Key Findings:
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Data from over 3.3 million patient episodes with leg ulcers shows that FDA classification does not meaningfully predict the real-world effectiveness of cellular, acellular, and matrix-like products (CAMPs).
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Regardless of regulatory classifications, all CAMPs significantly outperformed standard of care (SOC) alone, showing lower mortality rates and fewer amputations
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CAMP treatments substantially reduced utilization of emergency departments (ED), intensive care units (ICU), and critical care units (CCU) compared to SOC
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The findings challenge current reimbursement models that tier payment based on regulatory categories, as clinical outcomes across these technologies appear statistically similar.
CHARLOTTE, NC (April 9, 2026) — Groundbreaking research utilizing a comprehensive Medicare data set suggests that the FDA regulatory classifications for wound care products do not correlate with their clinical performance in real-world settings. These findings were shared today by William H. Tettelbach, MD, FACP, FIDSA, FUHM, MAPWCA, CWSP, Chief Medical Officer at RestorixHealth, in a First-to-Podium presentation at the 2026 Symposium on Advanced Wound Care (SAWC) Spring | Wound Healing Society (WHS).
Researchers evaluated cellular, acellular, and matrix-like products (CAMPs) which are widely used to treat lower-extremity diabetic ulcers (LEDUs) and venous leg ulcers (VLUs). Despite the widespread belief that products with a higher FDA regulatory category such as premarket approval (PMA) equates to better clinical outcomes, this study found no such correlation.
The rigorous analysis of longitudinal data from 2.65 million LEDU episodes and over 745,000 VLU episodes found that a regulatory label is not a reliable proxy for the actual healing potential of a product.
Challenging the Reimbursement Framework
Current healthcare reimbursement frameworks often assume that the FDA regulatory category (whether a product is regulated as a 361 tissue, a 510(k) device, or a PMA biologic) reflects its clinical efficacy. However, evidence validating these assumptions has historically been limited.
Researchers used a CMS limited data set (2016–2024) to compare longitudinal data from more than 3 million cases. CAMP-treated episodes were assigned to their respective regulatory categories and matched with SOC episodes using a rigorous four-way matching process based on age, sex, comorbidities, debridement depth, and time to treatment. The results demonstrated that regulatory classification did not meaningfully predict clinical outcomes across matched cohorts.
Differences in performance among PMA, 510(k), and 361 products were largely non-significant. Notably, all CAMP usage significantly reduced mortality compared to SOC.
In LEDU cases, mortality ranged from 9.5–11.1% for CAMPs versus 12.7% for SOC. In VLU cases, mortality was 10.0–12.2% for CAMPs versus 13.2% for SOC. Quality of life was substantially improved with fewer amputations and lower infection rates when CAMPs were used compared to SOC.
While SOC episodes showed a slightly shorter length-of-treatment, they were plagued by substantially higher complication rates and increased hospital utilization, including more frequent ICU and CCU stays. Researchers noted that these findings challenge reimbursement models tiered by regulatory category.
“These findings challenge the assumption that FDA regulatory category is a reliable proxy for clinical performance. In this large real-world Medicare analysis, CAMPs consistently improved outcomes compared with standard of care alone, regardless of whether the product was regulated through Section 361, 510(k), or PMA. Patient access should be guided by clinical need and demonstrated outcomes, not by regulatory label alone,” said Dr. Tettelbach.
Patient access to CAMPs should be driven by clinical need
The study’s findings spotlight that FDA regulatory classifications do not always predict real-world efficacy and is certainly not the case for CAMPs usage with hard-to-heal ulcers. CAMPs, regardless of their category, consistently reduce mortality, prevent amputations, and decrease the burden on the hospital system compared to SOC alone.
As the healthcare industry moves toward value-based care, this study provides a vital foundation for restructuring how advanced wound care technologies are evaluated and reimbursed, ensuring that the focus remains on consistently providing clinical benefits to patients.