Artes Medical, Inc. (ARTE) - 500 Beiträge pro Seite

[panik]

Profile:Artes Medical, Inc., a development stage medical technology company, focuses on developing, manufacturing, and commercializing injectable aesthetic products for the dermatology and plastic surgery markets. Its principal product candidate, ArteFill, is a permanent aesthetic micro-injectable product, which is under review by the FDA for the correction of nasolabial folds, known as smile lines. The company’s product pipeline comprises ArteFlux, used for the treatment of gastroesophageal reflux disease; and ArteSure, for the treatment of stress urinary incontinence. Artes Medical, formerly known as Artes Medical USA, Inc., was co-founded by Stefan M. Lemperle and Gottfried Lemperle in 1999. The company is headquartered in San Diego, California.

http://www.artesmedical.com/

[panik]

IPO Analysis: Artes Medical
Posted on Dec 10th, 2006 with stocks: ARTE

Artes Medical (ARTE) of San Diego is in the line-up to make its IPO this week. The company is in an interesting position: the FDA recently approved ArteFill, its injectable aesthetic inplant product that “corrects” those nasty smile-lines, which used to be accepted as a normal part of aging. But the company will not begin marketing the product until early next year. In fact, much of the proceeds of the IPO are earmarked to building a marketing effort.

Although the company originally filed for its IPO in May, the underwriters have held off on advancing Artes until the approval was in hand. With that element of risk now off the table, the other - will the market accept the new product? - is the question investors must face.

The newly approved product for Artes, ArteFill, fits right into the continuum of products offered that treat the dermatological effects of aging in the face, as we pointed out in our recent overview of the field (see The Quest to Look Younger Fuels an Injectable Boom).

It differs from its competitors in that Artes takes the commonly used ingredient of bovine-derived collagen and adds microspheres of polymethylmethacrylate [PMMA]. PMMA is the most commonly used artificial implant material used in the body. In ArteFill, it has the effect of making the injection non-resorbable, thereby lengthening the effect. The FDA allows Artes to claim that ArteFill lasts for a year, though Artes is about to examine how much of the original effect remains after five years. The company broadly hints that the beneficial effects of ArteFill are permanent.

There are some problems, however. Some reports of granuloma have surfaced, a frightening notion in a treatment that is supposed to be near-permanent. Artes counters by saying that the incidence of the problem is no higher than it is with normal collagen, and that it is treatable with steroids.

The use of a bovine-derived collagen means that patients must first undergo a test to prove that they are not allergic. Thus, patients must make an initial office visit and then wait while the test is being evaluated before making a second visit to the doctor’s office. Some of the competition has moved on to human-derived collagen that does not have the allergy problem.

And, finally, the company itself got in hot water when one of its co-founders, Dr. Gottfried Lemperle, injected ArteFill into the face of his son, another co-founder, Dr. Stefan Lemperle, before the product was approved. The FDA was investigating the company because of reports it was urging people to try ArteFill, pre-approval. The FDA invited Artes to come clean. But ArteFill did not disclose the incident. As a result, Dr. Stefan Lemperle left his CEO role in the company, though he remains on the board. His father, Dr. Gottfried Lamperle, stepped down from the board and from his position as Chief Scientific Officer.

An interesting point is that ArteFill will put the aesthetic dermatology industry into a dilemma. Will the industry be pleased to offer a product to customers that means patients will return to the office less frequently? Probably they will have to, if their competition is offering the product. They can, however, emphasize its drawbacks while presenting ArteFill as an option.

In the future, Isolagen (ILE) may offer a competing product that uses a person’s own skin cells. A sample is taken and then cells are grown in a lab, which are injected as a filler. That product has the prospect of having an infinite life, plus it could be easier to work with than ArteFill. But Isolagen’s dermal filler is probably at least three years away from the market, giving time for ArteFill to establish its presence.

