Irish Times overall Innovation Award winner Atlantic Therapeutics is set to see major growth on the US market following Food and Drug Administration (FDA) approval to sell its Innovo device direct to consumers there. Innovo is a non-invasive, clinically proven technological solution for people suffering from urinary incontinence.
The wearable device, which is similar in style to a standard pair of cycling shorts, provides an effective therapy to strengthen the pelvic floor. "The shorts contain eight electrodes which contract and relax the pelvic floor muscles with a training and strengthening effect and helps them retake control of bladder function," explains global product manager Danny Forde.
“What is different about Innovo is that it is a clinically proven home-based treatment,” he adds. “It has proven results for a large proportion of patients who use it for 30 minutes a day, five days a week over 12 weeks. After that, they can reduce it to one or two days a week. That’s not a lot of time and we have found that people enjoy taking 30 minutes out of their day for themselves.”
The home-based nature of the treatment and its availability direct to patients are very important, according to Forde. “People don’t want to talk about urinary incontinence problems,” he says. “There is a social taboo in relation to it. They don’t even want to speak to their partner or GP about it. Our main sales channel is online, and people can order Innovo and have the product delivered discreetly to their home.”
The clinical evidence for the product’s efficacy is another key factor. “It is important to have the clinicians on board,” he says. “We have a very strong clinical advisory board that ensures we are doing the right things as a medical device company.”
The potential impact of the device is enormous with urinary incontinence affecting hundreds of millions of people around the world. According to Forde, it often goes untreated and unreported due to the embarrassment involved and the stigma felt by patients. As many as one in three women and one in 10 men suffer from bladder leaks every day, primarily due to weakened pelvic floor muscles caused by pregnancy, menopause, high-impact exercises and pelvic or prostate surgery.
But an effective treatment hasn’t been available up until now. “People just buy pads week in, week out and suffer in silence,” he says. “There is a sense that they are managing the condition by hiding it. Now they can do something to treat the problem. There is an alternative and they don’t have to accept it any more.”
The positive market response is not surprising in these circumstances. “Business has been great,” says Forde. “It was a prescription-only device in the US but in January the FDA granted approval for it to be sold direct to the consumer. We have been setting ourselves up to sell directly to US consumers since then. It’s a very exciting time for us and we’ve just launched a marketing campaign in the US. We’ve seen tremendous take-up there already.”
The US market is always going to be the number one prize for a medical device company, he adds. “We are finding that US consumers are very similar to Europeans. They are looking for something to tackle the problem, but they want to acquire it discreetly.”
UK marketing campaign
The US marketing campaign has also been launched in the UK. “The theme is ‘voice of change’ and it aims to challenge the status quo that dictates that people must put up with bladder weakness.”
Innovo is already being sold in a number of markets including the US, the UK, Germany, France, Spain, Saudi Arabia and Ireland. "When we are looking to new markets, we will look east to China, Japan and other Asian countries," says Forde. "We are also building on our success in existing markets and looking to expand into other European countries as well."
That process is continuing despite the impact of Covid-19. “We have all switched to remote working for the duration of the crisis. The response of our staff and our suppliers and partners has been tremendous.”
Meanwhile, there is another iteration of the product in development. “This will be an app-based version which will allow users to track their progress,” he explains. “This will be core of our development activity for this year and 2021. Innovo is having a really profound effect on the quality of people’s lives. We get feedback from people saying that hadn’t been exercising, weren’t able to play with their kids, had stopped enjoying life, but since Innovo that has all changed. It’s really great to have that impact.”