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Lasers/Flash lamps: Additional information

The following information is not going to be of interest to general consumers and is presented only for those who are interested in even minute details of my research. I provide it to show how thoroughly this topic has been researched in preparation for writing this document. Again, much of the legwork has been done by Ted Molczan, who has amassed an astonishing dossier on each of these companies (especially the financial information found on this page). Since Ted and I get nothing but the thanks of fellow consumers for writing this, I hope you'll write me if you have found this information useful, or if you have anything to add or clarify. I will be happy to forward your comments to Ted, or you may write to Ted directly if you wish.

[One final note: while the information presented here has been provided by many consumers and other concerned parties, the opinions expressed herein are mine only and are based on all the data that has been made available to me. -- A.J.]

Lasers and the electrolysis industry

The following information is only for those absolutely fascinated by this whole topic. There's no vital information for consumers, but then again, the details are rather telling. With all the money involved in a rapidly growing industry, the politics, lawsuits and infighting have produced quite a little soap opera. You can read all about laser companies and their legal/financial problems at additional laser information.

Simultaneously, there was a huge battle within the electrolysis profession as their professional organizations tried to sort out their own positions. Unfortunately, two of the three major U.S. electrologist organizations seem to have had questionable motivations.

SCME

The Society for Clinical and Medical Electrologists took a big hit in the credibility department when the leading electrology trade magazine exposed the SCME president's 1996 deal with the leading ruby laser manufacturer. By becoming a highly-paid Palomar employee, he pushed lasers on SCME members, which in my opinion is not in the best interests of consumers or SCME members. In fact, the inroads by Palomar into SCME have continued, with Palomar recently giving SCME a $50,000 "grant" which they claim is unrestricted, but I suspect is to help promote lasers through their organization (see below). As you can see, Palomar, through one of its business development officers, now is working closely with SCME on schemes to create a laser certification for non-medical personnel and plans to tap into electrologists' client bases.

IGPE

The International Guild of Professional Electrologists has also made a few missteps along the way, including being manipulated by laser companies and letting them present at electrology trade shows and conventions. But the most contentious problem caused by the IGPE was a now-revoked policy known as the Guild standard.

Some background on the "Guild standards": in 1979 the IGPE established a standard designed to help electrologists do a self-test to see how effective their treatment was. Although this standard was rescinded by the Guild several years ago because it was being misused by marketers, those same laser and transdermal electrolysis marketers still use it to define permanence.

The definition of permanency as established in the rescinded Guild standard is "no hair regrowth of 40% of treated hair for up to 9 weeks." I don't know about you, but that doesn't sound permanent to me. However, FDA accepted this standard as proof of permanence for the electric tweeezer company American Hair Removal Systems (AHRS). Following the AHRS lead, laser marketers have latched onto these Guild standards as proof of permanence. Fortunately, the FDA seems to have realized their mistake and has not cleared any laser companies to claim permanence based on the "Guild standard." See the linked article for more information on AHRS' temporary Transdermal Electrolysis devices.

AEA

Luckily, the American Electrology Association has staked out an intelligent wait-and-see position from the start. Their website has excellent information an position statements regarding laser hair removal. I believe they are the only professional organization which took the right objective stance from the beginning and has maintained it since. I have included several excerpts from their website at the link below.

This is the only group that has acted consistently in the consumer's and their industry's best interests.

If you're interested, you can read all about all these laser and electrology industry internal battles at additional laser information.

How lasers are sold to doctors and (now) electrologists

Again, the following information is only for those absolutely fascinated by this whole topic.

Lasers sold to medical personnel

Some laser companies sell their machines outright for $100,000 or more. Charlie Wittenberg, Thermolase VP, Business Development commented on this in the June 1997 Medical Laser Insight, p. 6:

That's a lot of money for a technology that is very new and constantly changing. By buying equipment with a risk of rapid obsolescence you're taking a technology risk. There's no flexibility once a physician commits to a capital purchase of such size. They take a risk on the efficacy of a technology and a risk on the cost-effectiveness of the purchase. And with so much of their money now tied up in a capital purchase of $100,000 or more, they're stuck and so is their practice.

