MW Medical, Inc.


MW Medical, Inc.

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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)