SOURCE: Xlear, Inc.

September 13, 2007 10:06 ET

Xlear Achieves ISO 9001:2000 and ISO 13485:2003 Certifications

Certifications Validate Company's Commitment to Quality in All Aspects of Business

OREM, UT--(Marketwire - September 13, 2007) - Xlear, Inc., a leading manufacturer of xylitol products, today announced that it has achieved ISO 9001:2000 and ISO 13485:2003 certification for quality management, which is the recognized international standard for medical device regulations around the world. The certification, awarded by the BSI Group, validates Xlear's focus on quality and allows the company to market Xlear Nasal Wash around the world as a medical device. In addition, Xlear can now affix CE marking to Xlear Nasal Wash packaging, indicating that it meets the essential health and safety requirements established by the European Union.

The certification process, which was completed following extensive preparation and a three-day audit in January 2007, evaluated every aspect of Xlear's business, from manufacturing to supply chain, and logistics to customer service. BSI also completed a follow-up assessment in July 2007. The ISO 9001:2000 quality management system provides Xlear with a management framework that will allow the company to continually monitor and quickly improve performance in any area of its business. By meeting the standards, Xlear has demonstrated that it has made efforts to streamline operations and reduce waste, manage risk and ensure that the needs of customers are being consistently considered and met.

"ISO certification is one of the crowning achievements in our organization's history," said Bob Astleford, director of operations for Xlear, Inc. "This recognition provides us with the quality seal of approval that we need to expand our manufacturing capabilities, and build business opportunities worldwide. Carrying the CE marking also demonstrates that our products are safe and effective according to EU standards, and European consumers can now benefit from our time-tested, doctor-recommended products. ISO certification provides us with a competitive advantage in a variety of areas, enhances our brand, and allows our employees to make even more of a positive impact on the direction and success of our company."

The certification was awarded to Xlear in its new 25,000 square foot Orem headquarters, which was completed in the fall of 2006. The building includes an industrial cleanroom, water purification system, and plumbing and sanitizing capabilities that allow Xlear to meet ISO manufacturing standards for its own products, as well as expand its contract manufacturing operations looking for an ISO-certified manufacturing partner. The company's goal is to use its new building 24 hours a day, seven days a week.

"We now have the quality management system in place that makes Xlear a truly attractive manufacturing partner to a variety of product companies," added Astleford. "The certification is a compliment to all of our employees that have worked hard to ensure that we think about our customers first in every aspect of our business. As a result, all of our customers will know that we build quality into all of our products, and will now carry a mark of quality that cannot be challenged by anyone."

About Xlear, Inc.

Founded in 2000, Xlear, Inc. is recognized as one of the leading manufacturers of xylitol products in the United States. Xlear, Inc. is committed to providing consumers with the health benefits of xylitol by manufacturing all-natural, health-enhancing products. Xlear, Inc. offers Xlear Nasal Wash, an award-winning, patented saline and xylitol solution; a complete line of dental health products under the Spry Dental Defense System brand; XyloSweet, raw xylitol crystals used as a sugar substitute in cooking, baking and general consumption; and Fine & Dandy Candy, a growing line of healthy, xylitol-based candies. Xlear, Inc. is a private company with headquarters in Orem, Utah.

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