Wittenberg continues, stating this leads to "too many docs with the same aging technology competing for the same market." What does that cause? Desperation on their part to recoup their $100,000. Even though no laser is allowed to claim permanent results, there is a strong temptation by these "stuck" doctors to imply lasers work better than they do to avoid losing lots of money. And when it comes down to losing the kids' college money or telling the truth, some doctors toss ethics right out the window.

Some companies lease the equipment, which lessens the risk to the physician, but nonetheless means he or she must recoup what is usually a flat fee up front (around $10,000) and a fee based on each use of the equipment. Again, the temptation to overpromise is very high. Doctors are not immune to slick marketing, and pharmaceutical and medical equipment companies are renowned as some of the slickest marketers on the planet.

Lasers sold to non-medical personnel

In fact, laser marketers are now aggressively marketing to the electrology industry, offering a similar buy or lease deal for electrologists. This angers many physicians, who have fought hard to keep lasers classified as a medical device which should only be used by specially-trained medical personnel. They are right in this respect: the use of lasers by non-medical personnel poses even greater risks to you and should be avoided at all costs.

Luckily, many states (notably California) have banned non-medical personnel from using lasers. The potential for serious complications and permanent skin damage make it very risky, so this is a move to protect consumers which I applaud.

Laser industry sucking up to the electrolysis industry

Laser sales reps originally did the hard sell, brow-beating poor electrologists who knew little about the issue by saying their industry is as good as dead, and they better bail while they can. Lately they've taken to a softer sell and suggest using it as a supplement to electrolysis.

To help blur the line between laser and electrolysis, and between medical and cosmetic, it seems the leading ruby laser manufacturer, Palomar, has used its connections with the Society of Clinical and Medical Electrologists (SCME) to form a new electrology certification, the Certified Medial Electrologist. They position this as a "second-level certification," implying other certifications are inferior, and a stepping stone to their new one. As mentioned earlier, the SCME leadership sold out to Palomar, abandoning the people they were supposed to protect.

Beyond the offer of a laser industry-endorsed certification, Palomar is now offering electrologists business support as well:

Cooperative marketing effort by Palomar Medical Technologies. The company announces a new business support service for electrologists who provide Lasertrolysis(tm), hair removal using the Palomar EpiLaser(tm). According to Alison Sahoo, Director of Business Development, Palomar will make available to those electrologists a series of attractively designed camera-ready ads that promote both electrolysis and the new laser treatment. Those ads can be inserted in the local media, to increase consumer awareness and attract new patients.

      -- Perspectives, Spring/Summer 1997 Highlights

Their latest attempt is a new certification for electrologists, called the CME.

 

The Certified Medical Electrologist (CME) credential, developed by the SCME in collaboration with Professional Examination Services (PES) of New York City, will be available to those who already carry the CCE or CPE designations. Its course work will focus on the newly emerging laser technologies, providing electrologists with in-depth knowledge of how laser systems work, and how they are used for hair removal. Like the first-level certifications, this second-level credential will also require continuing education-ensuring that the knowledge of those who claim it is current. This seems to meet a key need of the profession - in a recent nationwide survey of electrologists' interest in laser hair removal by the SCME, more than 90% respondents indicated that adequate training and credentialing was a major concern.

Roberts got his business partners Drs. Ron Wheeland and R. Rox Anderson (see Harvard Study) as the experts designing the certification.

Unfortunately, while cozying up to electrologists for the added legitimacy it can bring, laser companies continue to denigrate electrolysis to make themselves seem like a better option. They post billboards near electrolysis business which proclaim "Electrolysis has just become obsolete" and full page ads in national magazines such as Cosmopolitan and Redbook, which state "Needles sting," "Agonize over one more electrolysis appointment?" All this is clearly designed to lead the hair removal consumer away from electrolysis and to imply comparative claims without actually making them.

