Startup launches device for early detection of IV tissue infiltration to reduce complications

ivWatch 400--Courtesy of ivWatch

Intravenous administration of fluids and medication is incredibly common among hospital patients. But the failure rate of IVs is relatively high--estimated at more than 20%. These issues can result in leakage of fluid or drugs outside of a vein and into the surrounding tissue, which can cause complications including tissue damage and amputations.

To avoid such issues, rather than use an IV in a peripheral vein--as is done in over 150 million U.S. patients a year--healthcare providers might instead opt for a more invasive option of peripherally inserted central catheters, but these also carry the risk of bloodstream infections.

Startup ivWatch was formed in December 2010 in an effort to create technology that would enable safer use of peripheral IVs for infusion--by creating a device that continuously monitors a patient IV for early detections of infiltrations, when fluid or medicine leaks outside the vein into the surrounding tissue.

The Hampton, VA-based company is now launching the device, the ivWatch Model 400, following an FDA clearance in February 2015.

"It's like a seat belt. Since it's difficult to predict when an accident will occur, people wear their seat belt for the duration of their travel. Similarly, since it's difficult to predict when an infiltration will occur, and we know it occurs too frequently, the ivWatch Model 400 represents a seat belt for patients with an IV," said ivWatch President and CEO Gary Warren in a statement.

He added, "Our continuous monitoring device not only improves patient safety, but can help minimize the risk and avoidable costs for health care provider organizations."

The device uses a noninvasive sensor based on the detection of visible and near-infrared light to detect changes in the optical properties of tissue. The small sensor sits near the IV site, such as on the back of a patient's hand. This is paired with a pole-mounted patient monitor that offers practitioners notification of an infiltration before the onset of symptoms, thereby potentially reducing patient harm.

ivWatch was backed with Small Business Innovation Research (SBIR) and National Institutes of Health research grants. The startup has raised about $10 million mostly in equity since 2011, according to SEC filings. Its most recent cash infusion was $2.1 million out of an anticipated $8.2 million that was disclosed last September.

- here is the release

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