Initial Perioperative Data from CAPTAIN Randomized Trial Demonstrate MRI-Guided TULSA Provides Statistically Significant Improvement of Post-Operative Experience Vs. Robotic Radical Prostatectomy
Profound Medical has announced groundbreaking results from their CAPTAIN trial, comparing TULSA procedure with robotic radical prostatectomy (RP) for prostate cancer treatment. The Level 1 study, involving 201 randomized patients across 23 sites, demonstrates significant advantages for TULSA.
Key findings show TULSA patients experienced:
- Zero blood loss compared to 100-200mL for RP
- 0.29 days hospital stay versus 1.24 days for RP
- Significantly lower post-operative pain through day 6
- Higher overall health scores for 30 days post-treatment
TULSA patients showed notably better outcomes in mobility (0% vs 12% extreme problems), self-care (3% vs 17%), and usual activities (17% vs 40%). The study included balanced patient characteristics, with median age ~63 years and similar PSA levels between groups. These results position TULSA as a potentially superior alternative to traditional prostate cancer surgery.
Profound Medical ha annunciato risultati rivoluzionari dal loro studio CAPTAIN, che confronta la procedura TULSA con la prostatectomia radicale robotica (RP) per il trattamento del cancro alla prostata. Lo studio di livello 1, che ha coinvolto 201 pazienti randomizzati in 23 centri, evidenzia vantaggi significativi per TULSA.
I risultati principali mostrano che i pazienti trattati con TULSA hanno sperimentato:
- Perdita di sangue nulla rispetto ai 100-200 mL per RP
- 0,29 giorni di degenza ospedaliera contro 1,24 giorni per RP
- Dolore post-operatorio significativamente inferiore fino al giorno 6
- Punteggi di salute complessivi più elevati per 30 giorni dopo il trattamento
I pazienti TULSA hanno ottenuto risultati nettamente migliori in termini di mobilità (0% vs 12% problemi gravi), cura di sé (3% vs 17%) e attività abituali (17% vs 40%). Lo studio ha incluso caratteristiche dei pazienti bilanciate, con età mediana di circa 63 anni e livelli di PSA simili tra i gruppi. Questi risultati posizionano TULSA come una possibile alternativa superiore alla chirurgia tradizionale per il cancro alla prostata.
Profound Medical ha anunciado resultados innovadores de su ensayo CAPTAIN, que compara el procedimiento TULSA con la prostatectomía radical robótica (RP) para el tratamiento del cáncer de próstata. El estudio de nivel 1, que involucró a 201 pacientes aleatorizados en 23 centros, muestra ventajas significativas para TULSA.
Los hallazgos clave indican que los pacientes tratados con TULSA experimentaron:
- Pérdida de sangre nula en comparación con 100-200 mL para RP
- 0,29 días de estancia hospitalaria frente a 1,24 días para RP
- Dolor postoperatorio significativamente menor hasta el día 6
- Mejores puntuaciones generales de salud durante 30 días después del tratamiento
Los pacientes TULSA mostraron resultados notablemente mejores en movilidad (0% vs 12% con problemas graves), cuidado personal (3% vs 17%) y actividades habituales (17% vs 40%). El estudio incluyó características equilibradas de los pacientes, con edad media de aproximadamente 63 años y niveles similares de PSA entre grupos. Estos resultados posicionan a TULSA como una alternativa potencialmente superior a la cirugía tradicional para el cáncer de próstata.
Profound Medical은 전립선암 치료를 위한 TULSA 시술과 로봇 근치 전립선 절제술(RP)을 비교한 CAPTAIN 임상시험의 획기적인 결과를 발표했습니다. 23개 기관에서 201명의 무작위 환자를 대상으로 한 1상 연구로, TULSA의 유의미한 이점을 입증했습니다.
