CMS New Technology Add-On Payment Expands Access to RECELL® for Patients with Non-Burn Acute Wounds
AVITA Medical (NASDAQ: RCEL) announced that hospitals will now be eligible for New Technology Add-on Payment (NTAP) reimbursement from CMS when using RECELL to treat non-burn trauma and surgical full-thickness wounds. Starting October 1, 2025, hospitals can receive up to $4,875 in additional reimbursement per case through September 30, 2026.
The NTAP designation was granted under CMS's alternative pathway for FDA Breakthrough Devices. A clinical trial published in the Journal of Trauma and Acute Care Surgery demonstrated that RECELL achieved comparable wound closure while requiring 27% less donor skin compared to standard skin grafting. The technology prepares Spray-On Skin™ cells from a small sample of the patient's healthy skin.
AVITA Medical (NASDAQ: RCEL) ha annunciato che gli ospedali saranno ora idonei al rimborso NTAP (New Technology Add-on Payment) da CMS quando utilizzeranno RECELL per trattare traumi non da ustione e ferite chirurgiche a spessore completo. A partire dal 1 ottobre 2025, gli ospedali possono ricevere fino a 4.875 dollari in rimborso aggiuntivo per caso fino al 30 settembre 2026.
La designazione NTAP è stata concessa tramite il percorso alternativo di CMS per i dispositivi Breakthrough della FDA. Uno studio clinico pubblicato nel Journal of Trauma and Acute Care Surgery ha dimostrato che RECELL ha ottenuto una chiusura della ferita comparabile richiedendo il 27% di tessuto donatore in meno rispetto al trapianto standard di pelle. La tecnologia prepara cellule Spray-On Skin™ a partire da un piccolo campione della pelle sana del paziente.
AVITA Medical (NASDAQ: RCEL) anunció que los hospitales serán elegibles para el reembolso NTAP (New Technology Add-on Payment) de CMS cuando utilicen RECELL para tratar traumas no quemados y heridas quirúrgicas de espesor completo. A partir del 1 de octubre de 2025, los hospitales pueden recibir hasta $4,875 en reembolso adicional por caso hasta el 30 de septiembre de 2026.
La designación NTAP se concedió mediante la vía alternativa de CMS para Dispositivos Breakthrough de la FDA. Un ensayo clínico publicado en el Journal of Trauma and Acute Care Surgery demostró que RECELL logró una cierre de la herida comparable, requiriendo un 27% menos de piel donante en comparación con la piel injertada estándar. La tecnología prepara células Spray-On Skin™ a partir de una muestra pequeña de la piel sana del paciente.
AVITA Medical (NASDAQ: RCEL)은 RECELL을 사용하여 비화상 외상 및 수술 전체 피부 껍질 손상 치료 시 CMS의 NTAP(New Technology Add-on Payment) 보상을 병원이 받을 자격이 생겼다고 발표했습니다. 2025년 10월 1일부터 병원은 2026년 9월 30일 까지 건당 최대 $4,875의 추가 보상을 받을 수 있습니다.
NTAP 지정은 FDA Breakthrough Devices에 대한 CMS의 대체 경로를 통해 부여되었습니다. Journal of Trauma and Acute Care Surgery에 실린 임상 시험은 RECELL이 표준 피부 이식에 비해 기증 피부가 27% 덜 필요하면서 상처 폐쇄를 달성했다는 것을 보여주었습니다. 이 기술은 환자의 건강한 피부 소량 샘플에서 Spray-On Skin™ 세포를 준비합니다.
AVITA Medical (NASDAQ : RCEL) a annoncé que les hôpitaux seront désormais éligibles au remboursement NTAP (New Technology Add-on Payment) de CMS lorsqu'ils utiliseront RECELL pour traiter les traumatismes non brûlés et les plaies chirurgicales en profondeur. À partir du 1er octobre 2025, les hôpitaux peuvent percevoir jusqu'à 4 875 dollars de remboursement additionnel par cas jusqu’au 30 septembre 2026.
