Ventripoint Diagnostics Ltd. (VPT.V ) applies of AI (Artificial Intelligence) to echocardiography. Ventripoint's VMS products are powered by its proprietary KBR technology, which provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold-standard alternative allows cardiologists greater confidence in the management of their patients. 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.
Thesis
The Company’s KBR method, a form of Artificial Intelligence (AI), allows for the creation of a three dimensional model of all the chambers of the heart; right and left ventricles, and right and left atria, using images generated from existing 2D and 3D imaging equipment. The Company’s technology platform is applicable to all heart diseases.
The VMS system is based upon patented and proprietary technology that Ventripoint has licensed on an exclusive basis from the University of Washington. The VMS+3.0 system (hardware and software for 2D echocardiograms) and VMS+3.0 software (software only for 3D echocardiograms) has US FDA marketing clearance, Health Canada license and European CE Mark for all patients where volumetric information for any of the 4 chambers of the heart is warranted or desired.
The VMS enables medical professionals to economically obtain accurate three-dimensional models with critical volume and functional measurements of a patient’s heart chambers in only a few minutes more than the time needed for a routine echocardiogram. Measuring volume and function is fundamental in evaluating patients to determine the severity and progression of their disease, assess treatment effectiveness, gauge prognosis and decide on the timing of surgical and pharmacological interventions. These key measurements and the 3D model for visual assessment provide medical professionals with critical information necessary for clinical diagnosis and monitoring of their patient.
Ventripoint's VMS interfaces with all standard echocardiogram 2D cardiac ultrasound machines (GE, Siemens,Philips, Toshiba). VPT.V reports having spent more than 10 year and $30M development of VMS 3rd generation AI software which now elevates 2D echocardiogram to MRI level accuracy. Hence, VMS+3.0 takes 2D Echocardiogram (Cardiac Ultrasound) Images and can provides 3D cardiac measurements equivalent to MRI for a fraction of the cost and time.
VPT.V is approved for sale in USA, EU, Canada and China and has placed its product 16 clinical sites to date.
Can – 5 sites completed/2 additional sites in process " US – 1 site completed/4 additional sites in process " UK – 1 site completed and 3 sites in process " Europe – 1 site completed/2 sites in process " China – 8 sites completed.
News Releases
Feb. 16 - Advances Sales, Marketing, & Distribution Partnership in China. Provide a corporate update on sales and marketing activities in China by our joint-venture partner Yutian Medical Shanghai Inc. (“Yutian”). Yutian has achieved a number of milestones in its path from development to commercialization. Some of these are noted herein.
Yutian has developed a series of products based upon Ventripoint’s knowledge-based reconstruction technology under the name QAS™ to specifically meet the demands of the Chinese market using components sourced in China.
They have built and obtained a license for a manufacturing facility in Ma-anshan. The QAS (right ventricle only) has received Chinese FDA (“CFDA”) approval and the QAS analysis procedure has been added to the provincial medical billing catalog in Anhui Province (a province of 62 million people).
With market clearance obtained, 2020 was a very successful and foundational year for Yutian’s marketing efforts in China. They successfully installed the QAS in the hospitals of the top three medical universities in Anhui Province, as well as leading hospitals in the cities of Shanghai (one of the four direct-administered municipalities with 27 million people), Hangzhou (capital city of Zhejiang province with 57 million people), Wenzhou and Zhengzhou (capital city of Henan province with 94 million people). A total of 8 QAS machines are currently operational in China.
Feb. 23 - Ventripoint Heart Analysis System to be used at the Stollery Children’s Hospital to Study Atrial Dysfunction: Initiated a clinical study to measure atrial volumes and ejection fractions in children with suspected valvular disease.
The study is conducted by cardiologists in the Department of Pediatrics, Division of Pediatric Cardiology at the University of Alberta in collaboration with the Mazankowski Heart Institute and Stollery Children’s Hospital.
