In cases of natural disasters or mass-casualty incidents (MCI), first responders and rescuers must decide in real time who among the casualties is in mortal danger and therefore needs immediate medical care and onsite treatment, and who is injured in a way that allows for less urgent treatment. The need for a clear diagnosis is crucial. Mistakes in diagnosing which casulty needs to be treated first result in wrong medical decisions that cost lives as well as put an impossible burden on rescue centers and hospitals.
Israeli medtech startup CardioScale developed a portable sensor that can be used to check vital cardiovascular data in seconds and determine the patient's actual condition. Based on this data, the urgency of treatment for each patient can be determined, creating a real time onsite treatment prioritization tool.
“In emergency medical situations and trauma, every minute that passes without accurate diagnosis and treatment can significantly reduce the chances of success in saving the patient, and the difference between life and death is usually based on the medical team in the field (doctors, paramedics, medics) who need to make quick and effective decisions based on their experience,” says Tomer Epstein, director of Medical Equipment and Computerization in the Israeli Export Institute.
“The number of victims in medical emergency incidents is rising worldwide nowadays due to terrorist attacks, natural disasters, road accidents, injuries at home, and more,” Epstein continues.
“These cases, along with an ever-growing shortage of properly trained medical staff onsite, create an increasing need in the professionalization of medical teams on the ground and in innovative digital technologies, which constitute an essential tool in the management and operation of events. The accuracy of decision-making and medical care is critical in such situations, and the technology should enable rapid and effective response to patients, so that even the less experienced professionals will be able to save lives and manage emergency events,” he explains.
A decade of development
CardioScale is a medical device start-up in the cardiovascular field. Officially, the company exists since 2012 but as early as 2009, Dr. Uri Gabbay, a family physician and disease researcher, noticed a clinical diagnostic problem: patients with certain symptoms and other patients with the opposite symptoms were both diagnosed with heart failure.
He realized there was a clinical problem that the medical world could not yet decipher. Dr. Gabbay thought that the cardiovascular system should be examined as an engineering control system. He decided to recruit an electricity engineer to explore different control models, and to that end he turned to Prof. Ben-Zion Bobrovsky, a professor emeritus at Tel Aviv University, who specializes in control systems.
They began conducting a joint study. Two years into the research, the two shed light upon the problem. They developed an algorithm that decodes the ability of the cardiovascular system to function properly. In 2012, they established CardioScale together with Maoz Ben Ari, CEO of CardioScale.
“Our index and the devices that operate it measure how much ‘reserves’ a person has to function and whether he/she needs immediate care or life-saving operations,” says Ben Ari. “The device we developed is able to create a prioritization list for the treatment of patients, in real-time and based on their actual situation; in the first measurement it examines the patient’s condition and in second measurement it gives direction of the change in the patient’s condition, either improving or deteriorating.”
From algorithm to experiments
After developing the algorithm, CardioScale transitioned to the clinical stage. They collected medical information from databases of more than 900 patients in different conditions and analyzed their medical events, situations and outcome. The analysis gave good results and the study validated the algorithm.
“The algorithm, as we envision it, can also be used to analyze other systems because it is a system that prioritizes treatment in different critical situations,” Ben-Ari asserts.
He further explains that “The situation in which the body undergoes compensation indicates a condition that appears to be normal in terms of heart rate and blood pressure, when actually deterioration had already commenced. Our system is able to recognize the very early beginning of the deterioration, at a stage when the body compensates and falsely displays a non-alarming medical picture. No other existing model can identify deterioration as early as we do. This may save unnecessary treatments in intensive care, complications during surgery, patients discharged earlier than needed, etc.”
Measuring with the device is similar to a blood pressure test and is performed by a sleeve on the arm that measures breathing, pulse, blood pressure, saturation, CO2, and the patent-protected CVRI-CardioVascular Reserve Index. These measurements provide the ability to obtain all the data that is needed to allow the algorithm to preform appropriately.
As of June 2018, the company carried out five studies, of which two were performed by IDF Medical Corps and the Heller Institute at the Sheba Medical Center.
“The army conducted an early study and examined our technology to indicate deterioration. We were one of the companies the army selected for this study, and results were amazing. According to the study done and published by the IDF, our technology was found to be the best deterioration predictor, indicating deterioration while all other measures and vitals were still within normal range. The army published the results of the study in 2015 and since then we have been working with them on developing an instrument for the field. At the same time, we obtained global patent registration for our technology and devices,” says Ben Ari.
Winning first place that changed everything
“As a result of the experiments, we have begun to develop a small portable medical monitoring device weighing less than 900 grams giving all the indications for early detection of deterioration,” he says.
The device does not require medical skill and provides a medical indication, which is actually an optimization of treatment, and increases the ability to save more people in the field.
“With the device, we approached the Combating Terrorism Technology Startup Challenge (CTTSC3), which was initiated by the US Department of Defense together with the Administration for the Development of Weapons and Technological Infrastructure, a branch of the Israeli Ministry of Defense and the MIT Forum for Entrepreneurship at Tel Aviv University,” said Ben Ari.
There were approximately 80 judges in the competition: 50 from the United States and 30 from Israel. 220 companies started the process and 10 presented in the final stage. CardioScale won the competition, which won it $100,000 as a development grant and named it as an official project of the Ministry of Defense.
“After the competition, the attitude towards us changed dramatically. We received dozens of media articles from around the world, and we received inquiries from around the world: Mexico, France, the US, Chile, Brazil, Panama, China, Japan, Korea, Russia, Ukraine, and more.”
“Since then, we have continued to develop the device, and by the end of the year we will supply the army with the first batch of 40 devices manufactured in Israel. At a later stage, we will provide devices to the US Department of Defense,” says Ben Ari. “This is just the beginning of the development with the goal of developing a device that will efficiently handle multi-casualty incidents all over the world.”
“We are also looking forward to future developments that will enable the individual patient to perform the test at home to determine the stage at which he/she should rush to the hospital. This will save lives and the costs of overloading hospitals and unnecessary hospitalization,” he adds.
Israel Export Institute, Foreign Trade Administration see potential
“CardioScale is an excellent example of developing a solution that detects the health and deterioration of patients in the field in real time, while fully transferring the data to the medical staff enabling them to make quick, accurate decisions and save lives,” adds Tomer Epstein
“Israel is a world leader in the field of emergency medical technologies and offers a wide range of solutions, including medical emergency management software, wearable products for real-time monitoring, wound treatment, opening of airways, smart defibrillators, management and protection of infectious diseases and more.”
Epstein notes the Israel Export Institute assists these and other companies in creating platforms for business opportunities around the world, organizing meetings with opinion leaders and potential business partners.
“Our activity takes place in the framework of leading exhibitions in the world, in which we establish an Israeli national booth, as well as delegations of Israeli technology companies to target countries that are mostly focused on the fields of emergency medicine, rehabilitation, chronic diseases, digital health, and more. This March (2019) we will hold the fifth international MEDinISRAEL conference in Israel, which will present visitors from around the world with the most innovative Israeli technologies in the field,” he says.
Following the terror attacks in Paris few years ago, the company’s management together with the Israel Export Institute were part of a delegation to assist the French rescue forces and presented the French rescue forces with the company’s technology.
“CardioScale is a great example of a start-up that has successfully combined Israel’s expertise in the field of medical device with its unique expertise in the field of counter-terrorism and the treatment of terror victims and leveraging it to reflect the added value of Israeli industry,” said Yifat Alon Perel, the head of the Economy Ministry representation at the Israeli Embassy in Washington DC.
“The export of medical equipment to the United States requires compliance with the rules of the US Customs and Border Service so that any medical equipment that enters the United States is required to comply with the supervision and regulation of the FDA - Food and Drug Administration,” says Alon Perel. “The Economy Ministry representation at the Israeli Embassy follows the FDA’s regulatory requirements and changes and ensures that Israeli exporters are given the latest information.”
“In addition, the mission in Washington is responsible for managing the relationship with international financial institutions in the city, such as the World Bank and the Inter-American Development Bank (IDB). These institutions provide billions of dollars in loans and allotments to developing countries in order to improve their standard of living by exposing them to groundbreaking technologies, including medical equipment technologies.”
“The medical equipment sector is a desirable area in the developing world and many Israeli companies have important and relevant solutions for these markets. The Ministry of Economy and Industry is working to expose these institutions to Israeli technologies so that they are acquainted with these technologies and are able to use them at the right time. We encourage Israeli companies to use us in order to examine business opportunities in developing countries and to open up new avenues of activity,” Alon Perel concludes.
This article was written in collaboration with the Israel Export Institute.