Mr.
Hugh MacNaught reports
VENTRIPOINT PROVIDES 2025 UPDATE AND OUTLOOK
Ventripoint Diagnostics Ltd.
has provided a shareholder update.
Dear shareholders,
Further to the update that was provided in December, I am pleased to share our outlook and objectives for 2025.
Technology and product development
Last year represented significant advances with the development of VMS+3.2 and VMS+4.0, and the granting of CE mark and a Health Canada medical device licence for VMS+4.0. This morning, we announced the provision of supplemental information to the Food and Drug Administration to support our submission for 510(k) clearance and anticipate a response prior to the end of February.
Looking forward, we will continue to refine and enhance VMS+, but the fundamental development activities are completed, and our focus is turning to additional cardiac indications and improving the integration of VMS+ into clinical workflows. With regard to the latter our evolving relationship with Ascend cardiovascular is leading to actively collaborating on enabling VMS+ to become an essential functionality within its technology stack.
We are developing training modules and support resources for clinicians to fully leverage VMS+ for optimal patient care. By placing a stronger focus on training, installation and support, particularly with regard to connectivity and clinical integration, our customers will enjoy more positive experiences with the technology.
Our team is now actively engaged with our users to develop stronger insights and incorporating these into product planning and budgeting. This discipline will ensure that research and development expenditures are based on clear understanding of market need.
Business development and partnerships
Ascend cardiovascular:
We are progressing to a licence agreement for the integration of VMS+ 3-D capabilities directly into the Ascend technology stack. This will be structured to start with the current product and form factor and support the evolution to a more seamless integration of our software and technology.
Ollie Hinkle Foundation:
We continue to collaborate with OHF and are pleased to have received two very good referrals by the foundation in late fourth quarter of last year.
South Asia:
Our continuing engagement with an Asian family office is leading to discussions concerning distribution, joint ventures, manufacturing and financial opportunities in the region. With its large population, improving living standards and growing health care needs, this region is an ideal fit for VMS+.
Valvular disease:
We will be announcing the recruitment of an industry adviser from a leading structural heart business to provide guidance to the development of our plans for this indication. The heart valve repair and replacement market is estimated to be approximately $9-billion in 2024 with a compound annual growth rate of 10 per cent through 2034. A successful proposition in this specialty would be transformative for Ventripoint.
Sales and marketing
With the advancements in our technology and regulatory approvals, the company is more directly focused on sales in 2025. Our new business plan is based on achieving commercial traction, creating recurring revenues and scaling the user base.
We will continue to work with our distribution partners in the United Kingdom and European Union. There were several qualified leads that we hoped to close in Q4 last year that we are continuing to pursue. Beyond these, there are a substantial number of on-site demos that are being arranged for 2025 and that will be initiated once additional growth capital is secured.
This month, we will be completing the installation and training at a prestigious institution in the U.S. Midwest. Our team is working to develop a strong relationship with this site and hope to leverage that into additional orders.
Because of the importance of the American market, we are implementing a new sales program that more directly addresses the needs of these customers. The objectives of this program are to clearly demonstrate a repeatable sales model. The program will be supported with stronger product propositions and refined product positioning to more effectively communicate the benefits of more timely monitoring of heart conditions, improved patient outcomes and reduced health care costs. The pricing of VMS+ will be
updated upon 510(k) clearance and financing options introduced to make VMS+ more accessible to health care providers of all sizes.
Upon securing growth capital, we will expand the sales team to engage directly with health care providers 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 are continuing the rollout of our reference centre program, which will enhance Ventripoint's visibility and highlight the impact of VMS+. The goal of the program is to actively collaborate with select 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.
Finance
In 2024, we 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 and enabled the company to continue its essential work. Looking forward, it is essential that the company secures sufficient capital to execute our ambitious plans. There is a sense that financial markets are improving in 2025, but Ventripoint has near-term capital requirements which must be addressed to achieve its milestones and exploit its window of opportunity.
We recently announced a second closing for the current convertible debenture offering, which provides attractive terms. The proceeds from this financing will be deployed to support commercialization activities, manufacturing, regulatory submissions and operations. Thank you to those who responded to our last update with participation in this round. The offering is being extended, and we have already received additional inquiries regarding investment in the round and have the ability to include those of you who were unable to participate prior to year-end.
Since the last update, I have had the opportunity to speak with a growing number of shareholders and continue to value your vision and support as we continue to advance VMS+. For some, it has been a long journey, but we are now at the point of offering a greatly improved product that will contribute to better health care outcomes for the millions of people suffering heart defects, diseases and disorders.
Closing comments
Our ability to maintain progress is a direct result of your invaluable support. VMS+ has evolved considerably since VMS+1.0, and is now a much more sophisticated and refined
product. In the coming weeks and months, we will be providing regular updates on our progress, particularly with regard to commercial achievements. Thank you for your continued interest and for taking the time to read this update.
Sincerely,
Hugh MacNaught,
President and chief executive officer
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 KBR 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 its 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 United States, Europe and Canada.
We seek Safe Harbor.
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