Second Sight Medical Products, Inc. (Nasdaq:EYES) ("Second Sight" or
"the Company"), a developer, manufacturer and marketer of implantable
visual prosthetics to provide functional vision to blind patients, today
announced that InEK1, the German national system which
provides health insurance to 90% of the country’s population, has
renewed Status 1 for the Argus® II Retinal Prosthesis System under the
NUB2 innovation program.
The key objective of the NUB program is to facilitate the introduction
of innovative technologies. With designation of Status 1, the highest
level of NUB approval, the 19 approved German hospitals may offer Argus
II treatment to their patients and also negotiate for additional funding
to support Argus II implants. A NUB approval is valid for one year, and
is usually approved annually for qualifying innovative therapies until a
permanent reimbursement (DRG) plan is in place.
“This renewal is great news for the people of Germany. It will allow
more patients to have access to this life-changing technology and help
them in their daily lives,” said Prof Dr. med. Peter Walter
(Universitäts-Augenklinik, RWTH Aachen, Germany), who completed the 25th
Argus II implant in Germany last week.
In Europe, Argus II is indicated for blind people suffering from
advanced outer retinal degenerative diseases such as Retinitis
Pigmentosa (RP). RP, an inherited disease that often results in nearly
complete blindness, affects roughly 30,000 Germans and 167,000 persons
across Europe.
“The 2015 NUB renewal at the Status 1 level reflects the ongoing
recognition by InEK of the benefits of Argus II, which is supported by
the strong, continuing commitment among German ophthalmologists, to help
blind patients restore some of their vision,” said Dr. Robert Greenberg,
President and CEO of Second Sight. “We look forward to collaborating
with leaders in the ophthalmic and patient communities who are committed
to helping patients living with blindness as a result of severe diseases
such as RP, and to expand beyond the six centers in Germany that to-date
have implanted the Argus II.”
1 Das Institut für das Entgeltsystem im Krankenhaus (InEK)
GmbH
2 Neue Untersuchungs und Behandlungsmethoden (NUB)
About Outer Retinal Degeneration
Outer retinal degeneration is the deterioration of the outer layer of
the retina (e.g. the photoreceptors), caused by the progressive death of
the cells in this region of the retina. An important type of outer
retinal degeneration is Retinitis Pigmentosa (RP). RP is a rare,
hereditary disease that causes a progressive degeneration of the
light-sensitive cells of the retina, leading to significant visual
impairment and ultimately can lead to blindness. There are an estimated
1.5 million people worldwide with RP.
About the Argus® II Retinal Prosthesis System
The Argus II is the first artificial retina to receive approval in
Europe (CE Mark), and the first and only retinal prosthesis FDA-approved
in the U.S. The Argus II System is an advanced neurostimulation device
that bypasses defunct photo-receptor cells and stimulates remaining
viable retinal cells inducing visual perception in individuals with
severe to profound outer retinal degeneration. The Argus II works by
converting images captured by a miniature video camera mounted on the
patient’s glasses into a series of small electrical pulses, which are
transmitted wirelessly to an array of electrodes implanted on the
surface of the retina. These pulses are intended to stimulate the
retina’s remaining cells, resulting in the perception of patterns of
light in the brain. The patient then learns to interpret these visual
patterns, thereby regaining some visual function. The Argus II has been
implanted in more than 100 patients in the world and has demonstrated
long-term reliability, with some Argus II patients approaching eight
years of implant. The treatment is currently offered at approved centers
in Germany, France, Italy, Spain, Switzerland, United Kingdom,
Netherlands, Saudi Arabia, Turkey, the U.S., and Canada.
About Second Sight
Second Sight Medical Products, Inc. was founded in 1998 to create a
retinal prosthesis to provide sight to patients blinded from outer
retinal degenerations such as RP. Second Sight's mission is to develop,
manufacture, and market innovative implantable visual prosthetics to
enable blind individuals to achieve greater independence. The Company’s
Argus II retinal prosthesis is approved in the U.S. and Europe. Second
Sight is developing the OrionTM cortical prosthesis to
restore some vision to individuals who are blind due to causes other
than preventable or treatable conditions. The population of people
potentially eligible for the future Orion cortical prosthesis in Germany
is about 71,000. The company’s headquarters are in Sylmar, California,
and its European Headquarters are in Lausanne, Switzerland. For more
information, visit www.secondsight.com.
Safe Harbor
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange and Exchange Act of 1934, as
amended that are intended to be covered by the “safe harbor” created by
those sections. All statements in this release that are not based on
historical fact are “forward looking statements”. While management has
based any forward looking statements included in this release on its
current expectations, the information on which such expectations were
based may change. Forward-looking statements involve inherent risks and
uncertainties which could cause actual results to differ materially from
those in the forward-looking statements, as a result of various factors
including those risks and uncertainties described in the Risk Factors
and in Management’s Discussion and Analysis of Financial Condition and
Results of Operations sections contained within our final prospectus
filed with the United States Securities and Exchange Commission on
November 20, 2014. We urge you to consider those risks and uncertainties
in evaluating our forward-looking statements. We caution readers not to
place undue reliance upon any such forward-looking statements, which
speak only as of the date made. Except as otherwise required by the
federal securities laws, we disclaim any obligation or undertaking to
publicly release any updates or revisions to any forward-looking
statement contained herein (or elsewhere) to reflect any change in our
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
Copyright Business Wire 2015