It has been announced that Mainstay Medical will participate in the upcoming 13th German Spine Congress of the Deutsche Wirbelsäulengesellschaft (DWG; 6—8 December, Wiesbaden, Germany). DWG will be the first medical meeting at which pivotal clinical data from the company’s ReActiv8-B clinical study will be discussed.
A number of physicians, each of whom has deep experience with Reactiv8, will present the clinical data and the scientific background of the therapy, and describe commercial treatment of patients in Germany:
- Jörg Franke (Klinikum Magdeburg, Magdeburg, Germany), will chair the symposium where the results from the ReActiv8-B study will be presented, and also provide his experience with ReActiv8 in Germany;
- Chris Gilligan (Brigham & Women’s Hospital, Boston, USA), principal investigator of the study, will present the pivotal data from the ReActiv8-B study;
- Jan Schilling (Tabea Hospital, Hamburg, Germany), will introduce the scientific background and the underlying physiological mechanisms of this new restorative treatment for chronic low back pain; and
- Ardeshir Ardeshiri (Klinikum Itzehoe, Itzehoe, Germany), will present his “real world” experience with ReActiv8 in Germany via his initial series of patient outcomes.
“The data from the ReActiv8-B clinical study through one year, and the favourable safety profile demonstrate that ReActiv8 is a viable restorative treatment option for patients with chronic low back pain,” said Jörg Franke. “ReActiv8 has the potential to provide long-term pain relief to this patient population, which suffers from a lack of available treatment alternatives.”
The ReActiv8 B clinical study is an international, multi-centre, prospective, randomised, active-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the US Food & Drug Administration (FDA). A total of 204 patients were implanted with ReActiv8 at leading study centres in the USA, Europe and Australia and randomised 1:1 to therapy or control 14 days after implant. The initial results from this clinical study were announced by Mainstay on 19 November, 2018.
“The results from this study confirm the results we have seen in our own experience with chronic mechanical low back pain patients with ReActiv8,” said Jan Schilling. “There is an urgent need for new, effective therapies to treat long-term, mechanical low back pain, and the data from the studies demonstrate that ReActiv8 can provide sustained pain reduction over time.”
Mainstay will hold a ReActiv8-B symposium at which the physician faculty will make their presentations. The symposium will take place on Friday, 7 December from 13:00—14:30 in Studio 1.2 A & B at the Rhein Main Congress Centre.