AxoGen, Inc. announced that the RECON Study supporting its Biologic License Application (BLA) Submission for Avance Nerve Graft has reached its current enrollment milestone of 170 subjects. RECON is AxoGen’s phase three pivotal study comparing Avance Nerve Graft to manufactured conduits. The study requires a one year follow up period for all subjects and is designed to assess return of sensation in digital nerve injuries, quality of life outcomes, and subject satisfaction. The FDA-approved statistical analysis plan was designed with an interim blinded analysis to provide a safeguard for the assumptions used in the design of the protocol. It is possible to increase the study sample size to maintain the original power of the study in the event the pooled variance of the standard deviation, a key statistical assumption in the power analysis, is not consistent with the original assumptions. This interim analysis is designed to protect the validity and integrity of the study. AxoGen has submitted the interim analysis to the FDA for review with the intention of obtaining agreement on next steps, which could include continuing study enrollment. The Company will provide further updates upon completion of the review, the timing of which is uncertain based upon near-term funding issues faced by the FDA.
Axogen, Inc. is focused on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. It offers repair solutions for surgeons and healthcare providers. Its products include Avance nerve graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard Nerve Cap, Axotouch Two-Point Discriminator and Axoguard HA+ Nerve Protector. Avance nerve graft is a biologically active processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site. Axoguard Nerve Connector is a porcine submucosa extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves. Axoguard Nerve Protector is a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce nerve reconstruction while preventing soft tissue attachment. Axotouch Two-Point Discriminator is used to measure the innervation density of any surface area of the skin.
AXOGEN, INC. 
