Profound Medical Corp 6-K, filed Jul 15, 2020
Profound Medical Corp. (PROF)
About this 6-K
Profound Medical Corp filed this 6-K on July 15, 2020.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2020
Commission File Number: 001-39032
PROFOUND MEDICAL CORP.
(Translation of the registrant’s name into English)
2400 Skymark Avenue, Unit 6, Mississauga, Ontario L4W 5K5
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ¨ Form 40-F x
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
This Report on Form 6-K (including Exhibit 99.1 hereto) shall be incorporated by reference into the Registration Statement of Profound Medical Corp. on Form F-10 (File No. 333-233997).
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
In connection with a proposed offering of common shares in the United States (the “Offering”), the following information was disclosed to investors:
Recent Developments
Profound Medical Corp. (“Profound” or the “Corporation”) anticipates total revenues for the three months ended June 30, 2020 will be approximately C$1.4 million and that its cash balance as of June 30, 2020 will be approximately C$56 million. The foregoing amounts reflecting the Corporation’s anticipated revenues for the second quarter of 2020 are unaudited and preliminary estimates that: (i) represent the most current information available to management as of the date of this Report on Form 6-K; (ii) are subject to completion of interim review procedures that could result in significant changes to the estimated amounts; and (iii) do not present all information necessary for an understanding of the Corporation’s financial condition as of, and the Corporation’s results of operations for the three months ended June 30, 2020. Accordingly, readers should not place undue reliance on these preliminary estimates.
COVID-19
The COVID-19 outbreak has been declared a pandemic by the World Health Organization. It is too soon to gauge the impacts of the current outbreak, given the many unknowns related to COVID-19 including the duration and severity of the outbreak. COVID-19 is altering business and consumer activity in affected areas and beyond. The global response to the COVID-19 pandemic has resulted in, among other things, border closures, severe travel restrictions, the temporary shut-down of non-essential services and extreme fluctuations in financial and commodity markets. Additional measures may be implemented by one or more governments in jurisdictions where the Corporation operates. These measures have caused material disruption to businesses globally, resulting in an economic slowdown. The extent to which COVID-19 and any other pandemic or public health crisis impacts the Corporation’s business, affairs, operations, financial condition, liquidity, availability of credit and results of operations will depend on future developments that are highly uncertain and cannot be predicted with any meaningful precision, including new information which may emerge concerning the severity of the COVID-19 virus and the actions required to contain the COVID-19 virus or remedy its impact, among others.
Further, from an operational perspective, the Corporation’s employees, direct sales and marketing teams and distribution partners, as well as the workforce of vendors, services providers and counterparties with which the Corporation does business, may also be adversely affected by the COVID-19 pandemic or efforts to mitigate the pandemic, including government-mandated shutdowns, requests or orders for employees to work remotely, and other physical distancing measures, which could result in an adverse impact on the Corporation’ ability to conduct its businesses, including its ability to cultivate adoption of the TULSA-PRO technology, support clinical customers with the TULSA-PRO procedures and increase the utilization of the systems and disposable components.
To date, the economic downturn and uncertainty caused by the COVID-19 pandemic and global measures undertaken to contain its spread have affected all of the Corporation’s operations to some extent and, in particular, have caused volatility in demand for the TULSA-PRO systems and the disposable components related thereto. This has resulted in a reduction in anticipated sales and led to delays in the Corporation’s expectations regarding the rate at which agreements for new TULSA-PRO user sites will be entered into and when user sites will become operational for the initiation of patient treatments. Despite the COVID-19 pandemic, patient treatments are continuing and Profound continues to identify potential new TULSA-PRO user sites. Please see the Corporation’s Interim MD&A for the three months ended March 31, 2020 (“Interim MD&A”) for more information. The Corporation continues to evaluate the current and potential impact of the COVID-19 pandemic on its business, affairs, operations, financial condition, liquidity, availability of credit and results of operations.
