Craig Corrance, the twenty-year spine industry vet had only been in his chair as president of Centinel Spine for about eight months when a recruiter for Applied Spine Technologies (AST) came calling earlier this year.
AST was without a CEO after the departure of Tom Wood and it had voluntarily suspended its clinical trial for the Stabilimax NZ system after their pedicle screw had fractured in a small number of procedures.
The recruiter was fishing around to see if he’d move after such a short time. Corrance had only recently joined Raymedica, which was in the process of changing direction from nucleus arthroplasty to stand-alone fusion in both the cervical and lumbar spine areas. Raymedica had put its HydraFlex device on the back burner and hooked up with Surgicraft to form Centinel Spine.
Admittedly, Corrance was concerned about how this would look on his curriculum vitae. However, after reflecting on the opportunity, Corrance said, “It was Dr. Panjabi, the technology and going back to the motion preservation space that whetted my appetite to get involved.”
Corrance Joins AST
“It looked like a real opportunity to perform as a CEO and sit on a board where they’ve got four mature funds and be in an arena that is a comfortable zone for me, ” Corrance told OTW in an interview shortly after the announcement was made that he was joining Applied Spine as its CEO on May 11.
Bringing the product to market via a PMA, (not adjunct to fusion), his previous experience in pedicle anchored motion preserving devices and a chance to revisit prior relationships were other important reasons for his decision to join AST. Corrance had been a senior executive at Scient’x USA and Altiva Corporation before joining Raymedica.
According to the company, Stabilimax NZ is the culmination of more than 30 years of focused research by Manohar Panjabi, Ph.D.
The underlying premise of Stabilimax NZ is that painful spine motion increases in an injured spine and that this abnormal motion is most pronounced in the ‘Neutral Zone’—the area of laxity in the center portion of the spine’s range of motion. Stabilimax NZ utilizes a dual-spring mechanism with a variable dynamic feature that maximizes stiffness and support in the Neutral Zone, thus hopefully returning the Neutral Zone to its normal, limited range.
AST Challenges
Was he entering a company in turmoil and under stress after the departure of their CEO, Tom Wood and the voluntary suspension of their clinical trial?
Corrance told us that to a great extend, the clinical trial issue had already been fixed. “The headache had been that they ‘grit blasted’ their pedicle screw to try and roughen the surface to reduce the risk of screw loosening which had in turn caused the screw fracture in those small number of procedures..
The second generation screw is manufactured using industry standard manufacturing protocol. It has been cycle tested which allows us to have a great deal of confidence that the screw won’t fracture going forward, ” said Corrance.
Trial Resumed
The FDA has now permitted the resumption of the trial by allowing the enrollment of another 20 patients. The company is four patients into the 20 with another five already in their diary enlistment. The company wants to collect the data and present it to the FDA by the end of July.
In addition, by the end of June or early July, the company will be in a position to present one years’ data to the FDA with the first generation screw. Its hope is that it will be allowed to continue enrolling from that point onwards.
Corrance is quick to point out that he has inherited a terrific team at every level. He said Applied Spine did the right thing with the voluntary recall. He praised the FDA for responding well from the company’s point of view.
Speaking of doing the right thing, Corrance told us that former CEO Tom Wood came by his office to shake his hand and offer assistance. “That was a terrific gesture.”
Corrance concluded, “Panjabi is not unlike Henry Ford in the automotive industry. He’s changed the world in how we think as far as pedicle anchored motion preservation is concerned. That was really an attractive proposition.”
