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InVivo Therapeutics Announces Joint Research Collaboration with Q Therapeutics, Inc.

Posted On October 2, 2018 By OrthoSpineNews In Biologics /  

October 02, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries (SCIs), today announced that it has entered into a joint research agreement with Q Therapeutics, Inc., a privately held developer of clinical-stage cell therapies for central nervous system (CNS) disease and injury.

The research collaboration is focused on the evaluation of the combination of InVivo’s proprietary PLGA-PLL based Neuro-Spinal Scaffold with Q Therapeutics’ adult neural progenitor cells, including those from induced pluripotent stem cells (iPSCs). The two companies will share their respective technologies to explore the potential pre-clinical safety, feasibility and synergistic properties of the combined technologies for applications in the CNS.

Richard Toselli, M.D., InVivo’s President and Chief Executive Officer, said, “We are excited about our research collaboration with Q Therapeutics, a leading developer of adult neural progenitor cell therapies to treat debilitating CNS disease and injury. Although InVivo remains very focused on and optimistic about the potential clinical benefit of the Neuro-Spinal Scaffold as a stand-alone technology, we believe this scientific partnership will allow both parties the opportunity to evaluate in parallel whether there is also a potential additive preclinical benefit of the combined technologies.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA.

About Q Therapeutics, Inc.

Q Therapeutics is a clinical-stage company developing adult neural progenitor cell therapies to treat debilitating CNS disease and injury. The Company has patented processes to derive and manufacture neural progenitor cells from any tissue source, including iPSCs. Its first therapeutic product candidate, Q-Cells® (glial-restricted progenitor cells), is intended to restore or preserve normal CNS activity by supplying essential nerve cell functions. Q-Cells may be suitable to treat a range of CNS disorders, including demyelinating conditions such as multiple sclerosis (MS), transverse myelitis (TM), cerebral palsy and stroke, as well as neurodegenerative diseases and injuries such as amyotrophic lateral sclerosis (ALS), spinal cord injury, traumatic brain injury, and Alzheimer’s disease. Q Therapeutics has obtained Investigational New Drug (IND) clearance from the FDA for Phase 1/2a trials in both ALS and TM for Q-Cells. In addition, the FDA has granted Q-Cells orphan drug status in both ALS and TM as well as fast track designation in ALS. For more information, see www.qthera.com.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
ir@invivotherapeutics.com

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Kuros Biosciences Appoints Strategic Advisory Board

Posted On September 25, 2018 By OrthoSpineNews In Biologics, Spine /  

SCHLIEREN (ZURICH), Switzerland, Sept. 25, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the formation of its Strategic Advisory Board (SAB). The newly-formed SAB will work closely with Kuros’ leadership team to guide the strategic direction of the company. The SAB is assembled from key-opinion-leading surgeons and academic research experts, specialized in the treatment of disorders of the Spine. The board will sit for the first time in Los Angeles, USA on September 27, 2018, to coincide with the North American Spine Society annual meeting, at which Kuros Biosciences is presenting new scientific data in support of the Company’s bone graft product, MagnetOs, which was recently launched to market.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are pleased to welcome some of the most recognized names in the field of spinal research onto our Strategic Advisory Board. Our SAB will provide the necessary input to ensure that we match our strategy to the needs of the market and continue to build value for the future.”

Strategic Advisory Board Members:

R. Todd Allen, MD, PhD – UCSD, San Diego, CA, US
Richard (Todd) Allen, MD, is board-certified orthopedic surgeon with expertise in complex adult reconstruction procedures for deformity/scoliosis and tumors. He also specializes in complex disorders of the upper cervical spine and in degenerative, traumatic, and post-traumatic conditions.  Dr. Allen utilizes both a variety of minimally invasive and open surgical procedures for these conditions, focused on optimizing patient-centered outcomes.  As an associate professor in the Department of Orthopedic Surgery, Dr. Allen is active in educating medical students, residents and fellows at UC San Diego School of Medicine.  He is Spine Fellowship Director at UC San Diego and actively performs research on spinal deformity, biologics, disc replacement, and cost-effective/quality metrics in spine.  He has been lead or contributing author to numerous peer-reviewed research publications and book chapters. He has presented nationally and internationally, including such meetings as our North American Spine Society (NASS) and American Academy of Orthopedic Surgeons (AAOS) meetings.  He is part of the NASS Basic Science and Biologics Committee and continues to be highly active in several national committees advancing spine surgery research and outcomes.

