GemaKor: through risks – to the market
Blood test
Galina Kostina, "Expert" No. 48-2012
Seventeen years of research – and unique diagnostic systems that evaluate blood clotting are ready for use in medicine. The GemaKor company entered the market with them in November.
From the moment when Fazli Ataullakhanov, a professor of the Department of Biophysics of the Faculty of Physics of Moscow State University, suddenly stumbled in mid-sentence, telling students about the mechanism of blood clotting, and seventeen years passed before the creation of a system that implements the idea that originated then. The "Expert" has been following the development of this story for five of them. In 2008, the article "45 microns per minute" was published (see No. 50) about scientific experiments that showed in detail how a blood clot grows. As a result of these studies, it became clear that a unique system for diagnosing blood clotting may be born. A team and investors were needed. Created under a scientific idea, the company has passed all stages of the classic development of innovative business. First, R&D was supported by the RFBR, at the time of entering the stage of creating test diagnostic devices – business angels, and finally, when a strategic investor was needed, Rusnano and Sberbank Capital (see "Innovators in harsh conditions", "Expert" No. 22 for 2010). Not everything went smoothly. There were risks and difficulties. And yet, a company with ready-made systems for the diagnosis of thrombodynamics enters the Russian market. There are more ambitious goals ahead – entering the world market with a capacity of a billion dollars and improving the method to expand the scope of application.
See how the blood clot growsWhen the professor of Moscow State University and the head of the Hematology Research Center of the Russian Academy of Medical Sciences Fazli Ataullakhanov came up with the brilliant idea to try to simulate the process of blood clotting on a laboratory table, he could not believe that no one had put such experiments up to now.
It was strange: if the pattern of blood clotting was generally known, then its small but very important details were not. And it wasn't just a whim to delve into the nuances: the fundamental details could tell how the coagulation systems work in a particular person. And they can work in different ways. In traditional medicine at that time there were tests that showed a good tendency to poor clotting – hemophilia, but there were no tests for a tendency to thrombosis. Although hemophilia is a rare disease, and thrombosis is common.
It is known that the blood clotting system reacts to the slightest damage to blood vessels. A powerful system unfolds a whole network of various factors that lead to the formation of a blood clot that seals a hole in the vessel. The start of the clotting process is carried out by the so-called tissue factor. It is found in all tissues except the one that lines the inner wall of the vessels (if it were there, the blood would clot constantly). When the vessel is damaged, the blood comes into contact with the tissue factor and activates the coagulation system. This triggers a cascade of reactions in which various factors of the system accelerate clotting. No one, however, guessed how the system knows at what point it needs to stop and how it happens. After all, if the process is not stopped, then all the blood in the body will curdle.
During the experiment, scientists grew fibroblasts (skin cells) on a special plate, on the surface of which there is a tissue factor. The plate was brought into contact with blood plasma (it contains numerous elements of the coagulation system) and watched as a blood clot grows. The whole process was filmed on a digital camera. Numerous tests and observations have shown an amazing picture: the same protein started the clotting system, and it also initiated the stopping of this process. But nature used a little trick: the initiation of stopping blood clotting occurred slower than the accelerating clotting process to give time for a blood clot to form. The research allowed us to describe the whole process in detail. Scientists realized that the important characteristics of the process – the time of the onset of growth, the growth rate and the size of the blood clot – allow differentiating not only hemophilia and thrombophilia, but also their various variations. And this makes it possible to offer different approaches in therapy.
Fazli Ataullakhanov attracted to his research not only colleagues – Vasily Sarbash, George Guria, Rimma Volkova, Elena Sinauridze, but also his graduate students and students – Sergey Karamzin, Igor Pivovarov, Olga Fadeeva, Mikhail Panteleev. They formed a multidisciplinary team of biologists, physicists, chemists, engineers, mathematicians.
And the angels appearedIn order to conduct experiments, scientists assembled a kind of homegrown device, which, according to Ataullakhanov, at first resembled a hut on chicken legs.
An amateur camera was attached to a platform with laboratory glasses. And the technological process itself was quite complicated, it was necessary to grow fibroblasts, so that after some manipulations it was possible to observe the growth of a blood clot. It is clear that this was suitable only for laboratory experiments, but by no means for the clinic. In improving the device, not only the knowledge of scientists was useful, but also the experience and base of the then graduate student Igor Pivovarov, who simultaneously worked as a director of a company that produces laser medical equipment.
Scientists have been preoccupied with finding money all the time. At the stage of scientific experiments, they were helped by the Russian Foundation for Basic Research (RFBR), but when the project began to go into practice, other investors were needed. According to the Western classics, at this moment business angels are connected to the project. In Russia at that time, angels were not crowded, but connections still helped to find two. Perhaps the decisive factors were the clarity of the project and its uniqueness: there were no such systems in the world. Maxim Avdeev and Andrey Khmelinin, for whom venture has become something of a hobby, gave money to create an initial version of diagnostic devices and software, issue some patents and prepare a business plan. Later, business angels joined the team of authors of the project. According to Igor Pivovarov (now CEO of GemaKor), it is at this stage that many scientific projects fail: "We need relatively little money – one hundred thousand dollars – and help in project management so that scientists can move on. I have known many cases when scientists either could not clearly state the essence of the project and its prospects, or did not want to share intellectual property rights, or could not create a team."
