As Cyrcadia prepares to move to clinical markets, Matt Benardis, CEO; Jim Holmes, CFO; along
with our Clinical Research associate (CRA) met with clinical trial investigators and administration
at El Camino Hospital, in San Mateo, CA, to discuss previous participant follow-up and trial
resumption with our modified clinical product and associated study protocol.
Do note trial details are not revealed in advance nor can Cyrcadia, Inc., the study Sponsor, have
any impact on the procedures in order to maintain FDA trial integrity.
However, they did ascertain a number of positive aspects with El Camino trial manager
- Initial trial participant follow-up continues to contribute to the Artificial Intelligence
analytics improvement and population of the database.
- Trial managers confirmed their agreement and enthusiasm for protocol revisions
regarding the reduction of wear time for trail participants to 2 hours, potentially
accelerating participant subscription.
- Trial managers were very positive and affirmed their ongoing interest in the
resumption of the study and its completion providing study outcome data for FDA
It is important to understand one of our issues was women recently diagnosed with breast
cancer were reluctant to be committed to an up to 24-hour wear time. All agreed that our
revised 2-hour wear time protocol would potentially increase participation and accelerate trial
completion. It is notable that our artificial intelligence algorithm research has developed
verifiable evidence to substantiate a 2-hour wear time with equivalent accuracy results as
compared to the historical 24-hour wear time.
Updated production schedule from Jabil Electronics and Cyrcadia Asia to provide product
revisions related to shelf life and improved ease of use, as well as information for the revision
and clearance of the study protocol to coincide with product delivery via Cyrcadia Asia.