Benzinga | Feb 18, 2021 07:06AM EST

Axogen Sponsored REPOSE Study Completes Pilot Phase Analysis

ALACHUA, Fla., Feb. 18, 2021 (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 completion of pilot phase analysis for its REPOSE clinical study.



Analysis of the REPOSE study's 15-subject single arm pilot phase demonstrated that subjects experienced a clinically significant reduction in pain from baseline at each of the 3, 6, 9, and 12 month timepoints following surgical excision of the neuroma and placement of Axoguard Nerve Cap(r) (p<0.0001). Specifically, the study observed a mean reduction in pain of 69 points at 3 months and 80 points at 12 months as measured on the 100-point Visual Analog Scale (VAS). Additionally, subjects experienced clinically meaningful improvements in Fatigue, Physical Function, Sleep Disturbance, Pain Interference, Pain Intensity, and Pain Behavior as measured by the validated PROMIS(r) questionnaires, and pain medication utilization data showed positive indicators for a reduction of pain medication burden, including opioids, following the procedure.

"Neuroma pain can be a challenging clinical condition to manage, and results from historical treatment options, both surgical and pharmacological, can be limited," said Craig Thomajan, DPM, FACFAS, FAENS, Peripheral Nerve Surgeon at Austin Foot and Ankle Specialists, and the lead clinical investigator for REPOSE. "We are pleased with the early successes from REPOSE and are excited to continue this meaningful study. Access to impactful technologies for the treatment and prevention of symptomatic neuromas offers patients an opportunity for reduced pain and improved quality of life."

"We are pleased that the analysis of this pilot phase clinical data demonstrates the potential impact our Axoguard Nerve Cap can have on symptomatic neuroma pain. The outcomes reinforce the assumptions used in our study modeling and exceed those reported for standard neurectomy," said Karen Zaderej, chairman, CEO, and president. "We believe the comparative phase of the study will support the role of Axoguard Nerve Cap in the management of symptomatic neuroma. We continue to be committed to providing surgeons with clinical evidence advancing the science of nerve repair, including surgical treatments that provide clinically meaningful improvements for patients suffering with chronic nerve pain."

Enrollment in the comparative phase of REPOSE is underway and the company expects enrollment to be completed in the first quarter of 2022, assuming limited impact from COVID-19.