The drug delivery industry is often on a constant lookout for innovative ways to improve how drugs are delivered to patients who are suffering from a specific illness. Syringes or needles are one of the first preferred resources when the drug is required to be delivered directly into the patient’s body, passing through the skin. This is true in the case of medical emergencies—where quick action is required to ward off the risk of severities, a long-term consequence, or to manage a situation of stress or crisis.
However, in emergencies like an epileptic seizure, anaphylactic shock, or suffering an overdose—where patients are the victims—do needles and syringes guarantee to be an immediate therapeutic solution?
Crossject is a leading company that is revolutionizing the administration of well-established treatments in emergency situations by developing innovative life-saving solutions. ZENEO® is its injective approach which provides an alternative to using needles and syringes. Patients no longer have to fear needles as this product is a needle-free self-administration innovation designed to support patients in emergencies and life-threatening situations.
In an interview with Insights Care—Patrick Alexandre, the Founder of Crossject and President of its Executive Board—shares how his company’s innovation, ZENEO®, is dedicated to fulfilling the mission of saving the lives of patients across the world.
Below are the highlights of the interview:
Kindly brief us about the company. What led to its inception?
Crossject is a French speciality pharmaceutical company based in Dijon and spun off from Fournier Labs. The company has been listed on Euronext Growth in Paris since 2014. It receives funding from the United States BARDA (Biomedical Advanced Research and Development Authority) under contract n° 75A50122C00031 and from Bpifrance (French Government investment bank).
Crossject is developing and will soon commercialize a portfolio of treatments for emergencies, including epileptic seizures, adrenal insufficiency, anaphylactic shock, and opioid overdose, all based on its unique needle-free auto-injection platform, ZENEO®.
ZENEO® finds its origins in the combination and miniaturization of cutting-edge technologies used in the automotive, pharmaceutical, and aerospace sectors. Our technology relies on a specifically formed, siliconized, depyrogenated, pharmaceutical glass tube (unique technique worldwide) that can support up to 1,200 bars of pressure, in conjunction with a polycarbonate nozzle with submillimeter conduit that directs the injection thru clothing and into the skin/muscle in a precise minute stream to the desired depth of injection.
This unique delivery system is coupled to a state-of-the-art energy material-based gas generator with an actuator culminating in a simple-to-use, safe and efficient injection system.
Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company?
With its patented, needle-free auto-injection system, Crossject aims to become the world leader in self-administered emergency treatments.
In 1997, I began directing the conceptualization and development of needleless injection technology at Laboratoires Fournier, now Abbvie. In 2001, I built upon that acquired expertise to launch Crossject and ZENEO®, which has now proven to be a world-premiere technology to inject a drug without a needle, even through clothing.
I graduated from Supélec, a top engineering school in France, and was an R&D manager in the steel industry for 10 years before joining the pharmaceutical industry, where I worked for 15 years.
Can you elaborate upon the core values, mission and vision on which the company is built?
From the solid foundation of its unmatched technology, Crossject aims to become the world’s leading pharmaceutical laboratory for emergency needle-free auto-injectables.
Crossject’s incomparable technology is the fruit of no less than 20 years of R&D. Thanks to its continuous R&D efforts dating back to 1997, Crossject has created a high-performance auto-injection system protected by 400 patents worldwide until 2036. ZENEO® is the world’s first clinically proven prefilled needle-free auto-injector capable of delivering treatments intramuscularly or subcutaneously.
Crossject developed a needle-free injection technology, unique worldwide, capable of delivering treatments in less than a tenth of a second. To always move forward, Crossject has united a vanguard team of specialists from a range of industries and thus gathered the expertise it needs to empower each step of its evolution.
To save lives simply
The purpose of the revolutionary, needle-free auto-injection system ZENEO® is nothing less than to save lives in emergencies.
Brief us on the scientific process of drug delivery to the company’s target population.
ZENEO® uses miniaturized automotive industry technology from airbags and pre-tensioning seat belt systems to deliver drug products into the muscle without the use of a needle.
