kaleo


Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, dedicated to inventing, manufacturing, and commercializing life-transforming products for serious and life-threatening medical conditions. The company emphasizes innovation, quality, integrity, and patient-centric design, with a mission to improve quality of life and global health security through advanced drug delivery solutions. Kaléo actively develops medical countermeasures, including auto-injectors for emergency treatment of allergic reactions and opioid overdoses, with a strong portfolio of patents and FDA-approved products.

Industries

biotechnology
health-care
medical

Nr. of Employees

large (251-1000)

kaleo


Patents

Devices and methods for delivery of substances within a prefilled syringe

US-12478739-B2

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Medicament delivery devices for administration of a medicament within a prefilled syringe

US-12420016-B2

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Devices and methods for delivery of substances within a medicament container

US-12268847-B1

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Devices and methods for delivery of substances within a prefilled syringe

US-12017047-B2

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Devices and methods for delivering a lyophilized medicament

US-12005236-B2

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Medicament delivery devices with wireless connectivity and compliance detection

US-11929160-B2

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Products

Modular auto-injector platform for high-volume and high-viscosity formulations

A modular auto-injector platform supporting single- and dual-container and dual-chamber formats, electronic user guidance, automatic mixing of lyophilized and liquid components, and engineering to deliver higher volumes and handle high-viscosity formulations.

High-dose naloxone auto-injector for ultra-potent opioid exposure

A fixed-dose naloxone auto-injector developed for emergency treatment and temporary prophylaxis in settings where exposure to high-potency synthetic opioids is suspected; designed to meet defense and responder suitability requirements.

Epinephrine auto-injector with audible guidance and needle retraction

Compact epinephrine auto-injector incorporating step-by-step audible instructions and an automatic retractable needle mechanism intended for emergency treatment of anaphylaxis, and accompanied by trainer devices for user training.


Services

Collaborative development engagements covering device design, human factors testing, formulation/container compatibility assessment and integration with manufacturing for pharmaceutical and government partners.

Program execution, supply and fulfillment services for government medical countermeasure contracts, including meeting military suitability and environmental testing requirements.

Operational oversight of contract manufacturing partners, quality oversight, supply planning and distribution services to support commercial and government product supply chains.

Expertise Areas

  • Drug–device combination product development
  • Auto-injector mechanical and actuation engineering
  • Human factors and usability testing for medical devices
  • Automated robotic manufacturing and inline quality inspection
  • Show More (7)

Key Technologies

  • Gas-powered non-coaxial actuation mechanisms
  • Human factors engineering (HFE)
  • Audible and visual user guidance systems
  • Bluetooth connectivity for medical devices
  • Show More (4)

News & Updates

Appointment of Ted A. Marcuccio as Chief Business Officer responsible for business development and strategic growth initiatives.

First contract with the U.S. Department of Defense for the procurement of ROCS, a 10 mg Naloxone Auto-injector for weaponized opioids.

AUVI-Q selected for use in space missions to help protect astronauts from allergic emergencies.

AUVI-Q becomes available in Canada to address shortages and provide additional options for patients.

Recognition for the Auvi-Q epinephrine auto-injector with audio and visual cues, supporting safe and correct use.

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