Lumenis Bclear Photoclearing for Seb Derm/Psorias
I apologize if someone already posted this article but it seems interesting
and it seems like some of it may be covered by insurance–anybody know any
more about this?
Thanks,
RJ
Lumenis Receives FDA Marketing Clearance for Treatment of Eczema and
Dermatitis with the Multi-Application BClear(TM) Targeted PhotoClearing(TM)
System
YOKNEAM, Israel, May 22 /PRNewswire-FirstCall/ — Lumenis Ltd. (Nasdaq: LUME
- News) announced today that it has received FDA clearance to market its
BClear(TM) Targeted PhotoClearing(TM) System for the treatment of atopic
eczema and seborrheic dermatitis.The BClear system, which received marketing
clearance from the United States Food and Drug Administration (FDA) in
December 2001 for the treatment of psoriasis and vitiligo, is a unique
light-based therapy that combines the proven benefits of phototherapy with
the latest advances in fiber-optic technology.
Atopic eczema and seborrheic dermatitis are sources of much discomfort and
frustration to millions of patients and their physicians worldwide.
"Treating eczema and dermatitis with the BClear system can bring relief to
millions of patients, especially children and young adults who suffer from
these skin conditions," said Yacha Sutton, President and Chief Executive
Officer of Lumenis Ltd. "We are very excited about offering this drug free
alternative to traditional treatment options including topical and oral
medications such as corticosteroids, antihistamines and antibiotics," he
added.
Red, inflamed, scaling, and extremely itchy skin characterizes these
conditions, which often lead to secondary skin infections. In contrast to
conventional treatments that are not always effective or appropriate for
children and those sensitive to medication, the BClear(TM) system offers a
safe treatment option with generally very limited side-effects.
The innovative technology of the BClear system represents a significant
breakthrough in that it takes existing science to the next level by
combining the benefits of highly efficacious UVB light therapy with the
latest advances in fiber-optic delivered light technology. The computerized
BClear system delivers precisely targeted light through a fiber-optic cable,
in significantly higher doses than those used in traditional UVB light
therapy. This allows patients to experience successful results in fewer
treatment sessions.
The precision dosimetry and small beam output of the BClear system also
allows individually customized treatments that safely and effectively treat
all body surface locations and skin types (I-VI). "The versatile,
multi-application capabilities of the BClear system, now expanded to include
the treatment of atopic eczema and seborrheic dermatitis in addition to
psoriasis and vitiligo, will make it a very attractive and valuable addition
to dermatology practices worldwide," said Alon Maor, Executive Vice
President of Lumenis’ Aesthetic Business unit.
"I have treated various dermatological conditions with the BClear system and
have had consistently strong clinical results," stated Christine Dierickx,
M.D. of Boom, Belgium. "I find its capability to precisely target and
effectively treat diseased tissue while avoiding normal skin to be very
beneficial. My patients have also been very pleased with the results," she
added.
The BClear system is the first high intensity, targeted device to provide
reimbursable UVB treatments for eczema, dermatitis and psoriasis under
existing UVB phototherapy CPT codes. "Medicare reimbursement rates were
recently raised to more than $50 per treatment," said Mr. Maor. "We expect
that the combination of a safe and effective, localized UVB treatment — and
improved reimbursement rates — to substantially increase the number of
patient visits to dermatologists’ offices for these procedures."
About Atopic Eczema
Atopic eczema is associated with intense itchiness and infections that arise
following scratching. Atopic eczema is very common in all parts of the
world, and affects up to 20 percent of all children under the age of 11.
According to the American Academy of Dermatology (AAD), more than 15 million
people suffer from the disease, in the United States alone. Atopic eczema
also accounts for approximately 10 to 20 percent of all referrals to
dermatologists.
About Seborrheic Dermatitis
Seborrheic dermatitis is a chronic inflammatory condition of the skin that
occurs in areas of the skin that have a high concentration of active
sebaceous glands - on the face, trunk and especially on the scalp.
Seborrheic dermatitis is often considered to be a more severe form of
dandruff. Waxy scale, inflammation and red skin characterize seborrheic
dermatitis. It affects approximately 3% to 5% of the adult population, most
commonly men, and is most prevalent during infancy and middle age.
About Lumenis
The statements in this press release that are not historical facts are
forward-looking statements which are subject to risks and uncertainties. The
Company’s actual results could differ materially from those anticipated in
the forward looking statements based on a variety of factors, including,
among others: uncertainties with respect to market acceptance of the
Company’s products, obtaining regulatory approvals for new products or for
the sale of existing products in new markets and enforcement of intellectual
property rights; risks associated with competition and competitive pricing
pressures, economic conditions generally, the Company’s international
operations and the Company’s ability to integrate its operations with those
of acquired businesses; and other risks detailed from time to time in the
reports filed by Lumenis with the SEC, including its annual report on Form
10-K and quarterly reports on Form 10-Q.