Profound Medical Corp. 8-K Filings

Profound Medical Corp. (PROF) entered into a co-education agreement with Telix Pharmaceuticals Limited to educate physicians and prostate cancer centers about Telix’s PSMA-PET imaging and Profound’s MRI-guided TULSA-PRO across prostate care. Planned activities include scientific-meeting participation, educational summits, speaker programs, webinars, clinical case studies and best-practice materials. The collaboration is intended to support awareness of PSMA-informed treatment pathways, patient selection and treatment planning, and access to the TULSA Procedure.

Profound is also developing PSMA-PET/MR image-fusion capabilities for a planned future release of its Treatment Delivery Console software. The planned functionality is intended to incorporate Telix diagnostic PSMA-PET data into treatment planning alongside real-time intra-operative MR images.

Profound Medical Corp. expects preliminary unaudited third-quarter 2026 revenue of $9.8 million to $10.0 million for the three months ended September 30, 2026. Revenue is expected to increase approximately 85% to 89% year over year, compared with $5.3 million in the third quarter of 2025, and approximately 292% to 300% sequentially, compared with $2.5 million in the second quarter of 2026. Gross margin is expected to exceed 70%.

The expected revenue range is approximately 45% to 47% above Bloomberg’s mean analyst consensus of $6.78 million. Profound intends to report full third-quarter results after market close on November 5, 2026, and host a conference call at 4:30 p.m. ET.

Profound Medical Corp. (PROF) reported that its management will participate in the Lake Street Capital Markets “BIG10” Conference on September 10, 2026, in New York City, as disclosed under a Regulation FD communication. The event will consist of one-on-one investor meetings and will not include a webcast.

The accompanying press release also reiterates that Profound is a commercial-stage medical device company focused on MRI-guided, incision-free therapies through its TULSA-PRO and Sonalleve platforms, which are cleared or approved in multiple major global markets for various prostate, oncologic, and gynecologic indications.

Profound Medical Corp. (PROF) appointed Richard R. Fabian as President effective September 1, 2026, succeeding Mathieu Burtnyk, PhD, who moved to the new role of Chief Technology Officer. Fabian brings more than 29 years of experience in medical imaging and devices, including serving as President and CEO of Sonosite, Inc. and holding multiple senior roles at Philips Healthcare.

Under his employment agreement, Fabian receives an annual base salary of $550,000, is eligible for an annual discretionary bonus of up to 100% of base salary, and will be granted 200,000 restricted share units and options to purchase 475,000 common shares, subject to multi‑year vesting schedules. Profound will lease a Toronto residence for his first 12 months, provide a $1,000 monthly car allowance, and expects him to spend about 50% of his time at the Toronto office.

Profound Medical Corp. introduced new real-time interventional MRI Treatment Delivery Consol (TDC) software for its TULSA-PRO® prostate ablation platform. The software is being deployed across the TULSA-PRO installed base and builds on prior TULSA-AI® modules aimed at improving procedural efficiency, physician experience, and reducing planning complexity.

The upgrade adds real-time iMRI control to put surgeons more directly in control of TULSA-PRO’s supervised robotic autonomy, along with physician-requested user-interface and hardware-control improvements. Profound states that some physicians currently perform up to four TULSA Procedures™ per system per day, and the new software is intended to provide a roadmap for customers to achieve up to six procedures per system per day

Profound Medical Corp. appointed Matthew Sobczyk as Interim Chief Financial Officer effective August 14, 2026, following the same-day resignation of CFO Rashed Dewan. Sobczyk has held progressively senior finance roles at the company since 2017, most recently as Corporate Controller.

As Interim CFO, Sobczyk will receive an annual base salary of CAD 300,414.58 and is eligible for a discretionary bonus targeted at 15% of base salary. Dewan entered into a Mutual Separation Agreement, receiving a cash severance of $375,000, employer-paid benefits for 15 months, extended exercisability of vested stock options for up to 12 months, and reimbursement of up to CAD 5,000 in legal fees.

Under a separate Contractor Services Agreement, Dewan will provide transition and advisory services from August 17, 2026 through November 25, 2026, for CAD 200 per hour and will continue vesting on 20,000 restricted share units, supporting continuity during the finance leadership transition.

