Periodic Reporting for period 1 - STAAART SmarT Abdominal Aortic AneuRysm Treatment (World's first device-based treatment for small abdominal aortic aneurysms based on revolutionary new treatment paradigm)
Reporting period: 2024-01-01 to 2024-12-31
Over a lifetime, 1 in 20 Europeans suffers from abdominal aortic aneurysm (AAA), a dangerous, progressive dilation of the aorta, the largest blood vessel of the human body. If rupture occurs, 80% of patients die due to rapid internal bleeding. AAAs thus claim more lives annually in Europe than traffic accidents.
AAAs with diameters of 3-5 cm are termed small (early stage), while those with diameters greater than 5-5.5 cm are classified as large (late stage). Currently, 9 out of 10 patients are diagnosed with early AAAs, yet physicians cannot offer any therapy, as existing prosthetic treatments are reserved for late stage AAAs due to high complication rates and mortality. Consequently, patients remain without treatment and live with the psychologically trying threat of a "ticking time bomb" in their body.
The Angiolutions device “A3 Shield” is a first-of-its-kind device stopping the life-threatening progression of early-stage AAA. Angiolutions’ award-winning and patent-protected solution leverages a fundamentally new understanding of AAA growth discovered by the founders at Stanford University. They showed that aortic pulse waves, generated with every heartbeat, drive AAA progression. Based on this principle and together with key physicians, they developed a minimally-invasive, non-active aortic implant (class III). The nitinol-based device is positioned adjacent to the aneurysm sac via simple, catheter-based implantation. It is specifically designed to focally block aortic pulse waves from impacting the AAA . Hereby, they achieve a fast, low-risk, size-stabilizing treatment of small AAA.
The project is generally designed to 1) finish R&D activities prior to Angiolutions first-in-human study and 2) submit for regulatory clearance (CE mark) for the Angiolutions device within the scope of the “grant component” plus 3) initiate its commercialization thereafter with help of the “investment component”.
Angiolutions’ innovation will entirely change the present AAA therapy space as it unlocks the market for small AAA that cannot be addressed by current technologies. For the first time, patients will have access to a treatment that addresses their disease already at an early stage. At the same time, the treatment will prevent costly and risky interventions later on and therefore contribute to sustainable healthcare systems in Europe.
AAAs with diameters of 3-5 cm are termed small (early stage), while those with diameters greater than 5-5.5 cm are classified as large (late stage). Currently, 9 out of 10 patients are diagnosed with early AAAs, yet physicians cannot offer any therapy, as existing prosthetic treatments are reserved for late stage AAAs due to high complication rates and mortality. Consequently, patients remain without treatment and live with the psychologically trying threat of a "ticking time bomb" in their body.
The Angiolutions device “A3 Shield” is a first-of-its-kind device stopping the life-threatening progression of early-stage AAA. Angiolutions’ award-winning and patent-protected solution leverages a fundamentally new understanding of AAA growth discovered by the founders at Stanford University. They showed that aortic pulse waves, generated with every heartbeat, drive AAA progression. Based on this principle and together with key physicians, they developed a minimally-invasive, non-active aortic implant (class III). The nitinol-based device is positioned adjacent to the aneurysm sac via simple, catheter-based implantation. It is specifically designed to focally block aortic pulse waves from impacting the AAA . Hereby, they achieve a fast, low-risk, size-stabilizing treatment of small AAA.
The project is generally designed to 1) finish R&D activities prior to Angiolutions first-in-human study and 2) submit for regulatory clearance (CE mark) for the Angiolutions device within the scope of the “grant component” plus 3) initiate its commercialization thereafter with help of the “investment component”.
Angiolutions’ innovation will entirely change the present AAA therapy space as it unlocks the market for small AAA that cannot be addressed by current technologies. For the first time, patients will have access to a treatment that addresses their disease already at an early stage. At the same time, the treatment will prevent costly and risky interventions later on and therefore contribute to sustainable healthcare systems in Europe.
