Bioventus Launches DUROLANE® SJ (1mL) in Australia and New Zealand; Receives Expanded Indications for DUROLANE (3mL)
HOOFDDORP, The Netherlands--(BUSINESS WIRE)--Aug 12, 2019--
Bioventus, a global leader in orthobiologic solutions, is launching DUROLANE SJ(1mL), and has received expanded indications for DUROLANE (3mL), its single-injection joint-fluid osteoarthritis (OA) treatment, in Australia and New Zealand. Both are hyaluronic acid (HA)-based products and available from LMT Surgical.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190812005482/en/
DUROLANE, a single-injection, hyaluronic acid product used for joint lubrication in the treatment of pain associated with knee osteoarthritis, now has expanded indications in Australia and New Zealand (Photo: Business Wire)
DUROLANE SJ (1mL) has been approved by Australia’s Therapeutic Goods Association (TGA) and MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, and will launch in both countries later this year. It is indicated for symptomatic treatment associated with mild to moderate OA pain in the ankle, elbow, wrist, fingers, and toes. DUROLANE SJ (1mL) is also indicated for pain following joint arthroscopy in the presence of OA within three months of the procedure.
In addition, DUROLANE (3mL), which has been indicated for symptomatic treatment of mild to moderate knee OA pain in both countries for several years, received approval for expanded indications by both the TGA and MEDSAFE. These include symptomatic treatment of mild to moderate hip OA and the symptomatic treatment associated with mild to moderate OA pain in the ankle, shoulder, elbow, wrist, fingers, and toes. DUROLANE (3mL) is also indicated for pain following joint arthroscopy in the presence of OA within three months of the procedure.
“More than two million Australian citizens suffer from some form of osteoarthritis,” 1 said John Nosenzo, Chief Commercial Officer, Bioventus. “The availability of DUROLANE SJ, and the expanded indications for DUROLANE, gives them, and OA patients in New Zealand, even more options for OA pain relief.”
“We are excited to work with Bioventus and introduce both DUROLANE and DUROLANE SJ to more patients seeking OA pain relief,” said Kerry Lawford, Managing Director, LMT Surgical. “In addition, physicians now have more choices regarding appropriate volumes of HA for each affected joint.”
“ DUROLANE is the original single-injection HA treatment for knee OA and has a great track record in Australia and New Zealand,” said Andrew McCartney, Managing Director, International, Bioventus. “The broadened indications of the product, combined with the service offerings from LMT Surgical and its strong presence throughout the market, give us the opportunity to treat more OA patients than ever before.”
OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues and HA-based products like DUROLANE, help manage OA pain for patients. DUROLANE is non-avian and based on the safe, natural and unique NASHA ® technology. NASHA yields stabilized HA which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint.
DUROLANE, which was designed as a single-injection HA and has more Level 1 clinical studies than any other single-injection HA, has also been proven to provide greater reduction in OA knee pain versus Synvisc-One ®. 2 It has longer lasting pain relief versus a steroid injection, is safe for repeated courses of therapy, and repeated use of DUROLANE does not increase the incidence of adverse events. 3,4 Visit www.durolane.com for more information.
About LMT Surgical
LMT Surgical is known for introducing innovative products and services to benefit the healthcare industry and the patient, supporting Orthopaedic, Neurosurgery, Plastics, Spine and ENT specialties, to learn more visit www.lmtsurgical.com
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 orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone 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 DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Nestle Skin Health.
Synvisc-One is a registered trademark of Genzyme Corporation.
Summary of Indication for Use: DUROLANE (3mL) is indicated for symptomatic treatment of mild to moderate knee or hip osteoarthritis. In addition, DUROLANE has been approved for the symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes. DUROLANE is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within three months of the procedure. DUROLANE SJ (1mL) is indicated for Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes. DUROLANE SJ is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within three months of the procedure. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site. Indications presented are those approved in Australia; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.DUROLANE.com.
References: 1. Australian Institute of Health and Welfare www. www.aihw.gov.au2. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 3. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 4. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.
View source version on businesswire.com:https://www.businesswire.com/news/home/20190812005482/en/
CONTACT: Thomas Hill
KEYWORD: AUSTRALIA/OCEANIA NEW ZEALAND AUSTRALIA
INDUSTRY KEYWORD: BIOTECHNOLOGY MANAGED CARE GENERAL HEALTH HEALTH MEDICAL DEVICES RESEARCH SURGERY SCIENCE
Copyright Business Wire 2019.
PUB: 08/12/2019 05:00 PM/DISC: 08/12/2019 05:00 PM