US Market News
4 weeks ago
Profound Medical Annual General and Special Meeting of Shareholders Voting ResultsMay 13, 2026 8:41 PM
NewsfileToronto, Ontario--(Newsfile Corp. - May 13, 2026) - Profound Medical Corp. (TSX: PRN) (NASDAQ: PROF) ("Profound" or the "Company") is pleased to announce the voting results from its Annual General and Special Meeting of Shareholders that was held today (the "Meeting"). A total of 25,347,133 common shares, representing 69.754% of the common shares outstanding, were represented in person and by proxy at the Meeting. All of the matters put forward before the shareholders, as set out in the Company's management information circular dated April 2, 2026 (the "Information Circular"), were approved by the requisite majority of votes cast at the Meeting.Election of Directors At the meeting, the shareholders of the Company elected all eight (8) nominees for the board of directors (the "Board"). Detailed results of the voting in respect of the election of directors are as follows:NomineeFor% ForWithheld% WithheldArun Menawat12,773,37490.2571,378,7929.743Brian Ellacott11,541,68481.5542,610,48218.446Cynthia Lavoie11,586,79381.8732,565,37318.127Murielle Lortie11,586,69381.8722,565,47318.128Arthur Rosenthal11,180,11378.9992,972,05321.001Frank Baylis12,945,47391.4731,206,6938.527Thomas Wellner12,948,50991.4951,203,6578.505Vafa Jamali12,885,00391.0461,267,1638.954 Other Matters The Company's shareholders also approved the appointment of PricewaterhouseCoopers LLP as the auditor for the Company to hold office until the close of the next annual meeting or until its successor is duly appointed, at such remuneration as may be determined by the board of directors and an ordinary resolution approving all unallocated restricted share units and deferred share units under the Company's long-term incentive plan, as more particularly described in the Information Circular. Detailed voting results for all resolutions will be posted under the Company's profile at www.sedarplus.ca. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, 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 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, adenomyosis, pain palliation of bone metastases, desmoid tumors 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. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, statements relating to the expectations regarding the efficacy of Profound's technologies for disease conditions requiring ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma and the success of Profound's commercialization strategy and activities for TULSA-PRO and Sonalleve. 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 the Company. 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: 647.872.4849To view the source version of this press release, please visit https://www.newsfilecorp.com/release/297432 Original: Profound Medical Annual General and Special Meeting of Shareholders Voting Results
US Market News
1 month ago
Why Medtech Giants Are Quietly Paying Up for AI DiagnosticsApril 29, 2026 10:30 AM
PR Newswire (Canada)
ISSUED ON BEHALF OF VENTRIPOINT DIAGNOSTICS LTD.VANCOUVER, BC, April 29, 2026 /CNW/ -- USANewsGroup.com News Commentary – There's a quiet bidding war underway for AI diagnostics, and the price keeps climbing. The global AI in medical imaging market is on track to hit $2.20 billion in 2026, with a 34.8% growth rate baked in through 2033[1]. Q1 2026 healthcare M&A activity tells the same story: capital is rotating into AI-enabled platforms that already carry regulatory clearance, recurring revenue, and real clinical data behind them[2]. That description fits a short list of names worth knowing right now: VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF), Medtronic (NYSE: MDT), Danaher (NYSE: DHR), Profound Medical (NASDAQ: PROF), and DexCom (NASDAQ: DXCM).
Hospitals are voting with their wallets too. A fresh C-suite survey shows 57% now rank AI clinical solutions as their top technology priority for 2026 to 2027, up from just 19% in 2023[3]. The FDA has made it clear that real-world clinical evidence is now central to clearing AI software, which is exactly why institutional buyers are paying a clinical validation premium for platforms that already have multi-site data behind them[4].VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF) just picked up a Gold Medal at the 2026 Edison Awards for its AI-powered cardiac imaging platform, VMS+™ 4.0. The Edison Awards are widely considered one of the most prestigious innovation prizes in the world, often called "the Oscars of Innovation," and past Gold winners include Abbott, Medtronic, and Boston Scientific. For a small-cap medtech company out of Toronto, that is serious company to keep.The technology behind the award takes a standard 2D ultrasound scan and converts it into a detailed 3D model of the heart. The company says the results are comparable to a cardiac MRI, but without the million-dollar machine or the months-long wait list. VMS+™ 4.0 is already deployed in hospitals across the United States, Canada, the United Kingdom, and Europe, which is a key reason the Edison judges took notice. Their evaluation process places heavy weight on technologies that have moved past the pilot stage and into real clinical use.That momentum is showing up in VentriPoint's commercial pipeline. The company recently announced a collaboration with the Health Division of the Montecristo Group to roll out VMS+™ across Costa Rica's public and private hospital networks. The Montecristo Group's Hospital Metropolitano also has an existing relationship with Sanford Health, one of the largest healthcare systems in the United