NovoSorb® BTM Feasibility Study Results for US FDA

21 April 2020

PolyNovo is pleased to share 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. This trial was a prospective, multicentre, single-arm, open label, traditional feasibility study conducted in the USA, 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 10%–70% total body surface area (TBSA) across four leading burn centres:
• University of California Davis (Sacramento),
• University of Tennessee (Memphis),
• University of South Florida (Tampa) and
• Wake Forest University (Winston-Salem)

Fourteen subjects (aged 21–67 years, mean 45.1% TBSA deep dermal/full-thickness burns) 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Seven subjects completed their 12-month follow-up assessments and seven subjects were withdrawn: two subjects died due to serious adverse events unrelated to BTM, one subject was withdrawn by the investigator, and four subjects were lost to follow-up.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 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%, median of 98.89%, and a range of 78% to 100%. Similarly, SSG take rates available for 11 subjects were high with a mean of 97.53%, median of 100%, and a range of 75.0% to 100.0%.

Wound closure was assessed at various intervals after skin grafting. Mean wound closure rates at 1 month varied across anatomical locations in a range from 94.8% to 100%, increasing to a range of 99.8% to 100% at 3 months, demonstrating 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. Infections were common and occurred in 12 of 14 (85.7%) subjects, with 7 subjects (50%) experiencing wound infections at BTM-treated sites. These rarely resulted in removal of BTM, which occurred in 2 subjects (14.3%).

As a consequence of these results, PolyNovo anticipates our Pivotal Study IDE to be approved by the US FDA in June 2020.

PolyNovo’s CEO, Mr Paul Brennan said, “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.”

Read the full media release.


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