The first diagnostic devices were created and given for testing in several Russian laboratories, as well as in laboratories in the USA and France.
Meanwhile, the business angels' money was coming to an end, and the team needed to move on to a new, more capital-intensive stage – the creation of industrial samples of devices and tests, as well as clinical trials. As luck would have it, this moment coincided with the global financial crisis of 2008.
"Any revolutionary method that has no analogues in the world sooner or later becomes interesting to other scientific groups and companies,– explains Pivovarov. – And you either find money, move your project and get a good position in the market, because you have a head start, or you slowly crawl, they overtake you, leaving only the laurels of an honorary inventor."
A few Russian venture capitalists during the crisis were in no hurry to invest in young innovative companies. It remained to rely on the newly created state corporation "Rusnano". "There was practically no hope, however," says Igor Pivovarov. – We have heard that it is not easy to break into Rusnano with the project." Nevertheless, the team passed the expert council. However, it took almost another year and a half to coordinate all the details, create a new company for the project, write a completely new business plan, agree to a tight schedule and find a co-investor, which became Sberbank Capital. At this time, Igor Pivovarov and his company "Zhiva" also had to act as a business angel so that the project would not be slowed down: it was necessary to get results, refine the device.
Finally, in 2010, an agreement was signed with Rusnano, and the GemaKor company created for the project breathed more freely after receiving the first tranche.
Through risks to the marketThe total funding will amount to 640 million rubles.
This money is calculated for the first three years of the project's life. At the time of receiving the first tranche, business angels and team members spent approximately 9 million rubles. The investors' money was, in particular, to go to the creation of a complex mold for cuvettes, on which a nanocoating with a blood clotting activator is applied. Since the requirements for this consumable diagnostic material are high, the company has spent a lot of effort searching for the appropriate equipment and performers. It wasn't easy, there weren't any in Russia: they tried, but it didn't work out. So far, we have stopped at the fact that cuvettes are made under contract in Switzerland.
By the time the agreement with Rusnano was signed, the research part had not been finalized, and these are high risks for both the company and the investor. "When we did the scientific part, we used cells (fibroblasts) that were grown in culture, and they then activated clotting," says Fazli Ataullakhanov. – But for medicine, cells are very inconvenient, capricious. We needed to create a protein in a purified form that would have the same performance on the surface of plastic as a protein in a cell." Scientists learned how to make such a coating, but it was unstable and in some cases peeled off. In addition, these activators had a short life span – about a month. It was a serious task that was solved for almost a year and a half. But, fortunately, they made an ideal stable coating that can be stored for a long time. "There were several ideas," says Ataullakhanov, "and one of them worked. However, for this I had to go to the USA and ask my colleagues to work with their equipment for laser cleaning of plastic coatings." Then GemaKor acquired such a device for its production.
In two years, GemaKor has established small-scale production on leased areas. "We are not in a hurry with large production yet, otherwise it happens that innovators pour money into a huge factory, and then it turns out that the product does not find demand," says Igor Pivovarov. – We will move in stages. While we are starting to master the Russian market."
Until recently, diagnostic systems for the thrombodynamics test were supplied to research laboratories that conducted clinical studies. But the start of sales is marked: one system is sold. A dozen clinics have sent purchase requests. One diagnostic device costs 350 thousand rubles, one test costs 600 rubles.
Diagnostic laboratory system "Thrombodynamics Recorder T-2"
and a set of consumables for conducting research on 10 definitions
(images from the website of OOO "GemaKor" – VM)
The scope of use of such diagnostic systems is wide. "They are important in vascular surgery, cardiology, in intensive medicine, in any major operations after which anticoagulants are prescribed," says Ilya Serebriyskiy, head of the Clinical Research Department at GemaKor. – According to indications, antiplatelet agents and anticoagulants are prescribed after major operations, which prevent the formation of blood clots. But each person is different, and the differences in the coagulation system can be serious. After the test, the doctor is able to understand whether the therapy is adequate and adjust the treatment." These are obvious areas of application of diagnostic systems. In a good way, thrombodynamics should be measured in every polyclinic. The tendency to form blood clots can mean the risk of heart attacks and strokes in the future. And such a diagnosis is needed, if not all, then at least risk groups – men over fifty years old, hypertensive patients, diabetics, pregnant women.
So far, GemaKor is beginning to master the Russian market, but it is also preparing to enter the world market. "We continue to patent in different countries," says Igor Pivovarov. – Next year we will start clinical trials in Europe. If everything goes well, perhaps in a year we will be able to get a sales permit there." And the market for such tests in Europe and the USA is estimated at about a billion dollars. The company may have a good chance, since there are no such systems in the world yet.
The company has allocated a subsidiary project – the creation of diagnostic systems that make an analysis from whole blood, and not from plasma, as it is now, which will save time getting the result. This is important for the use of systems in extreme situations, for example, with extensive bleeding, when a decision must be made quickly. With this project, GemaKor became a resident of Skolkovo.
Portal "Eternal youth" http://vechnayamolodost.ru04.12.2012