Orthometrix (CE) (USOTC:OMRX)
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From Jan 2020 to Jan 2025
ORTHOMETRIX, INC. (OTCBB: OMRX) announced today that its
new Orbasone(TM) Pain Relief System received market approval from the
U.S. Food and Drug Administration ("FDA") for the treatment of chronic
plantar fasciitis (foot pain).
Already used in several countries in Europe and Asia by
podiatrists and orthopedic surgeons, the Orbasone(TM) was approved for
sale in Canada earlier this year. It is now manufactured in the United
States and available to U.S. podiatrists, orthopedic surgeons and
professional sport team physicians 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, mild pain can
become chronic pain which reduces mobility and quality of life.
According to a survey conducted by the American Podiatric Medical
Association in 2000, 38.6 million Americans suffer from plantar
fasciitis. The condition particularly affects 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. The extracorporeal shockwave therapy, or ESWT, 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 a
podiatrist.
Orthometrix has assembled a direct U.S. sales organization
consisting initially of 3 regional sales managers, reporting to a
senior sales executive to market the Orbasone to podiatrists,
orthopedic surgeons and professional sport team physicians.
Orthometrix's Team Orbasone also includes 2 application specialists
and 2 service engineers.
Commenting on the Orbasone, Reynald Bonmati, Chairman and Chief
Executive Officer of the Company, stated, "I am particularly excited
about our Orbasone system as I believe that it has significant market
potential. Our clinical trials have shown that the Orbasone is safe
and effective, and it is less expensive than larger systems. Our
Orbasone study was conducted with 179 people with chronic pain from
plantar fasciitis, at Weil Foot & Ankle Clinic in Des Plaines,
Illinois, Manhattan Podiatry in New York, New York and Sunset
Ambulatory Surgical Clinic in Los Angeles, California. The results
showed 69% of the Orbasone treated people had at least a 40% reduction
in pain at 12 weeks post-treatment, compared to 37% of the sham
people. Some people felt immediate pain relief, but it may take up to
6 weeks for pain relief to begin, and may continue for up to 12 weeks
after an Orbasone treatment session. The Orbasone is also the only
ESWT device approved in the United States for the treatment of chronic
plantar fasciitis that is also manufactured in the United States. Our
intent is to make ESWT treatment affordable to a larger segment of the
U.S. population."
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 www.orthometrix.net and 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 North
America, and other risks detailed in the documents periodically filed
with the Securities and Exchange Commission, specifically the most
recent reports on Forms 10-KSB and 10-QSB. 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.