OpGen, Inc. (NASDAQ:OPGN) Q4 2018 Earnings Conference Call Transcript

Feb 26, 2019 • 04:30 pm ET

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OpGen, Inc. (NASDAQ:OPGN) Q4 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Welcome to the OpGen Fourth Quarter 2018 Conference Call.

(Operator Instructions)

As a reminder, this conference is being recorded, today, February 26, 2019. I would now like to turn the conference over to Ms. Kim Golodetz. Please go ahead, ma'am.

Executive
Kim Golodetz

Thank you, Operator. This is Kim Golodetz with LHA. Thank you all for participating in today's call. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of OpGen. I encourage you to review OpGen's filings with the Securities and Exchange Commission, including without limitation, the Company's forms 10-K and 10-Q, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Factors that may affect the Company's results include, but are not limited to, its ability to successfully complete the demonstration project with New York State; successfully, timely and cost effectively seek and obtain regulatory clearance for and commercialize its product and service offerings; the rate of adoption of its products and services by hospitals and other health care providers; the success of its commercialization efforts; the effect on its business of existing and new regulatory requirements and other economic and competitive factors.

The content of this conference call contains time-sensitive information that is accurate only as of the date of the live call today, February 26, 2019. The Company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law.

I would now like to turn the call over to Evan Jones, OpGen's Chairman and CEO. Evan?

Executive
Evan Jones

Thank you, Kim, and thank you, everyone for joining us today. This afternoon, we will review our 2018 fourth quarter and full year financial results, provide an update on our business plans and discuss the Company's progress towards achieving key objectives for 2019. Our discussion will include an update on the ongoing FDA clinical trials for our Acuitas products, the New York State Infectious Disease Digital Health Initiative and our new products and pipeline with a focus on our first planned FDA submission for testing of antimicrobial resistance genes and bacterial isolates, as well as later planned FDA submissions for direct testing from urine and our Acuitas Lighthouse software.

We continue to work to submit three separate five(ph)FDA submissions for our lead rapid molecular diagnostic test, Acuitas AMR Gene Panel and the Acuitas Lighthouse software. These products are currently being marketed for Research Use Only. We completed the clinical trial for the detection of antimicrobial resistance genes in bacterial isolates having tested more than 1,000 clinical isolates at four participating clinical sites. Sites included the Johns Hopkins University School of Medicine; Wadsworth Center, New York State Department of Health; University Hospitals, Cleveland Medical Center; and IHMA Incorporated.

We expect to submit this first 510(k) submission to the FDA by the end of the first quarter. We are also continuing development