ESWT/Canada ArticlePosted by Elyse B on 5/12/05 at 08:50 (174808)
for anyone interested:
May 11, 2005 04:30 PM US Eastern Timezone
Orthometrix, Inc. Announces Canadian Medical Device License for Its New Orbasone ESWT Pain Relief System
International Foot and Ankle Congress
WHITE PLAINS, N.Y.--(BUSINESS WIRE)--May 11, 2005--ORTHOMETRIX, INC. (OTCBB: OMRX) announced today at the International Foot and Ankle Congress in Toronto, Ontario that its new Orbasone(TM) Pain Relief System received a Medical Device License from Health Canada and may now be sold in the Canadian market for treatment of chronic plantar fasciitis (foot pain). The Orbasone is manufactured in the US by Kimchuk, Inc. of Danbury, CT and distributed in Canada by Orthometrix.
Already used in several countries in Europe and Asia by podiatrists and orthopedic surgeons, the Orbasone now is available to podiatrists in Canada to treat chronic plantar fasciitis. Plantar fasciitis is an inflammation of the plantar fascia, i.e., the thick strand of collagen which is located under the foot and connects the calcaneus (heel bone) to the metatarsals. Injury of the fascia generally results from excessive tension, both from the muscles above and from the shape of the foot below. Once inflamed, the fascia develops microtears and mild pain can quickly turn into excruciating pain which reduces mobility and quality of life. The condition affects close to 40 million people in North America alone, particularly athletes and the elderly.
The Orbasone uses high-energy shock waves to relieve chronic heel pain. The technology is derived from a proven technology that has been used for the past 20 years to break up kidney stones without the use of surgery (lithotripsy). Unlike more expensive lithotripters that also may be used to treat heel pain, the Orbasone is small and compact. It has been specifically designed to treat pain in soft tissues. The shock waves are created by a spark plug enclosed in a soft dome filled with water. The membrane-covered dome is placed against the heel so that the shock waves pass through the membrane to the heel. Treatment typically takes about 30 to 40 minutes and is delivered to patients under the supervision and care of a physician such as an orthopedic surgeon or podiatrist.
The Orbasone is not available for sale in the U.S. The Company is continuing to work towards completion of the Premarket approval (PMA) process with the U.S. Food and Drug Administration (FDA). However, there is no assurance that the Orbasone will receive market approval from the FDA.
Orthometrix, Inc. markets, sells and services several musculoskeletal product lines used in pharmaceutical research, diagnostic and monitoring of bone and muscle disorders, sports medicine, rehabilitative medicine, physical therapy and pain management.
Our Web addresses are http://www.orthometrix.net and http://www.vibraflex.com .
'Safe Harbor' Statement under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this release are forward looking statements that involve risk and uncertainties, including, but not limited to, any effect on future financial results from efforts to broaden the Company's position in the rehabilitation, physical therapy and musculoskeletal markets, any potential impact on sales of the Orbasone in Canada, and other risks detailed in the documents periodically filed with the Securities and Exchange Commission, specifically the most recent reports on Forms 10-K and 10-Q. These risks and uncertainties could cause actual results to differ materially from those expected and/or contained in the forward-looking statements. Any forward-looking statement made in this release is made as of the date of this release and the Company assumes no obligation, subject to applicable law, to update such forward-looking statement.
Re: ESWT/Canada ArticleEd Davis, DPM on 5/13/05 at 18:38 (174956)
While on the subject of Canada, did you have a chance to read the Canadian portion of the Sonorex site? Go to http://www.sonorex.com
Once there, you can click on US citizen or non-US citizen. Click on the latter --- that will open the door to a lot of information of interest.
Re: ESWT/Canada ArticleElyse B on 5/14/05 at 17:22 (175031)
Ed, I just posted the ESWT article because I have 'google alerts' for anything coming up on the web for PF and thought it might of interest to someone. I read the ESWT boards with interest but never have considered having it. I must have the 'mild' version of PF, it is chronic and I have had for over a year but I have continued to run which I know is contraindicated by all. In fact I ran a half marathon this morning and beat my personal record by 10 minutes. Of course it was not pleasant and my feet hurt during and afterwards.