Second Sight Medical Products (NASDAQ:EYES) a leading developer
and marketer of implantable visual prosthetics that are intended to
create an artificial form of useful vision for blind individuals,
today announced U.S. Food and Drug Administration (FDA) has
approved the Argus 2s Retinal Prosthesis System, a redesigned set
of external hardware (glasses and video processing unit) initially
for use in combination with previously implanted Argus II systems
for the treatment of retinitis pigmentosa (RP). The Company expects
that the Argus 2s will be adapted to be the external system for the
next generation Orion Visual Cortical Prosthesis System currently
under development.
In addition to ergonomic improvements, the Argus 2s system
offers significantly more processing power, potentially allowing
for improved video processing.
“We are very pleased to have received this approval, as it
presents an opportunity to offer external hardware that we believe
enhance comfort and aesthetics compared with the legacy Argus II
system,” said Matthew Pfeffer, acting CEO of Second Sight.
A decision on when or if to begin production of the newly
approved hardware is pending completion of Second Sight’s planned
business combination with Pixium Vision, which currently is in
progress. Should the business combination be completed, the new
management team will then evaluate how best to proceed with the
Argus 2s Retinal Prosthesis System, as well as all other products
in development.
About Second Sight Medical Products Inc.
Second Sight Medical Products, Inc. (NASDAQ:EYES) develops and
markets implantable visual prosthetics that are intended to deliver
useful artificial vision to blind individuals. A recognized global
leader in neuromodulation devices for blindness, the Company is
committed to developing new technologies to treat the broadest
population of sight-impaired individuals. The Company’s
headquarters are in Los Angeles, California. More information is
available at https://secondsight.com.
About the Argus II Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation
that bypasses the defunct retinal cells and stimulates remaining
viable cells inducing visual perception in individuals with severe
to profound RP. 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 stimulate the retina's remaining cells, intending to
result in the perception of patterns of light in the brain. The
patient must learn to interpret these visual patterns, having the
potential to regain some visual function. The Argus II was the
first artificial retina to receive widespread commercial approval.
Second Sight has discontinued new implants of the Argus II system.
Further information on the long-term benefits and risks can be
found in the peer reviewed paper at:
http://www.sciencedirect.com/science/article/pii/S0161642016305796
About the Orion Visual Cortical Prosthesis System
Leveraging Second Sight’s 20 years of experience in
neuromodulation for vision, the Orion Visual Cortical Prosthesis
System (Orion) is an implanted cortical stimulation device intended
to provide useful artificial vision to individuals who are blind
due to a wide range of causes, including glaucoma, diabetic
retinopathy, optic nerve injury or disease, and eye injury. Orion
is intended to convert images captured by a miniature video camera
mounted on glasses into a series of small electrical pulses. The
device is designed to bypass diseased or injured eye anatomy and to
transmit these electrical pulses wirelessly to an array of
electrodes implanted on the surface of the brain’s visual cortex,
where it is intended to provide the perception of patterns of
light. A six-subject early feasibility study of the Orion is
currently underway at the Ronald Reagan UCLA Medical Center in Los
Angeles and the Baylor College of Medicine in Houston. No
peer-reviewed data is available yet for the Orion system.
Non-Solicitation
This press release does not constitute a solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed transaction. This press release also
does not constitute an offer to sell or the solicitation of an
offer to buy any securities, nor will there be any sale of
securities in any states or jurisdictions in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities will be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended, or an exemption therefrom.
Additional Information and Where to Find it
This communication may be deemed to be solicitation material in
respect of the proposed transaction between Second Sight and Pixium
Vision. Second Sight intends to file with the SEC preliminary and
definitive proxy statements in connection with the proposed
business combination and other matters and will mail a definitive
proxy statement to its shareholders as of the record date
established for voting on the proposed business combination. SECOND
SIGHT’S SHAREHOLDERS AND OTHER INTERESTED PERSONS ARE ADVISED TO
READ, ONCE AVAILABLE, THE PRELIMINARY PROXY STATEMENT AND ANY
AMENDMENTS THERETO AND, ONCE AVAILABLE, THE DEFINITIVE PROXY
STATEMENT, IN CONNECTION WITH SECOND SIGHT’S SOLICITATION OF
PROXIES FOR ITS SPECIAL MEETING OF STOCKHOLDERS TO BE HELD TO
APPROVE, AMONG OTHER THINGS, THE PROPOSED BUSINESS COMBINATION,
BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT
SECOND SIGHT, PIXIUM VISION AND THE PROPOSED BUSINESS COMBINATION.
