ON JULY 7, 1997, THE U.S. FOOD AND DRUG ADMINISTRATION
(FDA) COMPLETED THEIR REVIEW OF THE EPILIGHT HAIR
REMOVAL SYSTEM. BASED UPON THE TECHNICAL INFORMATION
AND CLINICAL DATA PROVIDED, THE FDA GRANTED CLEARANCE
FOR THE COMMERCIALIZATION IN THE USA OF THE EPILIGHT
HAIR REMOVAL SYSTEM FOR THE REMOVAL OF UNWANTED BODY
HAIR.
The following is a news release that describes the
FDA Approval of Epilight in detail:
Clearance Received from FDA to Market Epilight
Hair Removal
System
Needham, MA July 21, 1997. ESC Medical Systems announced
it received clearance from the U.S. Food and Drug
Administration to market the Epilight Hair Removal
System, a safe noninvasive treatment for the removal
of unwanted hair.
The EpiLight Hair Removal System uses patented intense
light energy to effectively eliminate undesired hair
of all colors from all parts of the body on nearly
all skin types while reducing potential side effects.
Known as photo-epilation, the EpiLight's unique method
enables the pulsed light to penetrate deeply enough
and with sufficient energy to damage the hair follicles
without harming the surrounding skin tissue. This
approach provides the physician and patient with important
clinical benefits over existing hair removal methods
like electrolysis, waxing, depilatories or laser procedures.
For the patient, hair removal using the EpiLight
System means effective results, faster treatment time
and minimal discomfort. For the physician, the device's
innovative technology allows him/her to adjust and
customize treatment parameters to the particular body
area, specific hair color and exact skin type of the
patient. This capability is largely due to the EpiLight's
unique capacity to select a wide range of treatment
parameters such as spectral output, pulse structure
and pulse duration, which is based on the same patented
technology as the successful PhotoDerm® VL/PL
for the treatment of vascular and pigmented lesions.
"In one treatment with the EpiLight, we have
obtained excellent immediate results on a large number
of hairs with minimal side effects," says Michael
Gold, M.D., who conducted clinical trial studies on
the EpiLight. "Many of my patients have spent
a lifetime battling unwanted hair growth and have
unsuccessfully tried other hair removal methods, such
as electrolysis and lasers. The EpiLight gives them
a renewed hope," notes Dr. Gold, who is a cosmetic
dermatologic surgeon in Nashville, TN.
The initial FDA clinical study examined more than
100 female and male patients who were treated once
to remove unwanted hair on the chin, mustache, neck,
trunk, bikini line, arm and leg. More than 200 anatomical
sites were monitored for a period of 3 months following
treatment. A transparent cooling gel was applied to
the treated area prior to light exposure, and no local
anesthesia was administered. Study results showed
EpiLight achieved an average clearance of 52% for
all hair colors, anatomical sites and skin pigmentation
types at 3 months after a single treatment.
Owing to its non-laser principles of operation, the
EpiLight Hair Removal System overcomes several critical
limitations inherent in laser systems. Distinct from
lasers which are set at a fixed wavelength, the EpiLight
uses a wide spectrum of wavelengths and pulse widths.
In particular, it offers an adjustable broad wavelength
range, unique light pulse capabilities, and a large
spot size. Also, the device's larger spot size means
it can cover more area faster and in fewer treatment
sessions. This unrivaled design provides optimum versatility
and maximum flexibility to remove all hair colors
from all body parts on most skin types quickly and
efficiently.
"At one year follow-up with only several treatment
sessions, we have achieved safe and effective hair
removal with minimal discomfort and minimal recovery
time," states Drs. Margaret A. and Robert A.
Weiss, associate professors of dermatology at John
Hopkins University in Baltimore. "Before the
EpiLight, removal of dense hair from huge areas, like
the back, was impossible. Now, the extremely large
footprint of each EpiLight pulse allows rapid treatment
of large body surfaces. We are delighted to be able
to offer our patients an exciting new solution for
unwanted body hair."
The scientific foundation underlying the EpiLight
Hair Removal System is the principle of selective
photothermolysis in which EpiLight's intense pulsed
light is converted into heat when it is absorbed by
melanin. Melanin is the most significant chromophore
in hair which absorbs light. When light is absorbed
in the hair follicle, hair shaft or the bulb, it raises
their temperature. Once the temperature reaches a
high enough level, the targeted hair structures are
destroyed and hair regrowth is impaired.
Epilight Hair Removal System is manufactured by ESC
Medical Systems Ltd. of Yokneam, Israel. Marketing
and clinical support for the U.S. market are provided
by ESC Medical Systems Inc., a wholly owned subsidiary
in Needham, MA. At present, there are more than 100
Epilight Systems installed in clinics worldwide.
(ESC Medical System's consumer hotline: 1-888-HAIR-011)
Device Name: Epilight Hair Removal System
Indications for Use: The Epilight Hair Removal System
is used for the removal of unwanted hair.
