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 ’s annual business plan competition to supporyt the development ofthe device, which mimics the shock-absorbinf function of a spinal disc in patientsz affected by injury, cancer or other problemse requiring the removal of the natura l disc. Spinal discs are located betweejn each vertebrae inthe spine, and are responsible for cushioninbg the impacts of movement such as walking or jumping that might otherwisee fracture the vertebrae.
Ionics CEO Laine Mashburn said he will likelyt seekabout $5 million in venture capital financinbg to launch the device on the but will also look for granrt opportunities that would allow him to keep full controlo of the company and the product. If he can, he said he hopew to produce the devices in the probably by High Point metal parts manufacturer , which produced the prototypes used duriny the development and testing Mashburn said. He said he expects there to be significant demand for the product and sales could reachabout $50 million in five He said he has not settled on a marketing approach. Sellinhg rights to the device to another companyt is alsoan option, he said.
His companyh previously inventeda “vertebral body replacement” device and sold it to device giant Medtronic in he said. The ingenuity Mashburn shower navigating the complex approval process bodes well for his abilitu to meet aggressivegrowth targets, said Jon CEO of PTEN. For Mashburn lined up severall allies who convinced UNC System President Erskine Bowlex to waive the usual fees for testingat UNC-Chapel Hill’s biomechanicsz laboratory, and later convincer the FDA that formal and extremely expensive clinical trials of the device weren’t “You don’t have to be in an urban county to have a high-technology venture,” Obermeyer said.
“Yoju just have to have the know-howa and the network contacts and the savvy and persistencw to get over allthe hurdles.” While Mashburb does not intend to move his company from Etherr to a location more central to the Obermeyer noted that there might be opportunitiea for other companies in areas such as specialty coatings and packaging to take part in the productiomn process if the device is eventuallg manufactured locally.