Profound Medical Corp. SEC filings document regulatory disclosures for a commercial-stage medical device company focused on interventional MRI procedures. Recent Form 8-K reports cover results of operations and financial condition, Regulation FD disclosures, furnished press releases, revenue guidance and business updates tied to TULSA-PRO®, the TULSA Procedure™ and Sonalleve®.
The filing record also includes clinical and commercial disclosure categories, such as CAPTAIN trial updates, scientific-meeting presentations and TULSA Procedure adoption milestones. Governance filings record director changes and board appointments, while exchange-act cover disclosures identify the company’s common shares registered on Nasdaq under the PROF symbol.
Profound Medical Corp. (PROF) announced five abstracts presented at the 15th Interventional MRI Symposium. In the CAPTAIN randomized trial, whole-gland TULSA patients were more than twice as likely to preserve both erectile function and pad-free continence at six months compared with robotic radical prostatectomy (risk ratio 2.1; p=0.004). A Mayo Clinic Florida series included 58 patients with up to 4.5 years of follow-up and reported 100% pad-free continence; 12% received secondary prostate cancer treatment. The company noted the results reflect a single-center study, patient selection and treatment heterogeneity.
A CARE Registry analysis covered 197 patients at five centers, with median follow-up of 24 months. Median catheterization was 13.5 days after whole-gland treatment and seven days after subtotal or focal treatment. Technical testing showed feasibility on Siemens’ 0.55T Free.Max MRI platform, but does not establish FDA clearance, clinical validation or commercial availability on that platform.
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 revenue of $7,820 (USD in thousands) for the six months ended June 30, 2026, up from $4,832 a year earlier, driven by higher capital equipment sales and recurring non‑capital revenue. Gross profit rose to $5,779 from $3,471, while operating expenses declined to $24,866 from $28,443, narrowing the net loss to $16,593 from $26,419; basic and diluted loss per share improved to $0.46 from $0.88.
Research and development spending was stable at $10,916 for the six‑month period, while selling, general and administrative expenses decreased to $13,950 from $17,537 as the company reduced salaries and commissions, travel, consulting fees and insurance costs. Cash was $38,271 at June 30, 2026 compared with $59,723 at December 31, 2025, after $19,921 of net cash used in operating activities; a $4,507 balance on the CIBC revolving credit facility was classified as current. Management states that existing cash and product and service sales are expected to fund operating and capital needs for at least the next 12 months and confirms compliance with financial covenants under the CIBC Credit Agreement.
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%.