Bracelet for stopping bleeding: Russian development is 1.5 times cheaper than foreign analogues

Heart attack surgery is performed by an endovascular surgeon through the radial artery. After surgery, every tenth patient has this artery closed, which means that in the future it will not be possible to carry out the necessary procedure through it, and a new operation will have to be performed through another arm or leg, which significantly increases the risk of bleeding and mortality. The Newman bracelet is an innovative technology that allows you to prevent the closure of the artery and preserve its functionality.

In 2022, the development of Dmitry Ognerubov, Candidate of Medical Sciences and cardiac surgeon, doctor of the Department of X–ray Endovascular Methods of Diagnosis and Treatment of the Federal State Budgetary Institution “NMIC of Cardiology” of the Ministry of Health of the Russian Federation, associate professor of the Department of Labor and Social Policy of the Institute of Public Administration and Management (IGSU) of the RANEPA became the winner of a major technological competition “Innovator of Moscow”. The monetary award made it possible to launch the next stage of registration of a medical device, namely toxicological testing of materials. This brought us closer to the future registration of the product in the territory of the Eurasian Economic Union and the first sales.

In an interview with our portal, he spoke in more detail about his development and shared his impressions of the competition.

How long did it take from the idea to the appearance of the first real samples of the bracelet device?

– Three years have passed from the appearance of the idea to the development of the first commercially available sample. Studying the literature while writing my dissertation, I realized that the existing radial artery closure mechanism in Russia and in the world is not ideal and it can be significantly improved. I talked with my engineer brother, Egor Ognerubov, who now works in the project team, about a possible solution. Together we have developed a prototype based on the hydrodynamic effect. In the early stages, I assembled the bracelet by hand, sewed it with threads. Later, we found companies that were able to create a device based on our 3D model made of polyurethane with an air cushion.

What is the Newman device?

– Newman is a polyurethane bracelet with Velcro on the sides for fixation on the patient’s wrist. There are two airbags on the device that inflate through valves that we have modified. We looked at how the valves were made by competitors, and developed a more convenient option with a Luer lock – this is a lock on the syringe that does not allow it to detach. The closest competitors, on the contrary, have a device that disconnects. In my medical opinion, this is not convenient. In addition, there are restrictions on the syringes used, whereas our device is suitable for all syringes. One of the airbags squeezes the radial artery, where the pulse is felt on the arm, and the other – the ulnar one. Our bracelet is transparent so that the doctor can see if there is bleeding. There is also a dot on the device that shows the place of greatest pressure so that the doctor can correctly position the bracelet on his arm.

Does Newman have competitors in the Russian and foreign markets? How is Newman superior to its competitors?

– Our two main competitors are devices from Japan and America. A competitor from Japan has a design consisting of one air cushion squeezing only one artery, and our bracelet squeezes two using two pillows. The American equivalent is a device with a different mechanism of action – in fact, it is a screw that mechanically presses on the radial artery. It should not be used for more than three hours, because the patient has pain. More recently, two Chinese analogues of the Japanese product have entered the market. As I said before, we have a technological advantage over them in the form of two airbags. Thanks to this, Newman surpasses its competitors in efficiency and price. Newman is 1.5 times cheaper than analogues from Japan and the USA.

At what stage is the project now?

– For the last two years, our project has been undergoing registration procedures. We want to start clinical trials with the N.V. Sklifosovsky Research Institute of Emergency Medicine, the I.V. Davydovsky, S.S. Yudin and V.V. Veresaev city clinical Hospitals as soon as possible, but this requires completing technical tests, which are mandatory for obtaining certification and registration certificate. It seemed to us that it would be fast, but the process was delayed. We also plan to receive support from the Moscow Innovation Agency in the amount of two million rubles to conduct a pilot at the L.A. Vorokhobov City Clinical Hospital No. 67. Despite the fact that we have pre-orders, we cannot carry them out without registration. We also plan to move all production to Moscow within three years, but this requires starting sales of the device. So far, Newman is partially manufactured abroad, since we do not have the funds to purchase expensive equipment and localize production.

Recently, colleagues from Mexico contacted us and asked us to send some samples. They want to sell our product in their country under their own brand. To do this, we need to obtain an international patent in Mexico, for which we plan to use the help of the Moscow Innovation Cluster for patenting abroad.

What advice can you give to doctors who are just about to launch their project?

– I think it is necessary to try to launch projects and not be afraid. Moscow makes very detailed, truthful, understandable and step-by-step contests that will help you go all the way from the idea to scaling and even entering foreign markets. There is no need to be afraid of something new, you just need to go, realizing that the city will support you at every stage by providing world-class expertise. This was the case with us when we decided to participate in the Moscow Innovator competition. I know that applications for a new cycle of the award are now open, to participate you need to fill out a questionnaire in detail, I suggest that everyone who is ready to declare their developments, do not delay and already start filling out an application. You will not regret participating, even if you fail to win a cash prize.

My mentor at one of the competitions told me: “There is no need to put the question squarely: medicine or entrepreneurship. It is necessary to put the union “and” and combine”.