What is your idea?
We have developed a device, ProVerum, to restore function to the urethra in BPH to allow patients with this condition to urinate normally, relieving their symptoms while not interfering with sexual function.
What problem are you solving and what is innovative about your approach?
In BPH, the walnut-shaped prostate gland that surrounds the urethra enlarges and compresses the urethra, the channel used for urination and ejaculation.
This can result in frequent urination (including the need to go to the bathroom several times in the night), weak urinary flow, and even, in severe cases, kidney failure.
The frontline treatment is medication, but side effects mean that about a third of patients need to stop the drugs.
The ‘gold standard’ surgical procedure for BPH is Trans-Urethral Resection of the Prostate or TURP, where the surgeon accesses the prostate through the penis and surgically cores out part of the enlarged gland to take pressure off the urethra.
It involves a general anaesthetic, catheterisation and typically a three-day stay in hospital, and side effects can include bleeding, ejaculation problems, and scarring of the urethra.
Our innovation is a unique expander device that can be easily and quickly placed inside the urethra under local anaesthetic. The patented design ensures that the device expands the urethra to allow normal urination while preserving sexual function. The biocompatible material and structure ensure that the device will not migrate or become encrusted.
This patient-focused approach will offer a less invasive treatment for men and it can be carried out as a day case, in a physician’s office, rather than incurring the time and expense of an operating theatre and hospital stay.
What’s the backstory here and how did you get involved?
My own background is a combination of medicine and business and I have worked with Goldman Sachs, the European Investment Fund and Venture Capital companies.
I was selected for the Enterprise Ireland-supported BioInnovate programme, where multi-disciplinary teams observe clinical practices and procedures. During clinical immersion, it became apparent there was an unmet clinical need for a better procedure to address BPH.
The ProVerum device was further developed through the Trinity Centre for Bioengineering, at Trinity College Dublin, supported by Enterprise Ireland Commercialisation Funding.
We have made prototypes, completed cadaver studies, completed a proof-of-concept pre-clinical study and we are currently carrying out a longer duration efficacy and safety pre-clinical study. A provisional patent application has been filed.
We have established a strong commercial and technical team with senior clinical advisors. We are preparing to spin out the company from TCD early in 2016.
How is this idea commercially attractive?
BPH affects approximately 50-60% of men over the age of 50. In the United States alone, around 28 million men are living with the condition, of whom 13 million are symptomatic and around 4 million are on drug therapy. The BPH market is worth over $5 billion in the US alone.
Approximately 600,000 surgeries are performed for BPH per year in the United States with an equal amount performed in Europe. This is a huge market yet there still remains the need for a minimally invasive treatment option.
ProVerum will offer this less invasive treatment option. We anticipate a favourable regulatory pathway for ProVerum with the CE mark achieved within two years and FDA approval shortly after.
What are you looking for at the Big Ideas event?
We are raising seed investment for our spin-out company, ProVerum Medical, to undertake first-in-man trials. Our goal is to get this device commercialised so that patients can benefit from this new treatment for BPH.