Seasoned sales veteran from Medtronic tasked to build and lead U.S. commercialization infrastructure as CytoSorbents sells CytoSorb under U.S. FDA Emergency Use Authorization for COVID-19 and leverages FDA Breakthrough Designation for potential future U.S. approval
MONMOUTH JUNCTION, N.J., Jan. 11, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces the immediate appointment of James Komsa as Vice President – U.S. Sales and Marketing.
Over a distinguished 18 year career at Medtronic, Mr. Komsa was most recently Vice President of the Restorative Therapy Group (RTG) and the U.S. Pain Organization, with annual sales of $400 million and $1.1 billion, respectively, at the time. There, he was responsible for 16 business units, including Medtronic Spine, Neurology, ENT, Pain and others. Prior to that, Jim led the successful turnaround of Kyphon as U.S. Vice President Medtronic Spine Division. Formerly as Vice President, Northeast Region, Medtronic Cardiac and Vascular Group (CVG), Mr. Komsa was responsible for sales, marketing and operations for the Coronary, Structural Heart, Endovascular, and Cardiac Rhythm Disease Management business units, encompassing more than 300 full-time employees and generating more than $310 million in annual sales.
Prior to his career at Medtronic, Mr. Komsa was Vice President at Hambrecht & Quist, where he helped lead the operations and rapid sales growth of two start-up companies, Paceart and Zymed, which were ultimately acquired by Medtronic and Philips, respectively. Most recently, Mr. Komsa was Executive Vice President and General Manager of privately-held Pathy Medical, a medical device company focused on improving surgical illumination.
Mr. James Komsa stated, “I am excited to join the talented CytoSorbents team and look forward to leading and building a world-class sales and marketing infrastructure for U.S. commercialization during this major growth period for the company overall. In the U.S., we will continue to build the CytoSorb brand, already started with U.S. COVID-19 sales, then focus on rapid ticagrelor and other blood thinner removal during on-pump emergent and urgent cardiothoracic surgery, and later on other key applications under development, including those in critical care. I believe CytoSorb’s unique and effective technology for ticagrelor and other antithrombotic drug adsorption is a fantastic near-term opportunity that should accelerate overall sales growth while benefitting tens of thousands of Americans each year. This may significantly reduce medical and societal costs, providing tremendous Clinical and Economic Value – a great story to communicate to customers. From my 18 years at Medtronic, I see this compelling application as a win-win for hospitals, physicians and patients, and just the start of what could be a long and outstanding growth story for the Company in this indication and future others.”
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents remarked, “It will be great to work with Jim in his role as VP of U.S. Sales and Marketing. Jim brings a wealth of cardiac medical device experience and best-of-class sales practices from his long tenure with Medtronic where he led sales teams in the cardiac surgery, pacing, spine, and neuromod divisions. His outstanding track record of building and managing high performing sales teams is expected to be the key to the success of our commercialization efforts here in the U.S. We plan to take advantage of our extensive history of selling CytoSorb in 67 countries worldwide to facilitate this process.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents added, “We are fortunate to have Jim, a seasoned and experienced sales and marketing leader from one of the largest and most respected medical device companies in the world, join our company. During 2021, Jim will help to maximize our CytoSorb sales opportunities under FDA Emergency Use Authorization for COVID-19 and more importantly, prepare the Company to rapidly target an estimated $250 million annual addressable U.S. market, contingent upon future U.S. approval of CytoSorb for ticagrelor removal during urgent and emergent cardiothoracic surgery.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 110,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 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), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions, including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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