Chronic venous disease (CVD) affects one in four adults and covers a range of conditions from enlarged varicose veins to distressing and uncomfortable open sores known as leg ulcers. Leg ulcers are notoriously difficult to manage, especially in older people with poor skin condition, and current treatments all have a downside and less than optimal outcomes.
In the United States alone, about 600,000 procedures are carried out every year to treat CVD. The market is growing by 15 per cent annually and at current medical insurer reimbursement rates is valued at about €500 million. The European Union market is of similar size and Galway-based fledgling medical technology company Venari Medical has its sights set on capturing a chunk of both with its pioneering CVD treatment that triggers the body's natural healing response to tackle the problem.
"The goal of all CVD treatments is to close the diseased vein, allowing blood to circulate effectively in healthy veins. For patients with leg ulcers this can mean their ulcer will heal faster and is less likely to recur, significantly improving their quality of life," explains Dr Nigel Phelan, Venari co-founder and chief medical officer.
“For patients with leg ulcers many of the current treatment options available such as compression bandaging, chemical injections, and laser and radio-frequency thermal treatments which essentially burn the vein, either don’t address the underlying cause or have poor efficacy and may in fact damage surrounding tissue. Ours is the first minimally invasive treatment for venous disease that uses the body’s own healing to close the vein and heal ulcers faster and it does so without the need for heat, chemicals or glue, making it a unique, purely mechanical treatment.”
Venari’s device is called BioVena and while it may look like a conventional catheter, its innovation is a helical coil at its tip that opens out only when it is in position in the body. This specially designed coil navigates the vein (without catching on or causing any damage to surrounding tissues) to disrupt the inner vessel lining to encourage it to scar naturally and close. This causes blood flow to be diverted away from the diseased vein and cures symptoms and, in the case of skin ulceration, leads to faster healing. The patient is awake during the procedure and only requires a single injection of local anaesthetic at the catheter entry point – usually the ankle or knee – and does not need a hospital stay.
Venari and BioVena are the result of participation by Phelan and his co-founders Stephen Cox and Seán Cummins in the BioInnovate fellowship at NUI Galway in 2016-2017. This programme puts teams of people from different disciplines together to pool their knowledge to identify unmet clinical needs over an intensive nine-month period. By the end of it, participants are expected to have a pretty good idea of the type of product or treatment they want to focus on. Phelan says that by month four the Venari team, who were assigned the area of vascular surgery, had come up with a number of options but attending an international vascular conference in Germany helped clinch the decision to concentrate on the treatment of CVD. Specifically, the founders wanted to cut the pain experienced by patients being treated for the disease.
“When we were researching potential interventions, we spent time in various hospitals and saw people in tears even before their procedures began because of the series of painful anaesthetic injections they had to go through first,” Phelan says. “This got us thinking about how to take away that pain element and with BioVena once the area is anaesthetised with one injection the patient feels nothing because there are no pain nerves inside the veins.”
The company’s device is made from Nitinol, the same shape memory metal used in cardiac stents but its finish needed to be different for the BioVena application and this posed a particular technical challenge for the team. “Cardiac stents are smooth but we needed ours to be ‘rough’ because it had to disrupt the inner lining of the vessel as it’s pulled through,” Phelan says.
“That was a hurdle but our CTO Seán Cummins is a very practical and hands-on biomedical engineer with previous experience in development roles for vascular medical devices at a large multinational. With his engineering knowledge and my experience of medical settings and knowledge of anatomy we were able to test out various theories and bounce ideas off each other.
“In fact, we had initially thought of developing some sort of implant but we quickly decided it was best to leave nothing behind. Our third co-founder, Stephen Cox [the company’s chief executive] also comes from a technical background so he was equally involved and we learned a lot from each other during the development process. That’s important because you really only get one chance to get something like this right.”
Phelan says what attracted him to co-found Venari was the opportunity to combine medicine and innovation to bring a significant benefit in patient care. The reason the trio opted to participate in BioInnovate was because it is a relatively fast-track route from lab bench to bedside. That said, as with all medical devices there are a series of regulatory hoops to be jumped through and it will still take roughly five years to progress from concept to market launch.
“The big potential for our device is venous leg ulcers [VLU],” Phelan says. “They account for 80 per cent of all leg ulcers or chronic leg wounds and are a real silent epidemic with a million VLU patients in the US and two million in the EU. They make up less than 5 per cent of current procedures but they need treatment the most.
“They currently undergo ineffective compression bandaging which doesn’t treat the underlying cause and costs €10,000 per patient per year due to the high costs of regular dressing changes. This consumes 2.5 per cent of total healthcare expenditure across the EU [€19 billion] and in the US [€13 billion per year]. Treating these patients represents a €3.6 billion market opportunity for our company. Cost-wise we will be competitively priced compared to existing treatments.”
Medical device lab
Venari is a spin-out from the Translational Medical Device Lab at NUIG which is under the direction of Dr Martin O'Halloran and to date investment in the company has been about €500,000 which has come largely from an Enterprise Ireland commercialisation grant. The company is now looking to raise €3 million to build out its team to roughly 10 people over the next few months and to begin full clinical trials and start the process of regulatory approval.
“We know there’s a ready market for our product and we won’t have to educate the medical community, they already know how it works and how to use it,” says Phelan whose company has already picked up its share of awards including the EU-backed EIT Health Headstart award and the Intertrade Ireland Seedcorn regional final.
The company also made it to the final five of the MedTech Innovator and in August 2019 won a place on the Texas Medical Centre Accelerator programme, which Phelan says provided the founders with useful access to the US healthcare system.