Dive Brief:

• Bigfoot Biomedical, developer of insulin-delivery devices targeted for launch next year, is poised to become a major competitor to established companies such as Medtronic, Dexcom and Insulet, Jefferies analyst Raj Denhoy predicts in a recent research note.
• The medtech earlier this month said it expects commercial launch in 2020 of its first two systems, the Bigfoot Loop and the Bigfoot Inject, pending completion of a pivotal clinical trial and regulatory approvals. The Loop is an infusion pump-based closed loop automated insulin delivery system, and the Inject is an insulin pen-based decision support system for patients on injection therapy.
• Bigfoot also announced an agreement with Eli Lilly to support integration of Lilly's insulin products into its systems in development. It already has an agreement with Abbott to integrate the FreeStyle Libre glucose-sensing technology with its insulin delivery systems.

Dive Insight:

Advances in medical technology aimed at making it easier for diabetics to control blood sugar levels are coming at a rapid pace. A number of medical device makers are working on closed loop insulin delivery systems that automatically monitor blood sugar and deliver insulin to regulate it.

Bigfoot says its vision is to deliver injection systems as a monthly subscription and bring together insulin dosing support and glucose management. Bigfoot also intends to provide methods for healthcare providers to review comprehensive data through a connected service, with the goal of improving dosing regimens.

Jefferies' Denhoy said Bigfoot's arrangement with Lilly ensures compatibility with Lilly's insulin products, and he expects similar deals with Novo and Sanofi. Bigfoot's subscription model is unique, he said, in that it creates accountability on the part of the company and aligns incentives between all the parties.

Bigfoot's collaboration with Abbott's Libre for CGM uses a third generation of the product that incorporates software changes intended to improve performance in the hypoglycemic range, among other aims. Abbott is likely to launch the new version of Libre in the second half of 2019, Denhoy said.

The analyst estimates Bigfoot's total addressable market at $21 billion in the United States alone, an opportunity that rivals even the largest of big pharma opportunities, he said.