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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): October 28, 2026
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) |
(IRS 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 1.01. Entry into a Material Definitive
Agreement.
On October 28, 2026,
Profound Medical (U.S.) Inc. (“Profound U.S.”), a wholly owned subsidiary of Profound Medical Corp. (the “Company”
or “Profound”), entered into a Supply and Distribution Agreement (the “Agreement”) with Cook Medical Holdings
LLC (“Cook”), effective as of October 23, 2026 (the “Effective Date”).
Appointment
Under the Agreement,
Profound U.S. appointed Cook as a non-exclusive distributor of the Company’s TULSA-PRO® system (the “Products”)
in the United States and its territories (the “Territory”). Cook is authorized to distribute and sell the Products only for
use with Cook’s intraoperative MRI (“iMRI”) suite equipment (“Cook Equipment”). Profound U.S. has agreed
not to appoint any other distributor or reseller to sell the Products for use with Cook Equipment in the Territory without Cook’s
prior written consent. That restriction ends only if a joint steering committee (or, if it is referred, the parties’ senior management)
determines that Cook has not met specified minimum sales percentages after a cure period. Those minimum sales percentages are measured
as the share of Cook Equipment unit sales that include the Products in a calendar quarter, beginning with the first full calendar quarter
after FDA clearance for use of the Products with Cook Equipment. A failure to meet the minimum percentages is not a breach of the Agreement.
Profound U.S. may also sell the Products directly to customers that bought Cook Equipment but not any Products through Cook during a calendar
quarter. The parties have also agreed to discuss in good faith adding other TULSA-PRO system configurations, with no binding commitment.
Term; Regulatory Condition
The Agreement is effective
as of the Effective Date. Its five-year initial term begins on the date Profound U.S. gives Cook written evidence of the FDA clearance
needed to commercially distribute the Products in the Territory (the “Regulatory Approval Date”). Before the Regulatory Approval
Date, Cook has no purchase, forecast, payment or performance obligations, and Profound U.S. may not ship Products. If the Regulatory Approval
Date has not occurred by April 30, 2027, Cook may terminate the Agreement without liability. After the initial term, the Agreement renews
automatically for successive 12-month periods unless either party gives at least 180 days’ notice of non-renewal.
Other Terms
Profound U.S. shall remain
as the manufacturer and regulatory license holder for the Products and shall be responsible for quality, labeling, installation, service,
warranty, complaint handling and field actions, as set out in the Agreement and a quality agreement the parties will enter into. The parties
will coordinate sales and marketing through a joint steering committee and have agreed to co-marketing and training obligations. The Agreement
contains customary representations, warranties, indemnification obligations, insurance requirements, confidentiality provisions and limitations
of liability.
Termination
Either party may terminate
the Agreement (i) without cause on 180 days’ prior written notice, (ii) if the other party commits an uncured material breach (after
a 30-day cure period), or (iii) if the other party becomes insolvent. Profound U.S. may also terminate if Cook breaches the Agreement’s
no-reverse-engineering or no-challenge covenants. If Profound U.S. undergoes a change of control, either party may terminate on 90 days’
written notice, but the termination cannot take effect earlier than 24 months after the Regulatory Approval Date.
The foregoing description
of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy
of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On October 30, 2026, the Company issued a press release announcing
the Agreement. A copy of 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 and 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 |
| 10.1†* |
|
Supply and Distribution Agreement, effective as of October 23, 2026, by and between Profound Medical (U.S.) Inc. and Cook Medical Holdings LLC |
| 99.1 |
|
Press Release, dated October 30, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within Inline XBRL document) |
†
Certain portions of this exhibit (indicated by “[***]”) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
* Certain schedules and exhibits to this agreement have been omitted
pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish a copy of any omitted schedule or exhibit to the SEC upon
request.
SIGNATURES
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. |
| |
|
|
|
| Date: |
November 3, 2026 |
By: |
/s/ Arun Menawat |
| |
|
|
Arun Menawat
Chief Executive Officer and Chairman |
Exhibit 99.1
Profound Medical and Cook Medical’s
iMRI Division Partner to Expand U.S. TULSA-PRO® Sales Channels and Drive Recurring Revenue Growth
New distribution agreement positions TULSA-PRO
within the iMRI Suite offering through Cook Medical’s Copernicus™ program, expanding Profound’s commercial reach
Profound retains direct TULSA-PRO recurring
treatment kit and service revenue relationships for systems sold through Cook Medical
Agreement complements Profound’s existing
Siemens Healthineers relationship and broader strategy to expand access to MRI-guided regional prostate ablation
TORONTO, ON (October 30, 2026) – Profound
Medical Corp. (NASDAQ:PROF; TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company
that develops and markets innovative interventional MRI ("iMRI") procedures, today announced that it has entered into a supply
and distribution agreement with the iMRI Division of Cook Medical ("Cook") to expand U.S. sales of its TULSA-PRO®
system.