The VMS+3.0 is uniquely able to measure volumes for all 4 chambers of the heart using 2D ultrasound and so can provide regular monitoring of children throughout their early years as the heart grows. This information is critical to determine the need and timing for therapeutic interventions.
This study aims to demonstrate the capabilities of the VMS+3.0 in assessing the performance and function of the left and right atria in combination with the ventricle assessment. For comparison purposes, the children will also be assessed by 3D ultrasound, as well as MRI, when possible.
Feb. 25 - Correction - Ventripoint Diagnostics Issues Shares in Final Payment of Debenture Interest: Announces correction to February 10, 2021 press release. The Company has issued an aggregate of 96,961 shares, rather than the 131,430 shares previously announced, for the final interest payment of $23,274 on Convertible Debentures issued by the Company on February 6,2020, replacement Convertible Debentures issued the same date, and Convertible Debentures issued September 11, 2020. The shares will be issued at a deemed price of $.24 per share. Two directors of the Company will receive a total of 30,186 common shares in final payment of $7,245.88 of interest on their debentures.
All convertible debentures have been converted and the Company is debt free.
Mar. 2 - Begins Training Chinese Cardiologists in Heart Analysis System and Achieves First Commercial Sales: Its partner, Yutian Medical Shanghai Inc. (“Yutian”), has reported a successful engagement with key opinion leaders in the echocardiography sector in China. A training session in the use of the QAS™ (VMS™ in China) has been conducted in China for approximately 60 echocardiologists. The session was offered in cooperation with one of the leading University Hospitals in China and organized by the China Medical Association, Intensive Care Division.
In addition, Yutian has appointed tier-1 distributors in major regions throughout China and has already signed agreements with minimum sales targets totaling 30 million RMB (~$6M Canadian) for 2021 from this initial group of distributors.
There are 34,000 hospitals in China and 1,000 new hospitals being built each year. The rate of admissions for CVD in China is almost twice that of the United States and Europe, as China has not been as successful in changing people’s habits and thus provides critical cardiac care.
Mar. 3 - Receives Additional Wage Subsidy Assistance and Updates Warrant Exercises: Receiving an additional temporary wage subsidy of up to $43,353 as part of the National Research Council of Canada Industrial Research Assistance Program’s (NRC IRAP) Innovation Assistance Program (IRAP IAP).
This follows the previous wage subsidy funding of the $176,103. The Company has continued to receive other loans and subsidies and so the total amount of government support has been approximately $524,000 to date.
In other news, 100% of the warrants issued in association with the convertible debentures (see NR February 3, 2021) and having an exercise price of $0.10 have been exercised and shares issued. The Company received gross proceeds of $2,393,700 from the exercise of these warrants.
Mar. 9 - Passes Regulatory Inspection of Manufacturing Facility and Audit of Quality Assurance System: completed another successful NRTL inspection of their manufacturing facility for the manufacture of the VMS+ 3.0. This signifies the conformance of the VMS+ 3.0 with electrical safety standards required to sell in Canada and the United States.
The Company has also successfully passed an MDD 93/42/EEC-Annex II audit for EC Certification of their Quality Assurance System. This audit involved a comprehensive review of the CE Marking Technical File of the VMS+ 3.0 by its Notified Body for compliance with the Essential Requirements of the European Union. This certification is a requirement for compliance with the EU Medical Devices Directive 93/42/EEC and will allow Ventripoint to continue to sell its products in the 27 Member States of the European Union.
Mar. 16 - Ventripoint JV Begins Process to have Heart Analysis System Certified for use in COVID Patients in China: Its partner, Yutian Medical Shanghai Inc. (“Yutian”), has reported Chinese guidelines for the diagnosis and treatment of COVID-19 patients now require the monitoring of rightventricular function by non-invasive techniques.
