- Axogen Inc AXGN has announced to suspend the market availability of Avive Soft Tissue Membrane (Avive) effective June 1, pending ongoing discussions with the FDA regarding the regulatory classification of Avive, according to SEC filing.
- This announcement applies only to Avive, representing approximately 5% of Company revenue and has no impact on any other Axogen product, including the Avance Nerve Graft.
- In a written agreement with the FDA, Axogen can continue legally market Avance as a tissue product under the FDA requirements for Human Cellular and Tissue-based Products (HCT/Ps) while taking the necessary steps to file a Biologics License Application (BLA).
- Avance received FDA’s Regenerative Medicine Advanced Therapy Designation in 2018, and the company plans to submit a marketing application for Avance in 2023.
- Avive is a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. It is currently processed and distributed following the FDA requirements as a 361 HCT/P tissue product.
- The company reiterates its full-year 2021 revenue outlook in the range of $133 million to $136 million.
- Additionally, the full-year 2021 gross margin is expected to remain above 80%.
- Further, pending the outcome with the FDA, the company may be required to record a write-down of Avive inventory of up to $1.5 million, which would negatively impact gross margin in the period recorded, and which is also contemplated in the full-year financial guidance.
- Earlier this week, PolarityTE Inc PTE also announced to terminate commercial sales of SkinTE (marketed under 361 HCT/P) and wind down commercial operations.
- Price Action: AXGN shares closed at $21.08 on Monday.
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