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FDA Approves Bioventus’ Therapy for Knee Pain

By Barry Teater, NCBiotech Writer

Durham-based Bioventus, a global orthobiologics company, has received approval from the U.S. Food and Drug Administration to market Durolane, a single-injection joint lubricant for treating pain from knee osteoarthritis.

The company said in a news release it plans to launch Durolane in the U.S. market in early 2018.

“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 osteoarthritis 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 U.S. patients, physicians and payers.”

Durolane contains hyaluronic acid (HA), a naturally occurring molecule that lubricates and cushions a normal, healthy joint. The product is pre-loaded into a syringe, ready for injection by a doctor.

Durolane will join two other HA-based products in Bioventus’ osteoarthritis portfolio: the three-injection HA Gelsyn-3TM and the five-injection HA Supartz FXTM.

Bioventus markets and sells Durolane in more than 25 countries including Canada, Mexico, Australia, and throughout much of Europe.

Knee osteoarthritis is caused by the breakdown of cartilage and the synovial fluid that cushions and lubricates joint tissues within the knee.

Bioventus has about 660 employees worldwide and annual revenues of about $250 million, according to its website. The company was formed in 2012 when Smith & Nephew, a global medical technology business, spun out its biologics division in Durham in partnership with Essex Woodlands, a healthcare growth equity firm, and other investors.

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