A Galway company behind the world’s first specialised miniature endoscope for ear surgery is hoping to get US approval for its device by the second quarter of 2023.
Tympany Medical recently raised €3.5 million in a funding round and now plans to increase staff numbers.
The Enterprise-Ireland backed company’s product is called OtoVU and is designed to assist surgeons operating on the human ear. It provides a wide-angle view of the ear and allows them to operate in a faster and less invasive manner.
Tympany is now working on obtaining approval from the Food and Drug Administration, the American regulatory organisation, to prove the safety and reliability of the device by the second quarter of 2023.
The firm, which currently employs six people, plans to sell its device to hospitals, starting in the US market before a move into Europe within five years. It aims to grow to a team of ten by the start of 2022.
“The funding we raised was crucial because it allowed us to accelerate some of our timelines,” Liz McGloughlin, Tympany’s co-founder and chief executive, said.
“Medical devices have a very capital-intensive development phase, so it was so important to have those experienced investors backing us.”
Patients with hearing loss can require surgery in their ears to repair the eardrum or remove benign tumours, for example. This can be done using an endoscope, but, according to McGloughlin, the endoscopes currently available are unwieldy and are not designed to allow surgeons to operate safely on the ear.
OtoVU, Tympany’s endoscope, is smaller and more intricate than existing products. It can also allow surgeons to operate using a safe two-handed technique, a development that the company hopes will revolutionise ear surgery.
“Our device reduces pain, procedure times and the post-operative care that patients need,” McGloughlin said.
None of the company’s competitors has developed a device specifically for ear surgery, meaning OtoVU is the world’s first two-handed device for the purpose. With almost 700,000 ear surgeries performed every year in Europe and the US, the market potential is significant.
In the long term, Tympany plans to develop other devices for use in the ear, nose and throat field of surgery.
“That market opportunity is more than €1.7 billion per annum,” McGloughlin said. “And we think we can be at the cutting edge from a product perspective.”
Tympany’s recent funding round was led by the Atlantic Bridge University Bridge Fund, and included significant investment from Ascentifi, alongside Western Development Commission, Enterprise Ireland, Mayo Clinic Ventures and Xenium Capital.
The company was founded by McGloughlin and Rory O’Callaghan in 2018 as a spinout from the BioInnovate Ireland programme at the National University of Ireland, Galway.
McGloughlin studied medicine at UCD and trained in anaesthesia and critical care before joining the BioInnovate programme. O’Callaghan is a product designer and Tympany’s chief technology officer.