Monday, June 26, 2017 6:36:31 PM
Cyrcadia is in the process of filing for it’s 510K Class II FDA clearance in the United States, and with sufficient funding will file for CE Mark clearance outside of the United States, by the first half of 2017. And that the current clinical trials have listed Cyrcadia is a minimal risk technology, and that the majority of state legislations now require density notification here in the US, we believe the FDA look favorably on our filing, which may help expedite the normal laborious FDA time period for clearance.
Cyrcadia has established distribution in Singapore serving Southeast Asia, and a second distribution agreement in Australia, which also serves the UK. Intended launch for this technology is in large populations of Southeast Asia, and Europe through CE Mark clearance. Depending upon the time period of FDA clearance, the US will follow. With adequate funding, Cyrcadia launch outside of US by mid-2017, with anticipation of clearance for US interests by the end of 2017.
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