Refinements for final design will be concluded through precision automation on a Pilot Production System for final testing in humans using the CCM® 3E™ LS™ AJP Platform. An expedited approval process is expected via either EUA or 510(k) notification process along with demonstrable, repeatable manufacturing processes.
Prior FDA Collaboration
Concepts have been verified ex-vivo for 3E™ LS™, and the ‘general’ wired enzyme capability has been verified in YSI controlled animal models [both single and continuous monitors]. The matter of employing interstitial fluid for a single point system is mitigated by the experimentally defined testing times as currently accepted clinical decision-making standards. The presence of signal has been verified for LS™ 2E™ in vivo on hand-built sensors. The larger clinical application of interstitial fluid as a valid measure is defined by the other continuous monitors that are already FDA approved as a predicate device for Pepex FDA submission. This scenario simultaneously validates our 510(K) approach which will involve a relatively straight forward clinical trial requiring less scale [less than 500 patients] and a compressed timeline.
Electrochemical Performance of the 3E Needle Sensor