Ann Arbor, MI-based Hygieia announced this week that its d-Nav Diabetes Insulin Guidance System (DIGS) has received a CE Mark, which is the European equivalent of FDA approval. This fall, two diabetes treatment centers in England and Ireland plan to start using the d-Nav DIGS, which was developed with technology from the University of Michigan.
“For a medical device startup like ours, it’s important to get a few wins and Europe is just far more receptive,” says Eran Bashan, Hygieia’s CEO. “We’re entering the commercialization space; it’s a really exciting time for us.”
If the typical glucose meter is a map, Bashan says the DIGS is a GPS device. It automatically updates insulin dosage as needed by analyzing a drop of blood before the insulin is administered and recommending a dosage. The device is self-contained, meaning patients don’t need to call a healthcare professional to confirm the recommended dosage.
Basham says studies show that insulin therapy is more effective when it can be frequently adjusted based on a patient’s blood glucose patterns. “For people who take insulin, the biggest scare is typically insulin delivery,” Bashan explains. “Rather than just tell you a number, our device gives a recommendation. The reality is nobody can see a physician once a week to make adjustments. Our device delivers that kind of care.”
The South Eastern Health and Social Care Trust’s Ulster Hospital in Northern Ireland will conduct a six-month d-Nav service evaluation. Basham says it’s an HMO that serves 350,000 patients. He estimates that out of the 20,000 patients with diabetes, 7,000 will be able to use Hygieia’s technology. The Heart of England Foundation Trust and the University of Birmingham are co-sponsoring a year-long d-Nav observational study at the Heartlands Hospital in Birmingham. “The challenge is how to scale within a healthcare system,” Bashan adds.
For now, Hygieia, which has 11 employees, will confine its trials to Europe—at least until the U.S. changes the way it treats diabetes. “In the American health care system, we like to pay for gadgets but we don’t have a good way of tying payments to results,” Bashan says. “In Europe, they only pay for things that are successful in generating good outcomes. The healthcare system here needs to be ready to pay for outcomes instead of tests and gadgets.”
