PROF 10-K & 10-Q changes, risk factors and insider trading

We commenced operations in June 2008 and only began generating revenues in 2017. As of December 31, 2024,2025, we had an accumulated deficit of $245,170,000$287,740,000 and had cash and cash equivalents of $54,912,000.$59,723,000. Since inception, we have incurred significant losses each year. For the year ended December 31, 2024,2025, we recorded a net loss of $27,816,000,$42,570,000, and for the year ended December 31, 2023,2024, we recorded a net loss of $28,323,000.$27,816,000. We have incurred and we expect to incur additional significant operating losses even as we begin to commercialize the TULSA-PRO system in the United States following our FDA clearance,States, which will requirerequires significant expenditures to increase our sales and marketing capabilities and expand our manufacturing and distribution capacity, as well as other expenses related to increasing reimbursement coverage and gaining market acceptance among patients, physicians/clinicians and others in the medical community. In addition, we plan to continue product research and development and clinical trials and may pursue additional regulatory approvals. WeWhile we currently expect to have sufficient cash to finance our operations for at least the next 18 months.months, our cash runway is based on a number of assumptions that may prove inaccurate, including the timing and level of product sales and gross margins, the pace of hiring and investments in commercial and manufacturing scale-up, and the timing and magnitude of clinical and regulatory expenditures. A shortfall in expected cash inflows or higher-than-anticipated cash outflows could require us to curtail, delay or eliminate planned activities and/or to seek additional financing sooner than we anticipate. There is no assurance that we will ever successfully commercialize our systems, generate significant revenues from our approved products or achieve profitability. Even if profitability is achieved, we may not be able to sustain or increase profitability. Our failure to achieve or maintain profitability could negatively impact the value of the Common Shares.

Our business requires substantial capital investment in order to commercialize our approved products, in particular to expand our sales and marketing capabilities and increase our manufacturing capacity, as well as to conduct research and development and to obtain regulatory approvals for existing products and future product candidates. In order to secure financing, if available, it is likely that we would need to sell additional Common Shares and/or securities that are exchangeable for or convertible into Common Shares, incur additional indebtedness and/or enter into development, manufacturing, distribution and/or licensing relationships. Our Amended and Restated Credit Agreement, dated March 3, 2025, between us and Canadian Imperial Bank of Commerce (“CIBC”) (the “CIBC Credit Agreement”) (which amended and restated our original credit agreement with CIBC entered into on November 3, 2022 (the “Original CIBC Credit Agreement”)), includes covenants which require us to achieve certain financial performance measures and contains restrictions on our ability to incur additional debt. Any future equity financing may be dilutive to existing shareholders. Any future debt financing arrangements we enter into would likely contain restrictive covenants that would impose significant operating and/or financial restrictions on us. The availability of equity or debt financing will be affected by, among other things, our commercial progress and market acceptance in respect of the TULSA-PRO system and other approved products, as well as the results of our research and development, our ability to obtain regulatory approvals, the state of the capital markets generally, strategic alliance agreements, and other relevant considerations.

We may set goals for and make public statements regarding the timing of the accomplishment of objectives material to our success, such as the timing and extent of product launches in the jurisdictions where they are approved for marketing and sale, in particular our expected commercialization of the TULSA-PRO system following FDA clearance in the United States; third-party reimbursement for our approved products; the timing and terms of any collaborations, partnerships, licenses, acquisitions or other agreements; the commencement and completion of clinical trials, including follow-up data on our TACT Pivotal Clinical Trial and CAPTAIN trial; and anticipated regulatory submission and approval dates for our products in additional jurisdictions, and for future product candidates. The actual timing of these events can vary dramatically due to factors such as the uncertainties inherent in the arrangements sufficient to commercialize our products, including in respect of manufacturing, distribution and marketing, as well as market competition and adverse results from our clinical trials, and other factors andas described herein, many of which are beyond our control. There can be no assurance that we will achieve our commercialization goals in respect of the TULSA-PRO system in the United States, or that future efficacy and safety results from our TACT Pivotal Clinical Trial and CAPTAIN trial will be favorable. If we fail to commercialize the TULSA-PRO system in the United States or any other approved products in the time frame and to the extent that we anticipate, our business, results of operations and financial condition may be materially adversely affected, and the price of the Common Shares could decline.

