Mayo Clinic finds surprising results on first-ever test of stem cell therapy to treat arthritis

Posted On December 28, 2016 By OrthoSpineNews In Biologics, Sports Medicine /

By Kevin Punsky – December 6, 2016

JACKSONVILLE, Fla. — Researchers at Mayo Clinic’s campus in Florida have conducted the world’s first prospective, blinded and placebo-controlled clinical study to test the benefit of using bone marrow stem cells, a regenerative medicine therapy, to reduce arthritic pain and disability in knees.

The researchers say such testing is needed because there are at least 600 stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated 100,000-plus patients, who pay thousands of dollars, out of pocket, for the treatment, which has not undergone demanding clinical study.

The findings in The American Journal of Sports Medicine include an anomalous finding — patients not only had a dramatic improvement in the knee that received stem cells, but also in their other knee, which also had painful arthritis but received only a saline control injection. Each of the 25 patients enrolled in the study had two bad knees, but did not know which knee received the stem cells.

Given that the stem cell-treated knee was no better than the control-treated knee — both were significantly better than before the study began — the researchers say the stem cells’ effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain, but they cannot yet recommend it for routine arthritis care.

“Our findings can be interpreted in ways that we now need to test — one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or whole-body fashion,” says the study’s lead author, Shane Shapiro, M.D., a Mayo Clinic orthopedic physician.

“One hypothesis is that the stem cells we tested can home to areas of injury where they are needed, which makes sense, given that stem cells injected intravenously in cancer treatments end up in the patients’ bone marrow where they need to go,” he says. “This is just a theory that can explain our results, so it needs further testing.”

Another explanation is that merely injecting any substance into a knee offered relief from pain.

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MiMedx EpiFix Receives Coverage From Aetna

Posted On December 27, 2016 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Dec. 27, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, today announced that the Company’s EpiFix^® product has received coverage from insurer Aetna Inc. effective December 23, 2016.

With this coverage decision, the approximately 17.5 million Aetna commercial members now have coverage for EpiFix. Aetna considers EpiFix medically necessary for treatment of partial and full-thickness neuropathic diabetic foot ulcers (DFUs) that are greater than six weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.

Parker H. “Pete” Petit, Chairman and CEO said, “We are very pleased to have received coverage from Aetna and with the significant progress we have made in gaining coverage for our allografts from both the commercial, as well as the federal and state payers. We believe we have substantial opportunities ahead as we continue to grow our advanced wound care products and broaden the other therapies and market sectors we serve with our allografts. Gaining coverage from all commercial payers has been a critical strategy for MiMedx. From our viewpoint, attainment of EpiFix coverage for the vast majority of the commercial covered lives has been a significant contributor to the success we have experienced in achieving and exceeding our growth projections.”

Bill Taylor, President and COO, stated, “The clinical efficacy and cost effectiveness of tissues and products are heavily scrutinized by the commercial health plans. It is clear to us that the evidence demonstrating that our allografts benefit their members clinically, as well as provide more cost effective care, has been a significant factor in our success in attaining coverage awards from insurers. We know the positive clinical and economic impact our allografts have on their covered populations, and we are always pleased when health plans come to this same conclusion.”

“Including Aetna, we now have over 200 commercial health plans representing more than 198 million covered lives providing insurance coverage. Within the more than 200 commercial health plans, Blue Cross/Blue Shield plans encompassing 47 states plus the District of Columbia also provide insurance coverage for their members. In addition to the commercial health plans, 40.3 million Medicare and 55.4 million Medicaid beneficiaries have insurance coverage for our allografts,” concluded Petit.

About MiMedx

MiMedx^® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human amniotic membrane utilizing our proprietary PURION^® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the belief that there are substantial opportunities ahead for the Company, attainment of EpiFix coverage for the vast majority of commercial covered lives has been a significant contributor to the Company’s success in achieving and exceeding growth projections, and the Company’s belief that a significant factor in its success with attaining coverage awards from insurers is that its allografts benefit members of health plans clinically as well as provide more cost effective care. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include opportunities for growth may not materialize as expected, provider usage may change due to multiple factors, insurance coverage for EpiFix may not be a significant contributor to the Company’s success in achieving and exceeding growth projections or may have no impact at all, reimbursement is always subject to change and may therefore impact cost effectiveness of care, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015, and its most recent Form 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Smith & Nephew wins prestigious Galien Award for PICO Negative Pressure Wound Therapy innovation

Posted On December 22, 2016 By OrthoSpineNews In Biologics /

21 December 2016

Smith & Nephew, (LSE:SN, NYSE:SNN), the global medical technology business, has been awarded the 2016 French Galien Award for PICO; the novel single-use negative pressure wound therapy (NPWT) system.

