FDA Events for Profound Medical (PROF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Profound Medical (PROF).
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:
- 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 (PROF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Profound Medical (PROF) has reported FDA regulatory activity for TULSA-PRO.
The most recent FDA-related event for Profound Medical occurred on June 10, 2025, involving TULSA-PRO. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Profound Medical has one therapy (TULSA-PRO) targeting the following condition: Versatile technologies currently available for the treatment of prostate disease..
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:PROF) was last updated on 7/11/2025 by MarketBeat.com Staff
