Despite Utah’s smaller population compared to other states, Utah packs an extraordinary wallop in the development of the global medical device industry, says David Parkinson, vice president of public relations at the Sorenson Companies.
“Industry titans and pioneers James LeVoy Sorenson, Dr. Willem Kolff, Dale Ballard and Dr. Homer Warner significantly shaped and accelerated the development of the worldwide industry.”
Shortly after co-founding Deseret Pharmaceutical in 1957 with Ballard and Victor Cartwright, Sorenson developed the world’s first large-scale disposable surgical mask in 1959. This invention was followed by a host of catheters and catheter systems in the 1960s and 1970s.
“Beginning in 1975, he collaborated with Dr. Homer Warner to create what is perhaps Sorenson’s crowning achievement—the first computer-based systems for monitoring the heart in real time,” Parkinson adds.
Ultimately, Deseret Pharmaceutical was the catalyst for a series of companies that played a significant role in the development of the medical device industry in Utah—and the world, Parkinson says. After the company was sold to Warner Lambert and then Becton Dickinson, it became BD Infusion Therapy Systems. Ballard Medical, which flowed out of Deseret Pharmaceutical, became a major branch of Kimberly-Clark. “Sorenson Research, which Sorenson founded in 1962, went on to create a dizzying array of medical innovations—including the plastic IV catheter, blood recycling and waste disposal systems, the disposable venous catheter and the continuous flushing catheter,” says Parkinson.
Willem Kolff, father of artificial organs including the first artificial kidney, led the development of a series of artificial hearts and other organs and processes at the University of Utah, while attracting and mentoring a generation of medical device innovators—including robotics pioneer Steve Jacobsen of Sarcos (now Raytheon-Sarcos); and Ted Stanley, founder of Anesta and co-founder of ZARS.
This year, three new medical devices are part of Utah’s continuing tradition of originating medical devices and give new hope to high-risk cancer patients, people with hearing loss and degenerative disc disease.
Andy Raguskus, president and CEO of OtoKinetics, Inc, explains that there are many different types of hearing loss caused by a variety of different problems. “While traditional hearing aids work for mild and moderate hearing loss, as people age their hearing loss becomes increasingly severe. They become dissatisfied with traditional hearing aids.”
In response to this situation, OtoKinetics invented and patented an implantable hearing aid that is designed to help people with more severe hearing losses. “It uses cutting edge technology to bypass the eardrum and the three tiny bones of the middle ear and it directly stimulates the fluid of the inner ear. Nothing like this has ever been done before,” says Raguskus. “The result is that even for people with severe hearing loss, we can help them hear as much as though they were unimpaired. Our device provides outstanding acoustic performance in a completely invisible package.”
Raguskus says that OtoKinetics will begin marketing the device to doctors in about two years. He adds that the team of people who started OtoKinetics are the same people who originated Sonic Innovation, which is now a large corporation in Utah.
Utah company Amedica Corporation is also working to control another chronic condition: degenerative disc disease. In 2006, Amedica received FDA clearance for the first ever load- bearing ceramic spinal device. And in 2007, the FDA cleared Amedica’s Valeo system of implants, which utilizes silicon nitride technology. “It’s a fancy kind of ceramic shown to have beneficial uses in the body for total disc, knee and hip implants,” explains Steve Zeiger, director of marketing for Amedica Corporation, adding that there are many different uses for the product, but the most common use is for degenerative disc disease.
“As the disease progresses, the disc collapses. The body tries to correct the situation by growing bone there, which may result in stenosis of the spinal canal and neural foramen,” Zeiger says. “This bone growth causes problems by impinging on the nerve roots and spinal cord. The result is pain and loss of function.” Such loss of function can lead to several disabilities including not being able to walk even short distances without resting.
Zeiger says that, although over time the spine may fuse itself, surgeons can medically fuse it by replacing the non-working anatomy. “By cutting away the extraneous bone growth, surgeons relieve pressure on the nerve roots and spinal canal. This alleviates pain. Functionality may or may not return. Lost function doesn’t always repair itself.” Surgeons replace the non-working parts with a Valeo spacer implant and use Amedica’s pedicle screw system to stabilize the spine.
Lung cancer is a common health battle that, according to the World Health Organization, will overtake heart disease as the leading cause of death in 2010. Steven Eror, president, CEO and founder of Freshmed, explains that most cancers can only be confirmed with an evaluation of tissue. Acquiring lung tissue involves a surgery that is dangerous, expensive and life threatening. The operation also carries a 5 percent mortality rate and a $70,000 price tag.
“There is no screening to detect lung cancer early. The CT scan is the first line of defense.” Eror explains. He adds that Mayo Clinic research indicates that CT scans often fail to distinguish between a malignant or benign tissue mass, showing up to 94 percent false positives in high risk patients.
However, Freshmed’s Transthoracic Bronchopulmonary Bioconductance Scanner offers non-invasive lung cancer detection for patients who are symptomatic, but have not been diagnosed with lung cancer.
“With so many people facing unnecessary surgery, our scan is designed to confirm the malignancy prior to surgery, during the same hospital visit as the CT scan,” says Eror.
Freshmed recently presented initial results of the scan’s third clinic trial at primary meetings of the American Thoracic Society. Eror says that the new device is now ready to go to market. “We’re an intrepid local company that is attacking a very large problem,” he explains. “Lung cancer is first in the parade of horribles. For the 200,000 lung cancer patients this year, early detection could result in 80 percent of patients, rather than 15 percent, enjoying survival five years after detection.”