HIGHBuilt-inRegulatory
FDA PMA approval for RECELL
“10-K Item 1A: 'Our business is highly dependent on the PMA we received in September 2018 from the FDA'”
RCEL · Concentration risk · 10-K extracted
Avita Medical (RCEL) concentration risks
Updated
The most significant concentration Avita Medical discloses is FDA PMA approval for RECELL, classified HIGH by disclosed size. Below: the full set from the latest 10-K — verbatim quotes, filing references, and a synthesis of what these exposures mean together.
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Source: Avita Medical’s SEC Form 10-K filed — view the filing on SEC EDGAR ↗
At a glance
Disclosed-size breakdown · 4 disclosed concentrations
HIGH2
MEDIUM2
LOW0
Disclosed concentrations
Each card carries a disclosed-size chip (HIGH / MEDIUM / LOW — how large the exposure is as a share of revenue, not how dangerous it is) and a nature tag: Built-in(the company’s own model, geography, or products) or Outside party (an external customer, supplier, or distributor it relies on).
HIGHOutside partySupplier
single-sourced material components
“10-K Item 1A: 'in 2023, we single-sourced some of our material components'”
MEDIUMBuilt-inGeographic
United States primary market
“10-K Item 1A: 'in the United States, our current primary market'”
MEDIUMBuilt-inCustomer
specialized burn centers
“10-K Item 1: 'approximately 140 specialized burn centers treating the majority of severe burn patients'”
TrendMatrix Research · concentration synthesis
What these concentrations mean together
updated 2026-10-18Avita Medical's concentrations are tightly linked and mostly structural. Its business is highly dependent on the PMA received in September 2018 from the FDA, a high-share exposure: one regulatory approval underpins the commercial product, so any adverse regulatory action would reach the whole business. On the supply side, the company single-sourced some of its material components, also a high-share exposure, though dependency in character. A disruption at a sole supplier could interrupt production of the same approved product, so the regulatory and supply exposures compound rather than offset each other. On the demand side, the United States is the current primary market, a medium-share geographic exposure, and the product reaches patients through approximately 140 specialized burn centers treating the majority of severe burn patients. That channel is a medium-share, structural concentration: a small, identifiable set of institutions controls access to the core patient population. Net, the single approval and single-sourced components are the idiosyncratic items that could move the verdict, while the U.S. and burn-center concentration describe a narrow addressable market.
For the engine’s reasoning on RCEL’s current verdict — including which dimensions drove the score — see the per-dimension breakdown.
Industry peers · Medical Devices
Peer concentration profile
| Symbol | Name | HIGH | MEDIUM | LOW | Total |
|---|---|---|---|---|---|
| AORT | Artivion, Inc. | 4 | 4 | 0 | 8 |
| RCEL● | Avita Medical, Inc. | 2 | 2 | 0 | 4 |
| ATEC | Alphatec Holdings, Inc. | 1 | 1 | 0 | 2 |
| ABT | Abbott Laboratories | 1 | 0 | 0 | 1 |
| AVR | Anteris Technologies Global Cor | 1 | 0 | 0 | 1 |
| AHCO | AdaptHealth Corp. | 0 | 0 | 0 | 0 |
Concentration counts reflect items disclosed in each peer’s most recent 10-K; disclosed-size classification uses TrendMatrix’s internal 10-K extraction taxonomy.