ROBOTIC SURGERY PARA-MEDICAL PROJECT "ROBOT NICK PIROGOV"

The main theme of the project is the multifunctional manipulator "Robot Nick Pirogov".
The main details - EK300-M coagulator and a line of welding tools for welding small diameter vessels and soft tissues are developed in Ukraine. The project team is ready to transfer the production and assembly of the main parts to Indian tool factories, to provide control over the manufacture and assembly, as well as the training of specialists (surgeons) for work. Control and documentary support from the Ukrainian side will be provided. In case of your interest, we are ready to organize a presentation of the main parts, to carry out documentary support of the project. All this can be done in Ukraine (Kiev-Odessa) and after signing the contract documents to organize a wide presentation in India, where you can attract interested parties to create a Financial Insurance Pool.

During the period of the Afghan military company, working in Odessa and the Moscow
Military Hospital named Burdenko one-stage entry of a large number of wounded with polytrauma, all hospital surgeons performed cavitary and other operations for several days, trepanation of the skull, as well as organ transplantation, limb suturing. After such "peak" operational, and detailed stories of military surgeons of the Second World War, it was decided to create a robotic operating unit.
A series of tools for sewing while open and closed (laparoscopic) operations was developed, which makes it possible to create a robotic surgical block. The program was approved by a city surgeon in Odessa. For its implementation, 200 thousand Soviet rubles were allocated, orders were placed at the factories "KINAP", "PRODMASH" and "Radial drilling machines". A prototype was made. But in 1991 with the collapse of the USSR and the withdrawal of troops from Afghanistan, the topic was closed.
Today, with the advent of new innovative technologies, at the factory “Instrument-Service Plus” according to my Patents I have made an experimental and then the working instrument for welding end-to-end vessels. With the help of a welding machine of firm "Svarmed", pre-clinical studies were conducted, which showed the effectiveness of welding end-to-end live tissues.

The Investment Project consists from 4 stages:
1. The improvement/enhancement of the coagulator EK300-M (SVARMED company)
2. Production of the welding instrument tools according to the schemes of Professor, Doctor of Medicine Borodulin Sergey Dmitrievich, director of company AMID & PS (Know-How)
The device is intended to be produced at instrumental factories in India, where would be held certification, standardization, patent supply for the whole number of tools.
The tool could be used in complete to improved coagulator EK300-M (SVARMED)
The welding complex (coagulator + tools) could be used offline (separately) before assembling the Robot.
3. For this purposed our specialists will provide the education of the Indian surgeons for work.
The productions will be supplied to Indian market and third countries, where Investor or Financial Insurance Pool could get the profit, which will be narrowed for the third stage of the Project - assembling the Robot from the parts which are produced from other factories in Asia/Europe/America.
4. The Program Software for the normal operation of the robot. India is the leading country in the world in respect to IT technologies that procedure could be done by Indian specialists.

Initiator of the whole Project - is Doctor of Medicine - Borodulin Sergey Dmitrievich.
Documental support for the Project, control for the production, education of the surgeons and others - would be held by him. After table meeting in Kiev, signing the contractual documents for the ownership, proprietary and value calculation of the Project, the working team is ready to visit India for the organization the working process, presentation of the Project among the interested parties via mass media, discussion marketing researches. There would be established in India a lawful structure, which will cooperate with Investor, hold, execute the Project.

Commercial annotation for EK-300M electro-coagulator
1. Distinctive features among analogues (ERBE, BOVA, Covidien, MARTIN, etc.):
The generator was built especially for the bipolar (most secure) effect on the tissue, which made it possible to automatically and semi-automatically adjust the power level for each specific application.
The generator allows in the bipolar mode to perform the dissection of large arrays of tissue with a reliable hemostatic effect of the vessels (by stopping capillary and small-vascular bleeding, with a diameter of up to 1-2 mm)
The generator has a patented automatic mode that allows, without human intervention, to weld intestinal vessels and other tissues and organs, and also to close the lumen of veins in the treatment of varicose disease of the lower extremities by analogy with laser or RF ablation.
all this leads to a reduction in the cost of the operation by saving clips and suture material - by 4-5 times; reduce the duration of the operation - by 30-40%; blood loss - 2-3 times

2. Advantages:
Compact and light weight
Intuitive interface and mode settings
Fully replicable technology used for most operations. Available after surgeon training - as part of a one-day program.
Development of the concept of the device and the automatic mode occurred in conjunction with the Institute of Electric Welding by E.O. Paton in 2007-2008
Since 2016, the development is 100% owned and manufactured by SVARMED
The production of modern bipolar instrument for open operations has been adjusted
Compatible with most bipolar laparoscopic instruments from other manufacturers
The proposed video materials provide a visual representation of the versatility of the automatic mode (the welding technology used), which allows us to expand the scope of application of the devices in surgery - even for certain areas.