Successful commercialization of our products for which we obtain marketing authorization, including our TULSA-PRO system, depends largely upon the cost of the system and the availability of coverage and adequate reimbursement for the system, and the medical procedure associated with its use, from third-party payers, such as government healthcare programs, private health insurers and other organizations, such as health maintenance organizations and managed care organizations. We expect that our systems will be purchased by healthcare providers, including clinics and hospitals that use MRI scanners that are compatible with our systems, and that these providers will subsequently bill various third-party payers or will be responsible for covering the costs of the system through the provider’s operating budget. Although we expect there to be an out-of-pocket market for our authorized products, an out-of-pocket market alone is unlikely to be sufficient to support successful commercialization of such products. To date we have not secured significant coverage or reimbursement for any of our products from government or third-party payers in the jurisdictions where we have obtained regulatory authorizations, including our TULSA-PRO system in the United States. We can provide no assurance that third-party payers will provide coverage and adequate reimbursement for our TULSA-PRO system to treat our targeted indications based on our existing clinical data (such as our TACT and CAPTAIN data) or the results of any future clinical trials, or at all. See “Risk Factors—Data from our clinical trials may not support regulatory approvals or clearances and/or coverage and reimbursement for our products” below. Accordingly, we likely will need to conduct additional research and successfully complete additional clinical trials in order to obtain such coverage (e.g., follow-up data from our TACT Pivotal Clinical Trial and CAPTAIN trial). Such additional research and clinical trials may require significant time and resources, and may not be successful, which could result in the postponement of or inability to obtain coverage and reimbursement for our authorized products, which could significantly delay or otherwise negatively affect our commercialization strategy. Any of the foregoing could, in turn, have a material adverse effect on our business, results of operations and financial condition.

We currently intend to partner with one or more additional QSR-compliantcGMP-compliant and FDA-registered contract manufacturers for our TULSA-PRO systems in the United States. However, we may not be successful in establishing or maintaining such partnerships on acceptable terms or in the timeframe necessary to commercialize our products successfully, or at all.

We, the FDA or other regulatory authorities may suspend or terminate a clinical trial at any time if it is determined that enrolled subjects may be or are being exposed to unacceptable health risks, including the risk of death, that our devices are not manufactured under acceptable conditions or with acceptable quality, or that the trial is not being conducted according to the protocol and in compliance with Good Clinical PracticeGCP and other regulatory requirements. Further, success in nonclinical studies and early clinical trials does not mean that future clinical trials will be successful because medical devices and/or treatment options in later stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other regulatory authorities despite having progressed through initial clinical trials. We cannot be sure that the later trials will replicate the results of prior trials.

Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and other regulatory authorities require us to comply with good clinical practiceGCP regulations and international standards relating to the conduct, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties, over which we have limited control, to manage those operations does not relieve us of these responsibilities and requirements. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the marketing authorization process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws. We also are required to register ongoing clinical trials and post the results of certain completed clinical trials on certain government-sponsored databases, such as ClinicalTrials.gov in the United States, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Our products are regulated as medical devices in the United States and other jurisdictions. We and our products are subject to extensive regulation in the United States and elsewhere, including by the FDA and its foreign counterparts. The FDA and foreign regulatory agencies regulate, among other things, with respect to medical devices: design, development and manufacturing; testing, labeling, content and language of instructions for use and storage; clinical trials; product safety; establishment registration and device listing; marketing, sales and distribution; pre-market clearance, classification and approval; recordkeepingrecord keeping procedures; advertising and promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; post-market approval trials; and product import and export.

The PMA approval, 510(k) clearance and De Novo classification processes can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process can take anywhere from three to 12 months or longer to complete. The process of obtaining aPMA PMAapproval or De Novo classification is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA. In addition, PMAs and De Novo classification requests generally require the applicant to have conducted one or more clinical trials. Despite the time, effort and cost expended in seeking a marketing authorization, there is no assurance that the FDA will grant it. Any delay or failure to obtain necessary regulatory marketing authorizations could harm our business. Furthermore, even if we are granted such marketing authorizations, they may include significant limitations on the indicated uses for the device, which may limit the potential commercial market for the device.

Clinical trials are subject to extensive monitoring, recordkeeping and reporting requirements. Clinical trials must be conducted under the oversight of an IRB and must comply with FDA regulations, including but not limited to those relating to goodGCP clinical practices.requirements. To conduct a clinical trial, we must also obtain each subject’s informed consent which must comply with FDA requirements, state and federal privacy regulations and human subject protection regulations. We, the FDA or the IRB could suspend a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. Additionally, we may decide at any time, for business or other reasons, to terminate a clinical trial. Following completion of a clinical trial, we would need to collect, analyze and present the data in an appropriate submission to the FDA. Even if a study is completed and submitted to the FDA, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device for its intended use, or may be equivocal or otherwise not be sufficient to obtain FDA clearance or approval of our product. In addition, the FDA may perform a bioresearch monitoring inspection of a study, and if it finds deficiencies, we will need to expend resources to correct those deficiencies, which may delay clearance or approval or the deficiencies may be so great that the FDA could refuse to accept all or part of the data or could trigger enforcement action.