Profound Medical Corp., a commercial-stage medical device company focused on interventional MRI (iMRI) procedures, reported the launch of Let’s Huddle, a global patient advocacy and community initiative supporting men and their families through the prostate care journey. Announced on August 13, 2026, the program is led by Global Patient Ambassador Leonard Wheeler, a former NFL player and prostate cancer survivor, and is designed to provide education, peer connection, survivor stories, and resources for patients and care partners.

The initiative aligns with Profound’s MRI-guided therapy platforms TULSA-PRO and Sonalleve by extending support beyond treatment delivery to include pre-diagnosis education, treatment decision support, and survivorship. Profound states that Let’s Huddle will grow through expanded educational programming, storytelling, awareness campaigns, and collaborations with healthcare providers and advocacy organizations worldwide.

Profound Medical Corp. reported second quarter 2026 results with total revenue of approximately $2.5 million, up 12% year-over-year, including about $1.6 million of recurring non-capital revenue and $871,000 from capital equipment sales. Around $3.1 million of TULSA shipments slipped from late June into July and will be recognized in the third quarter; excluding this timing, management states revenue would have been about $5.6 million, or 153% higher year-over-year.

Gross margin expanded to 78%, above the company’s 70% long-term target, while operating expenses fell 16% to roughly $13.0 million, driving a net loss of about $9.5 million, or $0.26 per share, a 39% improvement from a year earlier. Cash was approximately $38.3 million at June 30, 2026. The installed base of TULSA-PRO systems reached 84, the qualified sales pipeline was estimated at about $70.0 million, and payer coverage grew by roughly 18.3 million lives, including two large employer health plans. Based on record order activity and visibility into second-half shipments, Profound reiterated its 2026 revenue outlook of approximately $25.0 million, representing 56% growth, and continues to target full-year gross margin of at least 70%.

Profound Medical Corp. reports new quality-of-life data from the Level 1 post‑market CAPTAIN randomized controlled trial comparing its MRI‑guided TULSA Procedure with robotic radical prostatectomy in men with organ‑confined, intermediate‑risk Gleason Score 7 prostate cancer.

At 1 month, there was no median change in penile length after whole‑gland TULSA, versus a 0.65 cm median reduction after robotic radical prostatectomy, with a 0.42 cm between‑arm difference from a mixed‑effects model (p<0.001). CAPTAIN enrolled 211 patients at 20 U.S. sites, two in Canada and one in Europe, aiming to show non‑inferior cancer control for TULSA with superior quality‑of‑life outcomes, including preservation of erectile function and urinary continence.

Profound Medical Corp. plans to release its second quarter 2026 financial results after market close on Thursday, August 6, 2026, followed by a conference call at 4:30 p.m. Eastern Time to review the results and discuss business developments. The call will be broadcast live and archived in the Investors section of the company’s website.

Profound Medical is a commercial-stage medical device company focused on interventional MRI (iMRI) procedures. Its flagship TULSA-PRO platform enables MRI-guided, incision-free prostate ablation, while its Sonalleve system provides non-surgical MRI-guided therapy for certain bone, tumor, and gynecologic conditions.

Profound Medical Corp. announced that its MRI-guided, AI-powered, robotically driven and incisionless TULSA Procedure will be featured in multiple physician-led presentations at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, FL, scheduled for July 23-26, 2026.

Clinical talks will cover real-world outcomes, randomized trial primary safety data, single-center efficacy and safety, salvage treatment after prior therapies, and program adoption, with leading presenters from UT Southwestern and other centers. Profound will also be one of only eight companies spotlighted in the Society of Incisionless Surgery plenary session on imaging, AI and robotic autonomy.

Before the clinical program, management plans to participate in an SRS Investor Session on July 22, 2026, discussing innovative robotic technologies and TULSA-PRO. Profound describes itself as a commercial-stage medical device company focused on MRI-guided, incision-free therapies including TULSA-PRO and Sonalleve, which have clearances or approvals in multiple global markets.

