Profound sees Polish hospital complete 500th procedure

Executive Summary

• Profound Medical Corp. announced that Pro Familia Specialist Hospital in Rzeszow, Poland, has completed the 500th Sonalleve procedure, marking a significant commercial milestone for its incision-free gynecologic therapy.
• The Sonalleve system, which uses MRI-guided focused ultrasound, is gaining international traction with 10 operational devices currently in Europe, China, and Southeast Asia, having treated over 4,000 women to date.
• CEO Arun Menawat highlighted the dual growth of the company's portfolio, noting the primary priority remains the U.S. commercialization of Tulsa-Pro for prostate diseases, while Sonalleve expands access to uterine-sparing care for conditions like fibroids and adenomyosis.

Key Details

• Milestone: 500th Sonalleve procedure completed at Pro Familia Specialist Hospital in Rzeszow, Poland.
• Global Reach: 10 Sonalleve devices are currently operational in Europe, China, and Southeast Asia.
• Patient Volume: Over 4,000 women have been treated globally with Sonalleve for uterine fibroids and adenomyosis.
• Clinical Benefits: The procedure offers a non-surgical alternative with no incisions, no blood loss, no overnight hospital stay, faster recovery, and preservation of fertility/ovarian reserve.
• Research Funding: Approximately $10 million has been granted by research organizations in Europe and Canada over the past five years for clinical research on Sonalleve.
• Product Status: Sonalleve is currently offered primarily as a one-time capital sale and is gaining increasing commercial interest outside the United States.
• CEO Commentary: CEO Arun Menawat emphasized that while U.S. commercialization of Tulsa-Pro (for prostate diseases) is the primary priority, the international growth of Sonalleve is exciting due to its potential to treat gynecologic disorders without uterine removal.

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," said Dr. Tomasz Lozinski, president of Pro Familia.
• "It has been a privilege to collaborate with Dr. Lozinski, Dr. Justyna Filipowska and the entire Pro Familia team to expand access to this technology. They are true pioneers in advancing uterine-sparing care that relieves symptoms while preserving reproductive possibilities whenever can," said Arun Menawat, chief executive officer and chairman of Profound Medical.