Mainstay Medical International plc (“Mainstay”), a medical device company that is developing innovative therapies for people with debilitating Chronic Low Back Pain (“CLBP”), today announces its intention to raise funds through an initial public offering of new ordinary shares (the “Offer”) and to seek admission of its shares to trading on Euronext Paris and the Enterprise Securities Market of the Irish Stock Exchange.
Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. Mainstay is focused on the development of ReActiv8®, an innovative implantable medical device designed to treat people with Chronic Low Back Pain.
Mainstay is led by an experienced Board and management team with a strong track record in the medical device industry. Mainstay has a committed shareholder base, including experienced venture capital investors in France, Ireland, Belgium and the United States.
Highlights
- ReActiv8 is targeted at people with debilitating Chronic Low Back Pain. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.
- Mainstay estimates that the initial target market for ReActiv8 is approximately two million people in the US and Europe.
- ReActiv8 is an innovative implantable neurostimulation medical device. The design of ReActiv8 is based on experience gained in a European Feasibility Study conducted in 2011 and 2012, which showed the therapy provided by ReActiv8 yielded improvements in pain and disability of people with Chronic Low Back Pain.
- Product development of ReActiv8 is complete, and enrolment in clinical trials in Australia commenced in March 2014.
- Mainstay intends to progress clinical trials in Australia; obtain CE Mark in Europe; obtain initial approvals for US clinical trials; and subject to regulatory approval, advance the commercialisation of ReActiv8.
- Strong and experienced Board, management team and existing investor base to continue the commercialisation of ReActiv8.
- Existing shareholders have committed to make a substantial investment in the Offer.
Dr Oern Stuge, Chairman, commented:
“We believe that ReActiv8 offers an innovative therapy for the millions of people who suffer from Chronic Low Back Pain. We further believe there is a significant market opportunity for ReActiv8 and the results of the recent Feasibility Study demonstrate the premise of our unique therapeutic approach. The Board is confident that we have the right management team, led by Peter Crosby, to commercialise ReActiv8 and is excited about the prospects for Mainstay.”
Peter Crosby, Mainstay CEO, added:
“Back pain specialists from all over the world have indicated the need for a new approach to help people with Chronic Low Back Pain. We believe our approach of using electrical stimulation to help restore control to the key stabilizing muscles in the lower back can play an important role in helping these people.”
“The therapy was investigated in a recently completed European Feasibility Study. The results presented in mid-2013 showed improvement in back pain and the disabling effects of back pain.”
“The energy and experience of the Mainstay team has enabled us to complete the development of ReActiv8 and obtain approval to start the clinical trials within a year of the publication of Feasibility Study results, and we have now commenced clinical trials and have a clear plan to obtain regulatory approval and the commercialisation of ReActiv8.”
About Mainstay Medical
Mainstay is an Irish medical device company that is developing an innovative implantable neurostimulation medical device, ReActiv8™, for people with debilitating Chronic Low Back Pain.
Mainstay is headquartered in Dublin, Ireland and has subsidiaries in Australia and the United States. Mainstay is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).
Chronic Low Back Pain
Chronic Low Back Pain is generally defined as Low Back Pain where the pain persists for more than three months.
Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments. The Company estimates that in approximately 7% of all cases of Low Back Pain, the pain persists for more than three months.
ReActiv8
ReActiv8 represents a new approach to the treatment of Chronic Low Back Pain. ReActiv8 is an implantable device which applies electrical stimulation to nerves that supply one of the key stabilising muscles in the back, the lumbar multifidus muscle. The hypothesis on which ReActiv8 is based is that electrical stimulation of the nerve that innervates the lumbar multifidus muscle to cause contraction of the muscle can help reactivate the muscle control system, thereby leading to improved spine stability and a reduction in the effects of Chronic Low Back Pain.
Kempen & Co and Société Générale are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Initial Public Offering. Davy has been appointed as Co-Lead Manager and ESM advisor.
FOR FURTHER DETAILS, CONTACT:
Joint Global Coordinators and Joint Bookrunners
Kempen & Co N.V.
Beethovenstraat 300
1077 WZ Amsterdam
Postbus 75666
1070 AR Amsterdam
The Netherlands
Société Générale
Tour Société Générale
17, Cours Valmy,
92972 Paris La Défense Cedex
France
ESM Adviser and Co-Lead Manager
Davy
Davy House
49 Dawson Street
Dublin 2, Ireland
Media & Investor Relations Adviser
FTI Consulting (Dublin)
10 Merrion Square
Dublin 2, Ireland
+353 1 663 3600 or mainstay@fticonsulting.com
Eilish Joyce/Jonathan Neilan
FTI Consulting (Paris)
5, Rue Scribe
Paris, 75009, France
+33 1 47 03 68 10 or mainstay@fticonsulting.com
Arnaud de Cheffontaines/ Stephan Dubosq