FDA application will be in the next week.
Taken from the MD&A.
Meeting with MD Anderson pg. 17
"The Company announced on June 4, 2018, only a few weeks after obtaining FDA clearance, thatMD Anderson Hospital had ordered a 4C-VMS+ to use for routine clinical assessment of oncology patients to determine cardiac changes during and after treatments. The machine is operational, and the staff trained. It has been used on a number of patients and the Company is meeting with the principal cardiologist in May, 2019 to assess their experience to date. MD Anderson has been one of the top two cancer centers in the USA for decades."
Maz in May - Page 18, end of first paragraph.
The reduction in the number of contrast-enhanced 2D echo studies would represent a significant savings in time and costs for echocardiology departments. It would also reduce the need to inject the patient with contrast media. The use of contrast-enhanced ultrasound is increasing in the western world with the burgeoning population of heavier peoplemaking it more difficult to obtain clear images using ultrasound.On July 17, 2018, the Company announced the study had begun and the research team reports a publication will be coming out in May.
VMS 3.0 Technical Glitch/Delayed Q2/Q3 - Top of page 29.
During 2018 the Company beganramping up sales and marketing efforts, however, with the announcement of the next generation VMS+3.0 System in development(see NR August 8, 2018), which eliminates the need for patients to remain motionless during image acquisition,improves the workflow of the VMS+ through a more intuitive user interface, and has a much smaller footprintwith an innovative new tracking sensor technology, many potential purchasers opted to wait for the launch of the new system once regulatory approval is received. Aside from two sales of the current VMS+2.0 systems in early 2019, expected sales ramp up has been delayed until after regulatory approval has been received.
Given the average 12-18 month sales cycle to hospitals, we do not expect to see revenues from the VMS+ 3.0 to be recognized for accounting purposes until Q4 2019 (i.e. after delivery and clinical acceptance).
The Company had expected to be able to submit the 3.0 for approval in Q4 of 2018, however, a technical issue with the new technology, now resolved, held up the submissions to Health Canada, European CE Mark and the FDA. Applications for approval are expected to be submitted in early May, 2019.
