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In view of keen attention to the innovative development of TOR device by JSC Concern GRANIT in connection with the comments of experts who try to evaluate the device and the method underlying its creation, we offer answers to the most common questions and critical remarks, preserving the vocabulary of the commentators.
It should be noted that before making statements in the public space, none of the experts expressed a desire to familiarize themselves with the developer’s documentation, they did not request any clarification about the essence of the method.
JSC Concern GRANIT reserves the right to demand from the authors of early publications the compensation stipulated by the law the Russian Federation.
IgM, PCR and «negative values»
Some of experts, who are not specialists in physics, have obtained scientific title of Cand. Sc. Biology, and even “former graduate students”, were the first to comment on it, already on the day of the announcement of the TOR device, i.e. October 4, 2021. It was on this day that Deputy Minister of Industry and Trade Vasily Shpak announced the new Russian development at the Microelectronics 2021 forum.
The major criticism was the statement that a blood test for IgM antibodies showed a «negative result» as a result of the use of the TOR device. Moreover, the legitimacy of the use of the phrase “negative meaning” was also questioned — the vocabulary of the scientific discussion of young experts tended to be profanity.
Nevertheless, Federal Service on Surveillance in Health Care and Social Development of the Russian Federation has a different position regarding the use of the term «negative IgM»:
«If a person shows a positive result for the first time after negative IgM during a previous study upon regular screening examinations at the workplace, this is an occasion to undergo in-depth examination for COVID-19 symptoms.»
Source
Using this link, you can find the answer to the question of whether IgM is a marker of the acute phase of COVID-19:
“Indeed, IgM immunoglobulins are considered a marker of the acute course of an infectious disease. Usually, with a classical immune response, IgM have a short lifetime, their concentration in the blood quickly decreases with the increase of the amount of IgG. But in some people, COVID-19 can be detected in the blood for several months. According to some reports, it may be observed up to six months. «
Thus, the comments of experts regarding the impossibility of a scientific description of the effect of TOR device as a «negative value of IgM» are incorrect. The form of their presentation («it means that the radiation destroys immune cells» and «negative titers of immunoglobulin M. It is like having a negative amount dumplings in the fridge») suggests low level of knowledge of the speakers in the field of commenting and/or their engagement. It is possible to agree with the authors of such statements only in one of their conclusions: “Russian specialists were overtaken by a crisis of scientific reputations. The low level of qualifications of some people working in the field of science and medicine …» leads to the need to free the expert field from amateurs who have arrogated to themselves the right to judge in public space what is science, what is pseudo-science.This resembles the idle talks.
When using the TOR device, even before the start of clinical studies of its effectiveness in suppressing the pathogen specifically COVID-19, the developer noted a decrease of IgM antibodies up to «negative values» that is, zero (0) according to official interpretation of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare, in persons with confirmed cases of COVID-19. This means the following: the acute phase of the coronavirus infection passed faster in those who used the TOR device, while IgG antibodies, protective ones, were produced to normal values for the average course of the disease.
Considering the results of the clinical trials, their verification by Federal Service on Surveillance in Health Care and Social Development of the Russian Federation, which ended with issue of Registration Certificate (RC) for a medical device on the TOR device, JSC Concern GRANIT adheres to the final wording reflecting the test results: due to a remote non-invasive effect of the TOR device on hospitalized patients with moderate severity of the course of COVID-19 for 4 days ( 2 hours a day), a negative value of PCR tests was noted in 87% of all patients on the fifth consecutive day. Viral load indices decreased five or more times in comparison with the groups of patients who were not treated with TOR device: control and placebo.
How and on what basis TOR device was used before issue of of registration certificate by Federal Service on Surveillance in Health Care and Social Development of the Russian Federation
The safety of the TOR device and its antiviral efficacy were established during all the necessary technical tests and were initially confirmed by Federal Service on Surveillance in Health Care and Social Development of the Russian Federation in November 2020. We received documents allowing the use of TOR device as a sanitary mean for air purification. The device can be used without restrictions, in the presence of people, in residential, industrial premises, in medical institutions and outdoors.
