BSI required them to include alarms and that required additional studies and data to support that inclusion causing delay. This is because all their competitors have now included these alarms and it has become the standard.
BSI backlog and Brexit also caused some delay.
They are planning a soft launch two months after CE in UK and Germany to address all user feedback before a bigger rollout.
I anticipate that they are really close to CE latest July/August.
device is for type II diabetes and prediabetes and wearable health tech. No type I.
I don't think the stock will move much after CE announcement until they show some sales. their pipeline is robust and the potential is still HUGE but need sales.
No capital raise before CE but potential secondary offering to ramp up manufacturing after CE.
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