Our authorized products, and any other products for which we obtain regulatory clearance or approval, as well as the respective manufacturing processes, postmarket surveillance and reporting, post-approval clinical testing and promotional activities for such products, are subject to continued regulatory review, oversight and periodic inspections by the FDA and other regulatory bodies (and Notified Bodies, as applicable). In particular, we and some of our suppliers are required to comply with the QSR and internationalcGMP standards for the manufacture of productsmedical devices and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain regulatory clearance or approval. Regulatory bodies, such as the FDA, enforce gooddevice manufacturing practicecGMP requirements, such as the QSR and QMSR in the United States, and other regulations through periodic announced or unannounced inspections. We and our contract manufacturers have been, and anticipate in the future being, subject to such inspections.

In the United States, the FDA and other federal and state agencies, including the U.S. Department of Justice, closely regulate compliance with all requirements governing medical device products, including requirements pertaining to marketing and promotion of devices in accordance with the provisions of the approved labeling and manufacturing of products in accordance with QSRcGMP requirements. Violations of such requirements may lead to investigations alleging violations of the FFDCA and other statutes, including the False Claims Act and other federal and state healthcare fraud and abuse laws as well as state consumer protection laws. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, or the later discovery of previously unknown adverse events or other problems with our products could result in, among other things, any of the following enforcement actions:

We have developed and maintain a quality management system for medical devices intended to ensure quality of our products and activities. The system is designed to be in compliance with regulations in many different jurisdictions, including the QSRQSR, and the new QMSR effective as of February 2, 2026, mandated by the FDA in the United States and the requirements of the MDD and New EU MDR in the European Union, including the international standard ISO 13485 required by the member states in Europe that recognize the CE Mark. The FDA issued a final rule on January 31, 2024 describing revisions to the QSR to harmonize it with ISO 13485:2016. The harmonized regulations, which will be called the Quality Management System Regulation, or QMSR, will become effective on February 2, 2026.

Our contract manufacturers must comply with applicable FDA, EU, Health Canada and other applicable foreign regulations, which include quality control and quality assurance requirements, as well as the corresponding maintenance of records and documentation and manufacture of devices according to the specifications contained in the applicable regulatory file. The manufacturing practices of our third-party suppliers are subject to ongoing regulation and periodic inspection. In the United States, the methods used in, and the facilities used for, the manufacture of medical devices must comply with the QSR, and starting on February 2, 2026 the new QMSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, and servicing of medical devices. Furthermore, we will be required to verify that our suppliers maintain facilities, procedures and operations that comply with our quality standards and applicable regulatory requirements. The FDA enforces the QSR/QMSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Our authorized device products also subject to similar state regulations and various laws and regulations of other countries governing manufacturing. If our contract manufacturers do not or cannot comply with these requirements, our ability to commercialize our approved products may be adversely affected.

If a substantial change is made to a device relying on an MDD certificate it will no longer benefit from the transition period set out in the New EU MDR. In this case the product would need to be CE marked under the New EU MDR to be placed on the market. Once CE marked under the New EU MDR these changes must be disclosed to our Notified Body in the EU before implementation. The Notified Body will then assess the changes and verify whether they affect the products’product’s conformity with the General Safety and Performance Requirements. If the assessment is favorable the Notified Body will issue a new CE Certificate of Conformity or an addendum to the existing certificates attesting compliance with the General Safety and Performance Requirements. We may also be required to assess the new manufacturer’s compliance with all applicable regulations and guidelines, which could further impede our ability to manufacture our products in a timely manner. As a result, we could incur increased production costs, experience delays in deliveries of our products, suffer damage to our reputation, and experience a material adverse effect on our business, financial condition, and results of operations.

The governments and regulatory authorities in the United States, the European Commission,Union, Canada and other markets in which we expect to sell our devices may propose and adopt new legislation and regulatory requirements relating to medical product approval criteria, manufacturing and marketing requirements. In addition, regulations and guidance promulgated by the FDA, the European Commission, Health Canada, and other regulatory bodies are often revised or reinterpreted by the agency and other relevant regulatory bodies in ways that may significantly affect our business and products. It is impossible to predict whether legislative changes will be enacted or regulations, guidance or interpretations changed and what the impact of such changes, if any, may be. Such legislation or changes in regulatory requirements, or the failure to comply with such, could adversely impact our operations and could have a material adverse effect on our business, financial condition and results of operations.

Many state laws govern the privacy and security of personal information and data in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts. For example, the California Confidentiality of Medical Information Act (“CMIA”) imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information. In addition to fines and penalties imposed upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused. California’s patient privacy laws, for example, provide for penalties of up to $250,000 and permit injured parties to sue for damages. In addition to the CMIA, in 2018, California enacted the California Consumer Privacy Act (“CCPA”) which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. While there is currently an exception for PHI that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities. In addition, the California Privacy Rights Act (“CPRA”) was recently enacted to strengthen elements of the CCPA and became effective on January 1, 2023. A number of other states have consideredeither enacted their own omnibus privacy laws or continued to deliberate and introduce similar privacy proposals,law with states like Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah and Virginia enacting their own privacy laws.proposals. These privacy laws may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.

