For those who hate needles, Crossject's new product Zeneo will be a welcome relief. It is a needle-free, pre-filled, single-use injection device. Bruno Besse, MD Director Medical Affairs scratches the surface.
French company Crossject is a leader in the design and development of innovative needle-free device technology for the pharmaceuticals industry. Its main product platform Zeneo is a needle-free injection device that is able to adapt to different injection depths (intradermal, subcutaneous, intramuscular) and the physical characteristics of the injectable active substance. The advantages offered by Crossject's technology include ease of use, enabling products to be self-administered, elimination of the risk of needle-stick injury, improved accuracy both of location and of dose administered, and the elimination of needle phobia.
In partnership with the University of Bourgogne, the company has developed an innovative MRI method to assess the clinical performance of the device in human volunteers. Overall, seven clinical trials which included 198 volunteers (281 injections) were conducted with all versions of Zeneo. These were randomised controlled studies conducted in comparison with conventional needle injections.
Imaging was performed on a 3.0 T Siemens Trio Tim magnet. The protocol was carried out using a flexible body coil strapped to the injection site. The principle aim was to provide images with a sufficiently high contrast between the injected liquid (saline solution) and the surrounding tissues, and also a high spatial resolution to allow a precise localisation of the injected medium in the tissue as well as depth and volume injected. The quality of the injection was also clinically assessed (using visual scales), along with its safety and tolerance.
Three studies (64 volunteers) were conducted, for the assessment of different volumes of injection (0.5 ml and 0.8 ml) and different sites of injection (arm, thigh, abdomen). Each subject received one subcutaneous injection with Zeneo and one with a syringe/ needle. The sequence of injection was randomised. In all regards the product achieved results comparable to those of the standard needle syringe. All injections in both groups were well tolerated by all the subjects. No procedure-related adverse event was observed.
In one of the studies, the volunteers were also asked to rate the device versus the standard syringe/needle. Overall, the preferences were comparable, except that for chronic treatment by self-injection, 87.5% said they would prefer the device, compared to only 13% for the needle; 67% had a very favourable or favourable opinion of the device.
In conclusion, the Crossject needle-free injection device is safe and reliable for subcutaneous injections. Its performance and safety are comparable to the conventional needle/syringe injection.
Because the ex-vivo model in the laboratory was less accurate for intramuscular injections, the first magnetic resonance imaging (MRI) studies (90 volunteers) were used to fine-tune results.
The objective of the last study conducted in 40 volunteers with the final version was to compare the characteristics by magnetic MRI of an intramuscular injection in the deltoid using the Zeneo devices. The Crossject devices performed comparably with the standard injection, but with greater uniformity. The volume detected in the muscle was at least as good as measured with the needle, 0.46 ± 0.06ml for the Crossject device versus 0.40 ± 0.09ml for the needle and syringe. There were no safety concerns in either group.
The results of the pilot intradermal study were very encouraging. A development plan for Zeneo intradermal injection of vaccine is ongoing in partnership with the prestigious Pasteur Institute.
These MRI studies are a confirmation of the safety and reliability of the Crossject Zeneo device. We have now evidence collected from several well-controlled studies, for subcutaneous, intradermal and intramuscular delivery with this product; it continues to prove its adaptability to deliver many types of injected products.
The next steps are to test the device using active drugs. This has already been done successfully with the flu vaccine in humans, the canine DNA vaccine and with therapeutic proteins in pigs.
Using technology similar to that used in airbags, Crossject's new injection device circumvents needle phobia and reduces the risk of needle-stick injury.
Crossject's Zeneo is a needle-free, pre-filled, single-use injection device for intradermal, subcutaneous or intramuscular injections. It allows a fast, simple, two-step, injuryproof injection and offers an elegant solution for needle-phobic patients, needle-stick injury risk prevention and infectious waste management. Zeneo's ease of use makes it suitable for selfinjection therapy too.
The device uses the stored chemical energy in a miniscule blend of 'energetic' materials that is released to generate controlled pressure and activate a piston, similar to those in traditional syringes, which in turn generates a high-speed jet of liquid. This liquid penetrates the skin, the subcutaneous layers and tissues up to the desired depth.
From the beginning, Crossject's objective has been to target several poorly met public health needs, including:
Half of the pharmaceutical drugs currently in early clinical development require parenteral injection because of their pharmacokinetic properties.
Most of them are biological drugs. This creates a potential market of several billion US dollars for disposable needle-free injection devices. Several companies have tried to capture this opportunity over the past few years. Many succeeded as far as signing partnerships with big pharmas, but most failed when it came to providing simple devices and/or industrialising their production.
From the beginning, Crossject has recognised the technical challenges it faces.
Its strategy has been to bring together a pool of experts for the industrial development of its unique technology. Crossject has also attracted the best-in-class global partners in key areas such as glass technology and pharmaceutical manufacturing, and has succeeded where others have failed.
Crossject has developed its technology, passed the most stringent manufacturing tests and successfully run several clinical studies, including a 100-patient efficacy study sponsored by its partner GSK Biologicals.