Osteoid Osteoma

TORONTO, March 07, 2024 (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 reported financial results for the fourth quarter and full year ended December 31, 2023. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. Business Highlights Q4-2023 recurring revenue growth of 60% over Q4-2022. TULSA-PRO® systems installed base now totals 50; Profound continues to expect to grow that to 75 TULSA-PRO® systems in 2024. To date, TULSA-PRO® has been installed at, or contracted with, 10 of the top 20 cancer hospitals in the United States as ranked by U.S. News and World Report. Profound continued to see a wide variety of prostate disease patients treated by its TULSA-PRO® customers in Q4-2023: Approximately 67% were treated for prostate cancer, 23% were hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”), 7% were salvage, and 3% were men with BPH only; For cancer grade, approximately 13% were GG1, 55% were GG2, 22% were GG3, and 10% were GG4 & GG5; In terms of ablation, approximately 53% were whole gland; 23% were sub-total but more than half the gland; 24% were focal therapy; and For prostate size, approximately 3% were < 20cc; 39% were 20 – 40cc; 32% were 40-60cc; 21% were 60-100cc; and 5% were over 100cc. The ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy in men with localized prostate cancer remains on track to complete patient enrollment by the end of this year. Last week, Profound announced it had entered into non-exclusive collaboration with Siemens Healthineers designed to further expand physician and patient access to the TULSA procedure. Today, the Company announces the promotion of Mathieu Burtnyk, PhD, from SVP Product Leader to Chief Operating Officer. “Our preparations continue for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025, an anticipated inflection point for our business,” said Arun Menawat, Profound’s CEO and Chairman. “In addition, our next AI based module, called Contouring Assistant, that enables creation of suggested treatment design based upon the specific prostate anatomy of each patient, is now under U.S. Food and Drug Administration review. Based upon user feedback, we believe this upgrade will not only further increase urologists’ confidence in treating more of their patients with TULSA, but it is also expected to reduce total TULSA procedure times.” Summary Fourth Quarter 2023 Results For the quarter ended December 31, 2023, the Company recorded revenue of approximately $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO® consumables, lease of medical devices, procedures and services associated with extended warranties. Fourth quarter 2023 revenue increased 60% from approximately $1.3 million in the same three-month period a year ago. Total operating expenses, which consist of research and development (“R&D”), general and administrative (“G&A”), and selling and distribution (“S&D”) expenses, were approximately $9.8 million in the fourth quarter of 2023, an increase of 5% compared with approximately $9.4 million in the fourth quarter of 2022, which included the Company’s recognition of a non-cash impairment of approximately $2.5 million in the period. Expenditures for R&D for the three months ended December 31, 2023 were approximately $4.0 million, an increase of 28% compared with approximately $3.1 million in the three months ended December 31, 2022, primarily driven by improved enrollment for the CAPTAIN trial and recruitment efforts, additional consultants hired to assist with the clinical and regulatory affairs of the business, additional travel associated with system installation and testing, increased salaries and personnel during the period and increased software costs associated with thermal boost and artificial intelligence development. These were offset partially by a decrease to material costs. G&A expenses for the 2023 fourth quarter increased by 41% to approximately $3.0 million, compared with approximately $2.1 million in the same period in 2022. Salaries and benefits, consulting fees, rent expense and expected credit loss allowance increased due to higher cost of living salary increases and bonuses awarded to management, increased legal and accounting fees associated with the establishment of the Company’s at-the-market equity program, and lower refund for utility and tax overpayment. Partially offsetting this was a decrease to share-based compensation due to fewer options awarded to employees. Fourth quarter 2023 S&D expenses increased by 74% to approximately $2.9 million, compared with $1.7 million in the fourth quarter of 2022. This was