Texas Prostate and Dallas Medical Center Launch First-of-its-Kind TULSA Program, Expanding Access to Advanced Prostate Treatment
Profound Medical Corp. (NASDAQ:PROF) announced a groundbreaking partnership between Texas Prostate and Dallas Medical Center to launch a first-of-its-kind TULSA program. The collaboration expands Medicare patient access to the TULSA Procedure™, an advanced, AI-powered prostate treatment technology.
The program enables Texas Prostate to perform TULSA procedures at Dallas Medical Center's MRI suite, treating both prostate cancer and benign prostatic hyperplasia (BPH). This advancement follows Medicare's coverage approval in January 2025 for TULSA procedures across various healthcare settings.
The TULSA-PRO® system represents a significant innovation in prostate care, utilizing robotically-guided ultrasound within an MRI environment to precisely ablate targeted prostate tissue. The procedure offers key advantages including same-day discharge, no procedural blood loss, and reduced risk of complications like incontinence or erectile dysfunction.
Profound Medical Corp. (NASDAQ:PROF) ha annunciato una partnership innovativa tra Texas Prostate e Dallas Medical Center per lanciare un programma TULSA unico nel suo genere. La collaborazione amplia l’accesso ai pazienti Medicare al Procedura TULSA™, una tecnologia di trattamento della prostata avanzata e guidata dall’intelligenza artificiale.
Il programma consente a Texas Prostate di eseguire le procedure TULSA nel laboratorio MRI del Dallas Medical Center, trattando sia il cancro alla prostata sia l’iperplasia prostatica benigna (BPH). Questo progresso segue l’approvazione della copertura Medicare, annunciata nel gennaio 2025, per le procedure TULSA in diversi contesti assistenziali.
Il sistema TULSA-PRO® rappresenta una significativa innovazione nella cura della prostata, impiegando ultrasuoni guidati da robot all’interno di un ambiente MRI per eliminare in modo mirato tessuto prostatico. L’intervento offre vantaggi chiave come la dimissione nello stesso giorno, assenza di perdita di sangue durante la procedura e un ridotto rischio di complicazioni quali incontinenza o disfunzione erettile.
Profound Medical Corp. (NASDAQ:PROF) anunció una asociación pionera entre Texas Prostate y Dallas Medical Center para lanzar un programa TULSA sin precedentes. La colaboración amplía el acceso de los pacientes cubiertos por Medicare al Procedimiento TULSA™, una tecnología de tratamiento de la próstata avanzada y potenciada por IA.
El programa permite a Texas Prostate realizar procedimientos TULSA en la sala de RM del Dallas Medical Center, tratando tanto el cáncer de próstata como la hiperplasia prostática benigna (HBP). Este avance llega tras la aprobación de la cobertura de Medicare en enero de 2025 para los procedimientos TULSA en diversos entornos de atención sanitaria.
El sistema TULSA-PRO® representa una innovación significativa en el cuidado de la próstata, utilizando ultrasonido guiado por robots dentro de un entorno de RM para ablacion precisa del tejido prostático focal. El procedimiento ofrece ventajas clave como alta de alta en el mismo día, sin pérdida de sangre durante el procedimiento y menor riesgo de complicaciones como incontinencia o disfunción eréctil.
Profound Medical Corp. (NASDAQ:PROF)가 텍사스 프로스테이트와 달라스 메디컬 센터 간의 새로운 파트너십을 발표하며, 업계 최초의 TULSA 프로그램을 출시합니다. 이 협력은 Medicare 환자의 TULSA 절차™ 접근성을 확장하는 것으로, AI 기반의 고도화된 전립선 치료 기술입니다.
이 프로그램은 텍사스 프로스테이트가 달라스 메디컬 센터의 MRI 실에서 TULSA 절차를 시행하여 전립선암과 양성 전립선 비대증(BPH)을 치료할 수 있게 합니다. 이는 2025년 1월 Medicare의 TULSA 절차에 대한 커버리지 승인 이후의 진전으로, 다양한 의료 환경에서의 적용이 가능해졌습니다.
TULSA-PRO® 시스템은 MRI 환경 내에서 로봇으로 가이드된 초음파를 사용하여 표적 전립선 조직을 정밀하게 제거하는 전립선 관리의 중요한 혁신입니다. 이 절차는 당일 퇴원, 시술 중 출혈 없음, 요실금이나 발기부전과 같은 합병증 위험 감소 등 주요 이점을 제공합니다.
