What's next for MindWave.

We filed patent protection for our method of precise, confirmed alarm delivery. We began with a PCT application, and received a favorable written opinion from WIPO. We nationalized this to a fully granted patent in the US, and we are now nationalizing in additional countries.

We spoke extensively with hospital staff, administrators, and healthcare consumers to find out just how much alarm noise was a problem for them, and whether our solution would be accepted.

Our team built, tested, and refined a series of prototypes, translating 100 years of combined bedside ICU experience and an aviation-safety background into a system ready for real clinical environments.

We completed a clinical trial in India, validating benefits to patients and staff. Our results are currently being peer reviewed for publication. Our endpoints and study protocol are available at ClinicalTrials.gov and ISRCTN. Full trial results will be available here following peer-reviewed publication.

We are taking our prototype level design forward to full regulatory compliance and manufacturability.

We requested and received FDA designation for STeP (Safer Technologies Program), which mirrors the benefits of FDA's breakthrough device program for safety-focused innovations.

Completion of regulatory compliant engineering, verification and validation testing, and submission of completed FDA application for clearance.

We're forming partnerships with hospital systems to prepare for first U.S. implementations after FDA clearance. If your system wants to discuss participation, please reach out to us.

FDA clearance is anticipated following a successful engagement with the agency through the STeP sprint-discussion process with alignment of product, validation, and verification activities to agency satisfaction.

Initial clinical deployments will be piloted in partner institutions. Data from pilot studies further expand evidence on benefits observed in the international RCT.

We're targeting market availability within the next two years, bringing quiet, contingent alarm routing to hospitals throughout the United States.

We are preparing now for growth at scale. This begins with rigorous study of the potential benefits and designing for manufacturing and proper unit economics.