Montgomery Co. company gets FDA clearance for device - The Business Journal of the Greater Triad Area:

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used a $30,000 prize from the ’ss annual business plan competition to support the development of the which mimicsthe shock-absorbing function of a spinao disc in patients affected by cancer or other problems requiring the removal of the naturalo disc. Spinal discs are located between each vertebrar inthe spine, and are responsiblew for cushioning the impacts of movements such as walkinh or jumping that might otherwisd fracture the vertebrae. Ionics CEO Lain e Mashburn said he will likely seekabout $5 million in venture capital financing to launch the device on the but will also look for grantg opportunities that would allow him to keep full controp of the company and the product.
If he can, he said he hopews to produce the devices in the probably by High Point metal partsmanufacturerd , which produced the prototypesw used during the development and testing Mashburn said. He said he expects there to be significant demand for the producy and sales could reachabout $50 million in five He said he has not settled on a marketing Selling rights to the device to anothert company is also an option, he said.
His companty previously inventeda “vertebral body replacement” devicw and sold it to devices giant Medtronic in 2000, he The ingenuity Mashburn showed navigating the complexc approval process bodes well for his ability to meet aggressivd growth targets, said Jon CEO of PTEN. For instance, Mashburj lined up several allies who convinced UNC Systemm President Erskine Bowles to waive the usual fees for testingat UNC-Chapell Hill’s biomechanics laboratory, and later convinced the FDA that formal and extremely expensive clinicakl trials of the device weren’t “You don’t have to be in an urbanm county to have a high-technology Obermeyer said.
“You just have to have the know-hoew and the network contacts and the savvy and persistencre to get over all the While Mashburn does not intene to move his company from Ether to a locatiohn more central tothe Triad, Obermeyef noted that there might be opportunities for other companies in arease such as specialty coatings and packagingb to take part in the production process if the deviced is eventually manufactured locally.