LIVFRESH Becomes the World's First European Union CE Mark Certified Toothpaste for Prevention & Treatment of Periodontitis & Gingivitis as an adjunct to Professional Care
As Mounting Evidence Connects Gum Disease to Covid Complications, Silicon Valley Based LIVFRESH Dental Gel is approved in the European Union as the First Over the Counter Toothpaste for Consumers Suffering from Periodontitis or Gingivitis. These Oral Diseases Affect up to 90% of All Adults.
LOS GATOS, Calif., June 2, 2021 /PRNewswire-PRWeb/ -- As the world continues to fight COVID, and since serious gum disease (periodontitis) has been implicated as a complicating factor, good oral health is more important than ever. Livionex Inc., the company behind LivFresh Dental Gel, today, announced its therapeutic non-abrasive and detergent-free toothpaste is the first in the world to meet requirements under the European Medical Device Regulations as an over-the-counter toothpaste for the prevention and treatment of periodontitis and gingivitis. The company highlighted that LivFresh is positioned as the toothpaste of choice for daily home care, and a critical tool to support professional dental care for the effective treatment of periodontitis.
LivFresh Dental Gel has received European approval as a medical device with therapeutic claims. This is accomplished by getting a CE Mark certification, which means that LivFresh met strict safety and performance criteria under the European Medical Device Regulations as an over-the-counter product to both prevent and treat periodontitis and gingivitis.
LivFresh Dental Gel is registered as a CE Marked product with the German Federal Institute of Drugs and Devices. EU Medical Device approvals are recognized across European countries as well as in most Asian countries, all South and North American countries except USA, and Africa.
"LivFresh Dental Gel represents a huge breakthrough in oral care worldwide. While there are toothpastes that treat and prevent gingivitis, there is no toothpaste approved by any regulatory agency that can claim treatment and prevention of periodontitis, a severe form of gum disease," said Peter Jacobsen, DDS, PhD, a nationally recognized expert on dental pharmacology, and the former Chairman of the ADA Council on Dental Therapeutics.
"The timing of the certification couldn't have come at a more critical time as the incidence of gum disease worldwide has hit epidemic proportions. Research shows that periodontitis is linked as a risk factor, to many systemic diseases. Recently it has also been linked to a nine-fold (900%) increase in mortality of COVID-19 patients," added Hirsh Goswamy, VP of Marketing, Livionex.
Gum disease affects up to 90% of all adults in developed countries including USA and Europe. In the U.S., periodontal disease, a severe form of gum disease, affects 47.2% of adults aged 30 years and older, which is about 65 million Americans. The European prevalence of periodontitis is similar.
"The management of periodontitis requires effective daily plaque control by the patient. This remains a challenge for most patients. The LivFresh study results show that periodontitis patients can achieve significant benefits of better oral health, without changing their daily brushing habits," said Dr. Nicolaas Geurs, a leading internationally recognized periodontist and professor and chair of the Department of Periodontology at the University of Alabama at Birmingham School of Dentistry.
LivFresh's unique mechanism of action enables the tooth surface to repel plaque at the molecular level. This is different than traditional toothpastes which rely on scrubbing and antimicrobials to clean plaque. Multiple double-blind studies published in peer reviewed journals have documented the superiority of LivFresh Dental Gel over traditional toothpaste.
A groundbreaking double-blind clinical study recently published in the Journal of Periodontology, showed that the group that brushed with LivFresh dental gel saw 80% of their diseased pocket depths improve. Pocket depths are markers for periodontitis. These results are similar to the reported average improvement observed with professional scaling and root planing when used with FDA-approved locally delivered antibacterial drugs.
Additionally, the above study showed that compared to the group using the FDA approved anti-plaque, anti-gingivitis control toothpaste, subjects who brushed with LivFresh saw 2.5 times less gum inflammation and 1.9 times less gum bleeding.
"LivFresh study results indicate a big step forward in the arena of patient/professional co-treatment of inflammation-based periodontitis. LivFresh presents a novel and significant addition to the clinical control and management of periodontal disease," added Dr. Nicolaas Geurs.
LivFresh Dental Gel is currently available as a toothpaste for superior plaque removal on-line at GetLivFresh.com and in select dental offices across the country.
About LIVIONEX
Livionex Inc. was founded in 2009 with the goal of enhancing the quality and longevity of human life. Headquartered in Los Gatos, California, USA, Livionex develops novel therapies for a variety of age-related diseases affecting billions of people worldwide. The Company's products are based on its proprietary technology and has clinical stage products in ophthalmology, dermatology, and oral care. The first product to market is LivFresh Dental Gel. LivFresh is used and recommended by thousands of dentists and hygienist, and patients. It is currently available on-line and in select dental offices across the country. The technology underlying LivFresh has been validated by numerous studies and sources, including dental professionals, the U.S. Department of Defense, and the US National Institutes of Health. More can be found at http://www.GetLivFresh.com
Media Contact
Melanie Frenkel, LivFresh, 442-244-0621, [email protected]
SOURCE LivFresh
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