Dive Brief:
- Biocorp, maker of an Internet-connected cap for insulin pen injectors that can automatically transmit dosage data to a mobile app, said it has entered into exclusive negotiations for use of the device in Sanofi’s diabetes care platform.
- The Mallya smart sensor cap is the only connected device for injection pens that has been evaluated to meet the accuracy requirements for a CE Class IIb medical device designation by European regulators, the Issoire, France-based company said.
- Biocorp said it will receive an initial payment of €4 million from Sanofi to support related development activities under the exclusive negotiation, which is the first step toward a partnership with Sanofi.
Dive Insight:
Pre-filled insulin pens are becoming a more common method of insulin delivery as an alternative to syringes. Pens offer the convenience of combining the vial and syringe in a single device and allow for push-button injections.
Insulin pens accounted for 46% of insulin usage in 2016, up from 38% in 2012, according to a report from the nonprofit Health Care Cost Institute released earlier this year. Syringes remained the most common means of delivering insulin at 53% of usage in 2016, down from 61% in 2012.
The pens are also getting "smarter," eliminating the need for manual log books. Biocorp’s smart sensor cap is designed to work with a conventional insulin pen to help patients with diabetes manage their insulin use. The device records a patient’s insulin dose, plus the date and time of injection, and sends it to a dedicated mobile application. It can also create a summary report of dosing over a period up to 90 days.
San Diego-based Companion Medical in 2016 gained FDA clearance for the first wireless-enabled smart insulin pen called the InPen that can automatically calculate doses, track dosage history and timing, and send data reports to caregivers from a patient’s phone.
The device was cleared for use with Lilly and Novo Nordisk rapid acting insulin, with the app cleared for use with Apple iOS. The company began selling the pen in the United States in late 2017 and gained FDA clearance in 2018 for an Android version of the device. In June, Dexcom and Companion Medical announced a collaboration to enable an exchange of glucose monitoring data from Dexcom with insulin data from the InPen.
Abbott and Novo Nordisk in February announced a partnership to integrate insulin dose data from Novo’s pre-filled, connected pens into digital health tools compatible with Abbott’s FreeStyle Libre glucose-monitoring system. Dexcom is also set to integrate its products with Novo’s pens.
Abbott has another insulin delivery partnership in the works with potential market disruptor Bigfoot Biomedical, which plans to launch pump and pen products in 2020.
Biocorp, which specializes in drug delivery systems and medical plastics, boasts 30 products in its portfolio. The company has been publicly listed on Euronext since July 2015.