Profound Medical Corp. reported the results of its 2026 annual and special shareholder meeting. Shareholders elected eight directors, including two new nominees, to serve until the next annual meeting. Support for individual directors ranged from about 79% to 91% of votes cast.

Shareholders approved the appointment of PricewaterhouseCoopers LLP as auditors, with 25,193,910 votes for and 99.497% support. They also approved an ordinary resolution confirming all unallocated restricted share units and deferred share units under the long-term incentive plan, with 9,046,376 votes for and 63.922% support versus 36.078% against. The circular notes 36,337,637 common shares outstanding as of April 2, 2026, and describes the company’s equity-based compensation, governance structure, and executive/director pay philosophy.

Profound Medical Corp. furnished a current report describing plans to spotlight its MRI-guided TULSA Procedure™ at the American Urological Association’s 2026 Annual Meeting in Washington, DC. Four oral presentations on MRI-guided transurethral ultrasound ablation for localized prostate cancer will be delivered by clinicians from Mayo Clinic, Turku University Hospital and Sapporo Hokuyu Hospital.

The company will also demonstrate TULSA-PRO® and a Siemens Free.Max MR system at Booth #413 and has launched an initiative to explore integrating PSMA PET molecular imaging with TULSA-PRO treatment planning. This effort aims to support intent-to-treat decisions and patient monitoring across focal, subtotal and whole-gland prostate ablation strategies.

Profound Medical Corp. reported strong first quarter 2026 results, with revenue of about $5.3 million, up 104% from the same period in 2025. Capital equipment sales were approximately $2.9 million and recurring non-capital revenue, including one-time use devices and services, was about $2.5 million. Gross margin improved slightly to 72%.

Operating expenses fell 9% to roughly $11.8 million, helping narrow the net loss to about $7.0 million, or $0.19 per share, a 34% improvement year over year. Cash was approximately $50.3 million as of March 31, 2026. Management issued full-year 2026 guidance for $25 million in revenue, implying 56% annual growth, and expects gross margin of at least 70%. The TULSA-PRO installed base reached 80 systems, and Humana became the first U.S. national payor to cover the TULSA Procedure, adding about 8.5 million covered lives.

Profound Medical Corp. announced it will release its first quarter 2026 financial results after market close on Thursday, May 7, 2026, and host a conference call at 4:30 p.m. Eastern Time that day to review the results and discuss business developments.

The company is a commercial-stage medical device business focused on AI-powered, MRI-guided, incision-free therapies. Its flagship TULSA-PRO platform supports MRI-guided prostate therapy, while Sonalleve provides non-surgical, MRI-guided treatments for bone metastases, certain tumors, and gynecologic conditions.

Profound Medical Corp. filed a current report describing its participation in the 2026 Bloom Burton & Co. Healthcare Investor Conference. Management will present a business update on April 22, 2026, at 10:00 a.m. Eastern Time in Toronto, with a live and archived webcast on the company’s website.

The filing includes the related press release as an exhibit and notes that this information is furnished under Regulation FD, meaning it is provided for fair disclosure rather than as part of the company’s formally filed financial statements.

Profound Medical Corp. furnished information that its incision-free, MRI-guided TULSA Procedure™ for prostate disease will be featured in multiple physician presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting in Toronto from April 11-15, 2026.

The TULSA Procedure, performed with the company’s TULSA-PRO® system, uses robotically controlled ultrasound inside the urethra and real-time MRI thermography to ablate prostate tissue at 55-57°C while protecting surrounding structures. Presentations will cover clinical use in prostate cancer and benign prostatic hyperplasia, outcomes data, automated prostate segmentation, and initial perioperative results from the Level 1 post-market CAPTAIN trial.

Profound Medical Corp. filed an 8-K to share a press release celebrating a clinical milestone for its TULSA Procedure™, an MRI-guided, incision-free prostate therapy. Texas Prostate, led by Dr. James Cochran, has now completed its 100th TULSA Procedure in Dallas Medical Center’s MRI suite.

