Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents (NASDAQ: CTSO) announced that the FDA has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. DrugSorb-ATR aims to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft (CABG) surgery. The device has received FDA Breakthrough Device Designation, making it eligible for priority review.

The company anticipates an FDA decision in 2025. The application is based on data from the 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial. CytoSorbents believes DrugSorb-ATR will allow patients to proceed with CABG surgery safely and timely, avoiding the current 3-5 day delay recommended for ticagrelor washout. The company also plans to submit DrugSorb-ATR for Health Canada Medical Device Licensure.

CytoSorbents (NASDAQ: CTSO), a leader in blood purification for treating life-threatening conditions in intensive care and cardiac surgery, has announced it will report its third quarter 2024 operating and financial results after market close on Thursday, November 7, 2024. The company's management will host a live conference call, presentation webcast, and Q&A session starting at 4:30 PM ET on the same day.

Interested parties can access the webcast through the provided link or join via phone using the toll-free dial-in number. Participants are advised to dial in about 10 minutes before the call starts. An archived recording of the conference call will be made available on the Investor Relations section of CytoSorbents' website.

CytoSorbents (NASDAQ: CTSO) has submitted a De Novo marketing application to the U.S. FDA for DrugSorb™-ATR, a device designed to reduce bleeding severity in heart bypass surgery patients on ticagrelor. The application, submitted on September 27, 2024, is eligible for FDA priority review due to its Breakthrough Device Designation. CytoSorbents is also preparing to submit a Medical Device License application to Health Canada, pending MDSAP certification.

The submission is based on data from the 140-patient North American STAR-T trial, which evaluated DrugSorb-ATR's safety and efficacy in removing ticagrelor and reducing perioperative bleeding complications in urgent CABG surgery patients. FDA and Health Canada decisions are expected in 2025. This milestone represents years of clinical, regulatory, and manufacturing efforts by CytoSorbents and its collaborators.

CytoSorbents (NASDAQ: CTSO), a leader in blood purification technology for treating life-threatening conditions in intensive care and cardiac surgery, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel in New York, NY.

Key points:

• CEO Dr. Phillip Chan and CFO Peter J. Mariani will attend and present
• On-demand company presentation available from September 9 at 7:00 AM ET
• Management team available for one-on-one meetings on September 9
• Presentation replay will be accessible on CytoSorbents's website for 90 days

This conference provides an opportunity for CytoSorbents to showcase its innovative blood purification technology to potential investors and industry professionals.

CytoSorbents (NASDAQ: CTSO), a leader in blood purification technology for treating life-threatening conditions, has announced inducement equity awards for its newly-hired Chief Financial Officer, Peter J. Mariani. The awards, granted on August 14, 2024, include:

• A non-qualified stock option to purchase 215,000 shares of common stock, vesting based on performance milestones
• Restricted stock units (RSUs) for 65,000 shares, vesting over two years
• RSUs for 110,000 shares, vesting upon a change of control or after four years
• RSUs for 175,000 shares, vesting only upon a change of control
• A non-qualified stock option for 80,000 shares with staggered vesting

The options have an exercise price of $0.90 per share. These awards were approved under Nasdaq Listing Rule 5635(c)(4) as employment inducement grants.

CytoSorbents (NASDAQ: CTSO) reported Q2 2024 financial results, highlighting:

• 10% increase in product sales to $8.8 million
• 48% reduction in operating loss to $3.4 million
• 75% product gross margins, up from 74% in Q2 2023
• Achieved milestone of over 250,000 CytoSorb treatments delivered to date

The company is on track for DrugSorb-ATR U.S. FDA De Novo and Health Canada marketing submissions this quarter. CytoSorbents secured a $20 million credit facility, strengthening its financial position. Cost-cutting measures, including a 17% headcount reduction, are expected to save $5 million annually. The company appointed Peter J. Mariani as new CFO, succeeding retiring Kathleen P. Bloch.

CytoSorbents (NASDAQ: CTSO) has appointed Peter J. Mariani as its new Chief Financial Officer (CFO), effective August 14, 2024. Mariani brings over 25 years of experience in high-growth medical device companies, most recently serving as Executive VP & CFO at Axogen, Inc. During his tenure at Axogen, the company grew annual revenue from $27 million to nearly $160 million and raised approximately $250 million in capital.

Mariani replaces Kathleen P. Bloch, who is retiring but will continue as a consultant to ensure a smooth transition. CytoSorbents' CEO, Dr. Phillip Chan, expressed confidence in Mariani's ability to guide the company through its next phase of expected rapid growth, particularly as they pursue U.S. and Canadian marketing approval for DrugSorb-ATR and drive their OUS business with CytoSorb.

CytoSorbents (NASDAQ: CTSO), a leader in blood purification for treating life-threatening conditions in intensive care and cardiac surgery, has announced it will report its second quarter 2024 operating and financial results on Tuesday, August 13, 2024, after market close. The company's management will host a live conference call, presentation webcast, and Q&A session at 4:30 PM EDT on the same day.

Investors and interested parties can access the live webcast through the provided link or join via phone using the toll-free dial-in number. Participants are advised to dial in about 10 minutes before the call starts. An archived recording of the conference call will be available on the company's website under the Investor Relations section.

CytoSorbents (NASDAQ: CTSO) has regained compliance with Nasdaq's minimum bid price requirement of $1.00 per share. The company received notification from Nasdaq on July 26, 2024, confirming that its common stock had closed at or above $1.00 for 10 consecutive trading sessions ending July 25, 2024. This development strengthens CytoSorbents' market position as it approaches expected regulatory submissions for DrugSorb®-ATR marketing approval to the U.S. FDA and Health Canada in the coming months.

Dr. Phillip Chan, CEO of CytoSorbents, highlighted recent operational progress in clinical, regulatory, commercial, manufacturing, and financing areas, along with continued aggressive cost-cutting measures. These efforts are aimed at establishing a foundation for what the company believes will be an exciting new phase of its business.