Business Wire

Xlear Submits COVID-19 Pre-Emergency Use Authorization Request with FDA Regarding Use of Xlear Nasal Spray in Help in Combating SARS-CoV-2

Share

Xlear has filed a Pre-Emergency Use Authorization (Pre-EUA) Request with the U.S. Food and Drug Administration (FDA) seeking approval to make claims that the nasal spray is approved for use in preventing SARS-CoV-2 (COVID-19) transmission and infection. The Pre-EUA is a first step in seeking formal authorization of Xlear Nasal Spray as tool to help in combatting COVID-19.

Xlear previously filed a pre-EUA seeking approval for use of the nasal spray as a medical device in combatting COVID-19. However, because the FDA determined that Xlear “works against the virus,” the FDA told Xlear it would need to be considered as a drug or combination product EUA.

“Seeing that the FDA says Xlear works against the virus, we have decided to seek EUA approval as a drug,” said Nathan Jones, Xlear’s CEO.

Xlear’s Pre-EUA Request is based on recent studies showing the nasal spray is:

  • virucidal (it kills the virus);
  • antiviral (it blocks the adhesion of the virus to the nasal membrane, which is how most people get sick from COVID-19);
  • antibacterial against streptococcus bacteria, which is the leading cause of bacterial pneumonia (a COVID-19 complication linked to morbidity); and,
  • Reduces both the duration and severity of illness when used to treat COVID-19 patients.

Xlear is currently sold in over 50,000 pharmacies, grocery stores, and online as a nasal spray. “Xlear doesn’t require the EUA to be sold and used—we only need an EUA to be able to inform people about the benefits of using Xlear to protect themselves from COVID-19. It’s insane. Without the EUA, the Federal Trade Commission won’t let us simply inform people about new, published, independent scientific studies,” Jones added.

“We hope to move forward quickly with FDA to address gaps in current prevention and treatment strategies against SARS-CoV-2. People should be using Xlear as part of a layered defense to prevent getting COVID-19. If everyone used Xlear, in addition to taking other steps recommended by public health officials, we believe we could help the nation defeat COVID-19 faster,” Jones added.

More information on Xlear: https://xlear.com/

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

Contact information

Jeff Gulko
617.304.7339
jeff@thegulkogroup.com

About Business Wire

Business Wire
Business Wire



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

Quanergy’s 3D LiDAR Helps Waste Incineration Plant Optimize Recycling Process and Reduce Environmental Impact in China27.7.2021 16:18:00 CEST | Press release

Quanergy Systems, Inc., a leading provider of OPA-based solid state LiDAR sensors and smart 3D solutions for automotive and IoT, today announced a new smart LiDAR deployment automating waste plant operations, to ensure process efficiency and minimize the environmental impact of a waste-to-energy incineration plant in China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005789/en/ Quanergy’s 3D LiDAR Helps Waste Incineration Plant Optimize Recycling Process and Reduce Environmental Impact in China (Graphic: Business Wire) Deployed in collaboration with Hunan University, one of China’s top engineering research universities, and Hunan Qiaokang Bridge Health Intelligent Technology for Puxiang Bioenergy, Quanergy’s high accuracy M-Series 3D LiDAR sensors were applied to scan the surface of the waste piles at the incineration plant and create a 3D point cloud image, to accurately calculate the volume of the waste. The LiDAR

Andersen Global Enhances Gambian Foothold with Payce Consulting27.7.2021 15:30:00 CEST | Press release

Andersen Global continues its Africa expansion with the addition of collaborating firm Payce Consulting, adding dimension to the organization’s existing presence in The Gambia. Payce Consulting, founded in 2014 by Partner Paul Gaye, serves the public and private sectors at the local and international level including financial institutions, education, industrial and commerce, transportation, fish processing and export, hotel and leisure, seaport, energy, agriculture, information technology and government agencies. The tax and advisory firm provides corporate finance, business advisory, business structuring and insolvency, outsourcing, financial services and portfolio management services to clients. “Our client-focused approach, extensive industry knowledge and commitment to best-in-class service have allowed us to develop and maintain strong client relationships,” Paul said. “Our collaboration with Andersen Global is the next step for our firm as we look to provide our clients with the

Academy of Marketing Science Mary Kay Doctoral Dissertation Awards Announced at 2021 Annual Conference27.7.2021 15:03:00 CEST | Press release

