Bubs Australia (ASX: BUB) has commenced nationwide enrolment for a growth monitoring study (GMS) in the US as part of its ongoing commitment to serving the North American market.
The first infant was enrolled in late August and the company is actively enrolling more patients online and through 13 healthcare clinics across the country.
The GMS has been in the planning stages since the beginning of year and makes up a standard part of the US Food and Drug Administration (FDA) regulatory process.
It is designed to evaluate the growth, tolerance and safety of three Stage 1 goat and cow milk infant formulas on the market, using a commercially-available formula as the control.
It will also contain a breastfeeding cohort for reference.
Infant growth during the study will be measured by healthcare professionals at designated clinical sites, with additional input from parents and caregivers.
The GMS follows a protein efficiency ratio (PER) study in June which validated the product’s protein quality.
Bubs plans to submit results from the GMS to the FDA by September 2024 with a full infant formula submission the following month.
Bubs began exporting its infant formulas to the US in May 2022 as a response to widespread domestic shortages.
It became the first company to offer international assistance and participated in the US government’s Operation Fly Formula program which ensured approved imported formula could hit retail shelves as quickly as possible.
Since then, Bubs has been building its brand with caregivers and pediatricians and has cemented its position as the number one goat milk formula brand in the US.
Help during crisis
Chief operating officer Richard Paine said the company was proud to have helped out during the US market crisis.
“Bubs answered the call when [infant formula] was needed by American families and we established a trusted relationship with many US healthcare professionals, parents and caregivers,” he said.
“We are excited to build upon that relationship by providing the FDA with the data necessary for Bubs to take up its permanent place in the American market.”