Analysts expect Artes to charge about 50% more for ArteFill than the shorter-lived Restylene, which costs between $500 and $600 per syringe.

Artes Medical is offering 4.6 million shares in its IPO in a range of $12 to $14. After the IPO, the company will have 15.9 million shares outstanding. At the midpoint, the IPO will give Artes a market capitalization of $206.7 million. So far, investors have made $77 million in equity investments into Artes, and the company had cash on hand of $12.8 million on September 30, 2006. Artes would take in $51.8 million in the IPO after expenses, should the IPO take place at $13, the midpoint of the range. That does not include the overallotment, which is 690,000 shares.

The company says it will use $12 million of the proceeds for its sales and marketing effort, $5 million for a 1,000 patient post-approval safety study, $2.5 million to expand manufacturing capacity; and $2 million to seek additional uses for ArteFill. All of that adds up to $21.5 million, or less than half the amount the company seeks.

In 2005, Artes had a net loss of $20.3 million. The run rate increased in 2006 as the 9-month figure for the year is $17.2 million. The only promise the company has made for the future is that their costs will continue to rise as they beef up the sales and marketing effort. They expect to market their product directly to dermatologists and plastic surgeons.

More than the usual number of options are also overhanging the offering. There are 1.9 million options at $5.85 per share; 335,246 options at $10.63 each; 3.6 million reserved for future options grants; and 2.5 million from preferred and common stock warrants at $6.98 per share.

Despite the problems with the product, and despite the fact that the active ingredient for ArteFill may not be the most advanced on the market, the product does offer a significantly longer duration of effect. At one year, ArteFill is effective for approximately twice as long as any of the competition, and it seems to last more than a year. As such, ArteFill will probably find a niche, which may be a significant niche, in the aesthetic market. Plus, let’s face it, the market for these products is hot.

Disclosure: Author has no position in stocks mentioned.

[c-laus]

@panik

Bist Du schon bei Artes Medical investiert?

[c-laus]

Antwort auf Beitrag Nr.: 26.370.196 von c-laus am 21.12.06 14:18:40

Am 3. Mai kommen die ersten Verkaufszahlen raus. Im Februar war product-launch!
Sind die Zahlen gut, geht hier die Post ab!

[corvis]

[topbasher]

New Artes Subsidiary To Apply Company's Technology Beyond Wrinkles
Posted on Jun 13th, 2007 with stocks: ARTE

Spheris Medical, a new subsidiary launched Wednesday by San Diego-based Artes Medical (ARTE), will take Artes’ microsphere technology, currently used to make an anti-wrinkle filler, and apply it to serious medical conditions such as acid reflux, spinal disk repair, sleep apnea, and stress urinary and fecal incontinence.

The new subsidiary expands Artes beyond the dermatology and plastic surgery markets. The company’s main product is ArteFill, a non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds.

FDA approved in October 2006, ArteFill is a combination of precision-filtered microspheres made from polymethylmethacrylate [PMMA] and purified bovine collagen. PMMA is not absorbed by the body, so the microspheres remain intact beneath the skin creases, providing a permanent structure to support the wrinkle. ArteFill is the only FDA-approved non-resorbable aesthetic injectable implant on the market.


But Artes says this microsphere technology has applications beyond wrinkles — hence, Spheris. Pre-clinical studies have shown the technology effective at bulking of the esophageal and urinary sphincters, which could prove useful in treating acid reflux and stress urinary incontinence. The technology also has been evaluated for spinal disk bulking and repair. Additional potential uses include bulking of the soft palate and respiratory tissue to treat sleep apnea, adding cushioning to the bottom of the foot to treat painful foot syndrome, and treating fecal incontinence.

[c-laus]

Antwort auf Beitrag Nr.: 29.037.146 von c-laus am 27.04.07 22:35:50

Die Zahlen kommen am 6. August!

