Valeritas, Inc., a medical technology company focused on the development and commercialization of innovative drug delivery solutions, announced today it received CE Mark approval for its V-Go™ Disposable Insulin Delivery Device as well as ISO 13485: 2003 Quality Management System Certification. The V-Go is designed to provide simple basal-bolus therapy for adults who require insulin therapy.
"These are important corporate milestones for Valeritas as we evaluate the commercialization of the V-Go outside of the United States," said Valeritas CEO Kristine Peterson. "The CE Mark, coupled with our FDA 510(k) clearances in December 2010 and February 2011, affords us the opportunity to provide an innovative therapeutic option to the millions of adults who require insulin to treat their diabetes."
More than 55 million adults in Europe have diabetes – and in countries where the CE Mark applies there are approximately 37.5 million adults who suffer from diabetes. Valeritas estimates over 5 million of these patients use insulin today as part of their therapeutic regimen.
"The V-Go is a patient-friendly, basal-bolus insulin delivery device that could substantially improve compliance which would help patients better manage their diabetes," said Poul Strange, MD, PhD, Valeritas Medical Consultant and Founder of Integrated Medical Development.
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