Hi Codeai,
Just to clarify, the company is currently seeking BTS and the likes of the Calcification study, bench tests and SAVR trial plus a decade of evidence on Adapt are all part of the evidence to differentiate our device from the current standard of care and will be submitted in the near future for the application.
While not relevant at the moment Breakthrough Status may also possibly improve access to Medicare reimbursement down the track as this expands to cover devices like TAVR. Of course not to mention the boost this can give the SP once awarded (its important for various reasons that we get our SP up ASAP.) And of course BTS will be huge from a marketing, validation and valuation perspective.
So this is very important to me and may IMO be granted before we actually start our EFS in Q3 (fingers crossed).
”From the company’s announcement so far, looks like the current plan is to sign a partnership deal sometime around Q2/3 for the FIH TAVR trial.”
Can you please elaborate on the above comment and what part of any AVR announcements that you read that indicated this?
I don’t expect any deal / takeover action until after initial results from the EFS in Q4 21 or Q1 2022. While a partnership of some kind is possible I am increasingly accepting the idea that it might be a takeover offer. I find it hard to believe that one of the majors will want to share the spoils with us and not have 100% control of the device.
I suspect any deal or partnership will be with Medtronic or Edwards (I very much doubt it will be anyone else) who we have already met with many times and who know our device. Remember one of these companies have already completed due diligence on our science and know exactly what we own.
Don’t also forget our super strong connections to Medtronic. Micheal Oswell - Vice President of Technical operations and development at AVR did 9 years with MDT before joining us and when he left then he was their program manager.
Then there is the very important Dr Jeffrey Popma who was a key member of our Advisory Board and was instrumental in the development of DurAVR. He loves the science and believes in the device. Of course Dr Popma is now in a key position with Medtronic as VP and Chief Medical Officer in their structural heart decision and would be the key influencer when it comes to making any decisions around a partnership / takeover of AVR when it comes to the viability and value of our science / device.
So in a nutshell, this is all speculation and what will play no one knows but my money is on Medtronic to play a key role in our future one way or another.
DYOR and Not advice
(20min delay)