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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 16-Dec-16 BY BLAKE MOSSY, DECEMBER 16, 2016

REGULATORY
Safe Orthopaedics received CE Mark approval from the FDA for its Oak screw system used to treat thoracic vertebral fractures. The system is the only pedicle screw that offers simultaneous correction and fixation of trauma-related vertebral fractures. Oak is designed for minimally invasive surgeries and is compatible with the company's SteriSpine modular kits.

SpinalCyte received Institutional Review Board approval to begin clinical trials with its dermal fibroblast cell product, CybroCell, for the treatment of degenerative disc disease. The company is now approved to begin randomized, placebo-controlled, double-blind Phase I clinical trials.

Vericel received approval from the FDA for its MACI (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. MACI is reportedly the first FDA-approved cellularized scaffold that applies tissue engineering processes to grow cell on scaffolds using healthy autologous cartilage tissue.

PRODUCT INTRODUCTION & UPDATE
Bioventus entered into an agreement with Galderma to bring DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis, to the U.S. market. Bioventus currently owns the international rights to the product and has commercialized it outside of the U.S. Galderma manufactures DUROLANE and other hyaluronic acid products. The addition of DUROLANE to Bioventus' U.S. portfolio will complement its newly launched three-injection HA GELSYN-3 and five-injection HA SUPARTZ FX. The financial terms of the transaction have not been disclosed.

Zimmer Biomet launched its PrimaGen Advanced Allograft, an autograft substitute containing the same bone healing elements as autograft, but without the risks associated with donor site morbidity or harvest site complications. PrimaGen Advanced Allograft is indicated for use as an allogenic bone graft substitute containing viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.

DISTRIBUTION
aap Implantate entered into a distribution contract for its LOQTEQ trauma products with an unnamed U.S. healthcare service provider. Under the terms of the contract, a 12-month pilot phase allows the partner to sell LOQTEQ products in certain U.S. regions. If the pilot proves to be successful, distribution will gradually be rolled out to further states.

CLINICAL
Cellular Biomedicine Group announced interim 3-month safety data from its Phase I clinical trial in China for its AlloJoin off-the-shelf allogenic stem cell therapy for Knee Osteoarthritis (KOA). The data indicates that no serious adverse events were observed in any patients and that the most common adverse event was knee pain and swelling after injection. The company will report further safety data and efficacy data at the 6-month and 12-month periods.

OrthoSpace Ltd. announced a publication in the December issue of Musculoskeletal Surgery citing positive results for their InSpace System in the surgical treatment of massive rotator cuff tears (MRCTs). Patients undergoing the InSpace procedure experienced durable improvements in shoulder function and reductions in shoulder pain at 12 months of follow-up, demonstrating the benefits of InSpace as an effective alternative to existing surgical treatments.

Zimmer Biomet announced positive outcomes associated with use of its Trabecular Metal Cups in more than 9,500 patients undergoing revision hip arthroplasty. Based on data from the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man, indicated that Trabecular Metal Cups were associated with lower infection rates and a significant reduction in subsequent hip revision rates.

Zyga Technology announced results from a study of its SImmetry Sacroiliac (SI) Joint Fusion, evaluating long-term fusion and pain reduction in patients receiving SImmetry Sacroiliac Joint Fusion. The 12-month study results indicate significant reduction in pain and disability in patients suffering from decortication and bone grafting.

APPOINTMENTS
Alphatec Holdings,the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced that its Board of Directors has appointed Terry M. Rich as the Company’s Chief Executive Officer, effective December 10, 2016. Mr. Rich, who has also been appointed to the Company’s Board of Directors, will replace Leslie H. Cross, who has served as interim Chief Executive Officer since September 2016. The Company also announced today that its Board of Directors has appointed Mortimer Berkowitz III, a current member of the Company’s Board of Directors, as Chairman of the Board effective December 10, 2016, replacing Mr. Cross, who will step down as Chairman, but will remain on the Company’s Board of Directors. Finally, the Company announced new members of its commercial leadership team and equity inducement awards being granted to three new key employees.

Orthofix appointed Alexis V. Lukianov to its Board of Directors. Mr. Lukianov brings more than 30 years of experience and an extensive background in orthopedics. He has held senior executive positions with companies such as Medtronic SofamorDanek and Smith and Nephew Orthopaedics. Mr. Lukianov's appointment expands the Board to 10 directors, 9 of whom are independent directors.


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