11 Jul Kyron wins FDA approval for brain imaging technology
Wauwatosa, Wis. – After receiving FDA clearance for two new brain imaging applications, a local research and technology startup is prepared to market its products to healthcare providers.
Approval from the U.S. Food and Drug Administration Center for Devices and Radiologic Health in June allowed Kyron Clinical Imaging to add two new products to its line of brain mapping solutions based on functional and physiological magnetic resonance imaging technology.
These products allow physicians to combine and integrate information about brain anatomy, tumor biology, and brain functions prior to treatment, and potentially reduce post-surgical complications.
Kyron CEO Paul Schmelzer said the devices help physicians with the treatment, planning, and management of brain tumors by developing a functional map of the brain. “We know the areas that are activated by the motor, cognitive, and sensory centers of the brain, and we look at the circuitry of the brain to see how these functional areas interact,” he said.
Through the Prism
Kyron’s new products are part of its Prism line and include the Prism Acquire and the Prism Process.
The Process allows analysts to synchronize activities a patient is asked to perform in relation to imaging data captured by MRI scanners. An example would be asking patients to tap their fingers in a sequence. The scanner data would show which part of the brain is activated by the task.
The Acquire enables the acquisition of functional and physiological MRI data, quality control, and data management. With a functional map, a physician knows where those functions reside in relation to the physiology of the tumor itself, and can plan treatment with the knowledge of the tumor, Schmelzer said.
“This can provide a significant reduction of risk of permanent deficits or side-effects of the treatment plan,” he added.
Anywhere from 16 to 23 percent of brain cancer patients experience post-surgical complications, including paralysis, impeded speech, or encumbered motor skills.
There are an estimated 360,000 brain cancer patients in the United States, and the potential of these products prompted Froedtert Hospital to invest $1.5 million in Kyron in February.
The funding will allow the company to expand. Kyron is in the process of hiring more staff and, outfitted with FDA approval, will actively market its new applications in an attempt to expand its business base.
Kyron markets the software to hospital systems and healthcare providers, and also offers it on a service basis to smaller institutions for outpatient imaging. An example is Kyron’s current pilot service with the Center for Diagnostic Imaging in Milwaukee.
Given the uniqueness of its product, Schmelzer believes Kyron is positioned to become a market leader in advanced MRI studies.
“That’s the edge we’ve got,” he said.
• Froedtert invests $1.5M in local medical imaging startup
• Software to aid brain surgery is goal of Milwaukee startup
• Froedtert and Medical College plan $120 million expansion