On July 10, 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring data from the EU to the United States – the EU-US Data Privacy Framework (the “Framework”). The Framework provides EU individuals with several new rights, including the right to obtain access to their data, or obtain correction or deletion of incorrect or unlawfully handled data. The adequacy decision followed the signing of an executive order introducing new binding safeguards to address the points raised inby the SchremsCourt IIof decision.Justice of the European Union in a July 2020 decision that invalidated the previous EU-US data transfer framework. Notably, the new obligations were geared to ensure that data can be accessed by USU.S. intelligence agencies only to the extent necessary and proportionate and to establish an independent and impartial redress mechanism to handle complaints from Europeans concerning the collection of their data for national security purposes. The Commission will continually review developments in the USU.S. along with its adequacy decision. Adequacy decisions can be adapted or even withdrawn in the event of developments affecting the level of protection in the applicable jurisdiction. Future actions of EU data protection authorities are difficult to predict. Some patients or other service providers may respond to these evolving laws and regulations by asking us to make certain privacy or data-related contractual commitments that we are unable or unwilling to make. This could lead to the loss of current or prospective patients or other business relationships.

The ability of the FDA to review and authorize new medical products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptionsdisruptions at the FDA and other agencies may also slow the time necessary for new medical products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, overpolitical thedisputes lastin severalCongress years,may result in a shutdown of the U.S. government has shut down several times, including from December 22, 2018 through January 25, 2019,government, and congressional impasses periodically threaten to cause future government shutdowns. Most recently, the U.S. government nearly shutdown at the end of December 2024 due to disagreements in Congresssuch over a continuing resolution package to fund federal government operations. When a shutdown occurs,cases certain regulatory agencies, such as the FDA and the SEC, would have had to furlough critical FDA, SEC and other government employees and stop critical activities. Moreover, government shutdowns or slowdowns can increase the time needed for an agency to complete its review or make final approvals or other administrative decisions. If a prolonged government shutdown or slowdown occurs, it could significantly affect the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Our business, financial condition, cash flows and results of operations are subject to risks arising from our international operations.operations, including currently imposed and potential future tariffs and trade measures.

The market price of our Common Shares could decline as a result of issuances of securities (including our Common Shares) by us, exercises of outstanding options or warrants for additional Common Shares or sales by our existing shareholders of Common Shares in the market, or the perception that these issuances or sales could occur. Sales of Common Shares by shareholders may make it more difficult for us to sell equity securities at a time and price that we deem appropriate. As of December 31, 2024,2025, there were a total of 2,291,1522,142,522 outstanding share options issued under our Share Option Plan, 324,621859,335 Restricted Stock Units (“RSUs”), 91,670135,490 Deferred Stock Units (“DSUs”) issued. In addition, as of December 31, 2024,2025, the maximum number of Common Shares reserved for issuance under this plan is 3,905,1754,718,173 Common Shares or such other number as may be approved by the holders of the voting shares of the Company.

We are subject to certain of the requirements of Sarbanes-Oxley. Section 404 of Sarbanes-Oxley (“Section 404”) requires companies subject to the reporting requirements of the U.S. securities laws to complete a comprehensive evaluation of our internal controls over financial reporting. To comply with this statute, we are required to document and test our internal control procedures and our management are required to assess and issue a report concerning our internal controls over financial reporting. As a smaller reporting company, we are exempt from certain reporting requirements, including the independent auditor attestation requirements of Section 404(b) of Sarbanes-Oxley. Under this exemption, our independent auditor is not required to attest to and report on management’s assessment of our internal controls over financial reporting until we no longer qualify for such exemption. We continue to address our compliance with Section 404 by strengthening, assessing and testing our system of internal controls to provide the basis for our report. However, the continuous process of strengthening our internal controls and complying with Section 404 is complicated and time-consuming. Furthermore, we believe that our business will grow both domestically and internationally, in which case our internal controls will become more complex and will require significantly more resources and attention to ensure our internal controls remain effective overall. During the course of our testing, our management has identified and may identify additional material weaknesses or significant deficiencies, which may not be remedied in a timely manner to meet the deadline imposed by Sarbanes-Oxley. As described below, we have identified a material weakness in our internal control over financial reporting for the year ended December 31, 2024. If our management cannot favorably assess the effectiveness of our internal controls over financial reporting, or our independent registered public accounting firm identifies additional material weaknesses in our internal controls, investor confidence in our financial results may weaken, and the market price of our securities may suffer.