Alpesh A. Patel, MD, FACS – North Western Medicine, Chicago, IL, US
Alpesh A. Patel, MD is the Director of Orthopedic Spine Surgery at Northwestern and a spine surgeon with fellowship training in both Orthopedic Spine Surgery and Neurosurgery. Dr. Patel specializes in cervical spine surgery and minimally invasive spine surgery. His experience and research include the areas of cervical spine surgery, cervical myelopathy, herniated discs, minimally invasive surgery, spine trauma and spinal cord injuries. Dr. Patel is known for his clinical research on patient outcomes, genetics of spinal disease, and injuries of the spine and spinal cord. He is also known for his research in cost-effectiveness and value in spine care, making spine surgery at Northwestern, as well as throughout the United States and the world, safer and more effective.

Kornelis Poelstra, MD, PhD – Sacred Heart Hospital, FL, US
Kornelis Poelstra is board certified in orthopedic spine surgery. He specializes primarily in long-construct minimally invasive spine surgeries, adult spinal deformity, oncologic conditions, spinal fracture treatment and cervical disc replacements. He is one of the world leaders in Robotic Spine Surgery and has performed more than 600 complex robotic cases thus far. He has an extensive research background in implant associated wound infections, novel material sciences for both spine- as well as orthopedic implant designs and worked on stem cell implantation for spinal cord injury. The mechanical- and cellular processes salient for the formation of a stable arthrodesis and implant incorporation into the human body are of specific interest to him. He founded the Spine Center of Excellence at Sacred Heart Hospital in North-West Florida and has been directing this Institution since its inception.

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

Faheem Sandhu, MD, PhD – MedStar Health, Chevy Chase, MD, US
Faheem Sandhu, MD, PhD, is director of Spine Surgery at MedStar Georgetown University Hospital and professor of Neurological Surgery at Georgetown University Medical Center. He specializes in minimally invasive and complex spinal surgery. Dr. Sandhu is an innovator in the field and holds several patents. His practice includes all areas of spine conditions: degenerative, deformity, tumor, and trauma. He has special interest in minimally invasive spine surgery and applying these techniques to all aspects of spinal surgery as well as disc arthroplasty and disorders of the craniocervical junction. Dr. Sandhu has authored more than 50 peer-reviewed articles and book chapters and has presented his research at major meetings in the U.S. and abroad. He regularly teaches courses on techniques of minimally invasive spine surgery. He is a Diplomate of the American Board of Neurological Surgeons and a Fellow of the American Association of Neurological Surgeons.

Prof. Bill Walsh PhD – UNSW, Sydney, Australia 
W.R. Walsh, Ph.D. is a Professor in the Prince of Wales Clinical School, Division of Surgery at University of New South Wales in Sydney, Australia, and Director of Surgical & Orthopaedic Research Laboratories, Prince of Wales Hospital. His research lies at the interface between implanted materials, including autograft, allograft and synthetic biomaterials, and the connective tissues of the body. The foundation of his research interests center on understanding the biology and biomechanics of connective tissues during healing, age and disease; this involves research techniques from the macro to molecular level. Bill has over 385 peer reviewed journal publications, book chapters and patents. He is on several editorial boards including Biomaterials, CORR, Muscle Tendon Ligament Journal, Journal of Biomechanics, The Spine Journal and Frontiers in Surgery and Bone and Joint Research.

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

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

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

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

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Reinvent Biologics Appoints David Drez, MD as a Chief Medical Officer

Posted On September 25, 2018 By OrthoSpineNews In Biologics /  

September 25, 2018

FORT WORTH, Texas–(BUSINESS WIRE)–Fort Worth-based Reinvent Biologics announced the appointment of David Drez Jr., MD as Chief Medical Officer.

As Chief Medical Officer, Drez will provide strategic leadership on all of Reinvent Biologics medical education and research activities. He will research and track current clinical trends and provide training and support to medical professionals to optimize patient outcomes with Reinvent Biologics products. He will also serve as a resource on Reinvent’s sales efforts.

With a career spanning more than 42 years, Dr. Drez is one of the nation’s leading experts in orthopedics and sports medicine. The co-author of the highly acclaimed Orthopedic Sports Medicine and co-editor of Operative Techniques in Sports Medicine, Drez was the 2017 recipient of the Jack Weakley Award of Distinction from the National Athletic Trainer’s Association for a lifetime of outstanding contributions directly impacting health care in the area of athletics, athletic training, or sports medicine. Drez served as a team physician at McNeese State University for 37 years and was inducted into the University’s Hall of Fame. The rehabilitation area of the University’s Sports Medicine Center was named in his honor.

