Profound Medical's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Profound Medical (PRN).
Over the past two years, Profound Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TULSA-PRO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TULSA-PRO FDA Regulatory Timeline and Events
TULSA-PRO is a drug developed by Profound Medical for the following indication: Versatile technologies currently available for the treatment of prostate disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TULSA-PRO
- Announced Date:
- January 15, 2026
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. is pleased to announce the world-renowned Mount Sinai Hospital has successfully treated its first prostate cancer patient with the TULSA-PRO® system.
AI Summary
Profound Medical announced that Mount Sinai Hospital has successfully treated its first prostate cancer patient with the TULSA-PRO® system. A team from Mount Sinai’s urology and interventional radiology departments performed the procedure, and the patient was discharged the same day and is doing well. Mount Sinai is the first health system in the New York Metro Area to offer this option.
The TULSA Procedure uses robotically controlled directional ultrasound delivered from inside the urethra, guided by real-time MRI thermography and AI-enhanced planning. The system gently heats targeted prostate tissue to about 55–57°C while continuously visualizing and adjusting temperature to protect surrounding nerves and anatomy. The therapy is incision-free and tailored to each patient.
Benefits include no procedural blood loss, no overnight hospital stay, quicker recovery, and reduced risk of urinary incontinence and erectile dysfunction compared with many traditional treatments. The technology treats a wide range of prostate conditions, including prostate cancer and BPH, in a single session lasting a few hours.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- January 12, 2026
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. is pleased to announce that its TULSA-PRO® system installed base stood at 78 as of December 31, 2025 — higher than its previously announced goal of 75 installs by the end of 2025.
AI Summary
Profound Medical Corp. reported its TULSA‑PRO installed base reached 78 systems as of December 31, 2025, beating its goal of 75 installs for the year. The company also said its qualified sales pipeline grew to 97 systems in the verify, negotiate and contracting stages. CEO Arun Menawat said a larger installed base should increase patient treatments and drive high‑margin recurring revenue, noting TULSA’s ability to treat a broad range of prostate conditions while preserving continence and sexual function. Profound expects to release fourth‑quarter and full‑year 2025 results near the end of February 2026.
TULSA‑PRO combines MRI guidance, AI planning, robotically driven transurethral ultrasound and closed‑loop temperature control to precisely ablate targeted prostate tissue in a single session. Profound says the incision‑free procedure generally involves little bleeding, no hospital stay and quick recovery, supporting broader adoption and recurring revenue growth.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- January 6, 2026
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. announced that The Johns Hopkins Hospital has treated its first non-clinical-trial prostate cancer patient using the Company's TULSA-PRO® system.
AI Summary
Profound Medical announced that The Johns Hopkins Hospital treated its first non‑clinical‑trial prostate cancer patient using the company’s TULSA‑PRO system. This milestone marks the official launch of TULSA‑PRO at Johns Hopkins and coincides with the opening of the hospital’s new interventional MRI (iMRI) suite, reflecting a shift from MRI as only a diagnostic tool to a real‑time platform for therapy. Johns Hopkins, a leading center for prostate cancer care, will now offer TULSA‑PRO as an option for prostate cancer and enlarged prostate (BPH) patients.
The TULSA procedure delivers robotically controlled directional ultrasound through the urethra while real‑time MRI thermography continuously visualizes and autonomously adjusts temperature to heat targeted prostate tissue to about 55–57°C. This precision lets physicians tailor treatment, avoids incisions and blood loss, and usually requires no overnight hospital stay. Patients often recover faster and may face fewer side effects commonly tied to surgery or radiation, like urinary incontinence or erectile dysfunction.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- November 28, 2025
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. the upcoming launch of its TULSA-AI® Volume Reduction module for optimizing the treatment of patients with benign prostatic hyperplasia ("BPH"), or enlarged prostate, at the Radiological Society of North America ("RSNA") meeting taking place in Chicago, Nov. 30-Dec. 4.
AI Summary
Profound Medical Corp. will launch its TULSA-AI® Volume Reduction module to optimize treatment of benign prostatic hyperplasia (BPH) at the Radiological Society of North America (RSNA) meeting in Chicago, Nov. 30–Dec. 4. The module integrates with the TULSA-PRO® system, an incision-free, MRI-guided prostate ablation platform used for prostate cancer and BPH.
