STOCK TITAN

AVITA Medical Announces Positive PermeaDerm® Study Results Demonstrating 70% Economic Advantage over Allograft and Comparable Clinical Outcomes

(Moderate)
(Very Positive)
Tags

AVITA Medical (NASDAQ: RCEL) reported positive results from its multicenter, randomized controlled PermeaDerm-I study, showing PermeaDerm, a biosynthetic wound matrix, achieved the primary endpoint of a 70% economic advantage over cadaveric allograft based on mean product cost per percent total body surface area (%TBSA) treated (p<0.001).

According to the company, mean treatment cost was $148.70 per 1% TBSA with PermeaDerm versus $497.10 with allograft, a savings of about $348 per %TBSA. PermeaDerm reduced preparation time by 95.7% by eliminating tissue tracking, thawing, and meshing, while maintaining comparable operating room application time.

Clinical outcomes were comparable: about 94% of PermeaDerm patients achieved at least 95% graft take at one week, and all patients in both arms reached ≥95% wound healing by eight weeks, with no adverse events attributed to PermeaDerm. The study enrolled 40 patients across 11 U.S. burn centers. AVITA Medical will host a Key Opinion Leader webinar to review the data on August 18, 2026, at 4:30 p.m. ET.

Loading...
Loading translation...

Positive

  • 70% product cost reduction per %TBSA vs allograft (p<0.001)
  • $148.70 vs $497.10 mean cost per 1% TBSA; ~$348 savings
  • 95.7% lower preparation time due to off-the-shelf PermeaDerm
  • 94% of PermeaDerm patients with ≥95% graft take at one week
  • 100% of patients in both groups with ≥95% wound healing by eight weeks
  • Randomized trial in 40 patients across 11 U.S. burn centers completed

Negative

  • None.

Market Context

AVITA’s historical news record included both a 63.58% and -2.19% 24-hour reaction, creating a mixed ...
Analysis

AVITA’s historical news record included both a 63.58% and -2.19% 24-hour reaction, creating a mixed company-specific precedent. Net Buying added context; reimbursement, adoption, and execution remained items to watch.

Key Figures

Economic advantage: 70% P-value: p<0.001 PermeaDerm treatment cost: $148.70 per 1% TBSA +5 more
8 metrics
Economic advantage 70% PermeaDerm versus allograft
P-value p<0.001 Primary endpoint for mean cost per %TBSA treated
PermeaDerm treatment cost $148.70 per 1% TBSA Mean treatment cost
Allograft treatment cost $497.10 per 1% TBSA Mean treatment cost
Preparation time reduction 95.7% PermeaDerm versus allograft
Graft take 94% PermeaDerm patients achieving at least 95% graft take one week after autografting
Study enrollment 40 patients Multicenter randomized controlled study
Study centers 11 U.S. burn centers PermeaDerm-I clinical study

Historical Context

5 past events · Latest: Aug 09 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 09 Investor webinar Neutral -2.2% Investor webinar briefing followed Q2 earnings discussion
Aug 07 Conference participation Neutral +63.6% Conference participation announcement preceded a strong positive 24-hour reaction
Aug 06 Quarterly earnings Positive +63.6% Second-quarter results included raised 2026 revenue guidance and cash-flow breakeven expectations
Jul 14 Earnings date Neutral +17.7% Scheduled release of second-quarter 2026 financial results
Jun 18 Clinical experience Positive +1.8% U.K. clinical experience reported successful treatment and discharge outcomes

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive operating and clinical updates were followed by positive 24-hour reactions, while event notices produced mixed reactions.

Key Terms

allograft, biosynthetic wound matrix, wound temporization, graft take
4 terms
allograft medical
"clinically comparable outcomes to cadaveric allograft"
Tissue taken from one person and transplanted into another to repair or replace damaged body parts, such as bone, skin, or heart valves. For investors, allografts matter because their use involves manufacturing standards, supply and safety controls, regulatory approvals, and reimbursement rules that can affect sales, liability and growth for companies that process, store or sell these biological materials — similar to how sourcing and quality control of key parts affect a manufacturer’s business.
biosynthetic wound matrix medical
"PermeaDerm®, a biosynthetic wound matrix"
A biosynthetic wound matrix is a lab-made scaffold placed over a damaged area to guide and support the body’s natural healing, combining synthetic and biological components to mimic the structure of skin. Investors care because these products can shorten healing time, reduce complications and hospital stays, and command higher prices or tighter reimbursement — factors that affect sales, regulatory risk, and profit margins much like a superior construction scaffold speeds and simplifies a repair job.
wound temporization medical
"alternative to allograft for wound temporization"
A set of temporary medical steps or devices used to control bleeding, protect tissue, and stabilize a wound until definitive repair or healing can occur. Like putting a temporary patch on a leaking pipe, temporization can include dressings, packing, clotting agents, external pressure, or short-term wound vacuums; it matters to investors because demand for these products and the timing of downstream procedures can affect clinical costs, hospital workflows, and market size for wound-care technologies.
graft take medical
"achieved at least 95% graft take one week following autografting"
The extent to which a transplanted tissue or skin patch successfully attaches, establishes blood supply, and survives at the recipient site. Like a cutting that must take root to grow, graft take measures whether the graft becomes living, functional tissue rather than failing and being rejected or dying. For investors, graft take is a key clinical outcome because it affects a treatment’s safety, effectiveness, regulatory approval chances, and commercial adoption.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
  • Primary endpoint achieved, demonstrating a 70% economic advantage over allograft based on product cost per percent total body surface area treated (p<0.001)
  • 96% reduction in preparation time and comparable clinical outcomes to allograft including graft take, wound healing, and safety
  • Multi-center randomized controlled study supports PermeaDerm as a clinically comparable, economically advantaged alternative to allograft for wound temporization with off-the-shelf availability and no requirements for thawing, meshing, or tissue tracking logistics
  • Management to host Key Opinion Leader webinar at 4:30 p.m. ET on August 18

