Business Wire

Xlear Files Legal Response to Government’s Lawsuit

Share

Today, Xlear Inc. filed the company’s response to a Department of Justice lawsuit alleging violations of the Federal Trade Commission Act, among other allegations. The company denied all the Government’s allegations and leveled a series of affirmative defenses at the Government, including violations of Xlear’s First Amendment right to free speech. Nathan Jones, Xlear’s CEO, issued this statement regarding Xlear’s Response:

The United States faces an already raging pandemic and yet another new, wildfire Omicron variant, which studies show is more transmissible, vaccine resistant and as severe as other strains. As a result, across the nation new cases are spiking and breaking records; hospitals are once again overflowing; schools are closing again; not only are we seeing breakthrough infections—we are facing reinfections; the NFL and the NHL have been forced to postpone games; and, there is a real risk that our lives and economy will once again have to close. It’s another COVID-Christmas in America. The nation’s vaccine-only strategy is failing.

Despite this, the Federal Government continues to refuse to even discuss or consider other possible countermeasures—even though they are backed by sound science.

Xlear’s Response outlines a series of studies, including two randomized clinical trials (RCTs)* and other clinical and lab data, that more than substantiate Xlear’s statements regarding COVID-19. One recent RCT study found that the use of nasal hygiene in treating COVID-19-infected people over the age of 50 reduced the risk of hospitalization 8-fold.** The Government hasn’t meaningfully challenged the legitimacy of these studies—the Government can’t, they paid for some of them and have published some of them. Nor has the Government offered conflicting studies—they can’t. The Government has known about these other countermeasures since June 2020. Yet, the Government still refuses to even discuss or consider them.

The Response we filed also includes a new in vitro study done at Utah State University’s Institute for Antiviral Research.*** This new in vitro study (using human airway tissue) found that the components in Xlear were significantly more effective antivirals against the Delta strain of COVID-19 than Remdesivir, the Government-approved antiviral medicine. Ironically, the Government alleges it is Xlear that has misled the public.

Not only is the Government refusing to consider other countermeasures, the Government, through this lawsuit, has sought to censor us from informing the American people about the science. The American people have both the right and the need to know the science. We hope this lawsuit serves as a vehicle to inform the public, as well as expose the abject failures of our Government in responding to this pandemic.

Rather than try to silence science, the Government should follow the data and work with us to help end this pandemic.

*Kimura, K., et al., Interim analysis of an open-label randomized controlled trial evaluating nasal irrigations in nonhospitalized patients with coronavirus disease 2019. Int Forum Allergy Rhinol. 2020; 10: 1325– 1328, available at https://pubmed.ncbi.nlm.nih.gov/32914928/; Amy Baxter, et al., Rapid initiation of nasal saline irrigation to reduce morbidity and mortality in COVID+ outpatients: a randomized clinical trial compared to a national dataset, medRxiv 2021.08.16.21262044, doi:https://doi.org/10.1101/2021.08.16.21262044 available at https://www.medrxiv.org/content/10.1101/2021.08.16.21262044v2.

**Baxter, supra.

*** Institute for Antiviral Research, Utah State University, Study Report; Antiviral Efficacy Against Virus Infections in Human-Derived Tracheal/Bronchial Eplithelial Cells, Dec. 1, 2021 (forthcoming).

Other references, include but are not limited to:

Go, Camille Celeste, Pandav, Krunal, Sanchez-Gonzalez, Marcos A, Ferrer Gustavo, Potential Role of Xylitol Plus Grapefruit Seed Extract Nasal Spray Solution in COVID-19: Case Series (Nov. 2020), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645297/.

Ferrer, Gustavo, et al, A Nasal Spray Solution of Grapefruit Seed Extract plus Xylitol Displays Virucidal Activity Against SARS-CoV-2 In Vitro, BioRxiv (Nov. 25, 2020), available at https://www.biorxiv.org/content/10.1101/2020.11.23.394114v1.full.

Cannon, Mark, et al, In Vitro Analysis of the Anti-viral Potential of nasal spray constituents against SARS-CoV-2, bioRxiv 2020.12.02.408575, available at https://www.biorxiv.org/content/10.1101/2020.12.02.408575v2.full.pdf+html.

