January 8, 2023
Approved for remote monitoring of ECG, heart rate and blood oxygen level. The company will start implementing distribution agreements at $100 million. At the same time, it is also developing a chip that can be used in other manufacturers’ products
Kardiaxance Company (Cardiacsense) of Caesarea received the approval of the American FDA for three of the capabilities of the medical watch it developed for monitoring the activity of the heart – this is what the Mehravia holding company, which owns about 5.12% of the company, reported to the stock exchange this morning (Sunday). As part of the approval given by the FDA, the Cardiacense medical watch has been approved for use for monitoring they ECG, heart rate and blood oxygen level. The company estimates that the product has a market potential of billions of dollars per year.
The FDA approval actually gives the signal for the beginning of the commercialization phase of the medical watch. The company will be able to market in the United States as well as start implementing agreements Distribution of them has signed in different countries of the world, estimated at about 100 million dollars over a period of four years. Kardiaxens reported that the company is in advanced talks with strategic partners in the United States who will help it penetrate the American market.
Cardiacsense will soon start selling its watch across Europe, South America, Africa and Asia, having received 4 CE certifications and is expected to receive 2 more certifications during the first quarter of 2023. At the end of 2021, the company has already started making deliveries of the watch to about 20 countries. The company previously reported distribution agreements in Spain, Turkey, Uruguay, Australia, South Africa, Chile, India, Switzerland and the United Arab Emirates.
The company also announced that it recently signed a memorandum of understanding for the development of a chip based on its technology, which will form the basis for medical products of medical device manufacturers. The company did not provide additional details about the nature of the agreement and with whom it was signed.
Main target customers: chronic patients and hospitals
Cardiac-Sense has developed a personal medical monitoring accessory that allows monitoring heart rhythm disorders and identifying in advance the development of atrial fibrillation, which is the most common heart disorder that results in the death of approximately 130 thousand people a year in the United States alone. The accessory is based on a unique optical sensor and an algorithm that allows monitoring the activity of the heart and blood vessels by monitoring changes in blood vessel volume (PPG).
It can be used as an alternative to an EKG test, which is performed in a hospital or clinic, and thus monitor the cardiac activity of patients at risk remotely and continuously, 24 hours a day, and throughout the patient’s daily life. The company designates it for two main needs: remote monitoring of chronic patients and monitoring of hospitalized patients, for measuring with one device several medical parameters that are currently measured by several devices.
The company A.Y. AY Electronics is a strategic investor in the company, which also gives it the support and assistance in product development, engineering, supply chain management and production.
Listen to a conversation with the CEO of Cardiac-Sense, Eldad Shemesh, from our podcast program that appeared in May 2020:
Published in the categories: news, medical devices, Israeli industry
Posted in tags: medical devices, Cardiaxance
