Samsara Vision Reports That Patients Blinded by Macular Degeneration Benefit from Milestone in Implant Technology

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 successful clinical cases in Europe using their smaller-incision new-generation implantable miniature telescope (SING IMT) for people living with late-stage, age-related macular degeneration (AMD). The SING IMT, performed with the TSert™ delivery system, was successfully implanted in patients at two centers of excellence by by Tim Schultz, MD in Bochum, Germany and Suphi Taneri, MD in Münster, Germany, respectively.

The SING IMT is implanted into one eye of patients living with late-stage AMD, a disease which can result in a loss of central or “straight-ahead” vision and create a blind spot that is uncorrectable by glasses, drugs, injections or cataract surgery. This blind spot makes it difficult or impossible for patients to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care. Studies show that approximately 67 million people in the European Union are currently affected by AMD and this number is expected to increase by 15 percent until 2050.(1)

“We always strive to offer our patients the very best care and the most advanced treatments,” said Dr. Schultz “Our clinical case was successful, and we look forward to helping our patient learn to use the SING IMT and, then, hear about all the things they can see and do with improved vision.”

“The SING IMT is a game changer for the treatment of late-stage AMD, particularly because it’s so easy to implant in eligible patients. Further, we know that as our patients lose their central vision, they also lose connections to people they care about because it can be isolating to not feel confident going about your day with impaired vision. I’m confident that this technology will help people reconnect with the loved ones and activities that are important to them,” added Dr. Taneri.

The SING IMT is implanted during an out-patient procedure, typically taking about 30 minutes. The updated IMT device design, which includes foldable haptic loops, performed with the TSert™ delivery system also allows the physician to place the device in the patient’s eye using a smaller incision, meaning patients are expected to have a faster visual recovery. After recovering from surgery, patients work closely with 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.

“We’re pleased that Dr. Tim Schulz and Dr. Suphi Taneri both report promising results from their first two SING IMT clinical cases and thank them for bringing this innovation to patients in Germany. We believe that the SING IMT is an important advance for late-stage AMD patients. ” said Jerome Marzinski, Chief Commercial Officer of Medevise. “With the availability of the SING IMT in the EU, we are able to respond to a growing demand of vision restoration for late-stage AMD patients who are eager to see what they’ve been missing, which leads to a higher quality of life. We look forward to further introducing this technology to other practices in Germany, Switzerland, France, Italy and Spain.”

These initial implantations mark the first big milestone in the worldwide product launch. Samsara Vision is leveraging Medevise Consulting’s expertise, business reputation, and top-tier KOL network for reimbursement process guidance and communication services. The first target centers will be eye-care centers that focus on premium and high-quality delivery services.

David Keegan who is Consultant Vitreoretinal Surgeon and Head of Department at the Mater Misericordiae University Hospital, Dublin, will be hosting another product webinar training session on 1 June at 6 pm CET. Please click the registration link to secure your training slot.

About SING IMT

The Implantable Miniature Telescope (by Dr. Isaac Lipshitz) is indicated for monocular implantation to improve vision in patients who meet age requirements and with stable severe to profound vision impairment (best-corrected distance visual acuity 20/80 to 20/800) caused by bilateral central scotomas (blind areas) associated with Late-Stage AMD.

This level of visual impairment constitutes statutory (legal) blindness. The telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.

The implant is not a cure for Late-Stage AMD. As with any medical intervention, potential risks and complications exist with the telescope implant. Possible side effects include decreased vision or vision-impairing corneal swelling. The risks and benefits associated with the telescope implant are discussed in the Patient Information Booklet available at www.samsaravision.comand will be evaluated with each patient who might be a candidate for this study.

Patients and physicians can find more information about the telescope implant and related treatment program by visiting www.samsaravision.com or calling 1-877-997-4448.

About Samsara Vision

Samsara Vision is a privately held specialty 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. 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/

About Medevise Consulting

A new name in the industry, Medevise Consulting brings together a veteran team that embodies ophthalmology in Europe. From an Executive Board of Directors co-chaired by Jan Bonel and Michael Mrochen to Chief Commercial Officer Jérôme Marzinski and service leaders with deep ophthalmology knowledge, Medevise Consulting represents a new approach that marries Passion, Experience and Diligence to every project.

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Our Vision: To be the partner of choice for medical device innovators in ophthalmology.

Our Mission: To put the best medical device innovation into the hands of ophthalmologists across Europe to improve patient experience and outcomes.

Our Core Services: Market Access & Reimbursement, European Regulatory & Clinical Services and Medical Communications & Marketing

Follow us on LinkedIn @Medevise Consulting

For more information, please contact:

Jérôme Marzinski

Chief Commercial Officer, VP Europe

Medevise Consulting SAS

jerome@medevise-consulting.com

Mob: +33 6 73 98 05 25

(1) Li JQ, Welchowski T, Schmid M, et al Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.