On Dec. 1, Prolacta announced that in October, it began a clinical trial of its human milk product in Japan. The study is a precursor to Prolacta’s goal of selling its products to hospitals and other pediatric facilities in the country.
“Initiation of this study in Japan is another industry first, being led by Prolacta,” Scott Elster, the company’s chief executive, said in the announcement.
The clinical trial is being led by Katsumi Mizuno, senior professor of pediatrics at the Showa University School of Medicine in Tokyo and will be conducted at 10 hospital sites throughout Japan.
“This study is necessary to bring a higher level of nutritional care to our very low birth weight babies in Japan,” Mizuno said in the announcement.
Prolacta is the brainchild of serial entrepreneur Elena Medo, who has devoted much of her life to improving care for premature and critically ill infants.
The company uses breast milk from donors who use breast pumps to generate surplus milk. The breast milk is then transported to Prolacta’s manufacturing facility next to its Duarte headquarters. Nutritional fortifiers are then added to complete the human milk product.
By venturing into Japan, Prolacta’s hope is that it will encounter less resistance to its human milk product by touting the quality and safety standards of its manufacturing process.