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Biorestorative (BIO) Reports FDA Type B Meeting Ends With Positive Outcome

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Regulatory

February 11, 2026 — Biorestorative (BIO) reported that its Type B meeting with the U.S. Food and Drug Administration concluded with a positive outcome. The company’s management will review the feedback to guide the next steps in the regulatory pathway for its lead product, a biodegradable wound dressing. No immediate impact on stock price or trading was disclosed. The meeting followed a December 2025 submission of the device for 510(k) clearance.

EditorThomas Ho