# EDGAR Filing Document

**Accession Number:** 0001628808
**File Stem:** 0001171843-25-007221
**Filing Date:** 2025-11
**Character Count:** 17493
**Document Hash:** b6714ede005aa83a065d49bfa2375e6d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-25-007221.hdr.sgml**: 20251112

**ACCESSION NUMBER**: 0001171843-25-007221

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251111

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251112

**DATE AS OF CHANGE**: 20251112

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Profound Medical Corp.
- **CENTRAL INDEX KEY:** 0001628808
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **STATE OF INCORPORATION:** A6
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39032
- **FILM NUMBER:** 251469057

**BUSINESS ADDRESS:**
- **STREET 1:** 2400 SKYMARK AVENUE, UNIT 6
- **CITY:** MISSISSAUGA
- **STATE:** A6
- **ZIP:** L4W 5K5
- **BUSINESS PHONE:** 647-476-1350

**MAIL ADDRESS:**
- **STREET 1:** 2400 SKYMARK AVENUE, UNIT 6
- **CITY:** MISSISSAUGA
- **STATE:** A6
- **ZIP:** L4W 5K5

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Profound Medical Inc.
- **DATE OF NAME CHANGE:** 20141222

?xml version='1.0' encoding='ASCII'? Form 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

### Washington, D.C. 20549
_________________

### FORM 8-K
_________________

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): November 11, 2025
_______________________________

#### PROFOUND MEDICAL CORP.
(Exact name of registrant as specified in its charter)

_______________________________

---

| | | |
|:---|:---|:---|
| **Ontario, Canada** | **001-39032** | **Not Applicable** |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

#### 2400 Skymark Avenue, Unit 6

#### Mississauga, Ontario, Canada L4W 5K5
(Address of Principal Executive Offices) (Zip Code)

#### Registrant's Telephone Number, Including Area Code: 647-476-1350
(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Shares | PROF | The Nasdaq Stock Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 7.01. Regulation FD Disclosure.**

On November 11, 2025, Profound Medical Corp. (the "Company") issued a press release announcing that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, or the Securities Act. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the U.S. Securities Exchange Commission, or the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Item 9.01. Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| Exhibit No. | Description |
| [99.1](exh_991.htm) | [Press Release, dated November 11, 2025](exh_991.htm) |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |

---

#### SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **PROFOUND MEDICAL CORP.** | **PROFOUND MEDICAL CORP.** |
| Date: November 11, 2025 | By: | <u>/s/ Rashed Dewan&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  |  | Rashed Dewan |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Profound Medical Inks Exclusive Distribution Agreement for TULSA-PRO® and Sonalleve® with Al Faisaliah Medical Systems in Saudi Arabia**

*Agreement creates runway for Profound's incision-free and radiation-free therapies for the ablation of diseased tissue, to penetrate the largest healthcare market in the Middle East*

*All required regulatory approvals to import and sell Profound's two advanced ablative technologies in Saudi Arabia are already in place*

TORONTO and RIYADH, Saudi Arabia, Nov. 11, 2025 (GLOBE NEWSWIRE) -- <u>Profound Medical Corp.</u> (NASDAQ:PROF; TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets artificial intelligence ("AI")-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO<sup>®</sup> and Sonalleve<sup>®</sup> technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. ("FMS"), a subsidiary of one of the Kingdom's most prominent business conglomerates, Al Faisaliah Group ("AFG").

Profound is the only company that combines the real-time imaging and thermography capabilities of magnetic resonance ("MR") with AI-driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay.

U.S. commercialization of TULSA-PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, "BPH"), remains the top priority for the Company's direct sales team. The <u>TULSA Procedure</u>™, performed using Profound's TULSA-PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to 'kill temperature' (55-57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention-to-treat, while TULSA-PRO has the flexibility to be used for all ablations, including focal and hemi-gland, the majority of TULSA Procedures are either whole-gland or near-whole-gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule ("Final Rule") for the three new CPT<sup>®</sup> Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To-date, more than 4,000 men have undergone the TULSA Procedure, and as of <u>last report</u> (October 2025), Profound's TULSA-PRO installed base stood at 67 systems.

Profound's second product, Sonalleve, which is offered primarily as a one-time capital sale, is also 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 ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. 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.

As user interest in Profound's technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.

"We're honored to partner for the distribution of both TULSA-PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia," commented Profound's CEO and Chairman, Arun Menawat. "Successfully marketing and distributing our incision-free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients. With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we're confident that FMS is the ideal partner for us."

FMS' GM, Mr. Abdullah Al Melik, said, "As Saudi Arabia moves toward economic diversification under <u>Vision 2030</u>, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country's future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities. With our partnership with Profound, we're extremely excited to bring its unique, incision- and radiation-free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team."

**About with Al Faisaliah Medical Systems Co.**

Founded in 1973, FMS was initially the healthcare division of AFG, until its establishment as an independent company in 1993. Its broad portfolio of partners and products enables it to deliver complex, integrated, single-source healthcare equipment solutions to the largest healthcare providers in the region. With operations across the Kingdom of Saudi Arabia, FMS is a major provider of diversified healthcare solutions, supplying state-of-the-art equipment and solutions for various uses such as oncology, operations, monitoring and critical care, cardiovascular and others. For further information, visit <u>www.tibbiyah.com/fms</u>.

**About Al Faisaliah Group**

AFG is a privately held holding company headquartered in Riyadh, Saudi Arabia, operating across the wider Middle East. Its name is derived from the name of its founder, Abdullah Al Faisal, eldest son of the late King Faisal. Founded in 1971, the Group holds leading positions in multiple industries including Dairy, Electronics, Healthcare and Food Service. AFG also operates a corporate venture capital arm (Al Faisaliah Ventures) that invests in global and regional disruptive players. The Group is recognized across the region for its strongly-held values, professional management and decades-long strategic partnerships with leading local and global firms including notably Sony, Danone and Philips. For further information, visit <u>www.alfaisaliah.com</u>.

**About Profound Medical Corp.**

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

Profound is commercializing TULSA-PRO<sup>®</sup>, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The <u>TULSA Procedure</u>™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia ("BPH"); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients' urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. The TULSA Procedure is an incision- and radiation-free "one-and-done" procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. 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<sup>®</sup>, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. 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. Profound 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; the extent and timing of Profound's completion of TULSA-PRO<sup>®</sup> system sales from its qualified sales pipeline; Profound's expectations for future revenues; and the success of Profound'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. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at <u>www.sedarplus.ca</u> and <u>www.sec.gov</u>. 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

<u>skilmer@profoundmedical.com</u>

T: 647.872.4849