PolyNovo (ASX:PNV) has released the summary of results for the CP-002 Feasibility Study to assess the safety and effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the treatment of severe skin burn injuries.
The company said the trial was a prospective, multicentre, single-arm, open-label, traditional feasibility study conducted in the US, where NovoSorb BTM was used under an FDA Investigational Device Exemption (IDE).
This 12-month clinical study recruited 15 subjects with burns within the range of 10-70 per cent total body surface area (TBSA) across four leading burn centres.
Fourteen subjects had BTM applied to treat thermal/contact burns. One subject consented but was deemed ineligible during screening and did not have BTM applied. The first subject was enrolled in March 2017 and enrolment ended in August 2018.
Seven subjects completed their 12-month follow-up assessments and seven subjects were withdrawn: two subjects died due to serious adverse events unrelated to BTM, one subject was withdrawn by the investigator, and four subjects were lost to follow-up.
The co-primary effectiveness endpoints were BTM ‘take’ rate assessed after integration at the time of sealing membrane removal, and split-thickness skin graft (SSG) ‘take’ rate at 7–10 days after application.
The company said results available for 12 subjects indicate that BTM provided effective temporary wound coverage and integrated into the wound bed with a mean BTM take rate of 95.22 per cent, median of 98.89 per cent, and a range of 78 per cent to 100 per cent. It said SSG take rates available for 11 subjects were high with a mean of 97.53 per cent, median of 100 per cent, and a range of 75.0 per cent to 100.0 per cent.
Wound closure was also assessed at various intervals after skin grafting. The company said mean wound closure rates at one month varied across anatomical locations in a range from 94.8 per cent to 100 per cent, increasing to a range of 99.8 per cent to 100 per cent at three months, adding this demonstrated the success of the skin grafting procedures used to provide definitive wound closure in these large wounds.
No new risks related to the use of BTM were identified in this study, it said. Infections were common and occurred in 12 of 14 subjects, with seven subjects experiencing wound infections at BTM-treated sites. These rarely resulted in removal of BTM, which occurred in two subjects.
PolyNovo said it anticipates its Pivotal Study IDE to be approved by the FDA in June 2020.
According to CEO Paul Brennan, “These results are outstanding. Not only has NovoSorb BTM integrated well, the take of the split skin grafts and closure of these wounds is remarkable. Burns are often contaminated so seeing infections within this cohort is not unusual. What is unusual is seeing the Matrix continue to integrate and later for the skin graft to take to the matrix with an excellent clinical and cosmetic outcome. The health economics of this success is a strong selling message for us and in the forthcoming Pivotal trial gathering hard health economic data will add to our armoury and success.”