22 Oct Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN™ CITRELOCK™ Tendon Interference Screw System
First FDA-cleared thermoset bioresorbable synthetic polymer.
ALLENDALE, N.J., Oct. 21, 2020 /PRNewswire/ — Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITRELOCK™ Interference Screw System with CITREGEN™ material technology, a new generation thermoset bioresorbable synthetic polymer now FDA cleared. The CITRELOCK system is intended to attach tissue during orthopedic surgeries such as fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot extremities.
“The FDA clearance of the CITRELOCK system is an important milestone for Acuitive,” said Michael McCarthy, Managing Partner, Acuitive Technologies, Inc. “It’s the first biomaterial from our robust pipeline 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.
“The CITREGEN material is based on an unprecedented and innovative bioresorbable biomaterial technology developed to support the body’s normal healing processes and promote tissue regeneration,” stated inventor of citrate-based biomaterials Guillermo Ameer, Sc.D., the Daniel Hale Williams professor of Biomedical Engineering and Surgery and founding director of the Center for Advanced Regenerative Engineering at Northwestern University. “When used to fabricate devices for reconstruction of tissues such as ligaments, blood vessels, bladder and bone, results have been impressive and beyond expectations.”
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 as seen in currently marketed biodegradable polymers.
Additionally, the unique properties of CITREGEN allow for innovative implant designs that protect the soft tissue graft during insertion and increase the pull-out strength over time. The CITRELOCK System will be offered with both reusable surgical instruments or single-use instruments, and in a full range of device sizes. Acuitive will commercialize the CITRELOCK System in early 2021 with an orthopedic distribution partner.
“This regulatory milestone is an exciting breakthrough that validates more than 15 years of citrate-based biomaterials research,” observed co-inventor Jian Yang, Ph.D., Leader of the Transformative Biomaterials and Biotechnology lab and the Dorothy Foehr Huck and J. Lloyd Huck Chair in Regenerative Engineering at The Pennsylvania State University. “CITREGEN is a platform biomaterial that will tackle many clinical problems in wound treatment and tissue regeneration.”
CITREGEN 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.
About Acuitive Technologies
Acuitive Technologies 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. Acuitive was founded in 2014 by four partners with decades of orthopedic experience and successes in multiple start-up companies that have introduced new technologies to the marketplace.
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CITREGEN™ CITRELOCK™ are registered trademarks of Acuitive Technology, Inc.