Sanuwave Health (SNWV) Investor presentation summary

Market opportunity and industry trends

• Chronic wounds affect over 7 million Americans, with the US wound care market estimated at $76 billion annually, spanning pressure injuries, diabetic foot ulcers, venous leg ulcers, burns, and surgical wounds.

• The market is undergoing a shift toward evidence-based medicine, with payors reassessing reimbursement for traditional treatments and favoring technologies with strong clinical backing.

• CMS and commercial providers increasingly classify regenerative technology products as medically necessary, driving demand for innovative solutions.

• Recent CMS repricing of skin substitutes has drastically reduced their reimbursement, creating disruption and opportunity for alternative therapies.

Product overview and clinical efficacy

• Ultramist is a non-contact, non-thermal, low-frequency ultrasound device for wound care, FDA-cleared and supported by a nationwide CMS reimbursement code.

• The device uses ultrasonic energy to atomize saline, promoting fibroblast proliferation, angiogenesis, and reducing inflammation and bacterial load.

• Clinical studies show Ultramist achieves up to 72% greater healing rates at 12 weeks compared to standard care, with significant pain reduction and improved closure rates for chronic wounds.

• Over 325,000 procedures were performed in 2025, with strong patient and physician testimonials supporting rapid healing and improved quality of life.

Business model and financial performance

• Operates a razor/razorblade model: systems are sold for $35,000, with single-use applicators at $100 each, generating 55-65% of revenue from consumables.

• Gross margins are high at 77-78%, with FY 2025 revenue of $44.1M (+35% YoY) and adjusted EBITDA of $13.6M.

• Q1 2026 revenue was $9.6M (+3% YoY), with 1,382 active systems in the field and record applicator unit volume.

• Manufacturing is domestic and scalable, with recent upgrades increasing applicator capacity to 20,000 units per week.