The iMRI Suite, developed by Cook Medical and
Siemens Healthineers, is a fully integrated procedural environment that enables real-time MRI-guided interventions without ionizing radiation.
It is built for intervention from the ground up. Cook’s Copernicus™ program connects the iMRI Suite with designed-for-MRI
devices, clinical training, implementation support, and partner therapies, giving hospitals a single pathway from planning an iMRI program
to treating patients.
The agreement establishes an additional new capital
equipment sales channel for Profound by bringing its TULSA-PRO system into the Copernicus™ program alongside the iMRI Suite, enabling
Cook to offer a turnkey prostate disease treatment solution to urologists and hospitals. The collaboration is intended to increase TULSA-PRO
system placements, expand the base of systems generating recurring revenue, and broaden physician and patient access to the TULSA Procedure™.
Expanding Commercial Reach
Under the agreement, Cook will purchase TULSA-PRO
systems from Profound at a predetermined transfer price for distribution in the United States. Customers purchasing systems through Cook
will obtain single-use disposables and service contracts directly from Profound.
Profound’s existing capital sales team
will continue to sell TULSA-PRO directly to sites with compatible MRI systems. Together, these channels allow the Company to serve customers
using existing MRI infrastructure and those investing in new iMRI capabilities.
"This agreement broadens our commercial
reach by making TULSA-PRO part of a comprehensive offering for hospitals investing in MRI-guided intervention," said Arun Menawat,
Profound’s Chief Executive Officer and Chairman. "Cook’s expertise in minimally invasive procedures, its large presence
in urology, and its investment in iMRI complement our direct sales capabilities. Together, we have an opportunity to bring TULSA to more
institutions and build procedure volumes as new sites establish and expand their treatment programs."
"Cook Medical has spent decades helping
physicians perform minimally invasive procedures, and our iMRI Division is carrying that work into MRI-guided intervention," said
Pete Polverini, Vice President, Interventional MRI Division at Cook Medical. "Through our Copernicus™ program we help hospitals
plan, build, and sustain iMRI programs, and TULSA-PRO gives those hospitals an FDA-cleared, incision-free prostate therapy to offer patients
who want to return to their daily lives sooner. Together with Profound, we aim to bring the TULSA Procedure to more urologists and more
hospitals and, over time, to additional sites of care."
Building a Broader iMRI Ecosystem
The Cook agreement complements Profound’s
existing co-sales and co-marketing agreement with Siemens Healthineers to commercialize a total MRI-guided prostate therapy solution
combining TULSA-PRO with Siemens Healthineers’ MAGNETOM Free.Max magnetic resonance scanner.1
Separately, Cook Medical and Siemens Healthineers
unveiled the radiation-free iMRI Suite at the Society of Interventional Radiology’s 2026 Annual Scientific Meeting, highlighting
the expanding ecosystem of imaging technology, interventional devices and clinical workflows supporting MRI-guided procedures.
Together, these commercial relationships broaden
Profound’s access to customers across existing MRI installations and new interventional suites, strengthening the foundation for
sustained adoption of the TULSA Procedure.
Note
1 Profound is working with the U.S.
Food and Drug Administration ("FDA") to obtain 510(k) clearance for the use of TULSA-PRO with the MAGNETOM Free.Max MR scanner.
TULSA-PRO is already FDA-cleared for use with multiple compatible 1.5T and 3T MRI systems, and has been CE marked for use with MAGNETOM
Free.Max in Europe.
About Cook Medical
At Cook Medical, we are passionate
about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing, manufacturing, and delivering
medical devices, we provide healthcare professionals with the tools they need to help their patients return to living.
Our commitment to innovation
involves bringing new products to market and keeping existing products relevant to a changing healthcare landscape. We believe in using
our business to help people and communities thrive by creating inclusive, supportive, and healthy environments.
We are proud of our history of
innovative firsts and the impact we have on patients and communities. With headquarters in Bloomington, Indiana, and manufacturing facilities
and offices in various global locations, we challenge ourselves to maintain a global perspective while focusing on local impact.
Follow Cook Medical at CookMedical.com
and on LinkedIn.
About Profound Medical Corp.
Profound is a commercial-stage
medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®,
enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy
in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal,
hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the
potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
Profound also commercializes
Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases,
desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve
delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery —
and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional
clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.
Profound Medical’s technologies are approved
across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate
tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New
Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities.
Sonalleve is also cleared or approved in Europe, Canada, China, and Saudi Arabia.
Through real-time MRI guidance and data-driven
innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free
treatment options worldwide.
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
technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain
treatment, desmoid tumors, and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO®
and Sonalleve®. 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 www.sedarplus.com and www.sec.gov. 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,
Profound Medical — skilmer@profoundmedical.com — 647.872.4849
Marsha Lovejoy, Senior Manager,
Global Public Relations, Cook Medical — Marsha.Lovejoy@CookMedical.com — 812.320.6903