“Dr. Drez has spent his career sharing his knowledge and experience with future generations of physicians. He is a man of great character with a passion to teach,” said Bryant Gaines, CEO of Reinvent Biologics. “Throughout his distinguished career, he has elevated the standard of care provided to the patient. With such a great amount of research coming out on regenerative medicine, Dr. Drez will put us in a position to digest the data and effectively disseminate the knowledge to our distributors and customers.”

Drez earned his undergraduate and medical degrees from Tulane University. He completed a residency in general surgery and in orthopedic surgery at Charity Hospital in New Orleans – Tulane Service. He has published a large body of peer-reviewed research that has focused primarily on athletic injuries and their prevention and treatment options, particularly injuries of the knee and shoulder. He served as a Clinical Professor of Orthopaedics at Louisiana State University School of Medicine in New Orleans and a Clinical Assistant Professor of Orthopaedic Surgery at Baylor College of Medicine in Houston.

“Working with Reinvent Biologics will give me the opportunity to connect orthopedic medicine and regenerative medicine,” said Drez. “It’s the right time to increase awareness of the true benefits of regenerative medicine.”

About Reinvent Biologics

Fort Worth-based Reinvent Biologics, LLC discovers, invents, develops, manufactures, and commercializes new and innovative products in the field of regenerative medicine. Our goal is to address serious medical conditions, across multiple and diverse therapeutic areas. We are focused on providing physicians cost effective treatment options while improving the standard of care through a complete offering of science based biologic solutions. Learn more at www.reinventbiologics.com.

Contacts

Reinvent Biologics
Joe Moore, 817-736-1557

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Artoss, Inc. Announces Hiring of William “Billy” Lapp as Director of Sales, East Coast

Posted On September 24, 2018 By OrthoSpineNews In Biologics /  

September 24, 2018

Artoss, Inc. is pleased to announce the hiring of William “Billy” Lapp as Director of Sales, East Coast. In this role, Billy will be responsible for growing the sales of NanoBone® Bone Graft in the region from Maine to South Carolina and west to Ohio and for identifying, training, and managing independent distributors in that region.

Paul Byerley, Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, said, “Billy has built a very successful sales career with small companies in the biotech industry and more recently in orthobiologics and tissue regeneration. He is uniquely trained to articulate the key advantages of NanoBone to orthopaedic and neurosurgeons. He has earned the respect of distributor partners and I know he’ll contribute to the continued growth of NanoBone sales in the US.”

“I’m excited to be joining Artoss as this stage in its development and look forward to expanding sales of NanoBone Bone Graft along the east coast.” said Billy. “It has been my dream to help build a great company delivering products that improve patients’ lives.”

NanoBone Bone Graft products have been used in Europe and the US for more than ten years in more than 100,000 clinical cases across all indications. They have been available in the United States through Artoss, Inc. since 2015.

For further information, please contact:

Artoss, Inc.

425 E Saint Germain St., Suite 106

Saint Cloud, MN 56304

320-259-4321

info@artossinc.com

 

 

 

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NuVasive Expands Biologics Portfolio To Meet Clinical And Economic Needs

Posted On September 24, 2018 By OrthoSpineNews In Biologics /  

SAN DIEGO, Sept. 24, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ :NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. commercial launch of three new biologics offerings to include traditional bone allograft, amniotic membrane DS and additional form factors to the current PropelTM DBM product line. This portfolio expansion demonstrates the Company’s strategic efforts to deliver the most differentiated biologics portfolio in the spine industry.

NuVasive’s newest biologic product lines help promote enhanced clinical outcomes for patients, improved economic outcomes for hospital systems, as well as meet the variety of handling preferences of spine surgeons:

