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Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, recently announced the commercial availability of a complete line of bone grafting product solutions. Joining Trabexus EB, the company’s flagship bone grafting solution, Fortera is a completely synthetic calcium phosphate cement, capable of controlled delivery through a 16-gauge cannula. REGENTO is a resorbable, particulate b-TCP bone void filler with engineered macroporosity to promote protein deposition and cell attachment.
These newly introduced products join Trabexus EB, which first received 510(k) clearance in 2015. TRABEXUS EB is a self-setting, gradually resorbable, calcium phosphate matrix enhanced with partially demineralized allograft particles. The engineered bone component is formed into “hourglass” shapes (TRABS®) using a proprietary manufacturing process.
This novel shape provides multiple benefits, including increased “interconnectivity” of adjacent particles, creation of channels for accelerated remodeling and greater overall surface area. Further, the TRABS are partially demineralized, exposing key osteoinductive proteins, which are known to influence and direct the formation of new bone. Trabexus EB is resorbed and remodeled by the body as new bone formation occurs during the healing process.
“With the introduction of Fortera and Regento to our product portfolio, Vivorté now offers a complete line of synthetic biomaterials possessing a wide range of clinical performance attributes” said Ruth Voor, CEO of Vivorté, Inc. “Vivorté is a unique, emerging company, with multiple 510(k) cleared technologies, vertically-integrated manufacturing capability and an R&D pipeline of orthopedic biomaterials and traditional metallic implants. To date, our products have been well-received in the marketplace by orthopedic surgeons and hospitals, and we continue to expand our distribution network to reach institutions across the United States.”
According to BioMedGPS, the current market for bone graft substitute products exceeds $1.7B annually in the United States alone. Bone grafting procedures are necessary to fill defects or cavities in bone as the result of injury, reconstructive surgical procedures such as a joint replacement, or surgical excision following the removal of tumors or cysts.
Clinical considerations vary across these procedures, requiring biomaterials with differing handling characteristics, biological activity and mechanical performance. Vivorté continually seeks to understand the surgical environment in order to design and develop products that best complement each surgeon’s unique operative technique.
The Fortera and REGENTO products will be made available concurrent with the Orthopaedic Trauma Association (OTA) Annual Meeting, being held October 11-14, 2017 in Vancouver, B.C., Canada. Representatives from Vivorté will be attending the OTA meeting to further address product requests and inquiries.
For Further Information
More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials. This report covers the following market segments: orthopedic bone graft substitutes, orthopedic growth factors, orthopedic stem cell therapy, orthopedic hyaluronic acid viscosupplementations, orthopedic cartilage repairs, and spinal machined bone allografts.
The iData series on the market for orthopedic biomaterials covers the U.S., Japan, South Korea, Australia, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic biomaterials device market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Biomaterials brochure and synopsis.