PRO FAMILIA and Profound Medical Celebrate 500 Sonalleve(TM) Procedures, Expanding Access to Incision-Free Care for Women's Health

Executive Summary

• Profound Medical announced that PRO FAMILIA Specialist Hospital in Rzeszów, Poland has performed its 500th Sonalleve® MRI‑guided uterine fibroid/adenomyosis procedure.
• The milestone highlights growing international adoption of Sonalleve, with ten devices operating across Europe, China and Southeast Asia and over 4,000 women treated to date.
• Profound emphasized continued focus on U.S. commercialization of its TULSA‑PRO® prostate system while leveraging the expanding global market for Sonalleve.

Key Details

• 500th Procedure: Completed at PRO FAMILIA Specialist Hospital, Rzeszów, Poland – a non‑surgical, incision‑free MRI‑guided therapy for uterine fibroids and adenomyosis.
• Device Footprint: 10 Sonalleve systems currently installed in Europe, China and Southeast Asia.
• Patient Reach: >4,000 women treated worldwide with Sonalleve for uterine fibroids or adenomyosis; clinical data show pain/symptom relief without compromising ovarian reserve or fertility.
• Research Funding: Approximately $10 million granted by European and Canadian research organizations over the past five years to support further clinical studies of Sonalleve across multiple disease indications.
• Commercial Model: Sonalleve is primarily sold as a one‑time capital equipment purchase; demand is increasing, especially outside the United States.
• CEO Quote (Arun Menawat): Stated that while U.S. commercialization of TULSA‑PRO remains the primary priority, the international growth of Sonalleve is “exciting” and underscores the company’s broader iMRI platform potential.
• Future Outlook: Profound continues to explore additional indications for Sonalleve, including non‑invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Notable Quotes

“Sonalleve is giving more women access to a safer, gentler alternative to open surgery—one that can reduce complications and help preserve their ability to have children,” – Dr. Tomasz Lozinski, President, PRO FAMILIA.

“The U.S. commercialization of TULSA‑PRO remains our primary priority… but it is also exciting to see that another major iMRI technology in our portfolio is growing, particularly internationally,” – Arun Menawat, CEO & Chairman, Profound Medical.