Profound Medical (PROF) FDA Approvals $7.20 +0.10 (+1.41%) Closing price 04:00 PM EasternExtended Trading$7.18 -0.02 (-0.21%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Profound Medical's Drug in the FDA Approval ProcessThis 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. Oral presentation - May 14,2026Oral Presentation Drug: TULSA-PROAnnounced Date: May 14, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound Medical Corp. announce that the TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association's ("AUA") Annual Meeting in Washington, DC, in the session titled "Prostate Cancer: Localized: Ablative Therapy II" on May 16th from 1:00-3:00 p.m. ET.AI SummaryProfound Medical Corp. said the TULSA Procedure™ will be featured in four oral presentations at the American Urological Association’s annual meeting in Washington, DC, on May 16 from 1:00 to 3:00 p.m. ET. The talks will appear in the session “Prostate Cancer: Localized: Ablative Therapy II,” showing growing interest in MRI-guided prostate ablation. The company will also spotlight its iMRI-based prostate treatment approach at Booth #413, where attendees can see demonstrations of TULSA-PRO® and an actual Siemens MAGNETOM Free.Max MR system. Profound described TULSA as part of a complete interventional MRI solution for prostate ablation. In addition, Profound said it is starting an effort to study how PSMA PET molecular imaging could be combined with the TULSA Procedure. The goal is to improve treatment planning and help doctors monitor patients more effectively.Read AnnouncementProvided Update - January 15,2026Provided Update Drug: TULSA-PROAnnounced Date: January 15, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 AnnouncementProvided Update - January 12,2026Provided Update Drug: TULSA-PROAnnounced Date: January 12, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 AnnouncementProvided Update - January 6,2026Provided Update Drug: TULSA-PROAnnounced Date: January 6, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 AnnouncementProvided Update - November 28,2025Provided Update Drug: TULSA-PROAnnounced Date: November 28, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 AnnouncementProvided Update - June 10,2025Provided Update Drug: TULSA-PROAnnounced Date: June 10, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 AnnouncementProvided Update - June 4,2025Provided Update Drug: TULSA-PROAnnounced Date: June 4, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 AnnouncementData - April 29,2025Data Drug: TULSA-PROAnnounced Date: April 29, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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 Profound Medical FDA Events - Frequently Asked Questions Has Profound Medical received FDA approval? As of now, Profound Medical (PROF) has not received any FDA approvals for its therapy in the last two years. What drugs has Profound Medical submitted to the FDA? In the past two years, Profound Medical (PROF) has reported FDA regulatory activity for TULSA-PRO. What is the most recent FDA event for Profound Medical? The most recent FDA-related event for Profound Medical occurred on May 14, 2026, involving TULSA-PRO. The update was categorized as "Oral presentation," with the company reporting: "Profound Medical Corp. announce that the TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association's ("AUA") Annual Meeting in Washington, DC, in the session titled "Prostate Cancer: Localized: Ablative Therapy II" on May 16th from 1:00-3:00 p.m. ET." What conditions do Profound Medical's current drugs treat? 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 Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Aardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCelcuity FDA EventsClimb Bio FDA EventsCorvus Pharmaceuticals FDA EventsEditas Medicine FDA EventsEyepoint Pharmaceuticals FDA EventsGenprex FDA EventsGT Biopharma FDA EventsMiNK Therapeutics FDA Events 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 Related Companies Bioventus FDA Events Spyglass Pharma FDA Events SS Innovations International FDA Events Brainsway FDA Events Alpha Tau Medical FDA Events NeuroPace FDA Events Tactile Systems Technology FDA Events Delcath Systems FDA Events ClearPoint Neuro FDA Events Orchestra BioMed FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:PROF last updated on 5/14/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | SponsoredPeptide Company Lands Exclusive MMA Wellness PartnershipA publicly traded peptide company just signed an exclusive partnership with a NYSE-listed MMA media platform t...The Tomorrow Investor | SponsoredBlackRock, JPMorgan, and Goldman are all stock piling the same asset… are you?BlackRock, JPMorgan, Goldman Sachs, Fidelity, ARK Invest and Andreessen Horowitz are all buying the same asset...Awesomely, LLC | SponsoredThe cat is out the bagAlmost 80,000 tech jobs vanished in the first three months of 2026. Meta cut 14,000 roles, Microsoft offered s...Porter & Company | SponsoredIran War Update: Trump’s Hand-Written Letter Reveals What Comes NextJim Rickards has uncovered what he believes is Trump's economic plan, with a key trigger date of May 15. The F...Paradigm Press | SponsoredYour book is insideThe "Sucker's Bet" Most New Options Traders Fall For Most people who try options lose money the same way. ...Profits Run | SponsoredDistracted Americans set to miss out on quadrillionsTechnology expert and Washington D.C. insider Jeff Brown - who identified Bitcoin, Tesla, and Nvidia early - s...Brownstone Research | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Profound Medical Please log in to your account or sign up in order to add this asset to your watchlist. Share Profound Medical With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Oral presentation - May 14,2026Oral Presentation Drug: TULSA-PROAnnounced Date: May 14, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound Medical Corp. announce that the TULSA Procedure™ will be highlighted in four oral presentations at the upcoming American Urological Association's ("AUA") Annual Meeting in Washington, DC, in the session titled "Prostate Cancer: Localized: Ablative Therapy II" on May 16th from 1:00-3:00 p.m. ET.AI SummaryProfound Medical Corp. said the TULSA Procedure™ will be featured in four oral presentations at the American Urological Association’s annual meeting in Washington, DC, on May 16 from 1:00 to 3:00 p.m. ET. The talks will appear in the session “Prostate Cancer: Localized: Ablative Therapy II,” showing growing interest in MRI-guided prostate ablation. The company will also spotlight its iMRI-based prostate treatment approach at Booth #413, where attendees can see demonstrations of TULSA-PRO® and an actual Siemens MAGNETOM Free.Max MR system. Profound described TULSA as part of a complete interventional MRI solution for prostate ablation. In addition, Profound said it is starting an effort to study how PSMA PET molecular imaging could be combined with the TULSA Procedure. The goal is to improve treatment planning and help doctors monitor patients more effectively.Read Announcement
Provided Update - January 15,2026Provided Update Drug: TULSA-PROAnnounced Date: January 15, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
Provided Update - January 12,2026Provided Update Drug: TULSA-PROAnnounced Date: January 12, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
Provided Update - January 6,2026Provided Update Drug: TULSA-PROAnnounced Date: January 6, 2026Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
Provided Update - November 28,2025Provided Update Drug: TULSA-PROAnnounced Date: November 28, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
Provided Update - June 10,2025Provided Update Drug: TULSA-PROAnnounced Date: June 10, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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
Provided Update - June 4,2025Provided Update Drug: TULSA-PROAnnounced Date: June 4, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
Data - April 29,2025Data Drug: TULSA-PROAnnounced Date: April 29, 2025Indication: Versatile technologies currently available for the treatment of prostate disease.Other Companies Involved: TSE:PRN AnnouncementProfound 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 SummaryProfound 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