Business oriented:
Profit-oriented model: allows you to form the concept of development and changes in the apparatus every 3 years
Production is certified according to ISO 13485, a quality management system has been implemented
The product is certified in Ukraine according to most requirements of European standards for electromagnetic and radio frequency compatibility and safety
The device does not contain a large number of components and can be optimized for an assembly of 15-20 nodes
Ukraine has an established network of interaction with key surgeons, which allows for training within the framework of thematic conferences and master classes
SVARMED is a partner of the veterinary faculty of the agrarian agricultural academy in the city Belaya Tserkov, which allows efficiently to test the novelties and refinement of regimes in an experiment on rabbits or pigs, efficiently and in a short time

Offers to the Investor:
SVARMED company is interested in scaling up/multiplication the business by opening subsidiaries and joint ventures abroad according to one of the proposed schemes; transfer of license for SKD assembly and production on the Investor’s territory

Joint-Venture means
- Availability own or rented places – from 100 Sq. Meter
- The availability of electronic equipment worth from $ 40,000
- The presence of personnel (8 people), of which at least 4 narrow-profile specialists (quality management system manager, electronics engineer, adjuster, process engineer)
The company is ready to provide its KNOW-HOW to launch a new business model
The company is ready to train specialists of the joint company - both technical and medical profile, including, and - for product certification in the Investor’s territory
The company is ready to take part in a product modernization project with the goal of jointly launching a new (improved) product of the EKR-300 generator in Ukraine and in the investor’s territory.

Investment Project:
Welding of vessels of different diameter: end-to-end, side-to-side, end to side

The conditions for receiving investments:
- All the participants take a share in the distribution of profits from the activities of the established Joint-Venture in accordance with the investment agreement.
- Investors appeared first (at the stage of creation of the enterprise), receive the most favorable conditions for investment (in the ratio of invested and received volumes of enterprise capitalization)
- Manufacturing Company "SVARMED" Ltd. is a distributor of investment and co-founder of the new.
The strategy of the new company is expected to use the mini model of preparing and appearing on the market the EC-300M equipment - product of base production enterprise LLC "SVARMED".

Description of the product and its competitive advantages:
The product will allow to replace the process of crosslinking/stitching vessels (duration 15 minutes) -for their welding (duration 1 min.)
Man-made disasters, natural disasters, modern weapons, etc. cause Poly-trauma for person which is requiring a medical emergency. This requires creating new methods, guidelines and appropriate technical equipment of modern operating. This will provide emergency, emergency medical service in pitching, vibration, and eventually in weightlessness.
There is received the active instrument model (prof. Borodulin SD) for welding vessels end-to-end by using EC-300M complex ("SVARMED Ltd.)
The tests have shown that the completion of automatic welding mode is not required
The modernization of the complex will be in increasing the number of independent output devices for simultaneous operation by several surgeons; the creation of an ergonomic device’s body and connectors.
There are developed two lines of welding tools (closed – for laparoscopic and open – for transplantation); there are existing patents on that.
The welding tool has a clamping shape, the ends of which are provided with the working device "lock" with help of which the vessels are fixed before welding. In the center of fixing there is a matrix which is formed as a tubular body, while the one of edge coil turns to a linear segment. The fixing elements is made of a dielectric, face edge of the retainer in place of contact with the edge of the surgical wound, are provided with the welding electrodes. After welding vessels end-to-end, the matrix is removed from the vessel lumen.
Laparoscopic and endoscopic surgeries are provided with additional technical tools to ensure an efficient implementation of this type of online help.
Welding tools, which are used for open surgery, including organ transplantation, have their own distinctive characteristics. A welding tool consists of two halves, which allows two surgeons to work at a distance from each other near each part of the connective tissue. This model of interaction between surgeons the most suitable in emergency and especially difficult situations, as both surgical teams working in parallel, one surgical team records and marks the group of blood vessels of the distal half of the body, while the other captures a proximal group of blood vessels. Saving time in this case is 150% or more
After fixation and markings vessels, halves of welding tools are joined and the surgeon by pressing the pedal activates the generator and the tool is energized. As a result, through the tissue begins to flow the modulated current whose magnitude and the duration is automatically set by the microcontroller, which is part of the upgraded control system of device EC-300M. The welding process is considered completed, if the visual inspection, tension at break - vessels leak is not broken.
The versatility of the line welding tools for open and closed operations is - that the edge clamps of vessels are created removable and have different diameters from 2mm to 15mm. This makes it possible during operation without leaving the surgical field and disconnecting welding tools on the welding machine, to replace the welding work catches and continue welding of vessels of different diameters.

Business concept:
- Participation in exhibition projects in Dubai. Attracting investors, establishment of a joint multidisciplinary research and production company in one or more of the free economic zones, the selection of the primary staff
- Development of design and product technical documentation (the upgraded device with 2 or more outputs, and toolbars); preparation and submission of an application for patenting in accordance with the requirements of international law.
- Production of the current model and carrying out pre-production testing.
- Certification in Ukraine.
- Co-investors Attraction, the formation of investment on the principle of "insurance pool"
- Search for representative organizations in the United States, China, European Union; obtaining international patents, preparation for certification in the European area, to obtain the CE-mark / FDA
- Marketing and training of surgeons; popularization in Ukraine and CIS countries
- Sale of products on the markets of Ukraine and abroad, complete with a basic set of tools; implementation of additional line of tools from Borodulin SD
- Access to non-CIS markets;

Market and competitive environment:
- The closest competitor - the American company Valley Lab (Liga Sure), producing complex oscillator (force Triad) and tools (covidien)
- Shortcomings of competitors' products - the lack of tools for welding of vessels end to end, side to side, end to side; the high price of the product (20 000 $)
- The Ukrainian market – 100 - 200 units / year (about 3 million USD / year.)
- CIS market - 500 and more units / year
- Asia, Near West, the US and EU market requires further study, but not less than 1000 units / year


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