Avita Medical (NASDAQ:RCEL) presented results from its PermeaDerm-I study, a randomized controlled trial evaluating PermeaDerm as temporary wound coverage following excision and before split-thickness skin grafting, compared with cadaveric allograft.
During a key opinion leader webinar, the company said the study enrolled 40 patients with wounds covering up to 30% of total body surface area, or TBSA, across 11 burn centers. Patients were followed for eight weeks after receiving either PermeaDerm or allograft during the temporization period.
Cost and Workflow Findings
Mean product cost per percentage of TBSA treated was $148.70 for PermeaDerm, compared with $497.10 for allograft, according to the presentation. Saraswat said the difference equated to roughly $348 in savings for every 1% of TBSA treated.
The study also found that PermeaDerm reduced preparation time by nearly 96% versus allograft. Company representatives and clinicians attributed the difference to the absence of tissue tracking, thawing and meshing requirements associated with cadaveric allograft. Application time in the operating room was comparable between the two groups, Saraswat said.
PermeaDerm is a biosynthetic, bilayer wound matrix intended to provide temporary coverage before definitive closure. Katie Bush, Avita’s senior vice president of scientific and medical affairs, said the product is designed to protect the wound, permit oxygen exchange and provide clinicians with a transparent view of the wound bed. The product is removed before final reconstruction.
Comparable Healing and Safety Results
According to Saraswat, approximately 94% of PermeaDerm patients achieved at least 95% graft take one week after grafting, a result she described as essentially the same as the allograft group. By eight weeks, all patients in both treatment groups had achieved wound healing.
The company also reported no PermeaDerm-related adverse events. Overall adverse events were numerically lower in the PermeaDerm group than in the allograft group, including fewer events in the study area, according to the presentation. Wound-bed biopsies did not show meaningful differences in inflammation between the groups.
Investigators and patients each reported 100% satisfaction or high satisfaction with PermeaDerm, Saraswat said. She added that the product’s standardized sizes and synthetic supply chain could offer predictability relative to allograft, which may vary in size and thickness and can be subject to donor availability.
Surgeons Discuss Clinical Experience
Dr. Christina Sharon, burn director at Baton Rouge General, presented two cases from her practice in which PermeaDerm was used alongside Avita’s Cohealyx and RECELL products.
In one case involving a patient with a 45% TBSA burn, Sharon said PermeaDerm was applied after excision to provide temporary wound coverage while the patient was stabilized and the wound bed was assessed. The transparency of the material allowed her to identify areas that had converted and required additional excision while leaving other areas covered. The patient later received Cohealyx, a 6:1 wide-mesh split-thickness skin graft, RECELL and cultured epithelial autografts. Sharon said the patient was discharged on day 48 with 98% wound closure.
In a second case involving 22% TBSA burns to the lower extremities and hand, Sharon used PermeaDerm for eight days before definitive reconstruction. She highlighted a PermeaDerm glove configuration for hand coverage, saying it conformed to complex anatomy more efficiently than wrapping individual fingers. At a 45-day follow-up, she said the patient had healed.
During the question-and-answer session, Saraswat said she believed PermeaDerm could be used in burns exceeding the study’s 30% TBSA enrollment limit, though the trial itself did not evaluate that population. Sharon said she had personally used the product in patients with 45%, 60% and 70% TBSA burns and reported favorable outcomes.
Both surgeons said they would favor PermeaDerm over allograft even if product costs were identical, citing ease of use, visibility of the wound bed and reduced operating-room logistics. Bush noted that tissue-biopsy data from the study did not identify differences between PermeaDerm and allograft wound beds in the biological measures discussed during the call.
Avita positioned PermeaDerm as the temporary-coverage component of a broader acute wound-care portfolio, with Cohealyx intended to support wound-bed preparation and RECELL used during definitive skin restoration.
About Avita Medical (NASDAQ:RCEL)
Avita Medical, Inc (NASDAQ: RCEL) is a regenerative medicine company focused on the development and commercialization of cell?based therapies for acute and chronic wounds. Its flagship technology, the ReCell® Autologous Cell Harvesting Device, enables clinicians to create a suspension of a patient’s own skin cells at the point of care. The system is designed to accelerate wound healing, minimize donor?site requirements and reduce scarring for patients suffering from burns, traumatic wounds and a variety of surgical and reconstructive procedures.
Founded in 2009 and headquartered in Carlsbad, California, Avita Medical has secured regulatory clearances in key markets, including CE mark approval in the European Union and 510(k) clearance from the U.S.