Considering already confirmed safety, the developer has quickly accumulated its own statistics, which makes it possible to judge the effectiveness of the device TOR and TOR-M, which is an individual device with the same electromagnetic spectrum, in relieving course of COVID-19. Everyone who used TOR from the first days of the onset of symptoms had a mild illness without the need for hospitalization. Pprophylactic effect was also observed.
In November 2020, TOR device was also certified in accordance with the EurAsEC rules.
Thus, in November 2020, the TOR device received the documents necessary and sufficient for its unhindered and legal use.
To fix by the authorized department, i.e. Federal Service on Surveillance in Health Care and Social Development of the Russian Federation, at the official level, the causal relationship between the use of the TOR device as a sanitary mean and the observed not only preventive action, but also, above all, the relief of the course of COVID-19 in patients, the developer filed documents for obtaining a permit for clinical trials in the established order.
«Embezzlement». «Any permits can be bought in the Russian Federation»
JSC Concern GRANIT did not use any form of budgetary funding in the development, design and manufacture of the TOR device. All stages of creation, technical expertise and research were financed from the own funds of the company and its shareholders.
TOR device is a completely domestic development, any foreign investors did not pay for its invention or release at any of the stages. The TOR device does not depend on the import of any parts used in its production.
Interest in the device from foreign countries exists and persists throughout the entire process of technical testing and clinical trials. Concern GRANIT rejected several offers to purchase the technology itself, keeping the main priority, i.e. the development was carried out in the interests, first of all, of the Russian Federation.
The process of approving the documentation in order to organize clinical trials of the TOR device as a medical device took several months. The design of the study and all accompanying documentation was examined by the Federal Service for Surveillance in Healthcare of the Russian Federation, which instructed the developer to include in the study a record number of participants for medical devices of «hazard class» 2a (for more details, see clause 4), the number of participants — at least 225 people, having determined that all of them should have a clear clinical status at the time of hospital stay due to a confirmed diagnosis of COVID-19: the moderate severity of the course of coronavirus infection COVID-19.
Upon receipt of the results of the study, which lasted more than five months in total, Federal Service on Surveillance in Health Care and Social Development of the Russian Federation subjected the obtained results to a critical analysis, verification, including with an on-site inspection in Samara i.e. Samara State Medical University of the Ministry of Health of the Russian Federation, in whose clinics the TOR device was tested …
Thus, Concern GRANIT JSC declares that any accusations aimed at discrediting the obtained results of clinical trials on the basis of “corruption component” or “bribery” are libel, with the corresponding consequences: the developer reserves the right to demand application against persons disseminating such information, sanctions stipulated by law of the Russian Federation.
Safety of TOR device
Based on the results of a long-term technical examination carried out by the Federal State Budgetary Institution VNIIIMT of Federal Service for Surveillance in Healthcare of the Russian Federation (June — September 2020), TOR device was recognized as complying with the safety criteria with the assignment of a potential risk class — 2a.
The decision to assign a potential risk class above 1 to a non-invasive remote device, the technical parameters of which were recognized as undoubtedly safe, were dictated solely by its novelty: in the absence of analogues, the controlling authority preferred to show increased vigilance. The developer did not dispute the upgrade of the class that was not provided for by the regulatory framework, although this meant the need to enter full-scale clinical trials with delay in starting the use of the TOR device as a safe and, according to the developer’s conviction, an effective tool in the general fight against a new disease.
The regulations with respect to assigning classes of potential risk to a medical device — Order of the Ministry of Health of the Russian Federation dated 06.06.2012 in the current edition –
Order of the Ministry of Health of the Russian Federation dated 06.06.2012 in the current edition
It should be noted that TOR device according to the class even assigned with a reservation about the novelty of the potential risk (2a) is safer, for example, an electrocardiograph — this device has a higher risk class — 2b.