We are required to comply with the covenants in the CIBC Credit Agreement and such covenants may create a risk of default on our debt if we cannot satisfy or continue to satisfy these covenants. If we are determined not to have complied or in the future cannot comply with a debt covenant or anticipate that we will be unable to comply with a debt covenant under any debt instrument we are a party to, including the CIBC Loan,Credit Agreement, management may seek a waiver and/or amendment to the applicable debt instrument in respect of any such covenant in order to avoid any breach or default that might otherwise result therefrom. On March 31, 2024, we were in breach of the covenant in the Original CIBC LoanCredit Agreement that revenue for any fiscal quarter must be 15% greater than revenue for the same fiscal quarter in the prior fiscal year. Prior to such breach, we obtained a waiver from CIBC, pursuant to which CIBC has waived such breach. On September 26, 2023, an amendment to the CIBC LoanCredit Agreement changed financial covenants. The revised covenants specifyspecified that unrestricted cash must be greater than either (i) negative EBITDA for the most recent nine -month period or (ii) $7,500, reported monthly. Additionally, recurring revenue for any fiscal quarter must be 15% greater than the same quarter in the prior fiscal year, reported quarterly. As of December 31, 2024, we were in compliance with these covenants. On August 1, 2025, we were in breach of the covenant that unrestricted cash must be greater than either (i) negative EBITDA for the most recent nine-month period or (ii) $7,500. CIBC waived such breach for the period beginning on August 1, 2025 through the date of an amendment to the CIBC Credit Agreement on September 30, 2025, which revised the liquidity covenant to state that unrestricted cash must at all times be the greater of: (i) to the extent EBITDA is negative for such period, EBITDA for the most recent six-month period, or (ii) $10,000, reported on a monthly basis. As of December 31, 2025, we were in compliance with these financial covenants. Future compliance dependswith onthe financial covenants included in the CIBC Credit Agreement is dependent upon achieving specificcertain revenue, EBITDA, and anticipated cash levels. If we default under a debt instrument, including the CIBC Loan, and the default is not waived by the lender(s), the debt extended pursuant to the CIBC Loan and any other debt instruments could become due and payable prior to its stated due date. If such event were to occur in the future, we cannot give any assurance that (i) CIBC and/or our other lenders will agree to any covenant amendments or waive any covenant breaches or defaults that may occur, and (ii) we could pay this debt if it became due prior to its stated due date. Accordingly, if we are unable to negotiate a covenant waiver or replace or refinance our existing debt on favorable terms or at all, such default could materially adversely impact our results of operations and financial results and may have a material adverse effect on the trading price of our Common Shares. Future compliance with the financial covenants included in the CIBC LoanCredit Agreement is dependent upon achieving certain revenue, EBITDA, and anticipated unrestricted cash levels. Management considers there is a potential for a breach of these covenants in the future due to the volatility and unpredictability of our revenues.

We are a commercial-stage medical device company focused on the development and marketing of customizable,AI-powered, MRI-guided, incision-free therapeutic systemstherapies for the image guided ablation of diseased tissue utilizing itsour platform technologies and leveraging the healthcare system’s existing imaging infrastructure. Our lead product (the “TULSA-PRO system”) combines real-time MRI, robotically driven transurethral sweeping-action thermal ultrasound with closed-loop temperature feedback control for the ablation of prostate tissue. The product is comprised of one-time-use devices and durablecapital equipment that are used in conjunction with a customer’s existing MRI scanner.

We deploy a hybrid recurring revenue business model in the United States to market TULSA-PRO,TULSA-PRO i) charging a one-time payment that includes a supply of our one-time-use device, use of the system as well as our Genius services that support each TULSA center with clinical and patient recruitment and ii) a traditional model ofby charging for the system separately as capital and an additional per patient charge for the one-time-use devices and associated Genius services.devices. The Sonalleve product is marketed primarily outside North America in European and Asian countries deploying a one-time capital sales model with limited recurring service revenue. Outside of North America, we generate most of our revenues from our system sales (both TULSA-PRO and Sonalleve) in Europe and Asia where we deploy a more traditional hybrid business model, charging for the system separately as capital and an additional per patient charge for the one-time-use devices and associated Genius services.devices. Revenue is comprised of (a) recurring – non-capital revenue, which consists of the sale of one-time-use devices, lease of medical devices, proceduresdevices and services associated with extended warranties and (b) capital equipment, which is the one-time sale of capital equipment and the lease of capital equipment.

For the year ended December 31, 2025, we recorded revenue totaling $16,098, with $6,368 from the one-time sale of capital equipment and $9,730 from recurring – non-capital revenue. For the year ended December 31, 2024, we recorded revenue totalingof $10,680, with $2,440 from the one-time sale of capital equipment and $8,240 from recurring – non-capital revenue. For the year ended December 31, 2023, we recorded revenue of $7,199, with $393 from the one-time sale of capital equipment and $6,806 from recurring – non-capital revenue. The increase of $3,481$5,418 or 48%51% in revenue for the year ended December 31, 2024,2025, was the result of higher recurring revenue and capital sales in the United States and overseas during 2024.2025.

