- PolarityTE Inc PTE has announced preliminary topline data from a multi-center randomized controlled trial evaluating SkinTE for the treatment of Diabetic Foot Ulcers.
- The 100-subject trial, which assessed SkinTE plus standard of care (SOC) vs. SOC alone, met the primary endpoint of wound closure at 12 weeks and the secondary endpoint of Percent Area Reduction (PAR) at 12 weeks.
- 70% (35/50) of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of patients receiving SOC alone.
- Percent Area Reduction (PAR) at 12 weeks was significantly greater for the SkinTE plus SOC treatment group (84.4%) vs. SOC alone (53.5%).
- PolarityTE today also reported the recent publication of a peer-reviewed manuscript in the International Wound Journal reporting the interim analysis results of the Company's Diabetic Foot Ulcer Study. These data demonstrated that the AHSC+SOC 12-week closure rates were significantly greater than the SOC alone closure rates (72% vs. 32%, P = .005).
- SkinTE is a human cellular, and tissue-based product derived from a patient's own skin (autologous) intended to repair, reconstruct, replace, or supplement skin tissue.
- SkinTE is currently marketed as a human cell, tissue, and cellular and tissue-based product regulated solely under Section 361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271 (i.e., as a 361 HCT/P).
- PolarityTE plans to file an investigational new drug application with the FDA, followed by a biologics license application to have SkinTE regulated as a biologic.
- Price Action: PTE shares are up 22.1% at $1.19 during the premarket trading on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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