States. VentriPoint also recently partnered with First Light Health, an Indigenous-owned medical services company, to bring cardiac diagnostics to Indigenous and remote communities across Canada through a hub-and-spoke model. That program builds on an earlier partnership with the Nisga'a Valley Health Authority in northern BC. South of the border, the company signed a commercial agreement with LG Consulting Solutions targeting cardiac centres in Northern California."Being awarded Gold affirms that VMS™ 4.0 has reached that threshold, and reinforces our belief that our platform has significant room to grow as adoption accelerates and new applications emerge," said Hugh MacNaught, CEO of VentriPoint.VentriPoint holds regulatory approvals in the United States, Canada, and Europe. Its VMS+™ platform is vendor-agnostic, meaning it works with ultrasound equipment from any manufacturer, and is built on more than a decade of proprietary Knowledge Based Reconstruction technology. The core value proposition is MRI-grade cardiac imaging at a fraction of the cost, deployable anywhere a standard ultrasound machine already sits. With a growing global footprint, a validated technology platform, and independent recognition from one of the world's top innovation bodies, VentriPoint is positioning itself as a name to watch in precision health.CONTINUED… Read this and more news for VentriPoint Diagnostics at: https://usanewsgroup.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripointOther industry developments and happenings in the market include:Medtronic (NYSE: MDT) completed its acquisition of CathWorks, a privately held medical device company focused on coronary artery disease diagnosis and treatment, for $585 million with potential additional earn-out payments. The deal follows a 2022 co-promotion agreement and brings the CathWorks FFRangio System, an AI-powered, drug-free, wire-free coronary assessment platform, into Medtronic's interventional cardiology portfolio."The acquisition of CathWorks significantly enhances Medtronic's interventional cardiology portfolio with an innovative system that empowers physicians with data-driven insights for the diagnosis and treatment of coronary artery disease," said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, part of the Cardiovascular Portfolio at Medtronic. "Through our global footprint, welcoming CathWorks to Medtronic will expand access to the transformative FFRangio technology for our customers and their patients worldwide."The FFRangio System recently demonstrated non-inferiority to wire-based physiology in the ALL-RISE randomized control trial, which enrolled more than 1,900 patients across 59 sites globally. The acquisition is expected to be immaterial to Medtronic's fiscal year 2027 earnings and neutral to accretive thereafter, continuing the company's strategy of targeted tuck-in acquisitions to strengthen its core franchises.Danaher (NYSE: DHR) reported first quarter 2026 results showing revenues of $6.0 billion, up 3.5% year-over-year, with non-GAAP adjusted diluted EPS growing 9.5% to $2.06. Operating cash flow reached $1.3 billion, supported by strength in Bioprocessing and better-than-expected Life Sciences performance."Our team executed well in the first quarter, which enabled us to accelerate innovation, drive productivity gains, and deliver nearly 10% adjusted EPS growth," said Rainer M. Blair, President and CEO of Danaher. "On the top line, we continued on a steady recovery path with strength in Bioprocessing and better-than-expected performance in Life Sciences largely offsetting the impact of a lighter-than-typical Q1 respiratory season at Cepheid."Danaher raised its full year 2026 adjusted diluted EPS guidance to $8.35 to $8.55, up from prior guidance of $8.35 to $8.50, and expects full year core revenue growth of 3% to 6%. The company also announced its intention to acquire Masimo Corporation, a provider of pulse oximetry and patient monitoring solutions, citing opportunities to enhance performance through the Danaher Business System and its global scale.Profound Medical (NASDAQ: PROF) is highlighting its TULSA-PRO system across seven presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting in Toronto, April 11-15. The commercial-stage medical device company's AI-powered, MRI-guided TULSA Procedure treats prostate cancer and benign prostatic hyperplasia without incisions, eliminating procedural blood loss and overnight hospital stays while minimizing side effects such as urinary incontinence and erectile dysfunction."Our significant presence at SIR 2026 comes at an opportune time as leading iMRI procedures, including MRI-guided biopsy and TULSA, are poised to transform how unmet medical needs across the prostate disease spectrum are being addressed," said Arun Menawat, CEO and Chairman of Profound Medical. "Awareness and acceptance of the TULSA Procedure's strong clinical profile, as well as its potential to become the next mainstream treatment modality for most men with prostate disease, is growing."Presentations will feature data from the Level 1 post-market CAPTAIN randomized controlled trial comparing TULSA against robotic prostatectomy for intermediate-risk prostate cancer. Profound Medical also commercializes Sonalleve, an MRI-guided therapy addressing bone metastases pain palliation, uterine fibroids, and adenomyosis, with its technologies approved across major global markets including the United States, Europe, and Canada.DexCom (NASDAQ: DXCM) is showcasing new clinical evidence at the 19th annual Advanced Technologies and Treatments for Diabetes Conference in Barcelona, reinforcing the role of continuous glucose monitoring