Dear Friend; Attached is a news release. Here is some background:
1. The VMS+ with analysis of all 4 chambers of the heart using 2D or 3D ultrasound was approved a year ago by the US-FDA. Ongoing consultation with the cardiology community identified ways to improve the VMS+ to make it more user-friendly as well as to reduce the cost of production. The result was the development of the VMS+3.0.
2. A key novel component was the creation and patenting of a tracking system based on modern microcircuits and advanced positioning software. This new tracking system was also established to allow patient movement during the exam, which was a major source of error and the most common complaint from sonographers, who usually move the patient to get the best window for scanning. Since the Company now manufactures the new tracking system, the cost is a fraction of the off-the-shelf system we purchased from an outside vendor and used in all previous VMS versions.
3. The Company has completed a usability study with 13 cardiac sonographers and they unanimously found the VMS+3.0 intuitively easy to learn and use. More on this in a future news release.
4. The next step is to complete the submissions to the US-FDA, Health Canada and Europe. These are minor submissions as we are not asking for a change in the label, simply updating them on the change in technology and sending them the data to show equivalency.
5. We anticipate the approvals will take a few weeks and so the sales team are gearing up to close some sales based on the delivery of the VMS+3.0. This is good timing as the MAJOR conference of the year is the Annual Congress of the American Society of Echocardiography and this year it is in Portland, June 21-25. While it is unlikely we would have US-FDA clearance for the ASE, we will likely have Canada and Europe and the congress is attended by cardiologists from all over the world.
6. The new tracking system will make it much easier to integrate the VMS+3.0 into an existing 2D ultrasound device and we are assessing various devices to see which device and company would be the best partner. Again more on this later.
I know it has been a long haul, but making cardiac diagnosis and treatment better for all and especially for children is worth it. I believe the new VMS+3.0 is the clinical tool cardiologists have been waiting for.
