PROF

EX-99.1

2 exh_991.htm

PRESS RELEASE

EdgarFiling

EXHIBIT 99.1

Profound Medical Reports Strong Preliminary Third Quarter 2026 Revenue

Anticipates Q3-2026 revenue of $9.8 million to $10.0 million, exceeding Bloomberg analyst consensus by approximately 45% to 47%

TORONTO, Oct. 07, 2026 (GLOBE NEWSWIRE) -- 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 preliminary unaudited revenues for the third quarter ended September 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars.

Based on these preliminary results, the Company expects to report record-breaking quarterly revenue that is above current Wall Street expectations.

Preliminary Financial Highlights:

Total Revenue: Expected to be in the range of $9.8 million to $10.0 million.

Year-over-Year Growth: Expected to increase approximately 85% to 89% compared with $5.3 million in the third quarter of 2025.

Sequential Quarter-over-Quarter Growth: Expected to increase approximately 292% to 300% compared with $2.5 million in the second quarter of 2026.

Versus Consensus: Expected revenue is approximately 45% to 47% above the Bloomberg mean analyst consensus of $6.78 million.1

Gross Margin: Q3-2026 gross margin is again expected to exceed 70%, reflecting continued progress in the Company’s commercial operations and scale.

“The significant increase in revenue we expect to report this quarter represents a historic milestone for Profound, reflecting the strong commercial momentum building behind our technology,” said Arun Menawat, Profound’s CEO and Chairman. “The expected year-over-year and sequential growth in the third quarter reflects increased commercial activity across our installed base and new customer accounts.”

Dr. Menawat continued, “With preliminary revenue of approximately $9.8 million to $10.0 million and gross margin expected to exceed 70%, we believe the third quarter represents an important step in the continued expansion of our commercial business. We remain focused on supporting customer adoption, increasing utilization of our installed base, and building a profitable growth company over the long-term.”

These figures are preliminary and unaudited, and actual revenues may differ. In addition, consensus estimates are based on the work of third-party analysts, and the Company does not endorse, adopt, or control them. Profound intends to report full third quarter 2026 financial results after market close on Thursday, November 5th and will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period.

Third Quarter 2026 Results Conference Call Details:

Date: Thursday, November 5, 2026

Time: 4:30 p.m. ET

Live Call Registration: https://register-conf.media-server.com/register/BI38c9375e5dd147bc971da6a4bb029d8c

The call will also be broadcast live and archived on the Company's website in the Investors section here.

Source

1 As compared to the Bloomberg consensus estimate compiled as of October 7, 2026 at 9:02 a.m. ET.

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 t

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EX-99.1

2 exh_991.htm

PRESS RELEASE

EdgarFiling

EXHIBIT 99.1

Profound Medical Reports Strong First Quarter 2026 Financial Results

– Quarterly results marked by 104% revenue growth and improved operating performance –

– Company issues full-year 2026 revenue guidance –

– Announces Humana is now covering the TULSA Procedure™ –

TORONTO, May 07, 2026 (GLOBE NEWSWIRE) -- 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 reported financial results for the first quarter ended March 31, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP).

“We continued to execute well across our business in the first quarter, delivering triple-digit revenue growth combined with strong gross margin and lower operating expenses. We were also pleased to see statistically significant and clinically meaningful benefit from the TULSA Procedure beginning to readout from the randomized post-market CAPTAIN clinical trial comparing it to robotic radical prostatectomy, the current standard of care,” said Arun Menawat, Profound’s CEO and Chairman. “These and other anticipated tailwinds, including the expansion of payer coverage for the TULSA Procedure, give us confidence that we are moving closer to a pivotal inflection point in our growth trajectory. Nevertheless, it continues to be difficult for the investment community to accurately predict our revenues in the short-term. Accordingly, we are setting what we believe is a reasonable bar for our total annual revenue in 2026.”

Business Highlights

Profound’s TULSA-PRO installed base stood at 80 at the end of Q1-2026, and the Company shipped an additional six (6) systems during the first quarter that had yet to be installed. In March 2026, Profound announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure with robotic radical prostatectomy in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The Company looks forward to announcing additional clinical outcomes from this unique, potentially paradigm-changing study when they become available later this year. Also in March, Texas Prostate achieved its 100th TULSA Procedure. Prior to that, in September 2025, Profound announced the launch of a first-of-its-kind ‘TULSA-PROgram’ under which Texas Prostate began performing TULSA Procedures for men with disease conditions requiring prostate tissue ablation in Dallas Medical Center’s state-of-the-art MRI suite. This model — bridging private-pay practices and Medicare-participating hospitals — is designed to allow more men to benefit from the TULSA Procedure’s versatility across several prostate conditions requiring medical intervention. In April 2026, the TULSA Procedure was highlighted in several presentations at the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting, which was held in Toronto, ON. Today, Profound is pleased to announce that Humana has become the first national payor in the United States to cover the TULSA Procedure. Humana is one of the largest commercial payers in the U.S., and crucial for many health systems due to its large Medicare Advantage enrollment numbers. The addition of approximately 8.5 million covered lives in the first quarter (6.9 million covered lives with Humana alone) represents meaningful progress toward ensuring more patients have access to the TULSA Procedure. Profound will continue to work collaboratively with payers, providers, and health systems to expand coverage and streamline patient access pathways for the TULSA Procedure.

Q1-2026 Clinical Utilization Trends

Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the first quarter of 2026:

Prostate Condition

Ablation of malignant prostate tissueAblation of malignant and benign enlarged prostate tissueAblation of recurrent malignant prostate tissueAblation of benign enlarged prostate tissue

71%

(9% GG1, 61% GG2, 21% GG3, 9% GG4&5)16%

9% 4%

Intention-to-Treat

Whole-glandSub-total but more than half the glandHemi-ablationFocal therapy

42% 26% 23% 9%

Prostate Size

< 20 cc20-40 cc40-60 cc60-100 cc> 100 cc

8% 44% 29% 15% 4%

TULSA INDEX20

The following table sets out a supplemental ‘same-store’ TULSA Procedure volume analysis designed to assist investors in following the Company’s progress over time. As the name implies, this new TULSA INDEX20 is comprised of 20 active commercial sites that have been performing TULSA Procedures for at least 12-months. The index includes a representative variety of providers, including teaching hospitals and private-pay practices. Geographically, 80% of