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Artes Medical Reports Second Quarter 2007 Financial Results
Thursday August 9, 7:30 am ET


SAN DIEGO--(BUSINESS WIRE)--Artes Medical, Inc. (Nasdaq:ARTE - News), a medical technology company focused on developing, manufacturing and commercializing a new category of aesthetic injectable products for men and women, today reported recent company highlights and financial results for the second quarter ended June 30, 2007.
Recent Company Highlights

Total revenues were $4.2 million for the first six months of 2007, which includes ArteFill® product sales of $3.5 million and technology license revenues of $732,000.
Over 800 physicians have opened accounts with Artes Medical in order to offer ArteFill to their patients. Of these 800 physicians, over 600 board certified dermatologists, plastic surgeons, and cosmetic surgeons have completed their ArteFill training and are currently listed on the "Find A Doctor" physician locator on the ArteFill.com website, providing consumers the opportunity to easily identify an ArteFill-trained physician in their area.
Presentation of 5 year U.S. pivotal study results were presented by Steven R. Cohen, M.D., F.A.C.S., Clinical Professor, Division of Plastic Surgery, University of California, San Diego, School of Medicine and lead ArteFill clinical investigator, at the annual meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) in April 2007 in New York City. Additionally at ASAPS, over 400 physicians observed a live demonstration showing the straightforward nature of ArteFill's injection technique.
Greg J. Kricorian, M.D., Chief Medical Officer, joined the Artes Medical team, and will have responsibility for Clinical Development and Medical Affairs. He will also chair the Artes Medical Advisory Board, and enhance the Company's involvement in the medical community.
Artes announced the creation of a new wholly-owned subsidiary formed in order to pursue the development and commercialization of new and innovative medical applications of Artes Medical's proprietary microsphere tissue bulking technology through collaborative agreements with third parties.
"We are pleased with our physician training efforts, and we now have over 600 physicians on our 'Find a Doctor' website locator. We are now accelerating our marketing efforts to increase both consumer and physician awareness of ArteFill's differentiated formulation that provides a safe and long-lasting solution for wrinkle correction of smile lines," said Diane S. Goostree, President and Chief Executive Officer.

Financial Results

The Company reported total revenues of $2.8 million for the three months ended June 30, 2007, which included ArteFill product sales of $2.1 million and technology license revenues of $732,000. The Company reported a net loss of $6.7 million for the three months ended June 30, 2007, an increase of $0.5 million compared to three months ended June 30, 2006 of $6.2 million. Gross profit for the three months ended June 30, 2007 was $628,000, which included an obsolete inventory reserve provision of $475,000 related to expired product produced in 2006 in anticipation of an earlier FDA approval and product launch. Total operating expenses for the three months ended June 30, 2007 were $7.5 million, an increase of $1.1 million, over the three months ended June 30, 2006 operating expenses of $6.4 million. The increase in second quarter 2007 operating expenses compared to second quarter 2006 is primarily attributable to the transition of the Company from a development stage organization to a commercial operation required in order to manufacture and distribute our FDA-approved product ArteFill.

Cash, cash equivalents and short-term investments were $31.0 million as of June 30, 2007.

Conference Call and Webcast Information

Artes Medical will host a webcast and conference call today, August 9, 2007 at 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) to discuss the financial results. The dial-in numbers are [phone] for domestic callers, and [phone] for international callers. The passcode for both domestic and international callers is 39932848. A live webcast of the conference call will be available online from the investor relations page of the Company's corporate website at www.artesmedical.com. Participating in the call will be Diane S. Goostree, President and Chief Executive Officer, and Peter C. Wulff, Executive Vice President and Chief Financial Officer.

After the live webcast, the call will remain available on Artes Medical's web site for at least 30 days following the presentation. In addition, a telephonic replay of the call will be available for 7 days. The replay dial-in numbers are [phone] for domestic callers, and [phone] for international callers. The passcode for both domestic and international callers is 17317938.