Second Sight’s shareholders may also obtain a copy of the
preliminary or definitive proxy statement, once available, as well
as other documents filed with the SEC by Second Sight, without
charge, at the SEC’s website located at www.sec.gov or by directing
a request to: Second Sight Medical Products, Inc., 13170 Telfair
Avenue, Sylmar CA 91342.
Participants in the Solicitation
Second Sight, Pixium Vision, and their respective directors,
executive officers and employees and other persons may be deemed to
be participants in the solicitation of proxies from the holders of
Second Sight common stock in respect of the proposed transaction
described herein. Information about Second Sight’s directors and
executive officers and their ownership of Second Sight’s common
stock is set forth in Second Sight’s Annual Report on Form 10-K for
the year ended December 31, 2019 filed with the SEC. Other
information regarding the interests of the participants in the
proxy solicitation will be included in the proxy statement
pertaining to the proposed transaction when it becomes available.
These documents can be obtained free of charge from the sources
indicated above.
Safe Harbor
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” and other similar expressions that predict
or indicate future events or trends or that are not statements of
historical matters. Examples of forward-looking statements include,
among others, statements made in this press release regarding the
proposed business combination, including the benefits of the
proposed business combination, integration plans, expected
synergies and opportunities, the expected management and governance
of the combined company, and the expected timing of the proposed
transactions contemplated by the definitive agreement.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
Second Sight’s and Pixium Vision’s managements’ current beliefs,
expectations and assumptions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict
and many of which are outside of our control. Actual results and
outcomes may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward- looking statements. Important factors that could
cause actual results and outcomes to differ materially from those
indicated in the forward-looking statements include, among others,
the following: (1) the occurrence of any event, change or other
circumstances that could give rise to the termination of the
Memorandum of Understanding or could otherwise cause the business
combination to fail to close; (2) the outcome of any legal
proceedings that may be instituted against Second Sight or Pixium
Vision following the announcement of the Memorandum of
Understanding and the business combination; (3) the inability to
complete the business combination, including due to failure to
obtain approval of the shareholders of Second Sight or Pixium
Vision, failure to complete the $25 million financing, or inability
to satisfy any of the other conditions to closing in the Memorandum
of Understanding; (4) the receipt of an unsolicited offer from
another party for an alternative business transaction that could
interfere with the business combination; (5) the inability to
obtain the listing of the shares of common stock of the
post-acquisition company on the Nasdaq Stock Market following the
business combination; (6) the risk that the announcement and
consummation of the business combination disrupts current plans and
operations; (7) the ability to recognize the anticipated benefits
of the business combination, which may be affected by, among other
things, competition, the ability of the combined company to grow
and manage growth profitably and retain its key employees; (8)
costs related to the business combination; (9) changes in
applicable laws or regulations; (10) the possibility that Second
Sight may be adversely affected by other economic, business, and/or
competitive factors; (11) the impact of COVID-19 on the combined
company’s business; and (12) other risks and uncertainties
indicated from time to time in the proxy statement to be filed
relating to the business combination, including those under “Risk
Factors” therein, and in Second Sight’s other filings with the SEC.
Some of these risks and uncertainties may in the future be
amplified by the COVID-19 outbreak and there may be additional
risks that Second Sight considers immaterial or which are unknown.
A further list and description of risks and uncertainties can be
found in Second Sight’s Annual Report on Form 10-K, filed on March
19, 2020, Form 10K/A filed April 28, 2020, Forms 10-Q filed June
26, 2020, August 13, 2020, and November 12, 2020 and in the proxy
statement on Schedule 14A that will be filed with the SEC by Second
Sight in connection with the proposed transaction, and other
documents that the parties may file or furnish with the SEC, which
you are encouraged to read. Any forward-looking statement made by
us in this press release is based only on information currently
available to Second Sight and Pixium Vision and speaks only as of
the date on which it is made. Second Sight and Pixium Vision
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210305005098/en/
Investor Relations: Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793 E: lwilson@insitecony.com
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