The Prix Galien acknowledges significant advances in pharmaceuticals and medical devices which deliver real improvements to human life. The prize, awarded in the Medical Disability Compensation and Return to Social Life category, rewards Smith & Nephew’s determination to improve the daily lives of patients and professionals with the management of wounds.

Managing Director of Smith & Nephew SAS (France), Bertrand L’Huillier, said: “Receiving the Galien Award is a huge honour and recognition of our contribution to medical research and ability to innovate. It is also a great encouragement to continue our investment to support healthcare professionals in their daily efforts to improve the lives of patients worldwide.”

Improving community healthcare and patient outcomes

Managing wounds, whether chronic, acute or post-surgical, has a significant impact to a patients’ quality of life as well as a financial impact on the health economy^[i]. Chronic wounds are often hard to heal, resulting in a cycle of pain, anxiety, frequent home visits and reduced quality of life. However, with the availability of the PICO system in the community, the lives of patients with wounds are significantly improved^[i].

A study of 326 community based patients whom received PICO treatment for pressure ulcers, leg ulcers, diabetic foot ulcers, trauma wounds and dehisced surgical wounds, showed that prior to using PICO wound dressings were being changed four times a week^[ii]^. This fell to two dressing changes a week when using PICO, and to 1.8 times a week, on average, in the four-week follow-up period. Fewer dressing changes resulted in considerable cost savings; the total cost of care using PICO was three times less than the baseline^[iii]^.

About PICO

PICO is a novel, canister-free single use system that offers portable, accessible and affordable NPWT, overcoming many of the disadvantages of conventional NPWT devices. PICO’s unique dressing technology not only absorbs and locks exudate but is designed to move exudate away from the wound and aids evaporation of fluid^iv. The PICO pump maintains negative pressure at -80mmHg through the wound bed and dressing^[iv]. The PICO system can be used up to 7 days depending on levels of exudate, and includes two dressings.

PICO is cleared for use in hospital and homecare settings in Europe, US, Canada, and Australia. In Japan PICO is cleared for use in open wounds only. For more information about the PICO system and the NPWT portfolio of products from Smith & Nephew, please visit www.smith-nephew.com. Clinicians and patients may also refer to the 24/7 Negative Pressure Wound Therapy hotline, 0800 9155394 (UK) and 1800 303 622 (Ireland).

About the Prix Galien

Each year, the Prix Galien rewards therapeutic innovations made available to healthcare professionals and patients as well as pharmaceutical research. The honor committee includes the most prominent figures in the scientific world, including several Nobel Prize winners. The Prix Galien is regarded as the highest distinction awarded each year to pharmaceutical research.

Recognition at the French Galien Awards means that Smith & Nephew will now be able to enter PICO into the international Galien Awards, held in 2018.

A full press pack, containing clinical and product imagery, videos, and background information is available on this page.

Enquiries

Media
Beth Lowes or Rachel Cunningham	0208 995 5832
ROAD Communications on behalf of	firstname@roadcommunications.co.uk

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce surgical site complications, please visit www.closertozero.com

_{Forward-looking Statements}

_{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

_{◊Trademark of Smith & Nephew.}

References

[i] Reducing the burden of chronic wounds in the community with single-use NPWT’ JCN supplement 2015, Vol 29, No 5

[ii] Hurd et al., Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: A case series. Ostomy Wound Management, March 2014.

[iii] Hampton J, Providing cost-effective treatment of hard-to-heal wounds in the community through use of NPWT. British Journal of Community Nursing, Vol 20, No 6, Community Wound Care, June 2015.

[iv] Malmsjö M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty 2014;14:e15.