VALENCIA, Calif., Aug. 18, 2026 (GLOBE NEWSWIRE) -- AVITA Medical®, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company, today announced positive results from its multicenter, randomized controlled PermeaDerm-I clinical study demonstrating PermeaDerm®, a biosynthetic wound matrix, delivered clinically comparable outcomes to cadaveric allograft while reducing product cost by 70%.

The study met its primary endpoint, demonstrating statistically significant superiority (p<0.001) for mean cost per percent total body surface area (%TBSA) treated. Mean treatment cost was $148.70 for every 1% TBSA treated with PermeaDerm compared with $497.10 for allograft, representing a savings of approximately $348 per %TBSA.

As an off-the-shelf product, PermeaDerm reduced preparation time by 95.7% compared with allograft by eliminating tissue tracking, thawing, and meshing, while maintaining comparable application time in the operating room.

Clinical outcomes were comparable between treatment groups. Approximately 94% of PermeaDerm patients achieved at least 95% graft take one week following autografting, comparable to allograft, and all patients in both groups achieved 95% or greater wound healing by eight weeks. No adverse events were attributed to PermeaDerm during the study.

“Temporary wound coverage is a critical step between excision and definitive closure when a wound bed is not yet ready for autograft placement,” said Anju Saraswat, MD, Associate Burn Director and Assistant Professor of Surgery at Atrium Health Wake Forest Baptist Burn Center and study investigator. “These results demonstrate that PermeaDerm provided clinical performance comparable to allograft with the added benefit of product transparency enabling direct visualization of the wound bed. By eliminating tissue bank logistics and preparation time, PermeaDerm offers a more efficient approach to wound temporization without any compromise to healing outcomes and reducing cost.”

“The PermeaDerm-I study establishes compelling clinical and economic evidence supporting PermeaDerm as a modern alternative to allograft,” said Cary Vance, President and Chief Executive Officer of AVITA Medical. “By combining comparable clinical performance with meaningful economic value and a simpler workflow, we believe PermeaDerm addresses an important need for hospitals while strengthening AVITA's differentiated acute wound care portfolio.”

The randomized controlled study enrolled 40 patients across 11 U.S. burn centers with wounds involving up to 30% TBSA eligible. Following excision, patients were randomized to receive either PermeaDerm or cadaveric allograft during the temporization period before definitive split-thickness skin grafting.

At final follow-up, all responding investigators and patients reported satisfaction, with responses rated as satisfied or very satisfied.

Virtual Analyst and Investor Event

AVITA Medical will host a Key Opinion Leader webinar featuring Dr. Anju Saraswat, Associate Burn Director and Assistant Professor of Surgery at Atrium Health Wake Forest Baptist Burn Center and Dr. Christina Sharon, Burn and Acute Care Surgeon, Burn Center Director at Baton Rouge General, Baton Rouge, Louisiana to review the PermeaDerm-I clinical data and discuss clinical experience using PermeaDerm on Tuesday, August 18, 2026, at 4:30 p.m. Eastern Time (Wednesday, April 19, 2026, at 6.30 a.m. Australian Eastern Standard Time).

Direct webcast link:
https://edge.media-server.com/mmc/p/mutcdcpe

To participate by phone, please register in advance to receive dial-in details and a personal PIN:
https://register-conf.media-server.com/register/BI5acf2c543d9d4f8490ea42e28ae998e1

A replay of the webcast will be available shortly after the event under the Events & Presentations section of the AVITA Medical website at: https://ir.avitamedical.com/.

About PermeaDerm

PermeaDerm is a biosynthetic wound matrix designed to provide temporary wound coverage during the period between surgical excision and definitive closure. The transparent bilayer matrix protects and stabilizes the wound while allowing clinicians to visualize the wound bed without removing the product. PermeaDerm can be used to temporarily stabilize and protect the wound before subsequent reconstruction, and is a part of AVITA Medical's broader acute wound care portfolio alongside Cohealyx® and RECELL®.

