chief Operating Officer, respectively.

“Both Patrick and Brian have shown tremendous leadership at Organogenesis over the years, and we are proud to welcome them to these key positions,” said Gary S. Gillheeney, Sr., President and CEO of Organogenesis.  “Both gentlemen bring decades of combined experience in regenerative medicine and advanced wound care, and have contributed greatly to Organogenesis’ success. Their guidance and expertise will help us as we expand into new markets.”

As Chief Commercial Officer, Grow will oversee Sales and Marketing for the company, leading the wound care sales forces, as well as the planned expansion of Organogenesis’ product portfolio into the burn and surgical markets.  Grow previously served as Director of Commercial Operations for Organogenesis and has been with the company since 2004.

Mr. Grow has more than 15 years of experience in the regenerative medicine, tissue-engineering and advanced wound care markets.  A founding member of the original Apligraf sales team in 2000, Grow has since held various leadership positions with the company in sales, sales management and marketing, and was instrumental in the launch of the PuraPly™ and PuraPly™ Antimicrobial product lines.  PuraPly Antimicrobial was recently named one of the “Top 10 Innovations in Podiatry” by Podiatry Today for the product’s impact on reducing bioburden in wounds.

“I’m honored to lead this dynamic and talented commercial team, and look forward to helping the company expand in the years ahead,” said Grow. “And now with the recent acquisition of NuTech Medical, we’re more excited than ever to be launching what we believe is the world’s most robust skin substitute portfolio.”

As Chief Operating Officer, Mr. Bilbo will oversee daily operations and execution of business strategy across departments, including the expansion of Organogenesis’ leading product portfolio and manufacturing operations to support the company’s planned growth. Bilbo previously served as Senior Vice President of Regulatory Affairs, Government Relations and Administration for Organogenesis, and has been with the company in a wide variety of roles for more than 20 years.

During his time at Organogenesis, Bilbo has focused on successfully overcoming the unique challenges of developing living cell-based and novel collagen biomaterial products for large scale commercialization and patient use.

Mr. Bilbo has extensive experience in the medical products industry, with a broad range of expertise in the commercialization of transformational devices, combination products and regenerative medicine therapies. Early in the company’s founding days, Bilbo worked on the Organogenesis research and product development team that developed the pioneering product Apligraf®, a cell-based product with approximately one million patient applications to date. He then advanced in various leadership positions in the company, including product development, clinical research, regulatory affairs and government relations. Bilbo led the successful development of the company’s novel PuraPly and PuraPly Antimicrobial product lines.

“This is an exciting time – both for Organogenesis and for the future of advanced wound care and regenerative medicine,” said Bilbo. “I’m thrilled to serve in this expanded capacity and look forward to helping the company capitalize on our leading cell, biomaterial and allograft therapies, as well as expanding our regenerative wound healing and surgical product portfolio to serve clinicians and patients with unmet medical needs.”

Already this year, the company acquired NuTech Medical and launched the company’s amniotic wound care line and its new surgical division.  Earlier in 2017, the company also announced that it had secured approximately $45 million in additional financing for the expansion of its commercial operations and product portfolio.

About Organogenesis
Originally founded as a spin-off from technology developed at MIT in 1985, Massachusetts-based Organogenesis Inc. offers a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

MiMedx To Host Shareholder Call On September 21, 2017 To Update Progress On Various Strategic Initiatives And Respond To Topics Requested By Shareholders

MARIETTA, Ga.Sept. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today it will be hosting a webcast on Thursday, September 21, 2017 beginning at 10:30 a.m. Eastern Time to discuss numerous strategic initiatives and provide in-depth information on other key topics requested by shareholders.

The Company reported that “Pete” Petit, Chairman and CEO; Bill Taylor, President and COO; Chris Cashman, EVP and Chief Commercialization Officer; and Debbie Dean, Executive Vice President, will be presenting during the September 21st call.

