Samsara Vision, a company focused on bringing vision and freedom
back to patients with late-stage, age-related macular degeneration
(AMD) through advanced visual prosthetic devices, today announced
the first completed SING IMT® (Smaller-Incision New-Generation
Implantable Miniature Telescope) procedure in China. Professor Li
Xiaorong, MD, PhD, member of the Chinese Ophthalmological Society,
specialist committee of the Chinese Ocular Fundus Diseases Society,
and Dean of the Tianjin Medical University Eye Hospital and School
of Optometry & Eye Institute, performed the first case in early
July at the First Affiliated Hospital of Hainan Medical University
Lecheng Hospital and is monitoring the recovery and vision
rehabilitation of his patient. Samsara Vision is partnering with
Lansheng Medical, a company with extensive experience introducing
ophthalmic products to the China market, who is leading the
registration, clinical trial requirements, surgeon acquisition and
training, and sales and marketing efforts in China, Hong Kong, and
Macau, with support from Samsara Vision and experienced surgeons to
provide training and expert counsel.
“The surgery went well as the device is designed for ease of
central insertion and we will monitor our patient’s visual
rehabilitation as they learn to use their new vision,” said Prof.
Li. “Many older adults in China live with central blindness caused
by late-stage, age-related macular degeneration and it impacts
their quality of life. I look forward to offering this procedure to
future patients as we advance through clinical trials and
anticipate regulatory approval in the future.”
”At Samsara Vision, we are rapidly developing a global network
of providers, researchers, health systems, and advocates who are
introducing our novel technology to people living with
non-preventable blindness caused by late-stage AMD,” said Thomas
Ruggia, President and CEO of Samsara Vision. “Our goal is for the
SING IMT to be the standard of care for people who advance to
late-stage AMD and we’re motivated by hearing the stories of
patients resuming the activities they love. We congratulate Prof.
Li and thank our partners at Lensheng Medical for their commitment
to advancing our presence in China.”
SING-IMT Reaches Hundreds of People Across The European
Union
Nearly one hundred surgeons in seventeen countries have
implanted the SING IMT in over 350 patients, with more than 63
percent performing multiple procedures, signaling technology
adoption. Most recently, Prof. MUDr. Petr Kolář, PhD, Head of the
Eye Clinic at Slovak Medical University, and MUDr. Nora Majtánová,
PhD, deputy head of the Eye Clinic at Slovak Medical University in
Bratislava, Slovakia performed over the course of a few days the
first six surgeries in that country, which made national headlines
with Radio and Television of Slovakia (Rozhlas a televize Slovenska
- RTV), the nationwide public broadcasting media organization and
other media covering the procedures, and with JUDr. Zuzana
Dolinková, Minister of Health of the Slovak Republic, in
attendance.
“Low vision often leads to social isolation, which is why it’s
so inspiring that hundreds of patients across Europe are seeing
better and reengaging with their families after getting the SING
IMT and participating in required low vision therapy,” said Jason
Herod, Vice President Commercial, International Markets, Samsara
Vision. “Our post-marketing studies show that these patients are
meeting vision milestones that improve their ability to read,
write, and discern what is in their straight-ahead central vision.
Our patients are seeing the faces of loved ones for the first time
in years.”
Physician confidence stems from gaining experience with the SING
IMT and from post-marketing studies demonstrating that the majority
of patients with late-stage AMD monocularly implanted with the SING
IMT™ had improved functional vision after participating in a
rehabilitation program focused on real-world tasks such as reading,
writing, visual motor integration and mobility, according to a
retrospective study published in Ophthalmology and Therapy. This is
important because reading performance is one of the best predictors
of patient-reported visual ability and vision-related quality of
life.
About the SING IMT® The SING IMT® is a Galilean
intraocular telescope designed to improve visual acuity and quality
of life for patients with late-stage AMD. The design improves upon
a U.S. Food and Drug Administration (FDA) 1st-generation miniature
telescope device implanted in more than 600 patients in that it has
a new foldable haptic design that enables enhanced stability and
centration during the out-patient procedure. In addition, there is
a new Tsert SI™ delivery system, which is designed to ensure
consistent, predictable delivery of the device. Combined, this
reduces the length of the surgical procedure, the incision size,
and the number of sutures, which hastens recovery. Images seen in
“straight-ahead” vision are enlarged 2.7x onto healthy retina
surrounding the macular in the back of the eye. This reduces the
impact of the AMD “blind spot” in central vision and allows
patients to see things that may have been unrecognizable
before.
