Valeritas Begins Medical Device Registration Process in China for Its V-Go® Wearable Insulin Delivery Device
BRIDGEWATER, N.J., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of V-Go® Wearable Insulin Delivery device, a simple, all-in-one, wearable insulin delivery option for patients with diabetes, announced today that it has started the process to register V-Go in China.
As part of this process, Valeritas has signed an agreement with an international contract research organization (CRO), who has extensive experience in China, who will work directly with the China National Drug Administration (CNDA) to complete the necessary requirements to gain regulatory approval for V-Go in China.
In 2016, China formally passed the framework for “ Healthy China 2030,” working towards the national goal of reaching a health standard on par with developed countries by 2030. Having an estimated 114 million adults living with diabetes, China contains almost one-third of the world’s patients who suffer with diabetes.
Commenting on the announcement, John Timberlake, CEO and President of Valeritas, stated, “The China market for V-Go is nothing short of enormous. We have now taken the first step to make the V-Go Wearable Insulin Delivery device available in China with the hope that it can become the insulin delivery method of choice for the millions of Chinese patients with type 2 diabetes.”
About Valeritas Holdings, Inc.
Valeritas is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. Valeritas’ flagship product, V-Go® Wearable Insulin Delivery device, is a simple, affordable, all-in-one basal-bolus insulin delivery option for patients with diabetes that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours, and it provides discreet on-demand bolus dosing at mealtimes. It is the only basal-bolus insulin delivery device on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in Marlborough, Massachusetts.
This press release may contain forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Valeritas technologies, business and product development plans and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue Valeritas’ business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize the V-Go® Wearable Insulin Delivery device with limited resources, competition in the industry in which Valeritas operates and overall market conditions. Statements or claims made by third parties regarding the efficacy or functionality of V-Go as compared to other products are statements made by such individual and should not be taken as evidence of clinical trial results supporting such statements or claims. Any forward-looking statements are made as of the date of this press release, and Valeritas assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Valeritas files with the SEC available at www.sec.gov.
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