Profound Medical (NASDAQ:PROF; TSX:PRN) announced today that PRO FAMILIA Specialist Hospital in Rzeszów, Poland has completed its 500th Sonalleve Procedure. The MRI-guided therapy provides women with a non-surgical alternative for treating common gynecologic conditions—delivering targeted relief with no incisions, no blood loss during the procedure, no overnight hospital stay, and a faster recovery.
In a statement, Dr. Tomasz Łoziński, president of PRO FAMILIA, commented, “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. The precision of MRI guidance enables us to focus treatment on the fibroids without harming healthy tissue. We’re proud that this technology has become a vital part of the care we provide.”
Sonalleve, Profound’s second product which is currently offered primarily as a one-time capital sale, is gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA-PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently 10 Sonalleve devices operational in parts of Europe, China and Southeast Asia—where more than 4,000 women have already been treated with the technology for two major diseases of the uterus—adenomyosis and uterine fibroids. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life-threatening, diseases.
Arun Menawat, CEO and chairman of Profound, remarked, “It has been a privilege to collaborate with Dr. Łoziński, 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 they can. The U.S. commercialization of TULSA-PRO remains our primary priority, and we are pleased with its increasing adoption driven by its unique ability to effectively treat the full spectrum of prostate diseases, while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. But it is also exciting to see that another major iMRI technology in our portfolio is growing, particularly internationally, due to its potential to treat gynecologic disorders while potentially offering the choice of not having to remove the uterus.”
Uterine fibroids and adenomyosis—an often-painful condition caused when endometrial tissue grows into the uterine muscle—are among the most common gynecologic disorders. Both can lead to heavy menstrual bleeding, pelvic pain, uterine enlargement, and in some cases, fertility challenges. Current treatments typically rely on hormonal therapy or invasive surgery. For women with adenomyosis in particular, care options are especially limited, and the condition frequently goes underdiagnosed or misdiagnosed.