As the American Electrology Association rightfully points out: "The laser manufacturers have millions of dollars to spend on PR and ThermoLase has already demonstrated just how far they will go to undermine electrology in favor of laser. Any true interest in electrologists, if affordable laser-based hair removal devices are ever placed in the hands of electrologists, involves a lucrative fee-splitting arrangement and credibility."

I worry the CME certification and the cooperative marketing programs will be a way to dupe electrologists into committing to laser machines in the same way they've gotten doctors involved. Then it becomes a question of recouping your money through unethical practices, or starve. For some people, the former will be too tempting.

EpiLaser results experienced by a Palomar employee

At the Electrolysis Forum, Palomar's Director of Business Development, Alison Sahoo, had been writing about her experiences with their EpiLaser product without giving many details. Alison finally relented to pressure and provided the following specific information on November 8, 1997. Ted was quick to respond with an analysis of her report, which follows Alison's post.

Here's my experience. I should emphasize that I am not representing this as typical. (Not that it is or isn't, just that I can't represent it as such). I had these treatments because I felt it was important for me to have personal experience with the treatment/product I am representing and any similar treatments. After all, how can I present information and answer questions with no personal experience?

All treatments were on the axilla (underarms). I am fair skinned (Fitzpatrick type III, Lancer type III) and dark haired, early 30s (so my hormones are active and I am vigorously growing hair) but not particularly hirsute. I consider myself a typical laser patient.

Last summer, I had one SoftLight treatment. The procedure was uncomfortable (particularly the pre-treatment waxing) and very loud. The laser energy interacting with the carbon lotion sounded like popcorn popping out of control. At one week post treatment, there was a good bit of growth in each treated area (20+ hairs). At 2 weeks post treatment, there were more than 50 hairs in each area. As time went on, all hair regrew within 1 month. There was no noticible difference in hair color or texture. I did not have a second treatment.

I let this hair grow for 3 months, untreated to monitor results. (Anyone whom I met at electrology trade shows last fall will attest to my hairy pits as I was showing them to any & all who asked to see them). I would estimate 100% regrowth within 1 - 2 months.

This summer (1 year after the SoftLight treatment), I had 2 EpiLaser treaments on the same area. As with the SoftLight treatment, I have not used any other hair removal method during the observation period. The first was in early summer. I was treated on a high setting (35 Joules/cm2) and experienced mild discomfort with no anesthetic. (ie. no EMLA, 5% benzocaine, etc.) Interestingly (and as with the SoftLight treatment), some parts of the axilla were more sentitive than others. I have been tracking week by week results and they are as follows:

After a series of test patches at 5 Joules/cm2 increments from 10 - 35 Joules/cm2 showed minimal redness and/or swelling at all settings, the highest setting of 35 Joules/cm2 was selected. Procedure time was approximately 30 minutes to treat both shaved underarms. No anesthetic was used, and the discomfort was mild but tolerable (similar to discomfort with SoftLight). Immediately after treatment, the skin was slightly red and sensitive; however, this dissipated within several hours. There was no change in pigmentation of the skin and I resumed normal hygiene (ie. soap,deodorant, etc.) immediately. No other topical lotions or treatments were used post procedure, however, an ice compress was applied for approximately 15 minutes immediately after the treatment. No changes were observed in the area's normal perspiration or moisture/oiliness (which would indicate changes in the activity of the sebaceous glands).

During weeks 1 - 4 after treatment, the skin was smooth and largely hair free. There was some ?shedding" of dead hairs from treated follicles, however, this was minimal.

Beginning in week 5, the area showed some slow growth (approximately 20 - 30 hairs) of light, fine hairs, 1 - 3 millimeters in length.

