May 2023 Update

Engineering progress and an update on our product development Roadmap

Latest updates

Brad speaking at Xchange Innovation Week
Brad speaking at Xchange Innovation Week

How you can help

Our key open role is an Algorithm Engineer. Bonus points if they’re comfortable with C and/or embedded software. Please send anybody you think of our way!

April's highlight

Sexy engineering photos coming up! It’s always fun to have new visuals to reflect our technical development. This month, we completed designs for our printed circuit boards, as well as a new visualization of our final device.

Front (top left) and bottom (top right) views of our latest device rendering. 3D model of the controller board (bottom left) and wiring layout for our sensor board (bottom right) for our trial device.

An updated look at our regulatory pathway and product roadmap

We’ve learned a lot since our launch one year ago, and that has helped to inform plans for approaching the FDA and commercialization.

First, we’ll be regulated as a drug-led combination product by the FDA. This means we’ll leverage the 505(b)(2) pathway rather than a 510(k) or De Novo application for our final autoinjector product. This adds some additional time to our development as drug approval often takes longer from the FDA.

Second, we’ve seen strong evidence for consumer demand for a “detection only” version of our product. The Masimo corporation is launching an overdose detection product and has estimated the market opportunity to be $4.5B. This is great news for us as we believe our product will be better suited for continuous wear than Masimo’s, and their interest in the space helps to validate the market for our technology. We wrote a review of our thoughts on this development here.

Thus, we’ve decided to launch a multi-phase approach to FDA submission:

  1. FDA application for an abdomen-worn respiratory monitor
  2. this will be used as a predicate device for step 2
  3. Depending on FDA feedback, we may skip directly to step 2
  4. Launch of our product as a “detection-only” device. The device will monitor a user for an opioid overdose, and if one is detected, it will sound an alarm and notify pre-set contacts including emergency responders.
  5. Launch of a closed-loop naloxone delivery system using a third party autoinjector. This will enable speed to market as we develop our autoinjector
  6. Resilient’s internally developed closed-loop naloxone delivery system.

The chart below places these steps upon our timeline for the coming years:

That’s all for this month.  Thanks for your continued support.

Brad + Charlie

Bradford Holden
Charlie Proctor
May 1, 2023
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