Thus, according to the results of an official technical examination in an authorized institution of the Federal Service for Surveillance in Healthcare of the Russian Federation, the TOR device was recognized as safe.
For the final confirmation of the conclusions of the technical expertise and the objective establishment of the declared by the developer the effectiveness of the TOR device in suppressing the causative agent of COVID-19, clinical trials began in January 2021.
Clinical trials and their results
Clinical studies on the basis and in accordance with the permits of the Federal Service for Surveillance in Healthcare of the Russian Federation took place on the basis of one of the oldest and most reputable institutions, i.e. clinics of the Samara State Medical University of the Ministry of Health of Russia. Information about their conduct was published in accordance with the established procedure in the official Register of Clinical Trials, which is maintained by Federal Service for Surveillance in Healthcare of the Russian Federation.
As a result, 236 people took part in the studies, providing voluntary informed consent. The study was carried out following a «blind, randomized, placebo-controlled» approach.
For each participant, an individual registration card of 37 pages was drawn up with fixing the main clinical parameters: body temperature, respiratory rate, heart rate, blood pressure, blood markers, ECG, etc. — in accordance with the approved design and research protocol for 28 days observations, during which monitoring was carried out at 7 (seven) visits of researchers with control of the clinical condition of patients. PCR testing was carried out on the first (all 236 participants were PCR-positive), on the fifth and fourteenth days of observation.
The results of clinical studies carried out in the clinics of the Samara State Medical University of the Ministry of Health of Russia have confirmed the safety of the TOR device and its clinical efficacy, a quote from the researcher’s: “obtained results of comparative assessment of the efficiency of medical device for non-invasive electromagnetic therapy TOR in treatment of COVID-19 made it possible to establish reliable advantages of its use in relation to patient mortality rates, the timing of virus elimination, with a confirmed improvement in the clinical status according to the WHO scale, respiration rate and SpO2 indices, and a significant decrease in the level of inflammation markers ”.
All participants of the study received adequate, according to the indications, treatment of the disease in accordance with the medical protocol.
All participants of the study received adequate, according to the indications, treatment of the disease in accordance with the medical protocol.
Attachment to Trial Protocol established the following: “Based on the clinical trials conducted, it can be argued that the medical device -“ The device of non-invasive electromagnetic therapy TOR according to BEMP.941523.001TU ”meets the declared characteristics, is convenient to use, has sufficient efficiency and safety for use according to intended to accelerate the elimination (elimination) of the SARS-CoV-2 virus from the nasopharynx of patients diagnosed with coronavirus infection, it meets the requirements of the manufacturer’s regulatory, technical and operational documentation. «
In the course of the research, it was established: due to remote non-invasive effect of the TOR device on hospitalized patients with moderate severity of the course of COVID-19 for 4 days (2 hours a day), a negative value of PCR tests was noted in 87% of all patients on the fifth consecutive day. Viral load indices decreased five or more times in comparison with the groups of patients who were not treated with TOR device: control and placebo. The fact that this criterion is one of the key is indisputable: everyone knows that the pathogen is not killed by drugs, but only by the immune cells of the person himself, and our method facilitates this task by inhibiting the replication of the causative agent of the disease, helping the immune system to form an adequate response without «overheating» which is a cytokine storm.
Considering such a significant difference between the group of subjects and the other two groups, experienced doctors, tired of the tense struggle with an invisible and insidious enemy, ask developer only one question: «What are you doing with the pathogen?»
Thus, according to the results of long-term and representative clinical studies, the safety of the «TOP» device was confirmed, its effectiveness in accelerating the elimination (death) of the pathogen COVID-19 with an improvement in the clinical status of patients included in the group that underwent the procedure of non-invasive remote exposure to the electromagnetic spectrum of the TOR device, is proved
“What are you doing with the pathogen?» About some aspects of the technology of TOR device
Considering objectively proven and additionally confirmed safety and established efficiency of TOR device, JSC Concern GRANIT reserves the right not to disclose all technological aspects of creation of an innovative device, developed, as already noted, without any third-party funding.
