AVITA Medical, Inc.

Company profile

• Therapeutic acute wound care company focused on improving wound healing, accelerating patient recovery, and delivering better clinical and economic outcomes across the wound care continuum.
• Core platform: RECELL autologous cell harvesting technology that creates a Spray-On Skin autograft from a patient’s own skin cells at the point of care.
• Strategic expansion to a multi-product acute wound platform, with complementary products and collaborations addressing wound bed preparation, coverage, and definitive closure.
• Primary markets: burns, traumatic injuries, surgical wounds, and full-thickness skin defects, with ongoing expansion into new indications and international markets.

Product portfolio

• RECELL (Autologous Cell Suspension / Spray-On Skin)
  • Indications: acute thermal burns (partial and full-thickness, including pediatric in updated approvals), full-thickness skin defects, and repigmentation of stable depigmented vitiligo lesions (approval in vitiligo; commercial investment paused).
  • Key devices and platforms: RECELL 1920, RECELL Ease-of-Use (EOU), RECELL GO (RPD + RPK), and RECELL GO mini (for wounds up to 480 cm²).
  • Regulatory/commercial milestones: RECELL GO mini FDA approval received December 23, 2024; commercial rollout began late Q1 2025. RECELL GO launched commercially in the U.S. on April 1, 2025.
• PermeaDerm
  • Biosynthetic wound matrix marketed and distributed exclusively in the U.S. under multi-year agreements with Stedical.
  • FDA-cleared for a range of wound types and sizes; designed for transparent monitoring, adjustable porosity, and adhesion across joints.
  • Post-market clinical study planned in 2025 to evaluate health economic impact versus alternatives.
• Cohealyx
  • Collagen-based dermal matrix developed with Regenity; AVITA holds exclusive U.S. rights to market, sell, and distribute, with potential EU/Australia/Japan expansion.
  • FDA 510(k) clearance obtained December 19, 2024; U.S. commercial launch on April 1, 2025.
  • Post-market studies underway to document time-to-graft reduction and support two-stage wound management.
• Regenity collaboration
  • Exclusive development and distribution agreement for Cohealyx, with potential broader expansion into EU, Australia, and Japan.
• International expansion
  • RECELL GO received CE mark in September 2025, enabling EU and CE-mark-recognized markets; international commercialization relies on distributor-led models.

How RECELL works

• Harvests a thin, split-thickness skin sample from the patient and processes it into an autologous cellular suspension in about 30 minutes.
• The suspension contains keratinocytes, fibroblasts, and melanocytes to support wound bed preparation and pigment restoration.
• Enables treatment of large wounds with a small donor skin sample, reducing donor-site morbidity and supporting outcomes comparable to or better than conventional grafting.

Market opportunity and customers

• U.S. burn treatment market is highly concentrated, with about 140 specialized burn centers treating the most severe cases.
• Addressable market for RECELL includes full-thickness skin defects across trauma, surgical wounds, and cancer-related resections; approximately 272,000 procedures annually in the U.S. may be eligible.
• Adoption is driven by hospital value analysis committees, payer reimbursement, and integration into burn/trauma/surgical care pathways.
• Reimbursement infrastructure includes MS-DRGs for inpatient care, CPT codes for Skin Cell Suspension Autograft (SCSA) procedures effective Jan 1, 2025, and a new NTAP for RECELL in combination with meshed autograft for certain inpatient non-thermal full-thickness skin defects effective Oct 1, 2025.

Regulatory and quality

• RECELL U.S. PMA approvals and supplements:
  • 2018: PMA for RECELL (burns in patients ≥18).
  • 2021: Pediatric expansion with meshed autograft.
  • 2023: Expanded to full-thickness skin defects and vitiligo repigmentation (EOU).
  • 2024: RECELL GO PMA approval for burns and full-thickness defects.
• Cohealyx: FDA 510(k) clearance (Dec 19, 2024).
• PermeaDerm: FDA 510(k) clearance; exclusive U.S. distribution through Stedical.
• International: CE mark for RECELL GO (September 2025); PMDA (Japan) and TGA (Australia) registrations noted.
• In-house quality testing capability established in August 2025 (U.S.) and October 2025 (EU).

Manufacturing, supply, and operations

• Primary manufacturing facility in Ventura, California (27,840 sq ft), cGMP and ISO 13485 compliant.
• Final assembly, packaging, and warehousing for RECELL and PermeaDerm conducted in Ventura.
• Supplier strategy includes multiple suppliers and some single-sourced critical components; efforts underway to diversify and qualify additional suppliers.

Intellectual property

• U.S. patents and applications (as of Dec 31, 2025): 6 issued utility patents, 1 issued design patent; 7 pending utility patent applications; 5 pending design patent applications.
• International patents granted in Australia, Brazil, Canada, China, Hong Kong, Japan, and multiple European jurisdictions; multiple German utility models and numerous registered designs.
• Patent expiration outlook: issued U.S. patents expected to expire 2034–2043; U.S. design patent expiring 2038; various international design registrations extend into the 2050s in some jurisdictions.
• Trademarks: 147 registered; 17 pending (examples: AVITA Medical, RECELL, RECELL GO, Cohealyx, Spray-On Skin).

Corporate and governance

• Public listings: Nasdaq (ticker RCEL) and ASX CDIs (AVH).
• Smaller reporting company status in the U.S.; ASX listing obligations maintained in parallel.
• Board composition 33% female; senior executive team 40% female; total employees 52.5% female (as of Dec 31, 2025).

Employment and human resources

• Approximately 226 full-time and part-time employees (as of Dec 31, 2025).
• A significant portion of management and professional staff have backgrounds in medical devices, biotech, and pharma.
• No collective bargaining agreements covering employees.

Financial highlights

• Net loss for the year ended December 31:
  • 2025: $(48.6) million
  • 2024: $(61.8) million
• Cumulative deficit through December 31, 2025: $(408.4) million
• Perceptive Credit Agreement (entered Jan 13, 2026):
  • Five-year senior secured term loan facility up to $60 million.
  • $50 million funded at closing; additional $10 million discretionary amount available by March 31, 2027 upon meeting a net revenue test.
  • Refinanced and repaid prior credit facility in full.

Government contracts and preparedness

• BARDA contract support since 2015; total payments under BARDA contracts totaled $40.7 million through Dec 31, 2025.
• BARDA inventory management arrangement ended in 2023. A standing agreement to provide access to RECELL inventory during emergencies existed until Sept 28, 2025, with nominal annual maintenance fees; renewal expected but delayed by a federal government shutdown.
• Supply and mass deployment readiness for emergency scenarios remains a strategic consideration.

Key risks and market factors

• Competitive and changing environment with reliance on regulatory approvals, clinical evidence, payer coverage, and adoption at burn/trauma/surgical centers.
• Revenue growth and profitability depend on RECELL adoption and expansion into new indications and geographies; reliance on distributors for non-U.S. markets.
• Manufacturing and supply chain risks, including single-source materials for some components and the need to scale production.
• Regulatory and post-market requirements, potential off-label promotion risk, and ongoing compliance with healthcare laws and privacy/security.
• Financial risks tied to debt covenants, potential need for additional capital, and stock price volatility driven by market and regulatory developments.