La désignation NTAP a été accordée dans le cadre de la voie alternative de CMS pour les dispositifs Breakthrough de la FDA. Une étude clinique publiée dans le Journal of Trauma and Acute Care Surgery a démontré que RECELL permettait une fermeture des plaies comparable tout en nécessitant 27 % de peau donneuse en moins par rapport à la greffe cutanée standard. La technologie prépare des cellules Spray-On Skin™ à partir d’un petit échantillon de la peau saine du patient.
AVITA Medical (NASDAQ: RCEL) hat bekannt gegeben, dass Krankenhäuser künftig Anspruch auf NTAP-Erstattung (New Technology Add-on Payment) von CMS haben, wenn sie RECELL zur Behandlung nicht-brennender Traumata und chirurgischer Vollschicht-Verletzungen verwenden. Ab dem 1. Oktober 2025 können Krankenhäuser bis zum 30. September 2026 bis zu 4.875 USD pro Fall zusätzlich erstattet bekommen.
Die NTAP-Bezeichnung wurde im Rahmen des alternativen Weges von CMS für FDA Breakthrough-Geräte gewährt. Eine klinische Studie, veröffentlicht im Journal of Trauma and Acute Care Surgery, zeigte, dass RECELL eine vergleichbare Wundheilung erzielt, während 27 % weniger Spenderhaut benötigt wird als bei der herkömmlichen Hauttransplantation. Die Technologie bereitet Spray-On Skin™-Zellen aus einer kleinen Probe der gesunden Haut des Patienten vor.
أعلنت AVITA Medical (المدرجة في ناسداك: RCEL) أن المستشفيات ستكون مؤهلة الآن للحصول على تعويض NTAP (New Technology Add-on Payment) من CMS عند استخدام RECELL لعلاج الإصابات غير الحرارية و الجروح الجراحية بطبقة كاملة. اعتباراً من 1 أكتوبر 2025، يمكن للمستشفيات أن تتلقى حتى $4,875 إضافية لكل حالة حتى 30 سبتمبر 2026.
تم منح تسمية NTAP وفقاً لمسار CMS البديل لأجهزة FDA Breakthrough. أظهرت تجربة سريرية نُشرت في Journal of Trauma and Acute Care Surgery أن RECELL حققت إغلاقاً للجروح بشكل مماثل مع الحاجة إلى 27% أقل من جلد المتبرع مقارنة بزراعة الجلد القياسية. التقنية تعد خلايا Spray-On Skin™ من عينة صغيرة من جلد المريض الصحي.
AVITA Medical（纳斯达克股票代码：RCEL）宣布，医院在使用 RECELL 治疗非烧伤创伤和外科全层创面的情况下，将有资格获得 CMS 的 NTAP（新技术附加支付）报销。从 2025 年 10 月 1 日起，医院在到 2026 年 9 月 30 日止，每例可获得最高 $4,875 的额外报销。
NTAP认证是通过 CMS 针对 FDA Breakthrough 设备的替代路径授予的。刊载于《Journal of Trauma and Acute Care Surgery》的临床研究显示，RECELL 实现了可比的创面闭合效果，同时比标准皮肤移植需要的捐献皮肤少 27%。该技术可从患者健康皮肤的少量样本中制备 Spray-On Skin™ 细胞。
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Insights
CMS reimbursement approval significantly expands RCEL's market opportunity, reducing hospital financial barriers while maintaining clinical effectiveness.
The CMS New Technology Add-on Payment (NTAP) approval for RECELL in non-burn applications represents a significant market expansion for AVITA Medical. This supplemental reimbursement of
What makes this development particularly valuable is the dual market expansion: not only does it open up the non-burn acute wound market (significantly larger than the burn market), but it also provides financial incentives for hospitals to adopt the technology. The NTAP designation, granted through CMS's alternative pathway for breakthrough devices, validates both the clinical and economic value proposition of RECELL.