About ArteFill®

ArteFill is the first and only FDA-approved non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds. The unique microspheres in ArteFill are not absorbed by the body and therefore provide the first-of-its-kind permanent support for long-lasting wrinkle correction in one to two treatments.

ArteFill was approved by the FDA in October 2006 based on data from the Company's 12-month controlled, randomized, double-masked, multi-center U.S. clinical trial, which compared outcomes for patients treated with ArteFill with those of patients treated with the leading bovine collagen-based filler. At the 6-month evaluation, which was the primary efficacy evaluation period for the clinical trial, the wrinkle correction in patients treated with ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment status. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.

In February 2007, the Company announced it completed a 5-year follow-up study of 145 patients who were treated with ArteFill in the Company's U.S. clinical trial.

In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant (p less than 0.001) improvement in patient wrinkle correction five years after the patient's last ArteFill treatment, and a statistically significant (p=0.002) improvement in wrinkle correction at the 5-year point compared to the 6-month evaluation period. As part of the study, physician investigators and patients were asked to provide their assessment of ArteFill treatment. Over 90% of the physician assessments were either "completely successful" or "very successful;" and over 90% of the patient assessments were either "very satisfied" or "satisfied." In March 2007, the Company submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill.

An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill treatment, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site.

ArteFill is a proprietary formulation comprised of polymethylmethacrylate, or PMMA, microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles. Artes Medical is the sole manufacturer of ArteFill, which is only available in the United States through our Company, and we have not entered into distribution or licensing arrangements with any third party for the distribution or sale of ArteFill outside the United States.

About Artes Medical, Inc.

Artes Medical is a medical technology company focused on developing, manufacturing and commercializing a new category of aesthetic injectable products for the dermatology and plastic surgery markets. There were approximately two million dermal filler procedures in the U.S. in 2006, an increase of 25% over the prior year, according to the American Society of Aesthetic Plastic Surgeons, or ASAPS. The Company's initial product, ArteFill, is being marketed to men and women as a treatment option for the correction of nasolabial folds. Additional information about Artes Medical and ArteFill is available at www.artesmedical.com and www.artefill.com.

Forward-Looking Statements

This news release may contain forward-looking statements that are based on the Company's current beliefs and assumptions and on information currently available to its management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. As a result of these risks, uncertainties and other factors, which include the Company's history of net losses, its reliance on its sole FDA-approved product, ArteFill, its limited experience in commercializing ArteFill, and its future receipt of FDA approval to enhance the product label for ArteFill to extend the efficacy period of ArteFill beyond six months, readers are cautioned not to place undue reliance on any forward-looking statements included in this press release. A more extensive set of risks and uncertainties is set forth in the Company's SEC filings available at www.sec.gov. These forward-looking statements represent beliefs and assumptions only as of the date of this news release, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

Artes Medical® and ArteFill® are registered trademarks of Artes Medical, Inc.

ARTES MEDICAL, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)

Three Months Ended Six Months Ended
June 30, June 30,
--------------------------------------------------
2007 2006 2007 2006
------------ ----------- ------------ ------------

Product sales $ 2,055 $ - $ 3,497 $ -
License revenue 732 390 732 390
----------- ---------- ----------- -----------
Total revenues 2,787 390 4,229 390

Cost of product
sales 2,159 3,879
----------- ---------- ----------- -----------

Gross profit 628 390 350 390

Operating expenses:
Research and
development 1,136 1,530 2,168 4,479
Selling, general
and
administrative 6,327 4,868 11,897 8,062
----------- ---------- ----------- -----------
Total operating
expenses 7,463 6,398 14,065 12,541
----------- ---------- ----------- -----------
Loss from
operations (6,835) (6,008) (13,715) (12,151)
Interest income 394 233 871 302
Interest expense (263) (457) (531) (2,387)
Other income
(expense), net (3) (12) 10 (31)
------------ ----------- ------------ ------------
Loss before benefit
for income taxes (6,707) (6,244) (13,365) (14,267)
Benefit for income
taxes 51 58 100 100
------------ ----------- ------------ ------------
Net loss $ (6,656) $ (6,186) $ (13,265) $ (14,167)
============ =========== ============ ============

