MINERAL WELLS, Texas–(BUSINESS WIRE)–Alpha-Stim, cranial
electrotherapy stimulation (CES) devices providing treatment for anxiety,
depression, insomnia and pain, announces its user-supported campaign to change
an FDA rule regarding Pre-Market Approval (PMA), the medical device equivalent
of a new drug application. FDA is proposing a rule that would now require PMA
for CES, while for the past 30 years CES devices have been legally cleared to
market in the USA
by FDA.
Approved for over the counter sales in Europe, China and Canada, the Alpha-Stim devices have
gone through an extensive review process for the FDA six times since 1981 and
have been cleared to market. Alpha-Stim is highly respected in the medical
industry (doctors, psychologists, addiction professionals, etc.) and military
communities, resulting, to date, in over 100 written objections to this
proposed rule on behalf of Alpha-Stim, indicating its safety, lack of side
effects, and above all, its effectiveness.
Texas Congressman Joe Barton has recently submitted the
following statement to the Congressional Subcommittee on Oversight and
Investigations: “The Medical Device Review Process at the Food and Drug Administration
(FDA) has become overly burdensome, unpredictable and inconsistent under its
current leadership…Small companies and entrepreneurs want to create businesses
and design products that will help save lives and be profitable.”
In its comments to the proposed rule submitted to FDA docket
No. FDA-2011-N-0504-0078 on October 12, 2011, Alpha-Stim has focused on three
main areas of concern in the proposed rule:
- FDAs review of the science
- FDAs review of safety data
- FDAs evaluation of the economic impact of this ruling
EPI inc., Alpha-Stims parent company, is asking for the
“valid scientific evidence” provided to FDA for CES be reviewed thoroughly and
fairly. EPI asks that FDA review all of the safety data provided and revise the
findings within the proposed rule. EPI has provided the FDA with valid
scientific evidence showing:
- 99.9% of actual Alpha-Stim users considered the device
effective. - Only 11 out of over 50,000 Alpha-Stim users (less than
0.02%) reported adverse effects from using Alpha-Stim. - 49 completed studies and 12 on-going studies conducted on
Alpha-Stim support the safety and effectiveness of the device.
The economic impact of the ruling is to impose a process
that the FDA estimates will cost the company $1 million, for a product they
approved over 30 years ago. Alpha-Stim and its supporters find the ruling
overly aggressive and in complete opposition to all the positive information
found in studies that Alpha-Stim diligently provided.
Through the use of its proprietary waveform, Alpha-Stim
technology applies a mild electrical current via electrodes that clip onto the
earlobes. The waveform works effectively in a safe and controlled manner to
gently coax the brains electrical signals to normalize. The result is safe and
effective treatment of anxiety, depression, insomnia, and pain. Alpha-Stim
works with the body instead of against it, and is non-invasive and gentle as
compared to the strong electrical signals from other devices used in both
physical medicine and psychiatry. The devices also operate without the side
effects that are common to prescription medications.
To view the FDA docket including proposed rule and letters
of support for Alpha-Stim, please visit www.regulations.gov and search using the proposed rules
docket number: FDA-2011-N-0504.
About Alpha-Stim
Alpha-Stim is an industry leader in cranial electrotherapy stimulation (CES)
devices, providing treatment for anxiety, depression, insomnia and pain,
without the side effects common to prescription medications. Alpha-Stim works
by applying a mild electrical current that works effectively in a safe and
controlled manner. Created by experienced medical industry leaders Dr. Daniel
Kirsch and the company he founded EPI inc., Alpha-Stim utilizes technology
based on more research than any other therapeutic device on the market. For
more information on Alpha-Stim, please visit www.alpha-stim.com
