HORSHAM, Pa.--(BUSINESS WIRE)--Aug. 7, 2014--
PhotoMedex, Inc. (NasdaqGS and TASE:PHMD) today announced that a
new independent clinical study demonstrated a substantial reduction in
hair regrowth following use of no!no! Hair using proprietary
Thermicon™ technology. PhotoMedex’s consumer products subsidiary
Radiancy Inc. manufactures and sells the no!no! product line worldwide.
The study was conducted by the Consumer Product Testing Company, a world
leader in contract laboratory testing of consumer medical and healthcare
products and funded by the company. The study included 44 subjects with
Fitzpatrick skin types II-VI and with blonde, black and brown hair. The
subjects were treated on their arms and legs for 12 weeks. Quantitative
hair counts were made by an independent evaluator reviewing a total of
160 treatment sites on the subjects over the course of three visits by
The statistically significant results (p<0.001) of this clinical trial
conclusively demonstrated a substantial reduction in hair regrowth in
the treated areas. The company will seek to publish the results in a
peer-reviewed journal in the near future or will otherwise make the
final study report available on its website.
PhotoMedex CEO Dolev Rafaeli stated, “This important new study directly
contradicts the claims of certain of our competitors, who have sought to
mislead consumers with a highly flawed study and claims. Beginning in
2011, Radiancy substantially curtailed its advertising claims regarding
the effectiveness of the no!no! Hair in an effort to deter overzealous
plaintiffs lawyers from bringing meritless claims against the company.”
Dr. Rafaeli added, “We will closely evaluate the results of this study
as a basis for expanding our advertising claims to provide consumers
with accurate information about the safety and effectiveness of our
no!no! Hair product line, the category leader. The decision to undertake
this blinded study was partly influenced by continued unsubstantiated
assertions in the marketplace from failing competitors and dishonest
short-sellers of our common stock about the effectiveness of no!no!
Hair, beginning with a competitor’s unsuccessful and ultimately
dismissed court battle in 2012."
Radiancy has a long-standing commitment to offering consumers products
with demonstrated track records of safety and effectiveness. Radiancy
has sold more than five million no!no! Hair products worldwide. Consumer
testimonials have attested to the fact that with proper and continued
use, no!no! Hair is a safe and effective product for immediate and
long-lasting hair removal results for women and men of all hair color
and skin types.
Radiancy remains committed to demonstrating the validity of consumer
testimonials and previous clinical studies as to the effectiveness and
safety of the no!no! Hair product line, and confirms that with proper
and continued use no!no! Hair provides safe, painless and long-lasting
Founded in 1998 and merged with PhotoMedex in December 2011, Radiancy
Inc. is a leading developer, manufacturer and seller of home-use and
professional aesthetic and dermatological devices. The company sells a
range of home-use devices under its proprietary no!no!™ brand for
various indications including hair removal, acne treatment and skin
rejuvenation. The company also offers a professional product line that
addresses acne clearance, skin tightening, psoriasis care and hair
removal sold to physician clinics and spas.
Radiancy’s products are supported by two core proprietary technologies
known as LHE™ (Light & Heat Energy) and Thermicon™. The company’s LHE™
technology is superior in cost performance, efficacy and ease of
application to both laser and intense pulse light (IPL) technologies.
LHE™ combines the use of direct heat and a wide-spectrum light source
and allows very large treatment spot sizes with less discomfort without
the requirement of skin cooling.
LHE™ technology is incorporated in Radiancy’s FDA-cleared professional
devices as well as its consumer products.
About Consumer Product Testing Company
Consumer Product Testing Company, based in Fairfield, N.J., is a
worldwide leader in the contract laboratory testing of cosmetics,
personal care, pharmaceuticals, medical devices and specialty chemicals.
It was incorporated in 1975.
PhotoMedex, Inc. is a Global Health products and services company
providing integrated disease management and aesthetic solutions to
dermatologists, professional aestheticians, ophthalmologists,
optometrists, consumers and patients. The Company provides proprietary
products and services that address skin conditions including psoriasis,
vitiligo, acne, actinic keratosis, photo damage and unwanted hair, as
well as fixed-site laser vision correction services at our LasikPlus®
vision centers. Its experience in the physician market provides the
platform to expand its skin health solutions to spa markets, as well as
traditional retail, online and infomercial outlets for home-use
products. PhotoMedex sells home-use devices under the no!no!™ brand for
various indications including hair removal, acne treatment and skin
rejuvenation. The company also offers a professional product line for
acne clearance, skin tightening, psoriasis care and hair removal sold to
physician clinics and spas. PhotoMedex further expanded its base through
the acquisition of LCA-Vision Inc., a leading provider of laser vision
correction services under the LasikPlus® brand. LCA-Vision
operates 60 LasikPlus® vision centers in the U.S., including 51
full-service LasikPlus® fixed-site laser vision correction
centers and nine pre- and post-operative LasikPlus® satellite
centers. LCA-Vision has performed more than 1.3 million procedures since
FDA approval of photorefractive keratectomy (PRK) in late 1995.
SAFE HARBOR STATEMENT
This press release contains forward looking statements, including,
but not limited to statements relating to PhotoMedex’s future financial
performance, strategies, potential sales and earnings growth. Some
portions of this release, particularly those describing PhotoMedex'
strategies, operating expense reductions and business plans will contain
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 that are subject to risks,
uncertainties and other factors. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements, including any statements of the plans,
strategies and objectives of management for future operations; any
statements regarding product development, product extensions, product
integration or product marketing; any statements regarding continued
compliance with government regulations, changing legislation or
regulatory environments; any statements of expectation or belief and any
statements of assumptions underlying any of the foregoing. In addition,
there are risks and uncertainties related to successfully integrating
the products and employees of the Company and Radiancy, as well as the
ability to ensure continued regulatory compliance, performance and/or
market growth. These risks, uncertainties and other factors, and
the general risks associated with the businesses of the Company
described in the reports and other documents filed with the SEC, could
cause actual results to differ materially from those referred to,
implied or expressed in the forward-looking statements. The
Company cautions readers not to rely on these forward-looking statements.
All forward-looking statements are based on information currently
available to the Company and are qualified in their entirety by this
cautionary statement. The Company anticipates that subsequent
events and developments will cause its views to change. The
information contained in this conference call speaks as of the date
hereof and the Company has or undertakes no obligation to update or
revise these forward-looking statements, whether as a result of new
information, future events or otherwise.
Source: PhotoMedex, Inc.
Kim Sutton Golodetz, 212-838-3777
Dennis McGrath, 215-619-3287
Chief Financial Officer