At 6 weeks, this fine growth had nearly doubled, to about light 60 hairs in each underarm area. Hair was evenly distributed over the area, with large patches of smooth skin in between. By 8 weeks post treatment, significant hair growth had occurred which was evenly distributed throughout the treated area. Although the hairs appeared somewhat finer than the growth which could be expected if the area were untreated, there didn't seem to be any significant reduction in the amount of hair.

A second EpiLaser treatment was performed exactly 10 weeks after the first treatment. One entire underarm area was exposed to 22 Joules/cm2 of energy; the other underarm was treated on a setting of 35 Joules/cm2 . As with the first treatment, no anesthetic was used. The area treated on the lower setting showed no effect (redness, swelling, etc.) post procedure, and in fact, I barely felt the treatment at all. The area treated on the higher setting was slightly reddenned and sore for 2 hours post treatment, and as with the first treatment, was somewhat uncomfortable. Unlike after the first treatment, however, an ice compress was not applied post procedure. (There is some feeling in the medical community that holding off on ice application allows the follicles prolonged exposure to the heat created from laser irradiation and enhances effectiveness of the treatment).

As with the first EpiLaser treatment, I did not observe any change in skin pigmentation or moisture content.

At 2 weeks after treatment, the area exposed to 22 Joules/cm2 was completely clear, showing no signs of shedding or other growth. The area that had been treated at 35 Joules/cm2 of energy showed approximately 20 follicles with dead hair sloughing off.

At 6 weeks post treatment, both areas were substantially clear, with approximately 15 - 20 fine, light hairs growing sparsely under both. This growth was only visible from very close proximity. Both areas appeared very hair free, with no further shedding. The skin appeared normal in every way.

It is now 9 weeks after the 2nd treatment, and both underarms still look very hair free. Growth is apparent only very close-up.

Obviously, this is not a controlled scientific study - it is only one person's experience, and it is also an ONGOING experience. However, I do routinely inquire as to the experiences of others who have had laser (SoftLight, ruby, alexandrite, flashlamp, etc.) treatments and I believe that this is valuable technology that meets a need of many, many people. If I did not believe this, I wouldn't represent this product.

You all can and should formulate your own opinions, however, I would encourage you to obtain as much information as possible, and not rely solely upon this bulletin board. I am amazed at how quickly this industry is changing and the speed with which new products are being introduced. It is also interesting how the commercial practitioners (physicians, electrologists, aestheticians, etc.) and medical researchers are continuously finding new ways to enhance results.

I hope this answers your question, ARB. Take care.

AGS

------------

Ted responded that day.

Alison,

Let's see what we can learn from your latest account of your experience with EpiLaser treatments of your underarms. Here is an approximate chronology of the major events and your observations:

• 28 Jun 97   Treatment #1
• 26 Jul 97   +4 weeks:
  • "showed some slow growth (approximately 20 - 30 hairs) of light, fine hairs, 1 - 3 millimeters in length"
• 09 Aug 97  +6 weeks:
  • "fine growth had nearly doubled, to about light 60 hairs in each underarm area"
• 23 Aug 97  +8 weeks:
  • "there didn't seem to be any significant reduction in the amount of hair"
• 06 Sep 97  Treatment #2

So it looks like you were substantially hair-free for about 4 weeks (about 26 July), but that all of the hair had regrown by 8 weeks (about 23 August). I judge this to be about twice as long-lasting as waxing.

Based on a current local price-list, waxing both under-arms costs about $10 U.S., so two treatments would cost $20. In comparison, one of the ruby laser manufacturers is recommending that its revenue-sharing partners charge about $940 U.S. to treat both underarms. So in this example, laser costs 47 times more than waxing would have cost. Your mileage may vary!

Now let's review some of the claims you posted here during between your first and second treatments:

On 11 Aug 97, comparing ruby and SoftLight laser hair removal, you wrote of ruby:

"I have also had these treatments performed, and can personally attest to far longer lasting results."