Profound Medical Corp. (NASDAQ:PROF) a annoncé un partenariat innovant entre Texas Prostate et Dallas Medical Center afin de lancer un programme TULSA unique en son genre. Cette collaboration élargit l’accès des patients Medicare au Procédure TULSA™, une technologie de traitement de la prostate avancée et alimentée par l’IA.
Le programme permet à Texas Prostate d’effectuer des procédures TULSA dans la salle d’IRM du Dallas Medical Center, traitant à la fois le cancer de la prostate et l’hyperplasie bénigne de la prostate (HBP). Cette avancée fait suite à l’approbation de la couverture par Medicare en janvier 2025 pour les procédures TULSA dans divers contextes de soins.
Le système TULSA-PRO® représente une innovation majeure dans les soins prostatiques, utilisant des ultrasons guidés par robot dans un environnement IRM pour ablater avec précision le tissu prostatique ciblé. La procédure offre des avantages clés tels que la sortie le jour même, aucune perte de sang pendant la procédure et un risque réduit de complications comme l’incontinence ou la dysfonction érectile.
Profound Medical Corp. (NASDAQ:PROF) kündigte eine bahnbrechende Partnerschaft zwischen Texas Prostate und Dallas Medical Center zur Einführung eines ersten TULSA-Programms an. Die Zusammenarbeit erweitert den Zugang von Medicare-Patienten zur TULSA Procedure™, einer fortschrittlichen, KI-gesteuerten Prostatabehandlungstechnologie.
Das Programm ermöglicht es Texas Prostate, TULSA-Verfahren im MRI-Saal des Dallas Medical Center durchzuführen und sowohl Prostatakrebs als auch benigne Prostataleiden (BPH) zu behandeln. Dieser Fortschritt folgt der Medicare-Abdeckung, die im Januar 2025 für TULSA-Verfahren in verschiedenen Versorgungseinstellungen genehmigt wurde.
Das TULSA-PRO®-System steht für eine bedeutende Innovation in der Prostatabehandlung, bei der robotergeführt Ultraschall in einer MRT-Umgebung verwendet wird, um Gewebe der Prostata präzise zu zerstören. Das Verfahren bietet zentrale Vorteile wie eine Entlassung am selben Tag, kein Blutverlust während des Eingriffs und ein reduziertes Risiko von Komplikationen wie Inkontinenz oder erektiler Dysfunktion.
Profound Medical Corp. (NASDAQ:PROF) أعلنت عن شراكة رائدة بين Texas Prostate وDallas Medical Center لإطلاق برنامج TULSA فريد من نوعه. يوسّع هذا التعاون وصول مرضى Medicare إلى الإجراء TULSA™، تكنولوجيا علاج البروستاتا المتقدمة المدعومة بالذكاء الاصطناعي.
يتيح البرنامج لـ Texas Prostate إجراء إجراءات TULSA في جناح MRI في Dallas Medical Center، مع علاج سرطان البروستاتا وبَرْد البروستاتا الحميد (BPH). يأتي هذا التقدم بعد موافقة Medicare على التغطية في يناير 2025 لإجراءات TULSA في مختلف مرافق الرعاية الصحية.
إن نظام TULSA-PRO® يمثل ابتكاراً هاماً في رعاية البروستاتا، حيث يستخدم موجات فوق صوتية موجهة بالروبوت ضمن بيئة RM لتبخير نسيج البروستاتا المستهدف بدقة. يوفر الإجراء مزايا رئيسية مثل الإخراج في اليوم نفسه، وعدم فقدان الدم أثناء الإجراء، وانخفاض مخاطر المضاعفات مثل السلس أو ضعف الانتصاب.
Profound Medical Corp. (NASDAQ:PROF) 宣布改革性伙伴关系：Texas Prostate 与 Dallas Medical Center 将启动前所未有的 TULSA 项目。该合作将扩大 Medicare 患者对 TULSA Procedures™ 的覆盖，推动一项人工智能驱动的前列腺治疗新技术。
该计划使 Texas Prostate 能在 Dallas Medical Center 的 MRI 诊室内执行 TULSA 程序，治疗前列腺癌以及良性前列腺增生（BPH）。这一进展紧随 Medicare 于 2025 年 1 月对 TULSA 程序在多种医疗场景中的覆盖批准之后。
TULSA-PRO® 系统代表前列腺护理的重要创新，使用在 MRI 环境中由机器人引导的超声波，精准消融目标前列腺组织。该程序的主要优势包括当天出院、手术中无出血，以及降低失禁或勃起功能障碍等并发症风险。
- Medicare coverage approval expands patient access to TULSA Procedure
- Partnership enables same-day treatment with no overnight hospital stay required
- Technology offers reduced risk of common side effects like incontinence and erectile dysfunction
- AI-powered system provides real-time visualization and customized treatment
- None.
