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Multi4 - the first surgical instrument for bladder cancer treatment through a 20-minute outpatient procedure

Periodic Reporting for period 1 - Multi4 (Multi4 - the first surgical instrument for bladder cancer treatment through a 20-minute outpatient procedure)

Okres sprawozdawczy: 2023-08-01 do 2024-07-31

Bladder Cancer (BC) is the fifth most common cancer in Europe, with 175,000 new cases every year. It has the highest lifetime treatment cost among all cancers, costing the European Union about €5 billion annually. BC also has the highest recurrence rate, with up to 75% of patients experiencing recurrences, requiring ongoing and costly monitoring and treatment. The primary method for diagnosing BC is cystoscopy, which often leads to a surgical procedure called Transurethral Resection of a Bladder Tumor (TURBT). This surgery involves weeks of waiting, causing significant patient distress and additional healthcare burdens. The invasive surgery can also lead to complications and high recurrence rates due to the exposure of healthy tissues to cancerous cells.
The Multi4 project aims to tackle these issues by introducing a new, patented technology that greatly improves the diagnostic and treatment processes for BC. This innovation will make the healthcare pathway for BC patients more efficient, less invasive, and cost-effective. The key innovation is a multifunctional instrument that combines four essential functions—needle for local anesthesia, biopsy forceps, burning electrode, and tissue transportation system—into a single device. This instrument allows for complete cancer treatment in an outpatient setting, reducing the need for multiple invasive procedures and hospital stays.

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Objectives:
1. Reimbursement Systems and Pricing Strategy Analysis: Conduct a comprehensive analysis of reimbursement schemes in key European markets, and validate and refine the initial pricing model for the Multi4 platform.
2. Business Plan Update and Go-to-Market Strategy Development: Select and prioritize launch markets within Europe and develop detailed market access strategies for the chosen markets, including the selection of distributors and key partners.
3. Key Opinion Leaders (KOL) Engagement and Communication: Identify and map key influencers and decision-makers in the target markets. Communicate the Multi4 technology to these stakeholders and plan future clinical studies to generate health-economic data.
4. Coaching and Mentoring for Leadership and Market Knowledge: Empower the CEO and the operational team with the necessary skills to successfully bring the Multi4 platform to market

Expected Impact
The Multi4 project is set to revolutionize the management of BC by introducing a less invasive, more efficient, and cost-effective treatment method. By allowing immediate treatment during diagnostic procedures, the Multi4 instrument drastically reduces patient waiting times, healthcare costs, and the risk of cancer recurrence. This innovation is expected to transform the BC patient treatment process, reducing the number of required healthcare staff and shortening the time spent in medical facilities.

Economic Impact:
• Cost Savings: Significant reduction in healthcare costs, decreasing the average treatment cost per patient by 66%.
Social Impact:
• Patient Well-being: Reduces patient distress associated with long waiting times and repeated invasive procedures.

Environmental Impact:
• Resource Efficiency: Lowers overall resource consumption in healthcare settings due to reduced hospital stays and procedures.
The project integrates insights from clinical end users to ensure the technology is user-friendly and addresses the emotional and psychological needs of patients, leading to better patient compliance, satisfaction, and overall outcomes.
Overview of Results: The Multi4 project has developed an innovative multifunctional instrument designed to revolutionize the diagnosis and treatment of bladder cancer. The primary outcomes include:

1. Development of the Multi4 Instrument.
2. Scalability and Manufacturing: Established processes for scalable production.

Potential Impacts:
1. Improved Patient Outcomes:
* Reduced Recurrence Rates: Minimized need for multiple procedures, reducing the risk of recurrence.
* Shorter Procedure Times: Decreased time required for diagnostic and therapeutic procedures.

2. Enhanced Healthcare Efficiency:
* Cost Reduction: Lowered costs associated with purchasing and maintaining multiple devices.
* Streamlined Procedures: More efficient and streamlined procedures.

Key Needs for Further Uptake and Success:
1. Further Research and Development:
* Ongoing R&D for continuous improvement and expanded indications.

2. Demonstration Projects:
* Implementing pilot programs and publishing case studies.

3. Access to Markets and Finance:
* Developing strategies for market entry and securing additional funding.

4. Internationalization:
* Strategies for international market expansion.

5. Supportive Regulatory and Standardization Framework:
* Working with regulatory bodies and contributing to industry standards.