Wednesday, August 14, 2024 5:05:25 PM
"We are developing more robust hardware."
"We are working closely with FDA... we successfully submitted to the FDA in April... "
"In prep for a positive FDA decision we remain bullish..."
"We are already engaged with our strategic partners... they see our solution as an integral part of their future initiatives."
"We see a $20B/year market opportunity"
"Our SOC... has yielded breakthrough in cuffless blood pressure monitoring."
"We have been making enhancements..."
"We are evaluating AI based individual calibration techniques"
"Blood pressure will be a significant addition"
"Shipped 5,305 rings in first quarter"
"Launch generated a great deal of excitement.... delays led to cancellations... will ensure ample inventory before taking orders again. Expanded launch of Evie ring... eventual launch of Evie Med."
"Proprietary RF technology"
"Turnkey solution" -- not sure what this means, I think Movano gets to not think about it - it's done for them.
"Valuable lessons, significant progress"
"Advancing to next stage of blood pressure clinical studies"
"Updates to FDA process? Recently re-filed some new clinical results which exceeded expectations, more accurate results than two FDA approved hospital-grade devices. We have, since putting in new data, have had back and forth communication with our reviewer. Thus far things are going pretty well."
"More detail on plans for launch of EvieMED? We continue to engage with all of our beta partners. All are looking forward to our FDA clearance. This will unlock a host of opportunities. Are currently building the backend to prepare for this. We have large groups ready to work for us."
"Comment on progress seen in blood pressure? Our next big step... one is to take blood pressure reference design and make it ready, prepare algorithm for June to facilitate fast-tracking Blood Pressure approval."
"When will you start shipping Evie Rings? We went through a challenging capital situation into late last year early this year, hamstrung us on what we were able to do. However, getting this into the marketplace was great for us. Now that we have funding we are optimizing delivery, ring enhancements, enhancements to customer service. We are working with suppliers to get raw materials so we have several months of product before starting shipping. We will have inventory maintained before we open the spigot."
"Any updates on strategic investor or other partnerships? The current strategic investor, it has been a great relationship, only a month old. Multiple meetings with their team, they have offered us support in areas where they have more expertise than us. And we have discussed further opportunities where the ring could be beneficial to what they're doing with customers and where they see the market trends going. Also they are interested in our proprietary RF in the areas of Blood Pressure and Glucose. Since this engagement started it has been nothing but positive on our side and theirs. We have shared with them our stratgic plan, and gotten feedback from them, we are in complete alignment."
"Blood pressure: First device a ring or wristband? Our chip is 4mm by 6mm. In first go around we want to make sure that we get through FDA as quick as possible with what we have been testing. (Sounds like bracelet). EvieMed trials for SPO2 and heartrate, we looked at men and women and people with different skin tones. That was not limited to women, is for all. Discussions we have had with potential partners in the healthcare space, some are developing female focused solutions, others are looking at men and women. Nothing prohibits the ring from being used by men or women. As EvieMed comes to market it will be for both men and women. All data partners like our direct to consumer world, in medical devices and hospital all see it as a unisex device."
"You sold $1Million of rings immediately. Had unexpected delays on manufacturing side, was frustrating to consumers. Was a learning for us. Have modified our processes and inventory controls so we can deliver all orders within 5-7 business days."
"Thanks for being on the call today. Please stay tuned to our website."
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