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.