Senseonics Holdings has filed an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were given in the filing for the 18.2 million shares with an overallotment option for an additional 2.7 million shares. The company expects to have up to $63.9 million in net proceeds from the offering, if underwriters full exercise their option. It intends to list on the NYSEMKT under the symbol SENS.
The underwriters for the offering are Leerink Partners, Canaccord Genuity, Raymond James and BTIG.
This company was originally incorporated as ASN Technologies. In December, 2015, It was reincorporated in Delaware and the name was changed to Senseonics. At the same time, the company entered into a merger agreement with Senseonics and SMSI Merger Sub to acquire Senseonics.
Senseonics is a medical technology company focused on the design, development and commercialization of glucose monitoring systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. The first generation continuous glucose monitoring (CGM) system, Eversense, is designed to be a reliable, long-term, implantable CGM system to continually and accurately measure glucose levels in people with diabetes for a period of up to 90 days, as compared to five to seven days for currently available CGM systems.
In the filing, the company detailed:
We believe Eversense will provide people with diabetes with a more convenient method to monitor their glucose levels in comparison to the traditional method of self-monitoring of blood glucose, or SMBG, as well as currently available CGM systems. In our European pivotal clinical trial, we observed that Eversense measured glucose levels over 90 days with a degree of accuracy comparable or superior to that of other currently available CGM systems. In July 2015, we applied for a CE mark and, subject to regulatory approval, we expect to begin marketing Eversense in select European markets in the first half of 2016. We have also received approval from the U.S. Food and Drug Administration, or FDA, of an investigational device exemption, or IDE, application to initiate clinical trials of Eversense in the United States, and we initiated a single pivotal clinical trial in the United States in the first quarter of 2016. If the results of the trial are favorable, we intend to apply as promptly as possible to market Eversense in the United States. We believe that we could file for U.S. marketing approval as early as the second half of 2016 and expect that the pre-market approval, or PMA, process could take between six and 18 months.
The company intends to use the net proceeds from this offering to complete its U.S. pivotal trial and seek regulatory approval for Eversense in the United States, as well as the further development of Eversense. The remainder will be used for working capital and general corporate purposes.
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