jopatclo wrote: Dear Friend;
I hope the summer break has been rejuvenating. The team at Ventripoint has been working hard to complete the next generation of the VMS+ product family and submit it for approval.
Here is some background:
1. VMS+3.0 is our current model, which is being used in hospitals in Canada, USA, Europe and UK. (VMS+2.0 is being manufactured and used in leading hospitals in China through a partnership).
2. VMS+4.0 is the next regeneration model which incorporates a number of novel measurements of heart function as well as novel ways to view the data in three dimensions. This newest version speeds up the analysis of the heart through AI-assisted point placements and automated view recognition. This makes the VMS+4.0 much easier to integrate into the standard workflow within an echocardiography service unit in a hospital, clinic or remote imaging center.
3. The company previously announced the submission to the US-FDA (see NR May 6, 2024).
4. Today we are announcing the submission to Health Canada, which was filed a few weeks ago (see attached NR). Health Canada typically responds more quickly than the US-FDA so expect this to move along quickly,
5. The Company is now preparing submissions for clearances in UK and EU (CE Mark).
6. The Company continues to engage existing users about the previously announced upgrade to VMS+3.2, which had an improved tracking component that did not have a magnet and so made the VMS+3.2 suitable for patients with ICDs like pacemakers and defibrillators. The upgrade also allows for rapid linkage and calibration to all existing 2D ultrasound devices sold by OEM manufacturers.
7. The Company will continue to sell the VMS+3.2 as the “standard" device and intends to sell the VMS+4.0 as a “premium" device at a premium price, once it has received regulatory clearances.
Thank you for your continued interest and support as we continue to improve heart diagnostics for everyone, everywhere and especially for children born with heart defects.
Regards,
Dr. George Adams ICD.D
Executive-Chairman
Ventripoint Diagnostics Ltd.
TSXV-VPT
www.ventripoint.com
519-803-6937