Samsara Vision is a medical device company 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. Pulse 2.0 interviewed Samsara Vision President and CEO Thomas Ruggia to learn more about the company.
Thomas Ruggia’s Background
What is Thomas Ruggia’s background? Ruggia said:
“I joined Samsara Vision in 2020 as the president and CEO. Samsara Vision is a privately held specialty medical device focused on the research and development of proprietary intraocular ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. In my short time, we have brought vision back to 350 late-stage macular degeneration patients around the world.”
“I’ve spent twenty-five years working exclusively in ophthalmology and vision, working to develop and commercialize ophthalmology products in diverse markets across the globe. Before joining Samsara Vision, I spent five years at Johnson & Johnson as Vice President of WW Customer Experience and Ocular Surface Disease, where I led global commercial teams. I also spent fifteen years at Alcon, a division of Novartis, in various sales and marketing roles, progressively advancing in responsibility.”
Core Products
What are the company’s core products and features? Ruggia explained:
“At Samsara Vision, we are dedicated to helping patients across the world reconnect with the people and activities in life that they love through improved vision.”
“The company’s primary medical technology is the Smaller-Incision, New Generation Implantable Miniature Telescope (SING IMT) for late-stage, age-related macular degeneration (AMD). We already secured a CE Mark for the device in CE-Referenced countries for people 55 years and older, and it is an investigational device in the United States and China. The SING IMT improves upon our first-generation device, called the Implantable Miniature Telescope (IMT), which remains the first and only U.S. Food and Drug Administration (FDA) approved intraocular device that is proven to improve vision and quality of life for people 65 years and older with late-stage AMD.”
“Already, more than 350 patients received the SING IMT in Europe, a procedure performed by 100 retina or cornea surgeons in 17 countries, of whom 60 percent have completed multiple procedures. To us, this signals technology adoption.”
Challenges Faced
What challenges have Ruggia and the team faced in building the company? Ruggia acknowledged:
“Securing our CE Mark for the SING IMT was an important milestone, but only the first part of our efforts to launch the device in different European countries, all of which have different regulatory requirements and insurance coverage rules. By emphasizing how our device uniquely improves vision in older adults with late-stage AMD, we secured coverage in country after country, 17 to date. We’ve also seen excitement build for the SING IMT procedure. For example, the Health Minister of Slovakia attended one of the first surgeries in that country and the procedure availability was covered by their national news media.”
“Another one of our opportunities is garnering reimbursement for our products around the world. We have been very successful in gaining stellar NUB Cat 1 reimbursement in Germany at 18k euro. This is commensurate for the vision that our patients come away with and sets the mark for our efforts in all countries in Europe as well as our efforts in China, Canada, and Australia. In the US, we are already covered under Medicare and all of our patients are 65 years of age and greater.”
Evolution Of Samsara Vision’s Technology
How has the company’s technology evolved since launching? Ruggia noted:
“The design of the SING IMT improves upon our first-generation device, called the Implantable Miniature Telescope (IMT), the first and only U.S. Food and Drug Administration (FDA) approved intraocular device that is proven to improve vision and quality of life for people 65 years and older with late-stage AMD.”
“What’s notable about the enhanced design of the SING IMT is that it now has a foldable haptic design that allows for improved stability and centration during the out-patient implantation procedure. In addition, there is a new device delivery system that supports consistent, predictable delivery of the device. Taken together, these improvements reduce the length of the surgical procedure and the number of sutures, which hastens recovery. We think this will appeal to corneal surgeons and patients alike.”
“The SING IMT is remarkably effective in helping people see better in their central vision. A recent study showed reading speed doubled following the required low vision therapy post-procedure. How it works is that while using natural eye movements, images seen in straight-ahead, central vision are projected and enlarged 2.7 times onto healthy photoreceptors surrounding the macula in the back of the eye. This reduces the impact of the AMD “blind spot” in central vision and allows patients to see images that may have been unrecognizable before.”
“The SING IMT uniquely allows people to use natural vision movements to see images at all distances and while performing multiple tasks in ways similar to natural vision, unlike traditional external optical or video magnifiers that can only help to enlarge vision at a particular distance or for a single activity.”
“Eligible patients undergo out-patient surgery in only one eye, while the other remains as is to preserve that eye’s peripheral vision. Importantly, 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 also 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 a 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.”
Significant Milestones
What have been some of the company’s most significant milestones? Ruggia cited:
“As mentioned earlier, our most significant, recent milestone was securing a CE Mark for the SING IMT in 2021. Since then, we’ve been working with different regulatory bodies and insurance providers to launch the device in CE-Referenced countries. To date, the SING IMT procedure and required vision rehabilitation is available in 17 European Union countries, with more than 350 procedures completed.”
