Samsara Vision Launches U.S. PMA Complementary Study of SING IMT™, Next-Generation Technology for Age-Related Macular Degeneration

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The CONCERTO trial will recruit older adults living with stable bilateral (non-active neovascularization) central scotomas (blind spots) due to advanced stage AMD and geographic atrophy involving a fovea or disciform scar to receive a SING IMT™ in an eye. Study participants, age 65 and older, cannot have had prior cataract surgery in the study eye and must agree to post-operative rehabilitation and training. The operative eye and the non-study eye will be evaluated before and after the operation over a period of 12 months (over five visits). The CONCERTO trial will include up to twenty clinical sites across the United States.

“What is exciting with this new technology is that the SING IMT™ procedure is performed with a pre-loaded delivery system, which is designed to provide consistent and predictable device insertion using an incision smaller cornea – a significant innovation the company has developed since premiering its new FDA-approved telescopic implant,” said Marc H. Levy, MD, neuro-ophthalmologist and orbital surgeon at Sarasota Retina Institute and CONCERTO Study Investigator and Surgeon.

“People with advanced AMD face reduced quality of life and isolation as their impaired vision prevents them from engaging in activities of daily living and there are still significant unmet treatment needs. At Samsara Vision, we are focused on bringing to market innovative, high-performance micro-optical devices that provide people living with serious vision conditions, such as end-stage AMD, with long-lasting vision improvements,” said said Hayley McKee, PhD, Vice President, Global Clinical and Medical Affairs.

SING IMT™ – Innovation for late-stage AMD

Nearly invisible inside the eye, the SING IMT™ is a Galilean-style telescopic implant designed to improve visual acuity and quality of life for patients with advanced AMD. It is implanted during typical outpatient cataract surgery with a corneal incision range between 6.5mm and 7.5mm. Images seen in “straight ahead” vision are magnified 2.7x and projected onto healthy, intact areas of the macula at the back of the eye, reducing the impact of AMD’s “blind spot” on central view. Already, the SING IMT™ is approved for advanced AMD patients aged 55 or older in CE-listed countries, but it is not currently FDA-approved in the United States.

“The launch of the CONCERTO trial advances our goal of bringing our new, life-changing technology to our US-based ophthalmology partners and their patients,” said Thomas Ruggia, Chief Executive Officer of Samsara Vision. “Clinical studies are the foundation for advancing medical breakthroughs. We look forward to sharing the results of CONCERTO and working closely with the United States Food and Drug Administration to determine an expedient pathway to commercialize SING IMT™ in the United States.

The implantable miniature telescope for AMD

Samsara Vision’s first-generation device, Isaac Lipshitz’s Implantable Miniature Telescope (IMT), was first approved in 2010 and has been implanted in more than 600 patients. The SING IMT™ has identical ultra-precision micro-optics using converging and diverging bi-convex and bi-concave micro-lenses, coupled with air lenses which, when combined with the patient’s cornea, create a magnified image on healthy retinal tissue surrounding the degenerated macula. In previous clinical studies, 90% of eyes implanted with IMT achieved at least a gain of 2 lines or better in distance or near best-corrected visual acuity (BCVA) at 12 months, maintained for up to 24 month. Quality of life scores (NEI-VFQ-25) were also improved by clinically meaningful levels.

Age-related macular degeneration (AMD) is a primary cause permanent vision loss in people aged 50 and over, and cause number one blindness in people aged 65 and over. As much as 11 million Americans are affected by a form of macular degeneration and that number will rise to 22 million by 2050. Almost 2 millions Americans have advanced forms of AMD with associated vision loss. Although there are treatments to try to slow the progression of AMD and there are assistive devices that can help people with reduced vision see better with magnification or more light, many patients will progress in their illness. There is no cure for advanced AMD.

IMT is not a cure for advanced AMD. It will not return vision to the level a patient had before AMD, nor will it completely compensate for vision loss. The most common risks of IMT and SING IMT™ surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal oedema, corneal edema impairing vision, corneal transplant and decreased visual acuity. There is a risk that telescope implant surgery could make your vision worse rather than better. Individual results may vary.

About Samsara Vision

Samsara Vision is a privately held, US-headquartered specialty medical device company engaged in the research, development, manufacturing and marketing of proprietary implantable ophthalmic devices and technologies intended to dramatically improve vision and vision. quality of life of people with incurable retinal disease. troubles. We believe rejuvenating sight revives the spirit, allowing people to reconnect with the things in life they love to see and do. Our approach is to work collaboratively with healthcare providers, researchers, payers and advocates to ensure that people living with impaired vision have access to our new technologies and pathways of support, thereby ensuring a future where they can see again. Learn more about https://www.samsaravision.com

Safe Harbor Statement

This press release contains express or implied forward-looking statements pursuant to United States federal securities laws. Forward-looking statements include those about the belief that the company name change better reflects Samsara’s focus and patient orientation and the belief that sight rejuvenation rekindles the spirit, enabling people to reconnect. to the things in life they like to see and do. These forward-looking statements and their implications are based on the current expectations of Samsara’s management 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: intellectual property ownership claims by other companies and persons; changes in technology and market requirements; Samsara may encounter delays or obstacles in initiating and/or completing its clinical trials; Samsara’s products may not be approved by regulatory agencies, Samsara’s technology may not be validated as it progresses, and its methods may not be accepted by the scientific community; Samsara may not be able to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the process of Samsara; Samsara’s products may end up being more expensive than expected; laboratory results may not translate to as good results under actual clinical conditions; results of preclinical studies may not correlate with results of human clinical trials; Samsara’s patents may not be enough; Samsara’s products may harm recipients; changes in legislation may negatively impact Samsara; failure to develop and introduce new technologies, products and applications on a timely basis; loss of market share and pricing pressure resulting from competition, which could cause Samsara’s actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Samsara undertakes no obligation to release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events.

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