Gut health startup Biomebank eyes US expansion despite DOGE uncertainty
The faecal transplant startup is raising $4m to develop a product for the US — but America’s regulatory environment in the era of DOGE and RFK is becoming increasingly unclear.
Two years after making headlines for securing world-first regulatory approval for its “poo transplant” gut treatment, Biomebank is plotting an overseas expansion.
The biotech startup — which transfers faecal matter from a healthy stomach into a troubled one — is finalising a $4 million bridging round to fund the development of a lab-grown alternative for the US market, founder Sam Costello told Capital Brief.
“We’ve had good early feedback from the FDA [US Food and Drug Administration] on our cultured therapy,” Costello said on the sidelines of Adelaide’s Southstart tech and venture capital conference. “We know the parameters for manufacture, and we are able to achieve those.”
Yet just as Costello prepares to work with the FDA, uncertainty is growing over how the regulator will function in the coming year, as Elon Musk’s Department of Government Efficiency (DOGE) moves to overhaul the regulatory landscape.