In your post of today, you said of your SoftLight experience:

"As time went on, all hair regrew within 1 month."

"I would estimate 100% regrowth within 1 - 2 months."

Since you seem a bit uncertain, let's split the difference, and say that after SoftLight, the hair regrew in about 1.5 months, or 6 weeks. Since you have now revealed that 100% regrowth after EpiLaser took 8 weeks, I find NO reasonable basis your claim the EpiLaser result is "far longer lasting" than the SoftLight result.

On 31 Aug 97, you wrote:

"My personal experience with the EpiLaser treatment is good. 6 weeks after one half-hour treatment on the underarms, I am seeing no regrowth. (I will emphasize, however, that I am seeing NEW growth, just as one would with any hair removal treatment)."

Alison, based on your message of today, you were 9 weeks after treatment, not 6 weeks. Also, you omitted to tell us what you told us today: "there didn't seem to be any significant reduction in the amount of hair". But the biggest problem is in your interpretation of the results: there is NO WAY that could have been 100 percent NEW growth, which is what your statements imply. It had to have been mostly REGROWTH!

Here is what you said on 15 September 97, referring to EpiLaser (aka Lasertrolysis) treatments:

"It is not permanent, however, some people have had very, very long lasting results. The advantage over electrolysis is speed. As you mentioned, electrolysis can be extremely slow - the laser treatment is much, much faster and offers far longer lasting results than waxing."

So you admitted the results are not permanent, but you continued to claim far longer lasting results than waxing. But that was only one week after your second treatment, so you were still talking about the results of the first treatment, which as I have just established, lasted only twice as long as waxing. Big deal!

Let's update the waxing vs. laser costs:

Through 15 Sep, some 11 weeks after the first treatment, waxing might have been required about 3 times, at a cost of about $30. The laser manufacturer I referred to earlier, suggests charging $700 for the second under-arm treatment, which when added to the $940 cost of the first treatment, brings the total $1,640.

So laser costs were running about 55 times those of waxing.

And though you admitted the results were not permanent, you insisted on making comparisons against electrolysis results, which are permanent. Certainly the laser produces a much faster initial clearance, but for $1,640, consumers are expecting THE FINAL OUTCOME to be permanence. I suspect that $1,640 worth of electrolysis treatments would go a long way toward complete and permanent removal of hair from the underarms. That is the issue for consumers.

Yesterday, you advised [a poster thanking me for advice]:

"You should be aware that Ted Molczan does not work for or closely with a laser company or practitioner of laser hair removal. (Correct me if I'm wrong Ted, but you haven't even had a treatment). Therefore, there is much information about this technology of which he is unaware."

Alison, by your reasoning, one would have to be a tobacco grower, cigarette manufacturer and retailer, and a cigarette smoker, in order to qualify to express an opinion about the health risks of smoking. Be serious!

No matter what the issue, the only qualification I need is my citizenship in a democracy. And my best tool to determine the approximate truth of a situation, is my sense of doubt, for doubt is central to understanding.

Ted Molczan

----------

Personally, I think this is very telling of what you can expect from lasers. If you're interested in reading more entertaining verbal sparring between Ted and Alison, it can all be found in the Electrolysis Forum's searchable archives. Do a search listing their names, or the name of a product you're researching. Ted doesn't let a single statement Alison makes go unrefuted.

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The soap opera of electrolysis professional associations

Please see my Laser Hair Removal for more on the electrologist trade organizations

 

AEA (American Electrology Association)

This is the only organization in my opinion that has taken the right stance since the beginning. Teresa E. Petricca, CPE, Executive Director of the AEA, makes the following statements at their excellent website.

Rather, we have an obligation to our members and the profession to distinguish between what is proven and what is not proven based on our research of the facts. We are obligated to maintain the integrity of our profession. This is the time for every electrologist and every state and national association to promote the validity of our profession as permanent hair removal practitioners.

