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| Saranas system--Courtesy of Saranas |
Houston's Saranas raised $4.5 million in equity to develop and commercialize its cardiac sheath for the early detection of internal bleeding in procedures requiring a catheter to access a blood vessel. Funders include Vanguard Ventures co-founder Jack Gill and members of the Goose Society, a group of Houston entrepreneurs.
Saranas says 5% of vascular access procedures conducted in the U.S. result in internal bleeding due to a catheter unintentionally hurting a blood vessel. Its sheath can detect the complications because it is surrounded by electrodes that measure the difference in electrical resistance across the vessel, according to the company's website.
Saranas has yet to earn any revenues but aims to file a 510(k) for FDA clearance soon, with a goal of making sales in 2016. The sheath will cost $250, Xconomy reports.
Electrical resistance is a signal of a ruptured vessel because it changes when the bleeding commences. "The sensors are picking up the characteristics of the tissue around the blood vessels, the fat, muscle, bone, to create a signature for every patient at the beginning of every procedure," Saranas founder Mehdi Razavi previously told Xconomy. "If you start introducing blood, then those properties start changing. That's what we can immediately detect."
The device is usually placed in the thigh, a common entry point for catheters as they make their way toward the heart or other bodily organ. An external monitor connected to the sheath by a chord displays the analytics collected by the device.
The company touts the clinical and economic benefits of detecting internal bleeding earlier, saying that the million cases per year in the U.S. result in mortality risk that's 9 times higher, and doubles the cost of care to around $25,000.
Saranas astutely points out that due to the Affordable Care Act, the quartile of hospitals with the highest rate of adverse events will be docked to the tune of 1% of their Medicare reimbursement (or an estimated $1.7 billion in total).
Xconomy reported earlier this month that the company raised $2.35 million, and it appears to have found more financing since then. Funder Jack Gill predicted that "that one or two sheath manufacturers will acquire this company, sooner rather than later."
- here's the Form D with the SEC
- here's Xconomy's take | here's more from Xconomy