Dr. Cochran notes that switching from focal HIFU to TULSA expanded the range of prostate diseases and sizes he can treat while improving safety. After moving from a private-pay to a Medicare-based model through collaboration with Dallas Medical Center, TULSA volumes at Texas Prostate increased by 500% and continue to grow with referrals from across Texas and nearby states.

Profound Medical Corp. filed a report highlighting new clinical data from its Level 1 CAPTAIN randomized trial comparing the MRI-guided, incision-free TULSA Procedure™ with robotic radical prostatectomy for intermediate‑risk localized prostate cancer.

The trial treated 211 patients and met its prespecified primary safety endpoint. At 6 months, 50% of men treated with TULSA preserved both erectile function and urinary continence, compared with 24% after surgery. TULSA also showed higher pad‑free continence (84% vs. 49%), similar erectile function preservation (56% vs. 47%), less blood loss, shorter hospital stays, fewer serious complications, and faster return to work. Secondary oncologic outcomes for the TULSA arm, including histology and 12‑month biopsy/MRI data, are pending and expected later in the year.

Profound Medical Corp. reported a board change. On March 5, 2026, director Kris Shah resigned from the Board, effective immediately, and the company states his resignation was not due to any disagreement. The Board simultaneously appointed Frank Baylis to fill the resulting vacancy.

Mr. Baylis will serve as a director until the company’s 2026 annual meeting of stockholders and until a successor is elected and qualified, or earlier departure. He has no disclosed arrangements, family relationships, or related-party transactions with the company. As a non-employee director, he will receive a pro-rated annual cash retainer of $50,000 and be eligible for an annual equity award, and he signed the company’s standard indemnification agreement.

Profound Medical Corp. plans to share the first clinical outcomes from its Level 1 post‑market CAPTAIN trial, which compares the TULSA Procedure™ to robotic radical prostatectomy in men with localized prostate cancer.

Results will be presented at the EAU 2026 Congress in London on March 13, 2026, followed by an investor webinar that day at 11:30 a.m. EDT featuring trial investigator Dr. Laurence Klotz and company management. Profound also plans one‑on‑one investor meetings at the 38th Annual Roth Conference from March 22‑24, 2026.

Profound Medical Corp. reported strong revenue growth but wider losses for 2025. Fourth quarter 2025 revenue reached $6.0 million, up 43% year-over-year, with $2.3 million from recurring non-capital sales and $3.7 million from capital equipment. Q4 gross margin was 67%, down from 71%, mainly due to product mix and introductory pricing in new international markets. Operating expenses were $11.4 million, leading to a Q4 net loss of $8.2 million, or $0.27 per share.

For full year 2025, revenue rose to $16.1 million from $10.7 million, and gross margin improved to 71% from 66%, driven by higher selling prices and more capital system sales. Operating expenses increased to $52.6 million, reflecting higher headcount, CAPTAIN trial costs, and commercial expansion, and net loss widened to $42.6 million, or $1.41 per share. Cash was $59.7 million as of December 31, 2025, supported by a $36.0 million registered direct offering and a $6.45 million private placement.

The TULSA-PRO installed base reached 78 systems, with a qualified pipeline of 110 potential new systems and an internal expectation of about 120 installs by the end of 2026. The company highlighted CMS reimbursement for the TULSA Procedure, new distribution agreements in Canada, Saudi Arabia, Australia and New Zealand, and upcoming Level 1 CAPTAIN trial outcome data. Profound also announced that Frank Baylis joined the Board, replacing Kris Shah.

Profound Medical Corp. filed a current report to let investors know when it will share its next results. The company plans to release its fourth quarter and full year 2025 financial results after market close on Thursday, March 5, 2026, and will host a conference call at 4:30 p.m. Eastern Time that day to review the numbers and discuss business developments.

Profound is a commercial-stage medical device company focused on interventional MRI procedures, including its TULSA-PRO® system for prostate disease and Sonalleve® platform for non-invasive treatment of uterine fibroids, certain bone and soft-tissue conditions, and other potential oncology and hyperthermia applications.

Profound Medical Corp. filed a current report describing a press release announcing that INOVAIT honored the company with its 2025–2026 Mount Logan Award, recognizing the TULSA Procedure for prostate disease. The award highlights Profound’s performance as an industry member in image‑guided therapy and AI.

