SAN FRANCISCO--(BUSINESS WIRE)--Providence Medical Technology, Inc. (PMT) today announced it received 510(k) clearance from the FDA for its PMT Cervical Cage. PMT Cervical Cage is a novel minimally-invasive implant and delivery system for cervical fusion procedures.
PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
This FDA clearance completes the company’s current U.S. product portfolio, which also includes DTRAX Spinal System, DTRAX Graft, and PMT Bone Screws. DTRAX Spinal System and DTRAX Graft are on the market, and PMT Cervical Cage and PMT Bone Screws will launch the third quarter of 2013.
“Providence has now developed a broad minimally-invasive cervical product portfolio,” commented Jeff Smith, Chief Executive Officer of Providence Medical Technology. “Our U.S. launch of PMT Cervical Cage will build upon our successful international experience, where we have sold over 500 DTRAX Facet System units since its launch in Q4 of 2011. The clinical outcomes achieved by our customers and their patients have surpassed our expectations, and we are excited to bring this clinical value to U.S. surgeons and patients.”
Providence also announced that Kevin Shaw has joined the company as Vice President, Sales. Mr. Shaw most recently served as Vice President, Sales for S-I BONE, Inc. Under his leadership, adoption of the company’s technology increased rapidly, reaching 5,000 patients treated in just four years from initial launch of its technology. Previously, Kevin was one of the four original Area Sales Directors responsible for the launch of the X-STOP IPD for St. Francis Medical Technologies. Kevin worked closely with Providence’s management in integrating St. Francis with Kyphon, and later with Medtronic, following its purchase of Kyphon.
“I’m excited for Kevin to lead our U.S. product launches and grow our U.S. sales team,” continued Mr. Smith. “Kevin’s track record in building successful distribution networks and delivering superior sales results with novel spinal implants is an ideal fit for Providence.”
Finally, Providence also announced that Edward Liou has been promoted to Vice President, Engineering and Operations. Mr. Liou joined Providence as Director, Engineering in 2010 from Speck Design, where he led development of the DTRAX Facet System, which is currently sold outside of the U.S. Before joining Speck, Ed co-founded Alter-G, a venture-backed technology-leader in the rehabilitation space.
“Ed has been an outstanding contributor to Providence’s success during his tenure with the company,” commented Mr. Smith. “He and his team have been responsible for four U.S. products and two 510(k) clearances in the past year. Most impressively, all four products progressed from concept through regulatory go-ahead in 12 months.”
Providence Medical Technology is a privately-held medical device company developing minimally invasive solutions addressing the $1 billion worldwide cervical spine market. We are commercializing the DTRAX platform of minimally invasive posterior cervical implants and instruments to treat cervical degenerative disc disease through indirect decompression and stabilization.