Innovus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s GlucoGorx™ Glucose Monitoring Test Kit that includes a glucose meter, test strips and lancet device (“GlucoGorx™ Kit”) under the 510(k) filing of its manufacturing partner, ACON Laboratories, Inc. (“ACON”) Innovus Pharma will offer the GlucoGorx™ Kit.
According to WebMD, diabetes is a lifelong disease. As of 2017, approximately 18.2 million Americans have been diagnosed with the disease and almost one-third (approximately 5.2 million) are unaware that they are living with it. An additional 41 million people have pre-diabetes and those with diabetes need to manage the disease to stay healthy; as of today, there is no cure for diabetes.
With an FDA-cleared glucometer and test strips, Innovus Pharma is now eligible to enter reimbursement and government supply programs, expanding the addressable market significantly for this product. To date, the Company has received notification that the GlucoGorx™ Kit is eligible for Medicare Part B reimbursement for its customers.
“We are very happy to be announcing the FDA clearance of the GlucoGorx™ Kit which is our second FDA cleared device in the US. The creation of a kit for monitoring a diabetic’s blood sugar levels expands our GlucoGorx™ clinical supplement offerings,” stated Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. “We strongly believe our GlucoGorx™ customers will be able to use our FDA cleared kit to monitor their blood sugar levels from the convenience of their own homes. We are excited that Innovus Pharma is entering this large glucose monitoring market and we look forward to offering GlucoGorx™ and the GlucoGorx™ Kit in the second half of 2018”, he continued.
About the GlucoGorx™ Glucose Monitor, Lancet and Test Strips
The GlucoGorx™ Kits are FDA-cleared tests for the monitoring of blood sugar levels in diabetics. The test has undergone clinical trials and the results can be seen by customers within four seconds
According to a June 22, 2017 Research and Markets published report, “Glucose Monitoring Global Market – Forecast to 2023”, the Glucose Monitoring global market is forcasted to reach to $11.24 billion by 2023 and grow at single digit CAGR.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our on-line channels, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.
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