Axogen Sponsored RANGER® Registry Reaches 2,000 Nerve Repair Enrollment Milestone
Largest peripheral nerve repair registry in the world generates clinical evidence of repair, safety, and outcomes data for peripheral nerve injuries
ALACHUA, Fla., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today announced that its RANGER registry enrollment has reached the milestone of 2,000 nerve injuries repaired with Avance® Nerve Graft.
RANGER is the largest multi-center clinical registry in peripheral nerve repair. The ongoing registry study allows for the evaluation of nerve injury, repair techniques, and outcomes in sensory, mixed, and motor nerves, across both short and long gap repairs, and has supported several peer-reviewed clinical publications and surgeon presentations at scientific meetings. At the September meeting of the American Society for Surgery of the Hand, data were presented from 511 upper extremity nerve repairs with an average follow-up of 14 months demonstrating a consistent meaningful recovery rate of 84% for Avance Nerve Graft with no graft related adverse events. Findings from the MATCHSM cohort of the RANGER study show Avance Nerve Graft had statistically significant improvements as compared to synthetic conduits in three essential areas: rate of recovery, overall degree of recovery, and average recovery of static two-point discrimination, a key sensory measure in the hand. The MATCH arm of RANGER serves as a contemporary cohort control, providing conduit and autograft data from participating centers.
“We are pleased with the depth and breadth of nerve repair clinical data that is developing from our RANGER registry,” said Karen Zaderej, chairman, CEO, and president. “We believe that data in the RANGER registry will continue to establish and further refine treatment algorithms for clinicians. We are committed to advancing clinical evidence in nerve repair and thank the surgeons who contribute to and use this data to better understand and improve nerve repair outcomes.”
The RANGER registry continues to provide significant new clinical evidence in the management of nerve injuries demonstrating meaningful recovery treating a variety of nerve injuries and gap lengths with Avance Nerve Graft. The data demonstrates the ability to restore sensory and motor function and shows positive outcomes while eliminating the donor site comorbidities associated with autograft.
About the RANGER® Registry
The RANGER registry, a multicenter Registry of Avance Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction, is an active, multicenter clinical registry designed to continuously monitor and collect injury, repair, safety, and outcomes data for peripheral nerve injuries repaired with processed nerve allograft (Avance Nerve Graft), nerve autograft, and manufactured conduits. The study, launched in 2008, includes more than 30 centers. RANGER is an Axogen sponsored ongoing open label registry study. Each patient outcome is dependent upon the nature and extent of nerve loss or damage, timing between nerve loss and repair, and the natural course of the patient’s recovery.
About Avance® Nerve Graft
Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site. Avance provides structural support for regenerating axons, and revascularizes and remodels into the patient’s own tissue. It is available in a variety of lengths and diameters.
Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. 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 the function of their peripheral nerves. 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 the initiation of pain.
Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft; 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; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, and several other European and international countries.
Peter Mariani, Chief Financial Officer
Released January 8, 2020