across all diabetes types. A multi-center primary care registry study showed that after one year of Dexcom G7 use, people with Type 2 diabetes not on insulin therapy saw significant improvements in A1C and weight management, while claims data linked Dexcom CGM initiation to meaningful reductions in DKA-related hospitalizations and emergency room visits in both children and adults with Type 1 diabetes."There is no better global stage than ATTD to showcase how we're shaping the future of glucose biosensing around the world," said Jake Leach, president and chief executive officer at DexCom. "The data presented at ATTD reinforces the need for Dexcom CGM to become the standard of care for all people with Type 2 diabetes, including those not using insulin."Beyond the clinical data, DexCom is presenting its near- and long-term product roadmap, including upcoming features for Dexcom G7, Dexcom G7 15 Day, and Stelo, its health and wellness offering. The company recently launched Dexcom G7 15 Day in the U.S. and continues expanding its Dexcom Academy HCP education platform across Europe and the Middle East.Further Reading: https://usanewsgroup.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripointCONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (MIQ). This article is being distributed for Baystreet.ca media Corp, who has been paid a fee for an advertising campaign. MIQ has not been paid a fee for Ventripoint Diagnostics Ltd. advertising or digital media, but the owner/operators of MIQ also co-owns Baystreet.ca Media Corp. (BAY) There may also be 3rd parties who may have shares of Ventripoint Diagnostics Ltd. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY own shares of Ventripoint Diagnostics Ltd and reserve the right to buy and sell, and will buy and sell shares of Ventripoint Diagnostics Ltd. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ on behalf of BAY has been approved by Ventripoint Diagnostics Ltd.; this is a paid advertisement, we currently own shares of Ventripoint Diagnostics Ltd. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.coherentmarketinsights.com/industry-reports/ai-in-medical-imaging-market https://www.sikich.com/insight/q1-2026-healthcare-ma-market-update/ https://hitconsultant.net/2026/03/24/sage-growth-partners-health-it-purchasing-forecast-2026-2027-ai-roi/ https://www.fda.gov/news-events/fda-voices/real-world-evidence-advancing-regulatory-decision-making-medical-devices Logo - https://mma.prnewswire.com/media/2838876/5919929/USA_News_Group_Logo.jpg
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Original: Why Medtech Giants Are Quietly Paying Up for AI Diagnostics
hayfarmer
3 years ago
Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO® Thermal Boost
The first of the TULSA AI modules, Thermal Boost enables predictable, customized ablation at the prostate capsule
TORONTO, Sept. 25, 2023 (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-free therapies for the ablation of diseased tissue, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA) for the Company’s Thermal Boost module for use in conjunction with TULSA-PRO®.
TULSA-PRO® enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low-, intermediate-, or high-risk prostate cancer; with benign prostatic hyperplasia (“BPH”); as well as those prostate cancer patients on active surveillance seeking treatment of their cancer and relief from their symptoms of BPH. Profound’s data indicates that, in a commercial setting, approximately 60% of the patients being treated with TULSA require whole gland ablation, whereas the remaining 40% receive partial gland ablation. In addition, TULSA surgeons are treating prostates of various shapes and sizes, ranging from prostate volumes of less than 20cc to greater than 250cc, confirming TULSA-PRO® as one of the most versatile technologies currently available for the treatment of prostate disease.
Recognizing that the TULSA patient population consists of a wide variety of prostate disease states, as well as prostate shapes and sizes, the Company is developing a novel set of software modules that will work in conjunction with TULSA-PRO® to further enable treating such variety with further customizability, ease of use, and higher confidence in clinical outcomes. Profound plans to market these new clinically relevant modules under the name brand ‘TULSA AI’.
Thermal Boost, Profound’s first FDA-cleared TULSA AI module, enables surgeons to temporarily increase the ablation target temperature in prostate regions where advanced stage cancer might reside, further increasing their confidence that aggressive cancer cells have been ablated. The Thermal Boost module is already CE-Marked and is being used in up to 50% of the TULSA patients being treated in Europe. Based on a recent TULSA-PRO® survey, European surgeons indicated that Thermal Boost resulted in improved treatment outcomes in 88% of their prostate cancer cases.
“The Thermal Boost feature is a significant development of the TULSA technology,” said Dr. Mikael Anttinen, Urologic Oncologist at Turku University Hospital in Finland. “It opens an important degree of freedom for the surgeon, allowing for controlled increased thermal dose to be delivered to selected regions of the treatment plan. Achieving complete thermal coverage is critical to successful prostate disease treatment, so being able to customize ablation temperature in real time has improved treatment efficacy as well as workflow efficiency. The Thermal Boost feature has allowed us to expand our confidence in patient selection, for example to include patients with MRI-visible lesions bulging the prostate capsule, and other higher risk features.”
