Bigfoot Biomedical has brought on Dr. Jim Malone — a 21-year clinical research veteran at Eli Lilly & Co. — as its chief medical officer, the diabetes treatment tech company said today.
Malone, an endocrinologist specializing in diabetes, also spent 12 years in clinical practice.
“Jim’s blended experience in medical practice and device development bring a dynamic perspective to our team,” Bigfoot Biomedical CEO Jeffrey Brewer said in a news release. “We are laser-focused on launching Bigfoot Unity, and Jim will play a large role in the regulatory review process, payer partnerships and user experience – from the lens of the healthcare provider.”
“Our goal is to reduce the burden on patients, healthcare providers and payers, so Jim’s experience in these areas is immense,” Brewer said.
Bigfoot is nearly finished with product development and FDA submission for the Bigfoot Unity diabetes management program. Bigfoot Unity is a real-time, dose-decision support system that utilizes proprietary, smartpen caps and integrating Abbott’s continuous glucose monitoring platform.
Company officials expect to submit for a 510(k) clearance for Bigfoot Unity this summer — and launch the program in 2021, pending regulatory clearance.