About Valeritas

Company Description

We are a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. We designed our first commercialized product, the V-Go Wearable Insulin Delivery Device, or V-Go, to help patients with Type 2 diabetes who require insulin to achieve and maintain their target blood glucose goals. V-Go is indicated for continuous subcutaneous infusion of insulin over 24 hours at preset rates and on-demand bolus dosing in two-unit increments in adult patients requiring insulin. V-Go is a small, discreet and easy-to-use disposable insulin delivery device that a patient adheres to his or her skin every 24 hours. V-Go enables patients to closely mimic the body’s normal physiologic pattern of insulin delivery throughout the day and to manage their diabetes with insulin without the need to plan a daily routine around multiple daily injections.V-Go enables patients to closely mimic the body’s normal physiologic pattern of insulin delivery by using one type of insulin (fast-acting) at a continuous preset (background) basal rate over a 24-hour period and provides on-demand bolus dosing for meals and snacks. In numerous real-world analyses V-Go has consistently shown to lower A1C’s with less insulin. The discreet and convenient basal-bolus insulin delivery method provided by V-Go empowers patients to simplify their insulin management thereby mitigating the need to plan their daily routine around multiple daily injections. V-Go is cleared for use in the United States and the E.U. is commercially available in the United States.

Valeritas is developing two next generation single-use disposable V-Go devices:

V-Go PreFill™ will allow the Company to sell V-Go along with the insulin in one commercial product as it will feature a prefilled insulin cartridge that the patient can snap into the V-Go device eliminating the insulin-filling process. V-Go PreFill™ will make insulin therapy even simpler thereby allowing broader healthcare professional and patient adoption, including those patients new to insulin.

V-Go SIM™ will feature one-way communication to smart devices such as phones and tablets through RF/Bluetooth technology. V-Go Link™ will provide real-time tracking information of basal and bolus dosing utilization, allowing patients and their healthcare professionals to have a deeper understanding of their current dosing habits.

Important Risk Information

If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery device may result in hypoglycemia. The following conditions may occur during insulin therapy with V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. V-Go should be removed before any magnetic resonance imaging (MRI) testing.