Toronto, Canada — April 10, 2025 — TheNewswire - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTC:VPTDF), a leading provider of innovative cardiac diagnostic solutions, is pleased to provide a shareholder update.
Dear Shareholders,
With the conclusion of the first quarter we are pleased to provide an update on advancements at Ventripoint and to express our ongoing appreciation for your support. Since our last update the Ventripoint team has maintained its focus on positioning the company to achieve sales and advance towards its growth phase.
Technology and Product Development
Building on the successful development of VMS+ v3.2, which featured our groundbreaking magnet-free sensors, the team completed the verification and validation of VMS+™ v4.0 and submitted applications to regulatory authorities for approval to market the product.
In the latter half of 2024 we received a Medical Device License from Health Canada. This was followed by European CE marking which enables v4.0 to be marketed in the E.U. and U.K. The submission to FDA earlier in the year resulted in a number of questions for which the decision was made to take extra care and retain external consultants to ensure the quality of our follow up. A number of studies and actions were undertaken to support the follow up, and FDA 510(k) clearance was obtained in late Q1 2025.
The production process for the new magnet-free sensors includes outsourcing the manufacture of a subcomponent. The supplier took longer than anticipated to consistently meet quality and performance standards, but is now matching expectations and sufficient sensors have been produced to enable customer site upgrades and new sales. Feedback from customer sites such as Seattle Children’s Hospital has been very positive.
We are now in the process of upgrading a number of customers to VMS+™ v4.0 with the objective of accelerating the adoption of the technology into routine clinical practice and increasing procedure volume. Higher procedure volumes contribute to increased operator experience and greater confidence in the system and quality of results.
Throughout the process of product development and regulatory approval our team has achieved successful quality and manufacturing audits which highlight their dedication and expertise.
Looking forward, we are placing a stronger focus on customer training, installation, and support, especially concerning connectivity and clinical integration. Our team is creating training videos which will be available to users, and will improve the customer experience. With growing adoption of VMS+™ for routine clinical use it is important that we ensure positive user experiences and workflow efficiency.
During the past year we have evolved the marketing function to include processes for characterizing market need prior to committing capital to sales and marketing for new applications. To that end the team is engaging customers and users in focused discussions that are generating valuable insights that will help to ensure optimal product-use fit.
Business Development and Partnerships
Ascend Cardiovascular: During 2024 we renewed and expanded our LOI to include 2D echo capabilities. We are working with Ascend to conclude a license agreement for the integration of VMS+™ 3D capabilities directly into the Ascend technology stack. This is taking longer than anticipated due to discussions related to technical specifications, but the relationship remains positive and constructive. Both companies are committed to building an increased presence in U.S. pediatric sites in 2025.
Ollie Hinkle Foundation: We continue to collaborate with OHF and anticipate their support of system placements in the USA forecast to occur mid-year.
Asia: We continue to engage with a family office to pursue distribution, joint ventures, manufacturing, and financial opportunities in South Asia. With its large population, improving living standards, and growing healthcare needs, this region is an ideal fit for VMS+™. We have received enquiries regarding other Asian markets and are qualifying these against our business plan and objectives.
Valvular Disease: We are actively developing insights and plans to expand VMS+™ use to include surgical planning and patient monitoring. We have recruited an industry advisor from a leading structural heart business and are currently engaging with KOLs to validate our assumptions and plans. The heart valve repair and replacement market is estimated to be approximately $9B in 2024 with a CAGR of 10% through 2034.
New Additions to the Ventripoint Team
The next stage of development for Ventripoint requires expansion of the commercial team to drive sales and growth. We have identified capable and experienced candidates and engaged several on a consulting basis with the expectation of transitioning them to full-time roles once sufficient capital has been raised. At the governance level we have initiated discussions with potential candidates with deep experience in medical product development, commercialization and financing.
Sales and Marketing
In 2024 we greatly reduced the number of trade shows and conferences which the company sponsored, and we will maintain this discipline in 2025. We will attend the AEPC meeting in Hamburg in May, and the ACHD meeting in Toronto in June. For both meetings we will showcase and promote VMS+™ v4.0. We continue to work with our European and UK distributors to close several sales which were previously slated for year-end 2024. Additional virtual demos have been conducted this year-to-date with more being arranged for 2025 and on-site demos will be conducted as capital resources allow.
We disclosed the addition of Mayo Clinic to our U.S. customer base in late 2024 and anticipate adding other prestigious institutions to the list in 2025. While we receive frequent shareholder inquiries about our customers, it’s important to respect industry norms regarding disclosure. Our clients are top-tier medical centers, and obtaining permission to share their names and logos typically involves a lengthy process as they are protective of their reputations.
Given the importance of the American market we have redefined our business and revenue model to more effectively expand our presence in the United States in 2025. The new program is designed to accelerate the adoption of VMS+™ by reducing friction within the sales process through clearer propositions, effective communications and attractive acquisition options.
Since our announcement welcoming Karl Pringle to the Ventripoint team he has reviewed the sales function and processes and has updated the plan. Upon securing growth capital we will accelerate execution of the plan by expanding the commercial team. They will engage directly with healthcare providers in the U.S. to validate the sales model and process prior to expansion through specialty distributors. The team will work with customers to guide them through the implementation and integration of Ventripoint’s VMS+™ AI echocardiography solutions.
