Satio said it has successful completed a Small Business Innovation Research contract awarded by the Advanced Research Projects Agency for Health (ARPA-H) for a new drug delivery device.
The company said SatioRx has been designed to provide stable and controlled delivery of liquid medicines through a hollow microneedle (HMN) array. Its approach combines a reusable motor-driven applicator with a low-cost disposable. The disposable element houses a standard drug cartridge, an adhesive patch, microneedles, and a Go/No-go pressure sensor and NFC antenna. It will accept a range of sizes from 1mL to 5mL.
With its controllable motors and sensors, the applicator for the device can be configured to deliver a very wide range of drug types for viscosities up to 100cP via intradermal and subcutaneous routes of administration. This approach addresses the challenges of autoinjectors which have limited ability to increase volume or viscosities, are stand-alone, and are thrown away after use (150 million per year).
Having chronic disease patients in rural areas who need recurring injections in mind, the ARPA-H contract stipulated three forward-looking approaches: a remotely controllable injection (to avoid travel), a reusable element (since the patient uses weekly or monthly), and microneedle delivery of 1.0mL of chronic disease drugs (to address needle fear and accelerate intradermal as a route).
Healthcare providers will be able to remotely administer a precise dose to patients whilst monitoring their real time vital signs on a dedicated software platform.
The expansive project of work to deliver this technology platform was completed in 18 months and included verification and validation testing that culminated in successful live animal trials. Short run manufacturing lots, FDA meetings toward a premarket application, and multiple letters of intent were also executed as deliverables within the contract.
In another use case, by applying precise automation to deliver drug to the immune cell rich intradermal skin, SatioRx will make at-home and intradermal delivery of therapeutic doses a reality for drug developers and patients.
These products are not FDA approved for sale in the US nor approved in any other territories.
