Business Highlights
- Q4-2025 revenue grew 43% year-over-year and 13% sequentially quarter-over-quarter to a record
$6.0 million .
- Profound’s TULSA-PRO® qualified sales pipeline also continues to grow, and currently stands at 110 new systems being classified within one of the “Verify, Negotiate and Contracting” stages.
- The Company’s TULSA-PRO installed base stood at 78 as of
December 31, 2025 and, due to its strong capital sales pipeline, Profound currently expects to reach approximately 120 installs by the end of 2026. - Profound continued to see a wide variety of prostate disease patients treated by its TULSA-PRO customers in the fourth quarter of 2025:
- 67% were treated for prostate cancer only, 17% were hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”), 13% were salvage, and 3% were men with BPH only;
- For cancer grade, 5% were GG1, 57% were GG2, 29% were GG3, and 9% were GG4 & GG5;
- By intention-to-treat, 44% were whole gland; 24% were sub-total but more than half the gland; 24% were hemi-ablations, and 9% were focal therapy; and
- For prostate size, 9% were <20cc; 42% were 20-40cc; 31% were 40-60cc; 17% were 60-100cc; and 2% were over 100cc.
- In
October 2025 , Profound unveiled new, real-world data from the internationally recognized Busch Center. The data — marking the center’s milestone of 500 completed TULSA Procedures™ — demonstrated the procedure’s versatility and success in treating a broad spectrum of prostate diseases, severities, and aggressions. - 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. InNovember 2025 , Profound:- Regained exclusive distribution rights for TULSA-PRO in
Canada ; - Entered into an exclusive distribution and supply agreement for its TULSA-PRO and Sonalleve® technologies in
Saudi Arabia with AlFaisaliah Medical Systems Co. (FMS), a subsidiary of one of the Kingdom’s most prominent business conglomerates,Al Faisaliah Group (AFG); and - Entered into a strategic distribution agreement with
Getz Healthcare to introduce TULSA-PRO inAustralia and New Zealand .
- Regained exclusive distribution rights for TULSA-PRO in
- Also in November, Profound announced that the Hong Center Scottsdale, led by Dr.
Y. Mark Hong of Integrative Urology inPhoenix, Arizona , achieved a world-first milestone: 200 TULSA Procedures performed independently by a urologist, without radiologist involvement. - In November/
December 2025 , Profound launched its TULSA-AI® Volume Reduction module for optimizing the treatment of patients with BPH at theRadiological Society of North America meeting inChicago, IL. The use of AI to streamline the workflow and reduce procedure times is a significant advancement that makes using TULSA-PRO for treating enlarged prostate just as efficient as other modern procedures, but with the advanced benefits of precision and customization to any prostate shape or size. The Company believes the reduced procedure times for BPH will increase adoption of the TULSA Procedure and triple Profound’s total available market in prostate disease to about 600,000 patients annually. - In
December 2025 ,Pejman Ghanouni , MD, PhD, Associate Professor in theDepartment of Radiology ,Division of Body MRI atStanford University School of Medicine , received theCum Laude award for his presentation titled "CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy" at the 2025Radiological Society of North America ("RSNA") Annual Meeting. - Also in December, the Company significantly strengthened its balance sheet via the closing of a
$36.0 million registered direct offering inthe United States and an upsized$6.45 million private placement inCanada . Both the registered direct offering and private placement were structured as straightforward equity investments with no warrant coverage and were led by healthcare-dedicated investors alongside existing shareholders. - In
January 2026 , Profound announced twoU.S. commercial milestones. TheJohns Hopkins Hospital (Baltimore, MD ) treated its first non-clinical-trial prostate cancer patient using the Company’s TULSA-PRO system, marking the official launch of Profound’s technology at one of the world’s most influential centers for prostate cancer innovation and coinciding with the opening of Johns Hopkins Medicine’s new iMRI suite. Soon thereafter, the world-renownedMount Sinai Hospital (New York, NY ) successfully treated its first prostate cancer patient with the TULSA-PRO system, becoming the first health system in theNew York metropolitan area to offer the TULSA Procedure. - In
February 2026 ,PRO FAMILIA Specialist Hospital in Rzeszów,Poland completed its 500th Sonalleve® Procedure. - Also in February, the Company received the 2025/2026
Mount Logan Award from INOVAIT, the Canadian national network for commercializing breakthroughs in image-guided therapy (IGT) and AI. The award recognizes Profound’s achievement of significant milestones, including treating the 4,000th TULSA Procedure patient, securing reimbursement for the TULSA Procedure by theU.S. Centers for Medicare & Medicaid Services (CMS) at Urology APC Level 7, and establishing strategic partnerships to expand patient access to TULSA-PRO globally. - Today, Profound is pleased to announce that
Laurence Klotz , M.D., FRCSC, an esteemed urologist and professor of surgery at theUniversity of Toronto and the Sunnybrook Chair ofProstate Cancer Research , will present the first clinical outcomes from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA Procedure with robotic radical prostatectomy in men with localized prostate cancer next week at the 41st AnnualEuropean Association of Urology (EAU) Congress inLondon, UK . EAU26 is a premier academic urology meeting, and the Company is pleased that the data have been selected for inclusion in the meeting’s Late-Breaking and High-Impact session onFriday, March 13 th.
