- Experienced medical device specialist secured as exclusive distribution partner in the country
- Training and marketing to commence in coming months, with shipments to follow after
- Good progress made on US FDA regulatory pathway in the meantime
Perth, Australia & Malta – 19 June 2017 – Neurotech International Limited (ASX: NTI) (“Neurotech” or the “Company”), developer of quality medical solutions in the neuroscience space, has secured Attieh Medico Ltd as its exclusive marketing and distribution partner for Mente Autism in Saudi Arabia.
Founded in 1992, Attieh Medico is an experienced medical devices specialist based in Jeddah, with branches in Riyadh and other regions of Saudi Arabia. The company represents a wide range of hightech medical equipment manufactured by companies from the USA and Europe. Attieh employs more than 100 personnel, including sales and service engineers as well as medical doctors. The company distributes medical devices for diagnostic imaging, ENT, IVF, surgery, urology, neuro-physiology, oncology, CSSD and psychiatry, among others.
The Neurotech commercial team will be providing in-depth training to Attieh Medico personnel. Several marketing initiatives are also planned for the region in the coming months, with shipments will commence once these are underway and all training activities completed.
Attieh Medico is subject to Neurotech’s standard distributor terms, with 50% payment made on confirmation of the order, with the remainder paid within five days of receipt of shipment.
Wolfgang Storf, CEO of Neurotech International said: “Attieh Medico is an established partner in the region with extensive experience in distributing medical devices and building partnerships with medical professionals and entities working in this field. With the global incidence of 1 in 68 children on the autism spectrum, there is a lot of potential to grow our business in this country and we believe Attieh are the right choice to help establish our products in the Kingdom.”
Mr Walid Attieh, Chairman of Attieh Medico said: “Mente Autism complements our product portfolio and will enable us to address a growing need for therapy solutions, particularly for those on the autism spectrum. We are honoured to be entrusted with the distribution of Mente Autism and we look forward to a mutually beneficial working relationship with Neurotech.”
PRE SUBMISSION MEETING WITH US FDA
Further to the announcement on 12 May 2017, Neurotech has conducted an instructive planning meeting with the United States Food and Drug Administration (FDA).
Neurotech management and Emergo, its regulatory consultant, met with the FDA panel of experts, who provided vital feedback on Neurotech’s regulatory and clinical plan to support FDA clearance of Mente Autism. The meeting followed the filing of the pre-submission package in March 2017, the purpose of which was to request for feedback for the 510(k) submission for Mente Autism.
Based on the feedback received during this meeting, Neurotech will now seek to market Mente Autism as a Class II regulated device in the United States (US) under the traditional 510(k) submission route. Neurotech is targeting final submission by early 2018.
About Neurotech
Neurotech International Limited is a medical device and solutions company incorporated in Australia and operating through its wholly-owned, Malta-based subsidiary AAT Research Limited. Neurotech’s primary mission is to improve the lives of people with neurological conditions, with a vision of becoming the global leader in home-use and clinical neurotechnology solutions that are both accessible and affordable. Through flagship device Mente Autism and its associated platform, Neurotech is focused on the development and commercialisation of technological solutions for the diagnosis and treatment of such conditions, starting with autism. For more information, visit: http://www.neurotechinternational.com