In addition, the actual and threatened spread of COVID-19 globally could also have a material adverse effect on the regional economies in which Profound operates, could continue to negatively impact stock markets, including the trading price of the Corporation’s common shares, could adversely impact the Corporation’s ability to raise capital, could cause continued interest rate volatility and movements that could make obtaining financing more challenging or more expensive.
Marketing Materials
In connection with the Offering, the Corporation intends to use an investor presentation, a copy of which is filed as Exhibit 99.1 hereto.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This Report on Form 6-K contains certain information that is “forward-looking information” or that constitutes “forward-looking statements” within the meaning of applicable securities legislation in Canada and the United States, which we refer to collectively as “forward-looking information”. The forward-looking information in this Report on Form 6-K is presented for the purpose of providing disclosure of management’s current expectations of the Corporation’s future events or results, having regard to current plans, objectives and proposals, and such information may not be appropriate for other purposes. Forward-looking information may also include information regarding the Corporation’s future plans or objectives and other information that is not comprised of historical fact. Forward-looking information is predictive in nature and depends upon or refers to future events or conditions. This Report on Form 6-K uses words such as “may”, “would”, “could”, “should”, “will” “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “propose” and similar expressions (including negative and grammatical variations thereof) suggesting future outcomes or events to identify forward-looking information, which includes, but is not limited to, statements regarding:
| · | statements with respect to the Corporation’s anticipated preliminary unaudited revenue for the fiscal quarter ended June 30, 2020; |
| · | the Corporation’s expectations regarding the impact of COVID-19 on the Corporation’s business, affairs, operations, financial condition, liquidity, availability of credit and results of operations; |
| · | the Corporation’s proposed use of the net proceeds from the Offering; |
| · | the anticipated listing of the Common Shares offered in the Offering on the Toronto Stock Exchange; |
| · | the Corporation’s expectations regarding commercializing its approved products (particularly the TULSA-PRO system following United States Food and Drug Administration clearance) and the Corporation’s ability to generate revenues and achieve profitability; |
| · | the Corporation’s expectations regarding the safety, efficacy and advantages of its products over its competitors and alternative treatment options; |
| · | the Corporation’s expectations regarding its products fulfilling unmet clinical needs and achieving market acceptance among patients, physicians and clinicians; |
| · | the Corporation’s expectations regarding reimbursement for its approved products from third-party payers; |
| · | the Corporation’s expectations regarding its relationship with RadNet Inc. (“RadNet”); |
| · | the Corporation’s expectations regarding its relationships with Koninklijke Philips N.V. and Siemens Healthcare GmbH and the Corporation’s ability to achieve compatibility of its systems with magnetic resonance imaging (“MRI”) scanners produced by other manufacturers; |
| · | the Corporation’s ability to attract, develop and maintain relationships with other suppliers, manufacturers, distributors and strategic partners; |
| · | the Corporation’s expectations regarding its pipeline of product development, including expanding the clinical application of the Corporation’s products to cover additional indications; |
| · | the Corporation’s expectations regarding current and future clinical trials, including the timing and results thereof; |
| · | the Corporation’s expectations regarding maintenance of the current regulatory approvals it has received, including its compliance with the conditions under such approvals, and the receipt of additional regulatory approvals for its products and future product candidates; |
| · | the Corporation’s mission and future growth plans; |
| · | the Corporation’s ability to attract and retain personnel; |
| · | the Corporation’s expectations regarding its competitive position for each of its products in the jurisdictions where they are approved; |
| · | the Corporation’s ability to raise debt and equity capital to fund future product development, pursue regulatory approvals and commercialize its approved products; and |
| · | anticipated trends and challenges in the Corporation’s business and the markets in which it currently operates or may in the future operate. |
Any such forward-looking information is based on information currently available to the Corporation, and is based on assumptions and analyses made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors believed to be appropriate in the circumstances.
