Hygieia’s d-Nav™ Receives CE Mark; First DIGS™ Use on U.K. Horizon

Hygieia to Observe Diabetes Insulin Guidance System in Action and Appraise its Ability to Scale ‘Best Practice’ Care Delivery

ANN ARBOR, Mich.--(BUSINESS WIRE)--Hygieia, Inc. today announced that the company’s d-Nav™ Diabetes Insulin Guidance System (DIGS™) has been granted a CE mark.

“Studies to date with DIGS have demonstrated the technology’s potential to bridge this gap between knowledge and more effective health care delivery to more people.”

d-Nav is the world’s very first Diabetes Insulin Guidance System. DIGS automatically updates insulin dosage as needed, and provides its users with the updates immediately, rather than waiting for the next visit to a healthcare professional. Multiple studies have shown that insulin therapy is more effective when it is frequently adjusted based on an individual’s blood glucose patterns.

Two major U.K. diabetes centers plan to start using d-Nav this fall. Both will focus on insulin treated patients with poor glycemic control.

The South Eastern Health and Social Care Trust’s Ulster Hospital in Northern Ireland will conduct a six-month d-Nav service evaluation, under the direction of Dr. Roy Harper.

The Heart of England Foundation Trust and the University of Birmingham are co-sponsoring a year-long observational study at the Heartlands Hospital in Birmingham, under the direction of Prof. Martin Stevens.

“Clinical evidence demonstrates that weekly insulin dosage adjustments can be safely made based solely on blood glucose data the patient generates. Unfortunately this knowledge doesn’t address the reality that our current health care delivery system lacks the time, attention or know-how to deliver that standard of care broadly,” says Prof. Stevens. “Studies to date with DIGS have demonstrated the technology’s potential to bridge this gap between knowledge and more effective health care delivery to more people.”

“d-Nav may provide the crucial ‘missing link’,” according to Dr. Roy Harper, Evaluation Lead at the Ulster Hospital. “d-Nav updates each patient’s insulin dosage using their own individual insulin therapy regimen and their glucose patterns. Setting up our patients with d-Nav will put expert insulin dosage advice in the palms of their hands between their too infrequent clinic appointments. This could be the key to providing high quality diabetes healthcare to many more of those folks with type 2 diabetes using insulin therapy. d-Nav may transform the type of support we can give to our patients and help us move from traditional episodic interactions to a much more continuous level of patient support.”

“We look forward to observing the real-world use of d-Nav and our DIGS technology,” said Eran Bashan, Hygieia’s Chief Executive Officer. “The data Dr. Harper, Prof. Stevens and their teams collect will help Hygieia to assess the d-Nav value proposition.”

About Hygieia, Inc.

Hygieia, Inc. is a diabetes health care company founded in Ann Arbor, Michigan to commercialize its proprietary diabetes insulin guidance system (DIGS™) technology. Hygieia’s first handheld medical device, the d-Nav™ Diabetes Insulin Guidance System, is designed to improve healthcare delivery. d-Nav makes it feasible for millions of insulin users to be more effectively and efficiently treated by thousands of health care professionals. d-Nav will be available to patients in select UK diabetes centres this fall. Visit http://www.hygieia.com or email [e-mail] for more information.

d-Nav has not at this time received regulatory clearance from the U.S. Food and Drug Administration.