MW Medical, Inc. Contact information
Available devices
After researching hair removal devices since 1995, I have serious
misgivings about MW Medical. Several key personnel who were formerly
with the company have been involved in highly unethical activities,
and their business practices seem very curious, based on their
filings with the US Securities Exchange Commission (SEC).
I would urge all practitioners
and patients to avoid this device for any type of hair removal
until there is more data on safety and efficacy.
On October 25, 1999 FDA cleared this device for hair removal,
but not for use on on facial areas. As I discuss in the
section on  microwave clinical
data, there are serious concerns about the safety and effectiveness
of these devices for use on facial hair.
In 1999, MW Medical began its initial production of the MW 2000
Microwave Delivery System and delivered 36 of the machines to
clinical sites across the country. Only two of these were reported
as sold. Of these machines, the Company has taken back 4 machines,
10 are with its national distributor pending order placement,
10 are involved in clinical trials and 12 have been returned to
the Company's inventory to receive upgrades or other product modification.1
These design changes, pulsed microwave capability and the modified
cryogen spray cooling system, have not been evaluated in published
clinical data.
Notes
On 1 May 2001, I received a reply to a series of questions I'd
asked of MW Medical, specifically regarding what they had expressed
were inaccuracies about their device and company. Chief Financial
Officer Dean Drummond's responses are marked as MWMD,
my replies are HF.
MWMD: "You state 'Several key individuals
in the Company have been involved in highly unethical activities.'
I am unaware of any unethical or highly unethical activities
by the current members of management or employees of this company.
If you are aware of any specific activities by the current management
or employees please list individuals and activities."
HF: I know of no unethical activities by
current MWMD employees. The key individuals to whom I was
referring were the former Global Sales Manager (alleged by
MWMD to have falsified sales figures), and Robert Spertell,
former Medical Director (who lost his license to practice
medicine due to a breach of ethics). Both have since left
the company.
MWMD: "You state 'These design changes,
pulsed microwave capability and the modified cryogen spray cooling
system, have not been evaluated.'"
HF: On 3 April 2001 FDA cleared MWMD's new
handpiece for use with the device. That means FDA has evaluated
submission data and cleared the device for safety. As far
as I know, this new handpiece had no bearing on the indications
for use. I should have specified that the modifications have
not been evaluated in a peer-reviewed publication in terms
of long-term effectiveness.
MWMD: "Your paragraph, 'On October 25,
1999 FDA cleared this device for hair removal, but not for use
on facial areas. As I discuss in the section on microwave clinical
data, there are serious concerns about the safety and effectiveness
of these devices for use on facial hair,' is also misleading.
It gives the impression the FDA has serious concerns. I don't
believe either of us are qualified to comment of the FDA concerns.
However, should you have documentation that the FDA has serious
concerns, please forward it to the company as it would be news
to us."
HF: I was not implying that FDA has serious
concerns, but FDA obviously required more data before allowing
the device to be used on facial areas. Some researchers have
serious concerns about the safety of microwaves around the
eyes and face.
MWMD: "You also state 'Several reports
in recent years have raised concerns about the unknown risks
of electromagnetic frequency (EMF) radiation taken in concentrated
doses to the head and near the eyes.' is similarly misleading.
Most of the reports you cite are not recent, they are at least
a decade old. Your blanket conclusion that the results of those
report are analogous with our equipment is unfounded. Attempts
to draw similar conclusions under different, possibly very different,
circumstances is inherently inaccurate and scientifically unsound.
I am not suggesting that these reports are incorrect. I am only
suggesting that without knowing the specific parameters of the
tests performed in the report and how they compare and differ
with the specifications and parameters of use for our equipment,
it is premature and inappropriate to draw any corollary conclusion
with our equipment. Even your most current report states, "In
general, while the possibility of "non-thermal" biological
effects may exist, whether or not such effects might indicate
a human health hazard is not presently known." (FCC 1999)"
HF: This is my point: microwave radiation
delivered to the face with this device constitutes an unknown
risk. My concerns echo general concerns about EMF radiation
and its long-term effect on tissues.
MWMD: "It is, however, known that microwave
based hyperthermia has been FDA approved since 1996 for benign
prostate hyperplasia. Additionally, patent filings in the year
2000 for microwave based medical development (or hyperthemia)
numbers 70. You can also reference a journal "Microwave
Theory and Techniques", last printing November 2000, that
follows a variety of developments in numerous medical and health
fields by worldwide experts in the respective areas.
HF: There are also hundreds of peer-reviewed
medical papers on microwave use in treating benign prostate
hyperplasia, dating to 1985. To my knowledge, there is no
peer-reviewed published data on the use of microwaves for
hair removal. Patents and journals which discuss theoretical
uses are no substitute for evidence-based facts about product
efficacy.
MWMD: You stated "...their business practices
seem very suspicious, based on their filings with the US Securities
Exchange Commission (SEC)." Just in case you are unaware,
all of our filings are reviewed by outside legal counsel for
accurate and appropriate legal disclosure and our annual filing
is also audited by an independent accounting firm prior to filing
with the SEC. If you are stating that there are inappropriate
activities occurring, could you please indicate which practices
are "suspicious" and provide us with documented support
of such allegations.
HF: I am referring specifically to the former
sales manager for MW Medical, whose sales figures were said
to have been inflated. It also seems highly unusual for a
company to borrow money from an officer. My questions about
sales figures are an example of what I will call the curious
nature of MW Medical.
MWMD: "As for your remaining questions,
I am rather surprised by the nature of the majority of these
questions. You seem to be more interested in the quantities
and dollar value of our sales than the safety and efficacy of
our product. In fact, you ask for information that, for our
company, is not publicly available, and, for the majority of
companies, generally is not provided to the public."
HF: My questions about sales figures were
based on several public disclosures by MW Medical regarding
their sales figures. Since they have also stated these figures
were inaccurate, I was simply asking for clarification.
I should point out that MWMD is not alone. All lasers on the
market were also rushed to market without adequate testing of
effectiveness. MWMD sells a product, and it is up to them to prove
to consumers that it's worth purchasing. I have not seen adequate
proof that consumers should pay to be treated with this device.
1 August 10, 2000 MW
MEDICAL INC (MWMD.OB) Quarterly Report (SEC form 10QSB)
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