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PRESS RELEASES

November 21, 2024

ProGear + Oxafence Masks Receive FDA Clearance and Launch in U.S. Healthcare

 

Prestige Ameritech, the United States’ largest wholly domestic surgical mask manufacturer, and Singletto, developer of Oxafence Active Protection technology, announce receipt of FDA clearance for the ProGear ASTM L3 Surgical Masks with Oxafence, which are now available at ProGearwithOxafence.com (individual purchases) and ProGearHealth.com (bulk purchases).

The ProGear+Oxafence Surgical Masks provide the highest level of ASTM performance plus Oxafence Active Protection technology, which inactivates 99.9% of tested viruses* after just five minutes. Specific viruses and conditions tested are detailed herein (see Indications for Use) and include H1N1 Influenza and OC43 Coronavirus isolates*.

Singletto and Prestige Ameritech believe Oxafence is the additional layer of protection on masks that healthcare workers and patients deserve.

“Oxafence enables all new product categories,” according to Singletto CEO John Bjornson, “We call it Active Protection. Healthcare workers and patients need the best possible protection and that means masks that are actively killing viruses while being worn.”

The ProGear+Oxafence Surgical Masks’ four-layer design provides Bacterial and Particulate Filtration Efficiency (BFE & PFE) and Fluid Barrier Protection that meet the latest ASTM Level 3 standards (F2100-23). The patented Wave-Fit pre-bent nosepiece allows for easier donning, per Prestige Ameritech.

A 50-year veteran of the mask industry, Prestige Ameritech CEO Dan Reese, says, “We have long searched for a technology like Oxafence. We already provide high-quality products, made right here in the USA. And now, we can offer additional protection – this product is like nothing else in the healthcare market today.”

Singletto Co-Founder and Chief Scientific Officer Dr. James (Jim) Chen adds, “After spending decades as a neurosurgeon and oncology researcher studying the pathogen-destroying benefits of antimicrobial photodynamic inactivation (aPDI), the core technology behind Oxafence, I am so proud to now have it in the hands of those who need it most.”

Though masks are the first Oxafence-powered product, Singletto Co-Founder and Chief Medical Officer Dr. Tom Lendvay, a pediatric surgeon, says, “We envision the day when all soft surfaces in the healthcare environment … from scrubs and PPE, to bedding, to surgical drapes, and more… are treated with Oxafence for ongoing pathogen inactivation. But we had to start somewhere – and that’s with these USA-made, high quality, Active Protection masks!”

The ProGear Surgical Masks with Oxafence are available for purchase at ProGearwithOxafence.com (individual purchases) and ProGearHealth.com (bulk purchases).

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Indications for Use: The ProGear Surgical Mask with Oxafence is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

*The ProGear Surgical Mask with Oxafence inactivates single isolates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux: Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3 log or 99.9% inactivation; Betacoronavirus 1 OC43 (ATCC VR-1558), 4 log or 99.99% inactivation; Feline Calicivirus F-9 (ATCC VR- 782), 4 log or 99.99% inactivation. Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.

For more information, contact: Info@Singletto.com

About Singletto

Singletto, Inc. licenses its proprietary Oxafence® Active Protection technology to healthcare, military, and consumer brands and manufacturers to provide solutions for existing and future products, technology, and systems.

www.Singletto.com

About Prestige Ameritech

Prestige Ameritech is the United States’ largest wholly domestic surgical mask manufacturer and a TERO Certified Native American-Owned Business. The company designs and manufactures premium disposable medical devices, including ProGear surgical masks, and the automated machinery that produces them.

www.PrestigeAmeritech.com | www.ProGearHealth.com

 

 

January 25, 2023

Prestige Ameritech Acquires Anexa Biomedical

 

  • Acquisition expands Prestige’s offerings to include sterile water and sterile saline, two products historically prone to shortages.

  • Transaction funded in part by previous investments from Premier, Inc. and 16 leading, national health systems.

North Richland Hills TX. — Prestige Ameritech (Prestige), one of the country’s largest manufacturers of personal protective equipment (PPE), today announced the acquisition of Anexa Biomedical.

 

Anexa is a domestic manufacturer of sterile water and sterile saline products, which are used daily in acute-care hospitals to treat respiratory illnesses such as COVID-19 and influenza, as well as reconstitute medications and flush intravenous lines. In a typical facility, hundreds of units of sterile water and sterile saline are used daily. Given high demand historically, sterile water and sterile saline have been prone to shortages, rolling on and off the U.S. Food and Drug Administration’s drug shortage list for more than five years.

 

“We are actively looking to grow our business by expanding into categories in need of a reliable domestic production option to prevent shortages,” said Dan Reese, Prestige co-founder and CEO. “As the COVID-19 pandemic proved, diverse and on-shore manufacturing of critical healthcare products is a national security issue. With these categories, we will seek long-term, multi-year commitments that give us certainty and allow us to dedicate our resources to increase production to address shortages of critical supply items.”

