Bioventus Launches Durolane in U.S. for Treating Knee Pain

Bioventus, a global orthobiologics company based in Durham, has launched Durolane, its single-injection, hyaluronic acid (HA) joint lubricant for treating knee osteoarthritis pain, following FDA approval last summer.

“Introducing Durolane to the U.S. market gives patients, physicians and payers access to a proven pain reliever for knee osteoarthritis that has improved the lives of more than 1 million people worldwide,” Bioventus CEO Tony Bihl said in a news release. “In addition, Durolane is very safe for patients and has more level-1 clinical studies than any other single-injection HA knee therapy on the market today.”

Durolane joins three-injection Gelsyn-3 and five-injection Supartz FX in the company’s osteoarthritis portfolio. Bioventus said it is the only company in the U.S. with a one-, three- and five-injection HA option for treating knee osteoarthritis pain.

Hyaluronic acid is a naturally occurring molecule that lubricates and cushions a normal joint. Knee osteoarthritis involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates tissues within the knee.

More than 20 million Americans have knee osteoarthritis. There is no cure, but the associated pain can be managed.

Durolane is intended for patients who have failed to respond adequately to conservative, non-drug therapy or simple analgesics such as acetaminophen.

Bioventus markets and sells Durolane in more than 25 countries including Canada, Mexico, Australia and many European countries.

Durolane provides greater reduction in knee pain than rival product Synvisc-One, according to a comparative study published in the Journal of Arthritis. It also provides longer-lasting pain relief than a methylprednisone steroid injection, according to a randomized trial reported in the journal Osteoarthritis and Cartilage.

Durolane is also safe for repeated courses of therapy. Repeated use does not increase the incidence of adverse events, according to the study in Osteoarthritis and Cartilage.

Bioventus also sells products for bone healing and bone graft.

Its Exogen Ultrasound Bone Healing System uses low-intensity pulsed ultrasound to stimulate the body’s natural healing process. Exogen has been used to treat more than 1 million patients worldwide.

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.