RCEL · CIK 1762303
What AVITA Medical, Inc. told the SEC could break it.
AVITA Medical's disclosures cluster on how concentrated and externally dependent its operations are. It produces, packages and warehouses RECELL and PermeaDerm at a single facility in Ventura, California, so damage or a force-majeure event there could halt operations, and it leans on sole or limited outside suppliers for key products and components — Cohealyx solely from Regenity, PermeaDerm through Stedical, and some RECELL components from global third-party manufacturers. Layered on top are financial and regulatory constraints: debt secured by substantially all its assets at SOFR+7.5% with revenue covenants and a $5 million minimum-cash requirement (it has needed waivers), and FDA medical-device oversight plus ex-U.S. approvals and healthcare laws governing how it deals with providers.
4 self-disclosed vulnerabilities, pulled from its own filings, each in the company’s words, with the source. This is the risk register almost nobody reads.
In its own words
What could break it.
Climate & physical
- single manufacturing facility (Ventura, California) for RECELL and PermeaDermmedium
AVITA produces, packages and warehouses RECELL and PermeaDerm at a single facility in Ventura, California; damage or a force-majeure event there (or at its third-party manufacturers) could materially impair its ability to operate.
“We have a manufacturing facility located in Ventura, California where we produce, package, and warehouse RECELL and PermeaDerm. We also rely on global third-party manufacturers for production of some of the components used in RECELL. If our facility or the facilities of our third-party contract manufacturers suffer damage or experience a force majeure event, this could materially impact our ability to operate.”
SEC filing →As of 2026
Liquidity & debt
- Perceptive Credit Agreement secured by substantially all assets, high rate, revenue covenantsmedium
AVITA's debt (Perceptive Credit Agreement, replacing $40M prior debt) is secured by substantially all assets at SOFR+7.5% (4% floor) with revenue covenants and a $5M minimum-cash requirement; it has needed covenant waivers, and a default could accelerate repayment.
“The indebtedness under the Perceptive Credit Agreement will be secured by substantially all of our assets and will accrue interest at a rate equal to the greater of (a) forward-looking one-month term SOFR rate and (b) four percent ( 4 %) per annum, plus seven and a half percent ( 7.5 %).”
SEC filing →As of 2026
Supplier concentration
- Cohealyx solely supplied by Regenity; PermeaDerm via Stedical; RECELL components from third-party manufacturersmedium
AVITA depends on third parties for key products/components — Cohealyx is manufactured and supplied solely by Regenity, PermeaDerm rights/revenue run through Stedical, and some RECELL components come from global third-party manufacturers — so a supplier disruption could interrupt product supply.
“We also rely on global third-party manufacturers for production of some of the components used in RECELL.”
SEC filing →As of 2026
Regulatory & policy
- FDA medical-device regulation, ex-US approvals (CE/PMDA/TGA), and healthcare/anti-kickback lawslow
AVITA's RECELL/PermeaDerm/Cohealyx are FDA-regulated medical devices requiring approvals/clearances (and ex-US CE/PMDA/TGA registrations), and as a device maker it is subject to healthcare laws governing HCP interactions and payment reporting — non-compliance could trigger enforcement.
“AVITA Medical is a manufacturer of medical devices, and therefore we are subject to regulations by the FDA and various federal and state healthcare laws and regulations. These regulations govern our advertising and promotional practices, our interactions with healthcare providers (“HCPs”), and our reporting of any payments made to HCPs.”
SEC filing →As of 2026
The hidden graph
Who it depends on, and who depends on it.
Relationships surfaced from filings, including ones disclosed by the other side, which is how the non-obvious ones come to light.
Its suppliers
Stedical Scientific, Inc.
“On March 17, 2025, the Company and Stedical entered into an Amendment Two (the “Amendment”) of the Distribution Agreement. Under the terms of the Amendment, the Company's share of revenue from PermeaDerm sales increased from 50 % to 60 % and Stedical becomes eligible for certain milestone payments conditioned upon AVITA Medical's achievement of specified sales targets.”
Cited →Collagen Matrix, Inc. (dba Regenity Biosciences)
“We also entered into an exclusive multi-year development and distribution agreement with Collagen Matrix, Inc. dba Regenity Biosciences (“Regenity”). Regenity manufactures and supplies Cohealyx , an AVITA Medical-branded, FDA-cleared, collagen-based dermal matrix.”
Cited →
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