The acquisition is made possible in part by previous investments and multi-year purchasing commitments, as previously announced, from Premier, Inc., a leading healthcare improvement and technology company, and 16 of its member health systems.

“We are proud to support Prestige’s expansion and mission to serve as a reliable domestic source for essential medical supplies,” said Andy Brailo, Premier, Inc.’s Chief Customer Officer. “The sterile water and sterile saline market is volatile, and we are confident that Prestige has the track record and skill sets needed to scale U.S. production to ensure a more reliable and resilient supply for healthcare providers.”

Prestige relocated the Anexa production equipment to Prestige’s main facility in North Richland Hills, Texas. Anexa’s prior owner is remaining with Prestige as a consultant to guarantee a smooth transition. Prestige also added two seasoned industry experts as consultants to successfully launch the new categories.

 

May 26, 2020

Premier Inc. and 15 Leading Health Systems Invest to Expand Domestic PPE Production Through Prestige Ameritech

 

Premier and 15 of its members acquired a minority stake in Prestige Ameritech, the nation’s largest domestic producer of face masks, as well as other personal protective equipment (PPE); Move represents a long-term strategy to invest in or partner with suppliers that source from multiple regions as well as domestic markets to help ensure that a greater proportion of healthcare products are insulated from shortages and available in times of need.

CHARLOTTE, N.C. — Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company, and 15 leading health systems acquired a minority stake in Prestige Ameritech, the largest domestic manufacturer of face masks, including N95 respirators and surgical masks.

Under the agreement, Premier members commit to purchase a portion of all face masks they use annually from Prestige Ameritech for up to six years, inclusive of a three-year renewal option.

The arrangement with Prestige Ameritech is part of Premier’s newly announced strategy to work with members to invest in domestic and geographically diverse suppliers of PPE and other medical equipment currently in shortage due to the COVID-19 pandemic.

PPE products critical for the daily operations of health systems are overwhelmingly sourced overseas, with approximately 80 percent coming from China and Southeast Asia. The risks of this overreliance on Asia came into sharp focus as COVID-19 swept across the globe and these nations closed borders and prevented U.S. access to supplies, triggering widespread shortages of PPE needed to protect healthcare workers and patients. In contrast, Prestige Ameritech represents a domestic supply chain, with production completed in the United States. Prestige also sells 100 percent of its products to U.S. customers.

“With past outbreaks such as SARS, H1N1 and Ebola, the nation talked about domestic manufacturing and expanding supply sources as the keys to preventing shortages, only to return to the same overleveraged overseas markets once the crisis was over,” said Premier President Michael J. Alkire. “This move is the latest step in our long-term commitment to changing the way we source critical products so that we never again experience shortages as a result of overreliance. Our economic prosperity can no longer be tied to things we buy – it must also come from things we make.”

“As COVID-19 proves, the United States is almost completely at the mercy of foreign nations for vital supplies,” said Dan Reese, Prestige Ameritech co-founder and CEO. “Diverse and on-shore manufacturing of critical healthcare products is clearly a national security issue. With this agreement, we have long-term, multi-year commitments that give us certainty and allow us to dedicate our resources to increase production. Not only does that help us today with COVID-19, but long-term commitments also create economies of scale for when we return to business as usual.”

Premier members participating in the initial investment include AdventHealth (Altamonte Springs, FL), Adventist Health (Roseville, CA), Advocate Aurora Health (Downers Grove, IL, and Milwaukee, WI), Ballad Health (Johnson City, TN), Banner Health (Phoenix, AZ), Baptist Health South Florida (Miami, FL), CommonSpirit Health (Chicago, IL), Genesis Health System (Davenport, IA), Henry Ford Health System (Detroit, MI), McLaren Health Care (Grand Blanc, MI), Riverside Health System (Newport News, VA), St. Luke’s University Health Network (Bethlehem, PA), Texas Health Resources (Arlington, TX), Universal Health Services, Inc. (King of Prussia, PA) and University Hospitals (Cleveland, OH).

“These members are true innovators, as they are the first to step up and fund the long-term domestic manufacturing of healthcare products,” continued Alkire. “This agreement and the added domestic supply it enables would not be possible without their commitments. Each one deserves recognition for its leadership and for its work to bring supplies back home to America.”

Financial terms of the agreement were not disclosed.

About Premier, Inc.

Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,000 U.S. hospitals and health systems and approximately 250,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier’s news and investor sites on www.premierinc.com; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier’s blog for more information about the company.

 

Contact: Public_Relations@premierinc.com

 

May 16, 2016
 

ProGear® Enters the Retail Market with Realtree® Xtra Camo Nuisance Dust Mask

​​DALLAS, Texas - Facemask maker Prestige Ameritech announced the release of the Realtree® Xtra Camo Mask through their ProGear® brand, which is now available in the retail market nationwide. In an industry filled with plain, white masks, the Realtree® Xtra Camo Mask by ProGear® is the first nuisance dust mask in the world to sport the licensed Realtree® Xtra camo pattern.

