Q1 2025 Update

TL;DR

• 2024 was a big year for us! We made a ton of technical progress and were awarded nearly $3.7M in federal grants.
• Speaking of federal funding, we emerged from the drama last week unscathed and expect no significant impact going forward.
• We have two huge upcoming technical milestones as we validate performance of our vital sign monitor to FDA standards and demonstrate proof of concept for our injection system.

2024 in Review

Here are a few top achievements from 2024:

1. Officially awarded NSF Phase I SBIR to develop autoinjector and naloxone formulation
2. Demonstrated that people with opioid use disorder are able to adhere to sustained wear of the Resilient Monitor
3. Officially awarded NIH Phase I / Phase II Fast-Track SBIR to develop overdose detection system
4. Produced a near-production ready prototype of the Resilient Pulse

Federal Funding Fiasco

We’ve received a lot of outreach from our supporters about the federal funding drama last week. There was a roughly 24-hour period where we didn’t have access to withdraw funds. However, the disruption to our business was minimal, mainly because we have several months of runway in our checking account. Going forward, we believe our funding won’t be a target of federal cuts, given that the current focus is on diversity initiatives, which we have not received any funding for.

Brad also spoke briefly with the Pittsburgh Post-Gazette on the topic as part of their two article series (Brad is quoted in the second link):

‍Pittsburgh researchers caught off guard by NIH funding confusion: ‘This could set us back decades’ ‍

How do scientists actually get NIH funding?

Upcoming Technical Milestones

1. Validation of our vital sign monitor

To date, building the hardware to measure vital signs has represented the majority of our efforts as a team.  Our internal testing now looks incredibly promising:

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Our SpO2 measurement’s root mean square error (RMSE) compared to a reference pulse oximeter was 4.61, where our target when measuring against a separate FDA approved pulse-oximeter device is 4.24. The primary deviations were due to time-shifts between the Masimo and our device. This is the least concerning error to see for a few reasons:

1. It can be expected due to different smoothing/averaging algorithms used in our device vs the Masimo device
2. We’re measuring oxygen saturation at different points on the body, so there’s potential that each device is accurately reporting oxygen saturation for a given time on the right body area
3. Our data sets had several measurements going below 70% SpO2, and for the FDA tests, we only need to go down to 70%
4. Most importantly, the SpO2 tests required for FDA approval are far more forgiving than the test we’re running. In the FDA tests, the subject will be stabilized at each SpO2 level (e.g. 100%, 90%, 80%, 70%) for several minutes, so we’ll measure our device’s reading against consistent values from the reference device, rather than trying to perfectly match rapidly changing values.

Given this, we’re quite confident that we’ll perform well for our measurements when we do the next rounds of testing with our next iteration of hardware improvements and a dramatically more forgiving testing procedure. Success in this measurement will be key to unlocking the next $3M in NIH funding from our SBIR grant. Our device also measures other vital signs such as breathing rate and pulse rate, and is doing quite well there. We’re most focused on SpO₂ as it is the most difficult of the vital signs to measure.  2. Completion and testing of our auto-injectorOur first version of the auto-injector is nearly ready for testing! Next week, Brad and Kevin will be testing the injection system in administering subcutaneous injections on pig skin. Success here will justify an application for Phase II SBIR funding from the National Science Foundation.That's all for now! As always, please reach out if you have any thoughts or questions; we'd love to hear from you.

Thank you for your continued support,

Brad + Charlie

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