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Classified in: Health
Subject: FDA

Philips receives U.S. FDA 510(k) clearance to market its Philips BlueControl, a wearable light therapy device to treat mild psoriasis at home



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.

Philips receives U.S. FDA 510(k) clearance to market its Philips BlueControl, a wearable light therapy device to treat mild psoriasis at home

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.

Royal Philips. (PRNewsFoto/Royal Philips)

SOURCE Royal Philips


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