Key Highlights

  • PermeaDerm achieved a statistically significant 70% cost advantage over cadaveric allograft based on treatment cost per 1% total body surface area.
  • Mean treatment cost was $148.70 per 1% TBSA treated with PermeaDerm versus $497.10 for allograft.
  • Preparation time was reduced by 95.7%, while clinical outcomes including graft take and wound healing were reported as comparable.
  • The randomized controlled study enrolled 40 patients across 11 U.S. burn centres, with no adverse events attributed to PermeaDerm.

AVITA Medical, Inc. (NASDAQ:RCEL) (ASX:AVH) has reported positive results from the PermeaDerm-I multicentre randomized controlled clinical study, with the biosynthetic wound matrix demonstrating a lower treatment cost than cadaveric allograft while producing comparable reported clinical outcomes.

The study's primary endpoint measured treatment cost per percentage of total body surface area treated. PermeaDerm recorded a mean cost of $148.70 for each 1% TBSA treated, compared with $497.10 for allograft. The resulting difference represents a saving of approximately $348 per percentage point of TBSA and a 70% lower product cost, with the primary endpoint achieving statistical significance at p<0.001.

The study was designed to evaluate PermeaDerm as temporary wound coverage following surgical excision and before definitive split-thickness skin grafting.

Preparation Time Reduced by 95.7%

PermeaDerm's off-the-shelf format was associated with a 95.7% reduction in preparation time compared with allograft. The product does not require the tissue tracking, thawing or meshing procedures associated with cadaveric allograft.

Despite the difference in preparation requirements, application time in the operating room was reported as comparable between the two treatment groups. PermeaDerm's transparent bilayer structure also allows clinicians to view the wound bed without removing the matrix.

These workflow characteristics were assessed alongside economic and clinical measures in the study.

Clinical Outcomes Reported as Comparable

The study enrolled 40 patients at 11 U.S. burn centres, with eligible wounds involving up to 30% TBSA. Following surgical excision, participants were randomized to receive either PermeaDerm or cadaveric allograft during the temporary coverage period.

Approximately 94% of patients treated with PermeaDerm achieved at least 95% graft take one week after autografting, a result described as comparable with allograft. At eight weeks, all patients in both treatment groups achieved at least 95% wound healing.

No adverse events were attributed to PermeaDerm during the study. At final follow-up, responding investigators and patients reported being satisfied or very satisfied with their treatment experience.

Study Design Supports Economic Comparison

PermeaDerm-I was a post-market, multicentre randomized controlled trial, with patients followed for eight weeks following definitive closure. In addition to treatment cost, the study assessed preparation time, application time, graft take, wound healing, inflammatory response, adverse events and surgeon and patient satisfaction.

The trial compared PermeaDerm directly with cadaveric allograft in patients requiring temporary wound coverage after excision. This design provides comparative data across both economic and clinical measures within the same study population.

The results therefore add to the company's clinical data for PermeaDerm as part of its acute wound care portfolio, although the announcement does not provide financial Revenue or Earnings data associated with the product.

PermeaDerm Within AVITA's Wound Care Portfolio

PermeaDerm is a biosynthetic wound matrix intended for temporary wound coverage between surgical excision and definitive wound closure. Its transparent construction is designed to protect and stabilize the wound while permitting visualization of the wound bed.

AVITA Medical's broader acute wound care portfolio includes RECELL and Cohealyx. RECELL is designed to use a patient's own skin to create Spray-On Skin, while Cohealyx is a collagen-based dermal matrix marketed by AVITA in the United States.

The company holds exclusive rights in the United States to manufacture, market, sell and distribute PermeaDerm.

Commercial Relevance of the Results

The reported study results provide two distinct measures of potential product differentiation: lower treatment cost and reduced preparation requirements. The reported 70% cost difference was based specifically on product cost per percentage of TBSA treated, rather than a broader hospital-system economic assessment.

Similarly, the 95.7% preparation-time reduction relates to the study's comparison of preparation procedures. The company has not stated that these figures represent a direct reduction in total hospital treatment costs.

The results nevertheless provide comparative clinical and economic data as AVITA continues to develop its acute wound care product portfolio.

Conclusion

AVITA Medical's PermeaDerm-I study reported a 70% lower treatment cost per percentage of TBSA treated compared with cadaveric allograft, alongside a 95.7% reduction in preparation time. The study also reported comparable graft take and wound-healing outcomes, with no adverse events attributed to PermeaDerm. The findings come from a 40-patient randomized study conducted across 11 U.S. burn centres and provide additional clinical and economic data for the biosynthetic wound matrix. The announcement does not report a change in AVITA Medical's revenue, NPAT or dividend.