driven by increased salaries and benefits, consulting fees, share-based compensation and marketing, due to increased salesforce and commission payments, reimbursement and foreign consultants engaged to assist with sales efforts, additional awards granted for employees and increased in-person conferences, customer meetings, release of patient videos and marketing materials. These were partially offset by a decrease in other expenses due to the reduced mobile MRI time as part of the Company’s U.S. sales initiative and lower general expenditures. Net finance costs for the three months ended December 31, 2023 were approximately $356,000, compared with approximately $499,000 in the three months ended December 31, 2022. Fourth quarter 2023 net loss was approximately $8.9 million, or $0.42 per common share, compared to approximately $9.5 million, or $0.46 per common share, in the three months ended December 31, 2022. Summary Full Year 2023 Results For the year ended December 31, 2023, the Company recorded revenue of approximately $7.2 million, with $6.8 million from recurring revenue and $393,000 from the one-time sale of capital equipment in international markets. This compares to revenue of approximately $6.7 million in the twelve months ended December 31, 2022, with $4.7 million from recurring revenue and $2.0 million from the one-time sale of capital equipment. Profound’s full year 2023 total operating expenses were approximately $33.0 million, a 6% decrease compared to approximately $35.1 million in 2022. Expenditures for R&D for the 12 months ended December 31, 2023 were approximately $14.4 million, a decrease of 2% compared with approximately $14.7 million in 2022. This was primarily driven by decreases in salaries and benefits, share-based compensation, and office supplies. Partially offsetting these was an increase in clinical trial costs, materials, consulting fees, rent and other expenditures. G&A expenses for the year ended December 31, 2023 decreased 3% to approximately $9.2 million from $9.5 million for the year ended December 31, 2022. This was due to a decrease in salaries and benefits, share-based compensation, software cost and other expense, offset partially by an increase in consulting fees, insurance costs and expected credit loss allowance. Full year 2023 S&D expenses were approximately $9.5 million, an increase of 12% from $8.5 million in 2022. Increases in salaries and benefits, consulting fees, marketing, travel and other expenses were partially offset by a decrease in share-based compensation due to fewer options awarded to employees. Net finance expense for the year ended December 31, 2023 was approximately $81,000, which compared to net finance income of approximately $3.7 million in 2022, which was primarily due to a foreign exchange in the year. The Company recorded a net loss for the year ended December 31, 2023 of approximately $28.6 million, or $1.35 per common share, compared to approximately $28.7 million, or $1.38 per common share, for the year ended December 31, 2023. Liquidity and Outstanding Share Capital As at December 31, 2023, Profound had cash of approximately $26.2 million. Subsequent to year end, the Company completed a public offering and a private placement of common shares, resulting it in having approximate cash of $45.4 million as at January 31, 2024. As at March 7, 2024, Profound had 24,428,899 common shares issued and outstanding. For complete financial results, please see Profound’s filings at , and on the Company’s website at under “Financial” in the Investors section. A hard copy of the Company’s annual report can also be requested free of charge at the bottom of the Investors section of its website. Conference Call Details Profound Medical is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed. To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN. The call will also be broadcast live and archived on the Company's website at under "Webcasts" in the Investors section. 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 is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma. 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 medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and 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 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. 