In response to a number of critical remarks from experts in the field of technology, namely physicists, who expressed their opinion on the same basis and in the absence of any requests for comments from the developer, we hereby inform:the specialists of the Scientific Center of the GRANIT Concern share the opinion that (quote) — “since RNA molecule itself does not emit anything, it is impossible to isolate its spectrum. In order for a molecule to emit something, it must first be excited, for example, with a laser … «
Exactly so: by the emission of the spectrum upon receipt of a certain impulse by the «RNA molecule», the desired spectrum was isolated. The laser was not used.in order to confirm the safety and effectiveness of the TOR device, all technical and clinical trials provided for by regulation (Russian regulation and EurAsEC rules) have been carried out, and therefore the developer does not find reason to believe (quote) that «it is strange that there is not a single link in the general access to scientific articles in leading journals about in vivo experiments (on living tissue), ” and this is exactly what the experts write. There is no need for separate in vivo studies with the publication of results in specialized (medical) journals, in fact, clinical studies have already taken place in a hospital with involvement of 236 people. The principles of the method (in terms of the effect of the electromagnetic spectrum on ionic solutions, which include both blood and lymph) are described in a scientific article published in the international natural science journal Polymers.
Reada new stage in the study of the effect of high-frequency electromagnetic fields on living tissues began due to the discovery of bubstons in 2016, as well as the finding of a way to simulate the processes occurring on the cell surface. Bubstones (from the English Bubbles Stabilized by Ions) were called stable gas nanobubbles with sizes from several tens to hundreds of nanometers, found in aqueous ionic solutions. To create stably repeating real conditions for the functioning of the membrane of a living cell, polymer analogs have been developed. A striking example is the Nafion ™ membrane, whose structure is as close as possible to the natural membrane of a living cell. In particular, the polymer fibers («filaments”) on the surface of Nafion ™ are structurally similar to the glycocalyx, a supramembrane complex that is involved in the formation of contacts between cells.
During the experiments, we used Ringer’s solution, which is widely used in medicine, including as a means of temporary replenishment of the circulating blood volume. The membrane was placed in a solution, which was exposed to an electromagnetic field. In this case, a change in the ionic conductivity of the membrane was recorded. Exposing a solution to an electromagnetic field leads to the formation of standing waves in clusters of bubstons. These clusters are continuously formed in the circulatory system and reach the cell membranes in every organ of the human body. In the course of the experiments, a hypothesis was put forward and subsequently confirmed, explaining the effect of the electromagnetic field on the cells of living systems. Conductive particles, which include pathogens, interact with electromagnetic radiation when approaching close to from bubston clusters and can change their electromagnetic characteristics at the moment of exposure.
The altered characteristics affect the permeability of the cell membrane to the pathogen. We called method of influencing the electromagnetic characteristics of the pathogen «noise pollution». This disclosed effect, along with the duration of its exposure revealed in ionic solutions studied and described in the article (Polymers) that allows us to speak about the effectiveness of the TOR devices in terms of disease prevention. Vasily Shpak, Deputy Minister of Industry and Trade of the Russian Federation, also considered it possible to declare this on October 4, 2021.
What is the role of Ministry of Industry and Trade of the Russian Federation?
Throughout the entire path: from idea (February 2020) to implementation (launch of serial production of the TOR device in November 2020) and receipt of Registration Certificate for TOR as a medical device (September 2021), we informed the state authorities about the development and first successes.
In the structure of the Ministry of Industry and Trade of the Russian Federation, there is a department of the radio-electronic industry.
The competence of this department also includes issues related to the release of new medical equipment — this division of the Ministry of Industry and Trade of the Russian Federation is in interdepartmental interaction with the Federal Service for Surveillance in Healthcare of the Russian Federation.
As a result of the self-isolation measures introduced in the spring of 2020, the transfer of enterprises, including industrial ones, to remote work and even their partial shutdown, it became obvious that the Russian economy could not bear a second such shock.
