medical technology

EDA-Supported CytoSorbents Creates Global Partnerships to Commercialize Life-Saving Blood Purification Device

New Jersey Economic Development Authority: When patients in the intensive care unit (ICU) develop severe deadly inflammation from life-threatening conditions, time is of the essence. Uncontrolled inflammation can rapidly lead to organ failure and death. This is when doctors turn to companies like Middlesex County-based CytoSorbents Corporation.

CytoSorbents, a Monmouth Junction medical device company focused on critical care immunotherapy, is commercializing a blood purification technology called CytoSorb® to reduce deadly inflammation common to many lethal conditions in the ICU such as sepsis and infection, trauma, liver failure, and complications of open heart surgery.

“CytoSorb® acts as a filter for your blood to remove a wide range of inflammatory substances from blood that fuel the fire of severe, body-wide inflammation,” CytoSorbents Chief Financial Officer Kathleen Bloch said. “Without treatment, patients often develop dangerous complications such as multiple organ failure, where the risk of death is extremely high. CytoSorb® is also being used to control severe inflammation generated during complex open heart surgery.”

CytoSorb®, which is reported to have been used safely in more than 14,000 human treatments to date, is currently approved in the European Union, and is being distributed in 40 countries around the world. Through a series of high-profile partnerships and agreements, CytoSorbents recently increased the global reach of its life-saving technology. In September, the company entered into a strategic partnership with Terumo Cardiovascular Group, a global leader in medical devices for cardiac and vascular surgery and subsidiary of Japan-based Terumo Corporation, to commercialize CytoSorb® for cardiac surgery applications in six countries in Europe. Terumo joins the list of existing strategic partners which include Fresenius Medical Care, the world’s largest dialysis company, and Biocon, the largest biopharmaceutical company in India. Most recently, the company announced that it had signed an agreement with medical device distributor Foxx Medical Chile SpA to distribute CytoSorb® in Chile, marking the first entry of CytoSorb® into the Americas.

CytoSorbents is currently conducting clinical trials to seek approval from the United States Food and Drug Administration (FDA) for use of CytoSorb® in cardiac surgery. The company recently completed a 40-patient feasibility and safety study called REFRESH (REduction in FREe Hemoglobin) I, demonstrating that intra-operative use of CytoSorb® in high risk cardiac surgery patients was safe, and plans to begin a pivotal registration trial in early 2017, designed to support U.S. regulatory approval by 2019.

CytoSorbents assembles and conducts all quality assurance and quality control on the CytoSorb® cartridge at their facility in New Jersey. The company employs approximately 70 people, with roughly two-thirds located at the Monmouth Junction facility.

“CytoSorbents is another example of a New Jersey company positively impacting critical care on the global stage,” New Jersey Economic Development Authority (EDA) Chief Executive Officer Melissa Orsen said. “Supporting these types of emerging businesses through all stages of growth remains at the core of the EDA’s mission.”

CytoSorbents has benefited significantly from EDA support. The company is a multi-year participant in the State’s Technology Business Tax Certificate Transfer (NOL) Program and was among 40 businesses recently approved to participate in this year’s program. Administered by the EDA and the New Jersey Department of Treasury’s Division of Taxation, this competitive program enables eligible technology and biotechnology companies to sell New Jersey tax losses and/or research and development tax credits to raise non-dilutive cash to finance their growth and operations.

Additionally, CytoSorbents was one of two dozen New Jersey companies to receive funding from the New Jersey Technology Council’s (NJTC) NJTC Fund 1, in which the EDA invested $7.15 million in a limited partnership investment. The EDA’s investment to the $70 million fund resulted in a public/private leverage multiplier of 51.76 times for the total $370 million of third party partner capital into New Jersey-based businesses. Earlier this month, the EDA announced approval for investment in Tech Council Ventures II, the NJTC’s newest venture fund.

Last week, NJBIZ announced that Bloch was named as NJBIZ Public Company CFO of the Year.

@NJEDATech asked Bloch about her company’s experience in New Jersey and its plans for the future:

Why did CytoSorbents choose to locate in New Jersey?
We chose to move to New Jersey in 2001 to take advantage of available laboratory space and New Jersey’s excellent workforce. Being a research and development company, it was important to be able to attract top scientific talent and Monmouth Junction was ideal.

How does CytoSorbents benefit from State resources like the NOL Program? 
The NOL program has provided CytoSorbents with more than $2 million in total funding during the past five years. This program has enabled us to turn our operating losses into cash, and that cash was critical to our growth initiatives.

What’s on the horizon for CytoSorbents?
We plan to continue growing our product sales in Europe and throughout the world, and expect to achieve operating profitability within approximately two years. Meanwhile, we plan to run our pivotal clinical trial here in the United States in cardiac surgery and, if successful, achieve FDA approval of CytoSorb® in the 2018 or 2019 timeframe, depending on the clinical path.  We look forward to bringing the story to life here at home and helping to improve clinical outcomes in cardiac surgery and critical illnesses in the United States.

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