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Denis Katz Medical Affairs

Denis Katz, MD

Healthcare systems face a growing economic crisis: more than 13 million patients suffer from chronic wounds each year, yet traditional health-economic models capture only a fraction of the true burden. Current accounting focuses on product prices and episode-level costs while missing the far larger impacts of delayed healing, lost productivity, caregiver strain, and preventable complications.

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Orthopedic implants are long-term, often lifelong, interventions that require rigorous evidence demonstrating sustained safety and performance. Traditional RCTs with limited follow-up and narrow populations cannot fully capture the complex real-world environment, especially given the variability in surgical techniques, patient comorbidities, and health system factors. As payer and regulatory expectations evolve, RWE has become indispensable for demonstrating lifetime device value and supporting continuous improvement.

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The next wave of musculoskeletal regenerative therapies won’t be decided by who has the most elegant science, but by who can prove impact most convincingly. Biomarkers are the connective tissue between mechanism, regulatory approval, and market adoption.

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