주요 결과는 TULSA 환자가 다음과 같은 경험을 했음을 보여줍니다:
- RP의 100-200mL와 달리 출혈 없음
- RP의 1.24일과 비교해 0.29일의 입원 기간
- 수술 후 6일까지 현저히 낮은 통증
- 치료 후 30일간 전반적인 건강 점수 상승
TULSA 환자는 이동성(0% vs 12% 심각 문제), 자기 관리(3% vs 17%), 일상 활동(17% vs 40%)에서 현저히 더 나은 결과를 보였습니다. 연구 대상자는 중간 연령 약 63세, PSA 수치가 유사한 균형 잡힌 특성을 가졌습니다. 이 결과는 TULSA가 전통적인 전립선암 수술에 비해 우수한 대안이 될 수 있음을 시사합니다.
Profound Medical a annoncé des résultats révolutionnaires issus de leur essai CAPTAIN, comparant la procédure TULSA à la prostatectomie radicale robotisée (RP) pour le traitement du cancer de la prostate. Cette étude de niveau 1, impliquant 201 patients randomisés dans 23 centres, met en évidence des avantages significatifs pour la TULSA.
Les résultats clés montrent que les patients traités par TULSA ont présenté :
- Une perte de sang nulle contre 100-200 mL pour la RP
- Un séjour hospitalier de 0,29 jour contre 1,24 jour pour la RP
- Une douleur post-opératoire nettement moindre jusqu’au 6e jour
- Des scores de santé globaux plus élevés pendant 30 jours après le traitement
Les patients TULSA ont obtenu des résultats nettement meilleurs en mobilité (0 % vs 12 % de problèmes graves), soins personnels (3 % vs 17 %) et activités habituelles (17 % vs 40 %). L’étude comprenait des caractéristiques équilibrées des patients, avec un âge médian d’environ 63 ans et des niveaux de PSA similaires entre les groupes. Ces résultats positionnent la TULSA comme une alternative potentiellement supérieure à la chirurgie traditionnelle du cancer de la prostate.
Profound Medical hat bahnbrechende Ergebnisse aus ihrer CAPTAIN-Studie bekanntgegeben, die das TULSA-Verfahren mit der robotergestützten radikalen Prostatektomie (RP) zur Behandlung von Prostatakrebs vergleicht. Die Level-1-Studie mit 201 randomisierten Patienten an 23 Standorten zeigt deutliche Vorteile für TULSA.
Wesentliche Ergebnisse zeigen, dass TULSA-Patienten:
- Keinen Blutverlust hatten im Vergleich zu 100-200 ml bei RP
- 0,29 Tage Krankenhausaufenthalt statt 1,24 Tage bei RP
- Bis zum 6. Tag deutlich weniger postoperative Schmerzen
- Höhere allgemeine Gesundheitswerte für 30 Tage nach der Behandlung
TULSA-Patienten erzielten deutlich bessere Ergebnisse bei Mobilität (0 % vs. 12 % schwere Probleme), Selbstversorgung (3 % vs. 17 %) und üblichen Aktivitäten (17 % vs. 40 %). Die Studie umfasste ausgewogene Patienteneigenschaften mit einem Medianalter von etwa 63 Jahren und ähnlichen PSA-Werten in beiden Gruppen. Diese Ergebnisse positionieren TULSA als potenziell überlegene Alternative zur herkömmlichen Prostatakrebsoperation.
- First Level 1 randomized controlled trial comparing TULSA to robotic radical prostatectomy successfully reached target enrollment (201 patients)
- TULSA demonstrated statistically significant superior outcomes vs. standard treatment in all perioperative measures
- Zero blood loss with TULSA vs. 100-200mL with RP, reducing medical costs and complications
- Significantly shorter hospital stay (0.29 days vs 1.24 days), improving facility throughput and reducing costs
- Strong clinical data supporting insurance coverage potential, as Level 1 trials are considered gold standard by insurance companies
- High patient satisfaction and demand potential, similar to early surgical robot adoption trends
- Uneven treatment distribution between study arms (69% TULSA vs 31% RP) could impact final study validity
- Long-term efficacy data still pending, which may affect market adoption
- Current results limited to perioperative outcomes only, lacking crucial long-term cancer control data
Insights
Profound's TULSA procedure shows superior perioperative outcomes vs. radical prostatectomy in landmark RCT, potentially transforming prostate cancer treatment standards.