About PermeaDerm-I

PermeaDerm-I is a post-market multicenter, randomized controlled clinical trial evaluating PermeaDerm compared with cadaveric allograft in patients with acute wounds requiring temporary coverage prior to definitive skin grafting.

Forty patients across 11 U.S. burn centers were randomized to receive either PermeaDerm or allograft following surgical excision. The primary endpoint evaluated treatment cost per percent total body surface area treated. Secondary endpoints included preparation time, application time, graft take, wound healing, inflammatory profile, adverse events, and surgeon and patient satisfaction.

Patients were followed for eight weeks following definitive closure.

For more information, visit ClinicalTrials.gov (NCT06750809).

About AVITA Medical, Inc.

AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is RECELL®, approved by the FDA for the treatment of thermal burn and trauma wounds. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to market, sell, and distribute Cohealyx®, an AVITA Medical-branded collagen-based dermal matrix, and the exclusive rights to manufacture, market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix.

In international markets, RECELL is approved to promote skin healing in a wide range of applications, including thermal burn and trauma wounds. RECELL and RECELL GO® are CE-marked in Europe, have TGA certification in Australia, and are listed with Medsafe in New Zealand; RECELL is PMDA-approved in Japan.

To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “could,” “expect,” “may,” “will,” and similar words or expressions, and the use of future dates. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation: industry market conditions; failure to obtain and/or maintain regulatory approvals and comply with applicable regulations; supply chain disruptions that could affect our ability to manufacture our products; market reaction to growth or product initiatives; market penetration of our products; changes in the legal or regulatory environments; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. Any forward-looking statements made herein are made as of the date of this press release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.

Investor & Media Contact:
Ben Atkins
Phone +1-805 341 1571
investor@avitamedical.com | media@avitamedical.com

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

©2026 AVITA Medical. AVITA Medical®, the AVITA Medical logo, Cohealyx®, RECELL®, RECELL GO®, and Spray-On Skin Cells are trademarks of AVITA Medical. PermeaDerm® is a registered trademark owned by Stedical Scientific, Inc. All other trademarks are the properties of their respective owners.


FAQ

What were the key results of AVITA Medical's PermeaDerm-I study for RCEL announced on August 18, 2026?

The PermeaDerm-I study showed PermeaDerm achieved a 70% economic advantage over allograft while maintaining comparable clinical outcomes. According to AVITA Medical, PermeaDerm significantly reduced product cost per percent total body surface area treated and preserved similar graft take, wound healing rates, and safety compared with cadaveric allograft.

How much cost savings did PermeaDerm provide compared with allograft in AVITA Medical's RCEL trial?

PermeaDerm reduced mean treatment cost to $148.70 per 1% TBSA versus $497.10 with allograft. According to AVITA Medical, this represents approximately $348 savings per percent total body surface area treated, translating into a reported 70% economic advantage at the product-cost level in the PermeaDerm-I study.

What clinical outcomes did PermeaDerm show versus allograft in AVITA Medical's PermeaDerm-I RCEL study?

PermeaDerm demonstrated clinical outcomes comparable to cadaveric allograft in graft take and wound healing. According to AVITA Medical, around 94% of PermeaDerm patients reached at least 95% graft take at one week, and all patients in both groups achieved at least 95% wound healing by eight weeks.

Were there any safety concerns with PermeaDerm in AVITA Medical's RCEL PermeaDerm-I trial?

No adverse events were attributed to PermeaDerm in the PermeaDerm-I study. According to AVITA Medical, all patients in both PermeaDerm and allograft groups ultimately achieved at least 95% wound healing by eight weeks, supporting a favorable safety and healing profile in this randomized trial.

How many patients and centers participated in AVITA Medical's PermeaDerm-I study for RCEL?

The PermeaDerm-I trial enrolled 40 patients across 11 U.S. burn centers with wounds up to 30% TBSA. According to AVITA Medical, patients were randomized to receive either PermeaDerm or cadaveric allograft for wound temporization before definitive split-thickness skin grafting.

How did PermeaDerm impact preparation time compared with allograft in AVITA Medical's RCEL trial?

PermeaDerm reduced preparation time by 95.7% relative to cadaveric allograft in the study. According to AVITA Medical, this reduction came from eliminating tissue tracking, thawing, and meshing, while maintaining comparable application time in the operating room during wound temporization.

When is AVITA Medical's Key Opinion Leader webinar on the PermeaDerm-I RCEL data and how can investors access it?

AVITA Medical will host its Key Opinion Leader webinar on August 18, 2026, at 4:30 p.m. Eastern Time. According to AVITA Medical, investors can access the live webcast and replay through links provided in the Events & Presentations section of the company’s investor relations website.