FAQs - SHYCOCAN
Q. Is the SHYCOCAN cleared or approved by the U.S. FDA?
Based on U.S. FDA’s guidance, the SHYCOCAN will currently be marketed under the “Enforcement Discretion Guidance” during the COVID-19 pandemic/public health emergency
Enforcement Discretion allows for the marketing of the SHYCOCAN device during the pandemic
A 510k submission is simultaneously being prepared by Shreis Scalene Therapeutics LLC together with Emergo (by UL) to submit to the U.S.FDA so that continuous marketing clearance can be achieved post pandemic without a break in distribution
The device is intended for the physical attenuation of the family of coronaviruses and can be used in most public or private settings
View the detailed position statement with regards to U.S. FDA HERE
Q. Why does the SHYCOCAN device not show up in the database of U.S.FDA’s cleared or approved devices?
The term “Cleared” is applied for devices that obtain a 510K submission
The term “Approved” is for devices that receive Pre-market approvals (PMA)
The SHYCOCAN device Is currently market-enabled as per the enforcement discretion guidance during the COVID-19 Public Health Emergency and will be listed on the U.S. FDA website once 510K clearance is obtained
Q. Who is the inventor and what is the SHYCOCAN patent status?
The inventor is Dr. Rajah Vijay Kumar, Chairman and CSO of Scalene Cybernetics, Bengaluru, India. He chose to protect the device by the design registration and the proprietary PMEE assembly made of a superalloy developed by Scalene for maximum release of kinetic energy required to create the electron cloud by bombardment of the photons to release electrons into the atmosphere
Q. What is SSTx relationship with the Inventor?
Shreis Scalene Group of companies, USA and Scalene Cybernetics Limited, India are separate and independent companies. Shreis Scalene Group of companies has more than a twenty-year partnership with the Inventor Dr. Kumar. Shreis Scalene Therapeutics has the exclusive, perpetual and irrevocable rights to manufacture and market the product in North & South America, Mexico and the Caribbean. We have appointed a distributor in Mexico who is independently identifying manufacturers to cover that market territory, regulated by the COFEPRIS. We can sell to other global regions on a case by case basis, in partnership with Dr. Kumar. Shreis is working on partnerships in Latin American and looking to do that same in Caribbean countries
Q. What are the biological safety level (BSL) lab tests completed for the SHYCOCAN?
Standard decontamination assay using Bacteriophage MS2 showed a 99.994% reduction ( >4 Log10 Reduction ) when exposed to the SHYCOCAN. The test results with an EPA-approved phylogenetic surrogate had a 99.963% reduction in infectivity in mammalian cells. Additional tests with the Influenza B strain showed significant destruction of the viral capsid and eliminated viral load greater than that exhaled by an infected individual, when exposed to the electron cloud from the SHYCOCAN. All three tests were conducted in a BSL-2 lab. Efforts are on-going to have the device tested in BSL-3 labs with SARS-CoV-2 once the demand for diagnostic testing during the pandemic reduces. Several US-based BSL3/4 labs had been approached at the earliest stages of testing (Battelle, Homeland Security, George Mason University Biodefence Lab, Army Future’s Command among others with no breakthrough due to the PHE)
Q. What is the U.S.FDA’s position on the SHYCOCAN?
We submitted the entire dossier with the safety data from the EU-CE marking (conducted by Underwriters Laboratories (UL) by Scalene, and our BSL-2 test viricidal assay results to the US-FDA during their interactive review in a Pre-Emergency Use Authorization (preEUA) process, as recommended during the PHE. The FDA has recommended manufacturing distribution and marketing under their Enforcement Discretion Guidance during the COVID-19 Public Health Emergency
Q. What field testing does SSTx intend doing post deployment?
Post-deployment, SSTx will collect real world evidence on
reduction in viral load in high risk areas
reduction in infectivity by testing nasal swabs of asymptomatic personnel exposed in these high risk-environments, and
obtaining samples from volunteers for study of immune reactivity to the physically attenuated virus in the presence of the SHYCOCAN
Q. Could you point me towards peer reviewed research that validates the techniques used by the Shycocan to deactivate airborne SARS-CoV-2?
Please see the US Press release on the Resource page that also refers to the efficacy testing done
In the context of peer reviewed information, a manuscript is in preparation by SSTx for publication and the data will be shortly available publicly
Needless to say, without these biological validations in lab assays, we could not have submitted the technology for interactive review to Regulatory authorities
Q. What kind of testing has the SHYCOCAN undergone that has proven greater than 99.99% decontamination indoors?
A standard decontamination assay using Bacteriophage MS2 showed a 99.994% reduction when exposed to the SHYCOCAN. There are 2 lab test reports mentioned in the Press Release. The first one was done with an EPA approved viral surrogate for SARS-CoV-2, for products like ours that need validation for mechanism of action, which showed a viral infectivity reduction of up to 3.435Log10 (99.963%). We have also tested for viral capsid destruction in Influenza B, an influenza virus which is seasonal as well. Very high efficiency of viral capsid destruction was reported, at levels of infective virus that a patient with influenza exhales in one breath. All these tests were done in BSL-2 labs. We will perform follow up testing specifically against SARS-CoV-2 as we continue to validate efficacy.
Q. What are the engineering specifications of the SHYCOCAN?
Please contact Shreis for detailed specifications of the SHYCOCAN
Q. What is the anticipated pricing per unit of the device?
The company intends to keep the market price low in order to make the device available widely
We are in discussions with a top tier manufacturing and distribution companies who will provide design and automation costs to scale up to meet the growing demand that can be met. Pricing will depend on projected numbers
At the moment it is looking to be in the ballpark of $600 USD MSRP
Q. What is the go-to market strategy?
We are uniquely focused on creating safe zones in homes, establishments (corporate, residential, industrial, schools, travel hubs like bus & train stations, airports, places of worship etc.) where people will be in the vicinity of SHYCOCAN and the recommended use of PPEs. Examples include:
First Responder areas
Hospitals/Clinics
Army Barracks
Commercial Buildings
Housing projects / senior-care facilities / day cares / nursing homes / schools / churches
Prisons
Homes
Q. How can I purchase a SHYCOCAN?
The SHYCOCAN can be purchased directly from the Shreis.org website.
Currently pre-orders for the SHYCOCAN device is available and will be fulfilled on a first come first served basis
Visit the SHYCOCAN page from the Products tab or click here to place an order. Visit the store and place a pre-order for the device
Q. When will the SHYCOCAN be available?
The global symbolic launch of the SHYCOCAN was on August 14th/ August 15th 2020
Due to the pandemic and the urgent need here in the US, we are planning on importing the first batch (~250 units) while we are setting up manufacturing and distribution in the U.S. We are planning to have pre-orders available by the end of August and devices ready for shipment by the first week in October
Based on the demand, we will either wait till manufacturing is setup in the US for the next batch of devices OR we will continue to import devices to meet the need till we can transition over to local manufacturing
Q. Does the SHYCOCAN come with a warranty?
Yes, the SHYCOCAN comes with a 1-year warranty against manufacturing defects
Q. Can I buy a SHYCOCAN for personal use/office etc.
Yes, there are no restrictions. The device is intended for the physical attenuation of the family of coronaviruses and can be used in most public or personal settings
Q. How long does it take for the SHYCOCAN to clear a room?
Once turned on, the SHYCOCAN acts like a light bulb in the sense that its effectivity is instantaneous because of the extremely high speed at which electrons travel
The fan at the back of the device is just to cool the SHYCOCAN as well as can be used to calculate how quickly the air can be recirculated within a room
Q. Does the SHYCOCAN kill the SARS-CoV-2 virus?
The SHYCOCAN disables the infectivity of the family of coronaviruses i.e. it does not kill the SARS-CoV-2 virus. It simply disables it from attaching and infecting the host
Q. What is the power consumption of the SHYCOCAN?
The electrical consumption of the SHYCOCAN is equivalent to a 40-watt bulb
Q. Should I use a UPS (uninterrupted power supply) with the SHYCOCAN
In critical care ICU or emergency / first responder units etc., the use of an uninterrupted power supply (UPS) unit might be recommended to ensure that there is no break in operation. There is no battery backup built into the device
Q. Is the SHYCOCAN safe? Does it produce ozone?
The SHYCOCAN device does not produce harmful ozone gas (SSTx LLC, Report No: SHY-OZ-05072020, Test No: SHY-2306-50-1, issue date May 16, 2020) nor does it kill bacteria, fungi or any eco-friendly microorganisms in the atmosphere that might impact humans, pets / plants in the home environment
Q. Can I stop wearing a mask/gloves or practicing social distancing if I have a SHYCOCAN?
NO. The SHYCOCAN is intended to attenuate/disable the infectivity of the family of coronaviruses that is airborne or on surfaces. It Is intended as a preventative measure and to create safe zones where the virus is disabled from infecting. It does not replace safe practices like social distancing or wearing masks and gloves (e.g.: it cannot prevent someone who is COVID-positive from coughing directly on you or touching you). Please continue to follow CDC standards for social distancing and wearing masks etc.
Q. Can I be a representative/broker/distributor of the SHYCOCAN?
Yes, you can. Please contact Shreis for details. You may also directly contact marketing@shreis.com
Q. Are there opportunities to be a manufacturer of the SHYCOCAN in North/South America, Mexico, Caribbean, UAE etc.?
Yes, we are looking to expand the manufacturing networks in our market territories. Please contact Shreis for details. You may also directly contact marketing@shreis.com
Q. Are there investment opportunities with the Shreis Group of companies?
Yes, please contact Shreis for investment opportunities and be specific about your request so it can be directed to the relevant parties
Q. Can I import the device into the US from another country?
Since Shreis Scalene Therapeutics LLC has the exclusive license from the Inventor for the North and South American markets including Mexico and the Caribbean, it is not legally feasible to import and distribute from any other external source other than Shreis Scalene Therapeutics LLC
