Bigfork medical device company named "one to watch"

Bigfork-based medical device company, Swan Valley Medical, was named to a shortlist of Montana biotech companies to watch by the Montana High Tech Business Alliance in partnership with the Montana BioScience Cluster Initiative. The recognition is designed to highlight promising startup and high-growth tech companies in the state and give visibility to Montana’s robust bioscience ecosystem. Eleven companies were recognized, including two in the Flathead Valley, the other being Truwl, a bioinformatics web application operating out of Whitefish.

Companies were nominated by experts from organizations like Two Bear Capital and the University of Montana, among others, which selected businesses that were poised to launch high-potential products or services, develop valuable intellectual property, possess expert leadership and plan to expand or add jobs.

Swan Valley Medical was founded in 2006 by entrepreneur Ron Zook and the late urologist Dr. Kenneth High. The company has developed a better alternative to traditional catheters that is less likely to result in a catheter-associated infection — the single-largest source of infections acquired within hospitals worldwide. Foley catheters are the medical standard, but are also prone to high rates of infection. The alternative is a subrapubic catheter, however current standards of practice to place these types of catheters come with increased risks of bowel injury and mortality, according to Swan Valley’s website. Swan Valley’s T-SPeC device provides a safe way to place subrpubic catheters, which could be game-changing in hospitals across the globe. In the thousands of procedures that have already been completed using T-SPeC, Zook reported a 0% mortality rate.

“The devices on the market before we developed T-SPeC had a very high mortality and morbidity associated with them. A 4.4% average mortality rate is a very high mortality rate for a simple little procedure. That basically compares to a kidney transplant mortality rate,” he explained. “We developed the T-SPeC to be a five-minute procedure that you do with a local [anesthetic] in a physician’s office and replace the open surgical procedure.”

The T-SPeC’s complication rate is just 1.8% compared to 45% for traditional catheters, Zook said. He explained that the device not only reduces the risk of complications or infection for patients, but will benefit hospitals’ bottom lines. When patients acquire infections in healthcare settings, Zook said hopsitals are not reimbursed for those services. An extended stay due to a hospital acquired urinary tract infection, for example, could be prevented with the use of T-SPeC technology in place of current standards of practice.

“That’s one of the reasons I left the aerospace industry to start a medical device company — helping people,” Zook said. “Saving lives and improving outcomes … that’s the rewarding part.”

One of Zook’s greatest challenges is educating the medical community and encouraging doctors and hospitals to embrace change. However, despite these hurdles T-SPeC is catching on. T-SPeC launched in Europe in 2012, was approved for the U.S. market the following year and has been utilized in medical facilities in both Canada and Mexico.

According to the Montana High Tech Business Alliance, Swan Valley Medical is projecting $700 million in annual income with distribution of its product to 230 U.S. hospitals.

The 2020 Montana Biotech Companies to Watch include:

Ahana, Missoula

VIRIS Detection Systems, Bozeman

FYR Diagnostics, Missoula

Golden Helix, Bozeman

NanoValent Pharmaceuticals, Bozeman

PatientOne, Missoula

PurCell Bio, Bozeman

Rocky Mountain Biologicals, Missoula

SOLO-DEX, Wolf Creek

Swan Valley Medical, Bigfork

Truwl, Whitefish