OpGen (OPGN) surges on business update and FDA clearance

OpGen (OPGN), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the third quarter of 2021 was approximately $1.2 million, up from $1.1 million in the third quarter of 2020. Cash as of September 30, 2021 was approximately $25.4 million, an increase from the $13.4 million as of December 31, 2020.

The company announced accomplishment of the following key milestones and recent developments in the third quarter as well as 2021 to date:

  • OpGen received 510(k) FDA clearance for its Acuitas AMR Gene Panel
  • OpGen initiated prospective multicenter clinical trial in the U.S. for the Unyvero UTI application
  • OpGen concluded search and expects to announce new CFO once appointment has been formalized
  • OpGen announced data from prospective randomized controlled multicenter clinical study using the Unyvero HPN panel for hospitalized patients with suspicion of pneumonia
  • OpGen filed a universal shelf registration statement on Form S-3 for up to $ 150 million
  • OpGen achieved key milestone in Unyvero A30 RQ development program with 10 systems now available for verification and validation testing which is ongoing
  • OpGen subsidiary Ares Genetics completed another project with Sandoz and continued commercial roll-out and growth of the ARESiss isolate sequencing service business

As we continue into the fourth quarter, we are extremely excited by the recent FDA 510(k) clearance of our Acuitas AMR Gene Panel which we believe to have the potential to aid clinicians in the diagnosis of and treatment decision making for patients with severe, life-threatening infections who are suffering from multi drug resistant organisms. We are getting ready for a swift commercial launch of the Acuitas AMR Gene Panel this quarter here in the U.S. We are also in regular dialog with the Chinese NMPA via our strategic partner Beijing Clear Bio. The Chinese NMPA has requested supplemental clinical data to be generated and submitted in China. We are working with our partners to finalize study design and prepare for subsequent study execution in due course, and we anticipate receiving feedback on the submission of the pneumonia application cartridge documents filed with the NMPA thus far. We are also thrilled to have successfully completed the search for our new Chief Financial Officer to join the OpGen team and we anticipate making the announcement upon formalizing the appointment. Together with our board, we are continuing to evaluate alternatives for financing the future growth of OpGen and believe these are steps that will help drive the company forward and on its desired path.

Oliver Schacht – CEO, OpGen

The FDA decision is “Substantially Equivalent (SESE).” Substantial equivalence means that the device is marked as safe and effective as the predicate. And the information submitted to FDA demonstrates that the device is marked as safe and effective as the legally marketed device.

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