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FDA Clearance and Launch of Clinical Strength Laser Hair Therapy Device for Home Hair Growth

Tue, 08/06/2013 - 11:03am
The Associated Press

Theradome, a medical device company focused on bringing clinical-strength technologies to the consumer market, announces the release of its LH80 laser helmet to treat hair loss. This system, recently cleared by the FDA, was designed by world leading experts in hair loss, dermatological health, and biomedical engineering. The system offers clinical strength hair growth therapy, previously found only in hair restoration clinics, in the comfort of one's own home for a fraction of the usual cost.

  • Theradome is the first and only FDA Over-The-Counter cleared wearable laser treatment for use in the home.
  • Theradome offers clinical results without the clinical price tag.
  • Theradome is taking specially discounted advance orders via Indiegogo.com.

Tamim Hamid, founder and CEO of Theradome, has personal experience with hair loss. "I had struggled with hair loss since I was thirty-two years old," he says. "I come from a family of physicians, I tried all the latest prescription drugs, but none of them worked for me. As a NASA scientist and with my doctoral work in biomedical engineering, I knew there had to be a better solution. So I began working on a way to get rid of my medications and effectively regain my hair."

The Theradome will initially be available on Indiegogo for a low introductory price. Theradome is also actively pursuing additional distribution channels to bring the device to every market across the globe.

In the United States, roughly 80 million people suffer from hair loss due to androgenic alopecia, including approximately 40 million women. Traditionally, therapies for meaningful female hair growth have only been available in clinical settings and typically cost thousands of dollars. Less expensive, non-clinical options deliver much less therapeutic light (typically under 5 percent of a clinical option) than clinical devices and in most cases have not been cleared by the FDA. The Theradome brings clinical strength hair restoration therapy to the home at a fraction of the price, and it has been cleared for both safety and efficacy by the FDA.

Sara Wasserbauer, M.D. and head surgeon at California Hair Restoration explains some key characteristics of a home use laser hair therapy device, "My advice to patients is to look for a device that is a laser, not an LED. Patients should also look for a device that is easy to use, like one that has hands free operation and a wavelength in the 670 nm range. This might seem like a technical detail, but according to the most recent scientific studies lasers in this wavelength are the ones that have proven effectiveness." The Theradome has all these essential features and more.

Key Theradome features:

  • The world's most powerful in-home solution to treat hair loss.
  • Produces results with just two 20-minute treatments each week.
  • Utilizes 80 proprietary lasers to generate over 440 joules and treats the full scalp area.
  • Delivers the optimum wavelength of light for hair growth (678 nanometers).
  • Hands-free operation allows the user to carry out other tasks during the therapy.

Key Theradomeclinical trial results:

  • Proven to grow hair in 98 percent of users.
  • Hair thickness, volume and density increased by 200% within six weeks.

Ms. Ghazal Gill, Miss Millennium 2013 and an early user of the Theradome, has experienced the full benefit of the therapy, "With my crazy beauty-pageant contestant lifestyle my hair had begun to fall out and had thinned, which wasn't helping my career. I knew I had to do something about it and do it fast. When this opportunity came along I found it was easy to use the Theradome. My confidence is back, I have a full head of long hair and I don't need extensions."

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