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. Stephen Kilmer Investor Relations skilmer@profoundmedical.com T: 647.872.4849 Profound Medical Corp. Consolidated Balance Sheets In USD (000s) 2023 $ 2022 $ Assets Current assets Cash 26,213 46,517 Trade and other receivables 7,288 6,344 Inventory 6,989 7,941 Prepaid expenses and deposits 1,406 1,222 Total current assets 41,896 62,024 Property and equipment 909 899 Intangible assets 490 680 Right-of-use assets 616 818 Total assets 43,911 64,421 Liabilities Current liabilities Accounts payable and accrued liabilities 3,282 2,033 Deferred revenue 721 471 Long-term debt 2,104 523 Provisions - 58 Derivative financial instrument - 563 Lease liabilities 259 239 Income taxes payable - 298 Total current liabilities 6,366 4,185 Deferred tax liability 59 - Long-term debt 5,000 6,651 Deferred revenue 728 764 Lease liabilities 578 817 Total liabilities 12,731 12,417 Shareholders’ Equity Share capital 217,393 205,825 Contributed surplus 19,687 18,704 Accumulated other comprehensive income 12,031 16,837 Deficit (217,931 ) (189,362 ) Total Shareholders’ Equity 31,180 52,004 Total Liabilities and Shareholders’ Equity 43,911 64,421 Profound Medical Corp. Consolidated Statements of Loss and Comprehensive Loss In USD (000s) 2023 $ 2022 $ Revenue Recurring - non-capital 6,806 4,677 Capital equipment 393 2,004 7,199 6,681 Cost of sales 2,817 3,660 Gross profit 4,382 3,021 Operating expenses Research and development 14,377 14,690 General and administrative 9,168 9,465 Selling and distribution 9,453 8,468 Impairment of goodwill - 2,524 Total operating expenses 32,998 35,147 Operating loss 28,616 32,126 Net finance expense (income) 81 (3,744 ) Loss before income taxes 28,697 28,382 Income tax (recovery) expense (187 ) 287 Deferred tax expense 59 - Net loss attributed to shareholders for the year 28,569 28,669 Other comprehensive (income) loss Item that may be reclassified to loss Foreign currency translation adjustment − net of tax 4,806 (12,091 ) Net loss and comprehensive loss for the year 33,375 16,578 Loss per share Basic and diluted loss per common share 1.35 1.38 Profound Medical Corp. Consolidated Statements of Cash Flows In USD (000s) 2023 $ 2022 $ Operating activities Net loss for the year (28,569 ) (28,669 ) Adjustments to reconcile net loss to net cash flows from operating activities: Depreciation of property and equipment 727 672 Amortization of intangible assets 202 704 Depreciation of right-of-use assets 217 228 Share-based compensation 3,417 4,238 Interest and accretion expense 770 174 Deferred revenue 187 (27 ) Change in fair value of derivative financial instrument 232 275 Net change in amortized cost of trade and other receivables 146 (290 ) Impairment of goodwill - 2,524 Changes in non-cash working capital balances Trade and other receivables (956 ) (1,424 ) Prepaid expenses and deposits (158 ) (157 ) Inventory 353 (1,864 ) Accounts payable and accrued liabilities 1,356 (566 ) Deferred tax liability 58 - Provisions - (24 ) Income taxes payable (299 ) 311 Foreign exchange on cash 20 (1,905 ) Net cash flow used in operating activities (22,297 ) (25,800 ) Financing activities Proceeds from long-term debt - 7,273 Long-term debt transaction costs - (149 ) Payment of long-term debt (912 ) (44 ) Proceeds from share options exercised 245 263 Proceeds from warrants exercised 2,423 - Payment of lease liabilities (292 ) (312 ) Total cash from financing activities 1,464 7,031 Net change in cash during the year (20,833 ) (18,769 ) Foreign exchange on cash 529 (1,866 ) Cash – Beginning of year 46,517 67,152 Cash – End of year 26,213 46,517

TORONTO, March 04, 2024 (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 management will participate in a fireside chat at the Barclays 26th Annual Global Healthcare Conference on Wednesday, March 13, 2024 at 11:15 a.m. Eastern Time at the Loews Miami Beach Hotel. The fireside chat will be broadcast live and archived on the Company's website at under "Webcasts" in the Investors section. 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. Stephen Kilmer Investor Relations skilmer@profoundmedical.com T: 647.872.4849

TORONTO, Feb. 27, 2024 (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 entered into a non-exclusive collaboration with Siemens Healthineers, a global leader in medical technology. The collaboration is aimed at laying the groundwork for Profound to begin marketing a complete therapeutics solution, combining its TULSA-PRO® system with the MAGNETOM Free.Max magnetic resonance (“MR”) scanner from Siemens Healthineers, via Profound’s own sales force. Profound will also continue to market TULSA-PRO® as a stand-alone offering, providing its customers with the flexibility to use the technology with the MR hardware of their choice. The Transurethral Ultrasound Ablation (“TULSA”) procedure, performed using Profound’s TULSA-PRO® system, employs real-time MR guidance for precision to save patients’ vital functions while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (55°C). 