Mr. Arun Menawat reports

PROFOUND MEDICAL ANNOUNCES CMS EXTENSION OF TEMPORARY 'CODE' FOR TULSA TO ASC SETTING

Pursuant to the 2024 final rule published yesterday by the U.S. Centers for Medicare and Medicaid Services (CMS), use of HCPCS C code C9734, previously established for the hospital outpatient prospective payment system (OPPS), has been extended for use in the ambulatory surgical centre (ASC) setting, and MRI-monitored (magnetic resonance imaging) transurethral ultrasound ablation (TULSA) of prostate tissue, performed using Profound Medical Corp.'s TULSA-Pro system, has been assigned device-intensive status. The ASC extension will go into effect on Jan. 1, 2024.

C9734 was one of 11 HCPCS C codes that were added to the ASC covered procedure list, out of the 235 procedure recommendations CMS received. CMS determined that these 11 codes correspond to procedures that are frequently performed in outpatient settings and increasingly show lower risks of serious complications and inpatient admissions.

"In June, 2003, we announced that, with sponsorship and support from multiple physician specialty societies, the American Medical Association had established three new Current Procedural Terminology Category 1 codes for TULSA to treat prostate diseases," said Arun Menawat, chief executive officer and chairman of Profound. "Those permanent CPT Category 1 codes will go into effect on Jan. 1, 2025. In the meantime, we are pleased that both U.S. hospitals and ASCs performing the TULSA procedure on Medicare patients will now be able to utilize the temporary C code, C9734."

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-Pro, a technology that combines real-time MRI, robotically driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-Pro is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. TULSA-Pro has the potential to be a flexible technology in customizable prostate ablation, including intermediate-stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large-volume benign prostatic hyperplasia (BPH). TULSA-Pro is CE (Conformite Europeenne) marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (FDA).

Profound is also commercializing Sonalleve, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. The company is in the early stages of exploring additional potential treatment markets for Sonalleve, where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

We seek Safe Harbor.