Mainstay Medical announces a positive outcome of the Interim Analysis in its U.S. Pivotal ReActiv8-B Study, comprising a definitive size and an estimated completion date.
Jason Hannon, CEO, to host business update call
Dublin – Ireland, 11 December 2017 – Mainstay Medical, a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces a positive outcome of the Interim Analysis in its U.S. Pivotal ReActiv8‑B Study (the “Study”), comprising a definitive size and an estimated completion date.
Key updates relative to the Study (and its design) are as follows:
- The Study utilizes an adaptive trial design, inclusive of an Interim Analysis, to determine the definitive size of the Study of up to 232 patients in the pivotal cohort. With this adaptive design, Mainstay commenced the Study with a sample size of 128 patients pending the Interim Analysis;
- The independent Data Monitoring Committee (“DMC”) has completed the Interim Analysis, which is based on data from the first 58 patients in the pivotal cohort to complete the primary endpoint. The DMC has recommended continuation of the Study with a definitive size of 168 evaluable patients. The ultimate number of patients in the Study will be slightly higher than 168 due to the nature of the enrollment process;
- The DMC also reported that they have observed no safety concerns in the Study; and
- The Study is expected to be fully enrolled by the end of the second quarter of 2018, and the Company expects to announce full data readout towards the end of 2018.
133 patients have been implanted in the pivotal cohort in the Study to date and clinical study sites have continued to implant patients pending the outcome of the Interim Analysis.
The Study is intended to gather data in support of an application for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the U.S..
Richard Rauck MD, President and Founder, Carolinas Pain Institute, Medical Director for The Center for Clinical Research, Pain Fellowship Director at Wake Forest University School of Medicine and Chairman of the DMC said: “The outcome of the Interim Analysis has validated the adaptive Study design agreed with the FDA, which provided for a sample size of up to 232 patients in the pivotal cohort. By following this course, we have been able to determine an appropriate sample size for the Study. We also reviewed the safety data and I am pleased to report there are no safety concerns in the Study thus far.”
Jason Hannon, CEO, said: “We are pleased to now have a definitive enrollment goal for the Study, which compares favorably in total size to other neuromodulation studies. We will now push forward to the data collection point in a highly efficient manner, and I am confident we will complete the Study in the coming months and announce the full data readout towards the end of 2018.”
Chris Gilligan MD, Chief, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical School, and Principal Investigator for the ReActiv8-B Study said: “The treatment of Chronic Low Back Pain is a significant challenge around the world with many patients experiencing disabling effects for large portions of their lives. These patients can be left with few treatment options. I’m proud to be part of a clinical study that is analyzing whether we can use ReActiv8 to help patients truly restore their muscle function and thereby reduce the effects of chronic pain, rather than rely on short term analgesics such as opioids. I look forward to the compilation of the data.”
Investor Conference Call and Business Update
Jason Hannon will host an investor conference call to discuss this positive news and will also provide a broader business update at 16:00 GMT (11:00 EST) on 11 December 2017 in English.
Dial-ins for the call are outlined below:
Europe: +44 203 139 4830
Ireland: +353 1 696 8154
USA: +1 718 873 9077
Participant PIN: 65178331#
In addition to the update on the Interim Analysis, the business update will include the following developments:
- The Company continues to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites. Four centers in Germany and Ireland have implanted patients with ReActiv8 to date, and several additional sites have been trained. We have begun recruiting an experienced sales team of direct Mainstay employees. The team currently consists of eight people, located in key regions in Germany and one person in Ireland.
- Mainstay is planning to add to its investment in commercial infrastructure to expand commercialization in Europe and in preparation for commercialization in other markets including Australia and the U.S. We will be building a market development team of clinical experts to drive market penetration, identify the right physician partners, help educate the market about Reactiv8, and support implants.
- We will also increase our investment in the training of physicians; the education of referring physicians regarding the potential of ReActiv8; and in the collection and dissemination of clinical data regarding the expanding use of ReActiv8.
- Cash on hand at 30 November 2017 was $12.7 million. The Company on an ongoing basis explores potential financing opportunities to fund the business.