InVivo Therapeutics Announces New Patient Enrollment into the INSPIRE Study

Posted On December 20, 2016 By OrthoSpineNews In Biologics, Neuro /

December 20, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that a new patient with a T8-9 fracture dislocation injury has been enrolled into The INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at the Carolinas Medical Center in Charlotte, NC. Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee, performed the implantation with his partner, Samuel Chewning, M.D. Surgery was performed approximately 19 hours after the injury occurred. Dr. Coric and Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-principal Investigators at this site.

“Implantation of the Neuro-Spinal Scaffold went smoothly and the patient is doing well,” Dr. Coric said. “I have now implanted five patients with different injury types and locations, and the implantation procedure has been consistently uncomplicated. I look forward to following this most recent patient’s progress.”

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We now have ten INSPIRE patients enrolled and in follow up, which is an important milestone in this study designed to enroll 20 evaluable patients. We thank Dr. Coric and his team for having enrolled five patients at their site, and look forward to continuing to make progress toward full enrollment.”

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

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 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the expected timing of additional enrollment. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

Skin cells ‘crawl’ together to heal wounds treated with unique hydrogel layer

Posted On December 20, 2016 By OrthoSpineNews In Biologics /

December 14, 2016 – Credit: Marit Mitchell / U of T Engineering

Time may not heal all wounds, but a proprietary mix of peptides and gel developed by U of T Engineering researchers heals most.

A team led by Professor Milica Radisic has demonstrated for the first time that their peptide-hydrogel biomaterial prompts skin cells to “crawl” toward one another, closing chronic, non-healing wounds often associated with diabetes, such as bed sores and foot ulcers.

The team tested their biomaterial on healthy cells from the surface of human skin, called keratinocytes, as well as on keratinocytes derived from elderly diabetic patients. They saw non-healing wounds close 200 per cent faster than with no treatment, and 60 per cent faster than treatment with a leading commercially used collagen-based product.

“We were happy when we saw the cells crawl together much faster with our biomatieral, but if it didn’t work with diabetic cells, that would have been the end of the story,” says Radisic. “But even the diabetic cells travelled much faster — that’s huge.”

Until now, most treatments for chronic wounds involved applying topical ointments that promote the growth of blood vessels to the area. But in diabetic patients, blood vessel growth is inhibited, making those treatments ineffective. Radisic and her team have been working with their special peptide — called QHREDGS, or Q-peptide for short — for almost 10 years. They knew it promoted survival of many different cell types, including stem cells, heart cells and fibroblasts (the cells that make connective tissues), but had never applied it to wound healing.

“We thought that if we were able to use our peptide to both promote survival and give these skin cells a substrate so they could crawl together, they would be able to close the wound more quickly,” says Radisic. “That was the underlying hypothesis.”

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Dec19_2016_Getty_539217189_BusinessmanTouchingDollarSign2011541471.jpg

Kuros Acquires Xpand to Form Orthobiologics Firm with Bone Graft Substitute

Posted On December 19, 2016 By OrthoSpineNews In Biologics, Financial /

December 19, 2016

Kuros Biosciences is to acquire Xpand Biotechnology by way of a share-swapping deal structured as an exchange of all Xpand shares for up to 2.105 million new Kuros shares. A total of 1.36 million Kuros shares will be issued immediately upon the deal closing. Another 0.74 million Kuros shares will be issued on the achievement of product approval milestones. Kuros says that if all milestones are achieved its shareholders will own about 71% of the combined company. The transaction has been approved by both firms’ boards of directors.

The combined entity will exploit two complementary technologies—Xpand’s synthetic surface science technology and Kuros’s fibrin/PTH biologics platform. The Netherlands-based Xpand Biotechnology develops products for bone repair and regeneration. A granular formulation of the firm’s bone graft substitute, MagnetOs, was approved in the EU during mid-2016 and is under FDA 510(k) review. A putty formulation of MagnetOs is also being prepared for submission in the EU for orthopedic and dental applications and for submission in the U.S. for spinal fusion applications.

Switerland-based Kuros says the acquisition will also give it an operation in the EU, and certified GMP manufacturing facilities. Kuros’s in-house pipeline is headed by lead product Neuroseal (KUR-023), a synthetic dural sealant for the prevention of cerebrospinal fluid (CSF) leakage following cranial or spinal surgery. KUR-023 is being submitted to the European regulator for CE marking, and market launch is projected for 2017. The Kuros pipeline also includes the fibrin/parathyroid hormone (PTH) bone graft KUR-111 and a fibrin/PTH bone-healing polymer candidate, KUR-113, both of which have completed Phase IIb clinical trials. KUR-113 is also being prepared for Phase II trials in spinal fusion, which are projected to start in 2018.

