AMSTERDAM, July 13, 2017 /PRNewswire/ -- Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced it has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) to market the Philips BlueControl
wearable light therapy device to treat mild psoriasis. In the U.S.,
BlueControl is a Class II prescription medical device designed for
home use.
Reducing the symptoms of mild psoriasis
Psoriasis is
the most common autoimmune disease in the U.S., affecting as many
as 7.5 million people in the country and a total of around 125
million people worldwide [1]. Clinical studies [2,3] have
demonstrated that the UV-free blue LED light emitted by Philips'
BlueControl wearable device induces natural, drug-free processes in
the skin to significantly reduce symptoms of mild psoriasis
vulgaris - the most common form of psoriasis - such as
redness, scaling and thickness of psoriasis plaques.
Building on the roll-out in Europe
Designed with patients in mind,
BlueControl's wearability provides complete freedom of movement. A
patient can wear the rechargeable, battery-powered device
comfortably on affected areas such as the arms, legs, elbows and
knees using the adjustable straps. Philips obtained CE-marking for
its BlueControl device in 2015, and has been successfully marketing
it in selected countries in Europe, including Germany and the UK. Following the FDA
clearance, Philips will start to engage with dermatologists and
patient support groups in the U.S. and prepare for the commercial
launch of BlueControl in the U.S. market in early 2018.
"As a company, we aim to improve people's health with a broad
portfolio of proven therapy solutions to enable patients with
chronic conditions to manage their health at home," said
David Aubert, General Manager of
Philips' Light & Health business. "Philips BlueControl is a
clinically proven light therapy device that can be easily
integrated into a patient's daily routine. We are pleased that we
can now start marketing this innovative home treatment solution for
psoriasis to dermatologists in the U.S., so that they will be able
to prescribe Philips BlueControl to their patients."
Psoriasis vulgaris
Eighty percent of psoriasis
patients worldwide suffer from the most common form – psoriasis
vulgaris, also known as plaque psoriasis [1]. It is caused by the
overly rapid proliferation of skin cells and can be accompanied by
painful inflammation. Philips BlueControl light therapy is enabled
by high-intensity blue LEDs with tailored light settings. It helps
the patient's skin to renew itself properly by slowing down the
accelerated production of skin cells associated with plaque
psoriasis [4]. With its anti-inflammatory properties, blue light
controls unregulated inflammation and can alleviate the symptoms of
affected skin [5].
Clinical studies
Philips conducted two consecutive
clinical studies [2,3] in partnership with the University Hospital
of Aachen in Germany to
investigate the efficacy and safety of Philips BlueControl to
reduce the symptoms of psoriasis vulgaris. In the second of these
studies, patients were treated for a duration of three months.
Eighty-four percent of patients showed an improvement in plaque
symptoms (thickness, redness and scaling) compared to the beginning
of the study. In some cases, complete disappearance of the plaque
was observed. Eighty-three percent of patients rated the usability
and comfort of the device as ideal or excellent [3].
[1] National Psoriasis Foundation USA "About Psoriasis" fact sheet
and media kit, accessed July 2017.
[2] Weinstabl A et al.
Dermatology. 2011; 223(3): 251-9.
[3] Pfaff S et
al. Dermatology. 2015; 231: 24-34.
[4]
Liebmann J, Born M, Kolb-Bachofen MV. Journal of Investigative
Dermatology. 2010; 130: 259-269.
[5] Fischer M et
al. Experimental Dermatology. 2013; 22: 554-563.
For further information, please contact:
Björn Teuwsen
Philips Emerging Businesses
Tel.: +31 6 130 789 75
E-mail: Bjorn.teuwsen@philips.com
Steve Klink
Philips Group Press Office
Tel.: +31 6 10888824
E-mail: steve.klink@philips.com
About Royal
Philips
Royal Philips
(NYSE: PHG, AEX: PHIA) is a leading health technology company
focused on improving people's health and enabling better outcomes
across the health continuum from healthy living and prevention, to
diagnosis, treatment and home care. Philips leverages advanced
technology and deep clinical and consumer insights to deliver
integrated solutions. Headquartered in the Netherlands, the company is a leader in
diagnostic imaging, image-guided therapy, patient monitoring and
health informatics, as well as in consumer health and home care.
Philips' health technology portfolio generated 2016 sales of
EUR 17.4 billion and employs
approximately 70,000 employees with sales and services in more than
100 countries. News about Philips can be found at
www.philips.com/newscenter.
View original content with
multimedia:http://www.prnewswire.com/news-releases/philips-receives-us-fda-510k-clearance-to-market-its-philips-bluecontrol-a-wearable-light-therapy-device-to-treat-mild-psoriasis-at-home-300487808.html
SOURCE Royal Philips