Mainstay Medical International plc is a global medical device company headquartered in Dublin, Ireland and with operations in the United States and Australia. The Company is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation system designed to treat people with Chronic Low Back Pain (“CLBP”) by helping to restore control to the muscles that dynamically stabilise the lumbar spine. 

Our company was founded in 2008 in Minnesota, USA. Our entrepreneurial team comprises dedicated scientists, engineers and clinical experts highly experienced in developing and commercializing technologies addressing unmet clinical needs

Corporate History

  • Dan Sachs MD filed a patent on the idea that led to ReActiv8
  • Mainstay Medical, Inc. (MMI) founded in Minneapolis
  • Peter Crosby recruited as CEO in early 2009 to build the Group (being the Company and its subsidiaries), its team and develop ReActiv8 for commercialisation
  • $6.1m capital raised in Series A Financing round in July 2010
  • Additional patent applications filed
  • First subject enrolled in the Feasibility Study, a study designed and sponsored by the Group to investigate the therapeutic approach on which ReActiv8 is based
  • First pre-Investigational Device Exemption (pre-IDE) package submitted to the FDA as a first step towards receiving Pre-Market Approval (PMA) in the U.S. for ReActiv8
  • Mainstay Medical Limited (MML) becomes the holding company of the Group
  • $20m capital raised in Series B Financing round in September 2012
  • Group HQ relocated to Dublin, Ireland
  • Last subject enrolled in the Feasibility Study in October
  • Appointment of Oern Stuge MD as independent Chairman of the Board,
  • Core U.S. Patent 8,428,728 issued in April 2013, with claims directed to a neuromuscular electrical stimulation system for improving stability of a patient’s lumbar spine
  • Summary results of the Feasibility Study presented at the meeting of the International Neuromodulation Society (INS) in Berlin and at the Neuromodulation Society of the United Kingdom and Ireland, in Oxford.
  • U.S. Patent 8,606,358 B2 issued December 2013 as a continuation of U.S. Patent 8,428,728
  • Development of the key implanted elements of ReActiv8, proprietary Implantable Stimulation Leads and an Implantable Pulse Generator, completed in 2013
  • Mainstay Medical International plc was incorporated and registered in Ireland on 17 February 2014 as a public company and became the holding company of the Group on 3 April 2014 in accordance with the 2014 Corporate Reorganisation
  • First subjects enrolled in international multi-centre clinical trial of ReActiv8 (the “ReActiv8-A Trial”) leading to an application for CE Mark
  • Completion of an initial public offering on Euronext Paris and the ESM of the Irish Stock Exchange raising over $26 million gross capital. Listing under ticker symbol “MSTY”
  • Achieved certification of its Quality Management System in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012
  • Submitted IDE application to the FDA to start a clinical trial of ReActiv8 (the “ReActiv8-B Trial”) to gather data in support of an application for PMA to the FDA
  • Mainstay Sponsored Feasibility study published in the peer reviewed journal, Neuromodulation
  • Gained FDA approval to start a US clinical trial of ReActiv8
  • Secured $15 Million debt financing from IPF Partners
  • Submitted application for CE mark for ReActiv8 based on the results of the ReActiv8-A Trial
  • Achieved CE mark for ReActiv8
  • €30 million capital raised through a placement with new and existing shareholders
  • ReAcitv8-B Clinical Trial commenced and first subjected implanted in October 2016
  • First sale and implant of ReActiv8 in Germany announced in February 2017
  • First sale and implant of ReActiv8 in Ireland announced in May 2017
  • ReActiv8-B Trial passed the mid-point in August 2017 as over half of the required implants have been performed
  • Jason Hannon appointed as Chief Executive Officer and joins Board of Directors in October 2017, resulting from succession planning associated with Peter Crosby’s retirement
  • €30 million capital raised through a placement with new and existing shareholders
  • Top-line data from ReActiv8-B Trial announced
  • Completion of Pre-Submission Meeting with FDA regarding Pre-Market Approval (PMA) Application for ReActiv8 
  • Completion of restructuring of IPF debt facility, new drawdown under the debt facility and placement or ordinary shares, providing approximately $28 million in cash runway extension
  • Acceptance for filing by the FDA of Pre-Market Approval (PMA) Application for ReActiv8
  • Regulatory approval from Australian Therapeutic Goods Administration (TGA) for ReActiv8
  • Completion of Day 100 Meeting with FDA regarding Pre-Market Approval (PMA) Application for ReActiv8
  • Establishment of a new Irish holding company (Mainstay Medical Holdings plc) for the Mainstay Group, and delisting of shares from Euronext Paris and the Euronext Growth market operated by Euronext Dublin
  • Completion of restructuring of IPF debt facility
  • Approval of ReActiv8 for inclusion in the Prostheses List of reimbursed products in Australia, making ReActiv8 eligible for reimbursement from all private health insurance funds in Australia
Last Updated on 11th June 2020