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7	7	Senseonics Holdings was originally incorporated as ASN Technologies, Inc. in Nevada on June 26, 2014. On December 4, 2015, the company were reincorporated in Delaware and changed its name to Senseonics Holdings, Inc. Also, on December 4, 2015, the company entered into a merger agreement with Senseonics, Incorporated and SMSI Merger Sub, Inc., or the Merger Agreement, to acquire Senseonics, Incorporated. Senseonics, Incorporated was originally incorporated on October 30, 1996 and commenced operations on January 15, 1997. The transactions contemplated by the Merger Agreement were consummated on December 7, 2015, referred to herein as the Acquisition. Pursuant to the terms of the Merger Agreement, (i) all issued and outstanding shares of Senseonics, Incorporated's preferred stock were converted into shares of Senseonics, Incorporated common stock, $0.01 par value per share, or the Senseonics Shares, (ii) all outstanding Senseonics Shares were exchanged for 57,739,953 shares of its common stock, $0.001 par value per share, or the Company Shares, reflecting an exchange ratio of one Senseonics Share for 2.0975 Company Shares, or the Exchange Ratio, and (iii) all outstanding options and warrants to purchase Senseonics Shares, or the Senseonics Options and Senseonics Warrants, respectively, were each exchanged or replaced with options and warrants to acquire shares of its common stock, or the Company Options and Company Warrants, respectively. Accordingly, Senseonics, Incorporated became its wholly-owned subsidiary.
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11	11	Senseonics Holdings is a medical technology company focused on the design, development and commercialization of glucose monitoring products to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. The company's continuous glucose monitoring, or CGM, systems, Eversense and Eversense XL, are reliable, long‑term, implantable CGM systems that Senseonics Holdings has designed to continually and accurately measure glucose levels in people with diabetes for a period of up to 90 and 180 days, respectively, as compared to six to fourteen days for currently available CGM systems. The company believe Eversense and Eversense XL will provide people with diabetes with a more convenient method to monitor their glucose levels in comparison with the traditional method of self‑monitoring of blood glucose, or SMBG, as well as currently available CGM systems. The company's Eversense and Eversense XL systems are currently approved for sale in Europe and the company submitted its Eversense system pre-market approval, or PMA, application to the U.S. Food and Drug Administration, or FDA, in October 2016. The company intend to initiate commercial launch in the United States promptly following the receipt of PMA approval.
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13		-==== Corporate History ====
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15	15	From its founding in 1996 until 2010, the company devoted substantially all of its resources to researching various sensor technologies and platforms. Beginning in 2010, the company narrowed its focus to designing, developing and refining a commercially viable glucose monitoring system. On May 10, 2016, the company received regulatory approval to commercialize Eversense in Europe. In June 2016, the company made its first product shipment of Eversense through its distribution agreement with Rubin Medical, or Rubin. Since its inception, Senseonics Holdings has funded its activities primarily through equity and debt financings.
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39	39	The company expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. In addition, the company expect that its expenses will increase substantially as the company continue the research and development of its other products and maintain, expand and protect its intellectual property portfolio and seek regulatory approvals in other jurisdictions. Furthermore, the company expect to continue to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that the company did not incur as a private company. The company will need to obtain substantial additional funding in connection with its continuing operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. However, the company may be unable to raise additional funds when needed on favorable terms or at all. The company's failure to raise such capital as and when needed would have a material and adverse impact on its financial condition and its ability to develop and commercialize Eversense and future products and its ability to pursue its business strategy. The company will need to generate significant revenues to achieve profitability, and the company may never do so.
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41		-==== Recent development ====
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43	43	March 01, 2018 Senseonics Holdings, Inc. a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the U.S. Food and Drug Administration (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel is scheduled to review the premarket approval application (PMA) for Eversense on Thursday, March 29, 2018.
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45	45	The Eversense PMA application contains data from Senseonics’ U.S. PRECISE II study. The study, considered one of the largest studies of a CGM system in the world, includes over 2 million sensor glucose readings, from 90 patients at eight clinical centers during the full 90-day study duration.
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47	47	“The scheduling of the advisory panel represents a meaningful milestone toward offering patients in the U.S. a long term, implantable CGM system,” stated Tim Goodnow, President and Chief Executive Officer of Senseonics. “We are excited for the opportunity to discuss the data in support of the Eversense PMA with the panel. We believe the Eversense system’s value to people with diabetes will resonate with the panel as it has with users in Europe .”
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