The system is designed to protect from emboli released during catheterization procedures. The FDA indication is for use of the Wirion system during carotid catheterization procedures.

The application was submitted in the 510(k) regulatory track based on the interim clinical data. In parallel, the company continues the enrollment of 120 additional patients in the clinical study according to the study protocol.

Asaf Alperovitz, CEO of Allium Medical: "We are taking another step towards FDA clearance for marketing the Gardia unique filter in the US. The application is based on the interim clinical results that include data from 120 out of the planned 240 patients and demonstrate that the safety profile (the primary end-point of the study) is significantly better compared to the control group (that includes data from cleared US products of global companies."

The interim clinical data submitted to the FDA clearly demonstrate that the system safety profile, the primary end-point of the study, is significantly better compared to the control group.

According to the study protocol, in order to meet the primary end-point at this early stage, the Company has to meet strict statistical criteria compared to the statistical criteria for the full cohort study.

According to the statistical method presented in the study protocol, the company did not meet the interim primary end-point that would allow its ending the study at interim. However, according to the alternative exact binomial statistical method, the Company met the study endpoint at interim.

In the correspondence between the Company and the FDA it was stated that the alternative exact binomial method proposed by the company will be considered by the FDA following the review of the totality of the full submission data.

To clarify, the FDA’s official and binding position, with respect to the Company’s decision to end the study early upon the recruitment of half of the patients, as well as the other components of the Company’s application for approval of the system, will only be presented as part of the review of the complete 510(k) application. There is no guarantee that the FDA will approve the Company’s position.

As stated, according to Company and its advisors, based on the interim results of 120 patients submitted to the FDA, probability of success in a full experiment with 240 patients are high, assuming the Company will be obliged to conduct it. As far as the Company knows, the FDA is expected to respond to the application within 90 days of receiving confirmation that all administrative conditions for this application were met.