SANUWAVE Health

What SANUWAVE Health does

SANUWAVE Health, Inc. (NASDAQ: SNWV) is a publicly traded medical technology company headquartered in Eden Prairie, Minnesota, that develops and commercializes the UltraMIST® System, an FDA-cleared, non-contact, low-frequency ultrasound (20-40 kHz) wound healing device. The system delivers acoustic energy through a saline mist to promote healing at the cellular level by controlling inflammation, reducing bacteria, breaking down biofilm, and increasing perfusion through vasodilation. It treats chronic and acute wounds including diabetic foot ulcers, venous leg ulcers, pressure ulcers, surgical wounds, and burn wounds, with 3-20 minute pain-free treatment times supported by an extensive clinical evidence base (meta-analysis of 54,888 patients across 8 randomized controlled trials, plus 20+ peer-reviewed publications). The underlying PACE (Pulsed Acoustic Cellular Expression) platform underpins the technology and represents a proprietary form of Extracorporeal Shockwave Therapy (ESWT) with potential adjacent applications.

The company monetizes UltraMIST through a two-stream model: capital equipment sales of the device to wound care centers, hospitals, home health agencies, and skilled nursing facilities, plus recurring revenue from consumable applicators. The treatment is reimbursable under CMS CPT code 97610 at a stable national schedule rate (unchanged for 2026). Distribution runs through direct enterprise field sales augmented by group purchasing organizations, with Healogics iSupply (added December 2025) as a key channel partner. SANUWAVE is led by CEO/Chairman Peter Sorensen (previously CFO) alongside an executive bench recruited from high-growth medical device commercial leaders (Abiomed, Smith & Nephew, Hill-ROM) and energy-based technology veterans (Bolt Medical, Alcon, Olympus-ACMI).

In FY2025, SANUWAVE generated a record $44.1 million in revenue (+35% YoY) with 624 UltraMIST systems sold (vs. 374 in 2024), $13.6 million in adjusted EBITDA (+89% YoY), and $11.8 million in net income (vs. a $33.1 million net loss in 2024). However, Q1 2026 preliminary revenue of $9.6-9.7 million (only 3-4% YoY growth) and Q2 2026 guidance of $8.5-9.5 million (revised down) signal a sharp deceleration attributed by management to capital equipment market softness and CMS reimbursement clawbacks. The company completed a comprehensive capital restructuring in October 2024 (1-for-375 reverse split, $43.2M convertible note exchange, $10.3M PIPE led by AWM) and refinanced $27.5M of legacy debt with J.P. Morgan in September 2025 to strengthen the balance sheet ahead of this growth transition.

Name

SANUWAVE Health

Legal name

SANUWAVE Health, Inc.

Website

https://sanuwave.com

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Short description

SANUWAVE Health (NASDAQ: SNWV) is a medical technology company commercializing the FDA-cleared UltraMIST® System, a non-contact low-frequency ultrasound device for chronic wound healing. It sells capital equipment and consumable applicators to US wound care centers, hospitals, and skilled nursing facilities.

Ownership category

akta.pro rank

Product category

Advanced Wound Care Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Ultrasound & Echography Systems (HLAHABAD)

akta.pro secondary industry

Wound Care & Ulcer Management (HLAKACAN)

Keywords

• Advanced wound care
• Ultrasound wound therapy
• Medical device manufacturing
• Acoustic wound healing
• Diabetic foot ulcer treatment

Headquarters

HQ city

Alpharetta

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. UltraMIST Capital Equipment Sales: Sale of UltraMIST wound care systems as capital equipment to healthcare providers. The company sold 624 UltraMIST systems in 2025 versus 374 in 2024, with Q4 2025 sales of 255 systems marking a company record.
2. Consumables/Applicators: Recurring revenue from consumable applicator sales for the UltraMIST system. Despite capital equipment market headwinds, consumable applicator volumes remain robust with the company on pace for a record quarterly unit volume of consumables shipments in Q2 2026.
3. CMS Reimbursement (Code 97610): National Schedule 1 CMS reimbursement under code 97610 for the UltraMIST procedure. The 2026 reimbursement rate remains unchanged from 2025, with rates expected to remain stable.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

SANUWAVE Health manufactures and sells the UltraMIST System, an FDA-cleared non-contact, low-frequency ultrasound device that delivers acoustic energy through saline mist to promote healing of chronic and acute wounds. The company also generates recurring revenue from consumable applicators used with each UltraMIST treatment. The system targets wound care centers, hospitals, home health agencies, and skilled nursing facilities for treatment of diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical wounds.

