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ROHNERT PARK and HEALDSBURG -- There’s a new kid on the medical-device block in Sonoma County. Joining Medtronic, TriVascular and more than a dozen smaller device makers is Hemotek Medical Inc., a tiny company with a good idea and backing from the U.S. Small Business Innovation Research (SBIR) grant program.
The startup has a solution to venous needle dislodgement (VND) in dialysis patients, a potentially fatal occurrence that continually worries dialysis centers and their insurers.
Should the needle returning blood to the patient’s body after it cycles through a hemodialysis machine become dislodged through unintended movement, the patient can bleed to death, an outcome that becomes more likely as more people go on dialysis.
“There are almost 2 million sessions of hemodialysis performed each week in the U.S. by more that 600,000 dialysis patients,” said Hemotek founder and CEO Patrick Rousche, Ph.D. “And the patient community is expanding every year.”
Medical studies and patient surveys suggest that in any given week more than 200 hemodialysis patients will suffer an incidence of VND and up to four of those patients may bleed to death as a direct result. Others will require hospitalization at high cost to insurers.
About $160 million is currently spent each year in the U.S. on hemodialysis needles, $1 billion globally.
Dr. Rousche, most recently a professor of bioengineering at the University of Illinois, two of his former students -- Chuck Ventura and the eponymous Peter Tek, Ph.D. -- and design engineer Rick Scribner designed the patent pending V-Needle.
It’s a simple, cost-effective device that doesn’t rely on sensors or excessive taping and constant monitoring by technicians, but rather on a mechanical process that both detects VND and halts any errant flow of blood.
“The beauty of the V-Needle is that it can be manufactured relatively simply, keeping costs down,” said Dr. Rousche.
Hemotek Medical (hemotekmedical.com) is currently just a handful of bioengineers working from Chicago, an office in Healdsburg and a lab at SoCo Nexus in Rohnert Park, but the company has tapped into a good source of early funding from the SBIR program through the National Institutes of Health, which kicked in an initial $200,000 via a competitive grant process.
“It’s enough to keep us going for a year while we build our first prototype,” said Dr. Rousche. “It’s a wonderful program, too little known among science startups.”
Prior to Hemotek he also founded Ensis Scientific Consulting (ensisconsulting.com) to help tech-based startups obtain the same funding.
Meanwhile, Hemotek can now compete for SBIR Phase II funding -- $1.5 million to start testing the device on animals. This will move the company one step closer to FDA approval, a process that may be speeded by similarities between the V Needle and other medical devices already on the market, he said.
Although speculation is premature, Dr. Rousche agreed that a possible partner in funding the FDA approval process may be an insurance company.
Wrongful death settlements after VND are typically confidential, but one settlement in Ohio was announced to be $4.75 million. Another in Chicago was disclosed to be at least $10 million.
“The insurance premiums required to offset this significant legal exposure represent a major concern for hemodialysis centers and hemodialysis system manufacturers, especially when viewed in the light of the steadily increasing numbers of people now dependent on hemodialysis,” said Dr. Rousche.