Sam Brusco, Associate Editor02.12.21
Acuitive Technologies obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CITREFIX Knotless Suture Anchor System with CITREGEN material technology, a new generation bioresorbable synthetic polymer. The CITREFIX system assists attachment of tissue to bone during fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle, and foot extremities.
"This FDA clearance for the CITREFIX system is an important milestone for Acuitive," said Acuitive managing partner Michael McCarthy said in a press release. "The CITREFIX Knotless Suture Anchor System expands our reach in both the Extremities and Sports Medicine Markets. It's the second innovative product from our robust pipeline that is cleared for commercialization in the U.S."
The CITREGEN synthetic biomaterial guides tissue regeneration by replicating the intrinsic cellular biochemical and structural support network. Its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule integral in bone regeneration, where it regulates cellular metabolic processes and formation of mineral structures. CITREGEN, the core material technology, releases molecules essential to bone formation throughout its bioresorption process, leaving behind a biomimetic ceramic structure to be metabolized by the host tissue. This bioresorption process avoids the potential for bulk degradation and chronic inflammation.
CITREGEN material technology is supported by an extensive licensed intellectual property (IP) portfolio from both Northwestern University and The Pennsylvania State University, following over 15 years of academic research and five years of Acuitive proprietary development.
Acuitive plans to commercialize the CITREFIX System in mid-year 2021 with an orthopedic distribution partner.
"This FDA clearance for the CITREFIX system is an important milestone for Acuitive," said Acuitive managing partner Michael McCarthy said in a press release. "The CITREFIX Knotless Suture Anchor System expands our reach in both the Extremities and Sports Medicine Markets. It's the second innovative product from our robust pipeline that is cleared for commercialization in the U.S."
The CITREGEN synthetic biomaterial guides tissue regeneration by replicating the intrinsic cellular biochemical and structural support network. Its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule integral in bone regeneration, where it regulates cellular metabolic processes and formation of mineral structures. CITREGEN, the core material technology, releases molecules essential to bone formation throughout its bioresorption process, leaving behind a biomimetic ceramic structure to be metabolized by the host tissue. This bioresorption process avoids the potential for bulk degradation and chronic inflammation.
CITREGEN material technology is supported by an extensive licensed intellectual property (IP) portfolio from both Northwestern University and The Pennsylvania State University, following over 15 years of academic research and five years of Acuitive proprietary development.
Acuitive plans to commercialize the CITREFIX System in mid-year 2021 with an orthopedic distribution partner.