CytoSorbents pushes into European cardiac market
- CytoSorbents Corp has begun commercialization of its CytoSorb product, designed to reduce symptoms related to cytokine release syndrome, in the European cardiology market, along with partner Terumo, according to a statement from the New Jersey-based manufacturer.
- Terumo, based in Michigan, will have exclusive rights to distribute the CytoSorb procedure pack (used for cardiac surgery) in France, Sweden, Denmark, Norway, Finland, and Iceland.
- The U.S. could follow — CytoSorbents will begin a pivotal Phase 3 study in complex cardiac surgery, in early 2017 to support Food and Drug Administration approval of the technology.
In sepsis, burn injury, cancer immunotherapy and other cases, patients can develop dangerously high levels of inflammation due to the release of inflammatory substances in what is known as a "cytokine storm" or cytokine release syndrome. CytoSorbents' CytoSorb, which clears out the excess cytokines and free hemoglobin that can lead to multiple organ failure and death, is already available in 39 countries.
The new launches, carried out by CytoSorbents' partner Terumo, will begin roll out of the CytoSorb in cardiac surgery, where it could improve outcomes, cut complications and potentially save money on patient care.
CytoSorb has already been used in thousands of cases of cardiac surgery, and its effect on free hemoglobin has been assessed in a feasibility study. This study looked at the safety of intra-operative CytoSorb use in combination with a heart-lung machine during complex cardiac surgery.
The data safety monitoring board has looked at the safety data from the first 24 patients and given it a positive evaluation, recommending that the trial continue without change. Data from the trial, expected by the end of 2016, will help to decide whether approval in the U.S. will be via the PMA or 510k route.
Once the pathway is determined, the data from the follow-up study will be used to support submission for approval in the U.S. That study is expected to start in early 2017.
The European commercialization follows close on the heels of last month's agreement between the two companies, which gave Terumo exclusive rights to distribute the CytoSorb cardiopulmonary bypass (CPB) procedure pack for use during cardiac surgery in France, Sweden, Denmark, Norway, Finland, and Iceland.
Analysts at Maxim Group predict that CytoSorbents' total revenues could rise to an estimated $8.4 million in 2016 and $14.4 million in 2017, from $5.5 million in 2015.
- CytoSorbents Statement
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