“We continued to execute well, delivering record revenues, an expanded TULSA-PRO installed base, and a stronger capital sales pipeline again in the fourth quarter — validating our belief that Q3-2025 marked an important inflection point in our business,” said
Summary Fourth Quarter 2025 Results
For the quarter ended
Gross margin for the fourth quarter of 2025 was 67%, compared to 71% in the prior year period. The lower than usual fourth quarter 2025 gross margin was primarily due to product mix and new market introductory prices with international distributors in
Total operating expenses in the fourth quarter of 2025 were approximately
Fourth quarter 2025 net loss was approximately
Summary Full Year 2025 Results
For the year ended
Profound’s full year 2025 gross margin was 71%, compared to 66% in the prior year period. Gross margin expansion in 2025 was primarily due to increased selling prices coupled with the growth in the number of capital systems sold.
Total operating expenses in the year ended
Profound recorded a net loss for the year ended
Liquidity and Outstanding Share Capital
As at
As at
For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.”
Changes to Board of Directors
Profound also announced today that
“On behalf of the Board and staff of Profound, I would like to take this opportunity to thank Kris for his many contributions to the Company and wish him all the best in his future endeavours,” said
Conference Call Details
To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN.
The call will also be broadcast live and archived on Profound's website in the Investors section here.
About
Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures, enabling precise, incision-free therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MRI guidance, Profound’s technologies are designed to replace uncertainty with clarity across treatment planning, delivery, and confirmation.
The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate therapy designed for precision and flexibility. The TULSA Procedure™ allows physicians to see, treat, 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 for the full spectrum of prostate disease, including prostate cancer and/or benign prostatic hyperplasia (BPH), while minimizing side effects 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 or approved in
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 technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® 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 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
For further information, please contact:
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Consolidated Balance Sheet
As at
In USD (000s)
| 2025 $ | 2024 $ | |||
| Assets | ||||
| Current assets: | ||||
| Cash | 59,723 | 54,912 | ||
| Trade and other receivables, net | 7,200 | 7,045 | ||
| Inventory | 8,238 | 5,801 | ||
| Prepaid expenses and deposits | 928 | 1,307 | ||
| Total current assets | 76,089 | 69,065 | ||
| Trade and other receivables, net | 300 | - | ||
| Property and equipment, net | 698 | 425 | ||
| Intangible assets, net | 138 | 261 | ||
| Right-of-use assets, net | 184 | 396 | ||
| Deferred tax assets, net | 66 | 87 | ||
| Total assets | 77,475 | 70,234 | ||
| Liabilities | ||||
| Current liabilities: | ||||
| Accounts payable | 1,563 | 1,317 | ||
| Accrued expenses and other current liabilities | 3,815 | 2,835 | ||
| Deferred revenue | 445 | 419 | ||
| Long-term debt | - | 1,737 | ||
| Lease liabilities | 213 | 257 | ||
| Income tax payable | 39 | - | ||
| Total current liabilities | 6,075 | 6,565 | ||
| Deferred revenue | 388 | 49 | ||
| Long-term debt | 4,499 | 2,924 | ||
| Lease liabilities | - | 203 | ||
| Other non-current liabilities | 79 | 71 | ||
| Total liabilities | 11,041 | 9,812 | ||
| Commitments and contingencies | ||||
| Shareholders’ equity | ||||
| Common shares, no par value, unlimited shares authorized, 36,293,640 and 30,039,809 issued and outstanding at | 323,839 | 281,552 | ||
