Our Progress
We are acting to bring our vision to reality. Â The steps we have completed are summarized below.
Patent
We have received a favorable determination on patentability through the World International Patent Organization, and hold a patent on our innovations in the USA.
Verification of functional principles.
We have verified the function of the basic operational components of our design.
Initial Prototype
We have developed an initial pre-clinical prototype for each component of our system, which demonstrates the ability of the components to properly interact and meet our design goals. This prototype confirms that system functions are viable in a basic configuration.
US FDA Meeting
We have met with FDA regulators for initial feedback through the Q-Sub process which allows informal review prior to applying for device approval. Initial feedback was positive, with suggested changes which we are incorporating.