AEA has always been the gatekeeper and truth-seeker and will continue to monitor and safe-guard our profession. If a new technology becomes available that is proven to be both permanent and safe. AEA will be the first to fully support and promote it as a new electrology modality.

Some of the concerns that the AEA has raised in the past regarding the use of lasers for hair removal include:

• Safety of the tissue surrounding the follicle.
• High incidence of hyper/hypopigmentation, which may last for months after treatment. Exposure to sun too soon after treatment can cause the skin to heal a darker shade than normal skin.
• Skin anomalies; such as herpes, etc. have been shown to worsen on lased skin.
• Unknown long-term adverse effects on the skin from potentially many years of repeated irradiation.
• Lack of training required for laser technicians.
• Lack of dermatological knowledge by technicians which would enable them to distinguish between a potential skin cancer and a harmless eruption. In the case of cancerous moles, the cancer may metastasize invisibly once the surface evidence has been removed by the laser. Eradicating a skin lesion and leaving no specimen available for a laboratory study makes proper diagnosis after removal impossible.
• Research studies have confirmed that the smoke plume contains toxic gases and vapors. At high concentrations, the smoke may cause ocular and upper respiratory tract irritation in health care personnel; it may also create visual problems for the surgeon.
• Scientific proof regarding lack of permanence. The few studies that are available have revealed a very rapid and nearly complete regrowth of hair, typically within 2 to 6 months after a single treatment. Multiple treatments have not demonstrated to significantly improve results.
• Poor cost-to- benefit ratio for patients. Treatment packages often cost as much as a full course of electrolysis, even though electrolysis results are permanent and laser results are temporary.

 

Laser hair removal is an experimental therapy and the first generation of patients are unwitting test subjects for the manufacturers. Laser manufacturers are exerting a tremendous public relations campaign intended to lead an unknowing public to believe this new technology is the gateway to less painful, faster and permanent hair removal.

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Legal/financial condition of laser hair removal companies

The major laser hair removal companies have not been having a good year. Much of the first half of 1997 was spent battling each other and the federal government in attempts to get clearance to market and protect patents. Here's some of the legal "highlights":

Summer 1997 saw a rash of lawsuits as each laser company sued each other over patents, business deals, etc. This was especially true with the LPRLs, which indicates they all use the same technology. One business reporter quipped that "product developers and distributors have courted and discarded each other like faithless lovers." Press releases the week of March 13 announced that MEHL/Biophile contended that Palomar infringed on its patented method of hair removal and alleged Palomar marketed its products before FDA clearance. MEHL sued several other companies over patent issues and also went through an ugly divorce between MEHL and Laser Industries, to break their laser hair removal joint venture. However, most of the legal action was quietly settled over the summer to avoid the bad publicity. All these companies are too vulnerable at the moment to be fighting each other.

Besides the legal woes, there has been even worse problems on the financial front for the companies as they scramble to stay afloat. Ted has provided the following financial summaries:

I closely monitor the laser manufacturers' SEC filings, press releases and other public statements, especially the three companies that are betting their futures mainly on laser hair removal: Thermolase, Palomar Medical Technologies, and MEHL/Biophile.

These are very small companies, which have been money-losers for years, and show no signs of improvement. Here are brief reports on each of them.

Thermolase

Despite nearly two years of intensive promotion, and mostly favourable media coverage, Thermolase's estimated 300 installed lasers revenued less than $6 million in its most recent fiscal quarter. Based on a six day work week, that is about $250 per laser per day, which represents a very severe under-utilization. Operating LOSSES have averaged about 100 percent for the past few quarters.

As a result, Thermolase announced in July that it was freezing the number of it Spa Thiras at 15, and was modifying its laser hair removal process. The new process, called SoftLight 2.0, does away with the pre-wax, but according to one consumer who contacted me shortly after her first treatment, NONE of the hair had been removed! Perhaps, as some have suspected, it was the waxing that used to remove the hair after all!

