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Mount Sinai Becomes First in Metro New York to Deliver Incision-Free, MRI-Guided Prostate Treatment with TULSA-PRO®

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Profound Medical (NASDAQ:PROF) announced that Mount Sinai Hospital performed its first incision-free, MRI-guided TULSA Procedure for prostate disease on Jan 15, 2026, making Mount Sinai the first health system in the New York Metro Area to offer TULSA-PRO.

The robotically controlled ultrasound system heats tissue to a kill temperature of 55–57°C with real-time MRI thermography and autonomous temperature adjustment, enabling tailored ablation with no procedural blood loss, same-day discharge, and intent to minimize urinary incontinence and erectile dysfunction versus surgery or radiation.

Mount Sinai is ranked No. 6 nationally for Urology (2025–26), and hospital clinicians plan future studies and guideline work using TULSA-PRO.

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Positive

  • First TULSA-PRO patient treated at Mount Sinai on Jan 15, 2026
  • Procedure delivers targeted 55–57°C kill temperature with real-time MRI thermography
  • Patient experienced same-day discharge after the procedure
  • Mount Sinai ranked No. 6 for Urology in 2025–26

Negative

  • None.

News Market Reaction – PROF

+9.45%
13 alerts
+9.45% News Effect
+5.7% Peak in 1 hr 24 min
+$27M Valuation Impact
$307M Market Cap
0.7x Rel. Volume

On the day this news was published, PROF gained 9.45%, reflecting a notable positive market reaction. Argus tracked a peak move of +5.7% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $27M to the company's valuation, bringing the market cap to $307M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Urology ranking: No. 6 nationally Kill temperature range: 55–57°C First patient treated: 1 patient +1 more
4 metrics
Urology ranking No. 6 nationally Mount Sinai Urology ranking by US News & World Report for 2025-26
Kill temperature range 55–57°C Target prostate tissue temperature during TULSA Procedure
First patient treated 1 patient First prostate cancer patient treated with TULSA-PRO at Mount Sinai
Ranking period 2025–26 US News & World Report ranking period for Mount Sinai Urology

Market Reality Check

Price: $6.96 Vol: Volume 470,185 is 1.76x t...
high vol
$6.96 Last Close
Volume Volume 470,185 is 1.76x the 20-day average of 267,306, indicating elevated pre-news activity. high
Technical Price 7.62 is trading above the 200-day MA of 5.72 and 14.86% below the 52-week high of 8.95.

Peers on Argus

PROF was down 9.07% while close peers showed mixed moves: OWLT (-1.27%), SERA (-...

PROF was down 9.07% while close peers showed mixed moves: OWLT (-1.27%), SERA (-1.39%) declined, RCEL (+0.86%) and LNSR (+1.71%) rose, and RPID gained 21.45%. This points to stock-specific dynamics rather than a uniform medical device sector move.

Historical Context

5 past events · Latest: Jan 12 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Jan 12 Installed base update Positive +2.5% Reported TULSA-PRO installed base reaching 78 systems, exceeding 2025 goal.
Jan 06 Adoption milestone Positive -0.5% Johns Hopkins treated first commercial TULSA-PRO prostate cancer case.
Dec 30 Private placement close Negative -0.1% Closed US$6.45M private placement at US$7.00 with resale restrictions.
Dec 24 Financing upsized Negative +1.5% Upsized planned private placement to raise up to US$6.45M at US$7.00.
Dec 23 Registered offering Negative +0.8% Closed $36M registered direct offering of 5,142,870 shares at $7.00.
Pattern Detected

Recent news has produced mixed reactions: positive commercial milestones and operational updates sometimes aligned with gains, while dilutive financings have not consistently led to declines, indicating uneven news-to-price alignment.

Recent Company History

Over the past several months, Profound Medical has combined commercial progress with balance sheet actions. On Dec 23, 2025, it closed a $36 million registered direct offering at $7.00 per share, followed by an upsized private placement targeting up to US$6.45 million and closing on Dec 30, 2025. Simultaneously, the TULSA-PRO platform expanded, with the installed base reaching 78 systems by Dec 31, 2025 and a 97-system qualified pipeline. Early 2026 updates, including the Johns Hopkins first commercial case, underscore growing adoption that today’s Mount Sinai milestone builds upon.