The QAS™ (VMS™ name in China) provides a safe and convenient solution to meet that requirement. Yutian is actively working with regulatory bodies to have the QAS certified for COVID patients and has been successful in placing the QAS devices in intensive care units (ICUs).
The Vice-Director of one of the leading hospitals in Shanghai, an early adopter of this application, thinks that they will need at least 3 QAS machines in their ICU department to be adequately resourced for potential future COVID needs.
Apr. 13 - Begins Publication of Case Studies Showing Meritorious Use of the VMS Heart Analysis System: Published its first case study of the meritorious use of the Ventripoint VMS whole-heart analysis system in routine clinical practice.
A series of case studies and white papers will be published over the next several months to showcase various limitations of current clinical practice, which are overcome by the VMS family of products. Coming topics include user experience perspectives, usability of the VMS products, and VMS use in patients infected with COVID-19.
Apr. 15 - Announces Sponsorship for the 2021 Canadian Society of Echocardiography Weekend Conference
Apr. 19 - Extends Patent Portfolio with U.S. Provisional Patent Filing of Heart Motion Tracking Technology: Filed a U.S. provisional patent application for its novel cardiac measurement approach.
This new measurement technique provides cardiologists with additional and more precise information about the function of the heart through motion tracking. This invention is as an extension of the Company’s existing artificial intelligence (AI) platform, which provides accurate and reliable volumetric measurements for all four heart chambers.
This new technology tracks the movement of heart and valves through the entire heartbeat and not just at the full and empty points in the cardiac cycle. This dynamic information can help in initial diagnosis and assessing the effectiveness of treatments, as well as the timing of interventions thereby improving clinical outcomes.
Apr. 20 - Attends 23rd Annual Canadian Echo Weekend and Grants Stock Options: Attends the 23rd Annual Canadian Echo Weekend – 2021 Digital Edition, which was organized by the Canadian Society of Echocardiography (CSE).
In other news, on April 12, 2021 the Company granted 100,000 stock option grants to a consultant and 100,000 option grants to an employee. The stock option grants vested immediately and have an exercise price of $.50. After this grant, the Company has 836,250 options remaining for future grants.
Apr. 27 - Collaborates with GE Healthcare to Bring More Functionality to its Cardiac Ultrasound Devices: Ventripoint has been added as an innovator under GE Healthcare’s Edison Developer Program,which helps healthcare providers gain access to market-ready applications. As an innovator under this program, our installed base will be enhanced and will drive Ventripoint’s commercial growth worldwide by accessing GE Healthcare’s global channel.
The collaboration between GE Healthcare and Ventripoint offers the potential to enable the medical technology company’s global customers to leverage the advanced 3D image analysis tools from the Ventripoint software applications for studies obtained using GE Healthcare’s suite of Vivid cardiac ultrasound products.
May 4 - Receives Government Funding To Advance Development of Next Generation of VMS+: Receiving advisory services and research and development funding of up to $120,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to further enhance cardiac measurement capabilities of the VMS+
It is a continuation of a previously successful NRC IRAP-funded project that resulted in the development of VMS+3.0.
The next generation of the VMS+ will incorporate advanced cardiac measurement features to add further clinical value to the VMS+ product thereby improving healthcare outcomes. The primary objective of this new proposed product is to provide a complete echo cardiac analysis package with conventional 2D measurements as well as the 3D measurements currently uniquely provided by the VMS+ using 2D ultrasound. This will provide more quantitative data to clinicians and a visual aid to outline the interrelationships of the heart.
May 21 - Announces Sponsorship for the 54th Annual Meeting of the Association of European Paediatric and Congenital Cardiology and Provide Financial Update: Bronze level sponsor for the 54th Annual Meeting of the Association of European Paediatric and Congenital Cardiology (AEPC) to be held digitally on May 25th- 27th, 2021.
