Bigfoot Biomedical Inc.06.15.20
Bigfoot Biomedical Inc. has appointed Dr. Jim Malone as chief medical officer. Malone, an endocrinologist specializing in diabetes, spent 12 years in clinical practice and 21 years in clinical research, where he developed diabetes products and delivery devices at Eli Lilly & Company.
“Jim’s blended experience in medical practice and device development bring a dynamic perspective to our team,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “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.”
Bigfoot is finalizing product development and FDA submission for the Bigfoot Unity Diabetes Management Program, a real-time, dose-decision support system utilizing proprietary, smart pen caps and integrating Abbott’s continuous glucose monitoring platform.
“I’ve known Jeffrey Brewer for years, first when he served as CEO of JDRF, and admire his vision and gumption to move to the Bay Area and start this amazing company,” said Malone. “Bigfoot has also been able to attract impressive talent to the company, and with more than 25 percent of the company having a personal connection to diabetes, they are incredibly motivated.”
FDA 510(K) submission of Bigfoot Unity is anticipated in summer 2020 with a target launch in 2021 pending regulatory clearance.
“Jim’s blended experience in medical practice and device development bring a dynamic perspective to our team,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “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.”
Bigfoot is finalizing product development and FDA submission for the Bigfoot Unity Diabetes Management Program, a real-time, dose-decision support system utilizing proprietary, smart pen caps and integrating Abbott’s continuous glucose monitoring platform.
“I’ve known Jeffrey Brewer for years, first when he served as CEO of JDRF, and admire his vision and gumption to move to the Bay Area and start this amazing company,” said Malone. “Bigfoot has also been able to attract impressive talent to the company, and with more than 25 percent of the company having a personal connection to diabetes, they are incredibly motivated.”
FDA 510(K) submission of Bigfoot Unity is anticipated in summer 2020 with a target launch in 2021 pending regulatory clearance.