Historical net loss
per common share:
Net loss per common
share - basic and
diluted $ (0.40) $ (4.59) $ (0.81) $ (10.71)
============ =========== ============ ============

Weighted average
shares - basic and
diluted 16,459,103 1,347,993 16,411,789 1,322,884
============ =========== ============ ============


(1) On December 26, 2006, the Company closed its initial public
offering. Immediately prior to the closing of the Company's initial
public offering, all outstanding shares of the Company's preferred
stock were converted into shares of common stock and warrants to
purchase shares of common stock were exercised. The impact of the
Company's initial public offering on its common stock outstanding is
as follows at December 31, 2006:

Capitalization summary upon closing of initial public offering:
Common stock issued and outstanding pre
initial public offering 1,427,400
Initial public offering sale of common
stock 5,290,000
Conversion of preferred stock upon initial
public offering into common stock 9,367,512
Cash exercise of warrants to purchase
common stock upon initial public offering 276,334
-----------
16,361,246
===========

ARTES MEDICAL, INC.
Condensed Consolidated Balance Sheet
(in thousands)

June 30, Dec. 31,
2007 2006
----------- ----------
(unaudited)
Assets:
Cash, cash equivalents, and marketable
securities $ 30,964 $ 46,258
Accounts receivable 642 -
Inventory 6,419 4,761
Other current assets 877 406
----------- ----------
Total current assets 38,902 51,425
Property and equipment, net 5,113 5,271
Intellectual property, net 2,981 3,578
Deposits and other assets 346 339
----------- ----------
Total assets $ 47,342 $ 60,613
=========== ==========

Liabilities and stockholders' equity:
Current liabilities $ 10,572 $ 12,019
Long-term obligations 3,363 4,040
Deferred tax liability 1,273 1,368
----------- ----------
Total liabilities 15,208 17,427

Total stockholders' equity 32,134 43,186
----------- ----------
Total liabilities and stockholders' equity $ 47,342 $ 60,613
=========== ==========



Contact:
Artes Medical, Inc. (Investor Relations)
Cheryl Monblatt Allen, 858-550-9999
[e-mail]
or
Schwartz Communications, Inc. (Corporate Media)
Brooke Chappell or Thea Lavin, 415-512-0770
[e-mail]

--------------------------------------------------------------------------------
Source: Artes Medical, Inc.

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ouch!


Medicis, Allergan fight over face-filler market
Allergan\'s fast-growing dermal filler Juvederm threatens industry leader Restylane, analysts say; Artes Medical competes by offering \'permanent\' face-filler.
By Aaron Smith, CNNMoney.com staff writer
August 24 2007: 6:18 AM EDT


NEW YORK (CNNMoney.com) -- The wrinkle-remover market is growing, and Allergan\'s dermal filler Juvederm could be closing in on the industry leader, Restylane from Medicis.

Allergan, Inc. (down $1.37 to $60.30, Charts) and Medicis Pharmaceutical (up $0.35 to $28.55, Charts) are fighting over the biggest stake in a worldwide dermal filler market estimated at between $400 million and $500 million, as challengers Artes Medical Inc. (down $0.28 to $4.80, Charts) and BioForm try to muscle in with competing products.

Alexander Arrow, analyst for Lazard Capital Markets, estimates that sales of Allergan\'s Juvederm franchise will overtake Medicis\' Restylane franchise as the leader of the dermal filler industry this year.

Arrow estimates that Juvederm and other dermal filler products from California-based Allergan will take 41 percent of the market share in 2007, up from 28 percent in 2006, usurping Medicis\' role as industry leader. Arrow projects that Medicis\' dermal filler franchise, including Restylane and Perlane, will slip from its 2006 level of 51 percent, to 36 percent in 2007.