The Ministry of Industry and Trade of the Russian Federation took with great interest the innovative development of the Scientific Center of the Concern GRANIT, supported technical and clinical trials at the stage of passing lengthy and thorough procedures, therefore it became quite natural to announce the latest domestic development by the Ministry of Industry and Trade of the Russian Federation within the framework of the thematic forum «Microelectronics 2021», already upon receipt of the Registration Certificate for the device TOR as a medical device from Federal Service for Surveillance in Healthcare of the Russian Federation in September 23, 2021
Criticism of Academician N.D. Devyatkov
The most unpleasant aspect of the reaction of the «expert community» to the new development of JSC «Concern GRANIT» for us was the indiscriminate criticism of one of the most significant scientists in the country in the field of military and medical electronics, i.e. academician Nikolai Dmitrievich Devyatkov (1907-2001), and those who did not do for domestic science even a fraction of what Academician Devyatkov, recognized by the world scientific community as the founder of medical electronics, did.
In the early 1960s, the first samples of electrical equipment appeared that made it possible to create high-frequency electromagnetic pulses, which immediately found application among scientists, allowing them to begin a series of experiments.
Our country was in the technical forefront of this new field of science. Already in 1965, Academician Devyatkov put forward the idea of a specific effect of high-frequency waves on living organisms and systems. In 1973, Devyatkov made a presentation at a session of the Academy of Sciences, in which he announced the results that aroused keen interest in academic circles. The academician and his group received comprehensive support in the form of state funding for new research programs, including for medical purposes.
The programs began in the 70s and continued until the 90s of the last century (when, for known reasons, scientific developments were practically frozen). As a result of the experiments, a number of hypotheses were put forward to explain the biophysical mechanisms of the effect of high-frequency electromagnetic generators on biological systems.
Academician N. D. Devyatkov and his associates laid the foundations for new methods of non-drug therapy.
Skeptics who continue to doubt the safety of the electromagnetic method can be helped by studying its application in order to suppress tumor processes. And we are not talking about «heating tissues» for a long time already. The greatest successes have been achieved by Japanese scientists. Research is underway in Russia, and there are some inspiring results. There is remarkable scientific article of the Rostov Research Institute of Oncology of the Ministry of Health of the Russian Federation, published in 2019. Its author, Doctor of Biological Sciences, Professor Elena Franceants, in particular, reports on the prerequisites for the use of electromagnetic effects on the permeability of the membranes of tumor cells, which leads to a better assimilation of chemotherapy drugs (which naturally results in decrease in doses and the level of general intoxication of the body), enhances the antitumor effect. Moreover, the article describes the enhancement of the analgesic effect when using electromagnetic therapy.
JSC Concern GRANIT confirms that the works of Academician N.D. Devyatkov, has formed the basis, on which, thanks to the modern level of technological development, it was possible to create an effective and safe non-drug therapy in cases when the usual medical methods of treatment no longer give the expected results, and the development of the pandemic process in the world continues, despite all efforts and means to contain it by conventional methods.
Implementation
We count on the widespread use of the new technology for suppressing COVID-19 in the Russian Federation and have already launched serial production of TOR devices.
We expect that our development will allow Russian citizens to feel additional protection in the face of current and new challenges. Having created the TOR device, team of JSC Concern GRANIT and many people who have applied the method over the past 11 months after the first certification of the TOR device have gained a sense of security.
According to the tradition that has developed over the past thirty years, not without the help of representatives of «expert community» playing a certain role in the trend towards «brain drain» and technology outside the country, which has intensified since 1998, thanks to the activities of the «Commission on Pseudoscience», we are used to that everything worthwhile comes from outside, that the Russian economy, scientific thought, and technological capabilities should lag further behind “developed countries”.
We have received and are receiving many grateful responses. Now, at the end of a long period of work and the registration of its results, we expect that the TOR device, which has no analogues in the world, will find application, first of all, in the Russian Federation.
