Closing this week: the Always There autoinjector on your phone

wefunder

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.

Elizabeth Reczek

Co-Founder & CEO

Edmund Pribitkin

Co-Founder & SAB Chairman

Shawn Marcell

Co-Founder & Executive Chairman

Greg Dale

Scott Hollander

Matthew Copeland

Sempresto

Sempresto’s CTO, Greg Dale, describes a working prototype that earned a 2026 Red Dot Design Award and notes the company holds 15 issued patents (with more pending) related to attaching an autoinjector to a mobile device. The update says Sempresto is raising on Wefunder to move from prototype to product, with launch targeted for 2028, and reiterates the autoinjector is investigational and not FDA-approved.

CTO letter: working prototype, 2026 Red Dot Design Award, and patent position; raise on Wefunder

Sempresto’s Wefunder round is scheduled to close next week. The team plans to develop the Sempresto companion app, complete user testing and design lock before manufacturing runs and stability testing with its production partner, and prepare an FDA submission under the 505(b)(2) pathway; timelines are estimates and approval is not guaranteed.

Wefunder round closes next week; plans include app, device user testing, and FDA 505(b)(2) submission

The update summarizes an interview on LeagueMed’s 5x5 podcast about Sempresto’s IP strength (15 issued patents and 10 pending) and its projected 505(b)(2) regulatory pathway, stating no new clinical efficacy trials are currently anticipated, subject to FDA review. It also notes a product feature described as a MagSafe-style case engineered to attach to the phone already carried.

Interview with LeagueMed covers Sempresto IP and projected 505(b)(2) regulatory pathway

Sempresto says it has welcomed nearly 250 investors and raised over $760K toward its goal of getting Sempresto through development and into the hands of allergy families. The update also states the round closes this month and the company may not open to community investors again.

Sempresto investor update: nearly 250 investors, over $760K raised; round closes this month

The company says its round closes in just a few weeks. It reports raising over $4.4M from more than 250 investors and encourages investors to invest now or add to their position via wefunder.com/sempresto.

Round closes in a few weeks; Sempresto has raised $4.4M from 250+ investors

Sempresto reports its Type B Pre-IND meeting is complete and that the 505(b)(2) regulatory pathway has been confirmed, relying on existing epinephrine safety data with no new clinical efficacy trials currently anticipated and targeting a 2028 launch. The update also states Angel Dominic J. Frederico has committed $2.5M to lead the round, and mentions 15 issued patents with 10 additional patents pending, plus a 2026 Red Dot Design Award and a strategic partnership with Thomas Jefferson University.

Sempresto update: completed Type B Pre-IND meeting, 505(b)(2) confirmed, aiming for 2028 launch

Sempresto will host a live investor webinar on October 1 at 12pm ET with co-founders Dr. Edmund Pribitkin and Shawn Marcell. The webinar will cover Sempresto’s phone-attached autoinjector and companion app, a recent positive FDA pre-IND meeting response with plans to file within 18 months (stated as not requiring clinical trials), and the proposed revenue path (device sales, annual refills, and a telehealth subscription), followed by a live Q&A.

Sempresto live webinar with co-founders and physician inventor; discusses FDA pre-IND plan

Since opening the round, Sempresto has raised over $680K from 140+ investors. The update also says Sempresto earned a Red Dot Award for its product design, is in the contracting phase with its CDMO for the next development/testing phase, and received a positive written response from the FDA in September for its 505(b)(2) bridging strategy (no clinical trials required).

Sempresto raises $680K+ from 140+ investors; Red Dot Award; FDA written response

Sempresto reports it received written feedback from the FDA following a Type B pre-IND meeting for its investigational smartphone-integrated epinephrine auto-injector. The feedback provided clarity on a proposed 505(b)(2) regulatory pathway and what data may be needed for a future submission, and the company says it will apply the feedback as it advances development.

FDA written feedback received after Type B pre-IND meeting for smartphone-integrated epinephrine auto-injector

Sempresto’s community round is now open to the public, allowing non-accredited investors to own a stake. The update states it has over $4M committed (including a lead investment from Dominic Frederico and a strategic partnership with Thomas Jefferson University) and includes claims of granted/pending patents plus an FDA filing targeted within 18 months.

Sempresto community round opens to the public; over $4M committed

Sempresto is preparing to open its round to the public and says it has raised over $4M from friends, family, and those closest to the team. The private investment window is closing, and investors are encouraged to invest or increase their investment before the public opening.

Final chance to invest before Sempresto opens its round to the public

Sempresto says its community round on Wefunder is now open, offering early access to discounted preferred early-bird terms before opening to the public. The update also cites traction to date of $2.5M committed and a Jefferson University strategic partner, along with claims about an autoinjector design and 15 issued patents with 10 pending applications.