PRO FAMILIA and Profound mark 500 Sonalleve procedures, expanding access to incision-free women's care

PRO FAMILIA and Profound Medical reported 500 Sonalleve procedures offering incision‑free options for women's health; Sonalleve is CE marked for several indications, approved in China for uterine fibroids, and holds an FDA Humanitarian Device Exemption for osteoid osteoma.

PRO FAMILIA and Profound Medical reported they have reached 500 Sonalleve procedures. The procedures provide incision‑free therapeutic options for women's health. Sonalleve is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. The system also has regulatory approval in China for non‑invasive treatment of uterine fibroids and an FDA Humanitarian Device Exemption for osteoid osteoma. Key facts: - 500 Sonalleve procedures reported by PRO FAMILIA and Profound Medical. - Sonalleve is CE marked for uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. - Approved in China for non‑invasive treatment of uterine fibroids. - Has an FDA Humanitarian Device Exemption for treatment of osteoid osteoma. - Profound is exploring additional potential treatment markets, including non‑invasive ablation of abdominal cancers and hyperthermia for cancer therapy. - The release includes forward‑looking statements about potential future performance and approvals. Summary: The announcement highlights expanded use of the Sonalleve system and reported experience with 500 incision‑free procedures. Profound indicates it is exploring additional treatment markets; the timing and outcome of such exploration are undetermined at this time.