I take it from the latest press release (Dow Jones) that Cytosorbents management is gonna expand the current facility in New Jersey and not seek a second facility elsewhere. Am I reading that correctly ?
CytoSorbents to Expand Manufacturing Facility
8:05 am ET February 18, 2021 (Dow Jones) Print
By Michael Dabaie
CytoSorbents Corp. said it plans to expand its manufacturing facility in New Jersey to accommodate a peak capacity of $350 million to $400 million in sales.
The critical care immunotherapy company, focusing on blood purification, said it estimates it will take about up to two years to build and bring the new facility on line, which is consistent with the timing of its growth projections.
The company said it would prioritize the path to U.S. regulatory approval of CytoSorb based on ticagrelor removal in cardiothoracic surgery.
"Last April, we achieved FDA Breakthrough Designation of CytoSorb to remove ticagrelor during urgent or emergent cardiothoracic surgery. However, expectedly, the Agency focused on the pandemic which significantly delayed the FDA's availability to advance non-COVID-19 applications," a stockholders letter from Chief Executive Phillip Chan said.
The company said it recently met again with the agency and believes it is now aligned on the positive benefit-risk profile of the therapy and the additional clinical data needed to support approval.
The company said its 2020 preliminary total revenue was $40.8 million and preliminary product sales are nearly $40 million.
Year-end cash balance was about $71 million.
The company said it expects to report fourth quarter and full year 2020 earnings on March 9.
"Although COVID-19 has disrupted many aspects of our business, it has also been a catalyst, helping to bring the dangers of hyperinflammation, and specifically the term 'cytokine storm,' into the collective consciousness, while shining a spotlight on CytoSorb," the stockholders letter said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
February 18, 2021 08:05 ET (13:05 GMT)
