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CytoPherx Raises $34M To Move Into U.S. Clinical Trials

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ANN ARBOR — CytoPherx Inc. announced it has completed a $34 million round of funding. A large syndicate of investors co-led by Early Stage Partners, Onset Ventures and Capital Midwest Fund, participated in the round.

The funds will be used to complete United States clinical trials and gain FDA approval to commercialize the CytoPherx anti-inflammatory therapy for acute kidney injury.

Dr. H. David Humes, CytoPherx Founder, explained that patients in the intensive care unit with kidney injury often suffer from extreme systemic inflammation, which in turn increases likelihood of death or long term illness and low quality of life. The CytoPherx treatment — which is added to the renal replacement circuit — is designed to focus on acute systemic inflammation that is not well addressed with currently available therapies.

CytoPherx president and CEO Jim Danehy noted that mortality rates of patients experiencing acute kidney injury combined with multi-organ failure or severe sepsis, and requiring continuous renal replacement therapy, are often greater than 50 percent.

“Our early trials have shown the potential of reducing this by as much as 15 percent,”  Danehy said.

Over 2.7 million hospitalized patients are diagnosed with acute renal failure in the U.S. annually, with approximately 160,000 receiving continuous renal replacement therapy.

“This represents a multi-billion dollar potential market opportunity for CytoPherx,” Danehy said.

Added Leslie Bottorff of Onset Ventures: “Based on the clinical trial outcomes to date, CytoPherx is a tremendously exciting company. Its therapy has the potential to dramatically reduce mortality in a group of very ill patients. No other medical innovation has moved the needle on mortality rates for these patients over the past 20-30 years. Importantly, this therapy also has the potential to significantly reduce health care costs for a very costly patient group. In today’s complex health care environment, this combination of better outcomes and cost-effectiveness is critical.”

CytoPherx has recently initiated a 344 Patient Pivotal Trial with leading nephrologists and medical institutions across the U.S. The primary trial end point is a clinically and statistically significant reduction in mortality through day 60 in these critically ill patients. In addition, the trial will evaluate the performance of the company’s proprietary Selective Cytopheretic Device for the reduction of mortality in severe sepsis patients, reduction of Acute Respiratory Distress Syndrome, and reduction of patients who need long-term dialysis.

According to Mike Bunker of Early Stage Partners, “Systemic inflammation is a health problem that goes well beyond the focus of the initial products from CytoPherx. Over time, the company has the potential of addressing a broad array of inflammatory disease states that are quite costly both to quality of life as well as financially.”

In addition to Early Stage Partners, Onset Ventures and Capital Midwest Fund, joining the financing are new investors Kaiser Permanente Ventures, Emergent Medical Partners, Charter Oak Equity, Aphelion Capital, and existing investors Lurie Investments, Dow/Union Carbide Employee Pension Plans, Apjohn Ventures and North Coast Technology Investors.

Said Danehy, “Having such a strong syndicate of investors is very valuable in helping us reach our goal of returning many critically ill patients to normal, productive lives.”

CytoPherx was founded in July 2007 and is headquartered in Ann Arbor. It is a venture backed, clinical stage medical device company addressing inflammation-based diseases and conditions. The company’s products are custom configurations of a proprietary selective cytopheresis-based inflammation modulating system.

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