We will shortly announce the first site within the Reference Centre Program, with the expectation of welcoming other sites prior to the end of the quarter. The goal of the program is to actively collaborate with these clinical partners to identify unmet clinical needs, validate new VMS+™ features and capabilities in real world settings, and enable prospective customers the opportunity to see the system being used by their peers. To ensure more effective management of these relationships we recently announced that Dr. Nic Coutin is overseeing the Clinical Affairs function.
As we continue our push to evolve our customer base from clinical research to routine cardiology practice it is important not to forget the tremendous strain placed on medical systems by growing demands. Staff shortages persist at many sites which impedes the ability to cope with growing numbers of patients and increased acuity of illnesses. VMS+™ offers a faster, less expensive and more accessible solution for many healthcare providers.
Finance
For the past year we have pursued several financing initiatives to support our growth and commercialization efforts. These initiatives were designed to leverage commitments from our team and insiders while avoiding unnecessary dilution. These efforts, coupled with careful management of expenses enabled the Company to complete development and secure approval for VMS+™ versions 3.2 and 4.0, and to close sales to two top tier institutions in the U.S. We believe that VMS+™ v4.0 provides a much-improved product-user fit and are now focused more directly on sales and growth, which is dependent on securing growth capital.
To that end we have engaged investment bankers to assist with securing capital, plus marketing groups to increase awareness of the company and investment opportunity. Capital markets were very challenging in 2024, and this year to date have been affected by historically unusual events. We remain optimistic of increased interest in Ventripoint and recognition by investors of the window of opportunity created by growing clinical need.
During the past quarter I’ve had the ongoing pleasure of speaking with many of you and greatly value your support as we continue to advance VMS+™. During the current quarter our profile will be higher due to events such as the CityAge AI in Cardiology Virtual Event on April 28th, the AEPC meeting in late May, and the ACHD meeting in June. We are excited to be moving ahead with a substantially improved product that will contribute to better healthcare outcomes for the millions of people suffering heart defects, diseases and disorders.
Shareholder Teleconference
The Company wishes to invite its shareholders to a videoconference to be held on April 15th, 2025. Dial-in numbers are listed below.
Closing Comments
We have emerged from a very challenging year with an updated and enhanced product and new commercialization plan. Timely and complete execution of this plan is dependent on securing growth capital which we are diligently pursuing. The entire Ventripoint team is committed to the Company’s success and we thank you for your continued support and for taking the time to read this update.
Sincerely,
Hugh MacNaught
President and CEO
This email address is being protected from spambots. You need JavaScript enabled to view it.
(604) 671-4201
Zoom Meeting on Tuesday, April 15th at 3pm EST.
https://us02web.zoom.us/j/84399789911?pwd=wNdxAVzE1oKnTacsdaHbG5zq3aPugG.1
Meeting ID: 843 9978 9911
Passcode 046727
One tap mobile
+16475580588,,84399789911#,,,,*046727# Canada
+17789072071,,84399789911#,,,,*046727# Canada
Dial by your location
• +1 647 558 0588 Canada
• +1 778 907 2071 Canada
• +1 780 666 0144 Canada
• +1 204 272 7920 Canada
• +1 438 809 7799 Canada
• +1 587 328 1099 Canada
• +1 647 374 4685 Canada
• +1 669 900 9128 US (San Jose)
• +1 689 278 1000 US
• +1 719 359 4580 US
• +1 253 205 0468 US
• +1 253 215 8782 US (Tacoma)
• +1 301 715 8592 US (Washington DC)
• +1 305 224 1968 US
• +1 309 205 3325 US
• +1 312 626 6799 US (Chicago)
• +1 346 248 7799 US (Houston)
• +1 360 209 5623 US
• +1 386 347 5053 US
• +1 507 473 4847 US
• +1 564 217 2000 US
• +1 646 558 8656 US (New York)
• +1 646 931 3860 US
• +1 669 444 9171 US
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
About Ventripoint Diagnostics Ltd.
Ventripoint has become an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint's VMS products are powered by its proprietary Knowledge Based Reconstruction technology, which is the result of a decade of development and provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold-standard alternative allows cardiologists greater confidence in the management of their patients. Providing better care to patients serves as a springboard and basic standard for all Ventripoint's products that guide our future developments. In addition, VMS+ is versatile and can be used with all ultrasound systems from any vendor supported by regulatory market approvals in the U.S., Europe, and Canada.
Forward Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. The use of any of the words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends'' and similar expressions are intended to identify forward-looking information or statements. The forward-looking statements and information are based on certain key expectations and assumptions made by the Company. Although the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information because the Company can give no assurance that they will prove to be correct.
Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to several factors and risks. Factors which could materially affect such forward-looking information are described in the risk factors in the Company's most recent annual management's discussion and analysis that is available on the Company's profile on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements included in this news release are expressly qualified by this cautionary statement. The forward-looking statements and information contained in this news release are made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, whether because of new information, future events or otherwise, unless so required by applicable securities laws.
Last Trade: | C$0.14 |
Daily Volume: | 10,500 |
Market Cap: | C$21.560M |
March 24, 2025 March 21, 2025 February 27, 2025 February 10, 2025 |
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
CLICK TO LEARN MOREC4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
CLICK TO LEARN MOREEnd of content
No more pages to load