A1XEH4 Crossject SA

CROSSJECT’s ZENEO® needle-free autoinjector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors

CROSSJECT’s ZENEO® needle-free autoinjector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors

Press Release

CROSSJECT’s ZENEO® needle-free auto-injector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors

  • Injection depth with ZENEO® matches that of 30-mm conventional intramuscular needles, out-performs length of needles imbedded in commercially available needle-based auto-injectors.
  • ZENEO® further demonstrates commercial adoption potential by eliminating usage errors and mimicking traditional intramuscular injection.

Dijon, France 15 May, 2025 (07.30 CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharma company in the advanced phases of development and registration of ZEPIZURE®, an emergency injectable for the management of epilepsy crises, announces excellent results for its proprietary ZENEO® auto-injector in its last Magnetic Resonance Imaging (MRI) depth validation study. The study included the precise monitoring of the pathway of the injected solution from skin to muscle, demonstrated, once again, a high reliability and consistent dose delivery with the intramuscular configuration of the ZENEO® needle-free auto-injector.

“These excellent results have shown that the ZENEO® auto-injector reaches the required depth as efficiently as a conventional 30-mm needle. The study firmly supports the clinical value of ZENEO® for use in emergency and rescue situations. Moreover, the performance of the ZENEO® device exceeded the needle length of many widely used auto-injectors. These positive results further validate the commercial potential of the ZENEO® technology that drives CROSSJECT’s marketing strategy and the development of its future products. In addition, this positive outcome supports our efforts to advance our work in the regulatory pathways to bring the needle-free auto-injector to market, beginning with ZEPIZURE® in the US,” said Patrick ALEXANDRE, CEO of CROSSJECT.

In the MRI study, with 50 healthy subjects, the mean injection depth for ZENEO® was 34 mm (±7.5 mm) when applied on bare skin, and 28 mmm (±8.4 mm) through clothing. Both depths sit well within the intended range for intramuscular injections, and are comparable to those with conventional 30-mm needles. Moreover, the measured results are better than the average range of currently available needle-based auto-injectors; for instance, the needle length of currently available epinephrine auto-injectors is between 11 and 25 mm. This is evidence that ZENEO® ensures the rapid and complete dose to the body, while also removing the risk of misuse and injuries.

Any local reactions to the treatment in the current study were transient, well-tolerated, and similar to those of an intramuscular injection with a needle. The study's results were consistent with an earlier clinical study showing that an injection of midazolam with ZENEO® is bioequivalent to an injection with a syringe equipped with a 30-mm needle (see press release May 30, 2024 ; ClinicalTrials.gov NCT05026567 ; ).

About CROSSJECT

CROSSJECT SA (Euronext: ALCJ; ) is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in the advanced regulatory development stage for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million acquisition contract* with BARDA. The Company’s versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company’s other products in development include mainly solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications.

* This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031.

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15/05/2025

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