TGA clears three surgeons to use NovoSorb BTM
The TGA has granted three Australian plastic surgeons authorisation to use PolyNovo Biomaterials’ NovoSorb BTM in free flap donor site surgery.
PolyNovo, a subsidiary of Calzada (ASX:CZD), said three surgeons from the Royal Adelaide Hospital (RAH) have requested and been granted approval to use NovoSorb BTM prior to full marketing approval.
The three surgeons had all been involved in a recent 10-patient trial of the product in free flap donor sites. During the trial, NovoSorb BTM was implanted into patients to act as a dermal scaffold allowing for tissue regeneration and skin grafting. BTM integration was 100% successful in nine of the patients.
RAH specialist plastic surgeon Dr Marcus Wagstaff said the positive results of the trial to date “give me confidence in the NovoSorb BTM’s safe use in patients with the aim of improving free flap donor site outcomes”.
The TGA has granted the approval under its early-access scheme, and other surgeons are able to apply to become authorised NovoSorb BTM prescribers.
PolyNovo added that it expects to file for US regulatory approval for NovoSorb BTM in surgical wound applications during the current quarter. The company has already submitted an application covering the non-BTM version of NovoSorb for use in topical negative pressure (TNP) procedures.
Calzada (ASX:CZD) shares were trading 12.16% higher at $0.083 as of around 2 pm on Thursday.
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