PolarityTE's SkinTE Meets Primary, Secondary Endpoint Goals In Diabetic Foot Ulcer Trial

PolarityTE Inc PTE has announced final data from a trial evaluating SkinTE plus standard of care (SOC) vs. SOC alone for Diabetic Foot Ulcers.

• The trial met the primary endpoint of wound closure at 12 weeks and the secondary endpoint of Percent Area Reduction (PAR), assessed at 4, 6, 8, 10, and 12 weeks. 
• Primary Endpoint: 70% of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% of participants receiving SOC alone.
• Secondary Endpoint: Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs. SOC alone.
• 90% of SkinTE plus SOC treated participants received a single application of SkinTE.
• Treatment with SkinTE plus SOC increased the odds of wound closure by 5.37 times versus SOC.
• PolarityTE also announced that a trial evaluating SkinTE versus SkinTE plus SOC in Venous Leg Ulcers is complete with a total of 29 enrolled participants. 
• Topline data from the trial will be announced in 2H of 2021.
• Price Action: PTE shares are up 3.1% at $0.84 during the market session on the last check Wednesday.