FDA Approves Intense Pulsed Light Technology
For Permanent Hair Reduction
February 2, 2000 (Needham, MA) – ESC Medical
Systems today announced that the US Food and Drug
Administration (FDA) has determined that its proprietary
Intense Pulsed Light (IPL) technology for hair removal
can be marketed to provide “permanent hair reduction.”
This new claim is based on strong scientific studies
with patients in multiple clinics and a carefully
constructed statistical analysis.
Permanent hair reduction is defined as long-term
stable reduction in the number of hairs regrowing
after a treatment regime. The number of regrowing
hairs must be stable over a time greater than the
duration of the complete growth cycle of hair follicles,
which varies from 4-12 months depending on body site.
“IPL photoepilation technology is the ONLY treatment
of its kind to demonstrate such high clearance rates
for hair removal,” said Neil Sadick, MD, Clinical
Associate Professor of Dermatology at New York Hospital-Cornell
Medical Center, New York, and co-investigator of the
study. “Unlike other laser systems, IPL therapy
appears to produce a genuine destruction of hair follicles,
rather than temporarily disabling them,” added
co-investigator Michael Gold, MD a Cosmetic Dermatologic
Surgeon in Nashville, TN.
Two separate studies were conducted to support this
claim. One measured the effect of IPL hair removal
after a single treatment; the second after two to
six treatments. Results showed an average clearance
rate of greater than 76% permanent hair reduction
at 12 months and 84% at 24 months following the treatment
regimen.
“The FDA determination for out IPL hair removal
technology is very exciting and demonstrates the Company’s
commitment to breakthrough research and clinical solutions
to raise the standard of patient care,” said
Louis Scafuri, CEO of the Americas for ESC Medical
Systems. “We’re confident that our current
and new IPL family of products will continue to drive
revenue growth and keep us and our customers competitive.”
IPL hair removal technology provides a gentle, noninvasive
treatment that is used to eliminate the full range
of unwanted hair problems. Bursts of intense light
energy, heat and damage the hair follicle, causing
the treated hair to fall out while sparing the healthy
surrounding tissue. Treatment parameters can be customized
according to a person’s skin color, hair density
and specific anatomical site, no matter how deep the
hair follicles reside.
ESC Medical Systems develops, manufactures and markets
medical devices utilizing state-of-the art proprietary
intense pulsed light source and laser technology.
Its systems are used in a variety of surgical and
medical applications, including ENT, OB/GYN and neurosurgery,
as well as for the noninvasive treatment of varicose
veins and other benign vascular lesions, pigmented
lesions, hair removal and skin rejuvenation.
FDA Approves Intense Pulsed Light Technology
For Hair Removal of Darkest Skin Types (TYPE VI)
February 29, 2000 (Needham, MA) – ESC Medical
Systems today announced that the US Food and Drug
Administration (FDA) has cleared its proprietary Intense
Pulsed Light (IPL) technology for hair removal of
skin type VI, or the darkest skin types, including
black skin. Now, for the first time ever, black-skinned
individuals have a treatment solution available to
them for removing unwanted hair. ESC’s IPL hair
removal systems are the only devices that have been
proven safe and effective on black skin.
Yacha Sutton, CEO of ESC Medical said, “This
represents a major breakthrough and is the second
FDA clearance received for our IPL technology in less
than a month. On February 2, we announced that the
FDA had cleared the technology for a claim of permanent
hair reduction on all body sites, which offers a significant
advantage over most other hair removal methods. We
are pleased to be recognized once again for our leadership
in light based technology with this gold standard
product.
Hair removal in the U.S. alone is a multi-billion
dollar market. This new clearance allows ESC to offer
treatment to another market segment consisting of
13% of the U.S. population.
“Until now, dark-complexioned patients had
few options for the removal of unwanted hair and the
results were at best temporary.” Said Franklin
Johnson, MD, a lead investigator in the clinical study
of the IPL system on skin type VI. “Now, with
the new longer wavelength, we can apply the deeper
effects of the technology for hair removal, while
bypassing the epidermal melanin present in dark-skinned
individuals,” explained Dr. Johnson, who is
a general surgeon affiliated with Winthrop University
Hospital in Mineola, NY.
Results of the multi-center clinical study to evaluate
the efficacy of one IPL treatment on very dark-skinned
patients were comparable to average hair clearance
rates reported in other studies on lighter skin types.
“We are extremely please to be the first in
the industry to provide a new segment of the population
access to this clinical advance in hair removal treatment,”
said Louis Scafuri, CEO of the Americas for ESC Medical
Systems. “It represents the cornerstone of our
growth strategy and demonstrates our leadership position
in the marketplace.”
ESC Medical Systems develops, manufactures and markets
medical devices utilizing state-of-the art proprietary
intense pulsed light source and laser technology.
Its systems are used in a variety of surgical and
medical applications, including ENT, OB/GYN and neurosurgery,
as well as for the noninvasive treatment of varicose
veins and other benign vascular lesions, pigmented
lesions, hair removal and skin rejuvenation.
