Endymed Received FDA Approval for Marketing and Sales of its Brand-New Laser based Hair Removal Device

Rhea-AI Summary

Endymed Ltd (TASE: ENDY) announced FDA approval for its Pure Laser hair removal device, developed by its subsidiary Endymed Medical Ltd. This device utilizes advanced laser technology and has received positive results from clinical tests conducted at the Company's R&D center. The approval allows Endymed to market the device in the U.S. through its subsidiary, with plans to expand into other countries through distribution agreements. Pure Laser is the first FDA-approved laser device in the Company's professional aesthetic portfolio, enhancing its offerings.

Positive

• FDA approval for Pure Laser device enhances product portfolio.
• Positive clinical test results indicate device safety and efficacy.
• Plans to market in the U.S. and expand internationally through distribution agreements.

Negative

• Uncertainty about the success of marketing efforts in the U.S. and international registration.

CAESAREA, Israel, Oct. 20, 2022 /PRNewswire/ -- Endymed Ltd (TASE: ENDY), currently traded on the Tel Aviv Stock Exchange, is proud to announce that it has been granted FDA approval for the marketing and sales of Pure Laser, a new hair removal device in the United States.

The Pure Laser was developed in the Company's labs by its subsidiary Endymed Medical Ltd. and is based on laser technology, designed to treat hair removal on all skin types. To obtain the approval, the Company conducted numerous clinical tests to evaluate the device's safety and efficacy. The clinical tests were carried out in the Company's R&D center and the outcomes were positive.

The Company intends to commence marketing in the US through its subsidiary, Endymed Medical Inc. and its marketing and sales team. Furthermore, the Company is working on registration and marketing of the device in other strategic countries, as well as establishing distribution agreements. 

Pure Laser is the Company's first laser-based device to receive FDA approval for marketing and sales within the US. It is a great addition to the Company's Professional portfolio enhancing the variety of its aesthetic offering to both the Company's partners and clients.

About Endymed

Endymed, through its subsidiary Endymed Medical Ltd, develops, manufactures and sales medical-aesthetic devices based on a unique radiofrequency technology, branded 3DEEP© RF used in micro-ablative fractional and non-ablative aesthetic treatments. With 3DEEP radiofrequency technology, the company is committed to change the way aesthetic professionals perform fractional skin resurfacing, treat wrinkles, and provide skin tightening and body contouring solutions, all in a non-invasive or minimally invasive manner.

ENDYMED offers energy based medical aesthetic treatment systems for both the professional and consumer markets. The first product line addresses the professional medical market – doctors, medical clinics and aesthetic providers, all utilizing the company's products to treat their patients. The second product line is intended for the consumer market. The company was able to minimize and harness its unique technology into a Home Use device, whose main purpose is stimulating the skin to naturally trigger collagen production, restoring the skin's elasticity, and visibly reducing wrinkles.

Contact:

Rami Aviram
info@endymed.com

Information regarding the Company's intent to market its device in the United States and to register it in other countries through distribution agreements is forward-looking statements, provided by the Company according to its current knowledge and based on information in its possession which had not been independently verified. Moreover, the Company cannot estimate, at the moment, the probability of the success of the device's marketing efforts in the US, its registration in other countries and any potential distribution agreements with third parties.

View original content:https://www.prnewswire.com/news-releases/endymed-received-fda-approval-for-marketing-and-sales-of-its-brand-new-laser-based-hair-removal-device-301655004.html

SOURCE Endymed

FAQ

What is the FDA approval status of Endymed's Pure Laser device?

Endymed received FDA approval on October 20, 2022, for its Pure Laser hair removal device.

What technology does the Pure Laser device use?

The Pure Laser device uses advanced laser technology designed for hair removal on all skin types.

What are the future plans for the Pure Laser device?

Endymed plans to market the Pure Laser in the U.S. and expand into other strategic countries through distribution agreements.

What is the market potential for the Pure Laser device?

The Pure Laser device enhances Endymed's aesthetic offerings and has significant market potential due to its FDA approval.

How does the approval of Pure Laser impact Endymed's business?

The approval is expected to enhance Endymed's product portfolio and competitive positioning in the aesthetic treatment market.