Valeritas Receives FDA Clearance for the V-Go Disposable Insulin Delivery Device

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Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the US Food and Drug Administration has cleared the company’s V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin.  V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).

“The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind,” said Valeritas CEO Kristine Peterson.  “We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control.”

“The addition of the V-Go Disposable Insulin Delivery Device as an insulin delivery option for the Type 2 diabetic population is a great step forward in patient care. The more options these patients have the better,” said Nancy Bohannon, MD, an endocrinologist from San Francisco, CA. “The V-Go provides a simple way to deliver basal-bolus insulin therapy, which I believe will increase patient compliance and improve glucose control in a very cost-effective manner compared to more traditional insulin delivery devices.”

Valeritas plans to commercialize the V-Go in the United States in 2011.

About the V-Go Disposable Insulin Delivery Device

The V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with diabetes. The V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes thereby providing an alternative to taking multiple daily insulin injections.

The V-Go is engineered to simplify basal-bolus insulin therapy for the millions of people suffering from Type 2 diabetes. The V-Go is small, lightweight, and worn under the patients’ clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. The V-Go is not electronic, making it easy to operate and use.

About Valeritas, Inc.

Valeritas is a medical technology company committed to the development and commercialization of innovative drug delivery solutions that contribute to clinical and humanistic outcomes for patients, with an initial focus on the treatment of diabetes.  The Valeritas medical technologies portfolio is headlined by the h-PatchTM technology. The V-Go Disposable Insulin Delivery Device, designed for the simple delivery of basal-bolus insulin therapy via a preset basal rate and on-demand bolus dosing around mealtimes, is the first use of the h-PatchTM technology.

In addition to the V-Go, the Valeritas delivery technology portfolio includes the

h-PatchTM for the delivery of other compounds in addition to insulin, the Mini-JectTM Pre-Filled Needle-Free Delivery System, and the Micro-TransTM Microneedle Delivery System.  These technologies, when combined with certain compounds, are designed to enhance the delivery of a variety of injectable drugs resulting in improved patient acceptance and outcomes.

Headquartered in Bridgewater, NJ, Valeritas operates its R&D and manufacturing in a state-of-the-art facility in Shrewsbury, MA. Valeritas’ primary investors include MPM Capital, Pitango Venture Capital, Abingworth, US Venture Partners, ONSET Ventures, ATV Capital, HLM Venture Partners, CHL Medical Partners, Kaiser Permanente Ventures, and Agate Medical Investments.

Information on Valeritas and the V-GoTM Disposable Insulin Delivery Device can be found at www.valeritas.com.

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Source:

http://www.valeritas.com/pr/newsletter.shtml

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