Product overview

SANUWAVE Health offers a single unified product line centered on the UltraMIST® System, an FDA-cleared non-contact low-frequency acoustic wave therapy device for advanced wound care. The system delivers acoustic energy through a saline mist to promote cellular-level healing, and is the company's sole commercially deployed product. The underlying technology is supported by SANUWAVE's PACE (Pulsed Acoustic Cellular Expression) platform and the company's Energy First™ treatment protocol.

Differentiator

Problem solved

Functional benefit

Brands

• UltraMIST: FDA-cleared, pain-free ultrasound delivered through saline mist for wound healing
• PACE Technology

Products and services

• UltraMIST® System The UltraMIST® System is an FDA-cleared non-contact, low-frequency acoustic wave therapy system that promotes wound healing by controlling inflammation, reducing bacteria, and increasing angiogenesis and perfusion through vasodilation. Administered using saline mist, the system treats chronic and acute wounds including venous leg ulcers, diabetic foot ulcers, pressure injuries, and surgical wounds. Treatments are pain-free and take 3–20 minutes depending on wound size. Sold as capital equipment to wound care centers, hospitals, home health agencies, and skilled nursing facilities.
• UltraMIST Consumable Applicators Single-use consumable applicators used with the UltraMIST system for each patient treatment, generating recurring usage-based revenue. The company was on pace for a record quarterly unit volume of consumables shipments in Q2 2026.

Quantifiable outcome

• 80% reduction in VAS pain score over 4 weeks (vs. 20% standard of care), p = 0.014
• +7 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Healogics iSupplycoreChannel Partner/ Reseller/ Distributor · 8 December 2025Healogics iSupply is a group purchasing organization for wound care providers. SANUWAVE's UltraMIST product line was added to the iSupply network, making the system available to iSupply members including Wound Care Centers, home health agencies, and skilled nursing facilities. The company planned to begin rolling out the system to initial Healogics iSupply locations by the end of 2025. Healogics has operated in advanced wound care for nearly 30 years and partners with hospitals and health systems across the United States.

Scale indicators15 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• 3M (KCI): Through its KCI acquisition, 3M is the dominant negative pressure wound therapy (V.A.C.) provider and a major incumbent in advanced wound care. Competes with SANUWAVE for the same wound care center and hospital budgets, though SANUWAVE focuses on ultrasonic adjunctive therapy rather than NPWT.
• Smith & Nephew: Global medical device company with a sizable Advanced Wound Management portfolio (Allevyn, PICO NPWT, OASIS). Targets the same wound care centers, home health agencies, and hospitals as SANUWAVE with a broader dressing- and device-led offering.
• Coloplast: Major wound and skin care medical device manufacturer with Biatain dressings and Biatain Ibu foam used in chronic wound management. Competes indirectly with UltraMIST for chronic wound treatment protocols in the same provider channels.
• Mölnlycke Health Care: Leading wound care and surgical solutions company best known for Mepilex dressings and Mepitel. Overlaps with SANUWAVE in chronic wound management customers and competes for clinical protocol inclusion in wound care centers.

Direct peers

• ConvaTec: Pure-play wound care and ostomy company with products across dressings, NPWT, and adjunctive therapies serving wound care centers and home health. A direct competitor in the advanced wound care channel that SANUWAVE also targets with UltraMIST.
• Organogenesis: U.S.-based regenerative medicine and wound care company selling Apligraf and Dermagraft skin substitutes to wound care centers and hospitals treating diabetic foot ulcers and venous leg ulcers — the same patient populations SANUWAVE addresses with UltraMIST.
• Integra LifeSciences: Medical device company with a dedicated Wound Care franchise (Integra Dermal Regeneration Template, AmnioExcel) addressing chronic and complex wounds in hospitals and wound clinics, making it a directly comparable advanced wound care peer.
• MiMedx Group: U.S. wound care and surgical recovery company selling EpiFix amniotic membrane grafts for diabetic foot ulcers, venous leg ulcers, and surgical wounds. Targets the same wound care center and podiatry call points as SANUWAVE.

Emerging players

• Bioventus: Acquired Misonix, which had previously commercialized ultrasonic wound debridement and therapy systems comparable to SANUWAVE's UltraMIST. The combined entity overlaps directly in ultrasonic wound care technology and serves similar clinical channels.

Others

• Cardinal Health: Major medical products distributor that includes wound care supplies and serves hospitals, home health, and SNFs. Comparable as a wound care channel participant and potential distribution partner alongside SANUWAVE's Healogics iSupply relationship.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sanuwave-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds14 records

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SANUWAVE Health