MONMOUTH JUNCTION, N.J., Dec. 7, 2016 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification therapy to treat deadly inflammation in critically-ill and cardiac surgery patients across 42 countries, announces the achievement of a permanent, dedicated reimbursement procedure code for the CytoSorb® therapy in Germany, providing for specific and enhanced reimbursement in the largest medical device market in Europe.
Dr. Christian Steiner, Vice President of Sales and Marketing for CytoSorbents stated, “We have worked diligently for the past several years to attain this key foundational milestone that is expected to catalyze major increases in adoption and sales of CytoSorb in Germany. The relatively short time frame in which this specific reimbursement code was granted is remarkable, and validates the importance and value of our CytoSorb therapy to physicians in Germany, where its usage has seen tremendous growth. Of note, this new reimbursement was achieved with the strong and broad support from several major German medical societies, across different medical specialties.”
Dr. Steiner continued, “Our previous reimbursement was more generic, and led in many cases to inadequate reimbursement, impeding usage and sales. Now, with several years of CytoSorb treatment cost data and a dedicated reimbursement code specific to our therapy, we believe our customers will be able to negotiate significantly higher reimbursement under the new code that covers not only the cost of the device, but the procedural costs as well. The new code has now been communicated throughout the entire CytoSorb hospital customer base in the country and becomes effective January 1, 2017. Furthermore, we expect that this enhanced reimbursement in the leading country in the European Union will have a positive impact on reimbursement in other countries as well.”
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 42 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. 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, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety of intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 17,000 human treatments to date.
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 and contract funding in excess of $18 million from DARPA, the U.S. Army, the U.S. Air Force, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL, HemoDefend™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites: https://cytosorbents.com and http://www.cytosorb.com and 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 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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2016, as updated by the risks reported in our Quarterly Reports on Form 10-Q, 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. 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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