Vivorté announces the commercial availability of FORTERA™ and REGENTO™ bone grafting solutions for orthopedic surgery
LOUISVILLE, KY — (October 3, 2017) — Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, today 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.
About Vivorté, Inc.
Vivorté, Inc., headquartered in Louisville, Kentucky, is a privately-held, ISO-certified orthopedic biomaterials manufacturer, focused on developing innovative and cost-effective, surgical products for the benefit of surgeons, hospitals and patients. The company’s products include TRABEXUS® EB™ Osteoinductive Bone Matrix, Fortera™ Injectable Bone Graft and Regento™ Bone Void Filler. To learn more, please visit our website at www.vivorte.com.
Contact: Therese Montano / Vivorté, Inc. / 502-714-7234 / tmontano@vivorte.com