Arun Menawat, PhD, Profound’s CEO and Chairman, commented, “We believe that the TULSA technology can be used to treat up to 600,000 patients per year in the United States, and based on the utilization data from Europe, Thermal Boost may have an application in the majority of late-stage disease cases. In addition, the feedback from European surgeons using the module indicates that Thermal Boost could significantly increase both the ease and speed of treatment in a certain subset of the patient population.”
Profound is continuing to develop additional TULSA AI modules, including one that will enable the creation of an AI-driven automated treatment plan, which will be based on a database of successful physician-created treatment designs. The Company is working with the FDA on a pathway to achieve the Agency’s clearance for this module.
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, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting 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 prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria 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 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. The Company 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.
hayfarmer
3 years ago
Profound Medical Announces At-the-Market Offering of up to US$30,000,000
TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX: PRN; NASDAQ: PROF) (“Profound” or the “Company”) announces that it has established an at-the-market equity program (the “ATM Program”) that allows the Company, through certain securities dealers acting as agents (together, the “Agents“), to issue and sell from time to time up to US$30,000,000 of common shares in the capital of the Company (the “Common Shares”).
Any Common Shares sold under the ATM Program will be made through “at-the-market distributions” as defined in the Canadian Securities Administrators’ National Instrument 44-102 - Shelf Distributions, including sales made through the Toronto Stock Exchange (the “TSX”) or the Nasdaq Stock Market LLC (the “Nasdaq”) or on any other trading market for the Common Shares. The TSX has conditionally approved the listing of the Common Shares that may be issued under the ATM Program and listing will be subject to the Company fulfilling all of the listing requirements of the TSX. Distributions of the Common Shares under the ATM Program will be made pursuant to the terms of an equity distribution agreement dated September 6, 2023 (the “Distribution Agreement”) between the Company and the Agents.
The Sales of Common Shares, if any, will be made at the market prices prevailing at the time of each sale and, as a result, prices may vary as between purchasers and during the period of the ATM Program. The volume and timing of distributions under the ATM Program will be determined at the Company’s discretion. The ATM Program will be effective until the earlier of the issuance and sale of all of the Common Shares issuable pursuant to the ATM Program and April 23, 2024, unless terminated prior to such date in accordance with the terms of the Distribution Agreement.
The offering of the Common Shares under the ATM Program will be made pursuant to a prospectus supplement dated September 6, 2023 (the “Prospectus Supplement”) to the Company’s short form base shelf prospectus dated March 23, 2022 (the “Base Shelf Prospectus”), which were each filed with the applicable securities regulatory authorities in each of the provinces and territories of Canada, and in the United States pursuant to a prospectus supplement dated September 6, 2023 (the “U.S. Prospectus Supplement”) to the Company’s U.S. base shelf prospectus (the ”U.S. Base Shelf Prospectus“) included in its registration statement on Form F-10, as amended (File No. 333-263248) (the “Registration Statement”), filed with the U.S. Securities and Exchange Commission under the U.S. Securities Act of 1933, as amended.
The timing and extent of the use of the ATM Program will be at the discretion of the Company. Accordingly, total gross proceeds from equity offerings under the ATM Program could be significantly less than US$30,000,000.
The Company intends to use the net proceeds of the Offering, if any: (i) to fund the continued commercialization of the TULSA-PRO® system in the United States, (ii) to fund the continued development and commercialization of the TULSA-PRO® system and the Sonalleve® system globally, and (iii) for working capital and general corporate purposes.
Copies of the Distribution Agreement, the Prospectus Supplement and the Base Shelf Prospectus are available on SEDAR+ at www.sedarplus.ca and the Distribution Agreement, the U.S. Prospectus Supplement, the U.S. Base Prospectus and the Registration Statement are available on EDGAR at www.sec.gov.
Copies of the Distribution Agreement, the Prospectus Supplement, the Base Shelf Prospectus, the U.S. Prospectus Supplement, the U.S. Base Shelf Prospectus and the Registration Statement may also be obtained directly from the Company at 2400 Skymark Avenue, Unit 6, Mississauga, Ontario, L4W 5K5, Telephone: (647) 476-1350.
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
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, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting 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 prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria 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 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. The Company 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 are not limited to, statements with respect to the ATM Program, including the use of proceeds thereof, the expected ATM Program jurisdictions, and the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. 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 the Company, including risks regarding the ATM Program (including that the Company may be unsuccessful in selling Common Shares under the ATM Program or that the Company’s use of proceeds of the ATM Program may differ from those indicated), the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition, and the other risks described in the Prospectus Supplement, the Base Shelf Prospectus, the U.S. Prospectus Supplement, the U.S. Base Shelf Prospectus and the Registration Statement, and the documents incorporated by reference therein. 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. All forward-looking information in this news release is as of the date of this news release. 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
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