Kaléo Marks 25 Years Advancing Drug Delivery Technology
The patented Aerio™ platform was designed to meet the highest standards of device function and form from food allergies to modern medical countermeasures
Glen Allen, VA, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Kaléo, a global leader in drug-device combinations and auto-injector innovation, recognizes its 25th anniversary by celebrating the people, purpose, and partnerships that have shaped a quarter century of advancing drug-delivery systems.
Founded in 2000, one of Kaléo’s goals was to reimagine how to make epinephrine more portable so that people with life-threatening allergic reactions, including anaphylaxis, could more easily have their medication with them at all times. Over the past 25 years, that mission combined with the evolving needs of patients and partners has expanded the company’s work from severe allergic reactions to frontline emergencies and other disease categories and environments.
“Kaléo—a name inspired by the Greek word for ‘calling’ or ‘purpose’ – fuels every innovation, partnership, and decision we make. The Kaléo portfolio, built on the patented Aerio™ platform, supports our wholly owned auto-injector franchise,” said Michael Wells, Chairman and Chief Executive Officer of Kaléo. “As we mark 25 years, we don’t only reflect on products or technologies, we also reflect on the people and purpose behind them. Our dedicated teams are working to help patients, families, caregivers, and those on the frontlines feel more prepared and supported today, tomorrow, and beyond.”
Our flagship product AUVI-Q® (epinephrine injection, USP) is the only voice-guided epinephrine auto-injector available in three weight-based doses designed for every age (weighing 7.5 kg or more), allowing treatment options to grow with the child. It is small and compact to easily take on the go (about the size of a credit card and thickness of a cell phone), has a never-see needle, gives easy-to-follow voice instructions, and doesn’t require experience. The AUVI-Q auto-injector uses audible and visible indicators to confirm medicine deployment, even if the needle is not felt. Common side effects of AUVI-Q include: fast, irregular, or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, breathing problems. Please see Important Safety Information below.
For some families living with severe food allergies, that sense of guidance and reassurance may be meaningful to them – especially during times of transition. To date, over 11 million devices have been distributed indicating the importance of considering the unique needs of patient populations when designing delivery devices.
“In my professional role, I have learned how personal anaphylaxis preparation is. Different families have different needs at different life stages and transitions,” said Eleanor Garrow-Holding, President and Chief Executive Officer of Food Allergy & Anaphylaxis Connection Team (FAACT). “When my son went away to college, it was important to him to have a familiar device to use in his new environment. In my absence, the voice instructions were reassuring to him, knowing that a calm voice was available to guide him through administration, should he need it.”
Kaléo’s impact extends beyond food allergies. The company has partnered with government agencies to support preparedness in high-risk and extreme environments, where reliability and clarity are essential. In 2025, AUVI-Q was selected by Axiom Space to support their crew members on board Axiom Mission 4 in the event of an allergic emergency during their June 25 - July 15 flight. Kaleo’s advanced auto-injector platform is also being used for modern medical countermeasures.
The Aerio platform offers flexibility to help meet the needs of patients across disease categories and environments as we partner with like-minded organizations seeking drug-delivery devices built to trust.
As Kaléo looks ahead, the company remains committed to advancing medicine through thoughtful device design, trusted technology, and an unwavering focus on the people who rely on it.
What is AUVI-Q?
AUVI-Q® (epinephrine injection) is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in adults and children who weigh 16.5 pounds or more who are at risk for or have a history of serious allergic reactions. AUVI-Q is for immediate self (or caregiver) administration.
Important Safety Information
What is the most important information I should know about AUVI-Q?
• Always carry two AUVI-Q devices with you because you may not know when a life-threatening allergic reaction may happen. If a second dose of AUVI-Q is needed, it should be given starting 5 minutes after the first. If you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses must be given by a healthcare provider.
• Talk to your healthcare provider about when it is necessary to get medical care for further treatment of the allergic emergency after using AUVI-Q.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q.
Before using AUVI-Q, tell your healthcare provider about all of your medical conditions, especially if you have heart problems, high blood pressure, diabetes, thyroid problems, kidney problems, history of depression, Parkinson’s disease, or are pregnant (or plan to become pregnant), are breastfeeding (or plan to breastfeed).
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. AUVI-Q and other medicines may affect each other, causing side effects.
AUVI-Q may cause serious side effects.
AUVI-Q should only be injected into your outer thigh, through your clothing if necessary. Do not inject AUVI-Q into your veins, buttocks, fingers, toes, hands, or feet. If this occurs, go to the nearest hospital emergency room right away and inform the healthcare provider of the location of the accidental injection.
Rarely, people who use AUVI-Q may get infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, the area feels warm to the touch.
If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg during an injection.
Common side effects of AUVI-Q include: fast, irregular, or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, breathing problems. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of AUVI-Q.
You are encouraged to report side effects to kaléo, Inc. at 1-877-302-8847 or to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
About Kaléo
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind. Our patented Aerio™ platform, with unmatched capabilities and Human Factors Engineering, powers our portfolio of auto-injector products, as well as products under development for third parties.
About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)
AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat emergency allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a first-line treatment for severe allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.
AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it, incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q visit www.auvi-q.com.
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Carrie Siragusa Kaléo 908-868-9263 carrie.siragusa@kaleo.com
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