Looking to the European market, digital therapeutics company Amalgam Rx has scored an E.U. CE Mark for its insulin titration algorithm, called iSage Rx, and its white-label variants.

This comes more than four years after the prescription-only technology landed FDA clearance in the U.S.

Users with diabetes are able to use the app for basal insulin titration and connect it with Bluetooth connected glucose meters from different devicemakers, including Roche, Lifescan and Ascensia. The tool allows users to capture and store their blood glucose and insulin dose values. According to the company, the product was developed to help simplifying insulin dosing process and to help users manage their A1C.

Coinciding with this announcement AmalgamRx has inked a commercialization deal with diabetes-focused startup Novo Nordisk to expand its white label version of the iSage Rx app called Dose Check into Europe and Asia.

Novo Nordisk has its own connected insulin pen. However, it is still unknown if there will be an integration between Dose Check and smart pen coming down the pipeline.

WHY IT MATTERS

Diabetes is a common condition around the world. According to the World Health Organization, in 2014 there were 422 million individuals living with the disease globally. The condition can be managed with diet, physical activity and medications.

In Europe, where the iSage now has clearance to go to market, there are about 60 million people living with diabetes, equating to roughly 10.3% of men and 9.6% of women over the age of 24, according to WHO data.

“Scaling prescription digital solutions remains one of the final frontiers of digital health. Having achieved regulatory clearance across three continents is a critical Amalgam milestone. Amalgam’s capabilities to market those products and integrate them into the provider workflow and patient’s daily lives are also necessary.

"It’s this end-to-end expertise that has attracted many of the world’s largest healthcare companies to our platform, which now supports millions of patients and thousands of providers across the globe,” said Chris Bergstrom, president of Amalgam Rx.  

THE LARGER TREND

Created by the founders of WellDoc Ryan Sysko and Dr. Suzanne Clough, the company emerged out of stealth in 2017. However, in January it announced the acquisition of clinical decision support company Avhana Health for an undisclosed sum.

This was shortly followed by the company's acquisition of conversational AI tool Geetha, which has developed AI models that can learn about patients' and health stakeholders' behavior and in turn to deliver behavior-change content.

AmalgamRx isn't the only company working on insulin titration tools. In 2018, Glooko received FDA clearance for its mobile insulin titration tool.