SceneRay Secures FDA Breakthrough Device Designation for Dual-Target DBS Therapy in Drug Addiction Treatment

Recently, SceneRay's dual-target deep brain stimulation (DBS) technology for the treatment of drug addiction indications received the Breakthrough Devices Program designation from the U.S. Food and Drug Administration (FDA). This marks the first time a Chinese company has obtained a breakthrough medical device designation in the field of neurological and psychiatric disorders.

Breakthrough Device Designation is an important initiative by the FDA to promote public health and device innovation, awarded to medical devices that address unmet clinical needs or demonstrate superior safety and effectiveness compared to existing treatment options. Manufacturers granted this designation can engage in frequent communication with the FDA during the premarket review phase to receive timely feedback, and their submissions may be prioritized for review to accelerate the product's pathway to market in the United States.

Currently, there are over 300 million patients worldwide suffering from drug addiction, posing significant risks and burdens to society and families. There is no clear guideline for drug addiction, and conventional treatment methods include mandatory detoxification and medication, accompanied by long-term psychological and physical therapy, which subjects patients to a prolonged and painful treatment process. Sceneray's pioneering dual-target brain-computer interface brain stimulator, based on the company’s self-developed dual-function area co-regulation theory, has achieved inspiring clinical results and received the Innovative Medical Device Fast-Track designation. It is currently in the registrational clinical development stage.

Sceneray is an innovative high-tech medical device enterprise that integrates research and development, production, and sales. For many years, it has focused on the field of deep brain stimulation therapy while leading the frontier exploration of invasive brain-computer interfaces for medical use. The company has gathered more than 200 top talents from China and abroad who are highly capable and experienced, adhering to independent research and development, global innovation, and self-manufacturing. Sceneray continues to expand into the "uncharted territory" of brain disease treatment, being the first to propose a dual-target stimulation treatment solution and developing a brain-computer interface dual-target deep brain stimulator. It has taken the international lead in treating refractory obsessive-compulsive disorder, drug addiction, alcohol addiction, and other indications, achieving breakthrough therapeutic effects.

In February this year, Sceneray announced the successful completion of a D+ round of financing worth 300 million RMB, jointly led by Sequoia China and Hillhouse Ventures. This round of financing follows the over 100 million RMB D round completed in April 2020, which was led by Yanchuang Capital. Huaxing Capital served as the exclusive financial advisor.

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