The timing is strategically important - with the payment effective October 1, 2025, hospitals can immediately incorporate RECELL into their treatment protocols without budget concerns. The clinical data showing
The one-year NTAP period (through September 2026) provides AVITA a critical window to demonstrate real-world economic and clinical benefits, potentially establishing RECELL as a new standard of care before the supplemental payment expires. For AVITA, this represents a clear catalyst for accelerated revenue growth in the non-burn segment while reinforcing their leadership position in regenerative wound care technology.
The NTAP designation addresses a critical economic barrier in the wound care space. With hospitals facing ongoing financial pressures, the
The CMS decision signals broader acceptance of RECELL's value proposition beyond its original burn indication. Importantly, this comes through the alternative NTAP pathway, which bypasses certain cost and clinical improvement thresholds required in the standard pathway - underscoring the recognized innovation value of breakthrough-designated technologies.
This reimbursement structure particularly benefits hospital systems, as the NTAP directly supplements the fixed DRG payment they receive for inpatient procedures. The economics become especially favorable when considering the downstream benefits: the
For investors, this development should be viewed as a meaningful inflection point. Healthcare adoption curves typically accelerate dramatically once reimbursement hurdles are removed. The NTAP creates a 12-month window during which AVITA can establish clinical workflows and physician preferences in this expanded indication, potentially creating sustained usage patterns even after the supplemental payment expires in 2026. This positions the company to capture value in the substantially larger trauma and surgical wound markets, diversifying beyond their burn care foundation.
- Hospitals may receive up to
$4,875 in added reimbursement when using RECELL to treat non-burn full-thickness acute wounds resulting from trauma or surgery
- Effective October 1, the add-on payment eases financial barriers, supporting broader use of RECELL
VALENCIA, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AVITA Medical®, Inc. (ASX: AVH, NASDAQ: RCEL), a leading therapeutic acute wound care company, today announced that beginning October 1, 2025, hospitals across the U.S. will be eligible for New Technology Add-on Payment (NTAP) reimbursement from the Centers for Medicare & Medicaid Services (CMS) when RECELL is used to treat acute, non-burn trauma and surgical full-thickness wounds.
This designation will remain in effect through September 30, 2026, providing hospitals with supplemental reimbursement of up to
“With only a select number of technologies reaching this milestone each year, CMS’s NTAP decision underscores the clinical value and innovation of RECELL,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By lowering financial barriers for hospitals, CMS is helping ensure that more patients can benefit from RECELL, which treats acute wounds effectively while requiring less donor skin and easing the challenges of recovery.”
Skin grafting is the standard of care for full-thickness acute wounds resulting from trauma or surgery. However, skin grafting requires the harvesting of a significant amount of donor skin, resulting in a larger wound to the patient. Significant pain, delayed healing, risk of infection, the potential need for multiple procedures, discoloration, and scarring are associated with donor site wounds.
RECELL is used by healthcare professionals to prepare a suspension of Spray-On Skin™ cells from a small sample of the patient’s own healthy skin. A multicenter, randomized-controlled trial published in the Journal of Trauma and Acute Care Surgery (2024) demonstrated that RECELL, when used with a widely meshed autograft, achieved wound closure just as effectively as standard skin grafting while requiring
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 the RECELL System, approved by the U.S. Food and Drug Administration 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 Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the rights to manufacture and exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including thermal burn and trauma wounds, with regulatory clearances in Europe, and excluding RECELL GO, in Australia and Japan.
To learn more, visit www.avitamedical.com.
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Investor & Media Contact:
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Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
FAQ
What is the new CMS reimbursement amount for RECELL (NASDAQ: RCEL) treatment?
How long will AVITA Medical's RECELL NTAP designation last?
What are the clinical benefits of RECELL compared to standard skin grafting?
What types of wounds can be treated with RECELL under the new NTAP coverage?
How does RECELL's Spray-On Skin technology work?