  • Traditional Bone Allograft includes cancellous chips, demineralized cancellous chips, cortical cancellous chips and cancellous crushed, which all function as economical bone graft options. Traditional Bone Allograft has osteoconductive properties that provide a scaffold for bone growth, and can be packed into bony voids or gaps in a patient’s skeletal system. This product is available in a variety of grind sizes and volumes.
  • Amniotic Membrane DS is a double-sided layer of human amniotic membrane intended to be a biologic barrier that may help prevent adhesions and reduce scar tissue formation near adjacent muscle, nerve and fascia layer tissue. The strong, pliable properties of this biologic help it adapt to the surrounding anatomy making it easy to handle and position into place. Amniotic Membrane DS is naturally rich in growth factors and has been shown to control inflammation and reduce bacterial and viral activity at the surgical site, supporting the patient’s overall healing process.
  • Propel DBM product line, launched in 2017, now introduces gel, gel plus and putty plus as additional form factors with enhanced handling properties to address surgeon preferences. The gel form factor is packaged in a syringe for convenient graft delivery, while Propel DBM putty plus and gel plus contain cancellous chips for additional osteoconductive properties helping promote bone growth. With a variety of DBM form factors available, surgeons can tailor the graft selection to the clinical needs of the patient.

“The addition of these three new product lines strengthens our comprehensive spine portfolio and further positions NuVasive as a full-service provider of biologics,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “NuVasive is committed to investing in innovative offerings to meet the clinical and economic needs of our patients, surgeons and hospital partners.”

About NuVasive
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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SpinalCyte to Feature Fibroblast-Based Cell Therapy Results at the 2018 North American Spine Society Annual Meeting

Posted On September 24, 2018 By OrthoSpineNews In Biologics /  

HOUSTON, Sept. 24, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of spinal discs using Human Dermal Fibroblasts, today announced it will be showcasing its fibroblast-based cell therapy product CybroCell at the North American Spine Society (NASS) 2018 Annual Meeting Sept. 26 – 29 in Los Angeles.

The company recently published data in The Spine Journal that suggest fibroblast cell therapies can prevent the degeneration and promote the regeneration of spinal discs. This publication is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/. The transplantation of dermal fibroblasts was found to significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged.

“The data we’re sharing at NASS demonstrate that CybroCell has the potential to fundamentally change the way back pain is treated,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “With our strong intellectual property position and ongoing Phase 1/Phase 2 trials, SpinalCyte has the potential to relieve pain and improve function for millions who currently have no viable treatment options.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact: 
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Related Links

http://www.spinalcyte.com

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MiMedx Provides Update on Previously Announced Senior Executive Separations

Posted On September 24, 2018 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., Sept. 20, 2018 /PRNewswire/ — The Board of Directors (the “Board”) of MiMedx Group, Inc. (Nasdaq :MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has determined that the previously announced separations of four senior MiMedx executives – Parker H. Petit, William C. Taylor, Michael J. Senken, and John E. Cranston (collectively, the “Separated Employees”) – be treated as terminations “for cause”. The Compensation Committee separately reached this determination as well.  These determinations are based on information identified as part of the Audit Committee’s ongoing independent investigation.

Mr. Petit is the Company’s former Chairman and Chief Executive Officer; Mr. Taylor is the Company’s former President and Chief Operating Officer and a former member of the Board; Mr. Senken is the Company’s former Chief Financial Officer and principal accounting officer; and Mr. Cranston is the Company’s former Vice President, Corporate Controller and Treasurer. Messrs. Petit and Taylor resigned as officers of the Company effective June 30, 2018, and Messrs. Senken and Cranston stepped down from their positions on June 6, 2018.  Mr. Taylor resigned from the Board effective June 30, 2018.

As a result of findings related to the conduct of the Separated Employees, the Board and the Compensation Committee, as the administrators of the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (the “2006 Plan”) and the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (together with the 2006 Plan, the “Plans”), have taken all required action to cause all equity and incentive awards outstanding under the Plans held by the Separated Employees to be forfeited.  The Board and Compensation Committee action was based on findings that the Separated Employees engaged in, among other things, conduct detrimental to the business or reputation of the Company.

In addition, the Board and the Compensation Committee have determined that action shall be taken to recover compensation previously paid to the Separated Employees pursuant to the Plans and the Company’s Compensation Recoupment Policy, based upon the final results of the Company’s restatement of its previously issued consolidated financial statements and financial information.

Additionally, the Board announced that Mr. Petit has resigned as a member of the MiMedx Board, effective immediately.

“The Board is taking the necessary steps to prepare MiMedx for its next chapter and a stronger future,” said Charles R. Evans, Chairman of the Board. “The Board is committed to taking the decisive actions necessary to develop enhanced systems and controls. Meanwhile, the Board and management team remain focused on executing the Company’s strategy to deliver operational and clinical successes to improve the lives of patients around the world and drive long-term business success and value creation.”

