Trimedyne, Inc. (OTCBB: TMED) announced it raised $ 3,250,000 through a private offering of 2,600,000 shares of Common Stock at a price of $1.25 per share. The offering was conducted by J. H. Darbie & Co., Inc., an international investment banking firm with its headquarters at 99 Wall Street, New York, NY. The investors include Crescent International Ltd. and Leviticus Partners LP and funds managed by Corsair Capital Management and Lewis Asset Management.

Marvin P. Loeb, Chairman of Trimedyne, said, “We are excited to have successfully concluded this offering. The net proceeds of slightly more than $3 million will allow us to finance the increase in sales anticipated from the introduction of our new Side Firing Laser Fiber to the market by Boston Scientific Corporation (NYSE:BSX) in the United States and Japan and by Lumenis, Ltd. throughout the rest of the world.” Mr. Loeb added, “We are also pleased the offering was completed at a very small discount from the market price of our common stock.” [more]

Radiancy Inc. announced the international launch of Mistral, a light-based, multi-application platform device for hair removal, skin photo rejuvenation, acne clearance, and psoriasis care at Medica Dusseldorf and CosmoProf Asia, 2006.

Mistral, using proprietary Light Heat Energy™ (LHE) technology, is one of today’s fastest and safest light-based devices available. “LHE is a fascinating technology,” said Dr. Dolev Rafaeli, Ph.D., C.E.O. of Radiancy. “By incorporating advances like OP2 and a computer-based upgradeable smart system, we take that technology to the next level.”

Mistral introduces OP2 (Optimized Pulse Protocol™). OP2 creates a protected environment for the safe delivery of energy. Within milliseconds, a train of pulses, optimized to application, skin type, and treatment parameters, is emitted. There is a slight pause between pulses, allowing skin to cool while the targeted chromophores retain and accumulate energy. This produces optimal results while the integrity of the skin remains protected. [more]

Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, announced that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription.
This consumer device was initially developed by Palomar and completed together with The Gillette Company, part of The Procter & Gamble Company (NYSE: PG), under a previously announced agreement to develop a light-based hair removal device for women. Designed specifically for use in the home and based on over a decade of research, this consumer device represents a major breakthrough in the aesthetic device industry. [more]

MedSurge Advances, the leading aesthetic medicine services provider for physicians, introduced TattooStar R™, a German laser system that offers an unparalleled combination of quality and value for medical spas seeking to provide advanced tattoo and pigment removal to their patients.
Tattoo removal is a booming business and a matter of priority for those whose tattoos have become a source of embarrassment and regret. A 2006 study conducted by the Journal of the American Academy of Dermatology found that almost one in four Americans between 18 and 50 has at least one tattoo. Of those, one in five regrets the decision – leaving aesthetic medicine practitioners to resolve potentially millions of unwanted tattoos.

Despite this consumer demand, effective tattoo removal has been prohibitively expensive for many patients and providers – until now, said Pascal Servell, Director of Education and Clinical Development for MedSurge Advances.

“TattooStar R is a new technology that offers advanced capabilities at a price that many more medical spas can afford,” Servell said. “Physicians can easily add TattooStar R to their aesthetic practices to deliver fast, effective, and cost-efficient removal of tattoos and undesirable skin pigmentation for their patients.”

Recently approved by the FDA, the TattooStar R is among a new generation of Q-switched ruby lasers that provide a higher level of beam homogeneity, which translates into superior treatment results. The system works more rapidly, is safer, and offers better protection of the skin than a conventional ruby laser. In addition to tattoo removal, TattooStar R is effective in treating pigmented disorders or smaller lesions, since the skin pigment melanin strongly absorbs ruby laser radiation.

MedSurge Advances
972.720.0425
www.medsurgeadvances.com

Cutera, Inc. (Nasdaq: CUTR), a leading provider of laser and other light-based aesthetic systems for practitioners worldwide, announced that Kevin Connors, the Company’s Chief Executive Officer, presented in November 2006 at the Lazard Capital Markets Third Annual Life Sciences Conference at The New York Palace Hotel. Mr. Connors also presented at the 8th Annual Piper Jaffray Healthcare Conference at The Pierre Hotel in New York.

The audio portion of the presentations was web cast live, and a replay of each presentation was available beginning three hours after its completion through December 15, 2006, on the Investor Relations page of the Company’s website at www.cutera.com.

Cutera
888.4-CUTERA (428-8372)
www.cutera.com

(Rancho Mirage, CA) — Most men today are on the go and active—whether they are hanging from a rock, windsurfing, skiing, jet skiing or riding a motorcycle, men are becoming more aware that their faces are taking as much of a beating as their bodies. To combat the damage done to the skin, Pure and Simple, Inc. introduces Hi-Rev, a new line of skin care for the active male. The new line will be launched during spring ’07 to coincide with the Champ Car racing season.

