TULSA-PRO® was front and center at AUA2022
TORONTO, May 17, 2022 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ: PROF; TSX: PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable incision devices-free therapies for the ablation of diseased tissue, has today announced that several clinical presentations and product demonstrations performed at the 2022 American Urological Association (“AUA”) Annual Meeting, held May 13-16 in New Orleans, highlighted demonstrates the ability of TULSA-PRO® to perform the safe and effective doctor-prescribed removal of prostate tissue in an unparalleled variety of patients with prostate cancer and benign prostatic hyperplasia (“BPH”).
Of particular note, Kenneth A. Goldberg, MD, assistant professor in the department of urology at UT Southwestern Medical Center, performed a semi-direct TULSA procedure during the afternoon plenary session on 13 may. The AAU has designated this activity for AMA PRA Category 1 creditsMTwhich requires a physician-led content review board to determine that the education is valid, fair, balanced, scientifically rigorous, and free from commercial bias.
“We were thrilled to have Dr. Goldberg perform a semi-live TULSA procedure at this year’s meeting, the largest gathering of urologists in the world,” said Arun Menawat, CEO and President of Profound. “Being so at the forefront of AUA2022 has been both a major milestone for Profound and an opportunity to demonstrate to urologists how TULSA can provide both therapeutic and quality of life benefits to their patients with AD. prostate cancer, BPH and some who suffer from both. We are extremely encouraged by the positive feedback we received at this event, which adds momentum to the ongoing marketing strategy. from Profound for TULSA-PRO.®.”
Earlier that day during the Friday morning plenary session, TULSA-PRO® was also presented by Scott Eggener, MD, of the University of Chicago, who included the TULSA procedure and follow-up data from the pivotal TACT study in his presentation, “Second opinion cases: Focal therapy for Prostate Cancer: Should does it replace standard of care?”
In addition, Mikael Anttinen, MD, Ph.D., University Hospital of Turku, presented a moderated poster presentation during the session titled “Benign Prostatic Hyperplasia: Surgical Therapy and New Technology I”, which included updated results from a Phase 1/2 clinical study. to evaluate the use of TULSA to treat patients with BPH. The study reported improvement over 6 months in patients’ quality of life, LUTS, sexual function and urine flow, with all men discontinuing their BPH treatment. These medium-term results reinforce previously reported findings from Turku University Hospital, with the authors concluding that TULSA is a safe and feasible treatment option for BPH with clinical results lasting up to 24 months.
Finally, Profound Medical unveiled its TULSA-PRO® Software version 2.11, which includes two new features. The first is “mpMRI Vision”, which imports live intra-procedural Diffusion-Weighted Imaging (DWI) and Apparent Diffusion Coefficient (ADC) maps, allowing physicians to confidently delineate targeted prostate tissue and guide sparing, as well as sensitivity-weighted imaging (SWI) to identify and avoid intraprostatic calcifications. The second is an optimized bladder suppression algorithm, which was developed in response to the fact that most US-based physicians have moved away from suprapubic catheterization in favor of urethral or Foley catheters. Each day of AUA2022, Profound presented the product and demonstrated this software for three different sample procedures: custom whole gland ablation, lesion-targeted partial gland ablation, and transition in a patient with BPH.
About Profound Medical Corp.
Profound is a commercial-stage medical device company that develops and markets customizable, incisionless therapies for the ablation of diseased tissue.
Profound markets TULSA-PRO®, a technology that combines real-time MRI, robotic transurethral ultrasound and closed-loop temperature monitoring. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively shielding the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable ablation of the prostate, including mid-stage cancer, localized radio-recurrent cancer, hematuria retention and palliation in locally advanced prostate cancer and the transition zone in large-volume benign prostatic hyperplasia (“BPH”). TULSA-PRO® is CE marked, Health Canada approved and 510(k) cleared by the United States Food and Drug Administration (“FDA”).
Profound also markets Sonallève®, an innovative and CE-marked therapeutic platform for the treatment of uterine fibroids and the palliative treatment of pain from bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has received FDA approval under a compassionate device exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential processing markets for Sonalleve® where the technology has been shown to have clinical applications, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer treatment.
This release contains forward-looking statements regarding Profound and its business which may include, but are not limited to, expectations regarding the effectiveness of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids , palliative treatment of pain and osteoid osteoma. Often, but not always, forward-looking statements can be identified by the use of words such as “anticipates”, “is planned”, “expects”, “anticipates”, “intends”, “intends “, “anticipates”, “believes”, “proposes” or variations (including negative variations) of these words and phrases, or states that certain actions, events or results “may”, “could”, “would”, “could” or “will” be taken, occur or be affected. These 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 on certain specific dates or may not occur at all and may differ materially due to known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulations, approvals, reimbursement, economic factors, stock markets generally, and the 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 the forward-looking statements, there may be other factors that cause actual actions, events or results differ from those anticipated, estimated or expected. . No forward-looking statement can be guaranteed. Additionally, there is uncertainty about the spread of the COVID-19 virus and its impact on Profound’s operations, demand for its products, global supply chains and economic activity generally. Except as required by applicable securities laws, forward-looking statements speak only as of the date they are made, and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether whether as a result of new information, future events, or otherwise, except as required by law.
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