Musculoskeletal News Roundup 25-May-17

May 25, 2017 | Blake Mossy

FUNDING

Organogeneis secured $20 million in financing led by Eastward Capital Partners. The new capital will be used to enhance its orthopedics and spine wound care product and technology portfolio.

PRODUCT INTRODUCTION & UPDATE

NovaBone launched its NovaBone IRM and NovaBone IRM MacroPOR products to its portfolio of biologically active bone graft substitutes. The two systems aim to optimize osteogenesis, stimulate osteoblastic activity and offer angiogenic properties. Both IRMs are highly resistant to irrigation and are designed with cohesion and handling being key properties.

REGULATORY

Zimmer Biomet issued a voluntary field safety corrective action for certain ROSA Brain, ROSA Spine and ROSA One devices due to the internal identification of an issue that may prevent the robot arm from reaching a desired position. Affected units were distributed between June 2015 and April 2017.

CLINICAL

Anika Therapeutics published study results from its Phase III data evaluating the efficacy and safety of its CINGAL, a hyaluronic-acid (HA)-corticosteroid combined with a viscosupplement for the treatment of symptoms related to osteoarthritis (OA) of the knee. The results indicate that CINGAL provided immediate and short-term pain relief after injection as compared to HA alone, and relief from OA-related pain, stiffness and function through 26 weeks.

BONESUPPORT announced the enrollment of the first patient in its Investigational Device Exemption (IDE) trial using its CERAMENT G product, an injectable antibiotic-eluting bone graft substitute. The trial aims to assess the products ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. Through the trial, the company aims to demonstrate an absence of deep infection at the fracture site, and a lack of secondary procedures required to promote fracture union.

Gramercy Extremity Orthopedics announced the first surgery using its GEO Bone Screw and GEO CART systems. The GEO CART is a computerized mobile implant and instrumentation inventory system that aims to reduce delays in surgery, decrease sterility risks for patients, eliminate billing mistakes and hand-written forms, reduce facility operating expenses and automatically generate the Implant Usage Form. The GEO Bone Screw System offers sterile, single-use, self-drilling and tapping, reverse-cutting screws for a variety of low profile titanium screw lengths, diameters, thread lengths and fully threaded options.

United Orthopedic (UOC) announced the first patient enrollment in its U-Propel study evaluating clinical performance and safety of the company’s U2 Knee system in primary total knee arthroplasty (TKA). The study will enroll up to 200 patients with follow-up out to five years. The study’s primary endpoint is implant survivorship, with the secondary endpoints being knee society score, radiographic success, subject satisfaction, and operative characteristics.

RESEARCH

NuVasive announced an increased investment and support of adult and pediatric deformity research, education, and awareness initiatives throughout 2017. The new initiatives include a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early onset scoliosis and addition research funding supporting groups such as Harm, Children’s Spine Study Group and the Growing Spine Study Group.

DISTRIBUTION

Integra LifeSciences entered into a distribution agreement with aap Implantate to distribute aap’s LOQTEQ Distral Radius System in the United States. The system offers multiple plate options to accommodate a variety of fracture patterns and anatomies, and offers instrumentation designed for intra-operative efficacy.

Vericel entered into a two-year agreement with Orsini Pharaceutical for the distribution of its Carticel autologous cultured chondrocytes and MACI in the U.S. and Puerto Rico. Orsini will work will Vericel’s service provider, Pro-Spectus, for management of patient cases related to the products.