Bioventus Receives US FDA Approval for DUROLANE®

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has received US FDA approval for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Hyaluronic acid is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee.

“More than 20 million Americans are afflicted with knee osteoarthritis and there is no cure, but the associated pain can be managed,” said Tony Bihl, CEO of Bioventus. “DUROLANE has been a proven knee OA pain reliever for more than 15 years, improving the lives of more than one million people worldwide. It will join our current offerings to provide even more efficacious treatment options for US patients, physicians and payers.”

DUROLANE will complement the company’s OA portfolio which includes three-injection HA GELSYN-3™ and the five-injection HA SUPARTZ FX™. Bioventus markets and sells DUROLANE in more than 25 countries including Canada, Mexico, Australia, and throughout much of Europe. It plans to launch DUROLANE the US market in early 2018.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3, is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corporation.