ALLENDALE, N.J., March 4, 2021 /PRNewswire/ -- Acuitive Technologies, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITRESPLINE™ and CITRELOCK™ Ligament Reconstruction Devices using their patented CITREGEN™ biomaterial technology, a market disruptive bioresorbable synthetic polymer. The CITRESPLINE/CITRELOCK system is intended to firmly engage tendons and ligaments within a bone tunnel while preserving the integrity of the soft tissue during insertion of the device. These products are intended to be used during orthopedic surgeries for fixation of ligament or tendon tissue repairs of the knee, shoulder, elbow, wrist, hand, ankle, and foot.
"This FDA clearance for the CITRESPLINE and CITRELOCK system is a significant milestone that allows Acuitive to compete in the Sports Medicine Market using innovative materials and designs that protect the soft tissue during insertion while improving fixation strength," said Michael McCarthy, Managing Partner, Acuitive Technologies, "The CITRESPLINE/CITRELOCK System is the third innovation from our robust pipeline of CITREGEN based products that is cleared for commercialization in the U.S."
Inspired by nature, CITREGEN is a synthetic biomaterial purposefully designed on a molecular level to guide 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 that plays a crucial role in bone regeneration, where it regulates cellular metabolic processes and the 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.
The CITREGEN material technology is supported by an extensive licensed intellectual property (IP) portfolio from both Northwestern University and The Pennsylvania State University, following more than 15 years of academic research and five years of Acuitive proprietary development. Acuitive plans to commercialize the CITRESPLINE and CITRELOCK System with an orthopedic distribution partner.
About Acuitive Technologies Acuitive Technologies, founded in 2014 by four partners with decades of orthopedic experience is devoted to improving medical device performance and patient outcomes. By using transformative CITREGEN biomaterials, Acuitive intends to offer patients cost effective, tissue regenerative products for musculoskeletal injury and disease.
Media Contact Michael McCarthy Acuitive Technologies, Inc. [email protected] 201.661.2680