Given the uncertainty and rapidly evolving circumstances surrounding the COVID-19 pandemic and related response from governments, regulatory authorities, businesses and customers, there is more uncertainty associated with the Corporation’s assumptions and expectations as compared to prior periods. For a discussion of certain additional assumptions related to the COVID-19 pandemic, see “COVID 19” above and the Interim MD&A.
Whether actual results and developments will conform with the expectations and predictions contained in the forward-looking information is subject to a number of risks and uncertainties, many of which are beyond the Corporation’s control, and the effects of which can be difficult to predict. Factors that could cause actual results or events to differ materially from those described in the forward-looking information include, but are not limited to, those that are described under the heading “COVID 19” above and elsewhere in this Report on Form 6-K and the Corporation’s filings with securities regulators, which are available electronically through the Canadian System for Electronic Document Analysis and Retrieval (“SEDAR”) at www.sedar.com and the SEC’s Electronic Data Gathering and Retrieval System (“EDGAR”) at www.sec.gov, such as:
| · | risks related to the Corporation’s limited operating history and history of net losses; |
| · | risks related to the Corporation’s ability to commercialize its approved products, including realizing the anticipated benefits of its commercial agreement with RadNet, expanding the Corporation’s sales and marketing capabilities, increasing the Corporation’s manufacturing and distribution capacity, increasing reimbursement coverage for the Corporation’s approved products and achieving and maintaining market acceptance for its products; |
| · | risks related to the regulation of the Corporation’s products, including in connection with obtaining regulatory approvals as well as post-marketing regulation; |
| · | risks related to the Corporation’s successful completion of future clinical trials with respect to its products and future product candidates; |
| · | risks related to managing growth, including in respect of obtaining additional funding and establishing and maintaining collaborative partnerships, to achieve the Corporation’s goals; |
| · | risks related to competition that may impact market acceptance of the Corporation’s products and limit its growth; |
| · | risks relating to fluctuating input prices and currency exchange rates; |
| · | risks related to the reimbursement models in relevant jurisdictions that may not be advantageous; |
| · | risks related to reliance on third parties, including the Corporation’s collaborative partners, manufacturers, distributors and suppliers, and increasing the compatibility of its systems with MRI scanners; |
| · | risks related to intellectual property, including license rights that are key to the Corporation’s business; |
| · | risks related to the extent and impact of COVID-19; and |
| · | risks related to the loss of key personnel. |
In evaluating any forward-looking information contained in this Report on Form 6-K, the Corporation cautions readers not to place undue reliance on any such forward-looking information. Unless otherwise required by applicable securities laws, the Corporation does not intend, nor does it undertake any obligation, to update or revise any forward-looking information contained in this Report on Form 6-K to reflect subsequent information, events, results, circumstances or otherwise. Additional information about the risks and uncertainties of forward-looking information and the assumptions upon which it is based is contained in the Corporation’s filings with securities regulators, which are available electronically through SEDAR at www.sedar.com and EDGAR at www.sec.gov.
Discrepancies between the financial information presented in the Corporation’s annual information form and MD&A for the year ended December 31, 2019 and the corresponding financial information reported in the Corporation’s audited financial statements for the year ended December 31, 2019 (the “2019 Audited Financial Statements”) should be resolved in favor of the information contained in the 2019 Audited Financial Statements, which to the extent of any conflict is the information that should be relied upon. There are no changes to the 2019 Audited Financial Statements or the report of the Corporation’s independent auditors thereon.
