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Here are 1-3 brief analogies to describe Profound Medical (PROF):

• Intuitive Surgical (ISRG) for MRI-guided prostate ablation.

• Medtronic (MDT) for prostate ablation, utilizing MRI-guided ultrasound.

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• TULSA-PRO: An MRI-guided transurethral ultrasound ablation system for the minimally invasive treatment of localized prostate cancer and benign prostatic hyperplasia (BPH).
• Sonalleve: An MRI-guided high-intensity focused ultrasound (HIFU) system primarily used for the non-invasive treatment of uterine fibroids and palliative pain management for bone metastases.

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Profound Medical (symbol: PROF) sells its medical devices, primarily TULSA-PRO and Sonablate, to other companies and healthcare institutions, rather than directly to individual patients. These customers are the facilities and practices that acquire and utilize the medical equipment for prostate ablation procedures.

The major categories of customers for Profound Medical include:

• Hospitals and Medical Centers: These are institutions with urology departments and surgical capabilities that integrate advanced therapeutic technologies for prostate conditions, including benign prostatic hyperplasia (BPH) and localized prostate cancer.
• Urology Clinics and Specialty Practices: This category encompasses private or group medical practices specializing in men's health and urology, offering a range of diagnostic and therapeutic options to their patients.
• Cancer Treatment Facilities: These are specialized centers focused on oncology and comprehensive cancer care, which may adopt Profound Medical's technology for localized prostate cancer treatment within their therapeutic offerings.

While Profound Medical's customers are indeed other organizations and businesses, the company does not typically disclose the names of specific individual hospitals, clinics, or healthcare systems as "major customers" in its public filings. Furthermore, these direct end-user customers are generally not publicly traded companies whose stock symbols would be relevant to list. Profound Medical's sales strategy involves selling its capital equipment and associated consumables directly in some markets (e.g., U.S., Germany) and through distribution partners in others, to a broad, global base of healthcare providers.

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Arun Menawat, Chairman & CEO

Dr. Menawat joined Profound Medical as Chief Executive Officer in August 2016, having served on the Board for approximately two years prior. He previously served as President and CEO of Novadaq Technologies Inc. for 13 years, leading the company from a startup to a NASDAQ-listed medical imaging company with a market capitalization often exceeding $1 billion. Novadaq Technologies Inc. was subsequently acquired by Stryker Corporation. Earlier, he was President of Cedara Software Corp., a medical imaging software company whose platform and big data collection are now part of IBM's Watson Health. He also held senior positions at Tenneco Inc. and Hercules Inc. Dr. Menawat was recognized as the EY Ontario Entrepreneur of the Year in the health sciences category in 2014.

Rashed Dewan, Chief Financial Officer

Mr. Dewan has over 20 years of finance and accounting experience in both public and private companies, with a particular focus on the medical device sector. His background includes extensive experience in systems design and implementation, alongside a strong track record in accounting, finance, sales, and operations management. He was previously promoted from Corporate Controller to VP of Finance in August 2016, and had assumed interim CFO responsibilities in November 2015. Information regarding him founding or managing other companies, selling companies he was previously involved with to an acquirer, or a pattern of managing companies backed by private equity firms is not available in the provided sources.

Mathieu Burtnyk, President

Dr. Burtnyk brings over 15 years of experience in the creation and development of imaging technologies and therapeutic ultrasound solutions, particularly in prostate disease. He earned his PhD in Medical Biophysics from the University of Toronto and Sunnybrook Health Sciences Center, and is the inventor of the patented closed-loop temperature feedback control algorithm utilized by Profound's TULSA-PRO system. He joined Profound Medical in 2011, where he has led the scientific design and execution of various clinical studies.

Thomas Tamberrino, Chief Commercial Officer

Mr. Tamberrino is an experienced leader with a notable career in sales and marketing leadership, business development, and executive management within the U.S. healthcare industry. His experience includes entrepreneurial ventures and significant contributions to the medical technology sector. Prior to joining Profound Medical, Mr. Tamberrino served as Vice President of Sales and Marketing at Novadaq Technologies Inc. for several years.

Robert Staruch, VP Clinical Science

No specific detailed background information is available in the provided sources beyond his title.

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Key Business Risks for Profound Medical (PROF)