For the year ended December 31, 2025, we recorded a cost of sales of $4,705, related to the sale of medical devices, capital and non-capital, which reflects a 71% gross profit. For the year ended December 31, 2024, we recorded a cost of sales of $3,643, related to the sale of medical devices, capital and non-capital, which reflects a 66% gross profit. For the year ended December 31, 2023, we recorded a cost of sales of $2,887, related to the sale of medical devices, capital and non-capital, which reflects a 60% gross profit. The gross profit was higher in 20242025 by $2,725$4,356 or 63%62% due to manufacturingincreased operatingselling atprices highercoupled efficiency rates based on improvements that have been implemented andwith the growth in the number of capital systems sold.

For the year ended December 31, 2024,2025, R&D expenses increased by $2,541,$3,631, or 18%21% to $16,965$20,596 compared to $14,424$16,965 for the year ended December 31, 2023.2024. The increase in R&D expenses was largely due to increased headcount and lower reimbursement of workforce costs associated with research projects,headcount, increased enrolment for the CAPTAIN trial and recruitment efforts, and higher material expenditures dueand totravel spending on R&D initiatives to increase compatibilityassociated with MRIthe scanners,trial, reduceand increased testing and design costs and improve efficiencies.modification. These expenses promote the ongoing development and improvement of the products while further strengthening the commitment to a reliable and customizable product.

SG&A expenses for the year ended December 31, 20242025 increased by $4,595,$8,917, or 25%39% to $23,134$32,051 compared to $18,539$23,134 for the year ended December 31, 2023.2024. The increase in SG&A was due to increased sales force and commission payments, the release of commercial segments and marketing advertisement campaigns, increased travel for conferences, badcustomer debt expensevisits and costs associated with hosting our educational eventevents Pro-Talkthroughout Livethe in September 2024.year. Offsetting these amounts was a decrease to insurance due to lower premium rates.rates and a reduction in bad debt expense.

Net finance (income) expense is primarily comprised of the following: (i) the CIBC Credit Agreement (as defined herein) accreting to the principal amount repayable and its related interest expense; and (ii) interest income from cash and cash equivalents; (iii) the lease liability interest expense; and (iv) the interest income on trade and other receivables.equivalents.

Net finance (income) expense increaseddecreased $661$366 to $($1,4361,070) during the year ended December 31, 2024,2025, compared to $($7751,436) during the year ended December 31, 2024. The increasedecrease in net finance (income) expense was due to the change in the amortized cost of trade and other receivables being fully recognized, increasedecrease in interest income from cash and cash equivalents anddue decreaseto ina thelower CIBCcash Loan interest and accretion expenses.balance.

We received net proceeds of $21,079$40,801 from the Public Offering and Private Placement completed in JanuaryDecember 2024.2025. We intend to use net proceeds from the Public Offering and Private Placement to fund the continued commercialization of the TULSA-PRO system in the United States, the continued development and commercialization of the TULSA-PRO system and the SONALLEVESonalleve system globally and for working capital and general corporate purposes. In addition, there have been no material adjustments to the cost or timing of the business objective previously disclosed in such prospectus supplement.

On December 10,22, 2024,2025, we received net proceeds of $36,132$34,379 from the public offering of 5,366,7055,142,870 Common Shares at $7.50.an offering price of $7.00 per share. On December 30, 2025, we received net proceeds of $6,422 from the private placement of 921,428 Common Shares at an offering price of $7.00 per share. We intend to use net proceeds from the public offering and private placement to fund the continued commercialization of the TULSA-PRO system in the United States, the continued development and commercialization of the TULSA-PRO system and the SONALLEVESonalleve system globally and for working capital and general corporate purposes. As of December 31, 2024,2025, we had yet to use any of the proceeds.

Revenue is derived primarily from the sale of the TULSA-PRO and Sonalleve systems and one timeone-time use devices. All products generally containinclude a one-year warranty.

TheWe Company recognizesrecognize revenue when the customer obtains control of promised goods or services and in an amount that reflects the consideration to which thewe Company expectsexpect to be entitled to receive in exchange for those goods or services. To achieve this core principle, thewe Company appliesapply the five-step revenue model to contracts within itsour scope: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

Capital equipment revenue consists of the sale of capital equipment including installation and training amounts.amounts, which includes sales to distributors. Revenue is recognized when the Company transfers control to the customer, which is generally at the time of shipment. The Company’s customer arrangements generally do not provide a right of return.

