The AORTICLAB mission is to respond the needs of patients suffering from severe aortic stenosis who have had no hope of cure to date because of their age or poor health. They also address to provide a safer TAVI procedure that protects patients from cerebral and peripheral risks, raising the quality and efficacy standards of aortic stenosis treatment.

Aortic stenosis (AS) is one of the most common and serious heart valve diseases. It is a narrowing of the aortic valve opening due to a calcium formation on the native leaflets. Because of aging or other comorbidities, the aortic valve starts to calcify, becoming more rigid and narrowing the blood flow orifice. This disease afflicts approximately 1-2% of the population over 65 years old and 4% of the people over 75 years old. The pathology can be diagnosed in different stages; when aortic stenosis reaches the final stage, the so-called "Severe AS", the survival rate of the untreated patients is 50% at 2 years.

AorticLab is developing a system composed by two devices to face these issues:FLOWer is an innovative Cerebral Embolic Protection Device (CEPD) designed to protect cerebral and peripheral vessels and is compatible with all TAVIs' delivery system. It is easily deployed and positioned in the ascending aorta. It fits perfectly with the aortic wall, and it covers all three main branches of the aortic arch (brachiocephalic trunk, left common carotid artery and left subclavian artery) and the systemic circulation. FLOWer filters, captures, and removes debris during TAVI, protecting patients from cerebral embolic injuries and embolism of peripheral organs. 3 sizes have been developed to easily adapt the device to different patient's aorta geometries. FLOWer features the exclusive CATCH&FLOW Technology, a net mesh with porosity under 70μm which captures even the most minute embolic debris without compromising the patient's normal fluid-dynamic conditions.FLOWer adoption will contribute to perform safer TAVIs' procedures by reducing serious adverse events incidence, thus extending the use of the procedure to patients with a medium risk profile who are typically younger and have longer life expectancy.

GEMINI is a TDD (Transcatheter Debridement Device) designed to break and fragment the dystrophic calcifications present on the native aortic leaflets and bioprosthetic leaflets. The calcium debridement is obtained by the PAIRPITCH Technology, a unique and innovative ultrasound treatment that generates a cavitation effect capable of breaking down calcifications both in the inner tissue and on the leaflets surface. During the treatment, the valve leaflets are blocked obtaining an effective debridement while the blood circulation is granted by a temporary prosthetic valve which is removed after the procedure. With the use of GEMINI is possible to treat severe AS avoiding the bioprostheses implantation.FLOWer has completed in vitro, in vivo and ex vivo tests confirming their safety and efficacy. Phase I clinical trial is ongoing, and 28 patients were treated up today. The study is expected to be completed in Q4 2022. This will allow FLOWER to obtain the CE mark and marketing authorization in EU in Q1 2023, with the launch of the product. GEMINI has completed in vitro and in vivo tests (sheep and pig model). The Phase I clinical trial is expected to begin in H1 2023, and his own commercialization is expected in the end of 2024 in Europe and in 2025-2026 in the United States.