Science Corporation has received European regulatory approval for its PRIMA ocular implant. The system uses augmented reality glasses and a subretinal chip to restore central vision for those suffering from geographic atrophy.
The self-powered chip that eliminates battery charging
The PRIMA system represents a departure from traditional medical implants by removing the need for internal batteries or external power cables. According to the report, the device is the first self-powered implant of its kind, generating electricity directly from light in a manner similar to solar panels. This innovation removes the risk and complexity associated with battery replacement surgeries or the inconvenience of daily charging cycles.
The technology functions through a sophisticated relay: augmented reality glasses equipped with a camera capture the user's field of view and transmit the data to a subretinal voltaic chip using near-infrared light . Because the human eye cannot perceive infrared light,this transmission does not interfere with any remaining natural sight. The chip then converts these light signals into electrical pulses that stimulate the retina's bipolar cells, which the brain interprets as visual images.
A solution for 8 million people with geographic atrophy
The PRIMA implant specifically targets geographic atrophy, a severe manifestation of dry age-related macular degeneration. As the report says, this condition affects approximately 8 million people worldwide and is characterized by the progressive death of cells in the macula. because these cells cannot regenerate, patients lose their sharp, straight-ahead central vision, making it nearly impossible to perform basic tasks.
By restoring "form vision," Science Corporation aims to give these patients the ability to recognize faces and read text again. This move is part of a broader trend in neuro-prosthetics where the goal has shifted from providing basic light perception to restoring functional, high-resolution utility. for the millions of elderly patients globally who have transitioned from mild vision loss to total central blindness, this represents a shift from palliative care to active restoration.
From CE marking in Europe to the FDA's breakthrough designation
The device has officially received CE marking under the European Union Medical Device Regulation, confirming it meets strict health and safety standards. The initial commercial rollout will begin in Germany, with Science Corporation planning to expand into other EU member states as they activate clinical sites. This European launch serves as a critical proof-of-concept for the company's global strategy.
Simultaneously, Science Corporation is pursuing entry into the American market. The PRIMA system has already been granted both breakthrough device designation and humanitarian use device designation by the U.S.. Food and Drug Administration (FDA). These designations typically accelerate the regulatory review process for technologies that treat life-threatening or severely debilitating conditions for which no satisfactory alternative exists.
Will reimbursement applications in Germany ensure patient access?
Despite the regulatory victory, a significant hurdle remains: the cost and accessibility of the hardware. The report notes that expansion across Europe depends on "country-specific reimbursement applications," meaning the device's success depends on whether national health insurers agree to pay for the surgery and the accompanying AR glasses.
Furthermore, the provided information focuses exclusively on the claims made by Science Corporation. It remains unclear what the specific success rate of the clinical trials was or how the "form vision" restored by PRIMA compares to natural sight in terms of clarity and color.. Without independent peer-reviewed data or a disclosed price point, it is difficult to determine how many of the 8 million affected individuals will actually be able to afford the treatment.
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