Plans to File PMA Application and Bring Product to the US
DURHAM, NC – December 14, 2016 – Bioventus, a global leader in orthobiologic solutions, today announced it has a new agreement with Galderma for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis. Financial terms of the transaction were not disclosed.
Bioventus plans to file a premarket approval application with the FDA in early 2017 to bring DUROLANE to the US market in the near future. It owns the international rights to the product and has commercialized it outside of the United States for nearly 15 years. Bioventus currently markets and sells it in more than 25 countries including Canada, Mexico, Australia and much of Europe. Galderma manufactures DUROLANE and other HA products.
“Bringing DUROLANE to the US is the next step in our strategy to offer osteoarthritis patients more choices for pain relief,” said Tony Bihl, CEO of Bioventus. “As a single-injection HA, it has improved the lives of more than one million people worldwide and we are pleased to work with Galderma to complete the process of introducing this solution to US patients.”
The addition of DUROLANE to the US portfolio for Bioventus will complement its newly launched three-injection HA GELSYN-3 and its popular five-injection HA SUPARTZ FX, giving the company an unmatched offering of options for patients, physicians and payers.
For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.
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. Bioventus 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 is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.
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.