Healthcare Equipment and Supplies
Company Overview of Valeritas, Inc.
Valeritas, Inc., a medical technology company, develops and commercializes drug delivery solutions that contribute to clinical and humanistic outcomes for patients with an initial focus on the treatment of diabetes. It offers V-Go, a disposable insulin delivery device for the continuous delivery of insulin in preset basal rates and with on-demand bolus dosing. The company also provides h-Patch for the delivery of other compounds beyond insulin; Mini-Ject, a pre-filled needle-free delivery system; and Micro-Trans, a microneedle transdermal delivery patch. It sells its products through authorized distributors. Valeritas, Inc. was founded in 2006 and is headquartered in Bridgewater, New Jersey....
750 Route 202 South
Bridgewater, NJ 08807
Founded in 2006
Key Executives for Valeritas, Inc.
Chief Executive Officer and Director
President and Chief Commercial Officer
Vice President of Operations and Microneedle R&D
Executive Vice President of Manufacturing Operations and R&D
Compensation as of Fiscal Year 2013.
Valeritas, Inc. Key Developments
Valeritas, Inc. Announces New Findings from Observational Study
Jun 22 13
Valeritas announced new findings from a planned interim analysis of data from the SIMPLE study that suggests that patients with Type 2 diabetes who switched to the V-Go insulin delivery device from their previous baseline treatment experienced improved glycemic control and a reduction in total daily insulin dose with no significant change in weight. Additionally, an independent and separate report conducted by clinicians at the Diabetes Center of Excellence at the University of Massachusetts Medical School, suggests improvement in glycemic control and a reduction in total daily insulin dose for patients requiring insulin who switched to the V-Go device. Both sets of data were presented at the American Diabetes Association's 73(rd) Scientific Sessions. V-Go is a simple, fully-disposable device that delivers a continuous preset basal rate of insulin for 24 hours with on-demand mealtime dosing. It is designed to be easier to use and assist with blood glucose control in adult patients who require insulin. SIMPLE study design and results: The SIMPLE study compares the changes in baseline and endpoint A1C measures and observes glycemic control, insulin dose requirements and other parameters. The study enrolled patients with Type 2 diabetes and a baseline A1C greater than 7%. Study participants are then switched from one of five baseline treatments to the V-Go for their basal and mealtime insulin delivery. The primary objective of this observational study is to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go. Study participants are followed on their current therapy for up to 6 weeks before starting the V-Go insulin delivery device. The study has no mandated or forced titration instructions to guide insulin therapy with the exception of starting doses for V-Go basal rate options. The interim analysis of the observational study suggests that 89 patients had continuous V-Go use for a minimum of 3 months. At the time of this interim analysis, A1C levels for the study participants reduced from a mean of 9.0% to 8.8% during the 4 to 6 week run-in phase. After the run-in period and starting the V-Go, the interim results suggest that patient A1C levels further improved with a mean change from 8.8% to 8.1%; P<0.0001 from month 0 to month 3. There was a small but statistically significant decrease in body weight and the total daily insulin dose was reduced by 11.4 units on average. Overall, the incidence of hypoglycemia after 3 months of V-Go use was low with 90% of patients reporting no hypoglycemia. A total of 10 patients reported hypoglycemia with 7 patients having documented hypoglycemia (<70 mg/dl) and 2 patients reporting severe hypoglycemia (requiring third party assistance). Patients across the three major subgroups of baseline insulin therapy (basal insulin subgroup, premixed insulin subgroup, and the multiple daily injection subgroup) also demonstrated significant reduction in A1C levels consistent with the overall findings. The most robust decrease in insulin was seen in patients previously on premixed insulin or taking multiple daily injections where the 3 month decrease in total daily insulin dose was 23 units and 18 units, respectively.
Valeritas Closes $100 Million Financing with Capital Royalty for V-Go
Jun 5 13
Valeritas has announced that it has closed a structured debt financing with Capital Royalty which will provide the company with about $100 million in order to further commercialize V-Go.
Valeritas, Inc. Presents at Citi 2013 Global Healthcare Conference, Feb-25-2013 02:15 PM
Feb 12 13
Valeritas, Inc. Presents at Citi 2013 Global Healthcare Conference, Feb-25-2013 02:15 PM. Venue: Hilton New York, 1335 Avenue of the Americas, New York, NY 10019, United States.
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