The Audit Committee is working with its advisors to complete the investigation expeditiously and has made significant progress. The investigation is ongoing, and there may be other actions taken based, at least in part, on information from the investigation. The Company is also working to prepare its financial statements for audit and regain compliance with its Securities and Exchange Commission reporting obligations as soon as practicable.

About MiMedx  
MiMedx® is a 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 the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million 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.

Safe Harbor Statement
This press release includes forward-looking statements including statements regarding the Audit Committee’s independent investigation and any actions that may arise in connection therewith.  Forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors, including, without limitation, uncertainties relating to the outcome of the Audit Committee’s investigation.  For more detailed information on the risks and uncertainties that may apply to the Company’s business and the ownership of Company common stock, please review the Risk Factors section of the Company’s most recent annual report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY

Posted On September 21, 2018 By OrthoSpineNews In Biologics /  

September 21, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance and is proceeding with a full commercial launch of BIOSPHERE® MIS PUTTY. BIOSPHERE® MIS PUTTY utilizes a pre-loaded bone graft cannula and trigger-based delivery system specifically designed for the unique challenges of minimally invasive surgery (MIS). The system permits controlled placement of Synergy’s proven, next-generation bone graft product (BIOSPHERE®PUTTY) in open, mini-open, and percutaneous minimally invasive settings.

“BIOSPHERE® MIS PUTTY was engineered to create a functionally ergonomic and easy to use bone graft delivery system,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “With the launch of BIOSPHERE® MIS, surgeons now have the means to precisely deliver BIOSPHERE®PUTTY to the surgical location.”

The BIOSPHERE® MIS PUTTY bone graft delivery system consists of a hand-held dispenser and cannula pre-loaded with BIOSPHERE® PUTTY. The system is easy-to-use and has a one-step assembly process that is achieved by attaching the cannula to the dispenser. As the trigger is engaged during delivery, a metered amount of BIOSPHERE® PUTTY is extruded from the cannula. By design, BIOSPHERE® MIS PUTTY can be extruded around implanted hardware or to remote anatomic locations in a targeted fashion. Delivery is controlled and stops as soon as the trigger is released. The dispenser and cannula were specifically engineered with a narrow sight line profile that maximize the surgeon’s view during graft placement. BIOSPHERE® MIS PUTTY is available in a kit (that includes a dispenser and putty-filled cannula), and also individual replacement cannulas to reload the delivery system, if additional bone graft is needed.

“The BIOSPHERE® MIS PUTTY delivery system improves the ability of a surgeon to place a bone graft material at a desired location. The system is significantly easier to use than standard graft funnels and allows for increased graft delivery due to the targeted placement,” stated Dr. Derek Thomas, MD. “The BIOSPHERE® MIS PUTTY delivery system is not only useful for MIS procedures, but also for open procedures with hard to reach graft areas.”

BIOSPHERE® MIS PUTTY utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a moldable bone graft material that has one of the highest bioactive glass contents on the market.

Synergy will be showcasing BIOSPHERE® MIS PUTTY and other products at Booth 2555 at the 2018 North American Spine Society Meeting in Los Angeles (September 26th – 28th).

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

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Osiris Therapeutics, Inc. Announces GrafixPL PRIME™ Launches October 1, 2018

Posted On September 18, 2018 By OrthoSpineNews In Biologics /  

COLUMBIA, Md., Sept. 17, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announces that GrafixPL PRIME™, a human placental membrane that can be stored at ambient temperatures, launches for sale on October 1, 2018.  The structural matrix, growth factors, and cell viability of GrafixPL PRIME is equivalent to those of Grafix®, a cryopreserved placental membrane, but without the constraints of ultra-low temperature storage.

GrafixPL PRIME is processed using Prestige LyotechnologySM, which is Osiris’s preservation technique for ambient storage of living tissues.  GrafixPL PRIME is flexible and conforming and designed as a wound cover/barrier for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.

Jason Keefer, Interim President and CEO said: “I am pleased to announce that our ambient temperature stable GrafixPL PRIME product will be available in all settings of care, in addition to our cryopreserved Grafix products.  This allograft will preserve the original characteristics of the fresh placental membrane that support natural tissue repair process, but in contrast to cold-stored cryopreserved tissues, GrafixPL PRIME is stored at ambient temperature.”

