Mr. Arun Menawat reports

PROFOUND MEDICAL TO LAUNCH AI-POWERED BPH MODULE, PRESENT NEW TULSA-PRO CLINICAL DATA, AT RSNA AND SUO MEETINGS

Profound Medical Corp. has provided an update on the coming 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 from Nov. 30 to Dec. 4.

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 Profound's Tulsa-Pro system, is the only incision-free procedure for prostate cancer, BPH, and patients who have both prostate cancer and BPH. With the Tulsa-AI volume reduction module, physicians can efficiently and easily stack multiple prostate cases in one day, using the same device hardware, clinical support staff and reimbursement codes. The Tulsa procedure's clinical flexibility -- along with real-world data demonstrating significantly reduced risk of loss of sexual function and incontinence and Captain perioperative data demonstrating the Tulsa procedure's superiority to robotic prostatectomy in blood loss, length of stay, postop pain and recovery time -- is fuelling strong demand for the incision-free procedure from both patients and health care providers.

"We're confident to launch the Tulsa-AI volume reduction module for BPH, following a successful pilot trial earlier this year," said Arun Menawat, Profound's chief executive officer and chairman. "The use of AI [artificial intelligence] to streamline the workflow and reduce procedure times is a significant advance that makes using Tulsa-Pro for treating enlarged prostate just as efficient as other modern procedures, but with the advanced benefits of precision and customization to any prostate shape or size. We expect the reduced procedure times will increase adoption of the Tulsa procedure and triple Profound's total available market in prostate disease to about 600,000 patients annually."

The company will also present new data on Tulsa-Pro for prostate cancer at both RSNA and the Society for Urologic Oncology (SUO) in Phoenix from Dec. 2 to Dec. 5.

RSNA event details:

• RSNA attendees can find Profound at booth No. 3153, South Hall A, for demonstrations of the newly launched Tulsa-AI volume reduction module, along with case studies and feature upgrades from the pilot launch.

Special sessions and presentations:

• "Captain Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (Tulsa) Versus Robotic Radical Prostatectomy," Dr. Pejman Ghanouni from Stanford; Monday, Dec. 1 at 12:15 p.m. CST, in the Learning Center;
• "Discover Tulsa-Pro: AI-powered MRI-guided Precision Prostate Ablation," Dr. Daniel Costa from the MD Anderson Cancer Center and Dr. Joseph Busch from The Busch Center; Tuesday, Dec. 2 at 11:30 a.m. CST, in the Innovation Theatre, booth No. 3316, South Hall A;
• "MR-guided transurethral ultrasound ablation (Tulsa): single center outcomes in 160 patients with organ-confined prostate cancer," Dr. Joseph Busch from the Busch Center; Tuesday, Dec. 2 at 1:30 p.m. CST, in Room E352.

On-demand educational presentations and learning centre:

• "Transurethral Ultrasound Ablation (Tulsa) for Prostate Cancer: Comprehensive Overview and Experience from a High-Volume Center," Dr. Raveen Rajamohan and Dr. Begovic of University of Texas Southwestern;
• "MRI-Guided Transurethral Ultrasound Ablation for Prostate Cancer: A Comprehensive Manual to mpMRI-Based Evaluation and Pitfall Avoidance," Dr. Enis Yilmaz, formerly of the National Institutes of Health (NIH);
• "Tulsa for Prostate Cancer: MRI-based Pre-treatment Planning and Post-Treatment Assessment -- an Emerging Alternative in the Focal Therapy Spectrum," Dr. Satoru Takahashi of Sapporo Hokuyu Hospital in Japan.

SUO event details:

• SUO attendees can learn more about how the Tulsa procedure is being applied across the prostate disease spectrum at the Profound Medical booth.

Presentation:

• "Randomized Controlled Trial evaluating MRI-Guided Transurethral Ultrasound Ablation (Tulsa) Versus Robotic Prostatectomy," Dr. Geoffrey Sonn from Stanford; Friday, Dec. 5 from 2:30 p.m. to 3:30 p.m. MST.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided (magnetic resonance imaging), 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. The Tulsa procedure employs real-time MR (magnetic resonance) guidance for precision to preserve patients' urinary continence and sexual function while killing the targeted prostate tissue through precise sound absorption technology that gently heats it to 55 to 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 routines. Tulsa-Pro is CE (Conformite Europeenne) 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, adenomyosis, pain palliation of bone metastases, desmoid tumours and osteoid osteoma. 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.

We seek Safe Harbor.