{"id":2075,"date":"2025-12-09T14:30:41","date_gmt":"2025-12-09T13:30:41","guid":{"rendered":"https:\/\/okuvision.de\/news\/pm-os2\/"},"modified":"2026-05-21T13:47:48","modified_gmt":"2026-05-21T11:47:48","slug":"pm-os2","status":"publish","type":"post","link":"https:\/\/okuvision.de\/en\/news\/pm-os2\/","title":{"rendered":"Press Release – CE Marking for OkuStim\u00ae 2"},"content":{"rendered":"

[vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”0″ top_padding=”0″ bottom_padding=”0″ back_color=”color-206913″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”100151″ back_color_type=”uncode-palette”][vc_column width=”1\/1″]\n

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\n \n Lesedauer ca. 3 Min. <\/span>\n \n 9. December 2025 <\/span>\n <\/div>\n \n

\n Press Release <\/h1>\n \n
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With OkuStim\u00ae<\/sup> 2, Okuvision is launching an innovative therapy platform that allows patients to perform Retinitis pigmentosa treatment at home. The neurostimulator for transcorneal electrical stimulation, featuring current CE marking in accordance with the EU Medical Device Regulation (MDR), was honored with the German Design Award 2026 (Gold) for its ergonomic design. <\/em><\/p>\n <\/div>\n \n <\/div>\n \n

\n Company & Network<\/span>\n <\/div>\n \n <\/div>\n \n \n
\n \"Press <\/div>\n <\/div>\n \n <\/div>\n \n<\/div>\n\n\n[\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”959669″ row_name=”Einleitung”][vc_column column_width_percent=”70″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”705359″][vc_custom_heading uncode_shortcode_id=”482356″]Neurostimulator receives CE marking for the treatment of rare eye disease[\/vc_custom_heading][vc_column_text uncode_shortcode_id=”786831″]Okuvision GmbH successfully completed the conformity assessment procedure in accordance with the EU Medical Device Regulation (MDR) for OkuStim\u00ae 2 on December 2, 2025. With the CE marking granted, the company confirms that the medical device meets current European requirements for safety and performance. OkuStim\u00ae\u202f2 is a consistent evolution of the established OkuStim\u00ae system and enables patients to carry out transcorneal electrical stimulation independently at home. This therapy can slow the progression of visual field loss in Retinitis pigmentosa, thereby supporting the preservation of vision over a longer period. The CE marking, which required extensive technical and clinical evidence, marks an important milestone for the Reutlingen-based company. <\/p>\n

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OkuStim\u00ae 2: A new standard in the treatment of Retinitis pigmentosa<\/strong><\/p>\n

The medical device OkuStim\u00ae 2 is designed for the treatment of patients with Retinitis pigmentosa \u2013 one of the most common causes of progressive blindness in the working-age population, affecting approximately 1 in 4,000 people worldwide. No causative treatment is currently available. <\/p>\n

\u201cWith OkuStim\u00ae 2, we are setting a new standard for the application of transcorneal electrical stimulation (TES),\u201d says Dr. Alfred Stett, CEO of Okuvision GmbH. \u201cThe system combines technical precision with a consistent focus on the user and is an expression of our commitment to preserving the vision of people with degenerative retinal diseases for as long as possible. In addition to Retinitis pigmentosa, we see great potential for transcorneal electrical stimulation in the treatment of glaucoma and age-related macular degeneration.\u201d <\/p>\n

The OkuStim\u00ae 2 system consists of the programmable neurostimulator and the ultra-thin, silver-coated OkuEl\u00ae M electrodes. The neurostimulator impresses with its ergonomic design, which facilitates handling and underlines the high standards of precision and safety. OkuStim\u00ae 2 was awarded the German Design Award 2026 in Gold in the Medical, Rehabilitation and Healthcare category for this. Software-supported patient workflows simplify procedures in clinics and practices, while flexible settings for stimulation parameters and pulse shapes open up new possibilities for research and clinical trials in ophthalmology and neuromodulation. <\/p>\n

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TES: A guideline-compliant therapy option<\/strong><\/p>\n

As a form of physical therapy, transcorneal electrical stimulation works via a fine electrode filament placed on the lower eyelid. Weak electrical impulses are targeted at the eye to stimulate the retina. The individually adjustable current intensity \u2013 safely below one milliampere \u2013 ensures precise and controlled application. Typically, the therapy is performed once a week for 30 minutes in the home environment. Thus, the OkuStim\u00ae 2 system combines therapeutic precision with a high degree of safety and comfort for patients. <\/p>\n

Transcorneal electrical stimulation is listed as a possible therapy option for Retinitis pigmentosa in the guidelines of the German Ophthalmological Society (DOG), the Professional Association of Ophthalmologists in Germany (BVA), and the Retinological Society (RG). Its long-term efficacy is currently being investigated as part of a multicenter Trial study (according to \u00a7 137e SGB V) commissioned by the Federal Joint Committee (G-BA) at 17 German eye clinics, in order to prepare for the inclusion of the treatment in the benefit catalog of statutory health insurance funds. <\/p>\n

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About Okuvision<\/strong><\/p>\n

Based in Reutlingen, Okuvision GmbH has been developing and manufacturing medical technology solutions to preserve visual function in degenerative retinal diseases since 2007. With the OkuStim\u00ae system, the company is considered a pioneer of transcorneal electrical stimulation in ophthalmology. Twenty specialized employees combine expertise from medical technology, neurobiology, ophthalmology, and regulatory affairs, pursuing a common goal: to preserve the vision of people with degenerative retinal diseases for as long as possible.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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