Profound Medical Receives FDA HDE Approval for Sonalleve®
Excerpt from the Press Release:
TORONTO, Nov. 30, 2020 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX: PRN) (“Profound” or the “Company”) announced today that Sonalleve® has received U.S. Food and Drug Administration (“FDA”) approval under a Humanitarian Device Exemption (“HDE”) for the treatment of osteoid osteoma.
Osteoid osteoma is a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. An osteoid osteoma causes a dull, aching pain that is moderate in intensity, but can worsen and become severe, especially at night. Computed tomography(CT)-guided radiofrequency ablation (RFA), the most commonly used osteoid osteoma treatment, requires drilling through muscle and soft tissue into bone, and also exposes the patient to radiation from the imaging necessary to guide the probe that is inserted to heat and destroy tumor tissue.
Sonalleve® is an innovative therapeutic platform that combines real-time Magnetic Resonance imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve® can offer patients suffering with an osteoid osteoma a treatment that can be performed safely with clinical improvement, but without any incisions, needles, or ionizing radiation exposure.
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