Ferrer, G., et al., In Vitro Analysis of the Anti-viral Potential of Nasal Spray Constituents Xylitol and Grapefruit Extract plus against SARS-CoV-2, forthcoming in Journal Virus Research.

Cegolon L, Javanbakht M, Mastrangelo G. Nasal disinfection for the prevention and control of COVID-19: A scoping review on potential chemo-preventive agents [published online ahead of print, 2020 Aug 18]. Int J Hyg Environ Health. 2020;230:113605. doi:10.1016/j.ijheh.2020.113605.

Lipworth B, Chan R, RuiWen Kuo C. COVID-19: Start with the nose. J Allergy Clin Immunol. 2020;146(5):1214. doi:10.1016/j.jaci.2020.06.038; Spinelli, M. et al., Importance of non-pharmaceutical interventions in lowering the viral inoculum to reduce susceptibility to infection by SARS-CoV-2 and potentially disease severity, The Lancet, Feb. 22, 2020, available at https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30982-8/fulltext.

Radulesco T, Lechien JR, Saussez S, Hopkins C, Michel J. Safety and Impact of Nasal Lavages During Viral Infections Such as SARS-CoV-2. Ear Nose Throat J. 2021;100(2_suppl):188S-191S. doi:10.1177/0145561320950491.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Xlear Media Relations
Nathan Jones
media@xlear.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

BitMEX Welcomes New Head of Trading Bill Beller25.1.2022 14:03:00 EET | Press release

Crypto investment platform BitMEX is delighted to welcome Bill Beller as Head of Trading, effective 1 January. Bill is in charge of spearheading the company’s trading strategies and expanding the BitMEX trading team and its capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005650/en/ BitMEX Welcomes New Head of Trading Bill Beller (Photo: Business Wire) Prior to joining BitMEX, Bill was Managing Director at Greenville Advisory for nearly five years, where he helped FinTech start-ups launch crypto exchange platforms and meet evolving regulatory requirements. Prior to that, he was Managing Director - Head of Equities for Sberbank CIB and Managing Director, Head of EEMEA Equity Derivatives Flow Trading at UniCredit. He brings over a decade of experience in risk management, building trading infrastructure, and managing equities and derivatives investments across global capital markets. Bill said: “BitMEX is fast

Lithion Recycling Enters a Partnership with IS Dongseo Company for an Exclusive License of its Lithium-ion Battery Recycling Technology in South Korea25.1.2022 14:00:00 EET | Press release

Lithion Recycling, Inc. (“Lithion”) is proud to announce it has reached an agreement with IS Dongseo Company Ltd (“ISD”), a Korea-based leading ESG company with an environmental business segment, for an exclusive business right for the use of its lithium-ion battery recycling technology on the Korean market. This partnership is the first of a series that Lithion aims to conclude in upcoming years for the use of its cutting-edge, eco-friendly technology on world markets. It will allow ISD to offer an environmentally friendly and cost-effective recycling solution to close the loop on battery materials in Korea. IS Dongseo plans to start building its first Korean facility capable of processing about 7,500 tons of waste batteries per year (or the equivalent of approximately 20,000 electric car batteries), this year. This first phase will be followed by a second one, with the construction of a hydrometallurgy plant based on Lithion’s technology, allowing ISD to supply over 15,000 tons of ba

Square Announces Official Launch in Spain After Successful Early Access Programme25.1.2022 13:30:00 EET | Press release

Square, the company specialising in software, payments, and hardware solutions for businesses of all sizes, announces its arrival in Spain following a successful Early Access Programme. Starting today, Spanish entrepreneurs, freelancers and business owners will be able to use Square's ecosystem of tools; the only end-to-end solution of its kind in the country. "We’ve been trialing Square’s suite of products both in-store and online and we love it,” said Miguel Gil, owner of Hop Hop Hurrah , one of the first businesses to use Square’s products in Spain. “Having a point-of-sale system with integrated payments and omnichannel solutions has transformed the way we’re able to run our business, making it an easy and seamless process. We’re pleased we were able to switch to Square and feel much more confident in our ability to grow, ensuring we never miss a sale, as we look towards the future.” Square is part of Block, Inc. a global technology company focused on financial services, founded in

