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.

***

For further information, please contact:

Investor Relation

Attachment



EN
15/05/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Crossject SA

 PRESS RELEASE

CROSSJECT’s ZENEO® needle-free autoinjector consistently matches depth...

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 de...

 PRESS RELEASE

L'auto-injecteur sans aiguille ZENEO® de CROSSJECT est conforme aux pr...

L'auto-injecteur sans aiguille ZENEO® de CROSSJECT est conforme aux profondeurs des injections intramusculaires traditionnelles et surpasse les longueurs des aiguilles des auto-injecteurs actuels Communiqué de Presse L'auto-injecteur sans aiguille ZENEO® de CROSSJECT est conforme aux profondeurs des injections intramusculaires traditionnelles et surpasse les longueurs des aiguilles des auto-injecteurs actuels La profondeur d'injection de ZENEO® correspond à celle des aiguilles intramusculaires conventionnelles de 30 mm et surpasse la longueur des aiguilles intégrées aux auto-injecteu...

Fabrice Farigoule
  • Fabrice Farigoule

Back to life?

Back to life? EARNINGS/SALES RELEASES CROSSJECT has provided an update on the EUA filing for Zepizure. Management has confirmed the filing will occur in June 2025, as previously indicated, demonstrating adherence to their timeline. This development is likely to enhance investor confidence, which had recently declined. Consequently, the market has reacted positively, although the successful launch of Zeneo is not yet fully reflected in the share price. Our target price remains unchanged at €6.7...

 PRESS RELEASE

CROSSJECT provides updates on the EUA filing of ZEPIZURE®

CROSSJECT provides updates on the EUA filing of ZEPIZURE® Press Release CROSSJECT provides updates on the EUA filing of ZEPIZURE® CROSSJECT and its EUROFINS CDMO partner successfully completed the aseptic filling of all ZEPIZURE® registration batches and anticipate the delivery of the last manufacturing data needed for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) submission in June 2025.CROSSJECT started the final regulatory activities for the ZEPIZURE® dossier submission under EUA.CROSSJECT began manufacturing EUA batches, intended as the first delivery ...

 PRESS RELEASE

CROSSJECT fait un point sur les dernières avancées dans le dépôt de la...

CROSSJECT fait un point sur les dernières avancées dans le dépôt de la demande EUA de ZEPIZURE® Communiqué de presse CROSSJECT fait un point sur les dernières avancées dans le dépôt de la demande EUA de ZEPIZURE® CROSSJECT et son partenaire EUROFINS ont achevé avec succès le remplissage aseptique de tous les lots d'enregistrement de ZEPIZURE® et prévoient la livraison des dernières données de fabrication nécessaires au dépôt de la demande d'autorisation d'utilisation en urgence (EUA) de la Food and Drug Administration (FDA) américaine en juin 2025.CROSSJECT a entamé les dernières a...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch