Vivani Medical, Inc. Subsidiary Cortigent Reports 5-Year Early Feasibility Study Update for the Orion® Visual Cortical Prosthesis System
11 Luglio 2023 - 12:00PM
Business Wire
Vivani Medical, Inc. (NASDAQ: VANI), an innovative,
near-clinical stage biopharmaceutical company that is developing
novel, miniature, long-term therapeutic implants, announced today
that its wholly-owned subsidiary Cortigent, Inc., a company
pioneering neurostimulation to recover critical body function, has
completed the fifth year of its Early Feasibility Study (EFS) of
profoundly blind patients implanted with the Orion® Visual Cortical
Prosthesis System. The National Institutes of Health - funded Orion
EFS commenced in 2017 and enrolled six subjects at two
universities, the University of California, Los Angeles (UCLA) and
Baylor College of Medicine. Five years after implantation of the
Orion device on the surface of the visual cortex area of the brain,
the three subjects who are still participating in the study have
reported no device malfunctions and continue to be able to use
their systems at home and in their communities. In terms of safety,
a single serious adverse event (SAE) was reported during initial
testing in the first three months after implantation which resolved
quickly and resulted in no permanent harm. No SAEs have been
reported since then.
“Reaching the five-year milestone reinforces the safety and
reliability profile of Orion observed to date,” said Dr. Ausaf
Bari, lead investigator at UCLA, “and considering the user benefits
observed during the three-year patient evaluations, we believe this
innovative medical device [if approved by regulatory authorities]
has the potential to deliver meaningful visual perception to
profoundly blind people.”
The Orion system is being developed with the goal of providing
useful visual perception to people who are profoundly blind due to
many common causes, comprising more than 82,000 Americans according
to a company-sponsored report. Five of the initial six subjects
participated in an efficacy evaluation at three years
post-implantation. All five were reported to have performed
significantly better with the Orion system turned on versus turned
off for “Square Localization” which involved pointing to a lighted
square on a computer screen, and “Direction of Motion” which
involved identifying the direction of motion of a line traversing a
computer screen. Two of the five subjects achieved measurable
“Grating Visual Acuity,” which is an established metric of visual
function.
Four subjects also participated in the “Functional Low-Vision
Observer Rated Assessment” (FLORA) at three years
post-implantation. This involved an independent specialist spending
time at the patients’ homes to observe various activities of daily
living such as navigating a sidewalk or sorting laundry. All four
subjects who completed the FLORA evaluation had positive or mildly
positive results with Orion turned on versus turned off, indicating
that the system was providing real-life benefits. Three subjects
have had the devices removed (explanted) for various reasons
unrelated to device safety or reliability. Cortigent anticipates
extending the EFS by one year to allow further observation of the
long-term safety, reliability, and visual function provided by the
Orion System. The Orion System is an investigational device that
will require successful completion of one or more large-scale
pivotal clinical trial(s) and subsequent U.S. Food and Drug
Administration (FDA) approval for commercialization.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani Medical
develops miniaturized, subdermal biopharmaceutical implants
designed to deliver drug molecules steadily at the intended dose
over extended periods of time, with the goal of improving patient
adherence and potentially improving tolerability to their
medication. Vivani’s lead program, NPM-119, is a miniature, 6-month
GLP-1 implant under investigation for the treatment of patients
with Type 2 diabetes and/or obesity. NPM-119 can provide patients
the opportunity to realize the full potential benefit of their
medication while avoiding the hassles associated with the daily or
weekly administration of oral and injectable products. Medication
non-adherence occurs when patients do not take their medication as
prescribed. This affects an alarming number of patients,
approximately 50%, including those taking daily pills. Medication
non-adherence and poor tolerability are main reasons why Type 2
diabetes and/or obesity treatments face challenges in achieving
optimal real-world effectiveness.
Vivani represents the August 2022 merger of Second Sight Medical
Products, Inc., and Nano Precision Medical, Inc. NPM-119 (GLP-1
implant) remains the top priority for the combined company and an
Investigational New Drug application remains on track for filing
with the U.S. Food and Drug Administration (FDA) in mid-2023 to
support initiation of a Phase 2 clinical study called Liberate-1.
Vivani is also developing a portfolio of innovative, highly
differentiated, new drug products leveraging its proprietary
NanoPortal implant technology, which has potential application
across a broad range of compounds including peptide therapeutics.
For more information, please visit www.vivani.com.
About Cortigent, Inc.
Cortigent Inc., a subsidiary of Vivani Medical, Inc., was formed
to continue the business of Second Sight Medical Products, a
pioneer in developing targeted neurostimulation systems to help
patients recover critical body functions including profound
blindness and the recovery of arm and hand function in patients who
are partially paralyzed due to stroke. Cortigent has publicly filed
a registration statement on Form S-1 with the U.S. Securities and
Exchange Commission (“SEC”) relating to a proposed initial public
offering of its common stock. Cortigent intends to list its common
stock on the Nasdaq Capital Market under the ticker symbol “CRGT.”
A registration statement relating to the proposed offering has been
filed with the SEC but has not yet become effective. These
securities may not be sold, nor may offers to buy be accepted,
prior to the time the Registration Statement becomes effective.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
state or jurisdiction. Any offers, solicitations or offers to buy,
or any sales of securities will be made in accordance with the
registration requirements of the Securities Act of 1933, as
amended.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “potential”, “may,” “anticipate,” “estimate,”
“would,” “could”, “should” “positioned,” “future,” and other
similar expressions that in this press release, including
statements regarding our business, products under development,
including the therapeutic potential thereof and the planned
development therefor, technology and strategy. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based only on our 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,
risks related to the development and commercialization of our
products under development, including NPM-119; delays and changes
in applicable laws, regulations and guidelines including potential
delays in submitting required regulatory applications to the U.S.
Food and Drug Administration (“FDA”); risks related to the
initiation, enrollment and conduct of our planned clinical trials
and the results therefrom; our history of losses and our ability to
achieve or sustain profitability in the future; and the impact of
COVID-19 on our business. A further list and description of risks
and uncertainties can be found in the Company’s most recent Annual
Report on Form 10-K, and any subsequent quarterly filings on Form
10-Q filed with the Securities and Exchange Commission. There may
be additional risks that the Company considers immaterial, or which
are unknown and new risks emerge from time to time. Any
forward-looking statement made by us in this press release is based
only on information currently available to the Company and speaks
only as of the date on which it is made. The Company undertakes 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 added information, future developments or
otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230711035392/en/
Company Contact: Donald Dwyer Chief Business Officer
info@vivani.com (415) 506-8462
Investor Relations Contact: Brigid Makes Chief Financial Officer
investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke
Sean.Leous@westwicke.com
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