Hi R-7,
The original 3 year supply agreement with Abiomed was announced on the 13th November 2017. According to that announcement Sensera began manufacturing the sensors in the first quarter 2018 and is now ramping up.
As far as I know the supply of sensors to Abiomed was not dependent on ISO 13485 certification.
Abiomed cannot sell the new Ampella device without the Sensera fluidics sensor.
Don't forget the Ampella device has FDA approval with the Sensera sensor included and that we own part of that IP, so it would be very hard for someone else to step in. What would that sensor / IP be worth to Abiomed which is a US15 bil giant dependent on the Ampella device ?
I notice in that Nov 13 announcement that Sensera was expecting between US$2.5 mil and US$3 mil in revenues from Abiomed for the 6 month period to 30 June 2018. One could easily extrapolate that to US$5 to US$6 mil for the 30 June 2019 year. I believe these numbers will prove conservative.
Amazing to think this is just one of the many verticals that Sensera has in play.