Sempresto is developing an end-to-end emergency medicine delivery platform centered on a cellphone-integrated epinephrine autoinjector. The device attaches to MagSafe or Qi2-compatible smartphones, is pocket-sized and ergonomically designed for rapid use, and is intended to deliver a standard epinephrine dose. The autoinjector is investigational and has not been approved by the FDA or authorized for sale.
The platform combines the autoinjector with a companion app that provides training, refill reminders, and 24/7 emergency telemedicine through Health Alliance Global’s Dr. Triage. The app uses GPS to direct emergency responders to the patient when further care is needed, creating a connected solution that aims to improve carry, timely administration, and access to professional guidance during anaphylactic events.
Sempresto holds a portfolio of 15 issued patents and 10 pending applications covering device design, safety features, heat shielding, and connectivity, with broad coverage for attaching autoinjectors to mobile devices domestically and internationally. The company intends to pursue FDA and EMEA clearance via the 505(b)(2) regulatory pathway to leverage existing epinephrine data, with a planned commercial launch in 2028 in the United States and the European Union.
Market and business model targets a 33 million Americans living with food allergies and a broader epinephrine autoinjector opportunity valued at over $3 billion in the United States and more than $6 billion globally. Revenue is expected from device sales and subscription-based revenue sharing with telehealth partners. The device would be prescribed through standard pharmaceutical channels; at launch, the landed cost is projected under $40 with a retail price below the current market average of about $225. Unit costs are anticipated to fall below $20 with gross margins above 85% at launch, and annual refills provide a recurring revenue stream. The companion app offers a free tier, while a premium tier enables 24/7 telehealth access; revenue sharing arrangements with Health Alliance Global are designed to avoid additional infrastructure costs for Sempresto. The platform is designed to scale to additional rescue medications over time.