TheWe Company marketsmarket and sellssell itsour products primarily through itsour direct sales force, which sells itsour products to end customers. A portion of the Company’sour revenue is generated by sales to distributorsdistributors. primarilyIn inmarkets Europewhere andwe Asia.do not maintain a direct presence, we engage distribution partners. When thewe Company transactstransact with a distributor, itsour contractual arrangement is with the distributor and not with the end customer. Whether thewe Company transactstransact business with and receivesreceive the order from a distributor or directly from an end customer, itsour revenue recognition policy and resulting pattern of revenue recognition for the order are generally the same.

The key judgements and estimates are used in determining the allowance for expected credit losses. Trade and other receivables are stated net of an allowance for expected credit losses. TheWe Company grantsgrant credit to customers in the normal course of business and maintains an allowance for expected credit losses which reflect the current estimate of expected credit losses expected to be incurred over the life of the receivables. TheWe Company considersconsider various factors in establishing, monitoring, and adjusting itsour allowance for expected credit losses, including the aging of the accounts and aging trends, the historical level of charge-offs, and specific credit exposures related to particular customers. The CompanyWe also monitorsmonitor other risk factors and forward-looking information, such as country risk, when determining credit limits for customers and establishing adequate allowances. Uncollectible accounts are written-off against the allowance when there is no reasonable expectation of recovery. Indicators that there is no reasonable expectation of recovery include, amongst others, failure to make contractual payments for a period of greater than 180 days past due.

We are commercializing TULSA-PRO, a technology that combines real-time MRI, 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. TULSA employs real-time MR guidance for pixel-by-pixel precision to preserve prostate disease patients’ urinary continence and sexual function, while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (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 generally 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”).

Comparison of Three and Six Months Ended MarchJune 31,30, 2026 and 2025

The following selected financial information as of and for the three and six months ended MarchJune 31,30, 2026 and 2025 have been derived from the unaudited consolidated financial statements and should be read in conjunction with those unaudited consolidated financial statements and related notes.

We deploy a hybrid revenue business model in the United States to market TULSA-PRO by charging for the system separately as capital and an additional charge for the one-time-use devices. The Sonalleve product is marketed primarily outside North America deploying a one-time capital sales model with limited recurring service revenue. Outside of North America, we generate most of our revenues from our system sales (both TULSA-PRO and Sonalleve) in Europe and Asia where we deploy a hybrid business model, charging for the system separately as capital and an additional charge for the one-time-use devices. Revenue is comprised of (a) recurring – non-capital revenue, which consists of the sale of one-time-use devices and services associated with extendedmaintenance warrantiescontracts and (b) capital equipment, which is the one-time sale of capital equipment and the lease of capital equipment.

For the three months ended MarchJune 31,30, 2026, we recorded revenue totaling $5,337,$2,483, consisting of $2,863$871 from the one-time sale of capital equipment and $2,474$1,612 from recurring – non-capital revenue. For the three months ended MarchJune 31,30, 2025, we recorded revenue of $2,621,$2,211, consisting of $820$650 from the one-time sale of capital equipment and $1,801$1,561 from recurring – non-capital revenue. The increase of $2,716,$272, or 104%,12%, in revenue for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 was the result of higher recurring revenue and capital sales in the United States and overseas during the firstsecond quarter of 2026.

For the three months ended MarchJune 31,30, 2026, we recorded a cost of sales of $1,505,$536, related to the sale of medical devices, capital and non-capital, which reflects a 72%78% gross profit. For the three months ended MarchJune 31,30, 2025, we recorded a cost of sales of $768, related to the sale of medical devices, capital and non-capital,$593, which reflects a 71%73% gross profit. The increasedecrease of $737,$57, or 96%,10%, in cost of sales for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 was the result of athe differentsale productof combinationmultiple wherebysystems moreunder capitalexisting equipmentoperating wasleases soldto which contains a higher margin.customers. The gross profit was higher in the three months ended MarchJune 31,30, 2026 by $1,979,$329, or 107%,20%, due to growth in the number of capitalone-time-use systemsdevices sold.

R&D expenses are comprised of costs incurred in performing R&D activities, including new product development, continuous product improvement, investment in clinical trials and related clinical manufacturing costs, materials and supplies, salaries and benefits, consulting fees, patent procurement costs, and occupancy costs related to R&D activity.

For the three months ended MarchJune 31,30, 2026, R&D expenses increaseddecreased by $454,$444, or 9%,7%, to $5,262$5,654 compared to $4,808$6,098 for the three months ended MarchJune 31,30, 2025. The increasedecrease in R&D expenses was largely due to a reduction in clinical trial costs due to CAPTAIN trial enrollment completion. Offsetting these costs was an increased headcount, travel expenditures and higher consulting expenditures due to spending on R&D initiatives to reduce designproduct costs and improve quality and efficiencies withof our products. Offsetting these costs were a reduction in clinical trial costs due to CAPTAIN trial enrollment completion. These expenses promote the ongoing development and improvement of the products while further strengthening the commitment to a reliable and customizable product.

