Xlear Files Legal Response to Government’s Lawsuit

(BUSINESS WIRE)-- 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.

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