Merhavia Holdings reported this morning (Sunday) that Cardiacsense Ltd, in which the company owns 5.12%, received FDA approval to measure heart rate at the single beat level using ECG technology and to measure the percentage of oxygen in the blood using the medical wristwatch it developed based on unique sensors that identify Arrhythmias that may cause cardiac arrest and stroke.
The FDA’s approval is a significant leap forward in the progress and growth of the company and allows it to begin selling and marketing to the American market, which is a significant share of the global market for medical devices, and may also allow it to promote strategic moves against leading players in the world, thereby significantly increasing the sales potential of Cardiacense.
To the best of Merhavia’s knowledge, Kardiaxens has already started talks with strategic partners in the United States for collaborations for the penetration of the medical watch into the American market. As of this time, Kardixens started selling its watch throughout Europe, South America, Africa and Asia, after receiving 4 CE certifications.
Cardiacense has developed a wearable device for measuring heart rhythm disorders. The company entered into distribution agreements with various distributors. In the company’s estimation, the approval received represents a significant leap forward in Cardiacense’s ability to sell the medical watch, the company expects to implement the distribution agreements and enter into sales in approximately 15 international markets.
Mehravia is traded on the Tel Aviv Stock Exchange according to a market value of only about NIS 30 million. Its shares have not yet started trading this morning.
Kardiaxens states that it has orders for hundreds of thousands of watches for the next four years for a cumulative amount of 100 million dollars. The company recently signed a memorandum of understanding to develop a chip based on the technology developed by the company and which will form the basis for many medical products of the world’s largest manufacturers. Prominent investors in the industry such as Merhavia Fund and Together Investments invested in the CardiacSense company.
The company is currently in a follow-up round of fundraising through Together Investments’ angel club, and allows its investors to join it with amounts of $25,000 or more. “CardiacSense’s medical watch can save the lives of millions of people a year, according to official medical data, the leading cause of death in the world is related to cardiac problems, the company’s announcement of receiving FDA approval is a big and significant step for the company, and will allow the company to start marketing and selling in the largest market in the world , the American market, and save the lives of many suffering from cardiological problems., says CPA Shoki Cohen Sharet, chairman of Together Investments.
Rani Lifshitz, chairman of Merhavia, said: “For years, Merhavia has believed in the foundation of excellent human capital and the unique technology developed at Cardiaxance and in the long-awaited achievement of receiving FDA approval. This is a very significant move which, in addition to the implementation of existing distribution agreements, will allow Cardiaxence to promote strategic moves against the leading players in the world and will increase the value of the company.”
Eldad Shemesh, CEO of Cardiacense said: “Cardiacense already has orders for hundreds of thousands of watches in the amount of about 100 million dollars which will be spread over the next four years. The company recently signed a memorandum of understanding for the development of a chip based on the company’s technology, which will form the basis of many medical products of the world’s largest manufacturers. Cardiacense will soon start selling its watch throughout Europe, South America, Africa and Asia, after receiving 4 CE certifications and is expected to receive 2 more certifications during the first quarter of 2023. These additional certifications will place the company at the forefront of diagnostic and medical monitoring watches, as a company with the number of certifications The most regulators. Cardiaxance’s groundbreaking and life-saving solution has a market potential estimated at billions of dollars per year. FDA approval is a huge step in the company’s growth and will enable a strong entry into the American market.”