“Elegant Implant”
Rick Sasso, M.D., founding member and president of Indiana Spine Group, professor and chief of spine surgery at the Indiana University School of Medicine, Department of Orthopaedic Surgery, was one of the investigators for the M6 trial. He also was its most prolific patient enroller.
He described the M6 cervical artificial disc to OTW. “The M6 is the most elegantly designed disc. It has the advantage of providing axial compression and dampening properties. All the other discs with the single exception of the Bryan disc, do not allow compressive motion in an axial plane. I love this design.”
“When we decide to use a motion preserving implant, we are striving to restore ‘normal’ motion in the cervical vertebral segment. One aspect of that motion that all the other discs ignore is the importance of dampening motion in the axial plane. The other cervical motion preserving discs are hard-on-hard—meaning they are metal on metal or metal on polymer and therefore do not absorb compressive loads.”
In one of the early reports on the M6 IDE study, Dr. Sasso and his investigational colleagues had reported that the average patient length of stay was approximately four hours. We mentioned that to Dr. Sasso, and he said, “The M6 is super easy to put in. My normal length of stay for patients receiving the M6 cervical disc implant was four hours.”
Wall Street Took Notice
Within hours of Orthofix’s press announcement, two the largest investment banks on Wall Street were alerting their institutional clients to the news.
Craig Bijou, senior analyst at Cantor Fitzgerald Equity Research wrote, “As we have noted in the past, the M6 disc has generated a significant amount of surgeon and sales rep interest in OFIX since the disc was acquired in the Spinal Kinetics acquisition. With the approval, we expect surgeon and rep interest to continue to build and believe that the recent realignment of OFIX’s spine businesses should help the company capitalize on the M6 and OFIX’s other differentiated products, particularly in the cervical spine.”
“We expect the M6, even in a limited launch, to be a key catalyst for OFIX’s spine franchise. Given the earlier than expected approval, we think the M6 could provide upside to our 2019 estimates, but we will wait to hear from management on expected revenue contribution. OFIX expects mid-single digit revenue growth in 2019 and double-digit organic growth in 2020, largely driven by the M6 disc.”
Jeff Cohen, managing director, Equity Research Healthcare & Medical Technologies at Ladenburg Thalmann & Co. Inc.—one of the oldest and largest investment banks in the world—said this: “Recall, the M6-C is developed to replace cervical disc damage caused by degeneration as an alternative to cervical fusion. The artificial disc restores the physiologic motion of the spine. The M6-C is designed to mimic the anatomic structure of a natural disc with a visco-elastic nucleus and fiber annulus which allows the disc to absorb naturally-occurring shock while also providing a controlled range of motion.”
Earlier, Mr. Cohen had put a BUY rating on Orthofix stock and specifically mentioned the M6 as a key driver behind his rating.
