Merhavia Investments reports today that Cardiaxense, in which the company holds about 5.67%, has received approval from the Medical Equipment Division (AMR) in the Ministry of Health, to register in the watch’s medical equipment book developed by the company for designation and heart rate monitoring and diagnosis of atrial fibrillation. 31.1.2021.
The medical equipment register is the certificate book of medical accessories and devices approved by AMR and managed by the Israeli Ministry of Health.
The Cardiacens medical watch is designed to measure heart rate and heart rate on a single beat basis and to detect the presence of atrial fibrillation lasting at least 5 minutes by using ECG and PGG. Medical watches also include the ability to detect arrhythmias, including atrial fibrillation, which is one of the main causes of stroke.
In March of this year, Cardiaxense signed its first distribution agreement with a company operating in South America that deals with the import, marketing and oral use of biomedical products for private and public medical institutions. The scope of the contract is about one and a half million dollars to be paid to Cardiaxens over three years.
Since then, the company has also reported additional distribution agreements in South Africa, Chile, Turkey, Northern Cyprus, Uruguay and India. In total, over the course of 3 months, the company signed eight distribution agreements for a cumulative amount of more than $ 61 million.
At the same time, Cardiaxense is promoting FDA approval for the medical watch, following a successful clinical trial that has proven more than 99% effective in detecting heart rhythm disorders, which will allow the company to sell the product in other major target countries, including the US market.
In June this year, Cardiaxens completed a $ 6 million fundraiser, in which Merhavia also participated in the $ 250,000 original project. Merhavia invested in the company in June 2017, a total of $ 500,000 at a company value of $ 6 million and has since participated in all investment rounds.