Insights
Profound's TULSA technology expansion through new Texas partnership increases Medicare patient access, demonstrating strong commercial adoption momentum.
This partnership between Texas Prostate and Dallas Medical Center represents a significant commercial milestone for Profound Medical's TULSA-PRO system. The collaboration establishes a dedicated program that will expand Medicare patient access across Texas for this non-invasive prostate treatment technology.
The announcement builds upon the January 2025 Medicare coverage approval for TULSA procedures across multiple clinical settings—Hospital Outpatient, Ambulatory Surgical Centers, and Private Office environments. This reimbursement pathway is crucial for driving adoption, as Medicare coverage typically removes a major barrier to utilization.
From a commercial perspective, this partnership demonstrates a viable business model that could be replicated nationwide: private urology practices partnering with Medicare-accepting hospitals to offer TULSA procedures. This template approach could accelerate market penetration beyond the current installation.
The TULSA-PRO's competitive positioning as "
For Profound, this partnership demonstrates commercial execution following the crucial Medicare reimbursement milestone. The company appears to be successfully transitioning from the regulatory/reimbursement phase to commercial expansion, which is typically when medical device companies begin generating meaningful revenue growth.
New program delivers TULSA Procedure’s precision treatment - minimal side effects, no overnight hospital stay – to Medicare patients across Texas
TORONTO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company developing AI-powered, incision-free therapies for ablating diseased tissue, announced today the launch of a first-of-its-kind TULSA program by Texas Prostate and Dallas Medical Center to meet the growing demand for advanced prostate treatment — without surgery. Under the program, Texas Prostate will perform TULSA procedures for men with prostate cancer and benign prostatic hyperplasia (“BPH”) in Dallas Medical Center’s state-of-the-art MRI suite, significantly expanding Medicare patient access to the TULSA Procedure™.
“The TULSA procedure is integral to our practice because it offers many men effective prostate treatment without the life-altering side effects of surgery — such as incontinence or erectile dysfunction,” said Dr. James Cochran, founder of Texas Prostate. “With Medicare coverage now available, we’ve been seeking ways to offer more men access to this transformative technology. Working with Dallas Medical Center allows us to do just that.”
In January, 2025 Medicare coverage was granted for the TULSA Procedure performed in Hospital Outpatient, Ambulatory Surgical Center and Private Office/Non-Facility settings, broadening access to the treatment. This collaboration makes the TULSA Procedure available under Medicare coverage, with Texas Prostate now performing TULSA procedures exclusively at Dallas Medical Center. The hospital gains both advanced technology and the Texas Prostate team’s proven expertise in performing TULSA Procedures.
“At Dallas Medical Center, we’re committed to bringing advanced, compassionate care to our patients,” said Ruben Garza, CEO of Dallas Medical Center. “By working with Texas Prostate, patients can be treated with the TULSA-PRO® system in our state-of-the-art MRI suite — and then return home the same day, with no procedural blood loss, and a significantly lower risk of complications.”
Profound Medical CEO Arun Menawat added, “The versatility of TULSA enables the treatment of a wide variety of prostate disease including whole gland or targeted gland treatments, and we are thrilled to see that this new program will provide access to a wider population of patients. Importantly, it also provides a model for private pay urology practices and Medicare accepting hospitals nationwide seeking to expand access to the TULSA procedure.”
The TULSA Procedure represents a major advancement in prostate care. Unlike traditional treatments that involve surgery, radiation, or lengthy recovery times, the TULSA Procedure is performed inside an MRI suite using robotically guided, directional ultrasound to precisely ablate targeted prostate tissue — without harming surrounding structures. The TULSA-PRO system — the technology behind the procedure — is the only AI-powered, MRI-guided robotic system for prostate treatment. It allows physicians to visualize the prostate in real time and customize therapy for each patient with unmatched precision.
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, any express or implied statements or guidance regarding current or future financial performance; 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 Profound, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges. 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
What is the TULSA Procedure offered by Profound Medical (NASDAQ:PROF)?
When did Medicare approve coverage for the TULSA Procedure?
What conditions can be treated with the TULSA-PRO system at Dallas Medical Center?
What are the advantages of the TULSA Procedure over traditional prostate treatments?
Where is the new TULSA program being implemented?
