Romanian startup CardioMedive has designed a medical-grade smart patch for remote patient monitoring and works to transform it from the current prototype into a product ready to market.

Last year, CardioMedive was a finalist at the Changeneers competition, targeting entrepreneurs and startups that use technology to improve the life of the community, and won one of the EUR 2,500 awards in the Future Makers competition, covering forward-looking business ideas.

They presented their Smart Patch, a discreet and easy-to-wear patch that is applied to the patient’s chest and measures continuously a series of vital signs and hemodynamic parameters. It can record them for up to 14 days, and these are measured, analyzed, and stored or streamed to the cloud.

The idea of the Smart Patch emerged four years ago, when the founder’s mother was suspected of suffering from heart problems. “After several medical consultations at different specialized medical centers, the cardiologists were unable to correctly determine her disease due to the limitation of current technologies. The available solutions allow diagnosis only if the cardiac episode occurs in the first 48 hours or until the disease becomes chronic. The fact is that if the possibility of recording cardiac activity over a long period of time existed, today she would not have been a chronic heart patient in need of permanent supervision and daily anticoagulant pills,” Ion Mocanu, the co-founder and CEO of CardioMedive, explains.

Mocanu has more than 15 years of experience as a software and hardware engineer designing wearable medical devices and over five years of experience as an entrepreneur. A technical military engineer by profession, he also brought to the project his experience and research background as a Ph.D. candidate in medical electrical biosensors to put forth what he describes as “a life-saver solution.”

The CardioMedive team brings together engineers, physicians, and business specialists. “The team is working intensively to finalize clinical tests with our medical partner institutions and [e.n. get] ready to launch the product in the shortest possible time on the market,” Mocanu explains.

After market research and interviews that Mocanu conducted with cardiologists to validate the idea, the company started developing its remote patient monitoring solution - a wireless patch designed to better detect cardiovascular risk and reduce the cost of medical services. “The final solution has gone through multiple stages of development and testing, being now in the final phase before clinical tests and market launch,” the co-founder says.

The solution developed by CardioMedive can be used for patients with cardiovascular diseases (CVD), in pre and postoperative monitoring, hospital monitoring, and ICU sections, for patients with chronic conditions, especially the elderly and people with walking difficulties, in monitoring patients under high-toxicity drug administration like chemotherapy procedures, in pregnancy, and in many other areas of medical assistance and 24/7 home monitoring, he explains.

The testing done so far was done in accordance with all technical and medical requirements, he says. “Developing a medical-grade device represents assuming tremendous responsibility and respecting with full strictness all the technical and medical requirements. All these preconditions have made us look from the beginning at each small detail and establish the end of a development stage only in conditions of complete safety and quality.”

The company already established several partnerships with several medical centers and plans to carry out other clinical trials at partner hospitals in the country this year.

“The Smart Patch has proven to be all along the way of real interest in the medical community not only at a national level but also internationally. We have received appreciation and support from physicians from different specialties, representatives of public and private hospitals, clinics, and medical institutes. We have established important partnerships with Emerald Medical Center, Sanopass, CardioMed, and many other names. […]

What was essential for us was to receive our partners’ validation, but also to expand the consumer market. We have scheduled at the beginning of next year [.e.n. the answers were provided at the end of 2020] other clinical trials within our partner hospitals from Romania, and some similar discussions are currently held with some other medical institutions. Also, our partners have already expressed interest in using the technologies as soon as they are commercially available,” Mocanu says.

How is the Smart Patch of CardioMedive different from the alternatives on the market? “Apart from the superior performance, validated with an extended set of measurements essentials in establishing an accurate diagnostic, it is reusable, has a 14-day autonomy time, and a higher yield. Even if comparable devices exist on the market, there is no complete solution including hardware, software, and a cloud-based platform, for complete remote patient care, from diagnostic through treatment. It is also important to mention that there are no such devices on the market in Romania,” Mocanu says.

As for the next stages in the development of the Smart Patch project, CardioMedive plans to complete the patent application along with the preclinical evaluations, followed by clinical trials. “The team is looking forward to transforming the Smart Patch from the current prototype into a functional product ready to market. Therefore, the main objectives starting from this point consist of completing the patent application along with the preclinical evaluations, followed by a period focused on clinical trials. The success of those steps would conclude with a fast implementation for production and commercialization. Until then, to achieve the objective of introducing CardioMedive massively into the market, it needs to answer perfectly the needs of any potential end-user, create a solid reputation and credibility, and avoid any market failure risks. For this reason, the company has to optimize the CardioMedive technology and create a market-ready product, able to cover all the requirements of the market segments to which the product is targeted,” the CEO explains.

The product would first be launched in Romania, but it addresses a global market. “The market that the CardioMedive solution addresses is a global one, but the product is intended to be launched first in Romania, then, gradually, in European countries and afterward on the US market. Next year, we are planning to start preparing the launch of the Smart Patch, a process constrained by the clinical tests and the future funding opportunities timeline.”

The company is also focused on attracting funding to cover the further development of its solution and expanding the team, among others. “We have spent the last four years working intensively on developing the Smart Patch along with nine team members. In the near future, we are focused on attracting EUR 600K, which will be used for expanding the team, finishing the development of our solution, the clinical trials, and obtaining the medical certifications.”

Meanwhile, the increased interest in and acceptance of telemedicine solutions, driven in part by the pandemic, provides the right context for its product. “In the current context of coronavirus pandemic, the interest and acceptance of telemedicine solutions has increased tremendously, and we predict that starting with 2021 the entire medical community will be more open to this type of solutions which involve medical interactions at a distance, without human touch, on a remote basis,” Mocanu says. “This new approach for continuous remote monitoring has proven us with all the tests and from the medical experts and advisors’ opinions that we are on the right track of improving classical medical interactions in an effective and commercially affordable way for a large number of patients who now have only the current limited technologies. The fact that our Smart Patch involves zero-contact between physician and patient, the risk of infection is prevented, at the same time offering more accurate diagnosis and an increased number of consultations performed in the same period by the medical personnel. This trend for finding innovative and quality-based alternatives will continue to surprise and will become very soon a normality, being completely integrated with the standard available medical services.”

When asked about other potential products for the medical field, Mocanu says they are “visualizing the Smart Patch combined with a remote examination device in the form of a complex kit used for complete remote patient monitoring, examination and diagnosis. Both solutions would be served by the same cloud-based app that covers the whole medical interaction and allows contact-free diagnostic and treatment for the whole duration of the disease or medical condition. After completing the development and market launch phases for the second device, CardioMedive will be able to cover multiple areas from the healthcare system as the existing solutions cover either the diagnostic or the monitoring areas, but not both.”

(All photos courtesy of CardioMedive)

simona@romania-insider.com