Minnesota-based disposable medical device startup United Medical Innovations Inc. is planning a product launch mid-year 2012, or immediately after it anticipates receiving U.S. Food and Drug Administration approval for its spring assisted syringe and manifold kit.
UMI develops and manufactures medical devices used in performing a coronary angiogram, an imaging technique that uses radioactive dye and X-ray technology to visualize the interiors of blood vessels and the heart.
The dye is usually injected through a catheter via a manual syringe onto an attached medical manifold. Over the past several years smaller catheters have been adopted to reduce the risk of complication, but a smaller puncture hole makes manual injection more difficult, as it should be done quickly to ensure the right density of contrast agent in the vessels.
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UMI’s first two products are a power-assist syringe and a semi-automatic manifold to replace the standard syringe and 3-gang manifold typically used during the procedure. It also has the two products working together as a kit to ensure quick, accurate delivery of the dye.
“We want to have a device that’s disposable and yet cheap to own and operate compared to a power syringe,” CEO Kevin Liu said.
Liu likens the syringe to power steering in a car, and the manifold to an automatic transmission. “Our product is definitely not groundbreaking in any sense,” he said. The angiogram procedure can work as is, but UMI’s products make it more efficient and reduce the risk for human error, he said.
Because the devices are low-risk, Liu anticipates that if he submits for FDA approval before the end of this year as planned, he can receive it in May and launch the products immediately. He will also pursue regulatory clearance overseas, he said.
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Liu developed the technology and founded UMI in 2009 with a partner, Shen Li. All of the company’s products are manufactured in a production facility in China that employs eight people.
The company was started with seed money from U.S. and Chinese investors, and Liu continued through a series A round after that. He declined to disclose the amount he secured but said it was enough to carry the company into a product launch, and that he didn’t anticipate another round for at least a year.
The market for disposable angiogram assist supplies is ripe, Liu said, with 75 percent of procedures using the traditional syringe and manifold because of the high cost associated with using more powerful machine syringes. This new technology is easily adoptable because doctors don’t need any training to use it.
More than a million patients undergo an angiogram every year. But a study published last year with data from the American College of Cardiology suggested the procedure may be overused in detecting risk for heart attack.
UMI is based in Maplewood, Minnesota, but will soon be moving to a space in University Enterprise Laboratories, a biotechnology incubator near the University of Minnesota.