EXHIBIT INDEX
The following document, which is attached as an exhibit hereto, is incorporated by reference herein:
| Exhibit | Title | |
| 99.1 | Investor Presentation, dated July 15, 2020. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| PROFOUND MEDICAL CORP. | |||
| (Registrant) | |||
| Date: July 15, 2020 | By: | /s/ Aaron Davidson | |
| Name: Aaron Davidson | |||
| Title: Chief Financial Officer | |||
Exhibit 99.1
NASDAQ: PROF TSX: PRN Corporate Presentation | July 15, 2020 – Offering of Common Shares © 2020 Profound Medical Corp. A final base shelf prospectus containing important information relating to the securities described in this document has been filed with the securities regulatory authorities in each of the provinces of Canada except Quebec . A copy of the final base shelf prospectus, any amendment to the final base shelf prospectus and any applicable shelf prospectus supplement that has been filed, is required to be delivered with this document . This document does not provide full disclosure of all material facts relating to the securities offered . Investors should read the final base shelf prospectus, any amendment and any applicable shelf prospectus supplement for disclosure of those facts, especially risk factors relating to the securities offered, before making an investment decision . The Company has filed a registration statement (including a prospectus) and a prospectus supplement with the U . S . Securities and Exchange Commission (the “SEC”) for the offering to which this presentation relates . Before you invest, you should read the prospectus in that registration statement, the prospectus supplement and other documents the Company has filed with the SEC for more complete information about the Company and this offering . You may get these documents for free by visiting EDGAR on the SEC Web site at www . sec . gov . Alternatively, the Company, any underwriter or any dealer participating in the offering will arrange to send you the prospectus if you request it by calling Jefferies LLC at 877 - 821 - 7388 or e - mailing Prospectus_Department@Jefferies . com , or by calling Cowen and Company, LLC at 833 - 297 - 2926 or e - mailing PostSaleManualRequests@broadridge . com . Customizable, Incision - Free Ablation Therapies
2 Forward - Looking Information Certain statements in this presentation may contain certain information that is “forward - looking information” or “forward - looking statements” within the meaning of applicable securities laws with respect to Profound Medical Corp . (“Profound” or the “Company”) . Such statements include all statements other than statements of historical fact contained in this presentation, such as statements that relate to the Company’s current expectations and views of future events . Often, but not always, forward - looking information can be identified by the use of words such as “may”, “will”, “expect”, “anticipate”, “predict”, “aim”, “estimate”, “intend”, “plan”, “seek”, “believe”, “potential”, “continue”, “is/are likely to”, “is/are projected to” or the negative of these terms, or other similar expressions, as well as future or conditional verbs such as “will”, “should”, “would”, and “could” intended to identify forward - looking statements . These forward - looking statements include, among other things, statements relating to our expectations regarding future clinical trials, expectations regarding regulatory approvals, expectations regarding the safety and efficacy of its products, our expectations regarding commercializing our approved products and our ability to generate revenues and achieve profitability ; our expectations regarding the impact of COVID - 19 on our business, affairs, operations, financial condition, liquidity, availability of credit and results of operations ; our expectations regarding the safety, efficacy and advantages of our products over our competitors and alternative treatment options ; our expectations regarding our products fulfilling unmet clinical needs and achieving market acceptance among patients, physicians and clinicians ; our expectations regarding reimbursement for our approved products from third - party payers ; our expectations regarding our relationship with with RadNet ; our expectations regarding our relationships with Philips and Siemens, and our ability to achieve compatibility of our systems with MRI scanners produced by other manufacturers ; our ability to attract, develop and maintain relationships with other suppliers, manufacturers, distributors and strategic partners ; our expectations regarding our pipeline of product development, including expanding the clinical application of our products to cover additional indications ; our expectations regarding current and future clinical trials, including the timing and results thereof ; our expectations regarding receipt of