Mary Kay Inc., a leading corporate advocate of women’s empowerment and entrepreneurship, continued its decades-long support of education and research with the announcement of the 2021 winners of the Mary Kay Doctoral Dissertation and Doctoral Dissertation Proposal Awards at the Academy of Marketing Science (AMS) Annual Conference held virtually last month. For more than 25 years, the global beauty company has awarded these annual grants to provide doctoral candidates in marketing the opportunity to showcase their successfully defended dissertations in front of their peers. Finalists are selected based on their final presentations at the AMS Annual Conference. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005230/en/ AMS Mary Kay Doctoral Dissertation Awards were presented to six deserving winners at the 2021 AMS Annual Conference held virtually. (Graphic: Mary Kay Inc.) Submissions are open to doctoral students from pr

Everbridge Launches Industry’s First Global Critical Event Management (CEM) Certification TM Program with Formalized Standards for Enterprise Resilience27.7.2021 14:00:00 CEST | Press release

Everbridge, Inc. (NASDAQ: EVBG) today announced the industry’s first Critical Event Management (CEM) Certification™ Program for assessing an organization’s enterprise resilience. Developed from 20 years of professional services engagements across tens of thousands of projects in over 150 countries and facilitating tens of billions of critical interactions, Everbridge’s proprietary CEM Standards FrameworkTM and related certification process offer organizations an end-to-end methodology for evaluating and benchmarking enterprise resilience preparedness. Businesses who achieve CEM CertificationTM status follow proven industry best practices for enterprise resilience to keep their people safe and organizations running, faster. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005510/en/ Everbridge Launches Industry’s First Global Critical Event Management (CEM) Certification Program with Formalized Standards for Enterprise Re

ExaGrid Named a Finalist for the 2021 Storage Awards27.7.2021 14:00:00 CEST | Press release

ExaGrid®, the industry’s only Tiered Backup Storage solution, today announced that it has been nominated in six categories for the 18th annual Storage Awards. ExaGrid has become a finalist for Enterprise Backup Hardware Company of the Year, Storage Innovators of the Year, Immutable Storage Vendors, Storage Performance Optimisation Company of the Year, Storage Product of the Year, and Storage Company of the Year. Voting to determine the winner in each category is underway now and closes on September 8, 2021. Winners of this year’s awards will be announced at “The Storries XVIII” awards ceremony held in London on September 22, 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005142/en/ “We are honored to be nominated in six categories,” said Graham Woods, ExaGrid’s Vice President of International Systems Engineering. “It is also exciting that The Storries awards ceremony will be held in person this year, as the pande

Additive Manufacturer Green Trade Association Announces New Members27.7.2021 13:59:00 CEST | Press release

The Additive Manufacturer Green Trade Association (AMGTA), a global trade organization created to promote the environmental benefits of additive manufacturing (AM), announced today that eight additional leading AM companies have joined the trade group to advance sustainability in AM, bringing its membership ranks to 28 members. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005192/en/ Joining the AMGTA as a new Founding Member is Stratasys, a global leader in polymer 3D printing solutions for industries such as aerospace, automotive, consumer products, and healthcare. Stratasys will serve alongside existing Founding Members ExOne, the pioneer and global leader in industrial 3D printing systems using binder jet 3D printing technology; QC Laboratories, an advanced non-destructive testing laboratory focused on AM components; Sintavia, a designer and 3D printer of a new generation of flight and launch components; and Taiyo

CBRE To Acquire Majority Interest in and Form Strategic Partnership With Turner & Townsend27.7.2021 13:30:00 CEST | Press release

CBRE Group, Inc. (NYSE:CBRE) and Turner & Townsend Holdings Limited today announced a definitive agreement whereby CBRE will acquire a 60% ownership interest in, and enter into a strategic partnership with Turner & Townsend, a United Kingdom-based global leader in program, project and cost management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005548/en/ CBRE will acquire a 60% stake for approximately £960 million ($1.3 billion) in cash, with 55% to be paid upon closing. The transaction preserves Turner & Townsend’s existing leadership team, heritage, operational independence and partnership structure, which will hold the remaining 40% ownership interest. The transaction values Turner & Townsend at approximately £1.6 billion ($2.2 billion) and is expected to be immediately accretive to CBRE’s earnings. Turner & Townsend provides program management, cost consultancy, project management and advisory consulting servic

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