Sanuwave Health (SNWV) investor relations material

Market overview and industry trends

• Wound care is a $76 billion U.S. market, driven by an aging population and increasing chronic wounds.

• The industry is shifting toward evidence-based medicine and cost-per-episode analysis, with payers driving changes.

• Recent CMS reimbursement cuts in the skin substitute space have caused significant disruption, forcing providers to adapt.

• Larger, more sophisticated providers are emerging, focusing on route density and holistic patient care.

• Hospitals are increasingly integrating mobile wound care to improve outcomes and reduce readmissions.

Product positioning and clinical evidence

• UltraMIST is a non-contact, non-thermal ultrasound device with FDA clearance and a nationwide CMS code.

• The system achieves 2x-3x faster healing rates and 80% pain reduction compared to standard care, supported by 18 peer-reviewed studies and 8 RCTs.

• Over 2 million procedures have been performed, with 325,000 in the last year.

• The device is highly portable, easy to use, and designed for a wide range of care settings.

• Only product with high-quality clinical evidence for efficacy in its category, enabling reliable reimbursement.

Business model and financial performance

• Operates a razor/razor blade model: systems list at $30,000, single-use applicators at $100, with 55%-65% of revenue from consumables.

• 1,382 active systems in the field at Q1, with 1.5% market penetration and significant room for growth.

• 2025 revenue projected at $44 million, with $9.3 million in Q1 and gross margins in the high 70s.

• 2024 saw 35% year-over-year revenue growth and a 30% cash EBITDA margin.

• Margins between systems and consumables are similar, with further improvements expected from new manufacturing processes.