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Profound Medical (PROF) FDA Events

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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.

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

  • 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 7/10/2025 by MarketBeat.com Staff
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