First in class lateral meniscus prothesis to relieve pain and restore mobility for KOA patients

Project Information

AL U KNEED

Grant agreement ID: 190115658

DOI

10.3030/190115658

Project closed

EC signature date 21 November 2022

Start date 1 April 2023

End date 31 March 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 570 575,00

EU contribution

€ 2 499 402,50

Coordinated by

ATRO MEDICAL BV
Netherlands

Periodic Reporting for period 1 - AL U KNEED (First in class lateral meniscus prothesis to relieve pain and restore mobility for KOA patients)

Reporting period: 2023-04-01 to 2024-06-30

Summary of the context and overall objectives of the project

Meniscectomy is one of the most common orthopaedic procedures with over 1M performed annually in the EU and US. The knee has a medial and lateral compartment and 40% of the procedures concern the lateral meniscus. A significant part of the patients that undergo a lateral meniscectomy will later develop knee osteoarthritis (KOA) resulting in pain, swelling and impaired mobility, and a profound negative effect on the quality of life. Unfortunately, no durable solution is available, until complaints become so severe that unicompartmental or total knee replacement (UKR/TKR) is considered. However, TKR is limited to older patients (>65) due to its limited life span. Currently a pool of 350.000 relatively young lateral patients, growing every year with 70.000 patients, are stuck in a huge treatment gap (~13yrs) without any options at all, besides taking an increasing amount of pain killers. This leads to an immense economic burden of lateral KOA due to high medical costs, absenteeism and disability (€40K-€79k per patient).
ATRO Medical has developed a revolutionary prosthesis that quickly relieves pain and restores mobility for KOA patients with a dysfunctional meniscus at substantial lower healthcare costs: Trammpolin. We offer a minimally invasive procedure due to our arthroscopic approach, flexible implant and its’ fixation method by ligament tape. Our prosthesis is composed of two highly biocompatible polymers to reduce the peak pressure on the knee cartilage like a new shock breaker, and with similar mechanical properties as the native meniscus. The technology has proven itself for the medial meniscus and received the Breakthrough Device Designation of the US FDA in 2020. However, no solution is available for lateral patients due to the technical challenges, which can be overcome by ATRO Medical as the first company worldwide. For a successful market entry in 2026, we now optimize our design, conduct a First In Human-study and obtain CE-marking. Besides, we will perform a health economics analysis as a crucial step towards obtaining reimbursement.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Several pre-clinical tests have been performed in the lab. These were performed to show the safety and effectiveness of our product.

Lab testing:
- 3x1 million dynamic endurance tests
- Mechanical testing
- Pull out testing
- Instrument testing
- Trial sizers design
- Risk management activities (FMEA etc)

With regards to the clinical study, the documentation has been set-up in collaboration with a partner, Avania. The documents have been submitted to the medical ethical committee, which had some questions. These questions have been answered and we expect approval for the study in the coming weeks. After approval, patient recruitment can start and the clinical trial can be started.

ATRO & Avania:
- Set-up First in Man study documentation

The development of the Health Technology Assessment (HTA) is sub-contracted out to Medip Analytics. They are building a model to calculate the financial and societal effectiveness of our product.
HTA by Medip Analytics:
- Initial assessment performed on Dutch situation
- Work started for complete health economics model in multiple countries
- Team of Medip Analytics will prepare publication of results in international scientific literature

Production & logistics:
- Production and sterilization of the 5 different sizes of meniscus prostheses
- Production and sterilization of the fixation materials (Tape, sleeve and screws)

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The pre-clinical results in bench and cadaveric testing look promising. The clinical approach has been assessed and deemed feasible. We need to wait for the results of the First in Man study before we can confirm these results. The potential impact is large: there is no clinical solution yet available to replace the lateral shock absorber in the knee joint, nor are we are of any project worldwide that has entered the clinical stage.