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. TULSA is a “one-and-done” procedure, performed in a single session that takes a few hours, and no hospital stay is required. Most TULSA patients report quick recovery to their normal routine. MAGNETOM Free.Max from Siemens Healthineers is an innovative MRI scanner that combines a 0.55 Tesla field strength with advanced hardware design and deep learning technologies. By doing so, the scanner broadens the range of MR clinical applications and provides customers with the inherent clinical benefits of a mid-field MR scanner. The first and only 80 cm wide-bore system available on the market, MAGNETOM Free.Max also facilitates MR scanning for larger and/or claustrophobic patients, enhancing the patient experience. At less than 7,700 Lbs and 80 inches high, MAGNETOM Free.Max is the most lightweight, compact whole-body scanner ever offered by Siemens Healthineers. Its reduced size permits installation with only minimal structural modifications. Furthermore, where MR scanners typically require several hundred liters of helium and a quench pipe for cooling purposes, the new magnet of the MAGNETOM Free.Max uses less than 1 liter of liquid helium, reducing lifecycle and infrastructure costs. For these reasons, MAGNETOM Free.Max has simplified MRI integration in locations previously not suitable for MR imaging. Mark Emberton, MD, FRCS, FMedSci, Professor of Interventional Oncology, Division of Surgery and Interventional Science, University College London (UCL) commented, “The updated guidelines from both the European Association of Urology and the American Association of Urology support use of MR imaging to aid in the diagnosis of prostate cancer. Beyond that, with the recent introduction of TULSA-PRO®, MR imaging now not only has the power to fundamentally change how prostate cancer is diagnosed, but also how it is treated. I commend the teams at Siemens Healthineers and Profound as they work to achieve the convergence of their respective diagnostic and interventional MR technologies. Their pioneering work has the potential to improve oncological and functional outcomes for a very significant number of prostate cancer patients.” “We are thrilled to be collaborating with Siemens Healthineers as we work toward offering a total diagnostic and interventional MR solution that can streamline workflow; optimize cost of care; and most importantly, improve the treatment experience for urologists and their patients by ensuring TULSA can be readily accessed in the most suitable settings,” said Arun Menawat, Profound’s CEO and Chairman. “This partnership continues to support the Modern Treatment Pathway that allows for more accurate and precise diagnosis, treatment, and follow-up; and brings us another step closer to realizing our long-term vision of creating a total diagnostic and interventional MR solution that will allow a prostate disease patient to be diagnosed in the morning via a diagnostic MR procedure, treated in the afternoon, perhaps even using the very same MR to guide TULSA, and then home in time for dinner with his family.” Donald Hardie, Vice President Global Marketing & Sales Magnetic Resonance at Siemens Healthineers, commented, “Our collaboration with Profound underscores our commitment to leveraging cutting-edge technologies such as TULSA-PRO® to make a difference in prostate cancer therapy. MAGNETOM Free.Max has already brought MR to new places, varying from orthopedic centers to rural hospitals, where patients need MR imaging most. We look forward to collaborating with Profound to help expand access to TULSA as well. Together, we are dedicated to advancing an integrated, MRI-centric approach for prostate cancer patients worldwide”. Subject to the completion of TULSA-PRO® and MAGNETOM Free.Max system integration, the companies currently expect Profound to initiate sales of the combined solution in 2025. 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 is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; Profound’s preliminary unaudited fourth quarter and full year 2023 revenues; 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 the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and 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 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. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. 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