kaleo
Kaléo is a privately held pharmaceutical company focused on development, manufacturing and commercialization of drug–device combination products, primarily pre-filled single‑use auto‑injector delivery systems for emergency indications. The company integrates device engineering, human factors‑driven design, automated industrialized manufacturing, regulatory engagement and distribution/ patient‑access programs. Kaléo has pursued commercial licensing, retail collaborations, government contracts and product donation programs and operates from Richmond, Virginia.
Industries
Nr. of Employees
large (251-1000)
Patents
Auto-injectors for administration of a medicament within a prefilled syringe
US-12667669-B2
View DetailsMedicament delivery devices for administration of a medicament within a prefilled syringe
US-12420016-B2
View DetailsDevices and methods for delivery of substances within a medicament container
US-12268847-B1
View Details
Auto-injectors for administration of a medicament within a prefilled syringe
US-12667669-B2
View DetailsMedicament delivery devices for administration of a medicament within a prefilled syringe
US-12420016-B2
View DetailsDevices and methods for delivery of substances within a medicament container
US-12268847-B1
View DetailsProducts
Epinephrine auto‑injector family (infant, pediatric, adult doses)
Pre‑filled, single‑use auto‑injectors for emergency treatment of anaphylaxis across age/weight groups; integrated audible/visual guidance and automatic needle retraction; trainer devices provided for practice.
Naloxone auto‑injector (high‑potency opioid countermeasure)
Pre‑filled auto‑injector systems developed for emergency opioid reversal and for prophylactic use by military and chemical incident responders in areas contaminated with high‑potency opioids.
Aerio Auto-Injector Platform
Kaléo’s Aerio Auto-Injector Platform ensures medical breakthroughs are paired with custom-designed drug-delivery devices capable of delivering complex therapeutic formulations with controlled injection flow rates.
Single Container Auto-Injector
Single container auto-injector version of the Aerio platform for automatic delivery of single dose up to 10 mL.
Dual Chamber Auto-Injector
Dual chamber auto-injector version of the Aerio platform for automatic delivery of lyophilized product or two different liquids.
AUVI-Q
Epinephrine injection, USP auto-injector device for patients needing reliable anaphylaxis rescue.
Epinephrine auto‑injector family (infant, pediatric, adult doses)
Pre‑filled, single‑use auto‑injectors for emergency treatment of anaphylaxis across age/weight groups; integrated audible/visual guidance and automatic needle retraction; trainer devices provided for practice.
Naloxone auto‑injector (high‑potency opioid countermeasure)
Pre‑filled auto‑injector systems developed for emergency opioid reversal and for prophylactic use by military and chemical incident responders in areas contaminated with high‑potency opioids.
Aerio Auto-Injector Platform
Kaléo’s Aerio Auto-Injector Platform ensures medical breakthroughs are paired with custom-designed drug-delivery devices capable of delivering complex therapeutic formulations with controlled injection flow rates.
Single Container Auto-Injector
Single container auto-injector version of the Aerio platform for automatic delivery of single dose up to 10 mL.
Dual Chamber Auto-Injector
Dual chamber auto-injector version of the Aerio platform for automatic delivery of lyophilized product or two different liquids.
AUVI-Q
Epinephrine injection, USP auto-injector device for patients needing reliable anaphylaxis rescue.
Services
Direct delivery and prescription fulfillment services including management of expiration tracking and home delivery for device products.
Programs and enrollment support to reduce out‑of‑pocket costs for commercially insured patients and to provide assistance for uninsured patients.
Negotiation and execution of multi‑year licensing, supply and commercialization agreements with regional pharmaceutical partners for market entry.
Coordination and delivery of donation programs to schools, relief organizations and emergency response efforts.
Direct delivery and prescription fulfillment services including management of expiration tracking and home delivery for device products.
Programs and enrollment support to reduce out‑of‑pocket costs for commercially insured patients and to provide assistance for uninsured patients.
Negotiation and execution of multi‑year licensing, supply and commercialization agreements with regional pharmaceutical partners for market entry.
Coordination and delivery of donation programs to schools, relief organizations and emergency response efforts.
Expertise Areas
- Drug–device combination development
- Auto‑injector platform engineering and industrialization
- Human factors engineering and device usability
- Automated robotic manufacturing and in‑line quality control
Key Technologies
- Auto‑injector platform engineering
- Voice‑guided audible instruction systems
- Embedded firmware and guidance logic
- Retractable‑needle injection mechanisms
News & Updates
Company announced availability of its epinephrine auto‑injector in Canada and included regulatory reporting contacts for Health Canada.
Entered a multi‑year licensing and supply agreement with a Canadian partner for regional commercialization of an epinephrine auto‑injector.
Announced formation of a Government Sector business unit focused on government procurement and countermeasure programs and several executive appointments to support commercial and government growth.
FDA approved a high‑dose naloxone auto‑injector indicated for emergency treatment and temporary prophylaxis in military personnel and chemical incident responders.
Government contract awarded to support advancement of an auto‑injector for U.S. chemical threat preparedness.
Acquisition agreement announced with Marathon Asset Management to support company growth and commercialization efforts.
Company announced availability of its epinephrine auto‑injector in Canada and included regulatory reporting contacts for Health Canada.
Entered a multi‑year licensing and supply agreement with a Canadian partner for regional commercialization of an epinephrine auto‑injector.
Announced formation of a Government Sector business unit focused on government procurement and countermeasure programs and several executive appointments to support commercial and government growth.
FDA approved a high‑dose naloxone auto‑injector indicated for emergency treatment and temporary prophylaxis in military personnel and chemical incident responders.
Government contract awarded to support advancement of an auto‑injector for U.S. chemical threat preparedness.
Acquisition agreement announced with Marathon Asset Management to support company growth and commercialization efforts.