The Company expects the planned presentation to last approximately 45 minutes. After the planned presentation, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentation include:

  • Short Selling Matters and Proactive Remedies
  • Patent and Intellectual Property Matters
  • IND and BLA Clinical Studies
  • Biopharma Market Valuations and Revenue Opportunities
  • Additional Revenue Opportunity from VLU Clinical Study

A listen-only simulcast of this MiMedx shareholder call and presentation slides will be available on-line at the Company’s website at www.mimedx.com beginning at 10:30 a.m. eastern timeSeptember 21, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company’s website at www.mimedx.com.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

 

SOURCE MiMedx Group, Inc.

MiMedx Files With The FDA To Initiate The Company’s Investigational New Drug Phase 2 Clinical Trial For Osteoarthritis Of The Knee

MARIETTA, Ga.Sept. 19, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 2 clinical trial for osteoarthritis of the knee.

The osteoarthritis clinical trial will study MiMedx’s AmnioFix® Injectable in a Phase 2, prospective, double-blinded, randomized controlled trial of the micronized dehydrated human amnion/chorion membrane (dHACM) injection as compared to saline placebo injection in the treatment of knee osteoarthritis. The Company expects patient enrollment to commence by the end of the year.

The trial will enroll approximately 318 study patients with a diagnosis of knee osteoarthritis defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. The IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of knee osteoarthritic pain.

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90, expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group. The Western Ontario and McMaster Universities (WOMAC) scores will be one of the study’s secondary endpoints measured at 30, 60, 90 and 180 days.

Osteoarthritis of the knee is an extremely common occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. There are 14 million individuals in the U.S. who have symptomatic knee osteoarthritis and there were 7.8 million knee joint pain injections in the U.S. in 2015.  Common medical treatment options include injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); and surgery, such as knee arthroscopy and knee replacement. Randomized trials have shown that corticosteroid injections may present short-term relief to patients with the condition, but unfortunately, the condition tends to recur, and complications may occur, such as systemic hyperglycemia, septic arthritis, and joint degradation.  Clinicians generally agree that a lifetime limit of 2-3 corticosteroid injections is appropriate in unresponsive patients.

HA injections may provide temporary symptomatic relief and are widely used. However, their use is not without controversy and is currently not recommended by the American Academy of Orthopedic Surgeons in their treatment guidelines.  PRP preparations have been popularly deployed in the treatment of knee osteoarthritis. However, concerns exist regarding this modality, since various methods of producing the material have differing bioactivity, and there is some debate in the literature about whether or not PRP is universally effective.

Bill Taylor, President and COO, stated, “With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option. We believe our PURION® Processed AmnioFix® Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation.”

The osteoarthritis study will be the fourth IND trial for MiMedx AmnioFix Injectable. The other three IND trials include the Plantar Fasciitis Phase 2B, Plantar Fasciitis Phase 3, and Achilles Tendonitis Phase 3 trials.  MiMedx also plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company’s Plantar Fasciitis Phase 3 trial completes.

Over 80 clinical studies documenting the efficacy and effectiveness of MiMedx allografts have been published to date. The Company’s robust compendium of current clinical activity includes 28 ongoing clinical studies in various stages of development and execution, 123 clinical sites under management, and 175 physicians currently contracted for research activities. This vigorous agenda of clinical activities encompasses over 450 legal agreements and contracts for study involvement.

Parker H. “Pete” Petit, CEO, said, “There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion.  We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company.  At that point, I did not think our level of expertise and accomplishments to date were fully appreciated.  However, having two ongoing phase 3 trials and one phase 2 trial at a large number of centers will be quite an accomplishment.  We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization (CRO).  We expect to continue to build our staff as our demands increase.  Along those lines, we will shortly announce additional very experienced biopharma executives to our staff.  They will help continue our rapid development of the opportunities we have with our placenta based technology.”

“We are anxious to commence the Phase 2 clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities,” added Taylor.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts.   MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee and expectations that study results will be compelling.  These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals.  For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

 

SOURCE MiMedx Group, Inc.