On March 23, 2017, the Company issued 10,396,938 warrants at an exercise price of $.50. Since the last update (see NR May 9, 2021), more of these warrants have been exercised. As of today, 3,385,127 (~33%) have been exercised for gross proceeds of $1,692,564. Insiders of the Company have exercised 612,500 of these warrants representing $306,250. There are 7,011,811 outstanding warrants, which expire May 23,2021.
There remains 1,286,666 of the warrants issued on October 2, 2019 and having an exercise price of $0.115. These warrants expire on October 2, 2022. There are no other warrants outstanding. Since the last update (see NR May 9, 2021), the Company has had 175,000 options exercised for gross proceeds of $63,750. There are 6,498,750 options outstanding with exercise prices between $.10 to $.50. 3,188,750 of these option grants have vested and the remainder will vest over the next 2.7 years. The Company has 1,828,685 options available for future grants.
July 2 - Issues Option Grants to Consultants and a Director of the Corporation: An aggregate of 850,000 options to consultants and a Director of the Corporation at an exercise price of $0.30 for a term of one year and vesting from immediately to over 9 months. The Corporation now has 1,078,685 options available for future grants under the Stock Option Plan as approved by shareholders at the last Special and Annual General Meeting on December 14, 2020."
July 5 - Engages Digital257 for Social Media and Investor Relations Services: In consideration of these services, the
company has agreed to pay Digital257 a fee of $92,500.00 (Canadian) for an approximately nine-month contract.
Aug. 9 - Announces Patent Application for Improved Heart Analysis: Filed an international application under the Patent Cooperation Treaty (PCT) to protect the recent novel improvements of cardiac measurement technology.
This latest application strengthens the company’s intellectual property position and coverage for the Ventripoint’s flagship products. With this one international patent application, Ventripoint registers its claim to this invention in at least 153 different contracting countries under the PCT.
The patent relates to the method of using 2D and 3D echocardiography data for mapping and displaying the anatomical structure of the heart for all four pumping chambers of the heart.
Summary
Yutian
Ventripoint Diagnostics (VPT.V) has a JV with Yutian Medical Shangai Inc. In February 2021, the company reported that Yutian had developed "a series of products" based on VPT.V's technology under the name of QAS (right ventricle only). In addition, to securing manufacturing, QAS received Chinese FDA (CFDA) approval.
There is a total of eight QAS machine currently operational in China. Specifically, in the hospital of the top three medical university in Anhui, along with leading hospital in Shangai, Hangzhou, Wenzhou and Zhengzhou.
In March 2021, Ventripoint Diagnostics reported that Yutian trained 60 Chinese Cardiologist in the Heart Analysis System and which was organized in conjunction with the China Medical Association, Intensive Care Division.
In addition, Yutian has appointed tier-1 distributors in major regions throughout China and has already signed agreements with minimum sales targets totaling 30 million RMB (~$6M Canadian) for 2021 from this initial group of distributors.
Also in March 2021, Yutian began the process of getting QAS certified for usage with COVID Patients in China.
The Vice-Director of one of the leading hospitals in Shanghai, an early adopter of this application, thinks that they will
need at least 3 QAS machines in their ICU department to be adequately resourced for potential future COVID needs.
GE Healthcare
In April 2021, Ventripoint Diagnostics was added as an innovator under GE Healthcare’s Edison Developer Program. The aim is to bring more functionality to its technology along with introducing it to healthcare providers.
The collaboration between GE Healthcare and Ventripoint offers the potential to enable the medical technology company’s global customers to leverage the advanced 3D image analysis tools from the Ventripoint software applications for studies obtained using GE Healthcare’s suite of Vivid cardiac ultrasound products.
Clinical Study
February 2021, a clinical study using Ventripoint Diagnostics' Heart Analysis system was reported. The aim is to measure atrial volumes and ejection fractions in children with suspected valvular disease.
The study is conducted by cardiologists in the Department of Pediatrics, Division of Pediatric Cardiology at the University of Alberta in collaboration with the Mazankowski Heart Institute and Stollery Children’s Hospital.