| Additional paid-in capital | 25,310 | 21,298 | ||
| Accumulated other comprehensive income | 5,025 | 2,742 | ||
| Accumulated deficit | (287,740) | (245,170) | ||
| Total shareholders’ equity | 66,434 | 60,422 | ||
| Total liabilities and shareholders’ equity | 77,475 | 70,234 | ||
Consolidated Statements of Operations and Comprehensive Loss
In USD (000s)
| Three months ended $ | Three months ended $ | Year ended $ | Year ended $ | ||
| Revenue | |||||
| Recurring - non-capital | 2,302 | 2,679 | 9,730 | 8,240 | |
| Capital equipment | 3,675 | 1,498 | 6,368 | 2,440 | |
| 5,977 | 4,177 | 16,098 | 10,680 | ||
| Cost of sales | 1,986 | 1,214 | 4,705 | 3,643 | |
| Gross profit | 3,991 | 2,963 | 11,393 | 7,037 | |
| Operating expenses | |||||
| Research and development | 4,272 | 4,649 | 20,596 | 16,965 | |
| Selling, general and administrative | 7,088 | 6,658 | 32,051 | 23,134 | |
| Total operating expenses | 11,360 | 11,307 | 52,647 | 40,099 | |
| Operating loss | 7,369 | 8,344 | 41,254 | 33,062 | |
| Other (income) expenses | |||||
| Net finance (income) expense | (160) | (332) | (1,070) | (1,436) | |
| Net foreign exchange (gain) loss | 940 | (2,828) | 2,134 | (3,808) | |
| Total other (income) expenses | 780 | (3,160) | 1,064 | (5,244) | |
| Net loss before income taxes | 8,149 | 5,184 | 42,318 | 27,818 | |
| Income tax expense | 12 | (92) | 231 | 144 | |
| Deferred tax (recovery) expense | 14 | (146) | 21 | (146) | |
| Total income tax (recovery) expense | 26 | (238) | 252 | (2) | |
| Net loss attributed to shareholders for the year | 8,175 | 4,946 | 42,570 | 27,816 | |
| Other comprehensive (income) loss | |||||
| Item that may be reclassified to (income) loss | |||||
| Foreign currency translation adjustment | (275) | (1,968) | (2,283) | 2,823 | |
| Net loss and other comprehensive loss for the year | 7,900 | 6,914 | 40,287 | 30,639 | |
| Loss per share | |||||
| Basic and diluted net loss per common share | 0.27 | 0.20 | 1.41 | 1.12 | |
| Basic and diluted weighted average common shares outstanding | 30,726,382 | 25,770,800 | 30,232,966 | 24,765,503 |
Consolidated Statements of Cash Flows
For the years ended
In USD (000s)
| 2025 $ | 2024 $ | |||
| Cash flows from operating activities | ||||
| Net loss for the year | (42,570) | (27,816) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||
| Depreciation of property and equipment | 373 | 707 | ||
| Amortization of intangible assets | 187 | 229 | ||
| Non-cash lease expense adjustment | (37) | (38) | ||
| Share-based compensation | 5,490 | 2,581 | ||
| Interest and accretion expense | 63 | 600 | ||
| Change in amortized cost of trade and other receivables | - | (307) | ||
| Changes in operating assets and liabilities: | ||||
| Trade and other receivables | (172) | 186 | ||
| Inventory | (2,822) | 656 | ||
| Prepaid expenses and deposits | 464 | 31 | ||
| Accounts payable, accrued expenses and other liabilities | 378 | 815 | ||
| Deferred revenue | 371 | (948) | ||
| Income taxes payable | 42 | - | ||
| Deferred tax liabilities | - | (58) | ||
| Deferred tax assets | 26 | (91) | ||
| Net cash used in operating activities | (38,207) | (23,453) | ||
| Cash flows from investing activities | ||||
| Purchase of property and equipment | (176) | - | ||
| Purchase of intangible assets | (66) | - | ||
| Net cash used in investing activities | (242) | - | ||
| Cash flows from financing activities | ||||
| Issuance of commons shares | 42,436 | 62,106 | ||
| Payments of financing costs | (1,016) | (4,895) | ||
| Repayments of long-term debt | (290) | (2,560) | ||
| Proceeds from the exercise of stock options | 8 | 45 | ||
| Net cash provided by financing activities | 41,138 | 54,696 | ||
| Net increase in cash and cash equivalents | 2,689 | 31,243 | ||
| Effect of exchange rate changes on cash | 2,122 | (2,544) | ||
| Cash, beginning of year | 54,912 | 26,213 | ||
| Cash, end of year | 59,723 | 54,912 | ||
