29 January 2015

Quantum Cure = UHF + electrophoresis + local chemistry

Startup of the Year at Zelenograd Nanocenter: Lex Quantum – cancer treatment

Elena Panasenko, <url>Medicine and electronics together can do much more in the treatment of oncological diseases – this is the idea of the MIET graduate development team led by Alexey Modyanov.

Doctors were the first to express it: if local chemotherapy is applied simultaneously with electrophoresis and UHF heating for localized superficial (for example, skin) tumors, treatment will be much more effective, and there will be fewer side effects for the body than from toxic general "chemistry". Zelenograd electronics engineers took up the technical implementation of the idea, so in 2011 Lex Quantum appeared, which entered the TOP 10 biomedical startups in Russia in 2014.

"There are five people in our team," says Alexey Modyanov, CEO of the company. – At first, we developed the project with our own funds. I graduated from the faculty of ECT MIET, and a friend with whom we studied together invited me to this startup to develop electronics for a future device. At the beginning of our story, there was an almost accidental meeting with Professor Molokanov from the Smolensk State Medical Academy, who shared with us his thoughts about such a technique.

Its essence is to ensure the targeted delivery of chemotherapy drugs to the site of the tumor, then the patient's body practically does not receive harm from them. Usually, such medications cannot act locally, a person drinks them or they are injected into the blood, they accumulate in the body, while poisoning it – this is the reason for half of all the negative consequences in the treatment of cancer. With the new technique, the effect of chemotherapy greatly increases, and the need for subsequent radiotherapy almost disappears. To date, we have already developed the second version of the prototype device, passed its clinical trials – we conducted them for lip cancer, it was the most affordable option."

Technology: Quantum Cure = UHF + electrophoresis + Local chemistryThe treatment of tumors and metastases without surgery and general chemotherapy using the Lex Quantum method is more than 95% effective – clinical trials have proven this, out of 100 patients, only two had subsequent complications.

Sessions can be performed on an outpatient basis with local anesthesia, procedures have minimal effect on healthy tissues and practically cause no side effects. Such treatment can also be used in the maintenance therapy of patients in the terminal stages, when other methods are contraindicated.

"During clinical trials, patients received 30-40 sessions every two days, that is, the cure period was about 90 days; one session lasts about 40-60 minutes. Our goal is to heal in 5-7 sessions. – Modyanov answers journalists' questions and shows the device itself. – Now clinical trials have been conducted specifically for the technique, it has been approved by the Ministry of Health, we have received two patents of the Russian Federation, developed an early prototype of the device. We still have to complete it and go through the certification of the device for compliance with the methodology. The technology of creating medical equipment is quite a complicated thing, everything is conservative here, because the price of a mistake is a person's life. We plan to enter the domestic market with a ready-made technique and device for the treatment of lip cancer and, possibly, skin cancer in two to three years."

The device itself is a "clothespin" on the lip, a medical drug is dripped on its working surfaces. "There are electrodes on top that give UHF heating, closer is a special conductive thread that provides electrophoresis. That is, these are physiotherapy procedures and drug delivery at the same time," explains the main developer. – There are no analogues of the device and our technology yet: there are separate devices for UHF or for electrophoresis, but there are no combined ones."


General view of the device and one of its electrodes (1) in section: electrode chamber (2), electrode grid (3),
package with medication (4), copper electrode (5), terminals to the UHF generator and to the electric current source.

In the near future, the team plans to take the next step – to apply the technology to other types of tumors in soft tissues, not only superficial, but also deep. Invasively, by injecting the drug with needles through a local puncture, many common tumors can be treated today: breast cancer, lymph nodes, lungs, pancreas. The newest technique of this direction is irreversible electroporation, when the tumor is additionally destroyed by intense emissions of electricity. At the same time, healthy tissues are not damaged, and multi-channel needles with electrodes allow avoiding surgical incision.