additional regulatory approvals for our products and future product candidates ; our mission and future growth plans ; our ability to attract and retain personnel ; our expectations regarding maintenance of the current regulatory approvals we have received, including our compliance with the conditions under such approvals ; our expectations regarding our competitive position for each of our products in the jurisdictions where they are approved ; our ability to raise debt and equity capital to fund future product development, pursue regulatory approvals and commercialize our approved products ; and anticipated trends and challenges in our business and the markets in which we currently operate or may in the future operate . Forward - looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements . The results, performance and achievements of the Company will be affected by, among other things, such as risks related to our limited operating history and history of net losses ; risks relating to the extent and impact of COVID - 19 ; risks related to our ability to commercialize our approved products, including expanding our sales and marketing capabilities, increasing our manufacturing and distribution capacity, realizing the anticipated benefits of our commercial agreement with RadNet , increasing reimbursement coverage for our approved products and achieving and maintaining market acceptance for our products ; risks related to the regulation of our products, including in connection with obtaining regulatory approvals as well as post - marketing regulation ; risks related to our successful completion of future clinical trials with respect to our products and future product candidates ; risks related to managing growth, including in respect of obtaining additional funding and establishing and maintaining collaborative partnerships, to achieve our goals ; risks related to competition that may impact market acceptance of our products and limit our growth ; risks relating to fluctuating input prices and currency exchange rates ; risks related to the reimbursement models in relevant jurisdictions that may not be advantageous ; risks related to reliance on third parties, including our collaborative partners, manufacturers, distributors and suppliers, and increasing the compatibility of our systems with MRI scanners ; risks related to intellectual property, including license rights that are key to our business ; and risks related to the loss of key personnel, and such other risks detailed from time to time in the other publicly filed disclosure documents of the Company which are available at www . sedar . com and www . sec . gov . The Company’s forward - looking statements are made only as of the date of this presentation and, except as required by applicable law, Profound disclaims any obligation to update any forward - looking statements, whether as a result of new information, future events or results or otherwise, unless required by applicable law . There can be no assurance that forward - looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements . Accordingly, and because of the above - noted risks, uncertainties and assumptions, readers should not place undue reliance on forward - looking statements due to the inherent uncertainty in them . TULSA - PRO and SONALLEVE are registered trademarks of Profound Medical Corp .
3 Market & Industry Data Use of Projections Market data and industry forecasts contained in this presentation have been obtained from industry publications, various publicly available third - party sources and subscription - based reports as well as from management’s good faith estimates, which are derived from management’s knowledge of the industry and independent sources that management believes to be reliable . Industry publications, surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable . Although Profound believes it to be reliable, the Company has not independently verified any of the information from third - party sources nor has it ascertained the validity or accuracy of the underlying economic assumptions relied upon therein . We disclaim responsibility or liability in respect of any third - party sources of market and industry data or information, to the extent permitted by law . This presentation may contain financial forecasts with respect to our estimated future performance . Our independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this presentation and, accordingly, neither of them expressed an opinion or provided any other form of assurance with respect thereto for the purpose of this presentation . These projections should not be relied upon as being necessarily indicative of future results . In this presentation certain of the above - mentioned projected financial information has been included for purposes of providing comparisons with historical data . The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information . Accordingly, there can be no assurance that the prospective results are indicative of our future performance or that actual results will not differ materially from those presented in the prospective financial information . Inclusion of the prospective financial information in this presentation should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved . The COVID - 19 outbreak has been declared a pandemic by the World Health Organization . It is too soon to gauge the impacts of the current outbreak, given the many unknowns related to COVID - 19 including the duration and severity of the outbreak . COVID - 19 is altering business and consumer activity in affected areas and beyond . The global response to the COVID - 19 outbreak has resulted in, among other things, border closures, severe travel restrictions, the temporary shut - down of non - essential services and extreme fluctuations in financial and commodity markets . Additional measures may be implemented by one or more governments in jurisdictions where the Company operates . These measures have caused material disruption to businesses globally, resulting in an economic slowdown . The extent to which COVID - 19 and any other pandemic or public health crisis impacts the Company’s business, affairs, operations, financial condition, liquidity, availability of credit and results of operations will depend on future developments that are highly uncertain and cannot be predicted with any meaningful precision, including new information which may emerge concerning the severity of the COVID - 19 virus and the actions required to contain the COVID - 19 virus or remedy its impact, among others . The actual and threatened spread of COVID - 19 globally could also have a material adverse effect on the regional economies in which the Company operates, could continue to negatively impact stock markets, including the trading price of Profound’s Common Shares, could adversely impact the Company’s ability to raise capital, and could cause continued interest rate volatility and movements that could make obtaining financing more challenging or more expensive . Further, from an operational perspective, the Company’s employees, direct sales and marketing teams and distribution partners, as well as the workforce of vendors, services providers and counterparties with which the Company does business, may also be adversely affected by the COVID - 19 pandemic or efforts to mitigate the pandemic, including government - mandated shutdowns, requests or orders for employees to work remotely, and other physical distancing measures, which could result in an adverse impact on the Company’ ability to conduct its businesses, including its ability to cultivate adoption of the TULSA - PRO technology, support clinical customers with the TULSA - PRO procedures and increase the utilization of the systems and disposable components . COVID - 19
“My life should not have to change” U.S. FDA Cleared, August 2019 Ablation of Prostate Tissue 4
5 Anatomy & Current Landscape in the United States (“U.S.”) Prostate Disease Figure: Kirby (1997) An Atlas of Prostatic Diseases, The Encyclopedia of Visual Medicine Series. 1 Based upon CMS data Common treatment options 1. Surgery to remove prostate 2. Radiation to kill it in place Common sides effects 1. Urinary and/or rectal incontinence 2. Erectile dysfunction > 3M ~175,000 60% 10M 300,000 new prostate cancer cases per year are > 65 years men living with diagnosed prostate cancer men living with Benign Prostatic Hyperplasia (“BPH”) 1 BPH surgical procedures per year 1
6 Our Solution TULSA - PRO How we control Closed - loop Thermal Feedback Robotic closed loop temperature control to enable whole gland ablation of any size prostate Ablation using real time MRI imaging and thermometry Transurethral Directional Thermal Ultrasound How we ablate Real - time MRI Guidance How we see & plan Transurethral heating of the prostate gently to 55º C without boiling tissue Post - procedure , the dead prostate tissue is slowly resorbed by the body
7 Patient MRI Bore, Physicians Create 3D Treatment Plan Using Real - Time MRI Visualization TULSA - PRO Real - time MRI Guidance How we see & plan
8 Transurethral Gentle Heating of Prostate to 55º C TULSA - PRO Sweeping ultrasound, continuous rotation Capable of treating both large and small prostate volumes Thermal protection of important anatomy Prostate Heating pattern Ultrasound applicator with individually controlled transducer elements Endorectal cooling device B ladder Transurethral Directional Thermal Ultrasound How we ablate
9 System Components TULSA - PRO Disposables Capital System Endorectal Cooling Device Transurethral Ultrasound Applicator Robotic Positioning System Interface Box Energy System Real - Time TULSA Thermal Images Closed - loop MRI Console How we control Closed - loop Thermal Feedback