TULSA-AI uses artificial intelligence to streamline workflow and shorten procedure times, allowing physicians to stack multiple prostate cases in a single day with the same device, clinical staff and reimbursement codes. A successful pilot trial supports the launch. Profound highlights the procedure’s clinical flexibility and real-world data showing reduced risks to sexual function and continence, and CAPTAIN perioperative data suggesting benefits versus robotic prostatectomy in blood loss, length of stay, post-op pain and recovery.
The company expects faster procedures to increase adoption and expand the addressable market to about 600,000 patients annually. RSNA attendees can view demos, case studies and feature updates at Booth #3153, South Hall A.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- June 10, 2025
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. , is pleased to announce that the first commercial benign prostatic hyperplasia ("BPH") treatment utilizing the TULSA-PRO® system's new TULSA-AI® Volume Reduction Module was successfully conducted yesterday by Naveen Kella, M.D., Founder of The Urology Place and an Adjunct Assistant Professor for the UT Health Science Center San Antonio.
AI Summary
Profound Medical Corp. announced a major milestone with the first commercial benign prostatic hyperplasia (BPH) treatment using its TULSA-PRO® system combined with the new TULSA-AI® Volume Reduction Module. The procedure was successfully performed by Dr. Naveen Kella, M.D., Founder of The Urology Place and Adjunct Assistant Professor at UT Health Science Center San Antonio. This innovative module uses state-of-the-art real-time MR imaging and AI-enhanced planning to create a personalized treatment plan that avoids key areas such as the peripheral prostate zone and ejaculatory ducts. The resulting treatment is incision-free, designed to reduce complications, and improves procedural efficiency by shortening the operation to an estimated 60–90 minutes. This breakthrough approach in BPH treatment could provide patients with a less invasive alternative and a quicker recovery process compared to traditional surgical methods.
Read Announcement - Drug:
- TULSA-PRO
- Announced Date:
- June 4, 2025
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp announce that it has entered into a consulting agreement with Leonard Wheeler, a former NFL player turned entrepreneur, author, corporate consultant, co-Executive Director of the NFL Legends Community, and more recently, national podcaster.
AI Summary
Profound Medical Corp. has entered into a consulting agreement with Leonard Wheeler, a former NFL player who has successfully reinvented himself as an entrepreneur, author, corporate consultant, and national podcaster. Wheeler, known for his role as co-Executive Director of the NFL Legends Community, will help build educational platforms and communities, both online and in-person, to drive global awareness for the TULSA-PRO® system. Having undergone the TULSA procedure for prostate cancer himself, Wheeler is passionate about sharing his experience and encouraging other men to explore this less invasive treatment. His rich background as an NFL player and later as a business leader offers a unique perspective that combines firsthand experience with expert knowledge. This partnership marks a significant step for Profound Medical, as it aims to empower men, expand patient education, and promote this innovative, incision-free therapy worldwide.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- April 29, 2025
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. announce initial perioperative data from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy ("RP") in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.
AI Summary
Profound Medical Corp. has announced promising initial perioperative data from the Level 1 post-market CAPTAIN trial. This study compared the safety and effectiveness of the TULSA procedure to radical prostatectomy (RP) in men with organ-confined, intermediate-risk, Gleason Score 7 prostate cancer. The trial provided a unique head-to-head look at these treatments using a randomized controlled approach.
The findings show that TULSA resulted in zero blood loss, eliminated the need for an overnight hospital stay, and significantly reduced post-procedure pain compared to RP. Patients experienced a quicker recovery and improved quality of life during the first month after treatment. These results indicate that TULSA may offer a less invasive, more patient-friendly option for men with this type of prostate cancer.
Read Announcement- Drug:
- TULSA-PRO
- Announced Date:
- May 14, 2024
- Indication:
- Versatile technologies currently available for the treatment of prostate disease.
Announcement
Profound Medical Corp. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the Company's second TULSA-AI module, Contouring Assistant, for use in conjunction with its TULSA-PRO® system.
Read Announcement
Profound Medical FDA Events - Frequently Asked Questions
As of now, Profound Medical (PRN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Profound Medical (PRN) has reported FDA regulatory activity for TULSA-PRO.
The most recent FDA-related event for Profound Medical occurred on January 15, 2026, involving TULSA-PRO. The update was categorized as "Provided Update," with the company reporting: "Profound Medical Corp. is pleased to announce the world-renowned Mount Sinai Hospital has successfully treated its first prostate cancer patient with the TULSA-PRO® system."
Currently, Profound Medical has one therapy (TULSA-PRO) targeting the following condition: Versatile technologies currently available for the treatment of prostate disease..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for TSE:PRN last updated on 1/15/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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