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AxoGen Announces RECON® Study Update: Study Supports Company’s Planned Biologic License Application (BLA) For Avance® Nerve Graf | NEWS-Line for Healthcare Professionals

AxoGen Announces RECON® Study Update: Study Supports Company’s Planned Biologic License Application (BLA) For Avance® Nerve Graf


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AxoGen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for damage or discontinuity to peripheral nerves, today 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.

“We are pleased to have achieved this important enrollment milestone, which we could not have reached without the dedication and commitment of each of the participating study teams,” said Karen Zaderej, chairman, CEO, and president of AxoGen. “We have been working diligently to transition our nerve graft from classification as a 361 HCT/P tissue product to a biologic product. The RECON® study is a critical step in this transition process.”

In September 2018, the FDA granted a Regenerative Medicine Advance Therapy (RMAT) designation for Avance® Nerve Graft. A regenerative medicine therapy is eligible for the designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such a disease or condition. The RMAT designation provides access to a streamlined approval process for regenerative medicine technologies and ensures continued informal meetings with the FDA in support of the BLA for Avance® Nerve Graft.

[photo credit: AxoGen]






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