“When my husband, John, was a professional racing driver his skin really took a beating from the sun exposure, wind and g-forces,” says Sally Peoples, President of Pure and Simple, Inc. “We found that 40% of the orders for our collagen-based Pure and Simple skin care products for women were being made by men. We knew that we had to create a line specifically for the active man who wanted his skin to look and feel great.” [more]

Science Based Skincare Redefines Approach to Skin Rejuvenation

Freeport, NY – December 14, 2006 – The newest buzzwords in skincare, appropriately, sound futuristic: Ultrasomes and Photosomes. These bio-engineered ingredients, designed to encourage the repair of the skin’s fragile DNA, represent the future of anti-aging, developed to treat photo-aged skin by targeting the source of the imbalance. Scientists say it’s melding the world of genomics with beauty. Dermatologists say it actually works.

In the December 2006 issue of Cosmetic Surgery Times, Dr. David H. McDaniel predicts an aggressive approach to anti-aging that includes DNA repair. The Virginia-based dermatologist suggests that the ability to truly individualize cosmeceuticals to a unique DNA and lifestyle is just around the corner. [more]

MedSurge Advances Introduces New German Technology to the U.S. Market, Delivering Superior Results at a More Affordable Price

DALLAS–(BUSINESS WIRE)–MedSurge Advances, the leading aesthetic medicine services provider for physicians, today introduced TattooStar R™, a German laser system that offers an unparalleled combination of quality and value for medical spas seeking to provide advanced tattoo and pigment removal to their patients.

Tattoo removal is a booming business and a matter of priority for those whose tattoos have become a source of embarrassment and regret. A 2006 study conducted by the Journal of the American Academy of Dermatology found that almost one in four Americans between 18 and 50 has at least one tattoo. Of those, one in five regrets the decision – leaving aesthetic medicine practitioners to resolve potentially millions of unwanted tattoos.

Despite this consumer demand, effective tattoo removal has been prohibitively expensive for many patients and providers – until now, said Pascal Servell, director of education and clinical development for MedSurge Advances.

“TattooStar R is a new technology that offers advanced capabilities at a price that many more medical spas can afford,” Servell said. “Physicians can easily add TattooStar R to their aesthetic practices to deliver fast, effective and cost-efficient removal of tattoos and undesirable skin pigmentation for their patients.”

Recently approved by the FDA, the TattooStar R is among a new generation of Q-switched ruby lasers that provide a higher level of beam homogeneity, which translates into superior treatment results. The system works more rapidly, is safer and offers better protection of the skin than a conventional ruby laser. In addition to tattoo removal, Tattoo Star R is effective in treating pigmented disorders or smaller lesions, since the skin pigment melanin strongly absorbs ruby laser radiation.

Said Servell: “TattooStar R has the ability to remove pigmented lesions and age spots without affecting adjacent tissue. This makes it an excellent choice and the preferred device when treating these types of lesions, particularly on darker skin types.”

TattooStar R is distributed exclusively in the United States by MedSurge Advances. It was developed and is manufactured by Asclepion Laser Technologies GmbH, a European leader in medical laser technology for 30 years. The German company has a rich, varied background in developing, producing and distributing laser systems for medical and aesthetic applications.

MedSurge Advances
www.medsurgeadvances.com
972.720.0425

LAKE FOREST, Calif.–(BUSINESS WIRE)–TRIMEDYNE, INC. (OTCBB: TMED) today announced it raised $ 3,250,000 through a private offering of 2,600,000 shares of Common Stock at a price of $1.25 per share. The offering was conducted by J. H. Darbie & Co., Inc., an international investment banking firm with its headquarters at 99 Wall Street, New York, NY. The investors include Crescent International Ltd. and Leviticus Partners LP and funds managed by Corsair Capital Management and Lewis Asset Management.

Marvin P. Loeb, Chairman of Trimedyne, said, “We are excited to have successfully concluded this offering. The net proceeds of slightly more than $3 million will allow us to finance the increase in sales anticipated from the introduction of our new Side Firing Laser Fiber to the market by Boston Scientific Corporation (NYSE:BSX) in the United States and Japan and by Lumenis, Ltd. throughout the rest of the world.” Mr. Loeb added, “We are also pleased the offering was completed at a very small discount from the market price of our common stock.”

