Juzheng Medical's Intracranial Laser Balloon Dilation Catheter Receives FDA Breakthrough Device Designation

Lotus Venture Capital Portfolio Companies——MARIX (hereinafter referred to as “MARIX”）MARIX’s Independently Developed Intracranial Laser Balloon Dilatation Catheter Recently Received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)This achievement marks a significant breakthrough for the company in the field of high-end neurointerventional devices, signifying that MARIX has officially joined the ranks of globally leading innovative enterprises. As one of the most prestigious regulatory pathways worldwide,This designation reflects the FDA’s high recognition of the product’s innovative value, potential clinical benefits, and its ability to address unmet medical needs.

As the “ultimate certification” for global cerebrovascular disease treatment, the FDA’s Breakthrough Device Designation"High Innovation, High Value, High Necessity"As the core standard, its certification results are widely recognized across the industry.

Intracranial Atherosclerotic Stenosis (ICAS is a high-prevalence disease in China. Although current management strategies dominated by pharmacological therapy can benefit some patients, a large number of patients still have limited response to drugs, and existing interventional treatment options also have many limitations in improving prognosis, making it difficult for patients with severe stenosis to obtain sufficient benefits.

MARIX’s laser balloon dilation catheter, focusing on intracranial atherosclerotic lesions, achieves precise energy control and selective dilation., with the potential to overcome traditional technical bottlenecks, for cases refractory to drug therapyProvides a more controllable and safer innovative treatment option for ICAS patients.

Neurointervention has long been regarded as the most challenging niche within the vascular intervention field, due to its complex anatomical structures and high procedural difficulty.MARIX, leveraging its proprietary technological reserves in energy control, minimally invasive design, and systematic instrument innovation, has obtainedThe FDA expert team unanimously affirmed it, making it a representative case of Chinese enterprises achieving a key breakthrough in the high-barrier neurointerventional field.This not only underscores the company’s robust R&D capabilities but also reflects the accelerating rise of China’s original medical devices in the global innovation landscape.

This timeThe FDA’s Breakthrough Therapy Designation not only validates MARIX’s technological prowess but also injects new momentum into the company’s global expansion.Recently, MARIX made its debut at the MEDICA International Medical Device Exhibition in Düsseldorf, Germany, showcasing China’s original neurointerventional technology to a global audience on a world-class platform.

Through in-depth engagement with multinational channel partners, clinical experts, and industry organizations, MARIX is accelerating the establishment of a global collaboration network to facilitate the more efficient entry of innovative technologies into international markets, thereby enabling Chinese original solutions to benefit a broader global patient population more rapidly.

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This article is reprinted fromMARIXOfficial Account

About Hetang Venture Capital

Hetang Venture Capital is a venture capital fund management institution held by Beijing Tsinghua Industrial Development Institute, established inEstablished in 2014 through restructuring against the strategic backdrop of promoting the commercialization of scientific and technological achievements in universities, Hetang Venture Capital is a professional investment management institution primarily focused on early-stage investments in technology-driven innovative enterprises. Hetang Venture Capital concentrates on key sectors including life sciences, medical devices, information technology, and modern manufacturing. It maintains a long-term focus on investing in innovative enterprises with core hard technologies, while distinguishing itself through the incubation and investment of scientific and technological achievements derived from clinical experts at universities and top-tier hospitals. Currently, Hetang Venture Capital manages funds totaling nearly RMB 4 billion and has cumulatively invested in over 100 projects. It supports scientists and entrepreneurs with significant research findings and technological innovations in realizing the practical application of their achievements, facilitating “commercial transformation from 0 to 1,” while consistently adhering to the strategy of selecting early-stage investments in high-barrier “pioneering technologies.” Due to its outstanding performance, Hetang Venture Capital has received honors such as being ranked among the “Top 50 Early-Stage Investment Institutions in China” by Zero2IPO Research and the “Top 50 Best Early-Stage Venture Capital Institutions in China” by CVSource.