Major Milestones in Our Journey to Transform Neonatal Care
We’re excited to share several major developments as we continue building the future of neonatal monitoring. From new clinical milestones to regulatory progress and research recognition, 2025 is shaping up to be a breakthrough year for our team.
We Received Our Patent for NeoMonki
Our team was awarded a U.S. patent for our core NAS monitoring technology. This innovation powers our wearable platform designed to detect early signs of NAS in neonates. Securing this patent protects our unique approach and supports future commercialization as we scale.
This technology represents a crucial step forward in non-invasive, continuous monitoring for at-risk infants, one that integrates real-time analytics and intelligent alerts for improved clinical outcomes.
30 Patients Enrolled at UNM, With More Clinical Trials Starting Soon
Our first clinical site at the University of New Mexico has successfully enrolled 30 patients in our neonatal abstinence syndrome (NAS) monitoring study. These initial enrollments validate both our technical readiness and our clinical team’s ability to execute on-site trials effectively.
We’re now expanding to additional clinical trial sites as part of a multicenter clinical trial. These studies will provide the data needed for regulatory submissions and further refine our platform's accuracy across diverse populations and care settings.
NIH Awards Us a Grant for Advancing NAS Care
We’re honored to have received a National Institutes of Health (NIH) grant to accelerate our research into neonatal abstinence syndrome. This non-dilutive funding supports continued development of our AI algorithms, clinical validation, and long-term study of real-world outcomes.
Receiving an NIH grant is a major validation of both our technology and our mission, and a testament to the clinical need for improved neonatal monitoring tools.
ISO 13485:2016 Recertification Achieved
Quality is at the heart of everything we do. We’re proud to share that our team has successfully completed ISO 13485:2016 survaliance audit, reaffirming our commitment to delivering safe, effective, and regulatory-compliant medical devices.
Maintaining this certification is essential as we prepare for broader clinical use and FDA submissions.
What’s Next?
With intellectual property secured, clinical trials expanding, and regulatory foundations in place, our focus is clear: deliver a world-class neonatal monitoring solution that gives clinicians the tools they need to intervene earlier, and improve the wellbeing of patients.
Stay tuned for updates as we announce new trial sites and continue building partnerships with hospitals and research institutions.
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