Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE Bioactive Bone Graft
DURHAM, NC – June 25, 2020 – Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new strip format. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips.1
SIGNAFUSE has been available as a putty since 2014; the new strips hydrate rapidly and provide exceptional handling properties for intraoperative flexibility. They come in multiple sizes ranging from 25 to 200 millimeters in length, with the longer strips providing a great option for large, multilevel procedures.
The biphasic mineral in SIGNAFUSE is composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate; a ratio supported by multiple prospective2 and randomized controlled trials.3-5
“We are excited to expand our portfolio of bone graft solutions with the SIGNAFUSE Bioactive Bone Graft strip,” said Megan Osorio, Vice President, Marketing, Bioventus. “Apart from the ideal combination of biomaterials that contribute to healing, and best-in-class handling, this product is unique in that it offers a great solution for patients that require more significant interventions such as spinal deformity correction.”
“We also believe SIGNAFUSE in the strip format will provide efficiencies for the hospital, either by opening fewer packages or cost savings opportunities vs. alternative grafts,” added John Nosenzo, Chief Commercial Officer, Bioventus.
The new strip format of SIGNAFUSE will be available in Q3 from our distributor partners across the country.
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. 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.bioventus.com and follow the company on LinkedIn and Twitter.
Media Contact: Thomas Hill, , [email protected]
Bioventus, the Bioventus logo and SIGNAFUSE are registered trademarks of Bioventus LLC.
Summary of Indications for Use
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
- Data on file. RPT-000962. Osteoblast Differentiation Study. 2. Cavagna R, Daculsi G, Bouler JM. Macroporous calcium phosphate ceramic: a prospective study of 106 cases in lumbar spinal fusion. J Long-Term Effects Med Implants, 1999;9:403-12. 3. Ransford AO, Morley T, Edgar MA, et al. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br. 1998;80-B:13-8. doi: 10.1302/0301-620x.80b1.7276 4. Delécrin J, Takahashi S, Gouin F, Passuti N. A synthetic porous ceramic as a bone graft substitute in the surgical management of scoliosis: a prospective, randomized study. Spine (Phila Pa 1976). 2000;25(5):563-9. doi: 10.1097/00007632-200003010-00006 5. Pascal-Moussellard H, Catonné Y, Robert R, Daculsi G. Anterior cervical fusion with PEEK cages: clinical results of a prospective, comparative, multicenter and randomized study comparing iliac graft and a macroporous biphasic calcium phosphate. Spine J. 2006;6(suppl 5):136S. Abstract P109. doi: 10.1016/j.spinee.2006.06.318
Bioventus Selects Bazis NN as Distributor of DUROLANE in Russia
HOOFDDORP, THE NETHERLANDS – June 15, 2020 – Bioventus, a global leader in orthobiologic solutions, has selected Bazis NN as its authorized distributor for DUROLANE, its single-injection joint-fluid osteoarthritis (OA) treatment. OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues.
According to official statistics, patients with OA make up one quarter of all patients with musculoskeletal system diseases and OA is detected in 4% of the entire adult population.1 Hyaluronic acid (HA)-based products like DUROLANE and DUROLANE SJ help manage pain in the knees, hips, wrists, elbows, ankles, finger and toe joints of patients with OA.
“We believe the OA market in Russia is underserved and the patients there will benefit greatly from DUROLANE,” said John Nosenzo, Chief Commercial Officer, Bioventus. “Bazis has a terrific track record in marketing and selling orthopaedic solutions in Russia and we are pleased they are helping Bioventus reach more patients and physicians with our proven pain reliever for osteoarthritis.”
“Bazis has been serving patients and physicians in Russia for more than 16 years,” said Aleksandr Alekseev, Director, Bazis NN. “We are excited to offer DUROLANE for knee and hip and DUROLANE SJ for small joints. Both are safe, single injection options for patients that provide powerful and long-lasting OA pain relief.”
DUROLANE and DUROLANE SJ are produced using a natural, safe and proven process called NASHA®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. It has been proven to provide greater reduction in OA knee pain versus Synvisc-One®2* and longer lasting pain relief versus a steroid injection3. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events.4
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. 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 LinkedIn and Twitter.
Media Contact: Thomas Hill, , [email protected]
Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.
Summary of Indication for Use: DUROLANE (3ml): Symptomatic treatment of mild to moderate knee or hip osteoarthritis. DUROLANE SJ (1ml): 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 and breastfeeding women, and in children. Risks can include transient pain, swelling and/or stiffness at the injection site. Indications presented are those approved in Russia; 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.(1mL / 3mL).
References: 1. Kabalyk M.A. Prevalence of Osteoarthritis in Russia: Regional Aspects of Trends in Statistical Parameters During 2011–2016 Rheumatology Science and Practice. 2018;56(4):416-422. (In Russ.) doi:10.14412/1995-4484-2018-416-422. 2. 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; 2018.
