Cork medtech firm seeks FDA clearance for Solo Tympanostomy Tube Device
Cork Institute of Technology spin-out AventaMed has completed a €1.8 million funding round led by Halo Business Angel Network (HBAN).
The investment will fund AventaMed through FDA (Food and Drug Administration) clearance and commercialisation of the Solo Tympanostomy Tube Device (Solo TTD) which enables the quick and simple insertion of ear grommets.
AventaMed was set up by Olive O’Driscoll and John Vaughan in 2013 to find a method of inserting ear tubes – or grommets – in children without requiring general anaesthetic. The insertion of grommets is used to treat recurring ear infections and hearing loss in children and adults. It is one of the most common surgeries carried out on children worldwide.
The five-strong company has spent the last four years developing the all in one handheld Solo device which simplifies the implantation process, reduces costs and improves patient outcomes. AventaMed is now looking to enter the US market, for which it requires FDA clearance.
This is the second round of angel and Enterprise Ireland funding that AventaMed has received. In 2015, it raised €1.3 million and successfully completed clinical trials and obtained European regulatory approval to commercialise the device in Europe.
Olive O’Driscoll, co-founder and CEO, AventaMed, said: “We are already treating patients in Europe with the Solo device; both parents and surgeons have experienced first-hand the benefits of placing grommets without the need for a full general anaesthetic. We are thrilled to close this investment round as it will enable AventaMed to obtain FDA clearance for the device so that patients in the USA may also benefit from our innovative technology.
“A lot of our investors come from very senior positions in multinational and Irish medical device and healthcare companies. They are always available to AventaMed to offer expert advice and make critical commercial introductions, which is hugely valuable as we execute our commercialisation strategy in Europe and the USA.”