Company Announcements

TORONTO, July 11, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that U.S. Centers for Medicare and Medicaid Services (CMS) has issued its proposed rules establishing, for the first time, a Category 1 CPT code for the Transurethral Ultrasound Ablation (“TULSA”) procedure, effective January 1, 2025.

According to the proposed rule, TULSA will have 3 physician codes to cover how therapy is delivered depending on if there are one or two physicians involved in the procedure: 5x006 TULSA Device Management and 5x007 TULSA Treatment, when two physicians are involved in the procedure, and 5x008 TULSA Complete Procedure, when performed by a single physician. TULSA will have a 0-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is performed. Physicians will thereby bill for any pre or post patient visit separately using existing codes. This will provide physicians with the most flexibility to assess the appropriate number of visits needed by each patient and enable their safe and fast recovery. TULSA codes have also been assigned to all three sites of service: Hospital Outpatient (“HOPD”), Ambulatory Surgical Center (“ASC”), and Private Office/Non-Facility (“OBL”). The spectrum of the location of service will ensure patients can be treated in whatever setting they and their physician believe appropriate and convenient for each patient.

For Hospital Payment, the proposed rule has established TULSA as a Level 6 Urology Ambulatory Payment Classification (“APC”) for 2025 for 5x008 of $9,208.50 (National Average). For ASCs, the facility payment for 5x008 will be $7,195.00 (National Average).

The Proposed Rule for the Physician Fee Schedule has set the total Facility (HOPD or ASC) Relative Value Units (“RVU”) at 6.53 for TULSA Device Management 5x006 and 14.68 RVU for the TULSA Treatment Physician 5x007 when 2 physicians are involved in the TULSA procedure. If one physician performs the complete TULSA procedure, the RVU is 18.01 for 5x008.

The Proposed Rule for Physician fee schedule for Non-Facility (OBL or Private Office) has set RVU at 16.50 for TULSA Device Management 5x006 and 267.47 RVU for the TULSA Treatment Physician 5x007 when 2 physicians are involved in the TULSA procedure. If one physician performs the complete TULSA procedure, the RVU is 276.65 for 5x008.

As noted above, the TULSA procedure will have a 0-day Global Period, which does not include payment for post-operative visits, while all other comparable prostate treatment procedures include payments for post-operative visits performed in the first 90 days. The typical range of post-operative office visits would be approximately 9-11 total RVUs in the first 90-days.

The below tables summarize the proposed rule Codes, RVUs and Facility Dollar Amounts.

Facility Fee Schedule:

CPT Code	Description	APC: HOPD		APC: ASC
5x008	TULSA Complete Procedure	$9,208.50		$7,195.00

Physician Fee Schedule:

CPT Code	Description	Physician Total RVU		Typical 90-Day Follow-up	Physician Total RVU with typical 90-day Follow-Up
		Facility (HOPD, ASC)	Non-Facility (OBL)		Facility	Non-Facility (OBL)
					(HOPD, ASC)
5x006	TULSA Device Management	6.53	16.50	9.39-11.67	15.92-18.20	25.89 - 28.17
5x007	TULSA Treatment	14.68	267.47	n/a	14.68	267.47
5x006 & 5x007 Total	Procedure Total	21.21	283.97	9.39-11.67	30.60-32.88	293.36 - 295.64
	(Two Physician)
5x008	TULSA Complete Procedure (One Physician)	18.01	276.65	9.39-11.67	27.40-29.68	286.04 - 288.32

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 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.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; CMS’ final CY2025 Rule for TULSA, which is currently anticipated to be published in November 2024; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO®. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195