1. Lack of Profitability and Reliance on External Financing: Profound Medical has consistently struggled with profitability since its TULSA-PRO device received FDA approval in 2019, despite experiencing periods of revenue growth. The company operates with negative net and operating margins and a significant cash burn, leading to a historical reliance on dilutive share offerings to fund operations. Analysts project continued losses in the near future, indicating a high risk that Profound Medical may need to raise additional capital through further equity dilution or high-interest debt if it fails to meet ambitious revenue targets.
2. Intense Competition and Challenges in Revenue Generation: The market for prostate treatment devices is highly competitive, with Profound Medical's TULSA-PRO facing similar devices from established players like EDAP (Focal One/Ablatherm), Sonablate Corp (Sonablate), and Insightec (Exablate Prostate). The company has experienced periods of stagnant revenue growth and delays in closing capital sales of its TULSA-PRO systems. These delays are attributed to complex hospital procurement cycles and challenges in converting its sales pipeline into actual installations, directly impacting revenue generation.
3. Uncertainty Regarding Long-Term Efficacy and Market Penetration of TULSA-PRO: While TULSA-PRO is an innovative product, its long-term efficacy, particularly in the localized prostate cancer market, and its ability to gain widespread adoption remain uncertain. Clinical data has shown that clinically significant prostate cancer occurred in a notable percentage of patients at a 12-month follow-up in one study, which could influence physician and patient confidence. The success of ongoing clinical trials, such as the CAPTAIN trial comparing TULSA-PRO to radical prostatectomy, is crucial for establishing the device's long-term effectiveness and expanding its market penetration.

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The increasing market penetration and efficacy of novel oral GnRH antagonist drugs (e.g., Elagolix, Relugolix) for the treatment of uterine fibroids. These drugs offer a non-invasive pharmaceutical alternative that can alleviate symptoms and reduce fibroid size, potentially diverting patients from device-based therapies such as Profound Medical's Sonalleve® MR-guided HIFU platform.

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Profound Medical's primary product, TULSA-PRO®, addresses a significant global market for prostate conditions. The company estimates that the total addressable market for TULSA-PRO is approximately $4.8 billion annually, targeting 200,000 cases of prostate cancer and 400,000 cases of benign prostatic hyperplasia (BPH) per year.

Profound Medical also commercializes Sonalleve®, an innovative therapeutic platform. While an explicit overall market size for Sonalleve was not identified in the search results, its applications include the treatment of uterine fibroids, adenomyosis, palliative pain treatment of bone metastases, desmoid tumors, and osteoid osteoma. Sonalleve has received CE Mark approval for these indications, and FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma in the U.S.

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Profound Medical (PROF) is anticipated to experience future revenue growth over the next two to three years driven by several key factors:

1. Increased TULSA-PRO System Installations and Utilization: Profound Medical expects to achieve new highs in the growth of its TULSA-PRO installed base and an increase in the utilization of existing systems. The company anticipates expanding its installed base from 67 to at least 75 by the end of 2025, which is projected to drive record total revenues.
2. Favorable CMS Reimbursement Changes: Significant updates to CMS (Centers for Medicare & Medicaid Services) reimbursement rules, effective in Q1 2025, are expected to position the TULSA procedure favorably. These changes are projected to lead to increased procedural adoption and new installations across various service locations. Furthermore, a partnership in Q3 2025 expanded Medicare patient access in Texas, building on Medicare coverage approval for TULSA procedures in January 2025 across multiple clinical settings.
3. Commercial Launch and Adoption of TULSA AI Module for BPH: The full commercial launch of the TULSA AI volume reduction software for benign prostatic hyperplasia (BPH) is planned for Q4 2025. This new software module is designed to offer fast, intelligent workflows, potentially reducing BPH procedure times to an estimated 60 to 90 minutes regardless of prostate size or shape.
4. Positive CAPTAIN Clinical Trial Results and Broader Acceptance: The results from the pivotal CAPTAIN trial, which compares the TULSA Procedure with traditional robotic prostate surgery, are expected to further validate the efficacy of the TULSA procedure. Initial perioperative data from the trial has already demonstrated a statistically significant improvement in the post-operative experience compared to robotic radical prostatectomy, which is anticipated to lead to broader acceptance and additional insurance coverage.
5. Strategic Shift to Capital Sales and Conversion of Sales Pipeline: Profound Medical has strategically pivoted to prioritize capital equipment sales of its TULSA-PRO system to hospitals in 2025. This shift aims to accelerate the adoption of its AI-enhanced prostate treatment platform and expand its installed base. The company maintains a robust sales pipeline, including nearly 500 TULSA-PRO prospects, over 100 engaged leads, and 80 qualified leads in various stages of verification, negotiation, or contracting, which are expected to contribute significantly to revenue growth in the latter half of 2025.

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Share Issuance

• Profound Medical completed an underwritten public offering in July 2020, issuing 3,172,414 common shares for aggregate gross proceeds of approximately US$46 million.
• In 2023, the company announced the pricing of a US$20 million public offering of common shares.
• Profound Medical closed an underwritten public offering in December 2024, issuing 5,366,705 common shares for aggregate gross proceeds of approximately US$40.25 million.

Capital Expenditures

• A primary focus for capital allocation has been to fund the commercial launch of the TULSA-PRO® system in the United States and support the global development and commercialization of both the TULSA-PRO® and Sonalleve® systems.
• The company's strategic shift to prioritize capital equipment sales of its TULSA-PRO system is aimed at accelerating adoption and expanding its installed base, indicating significant investment in scaling this capital-intensive business model.
• Operating expenses, which reflect the high cost of scaling their capital-driven model, were approximately $15.4 million in Q2 2025.