Venari Medical is testing a device that could help millions with varicose veins, writes Trish Dromey
Galway startup Venari Medical is preparing to conduct human trials of a medical device that is designed to be the first in the world to use the body’s natural response to treat varicose veins and venous ulcers. Raising €3m to fund a first human trial next year, Venari plans to launch in the US market in 2022, targeting a market opportunity in the US and Europe for the treatment of chronic venous disease estimated to be worth €2bn.
“Venous disease affects one in four people ranks as the fourth most common chronic disease in the world and can result in debilitating venous leg ulcers,” said Venari co-founder and CEO Stephen Cox, noting that there are in the region of 120m people in the US and Europe suffering from this disease.
He said that up until now it has been one of the most neglected and costly areas of healthcare and that existing treatments involve invasive surgery or methods which result in burning, chemical damage or tissue being glued.
Venari’s solution BioVena, Mr Cox explains, is a minimally invasive mechanical device that operates by triggering cell disruption in the body to close diseased veins so that blood can circulate effectively in healthy ones. With this “minimally invasive,effective pain-free treatment”,’ he said Venari is aiming to disrupt the global venous disease treatment market.
Because the device can be used by a vascular consultant to carry out treatment in a clinic setting, Mr Cox said BioVena can facilitate major change by allowing treatment to be moved completely out of hospitals and into clinics. At present 50% of vascular disease treatment in Europe is being provided in clinics although the figure for the US is much higher at 90%.
It is the US market, where the majority of treatment is already taking place in clinics, which Venari intends to target first. “Our focus will be on the 1m unserved US venous ulcer patients,” he said.
Formerly a computer scientist who worked in several technology startups, Mr Cox joined with biomedical engineer Sean Cummins and orthopaedic surgeon Nigel Phelan to set up Venari in mid-2018. All three had participated in the BioInnovate medical device fellowship in NUI Galway in 2016 and had identified the need for a new less invasive treatment for venous disease which could be carried out in a clinic setting.
Securing commercialisation funding from Enterprise Ireland they set about developing the device at NUI Galway. By early 2019, the BioVena prototype had been tested and refined and the company was ready to spin out.
Since 2018, the three founders have been working on design validation and verification. They participated in two medical device accelerator programmes in the US, MedTech Innovator and TMCx in Texas. “We have protected our IP in Europe and the US and have now completed five preclinical studies to prove the safety and efficacy of the device,” said Mr Cox.
Requiring funding to advance Venari to the next level, the company is now in advanced negotiations with international and Irish investors. “We plan to conclude the €3m funding raising in Q1 next year. This will support clinical development including a first-in-human trial in 2020 and allow us to secure regulatory approval in the US and Europe in 2021,” he said.
Once the funding has been secured, Venari plans to recruit six staff in research and development and quality and regulatory affairs.
Mr Cox said that next year the company also plans to secure new premises in Galway.
In early 2022 Venari plans to launch in the US, a market where 600,000 venous disease treatment procedures are currently being carried out annually. Following the US launch, the company plans to enter the market in Europe.
It was a Connacht and Leinster regional winner in this year’s InterTrade Ireland Seedcorn competition and is through to the all–island final at the end of the month.