FAR HILLS, N.J.--(BUSINESS WIRE)--Samsara Vision, a company focused on bringing vision and freedom back to late-stage, age-related macular degeneration (AMD) patients through advanced visual prosthetic devices, today announced the first three successful clinical cases in Italy using its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope) for people living with late-stage, age-related macular degeneration (AMD). The SING IMT™ was successfully implanted in patients in early February by Professor Stanislao Rizzo, director of the Ophthalmology Unit of the Agostino Gemelli IRCCS University Polyclinic Foundation and Ordinary of Ophthalmology Clinic at the Catholic University campus in Rome.
Nearly invisible inside the eye, the SING IMT™ is a Galilean telescope implant designed to improve visual acuity and quality of life for patients with late-stage AMD. Comprised of ultra-precise micro-optics, the SING IMT is implanted during typical, out-patient cataract surgery. After recovering from surgery, the patients work closely with a low vision specialist and occupational therapists to learn how to use their new vision, often practicing with exercises designed with their specific vision goals in mind. Images seen in “straight-ahead” vision are magnified 2.7x and projected onto healthy, undamaged areas of the macula in the back of the eye, reducing the impact of the AMD “blind spot” in central vision and allowing patients to see images that may have been unrecognizable before.
“It is incredibly exciting to introduce the SING IMT™ as a treatment option to patients in Italy whose vision has been severely compromised by late-stage AMD. Macular degeneration not only robs people of their vision, but of their independence as they have to rely on others to read to them or describe what is right in front of them. It can be isolating,” explained Professor Rizzo. “It’s a privilege to offer my patients high quality care and access to the most advanced treatment options. I’m hopeful that these first three patients are just the first of many who will experience improved vision and then reconnect to the people and activities that they enjoy.”
Advanced Technology Restores Vision for Older Adults
The leading cause of blindness in older adults, late-stage AMD is a disease which can result in a loss of central or “straight-ahead” vision, creating a blind spot that is uncorrectable by glasses, drugs, injections or cataract surgery. Other currently available treatments for late-stage AMD, such as intraocular injections, may slow or delay the progression of the disease but do not have a direct effect in regaining vision that SING IMT™ offers to eligible candidates. This blind spot makes it difficult or impossible for patients to recognize faces, read, and perform the tasks of everyday living such as watching TV, preparing meals, and performing self-care. A study published in British Journal of Ophthalmology determined that approximately 67 million people in the European Union are affected by AMD and this number is expected to grow by 15 percent until 2050.
“We’re gratified that Professor Stanislao Rizzo reports encouraging results from the first three Italian clinical cases using the SING IMT™ and appreciate his enthusiasm for bringing the latest ophthalmic innovations to patients in Italy,” said Dr. Maura Arsiero, Director, Global Market Development, Samsara Vision. “We are also currently working with other key opinion leaders across Europe to bring our novel and life-changing technology to their patients and meet the demands of these older adults who are eager to see more and see better, thereby enhancing their quality of life.”
Because AMD is a progressive disease, over time, patients have adapted with the loss of vision in the central field of vision. Before receiving the SING IMT™, patients must understand the possible and realistic outcomes post-op and commit to working with their ophthalmological team to use visual techniques and exercises to maximize the effectiveness of SING IMT™. Patients must also meet age, vision, cornea health, and other requirements noted in the Patient Information Booklet to determine if they are a candidate for the SING IMT™.
The telescopic implant is not a cure for late-stage AMD. It will not return your vision to the level a patient had before AMD, nor will it completely make up for vision loss. 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.
The SING IMT™ is approved for late-stage AMD patients who are 55 years of age or older in CE Referenced Countries and is not currently FDA approved in the United States. To learn more about SING IMT™, visit http://singimt.samsaravision.com
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 belief that the company’s name change better reflects Samsara’s patient centricity and focus 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; 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.
