Bioventus Expands European Reach with Italian Launch (English)
HOOFDDORP, THE NETHERLANDS – Bioventus, a global leader in active orthopaedic healing, expanded its European footprint today by officially launching its company and products in Italy. The company, which opened its International Headquarters in the Netherlands last month, delivers clinically proven, cost-effective solutions that help people recover and heal quickly and safely.
With corporate headquarters in the United States, Bioventus was formed in May 2012 as a strategic partnership between the company’s owners – Smith & Nephew, the global medical technology business, and an Essex Woodlands led investor syndicate group. With today’s launch, the Smith & Nephew biologics and clinical therapies business in Italy, including employees and products, transition over to Bioventus.
“With the Bioventus launch, our Italian customers will notice an increase in the level of support and product expertise available to them through our new multi-lingual customer care center that opened last month in our Netherlands’ office,” said Mark Augusti, CEO of Bioventus. “However, other than that, changes should be minor – our customers’ sales representatives will not change and our products will simply be rebranded.”
Augusti explained that Bioventus products available in Italy will switch from their current Smith & Nephew labeling to Bioventus. The products themselves will not change and will remain the same clinically proven, safe, effective solutions that physicians and patients know and trust. This includes:
• EXOGEN® Ultrasound Bone Healing System – a product indicated in Europe to accelerate the healing of recent fractures and to heal bones that have either delayed healing (delayed unions) or stopped healing completely (non-unions). EXOGEN has been shown to heal 86 percent of non-unions fractures* and accelerate the healing of fresh fractures up to 38 percent faster**. EXOGEN is developed and marketed by Bioventus in countries around the world. (See the EU indications statement below.)
• DUROLANE® – a single-injection, 3ml, joint-fluid treatment to relieve mild to moderate osteoarthritis (OA) pain of all sizes of synovial joints. A 1ml version of the product, DUROLANE SJ, is also available and indicated for treatment of OA pain in small joints. DUROLANE is developed/manufactured by Q-Med AB and marketed by Bioventus in many countries outside the U.S. (See the EU indications statement below.)
Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics that make it a global leader of 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.
EXOGEN and the Bioventus logo are registered trademarks of Bioventus LLC. DUROLANE is a registered trademark of Q-Med AB.
* Nolte et al (2001) Low Intensity Pulsed Ultrasound in the Treatment of Nonunions, J. Trauma 51 (4) 693-703
** Kristiansen et al (1997) J. Bone Joint Surg. 79A 961-973 Accelerated Healing of Distal Radial Fractures with the Use of Specific, Low-Intensity Ultrasound A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Study; Heckman JD, Ryaby JP, McCabe J et al. (1994) Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Journal of Bone & Joint Surgery – American Volume 76:26-34.
EXOGEN summary of indications for use in the EU:
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes: Treatment of delayed union and non-unions, accelerating the time to heal of fresh fractures, treatment of stress fractures, accelerating repair following osteotomy, accelerating repair in bone transport procedures, accelerating repair in distraction osteogenesis procedures, treatment of joint fusion. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found at www.healmybone.com. DUROLANE summary of indications for use in the EU: DUROLANE (3ml): 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, toes, and the temporomandibular and facet joints.
DUROLANE SJ (1ml): Symptomatic treatment associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, toes, and the temporomandibular and facet joints.
Both DUROLANE and DUROLANE SJ are also indicated for pain following joint arthroscopy either in the presence of osteoarthritis or subsequent to general surgical repair within 3 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. Full prescribing information can be found at www.durolane.com.