“In August 2024, we announced the first completed SING IMT procedure in China at the First Affiliated Hospital of Hainan Medical University Lecheng Hospital. This is a notable milestone because many manufacturers wait to invest in China; it’s a difficult regulatory system to navigate. We took the challenge head-on and are working with Lansheng Medical, a company with extensive experience introducing ophthalmic products in China, to advance the market introduction of the SING IMT to a country where there is the greatest number of people suffering from AMD.”
“Our U.S. clinical trial for the SING IMT, called CONCERTO was initiated in spring 2022 and is ongoing. Data from that trial will inform a supplemental PMA application. Notably, when we secured FDA approval in 2010 for our first-generation IMT, we simultaneously secured CMS (Medicare) coverage of the device, outpatient procedure, and required vision rehabilitation to make it affordable to patients and appealing to their healthcare team. This coverage will carry over for our second-generation device.”
Customer Success Stories
When asking Ruggia about customer success stories, he highlighted:
“The SING IMT procedure is a quick, outpatient procedure, but it requires vision rehabilitation for several months as people learn to use their new vision. Our vision therapists design exercises that match patients’ goals for their vision. We’ve got patients who are reading, watching TV, playing cards, gardening, dancing with their partners, painting, going to the movies, and more. When the doorbell rings, they can assess who is outside and even something as simple as picking out their favorite cereal from the grocery store shelf is easier and more enjoyable with improved central vision.”
“I had the opportunity to be in the OR in Ireland and speak with the patient on her first day after surgery. She shared that her daughter gave birth on the day of her surgery and this grandchild would be the first one where she could see the baby’s face! If that does not get you excited, I really don’t know what would. Another patient recently shared her story referring to her time prior to surgery as her ‘blind years’ and was talking about all the things she was doing now that she ‘was not blind any longer.’ This is remarkable and makes it easy to work hard to bring the technology to market.”
Funding
When asking Ruggia about the company’s funding details, he revealed:
“Samsara Vision is backed by a private equity firm, but we are actively speaking with investors to raise capital for our U.S. trials, addition European expansion, expansion in China through our partnership with Lansheng Medical, and a possible label expansion to include patients who have previously undergone cataract surgery, which is presently contraindicated and would effectively double our addressable target market. We are targeting 2026 to secure FDA approval and launch the SING IMT in the United States.”
“We are currently working on a Series B financing that can take us through the approval of the SING IMT in the United States. We are raising $25 million during this Series B.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Ruggia assessed:
“Age-related macular degeneration is the leading cause of blindness in older adults (link). Estimates suggest that approximately 67 million people in the EU are affected by AMD and this number is expected to grow by 15 percent until 2050. In the United States, as many as 11 million Americans are affected by some form of AMD and this number will increase to 22 million by 2050. Already, nearly 2 million Americans have advanced forms of AMD with associated vision loss. Currently, there are 26 million people living in China with AMD, and 6 million have progressed to late-stage AMD.”
“Globally, there are more than 200 million patients living with AMD, and 11 million of those have progressed to the late-stage of the disease and can benefit from vision improvements. Of these 11 million, roughly half have had a previous cataract surgery. We now have an R&D/Clinical program to expand our label with the SING IMT to bring our technology to those patients. These patients are referred to as pseudophakic because they are living with an intraocular lens implant.”
“Between our phakic and pseudophakic populations, we estimate that the Treatable Addressable Market (TAM) is worth $80 billion.”
Differentiation From The Competition
What differentiates the company from its competition? Ruggia affirmed:
“Despite the long availability of injections, vitamins, and other treatments for AMD, there is no cure. Some people inevitably progress to late-stage disease, which means their central, straight-ahead vision is blocked. Impaired vision can lead to depression and isolation. At Samsara Vision, we aren’t afraid to take on “non-preventable” blindness. We believe that our novel intraocular telescope will play a pivotal role in transforming the treatment landscape for late-stage AMD globally. As we expand our reach in Europe and work towards FDA approval in the U.S., our goal is to establish the SING IMT® as the standard of care. Soon, we will also launch clinical trials in China and are looking at other regions to expand our global footprint.”
“We want to help individuals reconnect with the world around them.”
Future Company Goals
What are some of the company’s future company goals? Ruggia concluded:
“Our future goals include:
— Increasing the availability of the SING IMT in CE Referenced countries
— Securing FDA approval and commercialization of the SING IMT in the United States
— Garnering top flight reimbursement in every geography
— Finalizing our R&D/Clinical plans for pseudophakic label expansion
— Expanding clinical trials and availability of the SING IMT in China and other regions, such as Canada, APAC, and South America.”
