Soteira CEO Larry Jasinski is no stranger to adversity.
In the last 5 years the spinal fusion device maker has overcome criticism from the research community and mid-application surprises from the FDA, but its newest 510(k) win is a testament to its persistence.
The Natick, Mass.-based vertebroplasty firm emerged from stealth mode once again at the end of last year to announce that it finally landed clearance for its Shield kyphoplasty system and is preparing for market launch
Being low-key is part of the company’s character, Jasinski told MassDevice, but so is tenacity.
When the FDA suddenly shifted its expectations of the Shield application, after having agreed to a pathway to clearance with Soteira, Jasinski didn’t fight the reviewers – he went over their heads.
"For any companies that are working in this space, I would have to encourage you to work further up the chain with the FDA if you have challenges along the way, because you can succeed if you follow those types of pathways," Jasinski told us. "I have found the upper management much better at that. I think the reviewers care, but it’s just a time when they’ve had too much turnover and too much change, which has made it difficult for industry and difficult for patients and others that are involved in this process."
Click here to listen to the MassDevice podcast interview with Soteira CEO Larry Jasinski
In 2009 the New England Journal of Medicine dedicated many pages of an issue to arguments against kyphoplasty, with some researchers arguing that the procedure was roughly the equivalent of doing nothing for a patient.
It was the same year Soteira filed its 510(k) application for the Shield system.
"The impact on Soteira was, primarily, the FDA came back and asked us a lot more questions, which I think was somewhat appropriate given the literature that was out there," Jasinski said. "That slowed us down and slowed down our competitors."
Although the company pushed through the FDA uncertainty and new studies eventually vindicated kyphoplasty as a good choice for the right patients, the road ahead will have its own challenges.
Soteira hasn’t yet determined how to market the Shield system, but it does have strong reimbursement status as a recognized procedure. The competition, however, is fierce, with big names like Medtronic (NYSE:MDT) and Stryker (NYSE:SYK) holding their own in the field.
"[The competition] is growing because it’s such an attractive space," Jasinski told us. "We are the 1st of the significant advanced augmentation companies to get an FDA clearance in the U.S., so we believe that suits us well. I know that our competitors are going to do significant studies that will take some time, similar to the types of things that we did."