The VMS+3.0 is uniquely able to measure volumes for all 4 chambers of the heart using 2D ultrasound. This study aims to
demonstrate the capabilities of the VMS+3.0 in assessing the performance and function of the left and right atria in
combination with the ventricle assessment. For comparison purposes, the children will also be assessed by 3D ultrasound, as well as MRI, when possible.
Earnings
VPT.V is still a pre-revenue company. However, it continues to raise cash from previous equity financing activities.
Financing
February 2021, VPT.V issued 96,961 shares ($0.24 cents) to pay convertible debentures. At that time the company reported that all debentures had been converted and that the company was debt free.
March 2021, a wage subsidy was received from NRC IRAP of $43,353. Also reported was that all of the warrant issued in
relation to the debentures ($0.10 cents) have been exercised resulting in a gross proceed of $2.3M.
May 2021, a NRC IRAP of up to $0.12M was disclosed to assist in the development of next generation VMS+. Also VPT.V provided an update on warrant exercise for a gross proceed of $1.69M.
Events
VPT.V has sponsored two events: the Canadian Society of Echocardiography Conference (April 2021) and the 54th Annual Meeting of the Association of European Paediatric and Congenital Cardiologist (May 2021) as well as publishing a few case study relating to the use of its technology.
Patents
April 2021, VPT.V file a provisional application to protect its IP relating to Heart Motion Tracking Technology.
This new technology tracks the movement of heart and valves through the entire heartbeat and not just at the full and
empty points in the cardiac cycle. This dynamic information can help in initial diagnosis and assessing the effectiveness of treatments, as well as the timing of interventions thereby improving clinical outcomes.
August 2021, VPT.V filed an international application under the Patent Cooperation Treaty (PCT) to protect its IP. This one application will cover over 150 countries.
The patent relates to the method of using 2D and 3D echocardiography data for mapping and displaying the anatomical
structure of the heart for all four pumping chambers of the heart.
Options
In July 2021, 850,000 options were granted at $0.30 cents for a year, vesting immediately over 9 months.
In Short
VPT.V has been valued as high as $0.67 and as low as $0.28 cents in the period. Much of the upswing in valuation came in March, April and early August 2021 when a number of disclosures were made in relation to Yutian (first commercial sales and initiation of certification for Covid-19 use), Regulatory Inspection completion (NTRL;US and Canada and MDD 93/42/EEC-Annex II audit; EU, 27 member states), and patent filings (US and up to 150 countries through PCT).
Furthermore, the addition as an innovator under GE Healthcare’s Edison Developer Program. was also a catalyst. Ventripoint Diagnostics also received NRC IRAP funding to further development of next generation VMS+.
However, earning reports to date indicates that VPT.V is still a pre-revenue venture. Most of the cash generated comes from previous equity financing activities; $2.45M in cash was reported in Q1 2021 and an additional $1.64M was reported in May 2021. The company also recently reported being debt free.
Nonetheless, VPT.V seems to have a robust revenue model and sizable addressable market for its targeted areas.
As per Q1 2021 MD&A , two items were notable.
Commercialization
The Company has sold or has new orders and commitments for a total of 19 VMS+3.0 devices. New orders have not been fulfilled due to the temporary restrictions of hospitals with COVID-19 pandemic. To date, the Company has installed six VMS+3.0 machines in cardiac centres in North America, one in UK, and one in Europe. The Company has sold and delivered three VMS+3.0 machines to its Chinese partners for demonstration and research use and received full payment.
VMS+3.0 Purchase Orders and Commitments to Customers
The Company has purchase orders and has committed to supply ten VMS+3.0 machines with expected revenue of approximately $300,000 in the next 6 months. Some of these purchases will be on a lease and pay-per-use arrangement and so the Company will be building recurring revenue streams with these leading cardiac centres.
Hence, the outlook for VPT.V appears to be promising.
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