NovaMin Technology Inc. Announces Milestone FDA Clearance
Oravive™ Tooth Revitalizing Paste Cleared As Therapy For Sensitive Teeth
ALACHUA, FL - May 17, 2004 -- NovaMin Technology, Inc. ("NTI") today announced the marketing clearance of Oravive™ Tooth Revitalizing Paste by the US Food and Drug Administration. This is the Company's third FDA clearance of a product using its proprietary NovaMin® active ingredient.
The clearance of Oravive™ as a therapy for dentin hypersensitivity is a milestone as it represents the first time that an over-the-counter toothpaste product has been cleared by the FDA under section 510(k) 'device' regulations. A device clearance is recognition of NovaMin's physical action of shielding the tooth nerve from hot and cold liquids through formation of a new calcium-based mineral layer. By contrast, other desensitizing toothpastes operate by deadening the tooth nerve, and are therefore are categorized as 'drugs' by the FDA.
"We are excited by the clearance of Oravive™, and in particular by the Agency's recognition of NovaMin's unique mode of action", said NTI Chief Technology Officer, Dr. David Greenspan. "We think this offers an important new option for consumers. We believe the nerve-deadening action of traditional sensitivity toothpastes is a fundamentally unsound way to treat this condition. Deadening the nerve treats the symptoms of sensitivity to hot and cold liquids, sweets or pressure -- but not the real problem, which is openings to the pulp along the gum line.
The nerve-deadening mode of action of traditional sensitivity toothpastes may also create vulnerability by reducing the users dental responsiveness to important and valuable sensations that can indicate a more serious condition. By contrast, NovaMin® (the active ingredient in Oravive™) creates a mineral shield that blocks the open 'tubules' along the gum line that provide access between the tooth nerve and the outside world. This mineral shield is made up of the same crystalline calcium-phosphate that comprises normal tooth mineral (called 'hydroxyapatite').
Oravive™ Tooth Remineralizing Paste is currently sold at the www.oravive.com website. Oravive™ has been sold for over a year as a cleaning dentifrice without the claims as a therapy for sensitive teeth, which were included in the FDA clearance.
NovaMin Technology Inc. is dedicated to innovation in oral health care. Its patented active ingredient for oral care products, NovaMin®, is the product of over 30 years of medical research into the mineralization processes of teeth and bones. Major consumer oral health care products manufacturers and selected profession-use dental products manufacturers are currently developing products based on the NovaMin® platform.
Contact:
Randy Scott, CEO
NovaMin Technology Inc.
+1-386-418-1551
rscott@novamin.com
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