The in vitro testing examined the removal of EVs directly from plasma & was reviewed and examined by an independent 3rd party commercial lab & by NAMSA, AEMD's CRO for its planned Australian oncology study. The data is a critical element enabling the company to move the Hemopurifier forward in clinical oncology studies towards potential regulatory approval and commercialization. The next step is for AEMD to add the data to its Clinical Investigator Brochure, which it will then submit to the Ethics Committees at clinical sites interested in participating in the planned trials in Australia and India. We expect AEMD to submit the Clinical Investigator Brochure this month. Depending on how long it takes the sites to review & potentially approve moving forward, we believe clinical efforts could begin in 2H24.
