31.05.2018
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DGAP-News: Artificial Iris of HumanOptics Received FDA Approval
DGAP-News: HumanOptics AG / Key word(s): Product Launch
Artificial Iris of HumanOptics Received FDA Approval
31.05.2018 / 10:10
The issuer is solely responsible for the content of this announcement.
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Artificial Iris of HumanOptics Received FDA Approval
Approval process under Breakthrough Devices Program completed within only
six months / Only FDA-approved artificial iris in the U.S. / Broad access
gained to a highly attractive market
Erlangen, May 31, 2018 - The ARTIFICIALIRIS prosthesis of HumanOptics AG
(ISIN DE000A1MMCR6) - a leading technology company in manufacturing
high-quality implants for eye surgery - received FDA approval.
Dr. Pierre Billardon, CEO of HumanOptics AG, is very pleased to have been
granted regulatory approval: "Our custom-made iris implant is a unique
product with extremely high benefits to patients. That is why our
ARTIFICIALIRIS
was accepted into the FDA's Breakthrough Devices Program on December 1,
2017. Just a few months later, we have already received approval for it. The
ARTIFICIALIRIS is at present the only product of this kind that is approved
for the highly attractive U.S. market and addresses this currently unmet
medical need in that market."
The ARTIFICIALIRIS is used to treat patients who have partially or
completely lost their iris as the result of an accident or who were born
without an iris. This affliction is very burdensome to patients in their
social lives and in other situations. Furthermore, it often comes with a
whole range of additional medical complications, such as light sensitivity,
loss of vision, or an above-average risk of glaucoma and cataract formation.
Every ARTIFICIALIRIS is customized by HumanOptics to match the original
appearance of the patient's iris. It is made of a flexible silicon material
that is inserted into the eye using a microsurgical technique - making it
well tolerated. This ensures both the patient's clinical and aesthetic needs
are met, achieving a high level of satisfaction.
HumanOptics AG has already established an excellent reputation for itself in
this highly specialized market for optical surgery in the U.S. As part of a
medical study begun in 2013, more than 600 successful operations have
already been performed at 12 hospitals throughout the country. The market
potential for our product is around 150 hospitals and 1,000 to 1,500
patients per year.
Dr. Billardon therefore expects this product to offer high potential for
revenue and income: "We predict that the artificial iris will become a top
product for our company over the medium term. Many of our current surgeons
already have waiting lists of patients who need our artificial iris but were
unable to be treated during the study. Besides the significant market
potential in the U.S., FDA approval will also boost our image in the
European markets, where we are already allowed to offer this product."
Company Profile:
HumanOptics AG (www.humanoptics.com) develops, produces, and markets
innovative implants for optical surgery, in particular intraocular lenses,
which are artificial lenses implanted in the human eye. The areas of
application include eye diseases such as cataracts, an affliction common
around the world. Intraocular implants are also used in refractive surgery
to correct refractive errors in the eye that can lead to poor vision. Their
product range includes an artificial iris, which can be used to treat iris
defects. The company also offers its target group, surgical eye doctors,
supplies and complementary products as well as comprehensive consulting
services. Shares of HumanOptics AG are listed on the Basic Board of the
Frankfurt Stock Exchange as ISIN DE000A1MMCR6.
Contact:
HumanOptics AG
Investor Relations
Spardorfer Str. 150
91054 Erlangen
Tel.: +49-(0)9131-50665-0
E-mail: [email protected]
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31.05.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: HumanOptics AG
Spardorfer Str. 150
91054 Erlangen
Germany
Phone: +49 (0)9131 - 50665-60
Fax: +49 (0)9131 - 50665-93
E-mail: [email protected]
Internet: www.humanoptics.de
ISIN: DE000A1MMCR6
WKN: A1MMCR
Listed: Regulated Unofficial Market in Berlin, Dusseldorf,
Frankfurt (Basic Board), Stuttgart
End of News DGAP News Service
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