Thermolase almost ran out of money sometime about July, and had to be bailed out with a loan by its parent company. Since then, it has negotiated a $115 million convertible debenture. Miraculously, its share price has rebounded from its low of $9 this spring, reaching $18 in recent weeks. Even more miraculously, that is the price that was touted by some brokers last spring, which also just happens to be slightly above the conversion price of the debenture sold in September. Looks fishy to me!

I am especially suspicious because the three Thermolase stock discussion boards I monitor have been virtually dead for months. Normally, I would expect to see lots of enthusiastic chatter by investors after such a large price rebound. Also, a huge 2 million shares are being held by short-sellers - betting that the price eventually will fall. I suspect that the smart money knows this is a loser.

Palomar

Palomar has never had a profitable quarter in its history. Laser hair removal hype took its stock from $2 in August 1995 to over $16 in May 1996. After the FDA failed to clear its EpiLaser for hair removal in July 1996, the stock quickly fell to $9, and then meandered between $6 and $9, while investors hoped and prayed for FDA clearance. But when the big day finally arrived in March 1997, MEHL/Biophile sued Palomar for patent infringement, and within days FDA cleared both MEHL's and Laser Industries' hair removal lasers, and then Palomar issued a disastrous earnings report. The stock has steadily declined ever since, trading at about $2 in recent weeks, and closing at $1.88 today.

Palomar is in the process of down-sizing, by getting rid of its electronics and computer businesses, and converting itself into solely a cosmetic laser company. However, based on recent financial statements, it appears that this will become a very small company, with annual revenues of perhaps $30 million, and operating losses of about 100 percent.

Despite announcing many tens of $millions in foreign EpiLaser sales in 1996, actual reported revenues have fallen far short. There was a brief surge of about $3 million in the final quarter of 1996, followed by a steep decline in the first quarter of 1997. Second quarter EpiLaser revenues bounced back strongly to nearly $6 million, on the heels of the FDA clearance for the U.S. market. However, Palomar continued its losses, so it is now getting out of the laser sales business!

Instead, Palomar has signed a leter of intent through which it would become an OEM (original equipment manufacturer), to Coherent Inc., which would become the exclusive EpiLaser distributor in the U.S. and most foreign countries. The deal would provide Palomar a much needed cash injection, and would allow it to cut its laser sales and support staff.

Palomar intends to become primarily a cosmetic laser center operator, through various joint venture agreements. This is a variation on Thermolase's concept; however, Palomar plans to provide skin-resurfacing, tattoo removal, and vein treatments, in addition to hair removal.

However, despite statements implying that as many as 10 laser clinics had been in operation for nearly six months through March 1997, Palomar still had not reported any revenues from them as of the end of June.

In July, Palomar explained the disastrous sales of its Tru-Pulse CO2 skin resurfacing laser, by claiming that fewer people wanted their skin peeled than they did two years ago. If that is true, then how does Palomar expect to prosper selling such treatments?

I cannot see how Palomar will profit from selling such expensive and minimally effective treatments as laser hair removal and skin-resurfacing.

MEHL/Biophile

Prior to its entry into laser hair removal, tiny MEHL/Biophile derived most of its revenue from ever diminishing foreign sales of its Finally Free electronic tweezer consumer hair removal device. (The product was banned from the U.S. market by the FDA in the early 1990's.) Even with the addition of laser hair removal, it revenued less than $3 million during the past four quarters, and operating LOSSES exceeded 500 percent.

MEHL expects to make most of its money through laser hair removal joint ventures with physicians. It began installing lasers in foreign countries about one year ago, and reportedly had over 30 lasers in service as of about 1 Jan 1997. However, revenues from these lasers have never come close to MEHL's publicly stated projections. In the quarter ending 31 May, revenues were only $228,000, which I estimate to be 84 percent below expectations. In the following quarter, ended 31 August, revenue actually declined to $121,541, despite the fact that MEHL installed many more lasers during this period. That is 91 percent below expectations (based on 31 lasers), and only one fifth of Thermolase's already disastrously low revenue per laser.

