Biologics

Biomet Biologics completes clinical trial enrollment for study of chronic tennis elbow treatment kit

Biomet, Inc., announced that its subsidiary, Biomet Biologics, LLC, has completed the required 230-subject enrollment for a study on the use of the Recover Kit device which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis). This multicenter, prospective, randomized, controlled, double-blind clinical trial will be completed when the last subject enrolled reaches 24 weeks follow-up in mid-2011. Enrollment was completed by 12 investigational sites in the United States, according to a press release.

The clinical trial is being performed under an FDA-approved Investigational Device Exemption (IDE) to evaluate the safety and efficacy of the company’s Recover Kit to treat chronic tennis elbow. Study subjects received either the investigational PRP treatment or an active control (bupivacaine). Adverse event profiles and clinical assessments of pain and function will be compared in the two treatment groups. The clinical data from this pivotal study will support a submission to the FDA requesting approval to market the kit to treat chronic tennis elbow, the company said.

“We are excited to complete the required enrollment for this study, as it addresses a very problematic issue for the patient and surgeon alike,” Stuart Kleopfer, president of Biomet Biologics, stated in the release. “We believe this is an important step forward in advancing the use of autologous, point-of-care therapies to treat chronic tendinopathies.”

About the author

Josh Sandberg

Josh Sandberg has been an executive search consultant focused exclusively on orthopedic and spine start-ups since 2004. He has had a tremendous impact in helping his clients avoid costly hiring mistakes by his deep industry knowledge and network. In 2010, Josh co-founded Ortho Spine Companies, which is the parent company of Ortho Spine Distributors (OSD), Surg.io and Ortho Sales Partners (OSP). OSD a searchable database that helps ease the frustration of finding orthopedic distributors throughout the country. Surg.io is the ultimate distributor toolkit that offers distributors the tools necessary to build the foundation of a scalable and highly functioning sales organization. OSP is an end-to-end solution that helps companies approach the Global Market in a cost efficient way. Our team has hundreds of years of experience and can help you navigate the many challenges present in bringing new technologies to the market.

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