SG&A expenses for the three months ended MarchJune 31,30, 2026 decreased by $1,620,$1,967, or 20%,21%, to $6,591$7,359 compared to $8,211$9,326 for the three months ended MarchJune 31,30, 2025. The decrease in SG&A was primarily due to decreased salaries, sales forcesalary and commission payments,expenses related to lower headcount in sales force, a reduction in consulting fees and travel expensesexpenses, andan overall discount in our insurance premiums for the same coverage from the prior year.year and a reduction in bad debt expense. Offsetting these expenses was an increase in promotion and marketing expenses.

Net finance (income) expense

Net finance (income) expense is primarily comprised of the following: (i) the CIBC Credit Agreement (as defined herein) accreting to the principal amount repayable and its related interest expense; and (ii) interest income from cash.

Net finance (income) expense decreased by $68$7 to $(377$336) during the three months ended MarchJune 31,30, 2026, compared to $(445$343) during the three months ended MarchJune 31,30, 2025. The decrease in net finance (income) expense was primarily due to a decrease in interest income from cash.

Net foreignfinance exchangeincome (gain) loss increaseddecreased by $(578)$75 to $(616$713) during the threesix months ended MarchJune 31,30, 2026, compared to $(38$788) during the threesix months ended MarchJune 31,30, 2025. The increasedecrease in net foreignfinance exchange (gain) lossincome was primarily due to increasea decrease in theinterest EURincome andfrom CAD currency rates.cash.

As of MarchJune 31,30, 2026, we had cash of $50,295$38,271 compared to $59,723 as of December 31, 2025. Historically, our primary source of cash has been financing activities, e.g., equity offerings as well as the CIBC Loan (as defined below).

We received net proceeds of $40,801 from the Publicpublic Offeringoffering and Privatethe Placementprivate placement (together, the “2025 Offering”) completed in December 2025. We intend to use net proceeds from the Public2025 Offering and Private Placement to fund the continued commercialization of the TULSA-PRO system in the United States, the continued development and commercialization of the TULSA-PRO system and the Sonalleve system globally and for working capital and general corporate purposes. In addition, there have been no material adjustments to the cost or timing of the business objective previously disclosed in such prospectus supplement.

On SeptemberMarch 30,3, 2025, we entered into an amended and restated credit agreement (the “CIBC Credit Agreement”) with Canadian Imperial Bank of Commerce (“CIBC”), which amended the terms of the loan with CIBC (the “CIBC Loan”) and the existing long-term debt provided under the original credit agreement with CIBC was repaid with proceeds from a new revolving line of credit provided by CIBC to us. The line of credit bears interest at the Wall Street Journal Prime Rate subject to a floor of 6.25%. Following an amendment to the CIBC Credit Agreement resultedon inSeptember a30, change to one of2025, the amended financial covenants.covenants The amended covenant isare that unrestricted cash mustis at all times be the greater of: (i) to the extent that EBITDA is a negative number or loss for the most recent six-month period, the amount of such loss, or (ii) $10,000, reported on a monthly basis and that revenue for the 12 month period must be 15% greater than revenue for the same period in the prior fiscal year, reported on a quarterly basis. We are in compliance with these financial covenants as of MarchJune 31,30, 2026. Future compliance with the financial covenants included in the CIBC Credit Agreement is dependent upon achieving certain revenue, EBITDA, and anticipated unrestricted cash levels.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $(8,58419,921)., Theprimarily principal use of the operating cash flows during the period relatedattributable to a net loss of $7,054$16,593 and an increase$5,593 in net operating assets and liabilitiesliabilities, partially offset by $2,265 of $2,733 and an increase in non-cash charges of $1,203.charges. The cash used in operating expensesactivities was primarily due to the increased efforts supporting the commercialization and expansion of our products. This resulted in an increase in headcount, travelmarketing and marketingpromotion fees.fees and increased travel. Non-cash charges consisted primarily of share-based compensation, amortization and depreciation.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $(8,28322,027). The principal use of the operating cash flows during the period related to a net loss of $10,724$26,419 and an increase in net operating assets and liabilities of $1,250$1,616 and an increase in non-cash charges of $1,191.$2,776. The cash used in operating expenses was primarily due to the increased efforts supporting the commercialization and expansion of our products. This resulted in an increase in headcount, travel, clinical trial costs and marketing fees. Non-cash charges consisted primarily of share-based compensation, amortization and depreciation.

Net cash provided by (used in) financing activities for the threesix months ended MarchJune 31,30, 2026 was $nil.

Net cash provided by (used in) financing activities for the threesix months ended MarchJune 31,30, 2025 was $(290) from the repayments of long-term debt principal.

Cash was impacted by the change in the foreign exchange rates for the Company’s foreign currency denominated cash (non-USD).cash. The value of our currencies decreased, resulting in a decrease in our cash holdings.