"Since this is a new technology, a full cycle of clinical trials will take about five to seven years," Modyanov predicts. – Treatment of cancer of internal organs, in principle, is also possible. You just need to understand how to do it correctly from the point of view of medicine: where to put the electrodes, how to position them correctly, simulate how the processes in the tissues will proceed. To do this, we work closely with medical scientists. And not only in Russia – two of our guys moved to the USA some time ago and got in touch with the Hershey Medical Center, Pennsylvania [Milton S.Hershey Medical Center] – this is one of the largest medical institutes in the USA dealing with the problem of cancer. Weiss Hymer, a professor of biochemistry at the University of Pennsylvania, became interested in this development and helps us in working out the methodology. And recently we talked with colleagues who suggested that we transform our methodology for veterinary medicine, animal treatment. We are currently studying the market, from the point of view of commercialization, everything is much simpler on it – such a long and complex certification is not required, and at the same time we will get some kind of clinical base and a commercial product that will bring funds for the development of a startup."

Business: "We plan to work out a new technology for grants"Lex Quantum estimates the global medical market for cancer treatment equipment at about $ 1.5 billion – and they are going to enter it by selling their device not only in Russia.

Two years ago, the company began processing patents in the United States with expansion to the EU and BRICS countries.

"We also did this at our own expense, almost no one invests money in startups at an early stage, the risk is too high. – Recalls Modyanov. – We came to everyone and heard in response: "Okay, guys, when you have clinical trials, at least on animals, then we will allocate money to you"... The only money was brought then by the "BIT" contest [in 2012 – Zelenograd.ru ], it was 200 thousand rubles. Before the appearance of the right "salesman" in our team, it was difficult to invest. In addition, medical projects themselves are very expensive and long-term. And then I suggested one of my friends, Andrey Lomonosov, to do this, he became interested and became our commercial director."

The startup has an English-language website focused on promotion abroad: "In the USA, 36 thousand people a year suffer from lip cancer, conventional radiotherapy and surgery take six weeks and more than 30 sessions, and the results in the form of pronounced side effects require additional treatment. Our technique allows you to reduce the dose of radiotherapy by up to 50%, significantly reducing the duration of treatment and reducing side effects and scarring of tissue. Everyone wins: patients' health improves and discomfort decreases, clinics increase efficiency, insurance companies and the government save costs," the project description emphasizes.

The logic of the benefits for the state budget, estimated at hundreds of millions of dollars of annual additional health care costs, the logic of the state significance of the new development – all this is relevant for the English-speaking world. Will the startup and its technology be in demand in Russia?

Since 2013 Lex Quantum has been a resident of Skolkovo and Zelenograd Nanocenter. In 2014, the team clearly declared itself: it won the Startup Village InBioMed competition and received a grant of 1.7 million rubles from the Bortnik Foundation, reached the finals of other high–tech competitions - Generation S (in the Biotechnological track), OncoBioMed. The project entered the TOP 10 biomedical startups in Russia in 2014, according to the Russian Startup Rating.

"As a resident of Skolkovo, we enjoy quite serious tax benefits. – Says Modyanov. – Now we are entering the Skolkovo grants, a mini-grant and a large grant, it can bring about another 5 million rubles. There are a lot of people who want to receive such grants, you need to present yourself correctly, interest people, show commercial effect and demonstrate that the team understands how to achieve it. We plan to use the money of the Bortnik and Skolkovo Foundation to work out a new technology with multi-channel needles and conduct clinical trials that are capacious in finance. In addition, we already have interested investors with whom we are negotiating."

In the Zelenograd nanocenter, the startup received premises, co-financing, there is an opportunity to use a biochemical laboratory. "ZNTC acts as a smart investor, providing not only commercial support to the project, but also technological consulting and supplementing the project with its R&D competencies in participating in developments. – Comments Oksana Shaimardanova, Head of Marketing and Advertising Department of Zelenograd Nanocenter. – Investments in the project are attracted from several parties, including Skolkovo-Biomed and our nanocenter, simultaneous financing has been agreed to form the maximum investment leverage."

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