Hemosphere, Inc.: Patrick Wethington, Chief Executive Officer

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Hemosphere, Inc., is a medical-device company that is pioneering innovative subcutaneous-based access solutions that revolutionize care and restore quality of life for end-stage renal disease (ESRD) hemodialysis patients with compromised vasculature.

As the company explains it, Hemosphere’s device, known as the Hemodialysis Reliable Outflow Graft or HeRO® Graft, is the only vascular-access device that is fully subcutaneous and clinically proven to provide long-term access for hemodialysis patients who have venous-outflow obstruction.

“The number one driver of infections in hospitals is patients with tunneled-dialysis catheters (TDCs),” Patrick Wethington, chief executive officer, said. “The cost per infection ranges from $23,000-$45,000 with an average length of stay of 17 days. The HeRO Graft provides catheter-dependent ESRD hemodialysis patients with a fully subcutaneous-access option, which has been clinically proven to lower the infection rate vs. catheters by 69 percent.”

Hemosphere received FDA market clearance for the HeRO therapy during the first half of 2008, and its commercialization efforts began in mid-2008. Currently, there are over 300 physicians across the country trained to implant the HeRO Graft.  Hemosphere is approaching 5,000 HeRO Graft patients.

Currently, Hemosphere’s distribution and commercialization efforts are exclusively in the United States, but the company recently received ISO TUV 13485/CMDCAS and EC certifications that pave the way for expansion into European and Canadian markets.

Improving patient outcomes

Beyond its innovative qualities, the HeRO Graft has proven its ability to enhance quality outcomes for dialysis patients. Given that patients receive dialysis treatment three times a week, the catheters protruding from the patients’ neck become susceptible to carrying infections and other germs.

The Centers for Disease Control and Prevention (CDC) announced in spring 2011 that it would begin tracking and ranking hospitals based on their ability to manage the bacteremia rate. For dialysis patients, the HeRO Graft has been clinically proven to lower the bacteremia rate by 69 percent compared to TDCs.

A great partner for hospitals

Wethington emphasized that Hemosphere is a great partner for hospitals who share the organization’s vision of catheter reduction to deliver safer, more effective treatment and management of dialysis patients.

Ascension Health Ventures has invested in Hemosphere based on their belief that the HeRO Graft has the potential to reduce hospital infection rates via catheter reduction.  The HeRO Graft has received the Innovation Award from Premier, the nation’s largest group-purchasing firm and has been featured in over 90 publications.

ESRD is a rapidly growing disease, particularly in a patient population that is unfortunately becoming quite young because of the rising epidemic of obesity, diabetes, and hypertension.  While TDCs provide a viable acute-access option for dialysis patients, they often are not only associated with higher infection rates, but also higher intervention rates since they need to be replaced so frequently. The HeRO Graft, much like a long bridge, restores blood flow in the central obstructed veins to the peripheral veins, resulting in higher blood flow and renal clearance, superior patency, and intervention rates in comparison to catheters.

-by Pete Fernbaugh

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