Cytosorbents Corp (NASDAQ: CTSO) is up 4.13% in the current market trading session at the price of $8.12 after the announcement of grant of second Breakthrough Device designation to DrugSorb-ATR.
Grant of Second Breakthrough Device Designation to DrugSorb-ATR
On 12th August 2021, CTSO announced that FDA Breakthrough designation had been granted to CytoSorbents’ DrugSorb-ATR. This Breakthrough Device designation helps the removal of Apixaban and Rivaroxaban to minimize the risk of bleeding during urgent cardiothoracic surgery.
CTSO Second Quarter 2021 Financial Report
On 3rd August 2021, CTSO announced financial and operating results for the second quarter and six months ending 30th June 2021. Total revenue for the second quarter of 2021 was $12.0 million, 23% up compared to $9.8 million in the same quarter of 2020. Second-quarter 2021 product sales grew 19% to $11.4 million compared to product sales of $9.5 million during Q2 2020. Gross profit increased to $9.3 million in the second quarter of 2021. The gross profit reported in the second quarter of 2020 was $6.5 million.
CEO Dr. Phillip Chan remarked that they continue working on the U.S. STAR-T trial. It gives a low-risk, rapid, and most acceptable path to U.S. marketing approval. After full FDA approval of IDE application in July, they are ramping activities to begin enrollment. The first patient enrollment is expected this quarter, and the trial will be completed next year, he added.
Target 100,000 International Fundraising Campaign to Counter COVID-19
On 30th July 2021, CTSO declared the completion of its 100,000 international fundraising campaign to fight against COVID-19. A check of $100,000 was presented to CARE
CARE is a global non-profit humanitarian organization. The funds raised for CARE’s Crisis Response Campaign will enable the organization to provide vaccinations, education, sanitation, and disinfectant initiatives to counter Covid-19.
CEO Dr. Phillip Chan had thanked all of their friends, business partners, colleagues, employees, and shareholders for their generous donations. It enabled them to fulfill their commitment of raising $100,000 to support CARE’s COVID-19 Emergency Fund, he added.
CTSO Received FDA Approval of Investigational Device Exemption for STAR-T Trial
On 6th July 2021, CTSO published the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T trial in the United States. This study was performed under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit.
EfthymiosDeliargyris, Chief Medical Officer, commented that they are happy to announce that FDA has granted full IDE approval for the randomized, controlled, and double-blind STAR-T trial. The STAR-T is designed to support regulatory clearance of the DrugSorb-ATR Antithrombotic Removal system to remove intraoperative ticagrelor during cardiothoracic surgery.
Appointment of Terri Anne Powers
On 1st June 2021, CTSO reported the appointment of Terri Anne Powers as Vice President of Investor Relations and Corporate Communications. Powers is an expert in financial and communications with over 15 years of experience in the healthcare system. She was appointed to expand affiliations with the broader stakeholder community by building best-in-class investor relations and corporate communications functions.
Future Expectations
The company anticipates COVID-19 product sales for the rest of the year to be less than $1 million. It is expecting near 30% YoY growth in the second half of 2021 and 30% YoY growth in the full-year 2021 in non-COVID-19 product sales. Overall, it expects higher product sales in the second half of 2021 than the first half of 2021.
