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What blocks the claim

• Company CEASED OPERATIONS and laid off staff around Dec 1, 2025 — ~one month after USDA approval and before selling a single product to a consumer (an 11th-hour funding attempt told to staff in November failed to materialize)
• Production economics never proven: 'production remains costly, scale elusive, and final products expensive'; the $6.20/lb target was conditional on a 50,000L scale never demonstrated

What blocks the claim

• Default object-storage path has high latency: ~400-600 ms p99 produce (docs now cite p99 produce 500 ms / p99 end-to-end 900 ms) and historically <1.5s p99 end-to-end on S3 Standard, unsuitable for latency-critical workloads without S3 Express opt-in
• Low-latency mode (Lightning Topics / S3 Express One Zone) raises cost (S3EOZ storage ~8x S3 Standard) and, per an independent 2026 comparison, drops ordering/transaction/idempotent-producer guarantees — re-introducing the tradeoff the product is sold to avoid

What blocks the claim

• FDA 510(k) clearance (K240632) rests on bench testing only — no clinical trial data was submitted or reviewed by FDA.
• Cleared indication is narrow: right arm/hand only, prescription-only, restricted to use by a licensed healthcare professional in a facility setting — not approved for home use or bilateral treatment.