Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone Graft

Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone GraftThe Associated PressDURHAM, N.C.

DURHAM, N.C.–(BUSINESS WIRE)–Jun 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

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200625005078/en/

Bioventus Receives 510(k) Clearance for its SIGNAFUSE Bioactive Bone Graft in the strip format. (Photo: Business Wire)

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 prospective 2 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, http://www.bioventus.com and follow the company on LinkedIn and Twitter.

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.

1. 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

View source version on businesswire.com:https://www.businesswire.com/news/home/20200625005078/en/

CONTACT: Thomas Hill

919-474-6715

thomas.hill@bioventusglobal.com

KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA SURGERY MEDICAL DEVICES HEALTH

SOURCE: Bioventus

PUB: 06/25/2020 10:00 AM/DISC: 06/25/2020 10:01 AM

http://www.businesswire.com/news/home/20200625005078/en

COMMENTS