As of 10 October, MEHL claims to have installed 120 lasers world-wide, half of them in the U.S.A. However, to become profitable, it must greatly increase revenue per laser, while holding the line on expenses. MEHL almost ran out of money about August 1997, but managed to negotiate a $7 million bridge loan to remain afloat. However, one of the terms of the loan allows the lender to convert millions of dollars in past loans into shares, at a discount to the stock market price, which will lead to significant dilution of stock prices in the future. MEHL's share price briefly peaked at about $10 in the spring of 1996, then quickly declined to between $3 and $4. It briefly bounced to about $6 in March 1997, on the FDA's clearance of its laser, but has gradually declined ever since, and has been trading at about $2 in recent weeks.

Recently, MEHL announced a letter of intent with a European medical device distributor, which would take over responsibility for laser clinic joint ventures in 10 European countries, and try to arrange an injection of $15 to $20 million into MEHL. This would allow MEHL to repay the present bridge loan, and allow it to survive a little longer - presumably until the business becomes profitable. One the other hand, it would see a reduced share of any European revenues - should they materialize. MEHL clearly is even weaker than Thermolase and Palomar, so it will be interesting to see if it can survive.

Back to Laser Hair Removal page

The future of the laser hair removal industry

Spectrum was purchased by Laser Industries to bolster its ruby laser manufacturing capacity, in anticipation of big demand for ruby laser hair removal.

Medical Alliance (MAI) originally signed a master services agreement with Palomar (3 Jun 96) to be the exclusive provider of mobile laser hair removal. They dropped Palomar after FDA rejected their original EpiLaser clearance for hair removal. MAI is suing Palomar over this. In Jan'97, MAI signed a deal with Thermolase.

Candela is rumoured to be planning an Alexandrite (755 nm) hair removal laser.

Continuum recently signed a deal with Thermolase, enabling doctors who use their ND:YAG lasers to offer SoftLight. Thermolase would provide carbon lotion, and would get a piece of the revenue. Continuum has yet to obtain FDA-clearance for the U.S. market.

Coherent is by far the world's largest laser manufacturer, active in scientific, industrial and medical markets. On 18 Sep, Coherent and Palomar announced a letter of intent in which Coherent will become exclusive distributor of EpiLaser. Palomar would in effect become an OEM (original equipment manufacturer) to Coherent.

ESC and Laser Industries announced a merger on November 10, 1997. No word on how their Epilight flash lamp and EpiTouch LPRL products will be affected.

DUSA Pharmaceuticals (DUSA = Deprenyl USA) came out with press releases promoting their version of laser hair removal in Spring 1995. These helped its stock price at the same time the LPRLs were getting boosts based on hopeful press releases. Their process called Photodynamic therapy (PDT) is currently under development. They report they have had some clinical trials using aluvenic acid (ALA) under the trademark drug name Levulan which seeks out and darkens certain pigmented growths, in conjunction with red-light lasers. I recently read a report on its use with certain esophageal cancers. DUSA began hair removal clinical trials on April 2, 1997. I'll post results as they become available.

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For even further information

FDA statement on laser hair removal

Laseaway 510 (k)

Some of Ted's other posts worth viewing:

• Ted debunks two non-permanent methods with one stone with the following observation about photos at a laser site and the Ultimate Hair Away site: "Take a look at the before and after photos of the man's arm on the Hair Away home page. Now, take a look at this laser hair removal web page in London, England, about two-thirds down the page. My, my - what a coincidence!! Did one site steal the photos from the other, or did they both obtain them from a third party?"

If you have questions about the FDA's policies concerning clearing devices to market, you may call them at: FDA Consumer Affairs 800-532-4440 (in Maryland, 301-594-2062)

More resources to come!