FAR HILLS, N.J.--(BUSINESS WIRE)--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.
