Tissue regeneration

Grader A: partial

Real routine use exists: bioengineered skin substitutes for diabetic foot and venous ulcers (Medicare-covered), MACI cartilage implants (FDA 2016, >5,000 US cases). No source shows 5% of relevant procedures; MACI is a tiny share of cartilage repair. Partial; could be a hit under a broad skin-substitute reading.

Test: D37 health: share of relevant patients, providers or procedures using it by 2022 (hit >=5%; partial <5% real use by 2022 or 5% in 2023-2025; miss no real use by 2025); relevant: patients with tissue defects (wounds, cartilage)

• Use of MACI in the United States: Expanded Experience over 5,000 Cases (2025): MACI approved Dec 2016; over 5,000 US cases
• LCD L36377 Skin Substitute Grafts/CTPs for DFU and VLU (2024): Medicare covers skin substitute grafts as routine wound care

Grader B: partial

Approved regenerative products are in routine use: MACI autologous chondrocyte implants (FDA, re-approved through 2024) and cellular skin substitutes for chronic wounds. No source found showing they reach 5% of the relevant procedures by 2022; use is real but niche.

Test: D37 health: >=5% of relevant procedures (e.g. cartilage repair, chronic wound care) use regenerative tissue products by 2022 = hit; real but smaller use = partial; none by 2025 = miss.

• MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane) (2024-08-23): FDA-approved cultured-cell scaffold that repairs knee cartilage defects; in clinical use.
• Approved Cellular and Gene Therapy Products (2026): Small list of approved cell-based regenerative products, indicating niche, specialised use.