While there are traditional external optical or video magnifiers
that can help to enlarge vision at a particular distance or for a
single activity, there is nothing like the SING IMT® that allows
people to use their new vision for seeing things at all distances,
stationary and in locomotion, and for performing multiple
activities in ways similar to natural vision.
Unmet Treatment Needs in Age-Related AMD Age-related
macular degeneration (AMD) is a leading cause of permanent vision
loss for people age 50 and older, and the number one cause of
blindness in people age 65 years and older. As many as 11 million
Americans are affected by some form of macular degeneration and
this number will increase to 22 million by 2050. Nearly 2 million
Americans have advanced forms of AMD with associated vision loss.
While treatments exist to try to slow the progression of AMD, and
there are assistive devices that can help people with reduced
vision see better with magnification, many patients will progress
in their disease. According to a study in the British Journal of
Ophthalmology, approximately 67 million people in the European
Union are affected by AMD and this number is expected to grow by 15
percent until 2050. In China, the prevalence of AMD among those
over 70 years old is 20.2 percent, and as the population ages, the
incidence of AMD continues to grow.
The SING IMT is approved for use in patients without previous
cataract surgery and 55 years and older in CE Referenced countries
and is under investigation in the United States.
There is no cure for late-stage AMD and the SING IMT® does not
return vision to the level a patient had before AMD, nor will it
completely make up for vision loss. Driving is contraindicated with
the device. The most common risks of the SING IMT® surgery include
inflammatory deposits or precipitates on the device and increased
intraocular pressure. Significant adverse events include corneal
edema, vision-impairing corneal edema, corneal transplant, and
decrease in visual acuity. There is a risk that having the
telescope implantation surgery could worsen your vision rather than
improve it. Individual results may vary.
About Samsara Vision Samsara Vision is a privately held
specialty medical device company headquartered in the United States
and engaged in the research, development, manufacture, and
marketing of proprietary implantable ophthalmic devices and
technologies that are intended to significantly improve vision and
quality of life for individuals with untreatable retinal disorders.
We believe that rejuvenating eyesight revives the spirit, allowing
people to reconnect to the things in life that they love to see and
do. Our approach includes working collaboratively with health care
providers, researchers, payers, and advocates to ensure that people
living with deteriorating vision have access to our novel
technologies and support paths thereby better ensuring a future
where they can see anew. Learn more at
https://www.samsaravision.com.
Safe Harbor Statement This press release contains express
or implied forward-looking statements pursuant to U.S. Federal
securities laws. Forward-looking statements include those about the
potential benefits to be derived from the SING IMT™ and the intent
to work closely with the FDA to determine a timely pathway to bring
the SING IMT™ to market in the United States and the belief that
rejuvenating eyesight revives the spirit, allowing people to
reconnect to the things in life that they love to see and do. These
forward-looking statements and their implications are based on the
current expectations of the management of Samsara only, and are
subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. The following factors, among others,
could cause actual results to differ materially from those
described in the forward-looking statements: claims by other
companies and persons regarding ownership over intellectual
property; changes in technology and market requirements; Samsara
may encounter delays or obstacles in launching and/or successfully
completing its clinical trials; Samsara’s products may not be
approved by regulatory agencies, Samsara’s technology may not be
validated as it progresses further and its methods may not be
accepted by the scientific community; Samsara may be unable to
retain or attract key employees whose knowledge is essential to the
development of its products; unforeseen scientific difficulties may
develop with Samsara’s process; Samsara’s products may wind up
being more expensive than it anticipates; results in the laboratory
may not translate to equally good results in real clinical
settings; results of preclinical studies may not correlate with the
results of human clinical trials; Samsara’s patents may not be
sufficient; Samsara’s products may harm recipients; changes in
legislation may adversely impact Samsara; inability to timely
develop and introduce new technologies, products and applications;
the risk factors and uncertainties described in the Registration
Statement on Form S-1, as amended (File No. 333-260742) filed with
the U.S. Securities and Exchange Commission; loss of market share
and pressure on pricing resulting from competition, which could
cause the actual results or performance of Samsara to differ
materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, Samsara undertakes
no obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
events.
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Media Contact: Jessica Daitch JLD Communication LLC For
Samsara Vision 917-816-6712 jessica@jldcommunications.com