|
|
| Press Releases |
Lerner Medical
Devices Announces 510(k) Clearance of
the
Levia™ Skin Treatment Suite
Unique Fiber-optic Hairbrush System for Scalp Psoriasis |
Los Angeles, CA. February 23, 2004-Leveraging its expertise in
biomedical optics, Lerner Medical Devices, Inc. announced today
that the Company has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for the Levia™ Skin
Treatment Suite, a UVB phototherapy system for the treatment of
psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic
dermatitis (dandruff), and leucoderma (stretch marks). The Levia™
Skin Treatment Suite emits UVB light within the spectral band of
290-320 nm directly to the affected area. This light has been
shown to be effective in the treatment of scalp psoriasis with
the patented Lerner Medical Fiber-optic Brush.
The Levia™ Skin Treatment Suite includes a Light Source, a
flexible Light Guide, a Fiberoptic Brush and a Spot Handpiece.
The desired dose is selected using controls on the Light Source
console and the delivery of light to either the Brush or the
Handpiece is controlled from the panel or with a foot switch.
According to the National Psoriasis Foundation, nearly one-third
of the 1.5 million Americans with moderate to severe psoriasis
are believed to have affected areas on the scalp. Other
available phototherapy treatments for this difficult to treat
surface have limited effectiveness due to blockage of the light
by hair. The patented fiber-optic delivery mechanism delivers
therapeutic UVB light directly to the affected area of the scalp
with minimal exposure to unaffected skin.
“Ultraviolet light is an accepted treatment modality for
psoriasis,” said Ethan Lerner, MD, PhD, CEO of Lerner Medical
Devices, Inc. and Associate Professor of Dermatology at Harvard
Medical School and the Massachusetts General Hospital. “We
believe that we have developed a significant improvement,
enabling physicians to consistently and conveniently deliver UVB
to patients suffering from scalp psoriasis. We are pleased to be
able to introduce this system to the dermatology community.”
Lerner Medical Devices, Inc., headquartered in Los Angeles, aims
to become a leader in biomedical optics. The Company develops
products, based on proprietary technology that optimize
filtering and coupling of light to optical fibers, for office
use by dermatologists and home use by patients. The diseases
currently targeted by Lerner’s products are psoriasis, including
scalp psoriasis, vitiligo, atopic dermatitis (eczema),
seborrheic dermatitis (dandruff), and leucoderma (stretch
marks). The company’s technology can be applied in photodynamic
therapy and other emerging treatments that benefit from
fiber-optic delivery of light.
Contact:
Dr. Ethan Lerner
1 (800) 8-LERNER (853-7637)
ethan@lernermedical.com
|
|