“Kuros and Xpand’s products are highly complementary,” commented Didier Cowling, CEO of Kuros. “As a result of the acquisition, we will have leading products in key segments of the orthobiologics field and the opportunity to build an integrated business with promising products on the market and in development.” Professor Joost de Bruijn, CEO of Xpand Biotechnology, will be joining the Kuros executive management team. He added, “we are pleased to be joining forces with Kuros. With the unique and complementary synthetic and biologic technology platforms of Kuros and Xpand, we can proceed to build a leading, commercial stage orthobiologics company.”

Kuros Biosciences was formed by the merger of Cytos Biotechnology and Kuros Biosurgery Holdings in January 2016.

BONESUPPORT confirms election of Dr. Håkan Björklund as Chairman of the Board

Posted On December 16, 2016 By OrthoSpineNews In Biologics, Financial /

Lund, Sweden, 16 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces, that Dr. Håkan Björklund has been confirmed as Chairman and that Ms. Tone Kvåle has been elected as a new Board Member. The appointments were made at an EGM held on 15 December 2016.

Dr. Björklund is Partner of Tellacq AB, a private investment firm. He joined the BONESUPPORT Board in September 2016 in conjunction with the Company’s $37 million (SEK 315 million) financing, which was led by Tellacq. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Tone Kvåle joins as a Board Member and Head of the Audit Committee. She is currently Chief Financial Officer of Nordic Nanovector, an Oslo-listed biopharmaceutical company, and has more than 20 years’ biotech industry experience. Prior to joining Nordic Nanovector, she was CFO of NorDiag, Kavli Holding and Dynal Biotech, and has held senior management positions at Invitrogen, Life Technologies and ThermoFisher (US). Ms. Kvåle has a diploma in Finance & Administration from Harstad University College.

Richard Davies, CEO of BONESUPPORT, said: “I am extremely happy that Håkan has been elected Chairman and that Tone will be joining the Board. This is an exciting period for BONESUPPORT following our recent $37 million (SEK 315 million) financing. We are now focused on building further additional shareholder value by growing sales of our current CERAMENT products, generating further data highlighting the clinical and health economic benefits these products deliver and progressing our pipeline. I am confident that Håkan’s and Tone’s experience will be valuable in helping us achieve our strategic goals.”

Dr. Björklund said: “I look forward to working with the management team and the Board to deliver BONESUPPORT’s potential to become a global leader in the management and treatment of bone disease based on the unique properties of its CERAMENT platform.”

Notes to Editor

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at high risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

MTF Wound Care’s AmnioBand® and AlloPatch® Pliable Receive the American Podiatric Medical Association Seal of Approval

Posted On December 15, 2016 By OrthoSpineNews In Biologics, Extremities /

EDISON, N.J., Dec. 14, 2016 /PRNewswire/ – After evaluating each MTF Wound Care allograft in several areas – including safety, quality and effectiveness – a panel of podiatric physicians from the American Podiatric Medical Association (APMA) has granted MTF Wound Care their Seal of Approval for its AmnioBand^® family of placental allografts and AlloPatch^® Pliable tissue forms.

MTF Wound Care, a division of the Musculoskeletal Transplant Foundation (MTF), is a non-profit organization offering highly advanced, safe, clinically proven and cost-effective allograft solutions.

“Receiving the APMA Seal of Approval gives podiatrists and clinicians the confidence that AmnioBand and AlloPatch Pliable are beneficial in healing patients’ wounds,” said Kim Rounds, Vice President, MTF Wound Care. “Placing our tissues through the APMA’s detailed evaluation demonstrates our commitment to be a partner of choice. We are proud of this notable accomplishment that recognizes the strength of our portfolio.”

As a primary resource for foot and ankle health information, the American Podiatric Medical Association (APMA) is the nation’s leading and recognized professional organization for doctors of podiatric medicine (DPMs).

