CTSO: INITIATION: Established medical device company with advanced proprietary blood purification technologies positioned for rapid profitable growth going forward.
NASDAQ:CTSO
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CytoSorbents Corporation (NASDAQ:CTSO) is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death.
In these diseases, the risk of death can be extremely high and there are few effective treatments. In certain critical illnesses, there are no approved treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure.
As of December 31, 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures.
CytoSorb has also received FDA Emergency Use Authorization (EUA) in the U.S for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb in the E.U., also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor (Brilinta®) and another for the removal of the direct oral anticoagulants (DOAC) apixaban (Eliquis®) and rivaroxaban (Xarelto®) in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. This designation is expected to help expedite the company’s regulatory goals.
The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the U.S. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban. On November 3, 2022, the company announced they were pausing the STAR-D trial in order to focus on the STAR-T study and to reduce costs. The STAR-D trial is expected to resume in the future based on the financial condition of the company and available capital.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. The company’s technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), and Air Force Material Command (USAF/AFMC).
The company has three approved and marketed products and six products under development based upon its unique blood purification technology. This technology is protected by many issued U.S. and international patents and registered trademarks. There are also multiple patent applications pending related to its product development pipeline.
In September 2022, the company announced that it had received ISO 13485 Certification for its new manufacturing facility in Princeton, New Jersey from its European Union (E.U.) notified body. This clears the way for full manufacturing of CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® from this site with capacity to add additional product lines under development. This state-of-the-art facility expands the company’s manufacturing capacity to support up to $350-$400 million in sales of commercialized products and will be a key component in the regulatory application and expected commercial launch of DrugSorb-ATR in the U.S.
As of December 31, 2022, the company had unaudited cash and equivalents totaling $23.8 million and a $5.0 short-term bridge loan. The quarterly burn rate starting in 2023 is approximately $4.0-$4.5 million and we believe the company is sufficiently funded to support operations through at least the 4th quarter or 2023.
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