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.

Kaléo

Kaléo

10900 Nuckols Rd, Suite 200, Glen Allen, VA 23060


What We Do

A flexible, patented auto-injector platform designed for precision, reliability, and adaptability across disease categories and environments, incorporating human factors engineering and automated manufacturing. The platform supports single, dual container, and dual chamber designs, with features such as electronic trainers, connected health, custom form factors, and environmental adaptability.

A compact, innovative epinephrine auto-injector with voice instructions and an auto-retractable needle, designed for emergency treatment of life-threatening allergic reactions (anaphylaxis) in adults and children. Available in multiple dosages, including a 0.1 mg version specifically for infants and small children. AUVI-Q is the only FDA-approved epinephrine auto-injector for infants and toddlers weighing 16.5 to 33 pounds.

A portable epinephrine auto-injector with a retractable needle and bilingual voice instruction system, available in Canada for emergency treatment of anaphylaxis. Available in 0.15 mg and 0.3 mg doses. Broadly covered by public and private insurance plans across Canadian provinces.

An FDA-approved auto-injector for rapid opioid countermeasure, developed for military and emergency use, recognized for its reliability and effectiveness in opioid overdose situations, including exposure to ultra-potent weaponized opioids. The ROCS device is indicated for emergency treatment and temporary prophylaxis in military and chemical incident responders.

An opioid antagonist auto-injector for emergency treatment of known or suspected opioid overdose, featuring voice and visual guidance for use by individuals without medical training. Covered by multiple patents, including for its electronic voice and visual instruction system.

A next-generation auto-injector device under development for the U.S. Department of Defense, designed to deliver atropine for nerve agent countermeasures, featuring innovative reconstitution technology for extended shelf life and stability.


Battlefield Resuscitation


Key People

Chairman & Chief Executive Officer

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Chief Business Officer

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Chief Development Officer

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Chief Manufacturing and Supply Chain Officer

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Chief Financial Officer

Chief Commercial Officer

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News & Updates

Kaléo received the inaugural Medical CBRN Defense Consortium Innovation Award for prototype development of its Rapid Opioid Countermeasure System (Naloxone HCl Injection, USP) Antidote.

Intelliject, Inc. (now Kaléo) received the George DiDomizio Industry Award from the Institute for Safe Medication Practices for pioneering advances in drug/device combination products with the Auvi-Q™ epinephrine auto-injector.

Kaléo and Parexel received the ACoP13 Quality Award from the American Conference on Pharmacometrics for research on Naloxone Auto-Injector (NAI) 10 mg.

The ROCS product team, including Kaléo, received the 2022 MHSRS Award for Outstanding Program Management for closing the capability gap for military personnel and first responders who may encounter highly potent opioids.

Kaléo collaborates with national organizations to address the increasing incidence of food allergies in early childcare settings.

AUVI-Q® was selected for use on Axiom Mission 4 to provide rapid epinephrine delivery in case of allergic emergencies in space.

Study finds AUVI-Q® prescriptions linked to lower rates of anaphylaxis-related hospitalizations compared to other epinephrine auto-injectors.

Walgreens becomes the first retail pharmacy to offer AUVI-Q® auto-injectors at no cost for eligible patients, improving access during supply shortages.

Kaléo Medical Affairs team discusses supporting caregivers of people with food allergies, offering advice and resources for managing food allergies and anaphylaxis.

Kaléo spearheaded the Early Childhood Anaphylaxis Collaborative to improve preparedness for food allergic emergencies in early childcare settings, focusing on education, resources, and access to undesignated epinephrine.

The FDA approved Kaléo’s Naloxone Auto-Injector 10 mg for emergency treatment and temporary prophylaxis in military personnel and chemical incident responders facing high-potency opioid threats.

Marathon Asset Management acquired Kaléo to accelerate its growth in the development, manufacture, and commercialization of life-transforming medical products. The acquisition is expected to drive expansion in anaphylaxis and other serious medical conditions.

Christine Waite was appointed as vice president, marketing and analytics, to drive growth and a consumer-focused approach for Kaléo’s marketed products.

Alfred Tenuto was named Chief Commercial Officer and Mark A. Herzog as Vice President, Global Corporate Affairs, Defense and Homeland Security, leading the new Government Sector business unit focused on medical countermeasures.

Kaléo announced five new appointments at the C-suite and management levels to promote business and growth strategies.

Kaléo reintroduced AUVI-Q® to the U.S. market with revamped manufacturing and quality systems to ensure reliable and accurate epinephrine dose delivery.

Intelliject, Inc. (now Kaléo) secured $15 million in debt financing from Hercules Technology Growth Capital to accelerate the development of key pipeline products.

Patent covers aspects of the electronic voice and visual instruction technology included in the FDA approved EVZIO® (naloxone HCl injection) Auto-injector. Kaléo has been awarded over 200 patents covering drug products, auto-injector platforms, demonstration devices, compliance tracking solutions, and other novel technologies.

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