Facet Solutions Inc. finished compiling two-year data from a Phase III clinical trial of its Acadia spinal implant, saying the patients experienced less leg and back pain and improved mobility two years after the procedure.
The Hopkinton, Mass.-based company also drummed up $2.1 million in an offering of debt, options, warrants or other securities to a group of 43 investors, according to a filing with the federal Securities & Exchange Commission.
Facet Solutions’ Acadia device is designed to treat lumbar spinal stenosis, a condition in which the facet joints of the lumbar spine wear down and impinge on spinal nerves. The standard surgical treatment is decompression with spinal fusion, in which doctors trim or remove the facet bones to relieve the impingement. Because the facet bones help provide stability to the vertebrae, surgeons then use an implant to fuse adjacent vertebrae.
The Acadia device is designed to restore the range of motion following decompression surgery by replacing the facet joints with an antomically designed implant, according to the company’s website.
The clinical trial of the device, slated to enroll 300 patients, examined physical function and severity of symptoms for 24 months after implantation. Two-thirds of the patients in the study received the Acadia implant, while the remainder underwent traditional decompression and fusion surgery.
Facet Solutions said patients in the study showed "significant and sustained improvement" in leg and back pain, measured using the visual analogue scale via questionnaire. Patients also showed "sustained improvement" in Oswestry Disability Index, a questionnaire-based measure of permanent functional disability.
"There were no re-operations in any of the patients, and all patients met the definition of success for ODI improvement," according to a press release.
Dr. James Youssef, a principal investigator for the study at SpineColorado in Durango, Colo., is scheduled to present a clinical update on the trial at the Spine Arthroplasty Society’s meeting in New Orleans April 30.
Facet Solutions president and CEO Geoff Pardo did not immediately return a call seeking comment.