J.P. Morgan to Acquire a Stake in Viva Wallet25.1.2022 13:00:00 EET | Press release

J.P. Morgan (NYSE: JPM) announced today that it has entered into an agreement with Viva Wallet Holdings Software Development S.A. (Viva Wallet), a leading European cloud-based payments fintech company, and its existing shareholders to acquire an ownership stake of approximately 49 percent, subject to regulatory approvals. Financial terms of the transaction were not disclosed. “We are very excited to make a strategic investment in Viva Wallet to support their vision to empower new growth and payments innovation targeted at European small and midsize businesses (SMBs) and middle market merchant services clients,” said Takis Georgakopoulos, Global Head of J.P. Morgan Payments. “The European payments landscape is fragmented yet large in terms of opportunity, with more than 17 million merchants1 ready to implement scalable payments solutions and this is a big focus area for added growth for J.P. Morgan Payments in the future.” Founded in 2000, Viva Wallet is headquartered in Athens, Greece,

The O-RAN ALLIANCE Announces the 5th Release of Its Open Source Software and An Industry Briefing at MWC Barcelona25.1.2022 12:49:00 EET | Press release

O-RAN ALLIANCE: O-RAN ALLIANCE Industry Briefing, March 1, 2022 at MWC Barcelona O-RAN ALLIANCE plans to hold its next industry event on March 1, 2022 from 17:15-18:00 CET, hosted at the Deutsche Telekom booth at MWC Barcelona 2022, Hall 3 Stand 3M31. The event will include keynotes from O-RAN ALLIANCE’s leadership and an industry panel discussion. Save the date and follow our website for further updates. 5th Release of Open Software for the RAN – “E” – Delivered by the O-RAN Software Community The O-RAN Software Community (OSC or O-RAN SC) was formed in partnership with the Linux Foundation in April 2019, to support software development of open RAN solutions available to everyone. In December 2021, following on the half year release cycle, the OSC published its 5th open software release dubbed "E". The E release further enhances the traffic steering use case, introduces basic RAN slicing feature and closed loop slice SLA assurance. With these enhanced features and the end-to-end integ

Samsung Introduces Smart All-in-One Fingerprint Security IC for Biometric Payment Cards25.1.2022 12:00:00 EET | Press release

Samsung Electronics Co., Ltd., a world leader in advanced semiconductor technology, today introduced its new fingerprint security IC (integrated circuit) ─ S3B512C ─ with enhanced security features. The new solution is EMVCo and Common Criteria Evaluation Assurance Level (CC EAL) 6+ certified and performs in line with Mastercard’s latest Biometric Evaluation Plan Summary (BEPS) specifications for biometric payment cards. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005609/en/ Samsung-Smart-All-in-One-Fingerprint-Security-IC (Photo: Business Wire) “S3B512C combines a fingerprint sensor, Secure Element (SE) and Secure Processor, adding an extra layer of authentication and security in payment cards,” said Kenny Han, vice president of System LSI marketing at Samsung Electronics. “The S3B512C is primarily designed for payment cards but can also be used in cards that require highly secured authentications such as student o

EcoVadis Upgrades INNIO Jenbacher Rating to Gold Medal for Continued Commitment to Global Sustainability25.1.2022 12:00:00 EET | Press release

INNIO today announced that its Jenbacher business unit has been recognized by EcoVadis with a Gold Medal as part of its annual sustainability performance rating, placing INNIO Jenbacher in the top 1% of industry peers evaluated by EcoVadis. EcoVadis awarded INNIO Jenbacher the upgrade from a Silver to a Gold Medal rating for its demonstrated improvements and contributions towards sustainable growth in the past year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005260/en/ INNIO Jenbacher, Recipient of EcoVadis Gold Medal Rating (Photo: Business Wire) Performed annually, EcoVadis’ assessment focuses on 21 issues grouped into four key themes: Environment, Labor & Human Rights, Ethics and Sustainable Procurement. These criteria are based upon international sustainability standards, including the Global Compact Principles, the International Labour Organization conventions and the Global Reporting Initiative standard. “As

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom