"More than a quarter of all men have symptomatic Benign prostatic hyperplasia (BPH) by the age of 50 and by age 80, approximately 80 per cent of men will suffer from the condition. It's not life threatening but it can have a devastating effect on their quality of life," says Dr Conor Harkin, founder of medtech start-up ProVerum, which has developed an innovative solution to the problem.
BPH occurs when the prostate gland becomes enlarged and compresses the urethra. This causes a frequent urge to urinate and often disrupts a sufferer's sleep. Harkin says more than $5 billion is spent annually in the United States alone on medication to manage BPH. In addition, nearly two million surgical procedures are performed worldwide each year to treat the condition.
“Our solution is a minimally invasive expander device that is placed inside the urethra to restore function,” Harkin explains. “Its unique design ensures normal urination and also preserves sexual function. In addition the biocompatible material and structure ensure the device will not move or become blocked.”
Harkin studied medicine at Trinity College Dublin and then spent six years working in surgery and radiology in Britain and Ireland. He loved medicine, but also had a keen interest in business and technology. In 2012, he brought the two strands together when he joined the Enterprise Irelandbacked BioInnovate programme.
BioInnovate brings individuals from multi-disciplinary backgrounds together to observe clinical practices and procedures with a view to identifying unmet clinical needs. By letting participants work directly with clinicians, Enterprise Ireland hopes they will develop new products/procedures with worldwide applications.
Harkin focused specifically on urology where he already had a head start as he had worked in this field while training as a surgeon.
“During the clinical immersion it became quite apparent there was a need for a procedure with less side effects to address BPH,” Harkin says. “Further analysis showed there to be a definite market gap and a compelling business case to develop this innovation.”
The current gold standard surgical procedure for BPH typically involves a general anaesthetic, a one-hour procedure and a three-day stay in hospital. There can also be side effects such as bleeding and incontinence.
By contrast the ProVerum treatment is carried out under local anaesthetic as a day procedure. It only takes 15 minutes and has significantly fewer side effects than surgery. The speed and non-residential nature of the treatment also has obvious benefits for cash-strapped health services globally.
Very straightforward
As of now, ProVerum faces little competition in its niche. Harkin says others have tried to come up with alternatives to traditional surgery, but they have not been widely adopted. “ProVerum is likely to succeed where others have failed because our device is truly minimally invasive,” he says. “We also anticipate a very straightforward regulatory path with CE mark approval likely by late 2017.”
The development of the ProVerum device has been supported by Enterprise Ireland under its commercialisation fund. It has taken about €500,000 to bring the project this far and Harkin is now looking to raise between €3 million and €4.5 million to accelerate the commercialisation and rollout of the product.
ProVerum is based in the Centre for Bioengineering at Trinity College Dublin and Harkin's team also includes CTO Ríona Ni Ghriallais who has worked in medical device R&D and R&D engineer Michael Burke. Prof Bruce Murphy of the Trinity Centre for Bioengineering is a technical adviser to the project while consultant urologist Prof Thomas Lynch of Trinity and St James's Hospital is the lead clinical adviser.
ProVerum will be spun out as a campus company later this year and the device will come to market in 2018. By this time Harkin expects ProVerum to be employing about 10 people.
– OLIVE KEOGH
