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Ekkyo Describes the First Benefits of Controlled Hyperthermia in Humans in "Lasers in Surgery and Medicine"
Date:7/22/2008

A Pilot Study Suggests That Ekkyo's New Approach of LASH (Laser Assisted

Scar Healing) can Drastically Improve Scar Healing Physiology

MARSEILLES, France, July 22 /PRNewswire/ -- Ekkyo (formerly known as Heatwave Technology) a photomedicine company, which develops first-in-class laser-based systems for skin scar prevention and reduction, announced today the publication of a scientific article in Lasers in Surgery and Medicine* reporting the results of a pilot study on cutaneous scar prevention by LASH.

Based on the therapeutic effects of controlled selective hyperthermia, Ekkyo's approach aims to stimulate the natural repair mechanisms of the skin, initiated at the critical moment of wound closure (ie the thrombotic phase). This innovative approach was validated in animals by a proof of concept study performed using an 810 nm laser diode system that showed its ability to speed up the healing process and avoid visible marks of the wounds (Capon, Souil et al. 2001 Lasers Surg Med. 2001;28(2):168-75).

To demonstrate the relevance of this approach in humans, a pilot** clinical trial, focused on abdominoplasty, was carried out at the Lille University Hospital Center (in September 2006 - December 2007). Conducted by Dr. Alexandre Capon, plastic surgeon, the aim of the study was twofold: evaluating the safety, as well as the therapeutic and cosmetic benefits of a treatment by an 810 nm laser diode. This is the base for the handheld laser Ekkylite(TM) the very first Laser Assisted Scar Healing system using a "smart" safety device in charge of recognizing, setting up and defining the parameters of the laser during treatment.

"The results of this study are very encouraging; they validate our approach from the view point of safety and efficacy in a difficult clinical context of abdominal plasty that usually leaves unsightly long scars ; they impact patients self esteem and decrease the benefits of the surgical intervention," comments Dr. Gwenaelle Iarmarcovai, head of Ekkyo's Clinical trials.

"This article confirms the benefits of the LASH technology to speed up the healing process and dramatically reduce or even prevent scars," said Alain Cornil, company CEO and co-founder. "We are now ready to launch EkkyLite(TM), our first laser system, which should soon become the reference for surgeons and their patients undergoing surgeries," he added.

**About the Clinical Pilot Study - Protocol no 0631

The clinical pilot study included 5 female patients with Fitzpatrick skin types I-IV with linear surgical scars of greater than 2 cm. The main objective of the trial was to evaluate safety and performance of the 810 nm laser diode system.

Each surgical incision was randomly divided in two parts ; 8 cm receiving an 810 nm laser diode treatment. The other part was not being treated. Patients were treated with doses ranging between 80 and 120 J/cm2.

Scar appearance was evaluated for inflammation, thickness, width, discretion and linearity by surgeon and patient at 10 days, 3 months, and 12 months.

The final scar analysis at 12 months after laser treatment showed that the treated portion of the scar is of better quality as measured by the surgeon and the patient relative to untreated scar parts. No significant complications occurred during or after the course of this study.

About Ekkyo

Created in 2006 by one specialist in photomedicine, one plastic surgeon, one marketing expert specialized in medical devices and one specialist in production and quality processes, EKKYO formerly known as Heatwave Technology is a photomedicine company that develops first-in-class laser-based systems for scar prevention and reduction.

Resulting mostly from the pioneering work of Ekkyo's founding scientists and clinicians, Ekkylite(TM) is the first company's product. This very first Laser Assisted Scar Healing system combines a handheld laser, a "smart" safety device that guides the surgeon's moves during the laser treatment and a sterile sheath for working in the operating room. EkkyLite(TM) activates and stimulates the skin regeneration process resulting in faster healing, while preventing, reducing and sometimes completely erasing surgical scars.

The therapeutic, aesthetic and practical benefits provided by EkkyLite(TM) makes it the first laser technology accessible to all surgeons: not only plastic surgeons but also specialists experiencing scarring issues such as dermatologists, obstetricians, trauma specialists...

Currently in clinical phase, the commercialization of the Ekkylite(TM) system is forecasted for 2008 in France and for 2009 successively in Europe and the United States. Based in Meyreuil, France, Ekkyo has 8 staff members as of December 2007.

More on http://www.ekkyo.com

*Alexandre C. Capon et al. LSM-08-0066 (20657)

Lasers in Surgery and Medicine publishes the highest quality research and clinical manuscripts in areas relating to the use of lasers in medicine and biology. The journal publishes basic and clinical studies on the therapeutic and diagnostic use of lasers in all the surgical and medical specialties.


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SOURCE EKKYO
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