NUI Galway BioInnovate spin-out Venari Medical has developed a minimally invasive medical device that it hopes can tackle CVD at early and extreme stages.
If the valves in the veins in your legs weaken, blood can flow backwards and pool in your lower limbs. While this condition, known as chronic venous disease (CVD), is typically not a serious threat to health, it can be painful and disabling for patients.
“Chronic venous disease doesn’t kill patients but it does ruin their lives,” said Stephen Cox, co-founder of Venari Medical. The failure of the veins to circulate blood effectively can lead to fluid leaking into surrounding tissue, causing pain, swelling, discolouration, varicose veins, breakdown of the skin and, in severe cases, venous leg ulcers.
CVD is more common in women with risk factors including genetic predisposition, low physical activity, pregnancy, smoking and obesity. Veins can also weaken as we grow older, so an ageing global population presents increased risk of this disease.
Currently, prevalence of CVD is highest in Western countries where it reportedly consumes up to 2pc of healthcare budgets. However, according to Cox, “current treatment options are unacceptable”.
“I’ll never forget the first time I saw a patient in tears undergoing market-leading thermal treatment,” he said, describing the procedure to close up a failing vein as being “stabbed a dozen times to inject a litre of fluid before the minimally invasive burning procedure started”.
While effective, Cox believes such treatment is too invasive and off-putting for patients who may then avoid early interventions.
Cox started Venari Medical following a 2017 BioInnovate fellowship where he was immersed in a clinical setting in order to identify an unmet need that he, as an entrepreneur, could attempt to address. It was during this fellowship at NUI Galway that he met his co-founders Sean Cummins and Dr Nigel Phelan.
Cummins is a “hands-on” medical device engineering lead with extensive experience in endovascular device R&D, while Phelan brings clinical experience in vascular surgery to the mix. Cox himself started out as a software developer and has had an accomplished career as a technologist. He was previously head of engineering at Boxever, the Dublin data analytics start-up acquired by Sitecore earlier this year.
These three minds came together to develop a medical device that they hope will have a life-changing impact for CVD patients. It is a mechanical vein catheter that takes what Cox described as “a micro-invasive approach” to CVD treatment.
“We’ve developed the world’s first pain-free and effective treatment for chronic venous disease,” Cox claimed. “It’s the first treatment which utilises the body’s natural healing response to cure symptoms, representing a major breakthrough as it does not require any additional invasive elements such as burning, chemicals or glue.”
According to Cox, Venari’s device can be used to treat all cases of CVD, even those patients experiencing advanced ulceration, with no risk of skin or nerve injury.
Cox leads Venari Medical as CEO with Cummins as CTO and Phelan as chief medical officer. “We work well together without overlapping responsibilities,” said Cox. “Nigel provides the scientific insight and method behind our approach, Sean builds it, and it’s my role to make sure we have enough money to do both.”
So far, so good for that side of the business as Venari Medical first received seed funding the Enterprise Ireland Commercialisation Fund and, last year, raised €4.5m in a round led by Japanese medtech manufacturer Nipro. The Western Development Commission and Enterprise Ireland also contributed to this early-stage funding, along with international medical device experts and vascular surgeons.
This investment set up Venari Medical to grow the business in Galway, with all three co-founders having made the move west.
“We’re based at the heart of the Galway medtech cluster,” said Cox. “Simply put, there is no better place to start a catheter-based medical device company in my mind. The access to top talent, suppliers and a network of successful medtech founders can’t be found anywhere else.”
The US might be a better base for early-stage investment but, for Cox, Ireland’s west coast makes up for that with a tightly connected support network for emerging businesses. “That ecosystem and goodwill is something we’re committed to in helping other early-stage companies in the cluster,” he said.
At Venari, Cox runs the company on the Pareto principle, prioritising the portion of work that delivers the most outcomes. “We strive to get to the answer as soon as is safely possible. If we fall, we want to fall forward,” he said.
“We learned a lot about our venous technology approach from the initial prototypes we built in-house using free samples. So, the sooner we faced these challenges, the sooner we were able to learn and overcome them without investing much time or money that we didn’t have in the early days.”
This approach appears to be working as, within four years, Venari has secured more than €5m in funding, designed a prototype, conducted bench testing and five successful pre-clinical trials, and filed multiple patents.
“We’ve won a number of start-up awards and successfully participated in two medical device accelerators in the US, which further validated our proposition, built our brand profile and attracted investment,” added Cox.
The next step is a first in-human clinical study planned for later this year and a €10m Series A round in 2022. This will support regulatory submissions to release a medical device in the US and EU as well as further scaling of the Venari team. It will also go towards a “pivotal” clinical comparison study checking its device against the current market leader.
For others seeking to replicate Venari’s early success, Cox recommends finding a big a problem that’s worth solving. “Then validate it over and over again, and then think about the technology to solve the problem – and do it in that order,” he advised.
“So many times, I see companies start this sequence in reverse, and while it feels nice to build something first, it hurts you later if people won’t buy it. You’ve got to be disciplined and commit to the opportunity.”