Amnis Therapeutics has announced successful results in its pre-clinical trials, which tested the safety and efficacy of the Golden Retriever neuro thrombectomy device. The safety trial was conducted in Israel, while the efficacy trial was conducted in a US lab.
According to a company press release, the safety trial comprised catheterisations 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 competing product.
In the trial, both angiographic parameters (radiographic visualisation of blood vessels during the catheterisation) and histologic parameters (microscopic blood vessel structure) were tested.
The results of the trial showed the Golden Retriever not to have any significant side effects during the catheterisation and the blood vessels to be altogether undamaged and fully functional following a 30-day follow-up period. On the other hand, the release states, the competing product demonstrated significant pathological findings in the blood vessels walls after 30 days (including trauma to artery layers and emboli) in two of the six treated vessels. Overall, this pre-clinical trial demonstrated the high safety profile of the Golden Retriever compared to the competitor in the tested animal model.
The efficacy trial comprised of 16 catheterisations, each including the extraction of blood clots from various arteries. The blood clots were similar in their qualities and size to those typically found in stroke cases. The interventionalists succeeded in extracting 15 of the 16 blood clots, with 13 clots extracted at first attempt, one at the second attempt and one at the third attempt. One catheterisation was deemed a failure.
Overall, the Golden Retriever achieved a score of 93.8% in the efficacy trial, as well as very positive feedback regarding its effectiveness and ease of use (an accumulated score of 30 of 30), the company release states.
The catheterisations were performed by the company’s consultants, Professor Ronit Agid, from Toronto Western Hospital in Canada and Professor Adnan Siddiqui, director of the Neurosurgical Stroke Service, Kaleida Health in Buffalo, New York, USA. Agid noted that, “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.”
Aviv Lotan, chief executive officer of Amnis Therapeutics, noted: “The results of the recent trials prove that the product is safe and effective in thrombectomy in an animal model. Moreover, the results significantly support the company’s belief of the Golden Retriever’s superiority over its competitors, and our ability to offer the market a product which was designed for neuro thrombectomy and is better, safer, more effective and easier for use. Neuro thrombectomy is a large market, growing impressively each year, so an effective solution is sure to be very attractive to target audiences and potential strategic partners alike.”
The company intends to continue the validation process towards a clinical trial estimated in Q4 2016.
The Golden Retriever is made of minuscule metallic strands, which open/deploy inside the blood clot and grip it strongly and it is expected to be the smallest in the market compared to current competition. Its size and flexibility enable quick and easy access to blood clots, usually located in middle cerebral artery in the brain. In addition, the device is capable of extracting large, long complex blood clots in a single procedure.
Amnis Therapeutics will present the positive results at the Advanced Treatment in Neuro Therapeutics Meeting on 2 May in Tel Aviv, Israel.