The CAPTAIN trial represents a significant clinical milestone as the first Level 1 study directly comparing TULSA to the gold standard robotic radical prostatectomy for prostate cancer. With 201 patients randomized across 23 international sites, the trial demonstrates robust methodology with well-balanced patient characteristics between arms.
The perioperative results show dramatic differences favoring TULSA across all measured dimensions:
- Blood loss: TULSA median 0mL vs. RP 100mL (p<0.001)
- Hospital stay: TULSA 0.29 days vs. RP 1.24 days (p<0.001)
- Pain scores: Significantly lower through post-treatment day 6 (p<0.05)
- Overall health scores: Higher for all 30 days post-treatment (p<0.05)
- Functional recovery: Dramatically fewer TULSA patients reported extreme problems with mobility (0% vs. 12%), self-care (3% vs. 17%), and usual activities (17% vs. 40%)
The inclusion of "some of the most talented and high volume surgeons" lends credibility to the surgical comparison arm, addressing potential concerns about surgical quality affecting outcomes. Dr. Meng notes that successful randomization was likely due to "TULSA's proven safety and efficacy for whole-gland ablation in intermediate-risk prostate cancer patients."
For hospitals and healthcare systems, these advantages could translate to improved resource utilization through reduced hospitalization time. The patient experience benefits appear substantial, with the CEO noting that "TULSA patients are often out at the restaurant with their families the night of their procedure rather than laying in a hospital bed."
While these perioperative results are promising, the long-term cancer control data will ultimately determine TULSA's position in treatment algorithms. Nevertheless, this Level 1 evidence represents a critical step in establishing TULSA as a minimally invasive alternative for intermediate-risk prostate cancer.
Profound Medical's CAPTAIN trial delivers strong perioperative results, potentially accelerating insurance coverage and market adoption for its TULSA technology.
The CAPTAIN trial results represent a potential commercial inflection point for Profound Medical (NASDAQ:PROF; TSX:PRN). By generating Level 1 evidence showing TULSA's superiority over radical prostatectomy in perioperative outcomes, the company has acquired essential data that could accelerate both market adoption and payer coverage.
The successful execution of this randomized controlled trial is itself noteworthy, with 201 patients randomized and 194 treated or scheduled across 23 sites. This demonstrates operational capability in managing a complex multi-center study that produced statistically significant results across all measured perioperative outcomes.
From a reimbursement perspective, these results are strategically valuable. CEO Arun Menawat specifically highlighted that the findings are "important for insurance companies who consider Level 1 randomized controlled trials the gold standard" for establishing coverage policies. The comparative data directly addresses resource utilization with TULSA showing:
- Near-elimination of hospital stays (0.29 vs. 1.24 days)
- Zero blood loss (vs. 100mL median for surgery)
- Faster recovery to baseline activities
These metrics provide compelling economic arguments alongside clinical benefits, potentially streamlining the path to reimbursement coverage – a critical hurdle for medical device adoption and commercialization.
The dramatic difference in recovery trajectory could drive patient preference and physician referrals, with the CEO noting that TULSA patients can often resume normal activities immediately versus two weeks for surgical patients. This experience advantage creates a natural patient demand driver that could accelerate market penetration.
While these perioperative results are encouraging, the company appropriately acknowledges that long-term cancer control outcomes will further inform TULSA's market position. Nevertheless, this data represents significant progress in Profound's clinical evidence strategy, potentially establishing TULSA as a preferred alternative for intermediate-risk prostate cancer treatment.
– First Level 1 study comparing an emerging technology head-to-head with RP in men with prostate cancer –
– TULSA had no blood loss and no overnight stay, along with reduced post-procedure pain, and more rapid recovery to baseline activities and overall health –
TORONTO, April 29, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, is pleased to 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.
The positive perioperative results were presented yesterday by Xiaosong Meng, M.D., Ph.D., an Assistant Professor in the Department of Urology at UT Southwestern Medical Center, at the American Urological Association (“AUA”) Annual Meeting.
