ProNova gets FDA approval

12/8/2016

The U.S. Food & Drug Administration has cleared the SC360 proton therapy system, made in Maryville by ProNova Solutions, the company announced.

The first is expected to be used in cancer treatment next year at the Provision CARES Proton Therapy Center in Knoxville, according to the news release.

“Of course that will mean lots of jobs and increase in business for ProNova and our community,” said Terry Douglass, executive chairman of ProNova’s parent company Provision Healthcare.

The Knoxville proton therapy center will expand from three treatment rooms to five, and the SC360 for each of those will be made in Maryville, he said.

Companies must tell the FDA at least 90 days before they plan to sell a new medical device, according to the FDA’s website. That pre-market notification, or 510(k) – so named for its section of the Food, Drug & Cosmetic Act – lets the agency decide whether the new device is equivalent to an existing piece of equipment.

“A lot of the purchases of the system and also investments in our company are contingent on getting this FDA 510(k) clearance,” Douglass said. “So by getting the clearance we’ll now be able to create the agreements for purchases of these systems.”

Between now and the end of 2017 the company plans to develop five proton therapy centers, each of which is likely to have three treatment rooms, he said. Each of the five centers is expected to cost about $50 million.

“Achieving this milestone is an enormous accomplishment for our company and will allow us to offer the most advanced technology without compromising features for proton therapy treatment through systems that are smaller, lighter and easier to install while increasing capabilities compared to our competitors,” ProNova President Joe Matteo said in the announcement. “The ProNova SC360 will not only improve proton therapy treatment, but due to its lower cost, will make proton therapy more accessible to patients worldwide.”

It has only been four years after research started on the device.

“This is the first and only compact 360-degree pencil beam scanning proton therapy system capable of treating patients at all angles without moving the patient, enabling the most efficient clinical workflows, improved accuracy of treatment, and patient comfort,” the company announced.

Provision Healthcare created its subsidiary ProNova in 2012 specifically to develop a better proton therapy system, according to the company. The design got continuous input from doctors, medical physicists and therapists.

Provision Solutions is ProNova’s exclusive distributor, and has “multiple agreements” to build proton therapy centers in the U.S., Europe and Asia, the news release said.

“This is a huge milestone for our locally grown company and will contribute to job growth at our Blount County manufacturing plant, ProNova, which is located at Pellissippi Place,” said Gretchen Crawley, spokesperson for the Provision Center for Proton Therapy, in the announcement. “We currently are building proton centers in Nashville and Orlando that will implement the SC360 system.”

The new technology will have a major impact on cancer care in East Tennessee and elsewhere, Douglass said.

“Our strategy is to be an open center, making this capability open to anyone,” he said.

Source: Knoxville News Sentinel

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