Trimedyne recently received FDA clearance to market a new, Side Firing Laser Fiber for use with Holmium Lasers for their FDA cleared indications, including the treatment of benign prostatic hyperplasia or BPH, commonly referred to as an “enlarged prostate”. BPH is a condition affecting about 55% of men over age 55 and a higher percentage at older ages.

When the prostate becomes enlarged, it blocks urine flow. While millions of men take drugs to relieve BPH, the drugs can become less effective over time. An estimated 200,000 electro-surgical procedures to treat BPH are performed each year in the United States, and about 1 million are performed each year outside the United States.

The electro-surgical procedure typically entails general anesthesia, a three-day average hospital stay and bleeding, in which 3% of the patients lose enough blood to require a blood transfusion. In addition, 3% of the men who were potent before the procedure become impotent and 3% become permanently incontinent. However, urine flow is usually restored to normal levels in this procedure.

Boston Scientific and Lumenis currently market Lumenis’ angled firing laser fibers for use with Lumenis’ Holmium lasers to treat BPH (with fiber royalty payments made to Trimedyne), in competition with Laserscope, Inc., which markets its own angled firing fiber and laser and was recently acquired by American Medical Systems Holdings, Inc. (NASDAQ:AMMD). In Boston Scientific’s, Lumenis’ and AMMD’s laser procedures, there is virtually no bleeding and the procedure is usually performed on an outpatient basis, with the urine flow rate returning to normal levels. Most importantly, the hospital stay and most of the adverse effects of the electro-surgical procedure are significantly reduced.
Upon completion of Trimedyne’s new Side Firing Laser Fiber and Boston Scientific’s review of Trimedyne’s manufacturing process and quality plan and fiber testing, Trimedyne’s new Side Firing Fiber will replace Lumenis’ angled firing laser fiber, which is presently being marketed by Boston Scientific and Lumenis. This review and testing is presently expected to be completed late in the second calendar quarter of 2007, the outcome of which cannot be assured.

Trimedyne plans to file a Registration Statement with the SEC covering the recently purchased shares, an additional 50,000 shares purchased by one of Trimedyne’s early investors, 212,000 shares underlying Warrants issued to J. H. Darbie and another banker in connection with the private placement, which expire in December 2011 and are exercisable at $1.25 per share, and 600,000 shares reserved for issuance of stock options which may be granted in the future to officers, directors, employees and consultants under Trimedyne’s 2007 Stock Option Plan. After deducting an estimated $300,000 of offering expenses, the net proceeds to Trimedyne from the recently purchased shares will be $3,012,500.

Trimedyne manufactures proprietary Holmium lasers and patented fiber optic laser devices for a variety of minimally invasive surgical procedures, many of which are performed on an outpatient basis at substantially less cost than conventional surgery.

Trimedyne, Inc.
www.trimedyne.com
949.951.3800

Clearance Opens Door To Home Use Hair Removal Market

BURLINGTON, Mass., Dec. 11 /PRNewswire-FirstCall/ — Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light- based systems for cosmetic treatments, today announced that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription.

This consumer device was initially developed by Palomar and completed together with The Gillette Company, part of The Procter & Gamble Company (NYSE: PG), under a previously announced agreement to develop a light-based hair removal device for women. Designed specifically for use in the home and based on over a decade of research, this consumer device represents a major breakthrough in the aesthetic device industry.

Commenting on the achievement, Palomar Chief Executive Officer Joseph P. Caruso said, “We are extremely pleased to receive FDA clearance for this patented OTC device. This is a significant milestone for Palomar. The market opportunity for an OTC product is bigger than any market we have addressed to date. We have demonstrated again that we are the clear leader in this technology, just as we did in 1997 when we received the first FDA clearance for a high powered light-based hair removal device for the professional market. Professional light-based hair removal treatments are among the most popular cosmetic treatments offered today with millions of treatments performed each year. This latest clearance further validates Palomar’s investment in research and development in the field of light-based hair removal and adds to the list of distinctions for Palomar as a technology leader in this industry.”
Mr. Caruso continued, “Years ago, we believed that light-based hair removal could be brought to the home. We invested significant resources in research, development and patent protection to make this a reality and ensure that Palomar would be the leader with this innovative technology. This clearance makes Palomar the only company in the world with both professional and direct-to-consumer light-based cosmetic devices cleared for U.S. marketing. We envision a strong potential market for an OTC product and an increase in consumer awareness to help drive growth in our professional business. We are fortunate to have developed this technology in close cooperation with Gillette.
“This is an exciting milestone, with significant future potential,” said Chip Bergh, President, Global Grooming, Gillette. “Our association with Palomar is yet another example of Gillette taking the lead in new and innovative technologies in hair removal.”

Palomar Medical Technologies Inc.
www.palomarmedical.com
800.937.5449