Dear Friend;
As I wrote yesterday the FDA clearance (their word for approval) could come any day and it came late yesterday. Here is the news release and some background:
1. The US market is one of the largest single markets for medical devices in the world. We estimate that it would take 16,000 VMS+3.0 to deal with all the patients who get echocardiograms per year. This number is growing at 7% per year (1,000 system per year more each year) with an expectation of 25M people over 65 years by 2030.
2. We are now approved to market the VMS+3.0 so we can contact several major centres who have indicated they wanted to know as soon as the VMS+3.0 was clearance for clinical use.
3. The label remains the same that the VMS+3.0 can be used on "any patient where the results are warrants or desired”, which means all the attending doctor only needs is to desire the analysis be done to help with the diagnosis or monitoring.
4. I remind you the VMS+3.0 is a portable device which can be added to any existing 2D ultrasound machine (GE, Phillips, Siemens, Toshiba, Samsung, Mindray…) and be operational in a few minutes. It now allows for patient movement during the exam and has a continuous user guide for the exam as well as the analysis. These features have made it very user friendly.
5. In addition, it is inexpensive to manufacture, which will allow us to offer it as “razor-razor blade” or per use sale to accelerate adoption.
6. FDA clearance helps us worldwide as everyone knows how difficult it is to get FDA approval.
7. This is a major milestone for the company, which has been a long time coming, but has finally arrived. The company is undervalued at $6M market cap. If we were a pharmaceutical company with a FDA-approved orphan drug for a $1B market we would be trading at 10-20 times this market cap. The news today should tell people we are a company with a large market opportunity.