Another analyst, Corey Davis of Natexis Bleichroeder, believes that Arizona-based Medicis will remain the market leader this year but by a mere $7 million. Davis projects 2007 sales of $140 million for the Restylane franchise versus $133 million for the Juvederm products.

Medicis chief executive Jonah Shacknai did not provide sales estimates for Restylane, which entered the U.S. market in 2003, but denied that\'s its industry leadership was being threatened.

\"Restylane is experiencing significant growth,\" said Shacknai to CNNMoney.com. \"We maintain overwhelming leadership in the dermal filler marketplace in the U.S. and the world.\"

Allergan spokesperson Caroline Van Hove said sales of Juvederm, which entered the U.S. market in 2006, were fast-growing, but she didn\'t break out the numbers for specific products.

A new wrinkle for face filler market
Dermal fillers are used to smooth wrinkles by injecting fillers made from various ingredients into the face. The effects generally wear off after about six months, requiring fresh injections. Competing products often last for different durations.

In July, the Food and Drug Administration approved Allergan\'s Juvederm to last for a year, from its prior duration of six months. Medicis\' Restylane is approved to last \"at least\" six months, according to the company.

Meanwhile, competitor Artes Medical is breaking into the market with its product ArteFill, which is FDA-approved to last one year but theoretically lasts forever.

\"The duration is one of the key factors that doctors decide on when choosing a brand of dermal filler,\" said Arrow of Lazard. \"Artes Medical has a unique advantage because it has a permanent dermal filler. Theoretically, it would last a lifetime.\"

Artes Medical, a San Diego company that went public in 2006, launched its permanent dermal filler ArteFill this year. ArteFill contains polymer microspheres that remain in the face long after its supporting gel fades away - supposedly forever.

But some analysts believe that doctors and patients might be afraid of a facial injection that\'s considered permanent. More people are seeking eternal youth, but just for a few months at a time, analysts say.

The wrinkle wars heat up
\"There are some doctors who won\'t use ArteFill because they\'re afraid that any mistakes they have are permanent, and some patients feel that way, as well,\" said Arrow of Lazard. \"That\'s why we think ArteFill will never become a market leader.\"

Arrow estimates that the newly-launched ArteFill will total $13 million in 2007, barely trailing competitor BioForm\'s Radiesse, which is expected to total $15 million.

Nonetheless, Artes Medical said that 800 physicians have opened accounts to use ArteFill, and 600 of those doctors have completed training to use the new product, a promising sign that product sales could grow in the near future.

\"The company trained over 600 physicians on the ArteFill procedure by July and is on track to train close to 1,000 by year end - well ahead of our previous expectations,\" wrote Sara Michelmore, analyst for Cowen and Co., in a note published Aug. 10.

But Aaron Gal, analyst for Sanford C. Bernstein, said \"the question is not how many doctors will sign on, but how many doctors will use your product, and how often. [ArteFill is] a permanent filler and doctors are afraid of committing to use this. Permanent use means permanent problems.\"

This might be partly responsible for Artes Medical\'s 40 percent plunge in stock so far this year, though Arrow of Lazard said much of the decline comes from a stock lockup that was lifted six months after the IPO.

Jose Haresco, analyst for Merriman Curhan Ford, said in a published note that Artes Medical might be getting squeezed by BioForm Medical, a privately-held California company that recently filed for an IPO.

BioForm\'s dermal filler Radiesse, which was approved by the FDA in 2006, lasts for a year \"on average,\" according to the company. BioForm licenses the technology to make its product from competitor Artes Medical.

Gal of Bernstein said that ArteFill might eventually pay off, but it will take a while.

\"[Artes Medical] has got a long road ahead of them to prove its product is good,\" said Gal. \"It\'s a competitive marketplace and they make a difficult proposition for a doctor to accept a permanent product. It\'s not going to be a walk in the park. But in the long run, if their product is good and has no side effects, then doctors will use it and the company will succeed.\"

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ouch!!!Things Get Ugly
Over a Beauty Injection
Maker of Antiwrinkle Shot,
Famed Skin Doctor Face Off
Over New Product's Safety
By RHONDA L. RUNDLE
August 29, 2007; Page B1

Diane Goostree had come to Arnold W. Klein's beach house overlooking the Pacific Ocean to try to dissuade the skin doctor to the aging rich and famous from leading a campaign to have her company's wrinkle-smoothing product, ArteFill, banned.

As they sipped flavored water in Laguna Beach, Calif., she laid out data that had persuaded the Food and Drug Administration to approve the amalgam of calf collagen and microscopic plastic beads that is injected into the face to permanently fill creases. But at the end of the calm exchange, the flamboyant 62-year-old Beverly Hills dermatologist remained "unimpressed," still worried that ArteFill and products like it could "destroy" the medical field he helped pioneer.

"There wasn't anything that showed the biological reaction of this stuff under the skin," Dr. Klein says. For her part, Ms. Goostree, chief executive of Artes Medical Inc., says his concerns are based on "inaccurate, out-of-date and/or incomplete information."


Dr. Klein has become the loudest voice in the hottest debate in the small world of cosmetic dermatology: How safe is a new wave of antiwrinkle shots that -- unlike their predecessors -- are long-lasting or even permanent? At medical conferences in recent months, doctors have bickered over whether these products receive rigorous enough testing to gain FDA approval. Products like ArteFill are considered implanted medical devices, not drugs, and undergo a different approval process because, unlike drugs, they are believed to basically be inert fillers, leaving bodily processes unchanged. Some doctors, however, believe that the effects of these products on tissue need to be studied before they are approved because unlike earlier facial injections -- such as Restylane, a device, or Botox, a drug -- these treatments don't just wear off in four to six months.

As Ms. Goostree points out, though, the only clinical study anyone can point to is the Artes study relied on by the FDA. An update, she adds, recently showed patients injected by properly trained physicians continue to do well after five years. "We have confidence in our product and in the FDA process that approved it as safe and effective," she says.

That hasn't stopped Dr. Klein, who has recruited like-minded, high-profile physicians and hired DBC Public Relations Experts in Washington to help spread his concerns. Dr. Klein says the longer duration of the new products comes with the risk of unsightly lumps that could require surgical removal and leave ugly scars -- something Ms. Goostree says doesn't happen when ArteFill is injected properly.

Dr. Klein and seven other physicians are asking the FDA for a public hearing to re-examine ArteFill's safety, even though the agency approved it in October. A letter from them, hand-delivered to the FDA commissioner in July, says ArteFill "may pose immediate, debilitating and disfiguring health risks."

Dermatologist Amy N. Newburger, who was part of an FDA panel that recommended ArteFill's approval, has sent a less strident letter. In an interview, Dr. Newburger says she wants the FDA to toughen its review process for aesthetic devices. "There needs to be a paradigm shift in the process so that people will know what risks they are embracing." Scores of emerging injectable fillers will be coming to the FDA, she says. Dr. Newburger practices in Scarsdale, N.Y. and says she doesn't have financial ties to industry.

Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, says he is aware of only one adverse event caused by ArteFill. But he said that in response to "a small number of physicians' complaints," the agency has set up a team to examine the post-marketing experience of all dermal fillers. While the size of required human tests of such devices is usually smaller than those for drugs, he says, the approval process "is very, very similar."

The role of physicians who become activists, like Dr. Klein, is complicated in a world where doctors often are paid by companies to perform scientific research and teach others how to use their products. In this case, Dr. Klein has past and current ties to ArteFill competitors. From 2000 until last April, Dr. Klein worked for Allergan Inc., which sells Botox and Juvederm, and since 2004 he has been a consultant to Restylane maker Medicis Pharmaceuticals Corp. Dr Klein, who made $250,000 a year from Allergan for several years, says such ties "have nothing to do whatsoever" with his concerns about ArteFill. "I refuse to see the field of soft-tissue augmentation destroyed," he says of his motivation. Allergan and Medicis say that Dr. Klein is acting on his own.

The attack on ArteFill is a challenge for Artes, San Diego, Calif., which raised about $28 million in a public offering in December and is struggling to get ArteFill off the ground. In March, Artes submitted favorable data to the FDA on a five-year follow-up study of 145 patients who were treated with an earlier version of the product.

ArteFill consists of microscopic plastic particles suspended in calf collagen. The collagen is absorbed by the body and then replaced by the patient's own collagen, Ms. Goostree says. The polymer beads are permanent. Ms. Goostree says similar polymers are used in other implanted medical devices, including bone cement and pacemaker covers.

The technology was invented by a German physician, Gottfried Lemperle, who co-founded Artes in 1999 with his sons, Stefan and Martin. Earlier versions of ArteFill, called Arteplast and Artecoll, have been sold by other companies for years in Europe and Canada. In 2001, the Swiss Federal Health Agency advised physicians against the use of any "non-resorbable filling material" for treatment of wrinkles, though it wasn't an outright ban.

In a Securities and Exchange Commission filing for its stock sale last year, Artes disclosed that Dr. Gottfried Lemperle illegally injected nine people in the U.S. before ArteFill was approved for marketing. The FDA, the filing said, confirmed to the company that it had opened a criminal investigation of the matter. A product-liability and fraud suit filed against the company and Gottfried and Stefan Lemperle, among others, was withdrawn after the FDA probe came to light, but an attorney for a patient who claims she was disfigured says he expects to refile it later. Artes says the Lemperles are no longer affiliated with the company, except as stockholders. Gottfried Lemperle's attorney, Megan Richmond, San Diego, Calif., declined to comment. Neither Stefan Lemperle or his attorney could be reached.

The FDA tests were conducted with Artecoll, and when they were finished, the agency said Artes would have to agree to some changes to gain approval: refinements to the process of making the beads, that the collagen be harvested from a tightly monitored herd in the U.S. and that the product be manufactured in an FDA-approved facility. After meeting those requirements, Artes changed the name to ArteFill.

Artes says it has so far trained about 600 doctors in the injection technique for ArteFill. Tina Alster, a Washington dermatologist, says her patients haven't had any problems with ArteFill. She says that patients who have spent "oodles" of money over the years are asking for something longer lasting. She charges about $1,800 per syringe of ArteFill, or more than double the $800 price for the first syringe of a temporary filler like Restylane.

Ms. Goostree says that when she met with Dr. Klein he wasn't aware of the data from the five-year study on the Artecoll patients and didn't understand the refinements that had been done at the FDA's request. Dr. Klein says the product's name keeps changing, but there's no evidence that it is improving because the new product was not the one tested. He and other critics also say the original Artes study was too small to yield reliable results and the follow-up study tracked only about 60% of the 234 patients treated with the product. Ms. Goostree says that is "a very, very good percentage."

A New York plastic surgeon who signed the letter, Daniel C. Baker, says he has seen half a dozen patients who had Artecoll injections in other countries "with significant deformities." Last month, "I did a pretty extensive operation to remove it" from the lips and smile lines of a woman injected in Paris, he says. Dr. Baker says he hasn't reviewed Artes's data, and adds that he has "no commercial interests or affiliations and I never have." Ms. Goostree says it was "quite likely" that the physician who had administered the shot hadn't been properly trained.

Another signer, San Francisco dermatologist Richard Glogau, says his primary goal is to persuade the FDA to overhaul its review process for cosmetic injectables, including requiring studies of what happens to human tissue when products like ArteFill are injected. Dr. Glogau consults for Allergan and Medicis, among other companies, but says those relationships don't sway his professional judgment.

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