Preclinical Studies Support Amnis Therapeutics' Golden Retriever Neurothrombectomy Device

April 12, 2016—Amnis Therapeutics, an Israel-based biomedical engineering company that specializes in endovascular technologies, announced successful results in its preclinical trials demonstrating the safety and efficacy of its Golden Retriever neurothrombectomy device. The data from the studies will be presented at ATNT, the Advanced Treatments in Neuro Therapeutics meeting on May 2 in Tel Aviv, Israel.

The safety trial was conducted in Israel, and the efficacy trial was conducted in a leading lab in the United States. The company intends to continue the validation process toward a clinical trial estimated to begin in Q4 of 2016.

Amnis Therapeutics stated that the Golden Retriever device is composed of minuscule metallic strands that deploy inside a blood clot and grip it strongly. Its size—designed to be smaller than currently available devices—and flexibility enable quick and easy access to blood clots, usually located in the middle cerebral artery of the brain. In addition, the device is capable of extracting large, long, complex blood clots in a single procedure.

The safety trial involved catheterizations in two animals. The effect of the product on the functioning of six blood vessels in which it was operated was tested and compared to a market-leading device. In the trial, both angiographic parameters (radiographic visualization of blood vessels during the catheterization) and histologic parameters (microscopic blood vessel structure) were tested.

According to the company, the safety results of the trial showed that the Golden Retriever device had no significant side effects during the catheterization procedure, and the blood vessels were undamaged and fully functional at 30-day follow-up. By contrast, the comparison device demonstrated significant pathological findings in the blood vessel walls after 30 days (including trauma to artery layers and emboli) in two of the six treated vessels. Overall, this trial demonstrated the comparatively high safety profile of the Golden Retriever in the tested animal model.

The efficacy trial involved 16 catheterizations, each including the extraction of thrombus from various arteries. The blood clots were similar in their qualities and size to those typically found in stroke cases. The interventionists succeeded in extracting 15 of the 16 blood clots, with 13 clots extracted on their first attempt, one on the second attempt, and one on the third attempt. One catheterization was deemed a failure. Overall, the Golden Retriever achieved a 93.8% efficacy rate, as well as very positive feedback regarding its effectiveness and ease of use (an accumulated score of 30 of 30).

The catheterizations were performed by Prof. Ronit Agid, MD, with Toronto Western Hospital in Toronto, Ontario, and Prof. Adnan Siddiqui, MD, Director of Neurosurgical Stroke Service at Kaleida Health in Buffalo, New York.

In the company's press release, Prof. Agid commented, “The ease of using the device, its small size, which enables the fast and relatively easy access to the clot, as well as its flexibility and effective grasp and grip of the clot, distinguish it and provide a substantial advantage over its competitors.”