Sienna Biopharmaceuticals Files 510(k) Submission With FDA


Sienna Biopharmaceuticals, Inc. recently announced the company has filed a Premarket Notification 510(k) submission to the US FDA for SNA-001, a topical pre-treatment to standard laser devices to remove unwanted light hair, and has received acknowledgement from FDA that the submission has been accepted. 

The purpose of the 510(k) notification is to allow for commercial use of SNA-001, in conjunction with a 810 nm Diode laser, for the removal of unwanted white, gray, blonde, light red and light brown hair in women or men.

Available for nearly 25 years, laser hair removal is one of the most commonly performed aesthetic procedures in the world. With more than 12 million laser hair procedures performed annually in the US, countless patients have benefitted from the lasting results of laser hair removal, except for those with light hair. Of the 53 million people in the United States who use laser treatments, waxing and other methods to remove unwanted hair, approximately one in three are light haired. People with white, gray, blonde and red hair, for whom lasers are ineffective, have generally been limited to using waxing and razors to remove their unwanted light hair. Market data indicate that a safe and effective laser treatment for people with light hair could increase the number of laser hair removal procedures by 27 percent in the United States.

As previously announced, Sienna has retained Cowen and Company as its investment bank to review financial and strategic alternatives, which the Company continues to pursue during its Chapter 11 proceedings before the United States Bankruptcy Court for the District of Delaware, with the goal of maximizing stakeholder value. Sienna also intends to continue to manage and operate its business during its Chapter 11 proceedings.

SNA-001 represents an advancement in medical aesthetic procedures, using silver particles applied to the skin to harness light energy from a medical laser to thermally target the hair follicle inside the pilosebaceous unit, resulting in reduction of light- and non-pigmented hair. SNA-001 is a topical, ready-to-use suspension applied to the treatment area on the skin and delivered into the pores. The silver particles are then activated by a laser to thermally target the hair follicle while sparing the surrounding tissue, a process called selective photothermolysis. The silver particles in SNA-001 are designed to work with the most common lasers already utilized in aesthetic clinics and laser centers today.

Sienna has a global patent portfolio covering SNA-001 and broad range of silver or gold nanoparticle compositions covering hair removal and/or treatment of acne, including 18 granted U.S. patents and 3 granted European patents, as well issued patents in various other countries (and pending patents in the United States, Europe and various other countries).

Sienna Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on bringing unconventional scientific innovations to patients whose lives remain burdened by their disease. We draw upon our deep knowledge and experience in drug development across multiple therapeutic areas as we build a unique, diversified, multi-asset portfolio of therapies in immunology and inflammation that target select pathways in specific tissues, with our initial focus on one of the most important ‘immune’ tissues, the skin. We are leading the way with our novel proprietary technology platform, applying a scientific design process to create potent targeted pharmacologically active molecules that are directed toward a specific target tissue and a select disease pathway, and with minimal to no systemic exposure. At Sienna, we are going where it still matters for patients. For more information, www.SiennaBio.com.

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