Strong results from PolyNovo's NovoSorb BTM trial
Calzada (ASX:CZD) subsidiary PolyNovo has announced positive results from a clinical trial of its NovoSorb BTM dermal scaffold in free-flap donor site repair.
Results from the 10-patient trial show that NovoSorb BTM (Biodegradable Temporising Matrix) was well tolerated in all cases.
BTM integration was 100% successful in nine of the patients. In the last case, a thigh wound donor site became infected due to an unrelated medical issue, causing 30% BTM loss. But after antibiotic treatment the remaining 70% integrated fully and was grafted over.
Surgeons reported that BTM implantation was straightforward and NovoSorb BTM demonstrated an efficiency of skin grafting, PolyNovo said.
NovoSorb BTM also demonstrated an ability to resist infection and to continue to integrate while the infection is being treated when one does occur. Patients also experienced minimal wound contraction.
These last findings are important because PolyNovo believes the collected data to be appropriate to deep-burn wounds.
In severe burns, wound infection is life-threatening. Minimising wound contraction prior to skin factor is also an important factor in these patients as it encourages patient survival and reduces the number of surgeries required.
“This is a significant clinical outcome that demonstrates the safety and performance of a NovoSorb implantable device for potential use in many deep wound and tissue repair applications,” PolyNovo CEO Laurent Fossaert said.
PolyNovo aims to file for US FDA approval of NovoSorb BTM in surgical wound applications by the end of Q1 2014.
The company also plans to use results from the trial to inform an approved study of the BTM scaffold in five patients with significant burn injuries, and a planned European trial in 10 patients that will form part of applications in this indication for the US and Europe.
PolyNovo last month filed for US approval for its related NovoSorb wound dressing in topical negative pressure (TNP) procedures involving vacuum-assisted closure of pressure sores.
Calzada (ASX:CZD) shares were trading 13.16% higher at $0.086 as of around 1.30 pm on Thursday.
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