Bioventus Enters Into New Agreement for DUROLANE
Bioventus Enters Into New Agreement for DUROLANE®
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.
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. 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.
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.
Media Contact:
Thomas Hill, +1 , [email protected]
Design Evolution of EXOGEN Enhances Patient Compliance
Design Evolution of EXOGEN®Enhances Patient Compliance
DURHAM, NC – December 5, 2016 – Bioventus, a global leader in orthobiologics, today announced that a published study reveals its latest generation EXOGEN Ultrasound Bone Healing System improves patient compliance by 10% and overall compliance never fell below 76%. EXOGEN uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1 The findings are published in the November 30, 2016 issue of Medical Devices: Evidence and Research available here.
The next generation EXOGEN device launched in 2014 and features a compliance calendar. The study found that among 12,984 patient data files analyzed, the patient compliance was 84%, while compliance with the previous generation EXOGEN device was 74%. In addition, incorporation of the calendar feature resulted in compliance never decreasing below 76% over the 6-month analysis period.
The researchers also analyzed 12 clinical trials on LIPUS where compliance was recorded. In eight of these clinical studies, where they met their end point, compliance was 88%. If the primary end point was unmet, compliance averaged 54%.
“This study clearly shows a correlation between clinical effectiveness and compliance rates of more than 70%,” said Neill Pounder, Director – Project Management, Bioventus. “The work also revealed that use of the next generation EXOGEN device resulted in a measurable improvement in patient adherence, which may help to optimize clinical outcomes and fracture healing. LIPUS technology can make a difference if it used as directed.”
Authors of this study are N.M. Pounder, J.T Jones and K.J. Tanis of Bioventus.
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. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. 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 and EXOGEN are registered trademarks of Bioventus LLC.
- Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus.J Bone Miner Res. 2001; 16(4):671-680.
Media Contact:
Thomas Hill, +1 , [email protected]