The press release notes milestones such as treating the 4,000th TULSA Procedure patient, securing new U.S. Medicare reimbursement codes, and expanding global access through strategic partnerships. Profound is commercializing its MRI‑guided TULSA-PRO system for prostate disease and the Sonalleve platform for several other indications, backed by multiple regulatory approvals.

Profound Medical Corp. furnished an update under Regulation FD noting clinical use of its Sonalleve technology. On February 5, 2026, the Company announced that the PRO FAMILIA Specialist Hospital in Rzeszów, Poland has completed its 500th Sonalleve® Procedure, marking a notable usage milestone at that site.

Profound Medical Corp. furnished a current report to let investors know it has issued a press release announcing upcoming investor events. The company attached this press release as Exhibit 99.1 so readers can access the full details of those events.

The company specifically states that the information about these investor events, including the exhibit, is being provided under Regulation FD and is considered "furnished" rather than "filed" under U.S. securities laws. This means it is not subject to certain liability provisions and is not automatically incorporated into other SEC filings.

Profound Medical Corp. reported that Mount Sinai Hospital has treated its first prostate cancer patient using the company’s TULSA-PRO® system. This update was shared through a press release dated January 15, 2026, which is included as an exhibit to the report. The disclosure is made under Regulation FD, meaning the company is sharing this operational milestone to keep all investors informed at the same time.

Profound Medical Corp. filed a current report to share an operational update on its TULSA-PRO® technology platform. The company announced in a press release that its installed base of TULSA-PRO® systems stood at 78 systems as of December 31, 2025. This figure reflects the number of systems placed at customer sites by the end of the year.

The press release containing this information is furnished as an exhibit and is not deemed filed for liability purposes under U.S. securities laws or incorporated by reference into other SEC filings.

Profound Medical Corp. (PROF) announced it has entered into an exclusive distribution and supply agreement with Getz Healthcare for its TULSA-PRO system in Australia and New Zealand. The company disclosed the news under Regulation FD, indicating a commercial channel partner will handle market distribution in these regions.

The announcement was provided via a press release furnished as Exhibit 99.1. As furnished information under Item 7.01, it is not deemed filed under Section 18 of the Exchange Act and is not incorporated by reference into other SEC filings.

Profound Medical Corp. (PROF) announced it entered into an exclusive distribution and supply agreement in Saudi Arabia with Al Faisaliah Medical Systems Co. covering its TULSA-PRO and Sonalleve technologies. The company disclosed the news via a press release furnished under Item 7.01 (Regulation FD).

The agreement designates a single distributor for these systems in Saudi Arabia, signaling a focused commercial pathway for Profound Medical’s prostate ablation (TULSA-PRO) and MR-guided therapeutic ultrasound (Sonalleve) platforms in that market. The press release was furnished as Exhibit 99.1.

Profound Medical Corp. reported under Regulation FD that it has regained exclusive distribution rights for its TULSA-PRO product in Canada from Knight Therapeutics Inc. The company announced the change in a press release dated November 10, 2025, which is furnished as Exhibit 99.1.

The Item 7.01 disclosure notes the press release is furnished, not filed, and is not incorporated by reference into other SEC filings.

Profound Medical Corp. filed a current report to note that it issued a press release on October 7, 2025 announcing certain preliminary unaudited financial results for the three months ended September 30, 2025 and providing a business update. The press release is furnished as Exhibit 99.1 under Item 2.02, which covers results of operations and financial condition. The company states that this information, including Exhibit 99.1, is furnished rather than filed, meaning it is not subject to certain liability provisions and is not automatically incorporated into other securities law filings.

Profound Medical Corp. furnished an update on its recent performance by reporting that it issued a press release with unaudited financial results for the three- and six-month periods ended June 30, 2025. The company also used the release to provide a broader business update.

The press release is attached as Exhibit 99.1 and is furnished, not filed, meaning it is not automatically subject to certain Exchange Act liabilities or incorporated into other securities filings unless specifically referenced. This 8-K is a disclosure vehicle pointing investors to that detailed financial and operational information.