PolarityTE : SkinTE Meets Primary Endpoints In Final Analysis From Diabetic Foot Ulcer Trial

PolarityTE Inc. (PTE) said that SkinTE met primary and secondary endpoints in final analysis from diabetic foot ulcer trial.

The multi-center randomized controlled trial, which evaluates treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE plus standard of care compared to standard of care alone, met the primary endpoint of wound closure at 12 weeks.

The trial also met the secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks.

The company noted that 100 participants were evaluated across 13 sites with 50 participants receiving SkinTE plus standard of care or SOC and 50 receiving standard of care alone.

The company said 70% of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone.

The company noted that Percent Area Reduction 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, the company said.

In addition, PolarityTE announced a randomized controlled trial evaluating SkinTE versus SkinTE plus SOC in Venous Leg Ulcers (VLUs) has been completed with a total of 29 enrolled participants. Data from the VLU trial will be announced via press release in the second half of 2021.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
HSBC Holdings Plc shares were gaining In London trading as well as in pre-market activity on the NYSE after the Asia-focused lender backed its positive outlook after reporting significantly higher third-quarter profit. Further, the company announced share buyback of $2 billion, which will be commenced shortly. Walmart is recalling certain Aromatherapy Room Spray due to the possible presence of a rare and dangerous bacteria that is suspected to be behind two deaths in the United States, the U.S. Consumer Product Safety Commission said. The recall involves about 3,900 bottles of Better Homes and Gardens-branded Essential Oil Infused Aromatherapy Room Spray with Gemstones in six different scents. Royal Caribbean Group's ultra-luxury brand Silversea Cruises is set to launch the world's first hybrid-powered cruise ship in the summer of 2023. This will also be the first ship with large-scale fuel cell technology to enable emission-free port operations. The fuel cells will provide 100% of power while at port.
Follow RTT