Risk Sleuth
PROF · 10-K filed 5 Mar 2026 · year to 31 Dec 2025

Profound Medical

23 named things its latest annual report says its results depend on, each in the company's own words. 16 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Suppliers

Single-source component suppliers

depends onnamed as a risk
We currently rely on a single source for the manufacture of some of the components of our TULSA-PRO and Sonalleve systems.Risk factors (Item 1A)

Also named by CSCO, LRCX, MTD, P, RMD

Partners and platforms

Sunnybrook Health Sciences Centre

depends on · C$250,000named as a risk
For instance, we license exclusive intellectual property rights from Sunnybrook that enable us to use, manufacture, distribute and sell the TULSA-PRO system.Risk factors (Item 1A)

Philips

depends onnamed as a risk
We currently rely on our collaborative partnerships for the sales and marketing and/or distribution of our approved products, in particular Philips, Siemens and GE Healthcare, who promote our systems that are compatible with the MRI scanners produced and sold by them to end users, including hospitals and clinics.Risk factors (Item 1A)

Also named by RMD

Siemens Healthineers

depends onnamed as a risk
On December 2, 2024, Profound Medical and Siemens Healthineers announced a definitive co-sales and co-marketing agreement of its TULSA-PRO and Free. Max MRI, to offer a complete solution for MRI-guided prostate therapy.Business (Item 1)

Also named by GEHC

GE Healthcare

depends onnamed as a risk
On December 21, 2020, we entered into a co-development agreement with GE Healthcare (the “GE Agreement”) whereby we and GE Healthcare agreed to a non-exclusive, worldwide license that will enable us to interface our TULSA-PRO system with certain GE Healthcare MRI scanners.Business (Item 1)

Also named by LNTH

Philips

depends onnamed as a risk
We have designed our TULSA-PRO system to be capable of integration with some of the MRI scanners from three of the major MRI manufacturers (Philips, Siemens and GE Healthcare), and the Sonalleve system with one MRI manufacturer (Philips).Risk factors (Item 1A)

Also named by RMD

Other companies

Canadian Imperial Bank of Commerce (CIBC)

depends on · $10,000named as a risk
We are required to comply with the covenants in the CIBC Credit Agreement and such covenants may create a risk of default on our debt if we cannot satisfy or continue to satisfy these covenants.Risk factors (Item 1A)

CAPTAIN trial

211 subjectsnamed as a risk
There can be no assurance that we will achieve our commercialization goals in respect of the TULSA-PRO system in the United States, or that future efficacy and safety results from our TACT Pivotal Clinical Trial and CAPTAIN trial will be favorable.Risk factors (Item 1A)

Sonalleve acquisition from Philips

named as a risk
For example, our ability to achieve the anticipated benefits of the Sonalleve Transaction depends in part on our ability to realize the anticipated growth opportunities and synergies from the acquired assets and technologies, including our further development of the Sonalleve system.Risk factors (Item 1A)

Places

Vantaa, Finland

operates in · 17 of our employeesnamed as a risk
As of December 31, 2025, 17 of our employees in Vantaa, Finland were unionized.Risk factors (Item 1A)

United States

concentrated in · approximately 76%
For the year ended December 31, 2025, approximately 76%, 5% and 19% of revenues were generated in the United States, EU and Asia, respectively, compared to approximately 78%, 8% and 14%, respectively for the year ended December 31, 2024.Business (Item 1)

Also named by ABBV, ADP, AJG, AMGN, APA, AXGN, AXP, BALL and 139 more

Asia

earns from · 19%
For the year ended December 31, 2025, approximately 76%, 5% and 19% of revenues were generated in the United States, EU and Asia, respectively, compared to approximately 78%, 8% and 14%, respectively for the year ended December 31, 2024.Business (Item 1)

Also named by AAPL, AYI, CART, CB, CDW, CHD, CLS, COHR and 31 more

European Union

earns from · 5%
For the year ended December 31, 2025, approximately 76%, 5% and 19% of revenues were generated in the United States, EU and Asia, respectively, compared to approximately 78%, 8% and 14%, respectively for the year ended December 31, 2024.Business (Item 1)

Also named by ABBV, ADM, AVY, BA, DXCM, ENB, FPI, GEHC and 4 more

Canada

operates innamed as a risk
In addition, the manufacturing facilities for our products sold in the U.S. are located in Canada and other jurisdictions outside of the U.S.Risk factors (Item 1A)

Also named by AAP, AJG, ALL, AMRC, AOS, ARE, BBY, BF/B and 97 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
Our products are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities and Notified Bodies.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Health Canada

subject tonamed as a risk
Our contract manufacturers must comply with applicable FDA, EU, Health Canada and other applicable foreign regulations, which include quality control and quality assurance requirements, as well as the corresponding maintenance of records and documentation and manufacture of devices according to the specifications contained in the applicable regulatory file.Risk factors (Item 1A)

Also named by BWXT, HIMS

Centers for Medicare and Medicaid Services (CMS)

subject to
On July 11, 2024, it was 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 TULSA procedure, which became effective January 1, 2025.Business (Item 1)

Also named by ABBV, CDNA, CHE, DGX, DOC, ENSG, GD, GEHC and 6 more

China National Medical Products Administration (NMPA)

subject to
In 2018, Sonalleve was also approved in China by the NMPA for the non-invasive treatment of uterine fibroids.Business (Item 1)

Also named by COO, CYRX, JBL, KVUE

Laws and programs

Medicare

earns from · $13,479
For Hospital Payment, the Final Rule has established TULSA CPT 55882 as a Level 7 Urology Ambulatory Payment Classification (“APC”) for 2026 with a Medicare National Average payment of $13,479.Business (Item 1)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

U.S. Anti-Kickback Statute

subject tonamed as a risk
This statute has been interpreted to apply to arrangements between device manufacturers on one hand and prescribers and purchasers on the other.Risk factors (Item 1A)

Also named by BSX, CAH, HCA, LH, ORCL, ZBH

FDA Quality Management System Regulation (QMSR)

subject tonamed as a risk
In the United States, the methods used in, and the facilities used for, the manufacture of medical devices must comply with the QSR, and starting on February 2, 2026 the new QMSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, and servicing of medical devices.Risk factors (Item 1A)

Also named by RMD

EU Medical Devices Regulation (EU) 2017/745

subject tonamed as a risk
Any delay or failure to comply with the New EU MDR could result in the sale of our authorized products being temporarily or permanently prohibited in EU member states and may affect our reputation, business, financial condition, results of operations and prospects.Risk factors (Item 1A)

U.S. tariffs on Canada-origin goods

subject tonamed as a risk
Under the tariff actions, most Canada- and Mexico-origin goods that do not claim and qualify for preferential treatment under the U.S. – Mexico – Canada Agreement (USMCA) are subject to additional duties.Risk factors (Item 1A)