This manufacturing marks a new strategic step in the ramp-up of our ZENEO® Factory. In fact, our extended production chain was recently modified to give CROSSJECT maximum flexibility in selecting its fill-finish subcontractors.
Until now, CROSSJECT entrusted its subcontractor with both sterile pre-assembly and filling of the injector.
From now on, with ZENEO® Nest, we are bringing sterile pre-assembly in-house. This decoupling significantly broadens the range of subcontractors that can handle the final step only. It also opens the door for CROSSJECT to more easily access markets that require part of the manufacturing to be done locally.
Another piece of good news: the publication of the latest results, which are very positive, from our MRI based injection depth evaluation study. This study confirms the effectiveness of ZENEO® for intramuscular injection in a fraction of a second. That’s equivalent to a hospital level performance using a conventional syringe or autoinjector with needle. No other market-ready technology can match this life-saving ability in a potentially lethal emergency.
Moreover, we have completed the calibration of ZENEO® for the use of ZEPIZURE® in the treatment of epilepsy seizures in children. A clinical ultrasound study allowed us to determine and validate the injection depth that is appropriate for pediatric physiology. This success of ZEPIZURE® Junior is another illustration of the potential of our auto-injection platform, which can be adapted to a wide range of therapeutic indications.
Finally, a financial update: our ongoing capital increase aims to secure our progress, in line with our prudent approach to tapping the market and diversifying our funding sources. This cash infusion will notably help neutralize any potential delays in the FDA’s response time, for example.
* Contract number 75A50122C00031