Regulatory & Risk Context

Active S-3 Shelf · $150,000,000
Shelf Active
Active S-3 Shelf Registration 2025-11-13
$150,000,000 registered capacity

An effective Form S-3 shelf filed on Nov 13, 2025 allows Profound Medical to offer up to $150,000,000 of various securities over time for working capital, capital expenditures, and general corporate purposes, with specific terms to be set in future prospectus supplements.

Market Pulse Summary

The stock moved +9.4% in the session following this news. A strong positive reaction aligns with the...
Analysis

The stock moved +9.4% in the session following this news. A strong positive reaction aligns with the pattern of investors rewarding clear adoption milestones, such as TULSA-PRO placements at leading centers like Johns Hopkins and now Mount Sinai. However, past financings, including a $36 million offering at $7.00, highlight ongoing capital needs that could temper enthusiasm. Historical news flow shows mixed alignment between positive updates and price moves, suggesting that sustained gains have depended on consistent execution rather than single-site announcements.

Key Terms

benign prostatic hyperplasia, urethra, mri thermography, interventional magnetic resonance imaging, +2 more
6 terms
benign prostatic hyperplasia medical
"used by physicians to treat prostate cancer and benign prostatic hyperplasia"
Benign prostatic hyperplasia is a noncancerous enlargement of the prostate gland that can squeeze the urethra and cause urinary symptoms like weak stream, urgency, and incomplete emptying; think of it as a garden hose being pinched so water flow slows. It matters to investors because it creates steady demand for medications, medical devices and procedures, regulatory approvals, and insurance coverage decisions—factors that can drive revenue and growth in healthcare companies serving an aging population.
urethra medical
"ultrasound is delivered from inside the urethra to precisely and gently heat"
The urethra is the narrow tube that carries urine from the bladder to the outside of the body. It matters to investors because many medical devices, drugs, and procedures target problems in or around this passage—such as blockages, infections, or the need for catheters—so changes in clinical evidence, regulation, or demand can create commercial opportunities or risks much like a clogged pipe affects a whole plumbing system.
mri thermography medical
"Real-time MRI thermography enables continuous visualization and autonomous"
MRI thermography is a technique that uses advanced imaging technology to measure temperature changes within the body. It creates detailed pictures showing how heat varies in tissues, which can help diagnose medical conditions or monitor treatments. For investors, understanding this technology highlights the growing importance of medical innovations and their potential impact on healthcare markets.
interventional magnetic resonance imaging medical
"interventional Magnetic Resonance Imaging, or iMRI, is emerging as a way"
Interventional magnetic resonance imaging (interventional MRI) is the use of real-time MRI scans to guide minimally invasive medical procedures, letting clinicians see soft tissues, instruments, and treatment effects as they work. Like a live GPS for the body, it improves precision and can reduce complications and recovery time, which matters to investors because it can drive demand for specialized MRI machines, compatible instruments, software and new clinical services, influencing sales, approvals and healthcare reimbursement trends.
robotically controlled directional ultrasound medical
"Robotically controlled directional ultrasound is delivered from inside the urethra"
A system that combines a robotic arm or guided positioning with focused ultrasound beams to aim sound energy at precise spots inside the body for imaging or treatment, like a movable magnifying glass focusing sunlight on a tiny target. It matters to investors because it can enable less invasive procedures, improve accuracy and outcomes, and open new medical markets, but commercial success depends on clinical proof, regulatory approval, and adoption by hospitals.
ablation medical
"incision-free therapies for the ablation of diseased tissue"
Ablation is a medical procedure that removes, destroys, or isolates unwanted tissue using heat, cold, electricity, or chemicals to stop a disease or correct a problem—think of cutting out a faulty wire to restore a machine or removing a weed so a garden can recover. Investors care because ablation drives demand for specific devices, consumables and training, affects clinical trial and regulatory outcomes, and can change treatment patterns, reimbursement and market size for healthcare companies.

AI-generated analysis. Not financial advice.

Mount Sinai advances prostate care with AI-powered therapy designed to preserve continence and sexual function

The Mount Sinai Hospital is ranked No. 6 nationally for Urology by US News & World Report® for 2025-26

TORONTO, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce the world-renowned Mount Sinai Hospital has successfully treated its first prostate cancer patient with the TULSA-PRO® system.

The TULSA Procedure™ represents a major advancement in prostate care, and is used by physicians to treat prostate cancer and benign prostatic hyperplasia (“BPH”, also known as an enlarged prostate). Robotically controlled directional ultrasound is delivered from inside the urethra to precisely and gently heat prostate tissue to ‘kill temperature’ (55-57°C), while protecting surrounding nerves and anatomy. Real-time MRI thermography enables continuous visualization and autonomous temperature adjustment throughout the procedure. This level of precision allows physicians to tailor therapy to each patient, resulting in no procedural blood loss, no overnight hospital stay, and a quicker return to everyday life, while minimizing side effects typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Michael Palese, MD, Chair, Department of Urology, Mount Sinai Downtown and Professor, Department of Urology at the Icahn School of Medicine at Mount Sinai; Neil Rofsky, MD, MHA, Dr. Charles and Marilyn Newman Professor and Chair of Diagnostic, Molecular and Interventional Radiology at the Mount Sinai Health System; Kyrollis Attalla, MD, Assistant Professor, Department of Urology and Christine Chen, MD, Associate Professor, Diagnostic, Molecular and Interventional Radiology, recently collaborated to perform the health system’s first TULSA Procedure, with the patient responding well to the treatment and being discharged the same day.

“With this milestone, Mount Sinai continues to establish itself as a leader in robotic surgical care, becoming the first health system in the New York Metro Area to offer the innovative, AI-driven, MRI-guided, and incision-free TULSA Procedure to prostate disease patients,” said Arun Menawat, Profound’s CEO and Chairman.

“This unique collaboration between the Department of Urology and the Department of Interventional Radiology at Mount Sinai will pave the way for future studies and guidelines in prostate cancer and BPH using TULSA-PRO. Patients will have another option for best-in-class treatment of these complex conditions,” said Ash Tewari, MD, MBBS, MCh, Surgeon-in-Chief Tisch Cancer Hospital & System, Chair of Urology and Professor at the Mount Sinai Health System.

“Today, interventional Magnetic Resonance Imaging, or iMRI, is emerging as a way of transforming how complex procedures and unmet medical needs are addressed, and we believe TULSA-PRO has the potential to become a beacon of iMRI’s incredible future,” continued Dr. Menawat. “What makes the TULSA Procedure unique is its ability to treat an unrivaled range of prostate diseases, severities, and aggressions, while preserving crucial functions like continence and sexual health. We are excited to welcome Mount Sinai as a valued TULSA-PRO site.”

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. The TULSA Procedure is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This press 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, palliative pain treatment and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO®. 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.ca 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
skilmer@profoundmedical.com
T: 647.872.4849

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195


FAQ

What did Profound Medical (PROF) announce about Mount Sinai on January 15, 2026?

Profound said Mount Sinai performed its first incision-free, MRI-guided TULSA Procedure for prostate disease on Jan 15, 2026.

How does the TULSA Procedure used at Mount Sinai work for prostate treatment?

TULSA uses robotically controlled directional ultrasound from inside the urethra with real-time MRI thermography to heat tissue to 55–57°C and tailor ablation.

What patient benefits did Mount Sinai report after the first TULSA-PRO treatment?

The announcement reports no procedural blood loss and the patient was discharged the same day, with reduced risk of incontinence or erectile dysfunction.

Why is Mount Sinai’s adoption of TULSA-PRO significant for PROF shareholders?

Mount Sinai is the first New York Metro health system to offer TULSA-PRO, marking an adoption milestone at a nationally ranked urology center that could support future clinical studies.

Will Mount Sinai perform further studies or use TULSA-PRO for BPH and prostate cancer?

Clinicians at Mount Sinai plan to pursue future studies and guideline work using TULSA-PRO for prostate cancer and BPH, per the announcement.

Where does Mount Sinai rank for urology and how might that affect TULSA-PRO visibility?

Mount Sinai is ranked No. 6 nationally for Urology (2025–26), potentially increasing clinical visibility for TULSA-PRO adoption.
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