10 Immediate Post PSA 6.0 ng/ml 3 - months Post PSA < 0.1 ng/ml 12 - months Post: 0.5 cc PSA < 0.1 ng/ml Screening: 58 cc PSA 5.5 ng/ml 10 Pivotal Study of Whole - Gland Ablation in a Clinically - Significant Patient Population TACT Clinical Trial Prostate volume significantly reduced: • Median prostate volume decreased 91% from 37 cc to 3 cc PSA primary efficacy endpoint resolutely met: • Median PSA reduction was 95% , stable to 2 years clinical sites 5 years old n = 115 13 countries 4 5 - 80 Intermediate (67%) Low (33%) Prostate Cancer Risk Pre - Treatment Nadir 1 year 2 years 6.3 ng/ml 0.34 ng/ml 0.53 ng/ml 0.63 ng/ml Extensive biopsy sampling demonstrated a histological benefit for nearly 80% of men 80% of men Underwent additional intervention for their prostate cancer by 2 years, comparable to accepted rates of relapse after standard prostate cancer treatments 7% of men
11 Adverse Events • No grade ≥ 4 adverse events • No intraoperative complications • No rectal injury, no rectal fistula • 7% of men experienced a serious adverse event, all resolved by 1 year Urinary Incontinence • No new onset between 1 and 2 years • 1% patients reported one or more leak per day, 7% wear a pad for security Erectile Dysfunction • One new onset between 1 and 2 years • 0% severe ED (medication not helpful) • Continued recovery of erectile function at 2 years, 17% previously potent patients reported erection firmness insufficient for penetration TACT 0% 20% 40% 60% 80% 100% Urinary continence ≤ 1 pad/day Pad-free urinary continence Leak-free urinary continence 0% 20% 40% 60% 80% 100% 0 6 12 18 24 Erection firmness sufficient for penetration Months Patient reported quality of life 83% 99% Safety & Patient Quality of Life
12 Whole Gland Ablation Unique Flexibility Analogous to surgery and radiation Whole gland post radiation failure Malignant lesion with lower urinary tract symptoms Hemi - gland Benign large prostate with lower urinary tract symptoms Flexibility to Treat Different Types of Patients TULSA - PRO
13 TULSA - PRO U.S. Market Entrance Strategy • TACT clinical data presented at >10 conferences (AUA, EAU, RSNA) • TULSA - PRO and TACT clinical data presentations • Low - cost / high - impact patient awareness initiatives • TULSA patient website with center locator • Imaging centers • Urology practice co - ops that focus on emerging technologies • Opinion leading hospitals / Centers of Excellence • Recurring revenue - only • Capital + consumables sales • Start - up clinical support • Flexibility – ablation of range of patients • Productivity • Patient awareness • Reimbursement Increase Awareness Potential Delivery Channels Business Models 'Profound Genius Services'
14 Recurring Revenue - Only Commercial Imaging Centers • 8,000 - 10,000 imaging centers in U.S.; 40% owned by private equity or public companies • Growing presence in urology due to MRI diagnostics, MRI - guided biopsy, MRI - guided follow - up • Centers provide: - Service - Technology - In - house Radiologist(s) - Local Specialist Relationships (Urologists, Anesthesiologists) - Marketing - Payer Networks Imaging Center Referring Physicians Urologists Diagnostic Procedure Radiologist + Anesthesiologist TULSA - PRO Procedure Urologist + Radiologist + Anesthesiologist Post TULSA Monitoring Radiologist 1. 2. 3. 4.
15 Capital + Consumables Sales Centers of Excellence • Includes many of the TACT study sites • Will likely be relatively low volume while TULSA is a patient self - pay procedure • Best positioned to help drive long - term adoption by: - Participate in additional trials designed to support reimbursement - Training next generation of urologists - Presenting at medical conferences - Publish papers in relevant journals TACT Trial Sites
16 Growing Resource for Prostate Patients New TULSA - PRO Patient Website TULSA Center Locator Page Detailed Information to Help Patients Understand Their Options Contact Forms to Reach Out to Each Center Directly Patient Testimonials 16
Longer Term Building an Incision - & Radiation - Free Ablative Therapeutic Platform Oncology, Highly Symptomatic Chronic Diseases 17
18 Current Approvals Europe: CE Marked China: CNMPA Approved Over 200 Publications from leading U.S. & European clinicians and hospitals SONALLEVE • Uterine Fibroid Treatment • Pain Management • Pediatric Bone • Hyperthermia • Abdominal Cancer
19 In Summary Business Model Designed to be Capital Efficient • TULSA - PRO: focus on U.S. • Sonalleve : focus on Asia with larger distribution partner Future Investments • Strategically expand U.S. - based sales team, continue work with MRI partners • Additional clinical trials for TULSA - PRO for reimbursement • Product enhancements Introducing TULSA - PRO to U.S. Market In Summary
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