Benzinga | Sep 16, 2020 08:14AM EDT

PolarityTE Reports SkinTE Health Economics-DFU Interim Analysis Data Showed Potential For Cost Savings, Improved Wound Closure

PolarityTE, Inc. (NASDAQ:PTE) today announced cost per product data from the protocol-specified interim analysis in the Company's ongoing randomized controlled trial (RCT) evaluating SkinTE for the treatment of diabetic foot ulcers (DFUs), which previously reported statistically significant wound closure rates of 72% for SkinTE plus the standard of care (SOC) vs 32% for the SOC alone (p=0.005).

Key Findings

* Favorable cost for SkinTE vs. data reported for skin substitute products: The SkinTE DFU RCT interim analysis demonstrated mean total product cost per treated wound of $1,311.20, which is 61% lower than the mean cost of product per treated wound reported by Samsell, et al.

* Higher wound closure rate vs. data reported for skin substitute products: The 12-week wound closure rate in the SkinTE DFU RCT interim analysis was 72%, which is 60% greater than the mean 12-week healing rate reported by Samsell, et al.

Mean total product cost per patient was calculated based on the current pricing for SkinTE multiplied by the number of applications required per patient. SkinTE mean total product cost per treated wound was $1,311.20, with 1.08 mean applications per patient.

A study published by Samsell, et al. in the Journal of Wound Care (September 2019) entitled, "Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes," reviewed the cost of eight widely used skin substitute products.1 Although SkinTE was not included in the study and the DFU RCT interim analysis reported on a smaller patient population, the cost of SkinTE appears to compare favorably to other products reviewed in the study.

In the Samsell, et al. study, the mean healing rate was 45% at 12 weeks (ranging from 28-62%) and 54% at 16 weeks (ranging from 33-68%) with skin substitutes, including products such as human fibroblastderived dermal substitutes, human acellular dermal matrices, bioengineered living cellular constructs, human placental membrane allografts, and collagen bilayer matrices. The mean cost of product per treated wound was $3,368 (ranging from $1,007.17 to $7,822.27). The mean number of applications required to treat one DFU was 4.45 and ranged from 1.2 to 10.1.

As noted above, the SkinTE DFU RCT interim analysis data demonstrated mean total product costs of $1,311.20, which is 61% lower than the mean cost of product per treated wound reported by Samsell, et al. Moreover, the mean of the number of applications reported by Samsell et al. is four times greater than the 1.08 applications per patient in the SkinTE DFU RCT interim analysis. Finally, the 12-week wound closure rate in the SkinTE DFU RCT interim analysis was 72%, which is 60% greater than the mean 12-week healing rate reported by Samsell, et al.

Richard Hague, President and Chief Operating Officer at PolarityTE commented, "It is important to note the DFU RCT interim analysis data is based on a limited set of 25 patients treated with SkinTE. However, we are encouraged by the data we've seen so far and look forward to reporting results from the completed study in due course." Mr. Hague continued, "We appreciate that the variable costs of skin substitutes combined with the high number of applications required to close a wound can create a challenging environment for patients, providers, and payors alike. We are heartened by the potential cost savings SkinTE offers all parties as a result of the low number of applications required to close DFUs in the interim analysis."

Nikolai Sopko, MD, PhD, Chief Scientific Officer commented, "The devastating impact of DFUs on patients is significant and the cost of DFUs to the US healthcare system is extensive. We view this data as highlighting the potential for SkinTE to provide cost savings for the treatment of DFUs."

As of September 15, 2020, approximately 78 patients have been enrolled in the Company's DFU RCT, which has a target enrollment of 102 patients. The Company expects enrollment to complete by the first quarter of 2021, with top line data available by the second quarter of 2021.

1 Samsell B, McLean J, Cazzell S, Dorsch K, Moyer PM, Moore M. Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes. J Wound Care. 2019;28(Sup9):S14-S26. doi:10.12968/jowc.2019.28.Sup9.S14