Thursday, February 18, 2021 10:23:43 AM
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)
Recent CTSO News
- CytoSorbents to Present at the H.C. Wainwright 26ᵗʰ Annual Global Investment Conference • GlobeNewswire Inc. • 08/27/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/20/2024 08:51:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:58:42 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:57:45 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/16/2024 09:28:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 09:12:04 PM
- CytoSorbents Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 08/16/2024 08:05:00 PM
- CytoSorbents Reports Second Quarter 2024 Financial and Operational Results • GlobeNewswire Inc. • 08/13/2024 08:19:55 PM
- CytoSorbents Appoints Peter J. Mariani Chief Financial Officer • GlobeNewswire Inc. • 08/13/2024 08:18:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:04:32 PM
- CytoSorbents to Report Second Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 08/07/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 08:12:56 PM
- CytoSorbents Announces Compliance with Nasdaq Minimum Bid Price Requirement • GlobeNewswire Inc. • 08/01/2024 11:00:00 AM
- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website • GlobeNewswire Inc. • 07/29/2024 12:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/26/2024 09:14:03 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/26/2024 09:11:21 PM
- CytoSorbents to Present at the Inaugural American Association of Physicians of Indian Origin (AAPI) World Health Congress • GlobeNewswire Inc. • 07/17/2024 11:00:00 AM
- CytoSorbents Secures $20 Million Credit Facility • GlobeNewswire Inc. • 07/02/2024 11:00:00 AM
- CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan • GlobeNewswire Inc. • 06/24/2024 11:00:00 AM
- CytoSorbents Announces the Launch and Immediate Availability of the PuriFi™ Blood Pump in the European Union • GlobeNewswire Inc. • 06/13/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2024 08:31:20 PM
- CytoSorbents to Host its 2024 Virtual Annual Stockholders Meeting • GlobeNewswire Inc. • 06/05/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2024 08:35:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 09:23:00 PM
- CytoSorbents Reports First Quarter 2024 Results • GlobeNewswire Inc. • 05/09/2024 08:17:23 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM