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Thursday, November 5, 2020

#AI #Stock News: GBT Tokenize (OTCPINK: $GTCH) to Add Blood Pressure Measurement Feature to qTerm Device - Version II Aim to Release Q1/2021 @GbtTechnologies #artificialintelligence

 #AI #Stock News: GBT Tokenize (OTCPINK: $GTCH) to Add Blood Pressure Measurement Feature to qTerm Device  - Version II Aim to Release Q1/2021 @GbtTechnologies #artificialintelligence

 


San Diego, CA, November 5, 2020 - (Investorideas.com Newswire) GBT Technologies Inc. (OTCPINK: GTCH) ("GBT”, or the “Company”), announced that its joint Venture GBT Tokenize Corp (“GBT/Tokenize”) is currently developing an additional feature for its qTerm device. The additional feature will be a blood pressure measurement system and it is planned to be released with the product's second release during Q1 2021.

 

Read this in full at https://www.investorideas.com/CO/GOPH/news/2020/11051qTerm-Blood-Pressure-Measurement.asp

 

Typical blood-pressure apparatus is built using bulky and mechanical cuff-based medical devices. qTerm is planned to introduce a solid-state based blood-pressure monitoring solution, in order to enable a more convenient measurement system that will make tracking and monitoring easier. Cardiovascular disease is a leading factor of death and disability, and elevated blood pressure is a major contributor to these types of health risks. Early detection of hypertension can alert users to follow with appropriate therapy and treatment.

 

GBT/Tokenize’s blood pressure solution will comprise a complete integrated optical sensor module, and an embedded microcontroller. A sensing firmware algorithm will provide the operation and control of the entire system. Such method is called photoplethysmography (PPG) and its goal is to detect blood volume changes in the microvascular tissues. qTerm users will be able to measure blood pressure simply by placing their finger on the device while resting, at any time and anywhere.

 

The Optical Blood Pressure analysis system works by illuminating the finger's skin with miniature LED light (Emitted by the sensing system, and controlled by the embedded microcontroller) and by further capturing the light that is scattered and modulated by the pulsation of the user's skin arterioles. These signals are fed into algorithms to mathematically calculate the body's blood pressure. qTerm device will be enhanced by the addition of a high-sensitivity optical sensor and microchip on its PCB board. The physical dimensions of the device are expected to grow slightly. GBT is currently evaluating advanced optical electronic systems. An integrated optical solution consumes low power and provides high accuracy. The device also received its TM (Trademark) allowance notice and will present it on the product/package as required by the United State Patent Office. The qTerm device is targeted to measure body temperature, blood pressure, blood oxygen level and heart rate – all with a simple touch of the finger.

 

In order to assist with the world's current situation, GBT/Tokenize has decided to introduce an initial release of qTerm. The early release of the product will include body temperature, heart rate and blood oxygen level features and is targeted to be released by the end of this year. These three (3) vitals measurements are essential to assist with the pandemic crisis since they provide important health factors for early viral infection detection. The Blood Pressure feature is planned to be released in qTerm second release, planned for Q1 2021.

"Our qTerm device was planned to provide major human vitals, one of them is blood pressure. We decided to rush our first version to the market in order to assist with the global pandemic. As qTerm general development is continuing we are now developing its originally planned feature; blood pressure. Using a digital embedded sensor electronic system, and machine-learning algorithms we develop an embedded optical based analysis system to measure blood pressure. This miniature system will be based on photophlethysmography (PPG) method and installed within our qTerm medical device" stated Danny Rittman, GBT’s CTO. "qTerm will measure the amount of light that is absorbed or reflected by blood vessels in human tissues, calculating responsive changes in the blood's volume. The sensor coverage area includes veins, arteries, and numerous capillaries. Software algorithm will calculate and conclude the numerical results. qTerm will include blood oxygen level, heart rate, body temperature and blood pressure vitals measurements and all with a touch of a finger, a none-invasive product. Users will be able to potentially monitor their health, potentially identify early signs of health issues, and take appropriate care. Blood pressure is a critical vital to address proper treatment and management. Many medical conditions require this data and qTerm will be offering an easy, convenient measurement capability that will enable users to take the time and potentially monitor their health frequently. No bulkier cuffs and discomfort measurement devices, but a simple none-invasive touch of a finger will make the process of blood pressure measurement comfortable, easier and faster. High blood pressure is associated with many chronic disease conditions, and is a major source of mortality and disabilities around the world. The device mobile app will support the additional feature by recording and analyzing the data. We strongly believe that this feature will be a significant addition to the qTerm device, making it a comprehensive, easy for use, mainly intuitive, medical device. We plan to expand the device furthermore the future, adding more features and AI analysis capabilities" continued Dr. Rittman.

 

About GBT Technologies Inc.

GBT Technologies Inc. (OTC PINK: GTCH) (“GBT”) (http://gbtti.com) is 
a development-stage company which considers itself a native IoT creator, developing Internet of Things (IoT) and Artificial Intelligence (AI) enabled mobile technology platforms.  GBT has a portfolio of Intellectual Property that, if commercialized, is designed to include smart microchips, mobile and security applications and protocols and supporting cloud software.  GBT’s system envisions the creation of a global mesh network.  The core of the system will be its advanced microchip technology that can be installed in any mobile or fixed device worldwide. GBT envisions this system as a low-cost, secure, private mesh network between any enabled devices, providing shared processing, advanced mobile database management/sharing and enhanced mobile features as an alternative to traditional carrier services.

 

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements".  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( http://www.sec.gov).  In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company’s ability to raise capital on acceptable terms, if at all, the Company’s successful development of its products and the integration into its existing products and the commercial acceptance of the Company’s products.  The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release.

 

Contact:

Dr. Danny Rittman, CTO
GBT Technologies Inc.

Media: press@gopherprotocol.com

 

GBT Technologies Inc. (OTCQB:GTCH) is a featured tech stock on

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Wednesday, November 4, 2020

#Medical #Technology #Stock Alert: Electromedical Technologies, Inc. (OTCQB: $EMED) and Energetic Wellness School of Naturopathy Announce Collaborative Certification Program in “Bioelectronics Therapist and Master Device Technician” @ElectromedicalT

 

#Medical #Technology #Stock Alert: Electromedical Technologies, Inc. (OTCQB: $EMED) and Energetic Wellness School of Naturopathy Announce Collaborative Certification Program in “Bioelectronics Therapist and Master Device Technician” @ElectromedicalT

 

Expand Product Awareness and on Boarding of NEW Device Representatives and Brand Ambassadors



SCOTTSDALE, Arizona November 4, 2020 -
(Investorideas.com Newswire) – Breaking Medical Technology stock news - Electromedical Technologies, Inc. (OTCQB: EMED)  (the “Company”), a pioneer in the development and manufacturing of bioelectronic devices, including the FDA cleared WellnessPro®, designed to relieve chronic, intractable and acute pains by using frequencies and electro-modulation, is pleased to announce a collaboration with Energetic Wellness School of Naturopathy to develop a new distribution platform and certification training program to onboard new medical device representatives and improve training for current Wellness Pro ambassadors.

 

Read this news featuring EMED in full at https://www.investorideas.com/news/2020/biotech/11041EMED-Bioelectronics-Therapist-Master-Device.asp

 

Dr. Michele Menzel, ND, D.psc, commented: “We are excited to work with Electromedical Technologies to develop and establish a curriculum/certification program that will include bioelectronics applications such as frequencies used, treatment protocols and treatment techniques, as well as books and materials for students and distributors.

 

Doctors and patients are realizing the importance of using methods that will have a positive effect in reducing pain without having negative effects on the immune system, especially in today’s pandemic environment. We will make this course available to our students, alumni distributors or anyone interested in the future of medicine to have an opportunity to take our course.”

 

Matthew Wolfson, CEO of Electromedical Technologies, commented, “This program fits perfectly with our plan of engaging and onboarding hundreds of new medical practitioners and distributors. In today’s economic environment, many people are seeking to create new revenue streams for their families. We have a way to help thousands of people to live a better quality of life, pain free and addiction free and at the same time provide a real income opportunity for anyone who wishes to join our brand ambassador team.” (https://electromedtech.com/register/)

 

The new Master Device Rep program will provide our current device representatives with added bonuses and give interested people who wish to join our team an incredible business opportunity as well. This certification program and curriculum are pending approval.

 

Energetic Wellness School of Naturopathy is located in Edmond, OK https://energeticwellnessok.com/. Its Alumni, health providers, their patients and clients will have access to training and certification in the area of bioelectronics and specifically will have access and training using the Wellness Pro® Plus device and future product line.

 

Dr. Lee Woolley, DNM, GNM, MBnC, commented: “The Wellness Pro® Plus device has a proven track-record with over 10 years of positive results. We have tested and researched various devices on the market and have not seen any device produce such powerful and long-term pain-relieving effects. That is why we chose to work with Electromedical to provide our students and new healthcare providers access and training on one of the best devices on the market today – The Wellness Pro® Plus.

 

We cannot wait for the company to release its new Wellness Pro® POD next year. This will be a game changer for practitioners to provide safer pain relief choices for their patients.

Since provider education is imperative in the effective usage of non-invasive, non-toxic bio-electronic wellness methodologies, training assists providers in understanding the foundation, application, research and various methods in effective pain care and management at home and in the office.  It is a great tool for future doctors to be able to run various programs for their patients at their home or office.”

 

Finally, Mr. Wolfson commented, “It was very important to collaborate with such a great institution as the Energetic Wellness School of Naturopathy so that more practitioners and distributors may gain comprehensive knowledge of Bioelectronics, and  modern effective medical devices and technologies that produce natural pain relief and overall wellness. Doctors and students will have access to the Wellness Pro® Plus devices, which will give them hands on understanding of the various techniques and benefits of using drug free application techniques for chronic, acute post traumatic and intractable pain. Bioelectronics will Electrify medicine in the next 5 years and will be the norm in treatments of not only Chronic pain but will also one day open doors to other treatments that will improve human well-being without addictive and harmful side effects. Electromedical (EMED) is part of the wave of the future."

 

About Electromedical Technologies:

Headquartered in Scottsdale Arizona, Electromedical Technologies, Inc. is an FDA cleared  commercial stage bioelectronic medical device manufacturing and distribution company initially focused on the treatment of various chronic, acute, intractable and post-operative pain conditions. Through university collaboration agreements the company is working to develop a comprehensive research program in defining the effects of electro-modulation on the human body by studying the impacts of electrical fields in cell signaling and effects on virus assembly and immune responses with the goal of improving human wellbeing. The company’s current cleared product indications are for chronic acute post traumatic and post-operative, intractable pain relief.

 

For more information, visit https://electromedtech.com

 

Our animal studies do not involve any human testing, and are not related to our current products. We are conducting this research to augment and advance the science of electro-modulation in healthcare.  The United States Food and Drug Administration has not reviewed or approved our animal research studies.

 

Safe Harbor Statement:

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance or guarantee that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: adverse economic conditions, competition, adverse federal, state and local government regulation, international governmental regulation, inadequate capital, inability to carry out research, development and commercialization plans, loss or retirement of key executives and other specific risks. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.

Electromedical Technologies, Inc.
Matthew Wolfson
Tel: 1.888.880.7888
email:
ceo@electromedtech.com
www.electromedtech.com

 

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Tuesday, November 3, 2020

#Covid19 /#Cytokine Storm Syndrome Alert - Sigyn Therapeutics (OTC: $SIGY) CEO Note Discusses Sigyn Therapy™ to address a significant unmet need in global health; @Sigyn_inc

 

#Covid19 /#Cytokine Storm Syndrome Alert - Sigyn Therapeutics (OTC: $SIGY) CEO Note Discusses Sigyn Therapy™ to address a significant unmet need in global health; @Sigyn_inc

 

SAN DIEGO, November 3, 2020 / Investorideas.com Newswire – Therapeutic technology stock news - Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), today released the following note authored by its Chairman and CEO, Jim Joyce.

                                            

Read this news, featuring SIGY in full at https://www.investorideas.com/news/2020/biotech/11031Sigyn-Therapeutics.asp

 

Dear Current and Candidate Shareholders,

 

We created Sigyn Therapy™ to address a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome (The Cytokine Storm). The intent of this communication (the first in a series) is to introduce and familiarize you with our technology and therapeutic opportunities, which include large market indications that remain beyond the reach of drug therapies.

 

Cytokine storm syndrome is characterized as a dysregulated response of the immune system, which can be induced by a wide-range of infectious and non-infectious conditions. Since the outset of the current pandemic, medical journals have widely reported cytokine storm syndrome to be a leading cause of death resulting from severe COVID-19 infections.  A hallmark of the cytokine storm is an excessive or uncontrolled release of pro-inflammatory cytokines, which can induce multiple organ failure and result in death.

 

To recalibrate this dysregulated immune response, we designed Sigyn Therapy to deplete a broad-spectrum of inflammatory contributors from the bloodstream. The most prevalent condition associated with cytokine storm syndrome is sepsis.  Earlier this year, the Journal Lancet reported that sepsis kills more people around the world than all forms of cancer combined.  The Lancet reported that in 2017, there were 48.9 million cases of sepsis and 11 million deaths.  In that same year, the journal reported an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5 years old.  In the United States, sepsis was reported to be the most common cause of in-hospital deaths and accounted for more than $24 billion in annual costs.

 

To date, more than 70 controlled human studies have been conducted to evaluate the safety and benefit of candidate drugs to treat sepsis. With one brief exception (Xigris from Eli Lilly), none of these studies resulted in an approved drug therapy.  When considering the breadth of contributing inflammatory factors, sepsis is likely to remain an elusive target for therapeutic drug agents.

 

As a result of this therapeutic void, a significant opportunity for non-pharmaceutical blood purification devices has emerged. In this regard, I encourage you to learn about CytoSorbents Corporation and Toray Industries, Inc.  Both are publicly-traded organizations that we highly respect for the advancement of their respective CytoSorb and Toraymyxin devices.  Each of these industry pioneering devices are market cleared and broadly deployed to treat a wide-range of inflammatory conditions outside of the U.S.  They are being clinically evaluated in the U.S. as candidates to treat severe COVID-19 infection under FDA-awarded Emergency Use Authorizations.

 

In regards to mechanism of action, Toraymyxin has a high specificity to bind circulating endotoxin, which is reported to be a potent activator of cytokine storm syndrome. However, the Toraymyxin device does not address pro-inflammatory cytokines. Conversely, the CytoSorb device incorporates an adsorbent component that depletes pro-inflammatory cytokines from circulation, but does not address endotoxin.

 

We designed Sigyn Therapy to deplete the presence of both endotoxin and pro-inflammatory cytokines. To further optimize the potential of our therapeutic outcomes, we expanded Sigyn Therapy’s mechanism to include the elimination of larger proteins that transport cytokines and other inflammatory cargos. We refer to these as CytoVesicles.  To address this breadth of targets, we incorporate a cocktail of adsorbent components within Sigyn Therapy that each have unique binding and capture characteristics. 

 

In the medical field, the term cocktail often refers to the simultaneous administration of multiple drugs with differing mechanisms of action. However, the dosing of multiple drugs is limited by toxicity and adverse events that may result from deleterious drug interactions. Sigyn Therapy is not constrained by such limitations as our cocktail of adsorbent components are not introduced into the body.  As a result, we are able to incorporate a substantial dose of multiple adsorbents, each with differing mechanisms and capabilities to optimize the ability of Sigyn Therapy to calm the cytokine storm that underlies life-threatening inflammatory conditions. 

 

Our therapeutic opportunities include, but are not limited to sepsis, virus induced Cytokine Storm (VICS), bacteria induced Cytokine Storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, including hepatic encephalopathy. 

 

To translate our therapeutic vision into a clinical reality, we are planning a series of studies whose outcomes will be included in an Investigational Device Exemption (IDE) that we intend to submit to FDA in 2021. At present, we are conducting an in vitro study designed to validate the ability of Sigyn Therapy to simultaneously reduce the presence of endotoxin and relevant pro-inflammatory cytokines from human blood plasma. In this study, our cytokine targets include interleukin-6 (IL-6), interleukin-1 (IL-1) and tumor necrosis factor alpha (TNF-a), which are each drug industry targets to treat COVID-19 infected individuals. 

 

Roche, Sanofi, Regeneron and EUSA Pharma are evaluating anti-IL-6 drugs as COVID-19 treatment candidates.  Additionally, SOBI is testing an IL-1 inhibitor and Amgen is evaluating the potential benefit of Enbrel to inhibit TNF-a in COVID-19 infected individuals.  The prospect of aligning a therapeutic drug with a specific cytokine may be limited as researchers at Stanford and Yale have reported that cytokine profiles in those suffering from severe COVID-19 infection to be consistent with those previously observed in sepsis patients.  We believe that a device with much broader capabilities will be required.

 

I look forward to keeping you updated on our endeavors to advance Sigyn Therapy.

 

Sincerely,

 

Jim Joyce 

Chairman and CEO 

Sigyn Therapeutics, Inc.

 

About Sigyn Therapeutics

Sigyn Therapeutics is a development-stage therapeutic technology company headquartered in San Diego, California USA. Our focus is directed toward a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission is to save lives.

 

Sigyn Therapy™ is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include, but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.

 

To learn more, visit www.SigynTherapeutics.com  or www.SigynTherapy.com

 

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about Sigyn’s future financial performance, the impact of management changes, any proposed organizational restructuring, results of operations, capital resources to fund operations; statements about Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements about the potential benefits of the transaction; the expected completion and timing of the transaction and other information relating to the transaction; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Sigyn makes due to a number of important factors, including (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the transaction, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, (iv) risks related to the ability to realize the anticipated benefits of the transaction, including the risk that the businesses will not be integrated successfully, (v) the effect of the announcement or pendency of the transaction on Sigyn’s business relationships, operating results and business generally, (vi) risks that the proposed transaction disrupts current plans and operations, (vii) risks related to the combined entity’s ability to up-list to a national securities exchange, (viii) risks related to the combined entity’s access to existing capital and fundraising prospects to fund its ongoing operations, (ix) risks related to diverting management’s attention from Sigyn’s ongoing business operations, (x) other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies, and (xi) the outcome of any legal proceedings that may be instituted against Sigyn related to the merger agreement or the transaction. Further risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements are discussed in “Risk Factors” and elsewhere in the previous Reign Resources Corporation Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other reports filed with the SEC. The forward-looking statements in this press release represent Sigyn’s views as of the date of this press release. Sigyn anticipates that subsequent events and developments may cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Sigyn’s views as of any date subsequent to the date of this press release.

 

Contact Sigyn Therapeutics, Inc.

Jim Joyce

Chairman, CEO

(619) 368-2000

jimjoyce@elevatescience.com

 

Paid News -Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Disclosure : this news release featuring Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), is a paid for service  on Investorideas.com . More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com

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Monday, November 2, 2020

#TherapeuticTechnology #Stock Sigyn Therapeutics (OTC: $SIGY) CEO Note: Rethinking the Treatment of Sepsis and Other Life-Threatening Inflammatory Conditions; #COVID19 #CytokineStorm @Sigyn_inc

 

#TherapeuticTechnology #Stock Sigyn Therapeutics (OTC: $SIGY) CEO Note: Rethinking the Treatment of Sepsis and Other Life-Threatening Inflammatory Conditions; #COVID19 #CytokineStorm @Sigyn_inc

 


SAN DIEGO, November 2, 2020 / Investorideas.com Newswire – Therapeutic technology stock news - Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), today released the following note authored by its Chairman and CEO, Jim Joyce.

                                            

Read this news, featuring SIGY in full at https://www.investorideas.com/news/2020/biotech/11021OTC-SIGY.asp

 

Dear Current and Candidate Shareholders,

 

We created Sigyn Therapy™ to address a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome (The Cytokine Storm). The intent of this communication (the first in a series) is to introduce and familiarize you with our technology and therapeutic opportunities, which include large market indications that remain beyond the reach of drug therapies.

 

Cytokine storm syndrome is characterized as a dysregulated response of the immune system, which can be induced by a wide-range of infectious and non-infectious conditions. Since the outset of the current pandemic, medical journals have widely reported cytokine storm syndrome to be a leading cause of death resulting from severe COVID-19 infections.  A hallmark of the cytokine storm is an excessive or uncontrolled release of pro-inflammatory cytokines, which can induce multiple organ failure and result in death.

 

To recalibrate this dysregulated immune response, we designed Sigyn Therapy to deplete a broad-spectrum of inflammatory contributors from the bloodstream. The most prevalent condition associated with cytokine storm syndrome is sepsis.  Earlier this year, the Journal Lancet reported that sepsis kills more people around the world than all forms of cancer combined.  The Lancet reported that in 2017, there were 48.9 million cases of sepsis and 11 million deaths.  In that same year, the journal reported an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5 years old.  In the United States, sepsis was reported to be the most common cause of in-hospital deaths and accounted for more than $24 billion in annual costs.

 

To date, more than 70 controlled human studies have been conducted to evaluate the safety and benefit of candidate drugs to treat sepsis. With one brief exception (Xigris from Eli Lilly), none of these studies resulted in an approved drug therapy.  When considering the breadth of contributing inflammatory factors, sepsis is likely to remain an elusive target for therapeutic drug agents.

 

As a result of this therapeutic void, a significant opportunity for non-pharmaceutical blood purification devices has emerged. In this regard, I encourage you to learn about CytoSorbents Corporation and Toray Industries, Inc.  Both are publicly-traded organizations that we highly respect for the advancement of their respective CytoSorb and Toraymyxin devices.  Each of these industry pioneering devices are market cleared and broadly deployed to treat a wide-range of inflammatory conditions outside of the U.S.  They are being clinically evaluated in the U.S. as candidates to treat severe COVID-19 infection under FDA-awarded Emergency Use Authorizations.

 

In regards to mechanism of action, Toraymyxin has a high specificity to bind circulating endotoxin, which is reported to be a potent activator of cytokine storm syndrome. However, the Toraymyxin device does not address pro-inflammatory cytokines. Conversely, the CytoSorb device incorporates an adsorbent component that depletes pro-inflammatory cytokines from circulation, but does not address endotoxin.

 

We designed Sigyn Therapy to deplete the presence of both endotoxin and pro-inflammatory cytokines. To further optimize the potential of our therapeutic outcomes, we expanded Sigyn Therapy’s mechanism to include the elimination of larger proteins that transport cytokines and other inflammatory cargos. We refer to these as CytoVesicles.  To address this breadth of targets, we incorporate a cocktail of adsorbent components within Sigyn Therapy that each have unique binding and capture characteristics. 

