MedX(R) Receives FDA Clearance for Oralase(TM), an Advanced Laser Treatment for Pain
MISSISSAUGA, ON, Oct. 6 /PRNewswire-FirstCall/ - MedX Health Corp. (TSXV: MDX), a global leader in developing drug free, non-invasive therapeutics for tissue repair and pain relief, today announced that the Oralase(TM) Portable Laser has been cleared for marketing by the Food and Drug Administration (FDA). MedX's distribution partner, Technology4Medicine, a laser company in San Clemente, CA will begin immediate distribution of Oralase to dental offices in the United States. Oralase is a photobiomodulation device, also known as low level laser therapy (LLLT), exclusively designed for dentists to alleviate pain and accelerate tissue repair following dental procedures.
"We are very pleased to have received the 510(k) Clearance Letter from the FDA so that we can begin to immediately provide the dental community with our non-invasive and drug free solution to relieve pain due to surgical and other procedures. Oralase will not only relieve the pain by accelerating tissue repair, but it will provide patients the increased comfort of accelerated healing," said Steve Guillen B.Sc., M.B.A., president and chief executive officer, MedX Health. "Through our partnership with Technology4Medicine, we expect to fulfill a great unmet need in the dental community as well as other markets including dermatology and plastic surgery."
"With this FDA clearance, we will offer Oralase to dentists across the U.S. taking dentistry to a new level, increasing production for the dental office, and providing a better experience for patients," stated Jeffrey W. Jones, chief executive officer of Technology4Medicine. "We are looking forward to launching Oralase at booth #3051 at the upcoming American Dental Association meeting in San Antonio, TX, October 15-18. Oralase should be a fundamental component of today's high tech practice. It can dramatically differentiate today's dentist. We believe we have a winning formula in bringing the latest technology for quick uptake and use in this $1 Billion marketplace."
For more than 35 years, LLLT has been used in Europe, Australia, Asia and Russia for the treatment of pain and tissue repair. MedX's LLLT was approved in Canada in 1999 and in the United States in 2002. LLLT uses a specific type of light to penetrate the skin's surface and underlying tissues to stimulate the body's natural repair processes. The result is faster healing and reduced pain, swelling and inflammation. The technology has advanced laser therapy significantly, and Oralase embodies the new generation of photobiomodulation technology for health care today.
MedX is a leading North American developer and manufacturer of low level laser and light medical devices, including dental, rehabilitation and wound care products. MedX is the world's only company focusing on developing and delivering a broad cross-section of technologies and products involved in healing using light therapy. MedX is committed to advocating for and bringing the non-invasive, drug-free healing nature of light to people seeking relief from pain and other physical ailments.
MedX plans to use the proceeds from its recent public offering to expand its distribution network; support its marketing program; continue development of new dental, rehabilitation and wound care products; undertake research and development for wound care products; and for working capital purposes. In particular, MedX plans to accelerate the development of a new product aimed at the rapidly-growing wound care market: its "Photobandage", a bandage technology that allows a wound to be bathed in light, designed to enhance the healing process. The Company intends to license this new technology to one or more major wound care companies for further development, marketing and sales. For more information, visit www.medxhealth.com.
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information may include statements regarding the Company's future plans, objectives, performance, growth, profits, operating expenses or its underlying assumptions. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "expects", or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", or "will be taken", "occur", or "be achieved". Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of MedX to be materially different from those expressed or implied by such forward-looking information, including uncertainty of successful development of new products, uncertainty of successful manufacturing or marketing of products, uncertainty of commercial acceptance of products, uncertainty concerning governmental regulation, dependency on key employees and relationships, rapid technological changes, foreign currency fluctuations. MedX does not undertake to update any forward-looking information, except in accordance with applicable securities laws.
Technology4Medicine to have exclusive U.S. distribution rights for Oralase in the U.S.
SOURCE MedX Health Corp.
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