Seattle, Washington, November 5, 2014 – Ventripoint Diagnostics Ltd. ("Ventripoint")
(TSXV:VPT) is pleased to provide this corporate update. - Major clinical paper published demonstrating excellent results for VMSTM in a number of clinically challenging heart conditions, including Hypoplastic Left Heart Syndrome
- New sales in Europe, Canada and the USA and marketing success in USA
- First VMS sent to China to be installed in major hospital
- Re-admission clinical study started with 17 heart-failure patients enrolled
More Clinical Success The group from L’hpital Universitaire Necker-Enfants Malades in Paris, France has published a paper entitled: “Knowledge-based 3D reconstruction compared to MRI for evaluation of right ventricular volumes and function in congenital heart diseases affecting the right ventricle” in Archives of Cardiovascular Diseases, Volume 107(9), 491-500. For the first time, along with a wide range of patients with congenital heart disease (CHD), patients with all stages of repaired Hypoplastic Left-Heart Syndrome (HLHS) were studied. The VMS allows for repeated evaluation of these very ill children, while MRI is very difficult and dangerous to perform. This is of particular concern in
these HLHS patients. The paper concludes: “3D-KR ... provides accurate and reproducible measurements of RV volumes. This new technique can be used as an accurate routine tool to assess RV function in CHD”. Sales in Canada and Europe The sales team has recently finalized the sale of a number of VMS units to hospitals in Europe and Canada. The institutions that purchased the VMS units are St. Antoniusziekenhuis, located in Nieuwegein, The Netherlands, Glenfield Hospital of the University Hospitals, Leicester, United Kingdom, and the Mazankowski Alberta Heart Institute in Edmonton. These hospitals specialize in adults with cardiac disease and heart failure and pediatric complex congenital cardiac disease. This demonstrates the continued adoption of the VMS for routine clinical use in a broad spectrum of heart diseases. The Company is currently waiting for purchase orders for an additional three units in Europe and one in Canada. Our distributor in France has also indicated a renewed interest in RV analysis and has identified seven hospitals interested in acquiring a VMS unit and is starting the sales cycle at each location.
The Company will be exhibiting at EuroEcho-Imaging 2014, the largest gathering of cardiologists focused on cardiac ultrasound in Europe. This year it will be held in Vienna, Austria from December 3-6, 2014. Marketing and Sales in the USA We are pleased to report that our new marketing and sales team has completed the review of US hospitals and has identified 400 cardiology hospital groups who have published research papers with a focus on right hearts in the last two years. The team is systematically approaching these hospitals for on-site presentations. The response has been very positive with nearly all of the first 20 hospitals that were contacted requesting a presentation. The team has completed on-site marketing presentations to five hospitals from within this identified group and has received indications that all five hospitals will purchase from one to three VMS units each. In addition, these hospitals have recommended the equipment to their associated hospitals.
The marketing group has also identified an additional 3,340 hospitals with special right heart clinics. These numbers do not include additional locations such as cardiac imaging centers and cardiac clinical groups (large offices). As observed at the annual meeting of the American Society for Echocardiography in June, there is an increasing interest in right heart analysis and the information it provides for patients with left and right heart failure. All indicators are positive for successful sales of the VMS heart analysis system.
We are also pleased to report that Nationwide Hospital in Columbus, Ohio has purchased the VMS unit that they used during the clinical trial.
“It is encouraging to see multiple hospitals assembling their cardiology teams to hear about the VMS and then going forward to seek funding to acquire one or more units,” said Jim Bodtke, V.P. of Clinical Affairs and Development at Ventripoint. “While the process to get a budget allocation within a large US hospital takes time, we are encouraged by the cardiology community’s receptiveness towards the VMS approach
for RV analysis in all types of heart-failure patients.” Sales in China The Company has received payment for the first VMS heart analysis system from our distribution partner (see press release on September 2, 2014) and the equipment has been sent to China for installation in a major cardiac hospital as a marketing and demonstration site, while regulatory approvals for routine clinical use are obtained. Deployments are expected to begin early in 2015 with machines being leased to the distributor and placed in hospitals on a pay-per-use basis. According to official data, one in five adults has cardiovascular disease in China, and this number is expected to rise by 50% over the next 20 years primarily due to a large population of smokers and the high prevalence of diabetes. With one of the highest death rates from heart disease, the Chinese Government is taking aggressive steps to identify ways to improve diagnosis and treatment. This represents a billion dollar opportunity as cardiovascular diseases are the number one killer in China. Re-Admission Clinical Study The clinical trial at Montefiore Hospital in New York City has begun and 17 patients have been enrolled to date. The study is designed to show that functional RV analysis, using the VMS on patients with left-heart failure, can aid in identifying patients who will be re-admitted to hospital within 30 days of initial discharge. The national average for the United States is 26% of patients return within 30 days. The Affordable-Care Act made cardiac re-admission rates a major metric for hospitals to improve. In 2013, approximately 2,300 hospitals had unacceptable re-admission rates and paid penalties totaling $330 million at the current 1% level of total billings to Medicare. In 2014, there
were still roughly 2,300 hospitals with unacceptable re-admission rates and the penalty increased to 2%. On October 1, 2014, the third year of the program started and the penalty was increased to the 3% level.
The Company has done an analysis of the effect of a 5% reduction in re-admission rates (from 26% to 21%) and determined the average hospital would benefit with $1.3 million in new or recovered revenue from better bed and MRI usage, as well as recovery of penalties and re-imbursements for the VMS procedures themselves. The study is ongoing and an interim analysis will be done once a sufficient number of patients has
completed the 30 day period. The study will also look at 90 day re-admission rates to determine additional benefits from functional RV analysis. Other News The Company also announces, subject to all necessary regulatory and TSX Venture Exchange approval, that it intends to issue 937,500 Common Shares at a deemed price of $0.064 per Common Share in payment of CDN$60,000.00 of accrued interest owing to the holders of outstanding debentures of the Company. About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate tool for measuring right ventricle heart function. The Corporation has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts - a multi-billion dollar market potential. |