Clarify's connected home phototherapy device gears for launch

By Dave Muoio

Clarify Medical will be debuting its handheld, smartphone-connected phototherapy device later this week at the American Academy of Dermatology Annual Meeting, according to a statement. The technology powering the Home Light Therapy System received FDA 510(k) clearance last June, and is to be used in the treatment of skin diseases including psoriasis, vitiligo, and eczema.

“The Clarify System solves problems that have prevented home phototherapy from being widely adopted — by providing treatment controls, reducing the physician’s workload, and helping to ensure patient treatment adherence,” Rex Bright, interim president and CEO of Clarify Medical, said in a statement. “We’re excited to introduce this innovative therapy to the medical community.”

The Clarify System uses an app on the patient’s smartphone to manage ultraviolet B light, therapy dosage, frequency, and duration, allowing users to receive the therapy in their own home. To ensure adherence and adjust prescribed therapy as needed, physicians can monitor progress through the Clarify portal, or by corresponding with Clarify Medical’s CarePartner team. The system does not allow a patient to administer treatment outside of a physician-prescribed protocol. The device itself is lightweight and requires no time to warm up. It is almost entirely controlled through the app’s guided interface.

"We have completed a very successful digital reservation campaign, inviting people with psoriasis and vitiligo to make a reservation for the Clarify system after we received FDA clearance,” then-CEO James M. Sweeney, a member of the board who was CEO of Clarify when the device was cleared said at the time. “Patient response was extremely positive. We quickly received a thousand confirmed reservations, and are now in the process of turning those reservations into orders.”

In June, Clarify Medical said that it planned to begin offering the system to patients by November. The company is currently accepting orders for the Home Light Therapy System on its website at the price of $999 — a $200 increase over its initial pricing.

Clarify completed a controlled study of the system among psoriasis patients in September, in which the company said that researchers found similar results among those using the system and those receiving in-office phototherapy. Testing among patients with vitiligo also demonstrated noticeable repigmentation in as few as four weeks, according to the company.

“Home Phototherapy is an effective way to bring pigmentation back to vitiligo lesions,” Dr. Amit Pandya, professor of dermatology at UT Southwestern and board member at Clarify, said in a statement. “It stimulates melanocytes to grow, migrate to the white vitiligo lesions and produce melanin, which results in a return of natural color to the skin.”