Spinal Simplicity Will Sell Implantable Device in Europe

Overland Park-based Spinal Simplicity LLC will begin selling its first product, an implantable spinal device, this summer in Europe, another big step to entering the U.S. market.

Jonathan Hess, the medical device startup’s vice president, said the company has received a CE Marking approval, symbolizing it has met the health, safety and environmental standards of the European Union, and International Organization of Standardization certification, a management system requirement for medical device companies.

Hess said the “Minuteman” should go on sale in July or August.

“We’re just excited to enter the market and offer a great treatment option for those suffering from lower back pain,” he said.

The Minuteman device, about an inch long and made of hollow metal to allow bones to grow over it and fuse together, is designed to alleviate pinched nerves in the spinal column.

Unlike other devices on the market, the Minuteman doesn’t require open surgery or long recovery times and can be used by a wider range of doctors and patients, such as the elderly.

Spinal Simplicity has submitted an application with the U.S. Food and Drug Administration for domestic sales, a process that could take a year or more, Hess said.

“We’re currently in discussions with the FDA, but I can’t elaborate much beyond that,” he said.

He added that the company is adding workers and should have eight by the time the Minuteman is introduced in Europe.