Exciting Regulatory Clearances and Expansion!
After 4 long years, the US utility patent issued in early 2017 safely limits the maximum temperature of Warmilu’s InstaWarmer to safely warm infant and adult patients without overheating them in the treatment of hypothermia and pain management. And, since 2017, all InstaWarmer and IncuBlanket materials are US-made nontoxic food or medical grade.
In other exciting news, last year, Warmilu’s infant warming blanket cleared the Kenya Pharmacy and Poisons Board (KPPB), Kenya’s local FDA equivalent. Additionally, the US FDA Class 1 IME for infant and adult warming packs successfully cleared with the US FDA. Finally, Warmilu successfully externally validated the autoclave gravimetric and dry cycle sterilization of the warming packs in a new reset method (the autoclave) through testing by Pacific BioLabs in 2018.
The IncuBlanket was also clinically validated in a trial at the Kempegowda Institute of Medical Sciences (Bangalore India, January-March 2013) with neonatologist Dr. Ranjan Pejaver. The IncuBlanket kept 20 low birthweight, preterm infants warm between 36.4–37.5°C. (97.5–99.5°F) for 5 hours and prevented hypothermia. The average weight of the infants were 1.75 kg (range 1.3-2.4 kg) and average gestational age 35.25 weeks (range 31-38 weeks) for 10 boys and 10 girls. There was no case of overheating, skin rashes, or erythema of significance noticed during or immediately after the study period.
With these regulatory clearances, the IncuBlanket is being used in 5 countries outside the United States: India, Kenya, Uganda, Tanzania, and Pakistan. Some of our key customers include Maternova, Relief for Africa Foundation, IRD Pakistan, UCSF Global Programs in Research and Training, the Kenya Medical Research Institute, The Pakistan National Institute of Child Health, Oregon Health and Science University, and Vital Health Africa and current partnerships are with Maternova, Relief for Africa, and Zona Pakistan (Private) Ltd. In the US, we are now selling in Oregon, California, Michigan, Rhode Island, Connecticut, Maryland, Idaho, Ohio, Texas, and New York. Keep an eye out for our products listed on more eCommerce sites!