Live from NASS: Implanet Poised for Entry into U.S. Spine Market

Implanet currently is on the verge of entering into the U.S. spine market with its Jazz implant, a system intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

In September this year, the company released interim data from a multi center study titled “Adolescent Idiopathic Scoliosis Treated by Posteromedial Translation Using Jazz Sublaminar Bands.” The study was carried out by the Department of Pediatric Orthopedic Surgery at the Robert Debré hospital, which is part of Paris Diderot University in Paris, France. It includes details of the results obtained with the help of the Jazz implant in the surgical treatment of adolescent idiopathic scoliosis by posteromedial translation, in particular in terms of the restoration of frontal and sagittal alignment. The study was conducted with 12-month follow-up of a consecutive series of 20 patients.

“With seven years of clinical data behind us, we know that the Jazz implant is effective in pediatric patients,” CEO Ludovic Lastennet told ODT during this year’s North American Spine Society Annual (NASS) Meeting held in San Francisco, Calif. “But people, especially women, are living longer now. The degeneration of bone can be a good indication for the type of fixation offered by Jazz. It will not replace screws, but it will help to make the fixation secure. It’s what we call an adjunct to fusion rather than a fusion device. Jazz can replace screws in certain cases, where the spine is so deformed that a screw cannot be placed, but where better fixation is still needed. This is what we plan to demonstrate in clinical studies in the United States. We believe this product will eventually be standard of care in the treatment of degenerative spine disease in aged patients.”

Last year, Implanet went public and raised $1.75 million that Lastennet explained will be used to finance strategic goals and the develop of product range, as the company aims for Jazz to be compatible with every screw and rod size on the market; to start a Jazz academy to train surgeons on indications for and the usage of the Jazz system; and to finance product deployment in the United States.

“We are now well structured for entry into the U.S. market,” Lastennet said. “We wanted at least two years of cash in hand before U.S. deployment, which is typically more expensive and takes longer than in Europe, so as not to be slowed down by a cash issue. We also will use the funds to drive health economic studies for Jazz, because we believe things are going to change in the coming year. We are going to have to document not only the clinical but the economic advantages of our product. Right now we are running some interesting health economic studies that we are going to publish q1 2015 in a peer reviewed journal. We want to show that by using our product we will reduce time of surgery, reduce blood loss, reduce cost of surgery by using less implants, and we believe we will reduce the cost of surgery by 10-25 percent by providing better clinical outcomes.”

Implanet recently appointed Brian Kwon, M.D., as medical advisor for the United States. With his help, the company hopes to establish a scientific advisory board by the end of the year to recruit centers to do a prospective multi-center study, Lastennet said. Brian Kwon, M.D., is an orthopedic surgeon specializing in the surgical management of adult spine disorders at New England Baptist Hospital in Boston, Mass., and he also holds a teaching appointment at Tufts University School of Medicine as Assistant Clinical Professor of Orthopedic Surgery. He serves on the editorial board for theJournal of Spinal Disorders & Techniques, a peer-reviewed multidisciplinary journal for spine clinicians. Kwon will assist Implanet in its approach to the adult degenerative spine market in the United States and in the use of its Jazz technology platform.

“We are a small company but we have to fulfill the same requirements in terms of research and development, regulatory, and quality assurance as a larger company,” Chief Operating Officer and Chief Financial Officer Denis Saint-Denis told ODT. “So we have to build a structure to be efficient enough to address all the registration aspects, and now we have to develop and win market share to demonstrate that our sub-laminar approach will be one of the most positive points in the next few years in spine surgery. I believe we are in a good position to do that.”

The executive team at Implanet is made up of spine industry veterans who have come from major players such as Zimmer Spine, Abbott, and Stryker. As Lastennet put it, after successfully launching their knee implant device in 2007 and achieving success in nations all across Europe, they are returning to their first love: spine.

“We have a very simple strategy, and that is to specialize in niche products. We didn’t want to go into mainstream products. We are not a screw and rods company,” Lastennet said. “We are concentrating on what we believe to be the future of fixation on and around the bone.”