 

In the medical field, the term cocktail often refers to the simultaneous administration of multiple drugs with differing mechanisms of action. However, the dosing of multiple drugs is limited by toxicity and adverse events that may result from deleterious drug interactions. Sigyn Therapy is not constrained by such limitations as our cocktail of adsorbent components are not introduced into the body.  As a result, we are able to incorporate a substantial dose of multiple adsorbents, each with differing mechanisms and capabilities to optimize the ability of Sigyn Therapy to calm the cytokine storm that underlies life-threatening inflammatory conditions.  

 

Our therapeutic opportunities include, but are not limited to sepsis, virus induced Cytokine Storm (VICS), bacteria induced Cytokine Storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, including hepatic encephalopathy. 

 

To translate our therapeutic vision into a clinical reality, we are planning a series of studies whose outcomes will be included in an Investigational Device Exemption (IDE) that we intend to submit to FDA in 2021. At present, we are conducting an in vitro study designed to validate the ability of Sigyn Therapy to simultaneously reduce the presence of endotoxin and relevant pro-inflammatory cytokines from human blood plasma. In this study, our cytokine targets include interleukin-6 (IL-6), interleukin-1 (IL-1) and tumor necrosis factor alpha (TNF-a), which are each drug industry targets to treat COVID-19 infected individuals.  

 

Roche, Sanofi, Regeneron and EUSA Pharma are evaluating anti-IL-6 drugs as COVID-19 treatment candidates.  Additionally, SOBI is testing an IL-1 inhibitor and Amgen is evaluating the potential benefit of Enbrel to inhibit TNF-a in COVID-19 infected individuals.  The prospect of aligning a therapeutic drug with a specific cytokine may be limited as researchers at Stanford and Yale have reported that cytokine profiles in those suffering from severe COVID-19 infection to be consistent with those previously observed in sepsis patients.  We believe that a device with much broader capabilities will be required.

 

I look forward to keeping you updated on our endeavors to advance Sigyn Therapy.

 

Sincerely,

 

Jim Joyce 

Chairman and CEO 

Sigyn Therapeutics, Inc.

 

About Sigyn Therapeutics

Sigyn Therapeutics is a development-stage therapeutic technology company headquartered in San Diego, California USA. Our focus is directed toward a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission is to save lives.

 

Sigyn Therapy™ is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include, but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.

 

To learn more, visit www.SigynTherapeutics.com  or www.SigynTherapy.com

 

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about Sigyn’s future financial performance, the impact of management changes, any proposed organizational restructuring, results of operations, capital resources to fund operations; statements about Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements about the potential benefits of the transaction; the expected completion and timing of the transaction and other information relating to the transaction; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Sigyn makes due to a number of important factors, including (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the transaction, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, (iv) risks related to the ability to realize the anticipated benefits of the transaction, including the risk that the businesses will not be integrated successfully, (v) the effect of the announcement or pendency of the transaction on Sigyn’s business relationships, operating results and business generally, (vi) risks that the proposed transaction disrupts current plans and operations, (vii) risks related to the combined entity’s ability to up-list to a national securities exchange, (viii) risks related to the combined entity’s access to existing capital and fundraising prospects to fund its ongoing operations, (ix) risks related to diverting management’s attention from Sigyn’s ongoing business operations, (x) other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies, and (xi) the outcome of any legal proceedings that may be instituted against Sigyn related to the merger agreement or the transaction. Further risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements are discussed in “Risk Factors” and elsewhere in the previous Reign Resources Corporation Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other reports filed with the SEC. The forward-looking statements in this press release represent Sigyn’s views as of the date of this press release. Sigyn anticipates that subsequent events and developments may cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Sigyn’s views as of any date subsequent to the date of this press release.

 

Contact Sigyn Therapeutics, Inc.

Jim Joyce

Chairman, CEO

(619) 368-2000

jimjoyce@elevatescience.com

 

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