BPH is a noncancerous enlargement of prostate gland that restricts urine flow from the bladder. Prostate enlargement occurs due to proliferation of smooth muscle & epithelial cells within the prostatic transition zone. BPH sufferers present with Lower Urinary Tract Symptoms (LUTS), sexual dysfunction, kidney damage, decreased urine stream, incomplete voiding & urinary retention resulting in a constant ‘topping up’ of never fully empty bladder which causes frequent urge to urinate, making it difficult to undertake day-time routine activities, insomnia at night-resulting in diminished quality of life. BPH develops as an age-related phenomenon in nearly all men.
Today, most urologists choose between drugs and surgical interventions. Both options are not ideal as they either offer limited effectiveness with significant side effects (drugs) or a procedure that takes significant surgery-room time, requires hospitalization and carries risks and side effects. Some physicians have one or more MIST (Minimally Invasive Surgical Therapy) options to offer. In most cases these treatments require long training (for the physician), require a significant investment in capital equipment (or in the device itself) and in most cases also carry risks and side effects. Both drugs and surgical interventions are not ideal from the payer perspective: Drugs are taken indefinitely and therefore generate continuing costs for the payer. Surgeries have a direct high cost due to the OR time required, surgeon time and hospitalization time. Surgeries also have potential high risk associated with the risks that may lead to other costly treatments.
The Butterfly device is a Nitinol implant designed to retract the lateral lobes of the prostate to alleviate BPH symptoms. The device is delivered in an elegant and intuitive procedure without cutting, burning or piercing tissue making it a true minimally invasive procedure. It is fully reversible, allowing future interventions if needed. 3 granted patents, CE mark, 6 peer-reviewed publications & multicentered FIH clinical trials (n=90 across 5 sites) place MPRD at TRL-7. EIC Project Objectives •Next generation low profile(22French), fully disposable delivery system for implant deployment within 4min •Gain FDA & MDR approvals •Conduct pivotal trials on further 222 patients in 20 EU & US hospitals
The focus during the first year of the project has been predominantly the Pivotal trial.
The number of enrolled patients has gone up from dramatically during the first year of the project to a point where it is almost complete by the end of the first year.
Our R&D project has also progressed dramatically from a concept to a finalized working device.
In terms of HR, we have hired a new CEO, an industry veteran that will lead the company to our upcoming commercial stage.
We have also been very successful in our fund-raising, during very challenging times, with our Round C almost complete.
During the second year of the project, we completed enrollment in our Pivotal trial which represents a major milestone for a significant project we have been working on.
We completed the funding round which enables us to move forward with our program.
We have made changes to the development plan for the new delivery system and by the end of the project we are done with the development and almost done with the required testing prior to launching a clinical trial.
Transition to MDR is progressing as planned with the 2025 audit by our Notified Body (MDC) completed with zero findings.