 

“We are very pleased by the market’s enthusiastic acceptance of the Realtree® Xtra Camo Mask. Now that we’ve proven the concept, we are developing a family of printed masks and respirators,” said Mike Bowen, Executive Vice President of Prestige Ameritech.

 

Mask Uses and Details

Realtree® Xtra Camo Masks are made to filter dust, pollen, animal dander, and grass, so they are ideal to wear while working outdoors. Dust masks are typically worn while sweeping, mowing, sanding a hobby project, brushing the family dog or doing other jobs around the house that may kick up a lot of dust. With the Realtree® Xtra camo pattern on them, the camo masks are also popular with hunters, especially in cold weather.

 

Why wear a plain mask when you can wear camo?

Realtree® camouflage prints have transcended the hunting and outdoor markets to become a $4 billion a year fashion phenomenon. Realtree® Xtra Camo Masks are neither white nor boring like the other masks found in hardware stores, so they stand out.

 

Availability and Pricing

Realtree® Xtra Camo Masks are available for purchase at camo-mask.com and select retailers across the United States. Suggested retail prices start at $4.99 for a 3-pack.

 

About ProGear® and Prestige Ameritech

Prestige Ameritech is the largest domestic manufacturer of face masks in America. ProGear® is Prestige Ameritech’s line of high-quality surgical masks and respirators that have been in the hospital market since 2007. More information can be found at progearmasks.com.

 

REALTREE® AP-XTRA Camouflage Design © 2012 of Jordan Outdoor Enterprises, Ltd. All Rights Reserved.

 

Contact

Mike Bowen

mike@camo-mask.com

817-898-0037

 

​​7.20.2012

Prestige Ameritech Buys 220,000 SF Texas Manufacturing Plant on Seventeen Acres

​NORTH RICHLAND HILLS, Texas - Prestige Ameritech announces the purchase of the 220,000 SF building that it has been leasing since November of 2009, when it resurrected a closed Kimberly Clark mask and respirator manufacturing facility.  “We began Prestige Ameritech in 2005 in a 3,000 square foot storefront not too far from here.  We’ve come a long way in a short time --- and we’re just getting started!”, said Dan Reese, President. 
​ 
Since 2006, Prestige Ameritech’s mission has been to put the US mask supply back under American control.  “This building will help us keep up with the demand for US-made masks and respirators”, said Mike Bowen, Vice President.

11.08.2010
Prestige Ameritech Unveils US-Made N95 Respirator as Flu Season Begins

NORTH RICHLAND HILLS, Texas - Prestige Ameritech has received NIOSH and FDA approval to market its new N95 Particulate Filter Respirator and Surgical Mask in time for the 2010 Flu Season. The new respirator will be sold by Owens & Minor and other distributors. Prestige Ameritech was recently awarded contracts for N95 respirators and surgical masks by the Premier and Med Assets Group Purchasing Organizations.

The ProGear® N95 Respirator has the highest fluid-resistance rating available, a larger-than-normal filter area for easier breathing and speaking, soft stretch-knit headbands for increased comfort, and a convenient dispensing method.

"We're going to show the healthcare industry that respirators don't have to be bulky, uncomfortable or expensive to be effective," said Dan Reese, President of Prestige Ameritech.

Prestige Ameritech's new N95 Respirator is another step toward its goal of placing America's surgical mask and respirator supply back under American control. Much of America's surgical mask and respirator supply is currently imported.

11.06.2009
Prestige Ameritech Reopening Former Kimberly-Clark Surgical Mask Factory to Fight H1N1, Create US Jobs

 

NORTH RICHLAND HILLS, Texas - Prestige Ameritech is turning a vacant, former Kimberly-Clark surgical mask factory into a Global Pandemic Preparedness and Response Center. The 220,000 square foot facility, on 17 acres in North Richland Hills, Texas, will open by January 31, 2010. Besides supplying America's hospitals with their normal supplies of masks and respirators, the center will help the US and other countries build surgical mask and N95 respirator stockpiles for use during the H1N1 and future pandemics. Stockpiling reduces the likelihood of mask and respirator shortages during global emergencies. America's hospitals are currently experiencing a pandemic related mask and respirator shortage.
Many of Prestige Ameritech's 200 employees once worked at the facility when it was operated by Kimberly-Clark. In 2006, Kimberly-Clark closed the factory when it and the rest of Americas major mask makers discontinued making surgical masks in the US. By securing America's mask supply with American made masks, Prestige Ameritech hopes to create another 200 jobs in the next few years.
"Prestige Ameritech will provide US healthcare systems with a secure, high quality American made surgical mask and respirator supply that cannot be diverted by foreign health agencies during global emergencies," said Dan Reese, Prestige Ameritech's founder and CEO.
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