PolyNovo (ASX: PNV) has announced that Associate Professor John Greenwood AM, and colleagues at the Royal Adelaide Hospital, have published a follow-up paper in ePlasty that documents positive clinical trial results in patients following the improvements that PolyNovo made to the Biodegradable Temporising Matrix (BTM) product in the aftermath of the Free Flap donor site reconstruction trial.
Included in the paper are sequential photographs of BTM integration and wound healing along with measurement data and histopathological analysis.
The authors report that NovoSorb polymer has almost completed biodegraded, resulting in neo-dermal skin structure replacing the polymer in every patient.
"This is consistent with the desired properties and in-use goals and represents the fulfilment of an important regulatory requirement," the company said.
"In addition, split-skin draft take (success) was 100%. No infections were observed, important in view of its intended use in burn patients and open wounds. The quality of the healing, minimal scarring and unhindered tendon movement support the use of BTM as a significant advancement on existing treatments, such as primary split-skin graft application."
According to CEO, Paul Brennan, "A/Prof John Greenwood has consistently recorded the progress of these patients and published a high level of evidence supporting the use of the BTM in surgical wounds. PolyNovo, through the clinical data we are amassing, including prospective clinical trials, provides substantive evidence to support both our regulatory and future commercial plans.
"We will consider further regulatory filings in the near term on the back of this clinical data."