The year 2024 has been pivotal for Angiolutions, characterized by substantial progress toward the objective of enabling first-in-human application of its innovative device for early aortic abdominal aneurysm (AAA) treatment. Under the framework of the EIC Accelerator scheme, this project has focused on addressing organizational and technical challenges to ensure operational proficiency and advance toward clinical implementation.
Key Achievements in 2024:
- Establishing robust company processes: This has ensured seamless execution of operational, technical, and regulatory tasks, laying a strong foundation for Angiolutions’ progress.
- Advancing the delivery device: Major progress has been achieved in optimizing and finalizing Angiolutions‘ delivery device.
- Development of an implantation planning algorithm: Angiolutions has successfully developed a precise algorithm to facilitate patient-specific device selection.
- Verification and validation: Comprehensive verification and validation was initiated to confirm adherence to safety and regulatory standards, solidifying readiness for clinical use.
- Clinical study preparations: Preparations for the clinical study have progressed significantly, with key activities including the creation of a trial protocol, addressing ethical considerations, and initiating collaborations with key partners. Conducting the clinical trial will be a primary focus of the next review period.
Key Achievements in 2024:
- Establishing robust company processes: This has ensured seamless execution of operational, technical, and regulatory tasks, laying a strong foundation for Angiolutions’ progress.
- Advancing the delivery device: Major progress has been achieved in optimizing and finalizing Angiolutions‘ delivery device.
- Development of an implantation planning algorithm: Angiolutions has successfully developed a precise algorithm to facilitate patient-specific device selection.
- Verification and validation: Comprehensive verification and validation was initiated to confirm adherence to safety and regulatory standards, solidifying readiness for clinical use.
- Clinical study preparations: Preparations for the clinical study have progressed significantly, with key activities including the creation of a trial protocol, addressing ethical considerations, and initiating collaborations with key partners. Conducting the clinical trial will be a primary focus of the next review period.
Building on the project's context and progress, the results achieved in 2024 mark significant advancements toward clinical application. The delivery device has been optimized with a "release control" feature for precise vascular deployment, while a validated implantation planning algorithm ensures standardized device selection and placement across varying patient anatomies.
These developments are expected to transform the treatment of early abdominal aortic aneurysms (AAAs). For the first time, patients can receive early-stage treatment, preventing disease progression and reducing the need for risky, costly interventions in later stages.
To ensure continued progress and success, the project has identified several key needs:
• Further research: Completion of the first-in-human (FIH) clinical trial will provide critical safety and efficacy data for regulatory approval.
• Market access and finance: Angiolutions will raise its Series A round to support clinical validation and initial commercialization.
• Commercialization: A market access strategy is in place, with EU-focused launch plans followed by further expansion especially to the US.
• Intellectual property: With 16 patents filed (3 granted), continued IP development will safeguard market leadership.
• Regulatory readiness: ISO 13485 certification has been maintained, with CE submission targeted following trial completion.
By prioritizing clinical validation, regulatory compliance, and funding readiness, the project is on track to deliver a groundbreaking solution for early AAA treatment, improving patient outcomes while reducing healthcare costs.
These developments are expected to transform the treatment of early abdominal aortic aneurysms (AAAs). For the first time, patients can receive early-stage treatment, preventing disease progression and reducing the need for risky, costly interventions in later stages.
To ensure continued progress and success, the project has identified several key needs:
• Further research: Completion of the first-in-human (FIH) clinical trial will provide critical safety and efficacy data for regulatory approval.
• Market access and finance: Angiolutions will raise its Series A round to support clinical validation and initial commercialization.
• Commercialization: A market access strategy is in place, with EU-focused launch plans followed by further expansion especially to the US.
• Intellectual property: With 16 patents filed (3 granted), continued IP development will safeguard market leadership.
• Regulatory readiness: ISO 13485 certification has been maintained, with CE submission targeted following trial completion.
By prioritizing clinical validation, regulatory compliance, and funding readiness, the project is on track to deliver a groundbreaking solution for early AAA treatment, improving patient outcomes while reducing healthcare costs.