Breakthrough treatments for breathlessness and bone infections are two of the technologies being showcased at this year's Enterprise Ireland-backed Big Ideas event.
Breathlessness is a debilitating problem affecting hundreds of thousands of people worldwide. Despite this the condition is often poorly managed. When electronic engineer Miriam Savage became aware of the scale of the problem during her participation in the BioInnovate medtech programme at NUIG, she was determined to do something about it.
Four years on and Savage and fellow BioInnovate participant Dr Dylan Creane have developed ResWave, a first-of-its-kind wearable therapy for breathlessness and have set up a company (Elevre Medical) to bring the device to market.
One of the biggest cohorts affected by breathlessness is patients suffering from chronic obstructive pulmonary disease (COPD). Roughly 250 million people globally live with the condition, and over half of them experience disabling levels of breathlessness.
“I first realised the extent of the problem while observing patients at a cardiology clinic, who were really struggling with their breathing,” Savage says. “People experiencing breathlessness describe it as a nightmare that takes away their ability to function and it contracts their world.
“One thing that stuck out for me were the words of a respiratory physio describing the vicious cycle of breathlessness that causes an avoidance of exertion, resulting in a further decline in physical fitness and even more breathlessness. That was the point at which I became passionate about bringing innovation to this very neglected space.”
Muscle groups
Elevre Medical’s device works by delivering a form of neuromuscular stimulation to specific muscle groups in the chest that contribute to the sensation of being breathless. “The underlying mechanism we’re using has been known about in the scientific literature for quite some time. However, it has never been translated into a marketable medical device due to technical challenges we have now overcome,” Savage says.
A second innovative aspect of Elevre’s technology is that it is unobtrusive. The device is embedded in an adjustable vest worn discreetly under clothing. “Up to now no therapy has directly targeted the sensation of breathlessness the way ResWave. Existing therapies fall short due to their impracticality or unwanted side effects.
“This has left a substantial gap in the market for an effective, practical and safe therapy. ResWave is non-invasive and would be considered very low risk for patients,” Savage says.
In addition to her engineering degree Savage has a master's in biomedical science. She worked briefly in financial software in London before moving into connected health medical device development with Nypro Healthcare and Becton Dickinson.
Creane is a software engineer who ran his own consultancy before retraining as a medical doctor and spending time in the Irish hospital system.
NUIG-based Elevre Medical was founded in 2019 and the co-founders expect to spin-out from the university next year. The company now has a prototype of its device ready to go, and its first human testing will begin with a small study at the Beacon hospital next year. A full scale clinical trial will follow in 2023.
The company employs four people and has received early-stage investment of €500,000 from Enterprise Ireland’s commercialisation fund. Employment is set to rise to seven next year and 10 in 2023 as the company ramps up for market launch in 2025.
The next step is a fundraising round of €3 million which will begin early next year.
Treating breathlessness puts a significant burden on healthcare systems worldwide, and Elevre Medical has set its sights on capturing a slice of an estimated €10.7 billion market associated with COPD in Europe and the US alone. The COPD devices market is forecast to grow at a compound annual growth rate of 4.3 per cent between 2020 and 2027.
Deep tissue and bone infections
Dr Lyn Markey and Camille O'Malley are the co-founders of XTremedy Medical, a 2020 start-up focused on tackling the serious problem of deep tissue and bone infections. They also met at BioInnovate and are backed by the Enterprise Ireland commercialisation fund.
Markey has a background in organic chemistry and nanomaterials, while O’Malley’s experience is in chemistry and biotech commercialisation.
"We were inspired to develop our BioBlate device having listened to surgeons discussing their difficulty in treating bone and deep tissue infections and the lifelong and devastating impact this has on patients," Markey says.
“Infected patients have compromised mobility. They also require high-strength antibiotics over prolonged periods, and they may need multiple surgeries to control the infection.
“Despite all of these interventions, infection cannot be controlled in around 20 per cent of patients and they will require an amputation. This drastically reduces life expectancy. When we saw the rudimentary tools available to surgeons to deal with the problem we could see an opportunity to improve the lives of patients with more efficient, effective surgery.
“Simply put our device passes short electrical signals through the infected wound and zaps the bacteria within it. In addition our device can deliver the signal non-invasively,” Markey adds.
“Currently surgeons are blind as to where an infection resides and whether it has been successfully removed. There are some solutions on the market but these fail as they only treat the surface or they use mechanical forces that can propel bacteria deeper into the wound and around 50 per cent of patients will require additional surgeries.
“Our technology is non-thermal and unique in that it treats both the surface and the area below without interfering with the integrity of the wound. Furthermore, the design of our device limits the spread of infected material deeper into the tissue which is a striking difference to competitor products.”
Feasibility studies
XTremedy Medical employs three people and is in the process of raising a seed round of €3 million to build out the team and conduct early feasibility studies in patients.
The fact that this is an emerging technology aimed at a very large patient group means the testing and regulatory process will be painstaking so it will be 2028 before the patent-pending BioBlate device is available on the market.
"With the continuing rise in anti-microbial resistance, infections are becoming more costly and difficult to treat," Markey says. "For diabetic foot ulcers alone there are over 300,000 procedures a year and a potential market of €600 million.
“While our plan is to start by addressing the diabetic foot infection market in the US and EU, our technology is broad-reaching and can also be applied in the wider chronic wounds, trauma and surgical site infection markets, with a total potential addressable market of €2.5 billion in the US alone.
“We believe there is a huge opportunity for XTremedy Medical to disrupt the global infection-treatment market which is cumulatively valued at over $80 billion.”