About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs.  We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO4® and Cartiform®.  We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products.  Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME™ Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO4® is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements
Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements.  Osiris Therapeutics, Inc. cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements.  These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018, as filed with the Securities and Exchange Commission (SEC).  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products.  Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome.  Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

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Bone Therapeutics SA announces final results from Phase I/IIA ALLOB delayed-union fracture study

Posted On September 14, 2018 By OrthoSpineNews In Biologics /  

Gosselies, Belgium, 14 September 2018, 7 am 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 final results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB in 21 patients, supporting the future clinical development of the delayed union indication.

The Company also announces the development of an optimized production process for ALLOB, which the Company believes delivers critical improvements in consistency, scalability, cost-effectiveness and ease of use. In order to streamline the progress of ALLOB through late stage clinical trials and towards commercialization, Bone Therapeutics intends to implement this optimized manufacturing process for all future clinical development programmes, including the Phase IIB trial of ALLOB in delayed union fractures.

Trial results

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. The study evaluated 21 patients, who each had a fracture that had failed to consolidate after a minimum of three and a maximum of seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (e.g. health status and pain).

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

From a radiological perspective, the patients improved by on average 3.84 points on the TUS score (statistically significant), almost twice the required increase of two points. This minimum two-point increase was achieved by 16 out of 21 patients (76%).

From a clinical perspective, the health status of patients, as measured by the GDE score, improved statistically significantly by on average 48%. The minimum 25% improvement was achieved by 16 out of 21 patients (76%). Pain at the fracture site, an important secondary endpoint, was statistically significantly reduced by on average 61%.

Overall, ALLOB was shown to be well-tolerated and the safety profile was consistent with the interim analysis reported on 20 September 2017. 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.

Manufacturing update

With its core focus on its off-the-shelf, allogeneic cell therapy platform, Bone Therapeutics has been optimizing its ALLOB manufacturing process in order to improve consistency, scalability, cost effectiveness and ease of use, which are critical for development and commercialisation in cell therapy.

The Company has successfully developed an optimized process that it believes will satisfy these objectives. The optimized production process significantly increases the production yield, generating tens of thousands of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level, making it readily available for patients in need. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation to large patient populations more affordably.

Bone Therapeutics believes the optimized manufacturing process is vital to the future commercial success of ALLOB. In order to avoid process changes in later phases of development, improve cost effectiveness and streamline ALLOB’s route to market, the Company will implement the optimized production process for all future clinical trials with ALLOB, including the planned Phase IIB delayed-union trial.

The Company’s immediate focus is on submitting a new clinical trial application (CTA) with the regulatory authorities to allow the start of a Phase IIB trial in delayed union, utilising the optimized production process. Bone Therapeutics is currently generating the non-clinical data required for the application and expects to submit the CTA for a multi-centre, randomized, controlled study in H2 2019.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “The continued positive clinical development progress with ALLOB, highlighted by these results today, paves the way for the next stage of development.”

“In cell therapy, a robust and consistent manufacturing process is critical to successful commercialisation. We are strongly encouraged by the progress we have made in optimising our manufacturing process, delivering a significant improvement which we believe safeguards the quality, consistency and cost-effectiveness of our allogeneic product and will support our future commercialisation strategy.”

“Whilst progressing this unique allogeneic bone cell therapy product to market as quickly as possible remains our top priority, we want to take this opportunity to align our clinical development as closely as possible with our future commercialization strategy. We believe the positive clinical data reported so far for ALLOB and the optimization of our manufacturing process put us in the right position to move forward with the clinical development of our allogeneic platform and achieve a competitive product profile.”

Key opinion leader event

The Company will host a Key Opinion Leader Event in Paris today at 12.30pm CEST. Presentations will be given by Prof. Dr. Frédéric Dubrana, Orthopaedic Surgeon at the University Hospital of Brest and Professor at the University of Western Brittany, alongside Thomas Lienard, Chief Executive Officer. The event in Paris will be held in French with an English language webcast of the same presentations at 3.30pm CEST. For more information please contact investorrelations@bonetherapeutics.com.

Webcast

To access the webcast, please go to the webcast link below. To participate in the Q&A, dial one of the appropriate numbers below quoting the confirmation code:

Belgium:    +32 (0)2 404 0659
France:   +33 (0)1 76 77 22 74
United Kingdom:   +44 (0)330 336 9105
United States:   +1 929-477-0324
Confirmation Code:   4247192

Webcast link: https://edge.media-server.com/m6/p/8ya7dmns

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.

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

The Company’s 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 of the hip.

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) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
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.

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