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The solution complements the company’s existing portfolio of nerve protection products.
June 24, 2024
By: Michael Barbella
Managing Editor
Axogen Inc. has launched Avive+ Soft Tissue Matrix, which is intended for use as a soft tissue barrier. Avive+ is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing. Avive+ is processed and distributed in accordance with U.S. Food and Drug Administration (FDA) requirements for Human Cellular and Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulations, U.S. State regulations as a 361 human tissue product. “Product innovation is integral to our mission at Axogen,” Axogen Chairman/President/CEO Karen Zaderej said. “With the introduction of Avive+ Soft Tissue Matrix, we are excited to enhance our comprehensive solutions for nerve protection and address a significant need for patients with compression or non-transected nerve injuries.” Nerve protection represents approximately $800 million of the overall nerve repair market and covers a wide range of injuries and defects, including carpal and cubital tunnel syndromes, crush injuries, and other non-transected traumatic nerve injuries. The diversity of these injury types and their anatomical locations present unique challenges and Axogen uses its solutions to address the needs of each injury type and the healing process. Avive+ Soft Tissue Matrix complements the company’s existing portfolio of nerve protection products, which includes Axoguard Nerve Protector and Axoguard HA+ Nerve Protector. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact their peripheral nerve function. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or pain. “As a hand surgeon, I’ve seen the positive impact of using Avive+ Soft Tissue Matrix,” stated Sunishka Wimalawansa, M.D., associate professor of Orthopedic and Plastic Surgery at Wright State University in Dayton, Ohio. “The multi-layer design provides ideal handling, a robust barrier that retains the inherent properties of an amniotic membrane, and most importantly, the opportunity to improve patient outcomes after acute traumatic injury.” Axogen is focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. The company provides clinically proven and economically effective repair solutions for surgeons and healthcare providers. Axogen’s peripheral nerve repair platform features a products used in various applications and surgical specialties, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and pain treatment. Scheduled procedures are often pursued by patients seeking relief from conditions caused by a nerve defect or previous surgical interventions. Such procedures include providing sensation for women undergoing breast reconstruction following a mastectomy, nerve reconstruction after the surgical removal of painful neuromas, and oral and maxillofacial procedures, as well as nerve decompression. Conversely, emergent procedures typically arise from injuries that initially present in an emergency room, with specialists intervening either immediately or within a few days following the initial injury. This broad range of applications underscores Axogen’s vital role in addressing diverse patient needs in peripheral nerve repair. Axogen’s platform for peripheral nerve repair product line includes Avance Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; Avive+ Soft Tissue Matrix, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue repair; and Axoguard Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international countries.
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