Starting in 2022, CAPTAIN patients were recruited at 20 sites in the United States, two in Canada and one in Europe. As of January 2025, 201 patients were randomized and, to-date, 194 have been treated or scheduled for treatment (
Dr. Meng’s AUA presentation highlighted that TULSA provided statistically significant improvement in all assessed perioperative measures:
- Blood loss: TULSA median 0 (IQR 0-0) mL vs. RP 100 (100-200) mL, p<0.001.
- Length of stay: TULSA median 0.29 (IQR 0.27-0.32) days vs. RP 1.24 (1.12-1.36) days, p<0.001.
- NRS (Numeric Rating Scale) pain: Significantly lower post-operative pain after TULSA procedure vs. RP through to post-treatment day 6, p<0.05.
- Patient-reported health-related QOL:
- Significantly higher overall health on the EQ-5D-5L 0-100 VAS (Visual Analog Scale) after TULSA vs. RP for all 30 days measured after treatment, p<0.05.
- During the first month post-treatment, significantly fewer TULSA patients reported experiencing extreme problems or inability with mobility (
0% for TULSA vs.12% for RP, p=0.001), self-care (3% for TULSA vs.17% for RP, p=0.005), and usual activities (17% for TULSA vs.40% for RP, p=0.008).
Dr. Meng commented, “I commend the Sponsor and the Study Investigators for taking on this audacious study, as CAPTAIN is the fist randomized controlled trial comparing a new technology to the standard of robotic radical prostatectomy to successfully recruit to target enrollment. In addition to including some of the most talented and high volume surgeons from academic hospitals and private practice, I believe successful randomization was in large part due to TULSA’s proven safety and efficacy for whole-gland ablation in intermediate-risk prostate cancer patients, which fostered equipoise between both arms. While TULSA already has a well-established body of clinical evidence, it now has hard data that shows quantitatively in a head-to-head fashion significantly superior post-treatment patient experience compared to robotic prostatectomy.”
“Zero blood loss and nearly a full 24 hours less at the hospital or clinic. Dramatic reduction in post procedure pain and significant improvement with patient mobility, self-care and ability to perform usual activities,” said Arun Menawat, Profound’s CEO and Chairman. “When we see the data that says that robotic prostatectomy patients take over two weeks of recovery, on average, to feel like a TULSA patient does the day after their procedure, we can understand how TULSA patients are often out at the restaurant with their families the night of their procedure rather than laying in a hospital bed. This superior patient experience leads to high patient satisfaction and patient demand, which interestingly is the same axis that drove adoption of the surgical robot in its early days.”
Dr. Menawat added, “We believe the CAPTAIN perioperative outcomes are not only central to patient demand, but are also important for insurance companies who consider Level 1 randomized controlled trials the gold standard in evidence-based research for establishing the effectiveness of interventions and making their coverage policies. We look forward to continue reporting CAPTAIN follow-up data, adding to the growing body of clinical evidence that demonstrates the unrivaled precision and flexibility of TULSA with consistent safe and effective outcomes across the full spectrum of prostate disease states.”
About CAPTAIN
CAPTAIN (A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants with Localized Prostate Cancer) is a prospective, multi-center randomized controlled trial aimed at comparing the safety and efficacy of the TULSA procedure (performed with the TULSA-PRO® system) with RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The goal of CAPTAIN is to demonstrate that the efficacy of the TULSA procedure is not inferior to RP, while demonstrating superior quality of life outcomes. The primary safety endpoint is the proportion of patients who preserve both erectile potency and urinary continence at one year after treatment. The primary efficacy endpoint is the proportion of patients who are free from any additional treatment for prostate cancer, free of metastases or prostate cancer related death by three years after treatment. Secondary endpoints include comparison of rates of complications, cost effectiveness, as well as histologic and biochemical failure.
About Profound Medical Corp.
Profound is a commercial-stage medical device company that develops and markets customizable, 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. TULSA 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. TULSA 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 TULSA. 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 and palliative pain treatment of bone metastases. 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 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 U.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
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