Dear Friend;
Attached is a news release, which announces our successful Human Factors Study with operators to verify the user-friendly and easy-of-use of the VMS+3.0. Here is some background:
1. Recently, we announced the filing with Health Canada, Europe and US-FDA for approves to market the VMS+3.0. All agencies have accepted our submissions as complete and they are under substantive technical review at this time.
2. As a new part of all medical device submissions is a “Human Factors Study” to verify that the software can be easily operated and understood by users. We conducted a study with clinicians wherein we trained them on the VMS+3.0 and then sent them away. A few days later they returned and were tested to see if they could operate the VMS+3.0 without assistance. We were overjoyed to have 100% success. Everyone easily was able to operate the system.
3. This study proves the the system is easily learned and not easily forgotten. The study participants even commented on how intuitive the system was and how it was obvious to them even in the training how to use the VMS+3.0.
4. The “ease-of-use” part is one feature of the upgraded system along with the guided procedure and no more need to keep the patient motionless. These are the features users of the VMS+2.0 had requested.
5. From a business perspective, the VMS+3.0 is much cheaper and easier to manufacture. As a result, we have established manufacturing for the VMS+3.0 in our headquarters. The lower mill cost will have a significant impact on our margins. The device is much smaller and is now portable. This makes it possible for our sales people to take it with them and do an on-site evaluation. These on-site evaluations are also what potential customers have been asking for. They want to be able to scan a patient and reconstruct a heart before committing to initiate the process to purchase the VMS+3.0
6. We are looking forward to exhibiting at the American Society of Echocardiography next week in Portland, Oregon. This is the largest conference of the year which is dedicated solely to cardiac ultrasound. The Mazankowski Heart Institute has a presentation on the VMS+ at the conference and will be reporting on their study of the reduction or elimination of contrast media in technically-challenging patients, which have “unreadable” conventional 2D echocardiograms. We believe the VMS+ can “read” the “unreadable” studies and there will be no need for contrast media. We await the report of their independent clinical assessment.