Q. Can the SHYCOCAN be used alongside air conditioners?
Yes, there are no issues with using the SHYCOCAN with air conditioners operating
Q. Can the SHYCOCAN cure someone that has COVID?
No. The SHYCOCAN is not intended to cure or treat a patient suffering with COVID. It’s designed to stop the infectivity of the the family of coronaviruses from the air and surfaces within closed spaces
Q. For a single level home, what is the best location to keep the SHYCOCAN?
It is best to keep the SHYCOCAN in an area that sees a lot of foot traffic from outside the home
Q. Is it ok to use in <number> sq.-ft home ?
Shreis recommends 1 SHYCOCAN device per 1000 sq.-ft
Ideally 1 device is recommended per level of the home if less than 1000 sq.-ft per level
An alternative is to use 1 device and move to different areas of the home cycling through rooms
Another alternative is to focus on the areas with the most traffic like rooms in the entrances to the home
Q. Do we need to keep the windows open when using the SHYCOCAN?
Ideally, to contain the electrons within the room specified, keeping the windows/doors closed is advised
Q. Are there any limitations, precautions, or prerequisites for using the SHYCOCAN?
Like any electronic device or component, please keep away from water and sprinklers etc.
Ensure correct voltage is used for you device. There are 110V - 240V versions of the SHYCOCAN
Q. Does the SHYCOCAN make a noise when on? What is the level of the sound output of the SHYCOCAN?
Like the fan in a desktop computer, the SHYCOCAN does have a minimal background hum while the device is on at 43-48 dBA
Q. Does the SHYCOCAN need any change of spares, parts, or materials after certain period of use?
No, the SHYCOCAN does not need spare parts or materials after a period of time
Q. Is there any recurring expenditure in the future, if I purchase the SHYCOCAN?
No, there is no anticipated recurring expenditure in the future
Q. Does the SHYCOCAN require a periodic 'recharge' of any of its components, and if so, at what intervals?
No, this would not be necessary. It is a plug and play device with extended shelf life
Q. Can the SHYCOCAN be run 24x7, all 365 days of the year?
There are no issues with running the SHYCOCAN 24/7. However, we recommend that you switch off the device when not on the premises for prolonged periods of time
Q. Does the SHYCOCAN deactivate the virus in all nooks and corners, shadow areas, hard to reach areas, splits, cracks, inner side of porous surfaces?
Yes, the electrons are freely distributed around the room and can reach most areas mentioned above
Q. Does the SHYCOCAN pierce, pass through all layers of face masks to deactivate virus on the inner layers of mask?
We have not conducted these tests to give an answer. However, the electrons generated by the device can attenuate the virus that is on the outside of the mask as with any other surface in the vicinity of the device
Note: Please follow CDC guidelines for use and discarding of disposable masks/gloves
Q. Where do you recommend I mount the SHYCOCAN?
A wall mount is recommended at heights not readily accessible to children, or it could be mounted on pedestals or carried from room to room to customize its operation to the facility being considered to deploy the unit
Q. Can I use the SHYCOCAN in an open backyard?
We recommend the SHYCOCAN be used in an enclosed space
However, if outdoors, the area around the SHYCOCAN could be considered safe but drops off exponentially the further away from the SHYCOCAN one gets
For e.g. it has been deployed just at the gatehouse of the security guard as people come in and out of a facility and in direct line of sight
Q. What is the effect of the SHYCOCAN on nearby electric/electronic devices like escalator lifts, diesel gensets, water treatment plant, laptops, nearby circuitry under the area of flux/impact?
The European Union CE certification by Underwriters Laboratory has approved the device for industrial and home use. It has been tested and cleared for all EMC/EMI
Q. Can the SHYCOCAN be used to disinfect the water supply (swimming pool, sewage treatment, portable water tanks, garbage storage room)?
No, testing has not been done in these areas with the SHYCOCAN
Q. What are the guidelines for usage of the Shycocan in an indoor environment with regards to:
Ventilation / Air Speed - for e.g., with fresh air ventilation on at maximum capacity of (for e.g.) 10 ACH (Air Changes per Hour), would the Shycocan still be effective? Yes. Switching on the SHYCOCAN is like switching on a light. The generation of photons and subsequent electrons is not affected by ventilation, air speed, air conditioning etc.
What are the humidity and temperature ranges within which the Shycocan is effective? Please contact Shreis for technical specifications
Any other extraneous conditions that affect the Shycocan's performance? It depends on what the user has in mind. Contact Shreis for specific questions
The SHYCOCAN is a precision device. Any mishandling and interference with the device and physical damage to the Unit that discharges the photons can incapacitate the device and render it ineffective. All such mishandling will not be covered under the manufacturer’s 1-year warranty
Q. Could you please provide me with a list of the approved Indian manufacturers who have been licensed to manufacture the SHYCOCAN?
Please contact Scalene Cybernetics Limited, Bengaluru, India for a list of the local manufacturers. Currently there is Eureka Forbes with the ‘Coronaguard’ and Medwin Healthcare who are two of the distributors
For any other questions or further inquiries, please contact Shreis HERE