The company will submit in the coming days a request to conduct the first clinical trial in Sweden.
Amnis announced today that it has completed the process of mechanical and biological tests (Validations & Verifications) of its product for retrieving blood clots from the brain, the Golden Retriever. In that process, the company has conducted two animal trails (safety and functionality) in addition to other tests as part of the requirements for clinical trials and receiving the European CE Mark.
The Company intends to file an application for an initial clinical trial at the Karolinska Medical Institute (Karolinska) in Stockholm, Sweden. The company is considering adding additional stroke centers around the world.
In another animal study conducted at the Karolinska Institute by two of the leading neuroradiologists in Europe, the Golden Retriever proved once again its efficacy and safety with quick, easy and safe blood clots retrieval in an animal.
The unique device is composed of flexible metal and is expected to be the smallest in the market today, while its size and deliverability enable faster retrieval of the blood clot. Golden’s gripping mechanism is designed to enable excellent clot engagement regardless of morphology and size.
Aviv Lotan, Amnis’ CEO, stated “I am very proud of our R&D and production departments that worked day and night to complete the hard work necessary to end the V & V process, and in Biomedical Strategies, led by Dr. Orna Oz, which led the application preparations to the Swedish authorities. The Golden Retriever successfully passed all the tests required by the European regulation and I am pleased to say that we are ready to begin the first clinical trial in humans. The Golden Retriever has distinct advantages over existing solutions in the market and we have great faith in it.”