Preceptis Medical is a small company that has big designs to clip the costs and boost the safety for the 1.3 million young children who undergo ear-tube surgeries each year.
"This is a simple story," said Preceptis CEO Steve Anderson. "We've come up with an effective tool that allows us to do the procedure under conscious sedation, avoiding the expense of the operating room, and avoiding the risk to young children of general anesthesia."
Anderson said the procedure can be done in a clinic or doctor's office for up to 70 percent less than the nearly $5,000 cost of the traditional surgical repair for infected ears in youngsters.
Dr. Frank Rimell, a veteran pediatric surgeon and a "principal investigator" testing the Preceptis tool at the University of Minnesota-Amplatz Child-ren's Hospital, said several ear-nose-and-throat surgeons are testing the tool at four Twin Cities hospitals. Rimell said he exp-ects to present the results of more than 50 procedures on children up to 5 years old at a May conference of pediatric ear, nose and thr-oat surgeons in Las Vegas.
"I want to get this procedure out of the operating room for multiple reasons," he said.
The goal, Rimell said, "is to see if we can make this most-common procedure among children in the United States even safer. And it is a safe procedure now. But even safer and more economical. We want to remove potential risks and make it cheaper."
Rimell said he is not a shareholder in the company and receives less than $5,000 annually for coordinating clinical trials.
The tests are being done using nitrous oxide, considered a safe and inexpensive sedative used by dentists for decades, instead of a general anesthetic.
The Preceptis tool was invented by Dr. Michael Loushin, a partner in Twin Cities Anesthesia Asso-ciates and an adjunct faculty member at the University of Minnesota medical school, and Keith Leland, a mechanical engineer and vice president of research and development at Preceptis. The company is headquartered in Ply-mouth, Minn.
According to Preceptis, the procedure requires one precise pass at the ear, taking about 10 seconds. The patient remains awake, though sedated with the nitrous oxide.
"All these things are converging in a way that makes the timing right for us," said Anderson, 51, a biomedical engineer who has worked for several medical-products companies.
Anesthesiologists, who stand to lose business, might not like this procedure. But it's the type of innovation that can help reduce health care costs.
With the Preceptis tool, surgeons are able to insert the tube on the first pass 85 to 95 percent of the time, Rimell said.
"The goal is to get this done in the office, so the family doesn't have to come to the office for the initial visit and then come back for surgery and the child doesn't have to go for a surgical physical, and the parents don't have to take off a second day of work," Rimell said. "Let's get the tube done that day."
Preceptis, which still needs federal regulatory clearance for its product, hopes to be selling it by fall and would likely be a candidate for acquisition by medical-products companies looking to extend their product lines.
So far, Preceptis is winning support from inves-tors.
Preceptis and its Tymp-anostomy Tube Intro-ducer, or TTI, were winners in last fall's Minnesota Cup entrepreneurial competition.
The company just raised $2 million in equity from mostly Minnesota individual investors who put up a minimum of $100,000 ea-ch.
Holders of $2.4 million in Preceptis debt this month simultaneously converted that debt to stock in the company.