Periodic Reporting for period 2 - ProVee (ProVee CE Mark and EU commercialisation plan)
Berichtszeitraum: 2021-05-01 bis 2022-04-30
PROBLEM/ISSUE BEING ADDRESSED:
Benign Prostatic Hyperplasia(BPH) is an extremely common condition in older men where the prostate gland enlarges causing impingement upon the urethra, the tube which eliminates urine from the bladder. Sufferers of BPH present with Lower Urinary Tract Symptoms (LUTS), including decreased urine stream, incomplete voiding and urinary retention, resulting in a constant ‘topping up’ of the never fully empty bladder causing a frequent urge to urinate, making it difficult to carry out routine activities during the day, insomnia at night and resulting in a profound effect on quality of life. The incidence of BPH is staggering; it develops as an age-related phenomenon in nearly all men. Autopsy studies show the histologic prevalence of BPH to be approximately 20% for men in their 40s, reaching 50% for men in their 60s, and 90% for men in their 80s. In Europe some 26 million men, are affected by bothersome LUTS due to BPH resulting in a cost to the EU Healthcare system of €18Bn p.a.
IMPORTANT FOR SOCIETY:
Patients
- ProVee is a tolerable BPH treatment option
- Low risk, effective and simple treatment
- Side-effect free
- Fast acting and a quick recovery
Physicians
- Minimally invasive surgical solution
- It is not associated with serious harms of surgery
- Can be delivered in the office setting with rapid recovery and symptom relief
- Easy to learn with consistent deployment
Healthcare system
- Cost savings
- No capital equipment purchase
- Less costs associated with the management of complications
OVERALL OBJECTIVES:
The overall objective is to develop a minimally invasive medical device that will relief a patient of BPH symptoms through a simple, 5 minute outpatient procedure to implant the ProVee device under local anesthetic. Once implanted, the ProVee addresses urinary problems, is well tolerated and early data suggests has an excellent safety profile.
Benign Prostatic Hyperplasia(BPH) is an extremely common condition in older men where the prostate gland enlarges causing impingement upon the urethra, the tube which eliminates urine from the bladder. Sufferers of BPH present with Lower Urinary Tract Symptoms (LUTS), including decreased urine stream, incomplete voiding and urinary retention, resulting in a constant ‘topping up’ of the never fully empty bladder causing a frequent urge to urinate, making it difficult to carry out routine activities during the day, insomnia at night and resulting in a profound effect on quality of life. The incidence of BPH is staggering; it develops as an age-related phenomenon in nearly all men. Autopsy studies show the histologic prevalence of BPH to be approximately 20% for men in their 40s, reaching 50% for men in their 60s, and 90% for men in their 80s. In Europe some 26 million men, are affected by bothersome LUTS due to BPH resulting in a cost to the EU Healthcare system of €18Bn p.a.
IMPORTANT FOR SOCIETY:
Patients
- ProVee is a tolerable BPH treatment option
- Low risk, effective and simple treatment
- Side-effect free
- Fast acting and a quick recovery
Physicians
- Minimally invasive surgical solution
- It is not associated with serious harms of surgery
- Can be delivered in the office setting with rapid recovery and symptom relief
- Easy to learn with consistent deployment
Healthcare system
- Cost savings
- No capital equipment purchase
- Less costs associated with the management of complications
OVERALL OBJECTIVES:
The overall objective is to develop a minimally invasive medical device that will relief a patient of BPH symptoms through a simple, 5 minute outpatient procedure to implant the ProVee device under local anesthetic. Once implanted, the ProVee addresses urinary problems, is well tolerated and early data suggests has an excellent safety profile.
The work performed to date by work package is as follows:
Work package 1 (project management) is complete. Monthly technical meetings were held and updates provided to senior management within ProVerum. Risks, procedures and objectives were regularly reviewed and amended when needed with all changes logged accordingly.
Work package 2 (regulatory submission) is ongoing. ProVerum achieved MDR compliance for the company's phase. The IDE submission package was compiled and submitted to the FDA. ProVerum received full Investigational Device Exemption (IDE) from the FDA in December 2021 ahead of plan.
Work package 3 (manufacturing development) is complete. The design and development of a validated manufacturing process to build ProVee product and associated V&V testing has been successfully completed.
Work package 4 (clinical study) is ongoing. The ProVIDE clinical study was approved for initiation in the US and the first patient was enrolled in the ProVIDE clinical study in Q2 2022.
Work package 5 (commercialisation strategy) is complete. The marketing and communication strategy has been developed. ProVerum attended five urological conferences during the project and will present clinical trial data at these events in future years. The assessment of reimbursement status in US and key European territories, the Health Economics Assessment and the Growth & Commercialisation plan have all been completed.
Further information can be provided in the detailed technical report on request.
Work package 1 (project management) is complete. Monthly technical meetings were held and updates provided to senior management within ProVerum. Risks, procedures and objectives were regularly reviewed and amended when needed with all changes logged accordingly.
Work package 2 (regulatory submission) is ongoing. ProVerum achieved MDR compliance for the company's phase. The IDE submission package was compiled and submitted to the FDA. ProVerum received full Investigational Device Exemption (IDE) from the FDA in December 2021 ahead of plan.
Work package 3 (manufacturing development) is complete. The design and development of a validated manufacturing process to build ProVee product and associated V&V testing has been successfully completed.
Work package 4 (clinical study) is ongoing. The ProVIDE clinical study was approved for initiation in the US and the first patient was enrolled in the ProVIDE clinical study in Q2 2022.
Work package 5 (commercialisation strategy) is complete. The marketing and communication strategy has been developed. ProVerum attended five urological conferences during the project and will present clinical trial data at these events in future years. The assessment of reimbursement status in US and key European territories, the Health Economics Assessment and the Growth & Commercialisation plan have all been completed.
Further information can be provided in the detailed technical report on request.
The ProVee delivery system will be the lowest profile of the BPH MIST products on the market or in late stage development. It also will provide the most accurate, rapid & targeted deployment of the implant with an overall deployment time is less than five minutes. ProVerum believes that the combination of a low-profile delivery system, capable of quickly and accurately deploying the purpose designed ProVee expander into the prostatic urethra will enable the treatment of bothersome LUTS to be performed in an Outpatient or Doctor’s Office setting under reduced anaesthesia. The ProVee allows for rapid recovery and symptom relief with no need for a hospital stay and a return to work and full preoperative activities within days.