Profound Medical Announces First Commercial BPH Patient Treatment Using TULSA-PRO® with TULSA-AI® Volume Reduction
BPH is a non-cancerous enlargement of the prostate gland due to an overgrowth of prostate cells. It is a common condition as men age, often impeding the flow of urine and creating significant lower urinary tract symptoms ('LUTS'). Current BPH treatment with transurethral resection of the prostate ('TURP') is largely unchanged over the past 100 years. Many alternative treatment methods have been investigated aiming to improve the patient experience and reduce the rates of complications such as bleeding, erectile dysfunction, loss of ejaculation, and the need to stay in the hospital overnight for one, two or more days.
The TULSA procedure, performed using the TULSA-PRO® system, has the potential to become 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 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 and AI-enhanced planning 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.
Prior to the new TULSA-AI® Volume Reduction module, the TULSA-PRO® system was already being used by surgeons world-wide to relieve LUTS in patients with BPH. A few days ago, investigators from the University of Turku and Turku University Hospital in Finland, published a prospective Phase II study demonstrating safe and effective treatment of BPH with TULSA, with clinically marked improvements in urinary function and quality of life while preserving continence and sexual functions. The International Prostate Symptom Score (IPSS) decreased from 17 to 4 (P < 0.001), and IPSS quality of life score improved from 4 to 1 (P < 0.001). The maximum urine flow rate increased from 11.1 to 18.3 mL/s (P < 0.001), and the average flow rate from 4.2 to 9.1 mL/s (P < 0.001). The 26-item Expanded Prostate Cancer Index Composite urinary irritative/obstructive scores improved from 66 to 94 (P < 0.001), and urinary incontinence scores improved from 86 to 100 (P = 0.008). Sexual function remained stable or improved. Of patients using BPH medications prior to TULSA, 96% discontinued it after the procedure. Meanwhile, 100% of patients who were on anti-coagulants did not discontinue their medication before TULSA.
As the name implies, the new TULSA-AI® Volume Reduction module streamlines TULSA procedures intended to decrease the volume of obstructive prostate tissue in men with LUTS due to BPH. This new software module builds upon the previously cleared TULSA-AI Contouring Assistant to quickly and easily provide personalized treatment plans that avoid peripheral zone ablation, the area physicians want to avoid when treating BPH, as well as the ejaculatory ducts that run inside the prostate. By leveraging state-of-the-art real-time MR imaging data, the software provides the surgeon with choices for ablation volume and duration based on the patients' unique anatomy, reducing planning complexity and improving consistency across cases. The primary benefit is enhanced procedural efficiency, decreasing total skin-to-skin time to an expected 60-90 minutes and allowing for faster, more personalized care.
Dr. Kella commented, 'BPH treatments have advanced at a tremendous pace. Patients and surgeons continue to look for effective treatments that offer minimal complications. We want no bleeding and no hospital stay, but we don't want to compromise results. TULSA-AI® Volume Reduction for BPH could be a game-changer in that regard, and it can be completed in 60 to 90 minutes.'
'As demonstrated in the recently published study from the University of Turku, TULSA offers significant improvements in international prostate symptom score, peak urine flow rates, and discontinuation of BPH medications," said Arun Menawat, Profound's CEO and Chairman. 'That said, while urologists have been treating LUTS using TULSA-PRO® since we received 510(k) clearance in 2019, and the technology is the only one capable of treating hybrid patients suffering from both prostate cancer and BPH, BPH-only patient volumes have been low due to the relatively longer treatment duration compared to other modalities. TULSA-AI® Volume Reduction is designed to maintain all of the many proven advantages of treating BPH with TULSA while leveling the playing field on the time it takes for a urologist to plan and complete of the procedure. Accordingly, we believe that TULSA-AI® will expand our total, truly tangible available market opportunity from 200,000 to 600,000 prostate disease patients per year.'
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 KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849
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