Periodic Reporting for period 2 - MPRD (Innovative, minimally invasive Medical Prostatic Retraction Device for the treatment of Benign Prostatic Hyperplasia (BPH) Patients in the office settings.)
Berichtszeitraum: 2024-09-01 bis 2025-08-31
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.
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.
Butterfly Medical is currently at TRL 7. The company has been developed over the past 8 years and raised about $12M to date. After completing the initial stages of product development, which included the design of several concepts of the device, testing of the different concepts in an ex-vivo trial, and the performance of a cadaver testing, the company launched its first human trial. The experience from the first ~10 clinical cases assisted in the process of designing new versions of the implant and delivery system and the creation of new patents. A multi-center clinical trials was launched in several hospitals in Israel and the company started to accumulate clinical data. Round A was raised and later round B. After the enrolment of about 60 patients in the Israeli multi-center trial, the journey toward launching a US Pivotal trial initiated. By the end of 2021, the company received initial approval from FDA to launch the Pivotal trial and in parallel the company received CE Mark.
Our to date marketing achievements have been focused on getting Urologists, & early adopter hospitals, on board for device validation. We have secured collaboration with implant manufacturer & assemblers. We have conducted detailed market (July 2017, quartery regular reviews since then ) & competitor analysis (Oct-2018, second review June-2019, third review Aug-2021, Fourth Review Oct-2022) across urologists in the EU & globally to ensure that the proposed value proposition of MPRD. We have interacted with early adopter urologists through conference attendance & the direct contacts of the company founders and management. Our most recent attendance was European Association of Urology (EAU), Netherlands in March 2022, and EAU 2023- Italy. Other events include AUA 2022, AUA 2021 (USA); EAU 2021 (virt.; EAU 2019 (Spain); Medica Exhibition, 2018 (Germany); DGU National Meeting (Germany). We have undertaken scientific advisory meetings. PR following successful fundraising and grants.
12 months update:
Our to date marketing achievements have been focused on getting Urologists, & early adopter hospitals, on board for device validation. We have secured collaboration with implant manufacturer & assemblers. We have conducted detailed market (July 2017, quartery regular reviews since then ) & competitor analysis (Oct-2018, second review June-2019, third review Aug-2021, Fourth Review Oct-2022) across urologists in the EU & globally to ensure that the proposed value proposition of MPRD. We have interacted with early adopter urologists through conference attendance & the direct contacts of the company founders and management. Our most recent attendance was European Association of Urology (EAU), Netherlands in March 2022, and EAU 2023- Italy. Other events include AUA 2022, AUA 2021 (USA); EAU 2021 (virt.; EAU 2019 (Spain); Medica Exhibition, 2018 (Germany); DGU National Meeting (Germany). We have undertaken scientific advisory meetings. PR following successful fundraising and grants.
12 months update:
The envisaged optimisations in the manufacturing process will ensure Butterfly's competitive advantage in terms of the scalability capabilities of its technology, stronger intellectual property and manufacturing knowhow. In addition, the improved process yield and higher throughput will lower the product cost and enable Butterfly better to compete in the market. Butterfly Implant is less invasive (no need to pierce the tissue like Urolift or burn tissue like Rezum) hence offers a superior safety profile and ensures shorter recovery time. The implant doesn’t require any additional new capital equipment. It offers same price regardless of prostate size. Procedure is full reversible & involves low post-surgical catheterization rates.