As soon as the device is pressed against the skin, the spring-loaded striker is released. It hits a gas generator located at the top of the device, and high pressure is released by the expansion of powders (slow and fast). This high pressure pushes down the liquid into a canal with a diameter of 0.4mm, and a thin jet of pharmaceutical product hits the skin at 200m/s and reaches the muscle.
Depending on the volume or viscosity of a drug, the device pressure profile can be modified to reach the targeted injection depth.
How does your company offer personalized treatment to the patient’s concerns?
ZENEO® address many issues that patients are facing with current solutions. One of the biggest fears regarding injectable drugs is the needle. Crossject goes beyond the needle and changes the injection paradigm for many people, as 20% of us fear the needle, and 10% are completely needle phobic.
ZENEO® has been developed to be very easy to use to make sure that even naïve users can inject a drug quickly and safely in less than 1/10th a second; it is particularly interesting for an emergency situation such as epileptic seizure where it is rather challenging for a non-professional caregiver to give an Intramuscular injection of Midazolam with a needle-based solution on a convulsing patient.
What diagnostic tools does Crossject find to be essential in conducting its operations?
Understanding patient needs, the different scenarios, and the environment has been at the centre of Crossject needle-free drug/device combinations products. The company has designed its unique solution with and for the patient and tested it through numerous Human Factors studies that assessed that the device was used properly and safely in different use environments.
What endeavours is Crossject currently pursuing to improve its measures for patients?
Crossject is constantly discussing with health authorities and patients to ensure its device meets crucial medical requirements. The company has been developing a portfolio of seven drugs, mostly for emergency use to bring to patients or their entourage solutions that can be safely used outside the hospital.
What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into drug delivery?
Maintain your enthusiasm, expand your knowledge base, and push for perfection in a rapid, sustainable methodology. Fail often, fail quickly, learn from your failures and move on towards success!
How do you envision scaling your organization’s services and operations in 2022 and beyond?
Through our partnerships with international pharmaceutical companies and government agencies, we intend to become the world’s foremost supplier of rapid, safe, easy-to-use needle-free auto-injectors for personal emergency use.
2022 has been an important year for Crossject as it has signed an agreement with BARDA for the late-stage development, regulatory approval and procurement of its lead compound ZENEO® Midazolam. This program has also shown positive outcomes through a bioequivalence study. This study demonstrated bioequivalence in an intra-muscular injection with ZENEO® Midazolam compared to an injection of midazolam with a syringe and 30-mm needle. It also demonstrated that clothing had zero impact concerning injection with ZENEO®.
2023 will be a crucial year for Crossject as it will file its first marketing authorization, a drug-device combination, ZENEO® Midazolam, as well as pursue other developments such as ZENEO® Hydrocortisone for which the company has signed a licensing agreement with ETON pharmaceuticals.
What are some of the testimonials or recognition that accurately highlight your organization’s position in the market?
Many patient advocacy groups within the epilepsy, food allergy and adrenal crisis world have expressed serious desires for a rapid, safe, easy-to-use emergency auto-injector. ZENEO®, Midazolam, ZENEO® Epinephrine and ZENEO® Hydrocortisone bring this desire to reality for these patients and their caregivers.
About ZENEO®, a Needle Free Auto-Injector
ZENEO® needle-free auto-injector is a device that has been designed with patients for patients. It enables a very easy injection in only two steps, “Open and push” onto the injection site. With this device, Crossject brings to the patient and caregivers the molecules that they would have received in the hospital before arrival. It is a unique technology for the needle-free injection of medicines.
The prefilled, single-use device propels the treatment through the skin in less than a tenth of a second. ZENEO® is factory-set as a function of the viscosity of the medicine, its dosage, and injection route (subcutaneous or intramuscular).
Its reliance has been reflected in the last Human Factors study conducted by Crossject in 2022, which showed a 99.6% success rate on the use scenario assessed.
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