“Podiatrists play a critical role in healing life- and limb-threatening wounds in patients with diabetes,” said APMA President R. Daniel Davis, DPM. “We depend on cutting-edge products, devices, and treatments to help us deliver outstanding care and reduce amputations and hospitalizations. APMA is pleased to award its Seal of Approval to MTF’s AlloPatch Pliable and AmnioBand tissue forms.”

Evaluation Process

The APMA Seal of Approval is granted to products that are beneficial to foot health. Companies must provide comprehensive information on each product: objective data from clinical and/or laboratory studies, intended use, patents, composition, and evidence of quality control. A detailed review is conducted by each committee member, and a recommendation is then sent to the APMA Board of Trustees, which may either accept or reject the recommendation.

About AmnioBand and AlloPatch Pliable

AmnioBand is offered in several forms, derived from dehydrated human placental tissue comprised both of the amnion and chorion layers. It is used as a scaffold for the treatment of chronic non-healing wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers. AmnioBand is aseptically processed, stored in ready to use “package to patient” configuration, and available in a variety of sizes.

AlloPatch Pliable is an acellular human dermal graft designed to support host tissue remodeling. It has an open architecture derived from a deeper layer in the dermal tissue, bringing faster graft incorporation and supporting repopulation and revascularization in host tissue. It is also aseptically processed to preserve the graft’s natural structure.

About MTF Wound Care

MTF Wound Care is a division of the Musculoskeletal Transplant Foundation, a non-profit organization based in Edison, NJ. MTF is a national consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions. For more, visit www.mtfwoundcare.org.

About the American Podiatric Medical Association

Founded in 1912, the American Podiatric Medical Association (APMA), headquartered in Bethesda, MD, is the leading resource for foot and ankle health information. Currently, the organization represents a vast majority of the estimated 15,000 podiatrists in the country. In addition to the national headquarters, APMA boasts 53 state component locations throughout the United States and its territories, as well as affiliated societies. For more, visit www.apma.org.

Contact: Cheri Lane
Cheri_Lane@mtf.org
732-661-3712

SOURCE MTF Wound Care

SpinalCyte, LLC Receives Institutional Review Board Approval for Phase I Clinical Trial

Posted On December 14, 2016 By OrthoSpineNews In Biologics, Spine /

December 13, 2016

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today it has received Institutional Review Board approval to begin clinical trials with its dermal fibroblast cell product, CybroCell, in the treatment of degenerative disc disease. SpinalCyte is now approved to begin randomized, placebo-controlled, double-blind Phase I clinical trials.

The clinical trials will enroll 18 patients between the ages of 18 and 85 who will either be administered CybroCell alone, in combination with platelet-rich plasma (PRP) or saline only. The primary endpoint of the study will measure outcome at 12 months. Multiple preclinical trials involving rabbits demonstrated the ability of CybroCell to regenerate the nucleus of the spinal disc in an animal model of degenerative disc disease.

“Initiating this clinical trial is an important step toward commercializing our first cell therapy product,” said Pete O’Heeron, CEO of SpinalCyte. “The opportunity to relieve the pain associated with degenerative disc disease presents an enormous benefit to the effected patient population and an equally large business opportunity for SpinalCyte.”

“Lower back pain due to degenerative disc disease can be a chronic and debilitating problem for our patients,” said Carlos Manuel Ruiz Macias, M.D., principle investigator of the SpinalCyte clinical trials. “SpinalCyte’s new cell therapy is a promising option for patients who could benefit from disc regeneration.”

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 12 U.S. and international issued patents, and has filed for an additional 39 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

Investor Contact:
SpinalCyte, LLC
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com
or
Media Contact:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

RTI Surgical® Names Robert P. Jordheim Interim CEO

Posted On December 14, 2016 By OrthoSpineNews In Biologics, Spine /

December 14, 2016

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that Robert P. Jordheim, executive vice president and chief financial officer of RTI, has been named interim CEO. He succeeds Brian K. Hutchison, who informed the RTI board of directors last August of his decision to retire from his position as president and chief executive officer and step down from the company’s board of directors. The transition will be completed December 17, 2016.

Jordheim’s CFO responsibilities will be assumed on an interim basis by Wy Louw, vice president and controller of RTI. The RTI board of directors continues to actively review candidates for the permanent chief executive officer position.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical
Wendy Crites Wacker, APR, 386-418-8888
Vice President, Global Communications
wwacker@rtix.com