Summary of the Conference Call for Xinwei Medical Industry and Company Overview - The conference call discusses Xinwei Medical's focus on interventional brain-machine interfaces (BMIs), leveraging its existing technology in the neurovascular field. The company aims to address complex issues such as paralysis through advanced medical devices [2][5]. Key Points and Arguments 1. Product Development Timeline: - Xinwei Medical plans to complete product optimization by 2025, conduct preclinical tests and animal experiments in 2026, and initiate non-blind clinical trials by the end of 2026 to early 2027. The entire process to finalize reports is expected to take two to three years [2][10]. 2. Market Potential: - Approximately 1.5 to 2 million new stroke patients are reported annually in China, with a cumulative patient population exceeding 30 million. This presents a significant demand for rehabilitation solutions [4][18]. 3. Technical Advantages: - The interventional approach offers a signal acquisition strength comparable to semi-invasive methods while maintaining lower infection risks and higher safety [3][5]. The existing technology from Xinwei Medical's thrombectomy stents facilitates easier entry into this market [5]. 4. Clinical Trial Costs: - The estimated cost for clinical trials is around 200,000 to 300,000 RMB per patient, with a minimum of 100 patients required for trials [12][13]. 5. Regulatory and Reimbursement Landscape: - Currently, there are no clear regulations for interventional BMIs in the national medical insurance directory. However, future alignment with interventional methods is anticipated as technology matures [14]. 6. Commercialization Strategy: - The product will be marketed through hospitals, requiring inclusion in reimbursement directories. The pricing strategy will consider production costs and potential reimbursement to alleviate patient financial burdens [15][19]. 7. Competitive Landscape: - Domestic competitors include Zhonghua Brain Machine, while international players like Zenko have initiated small-scale clinical studies. However, most companies are still in early development stages [2][7]. 8. Technical Barriers: - Significant challenges exist in hardware design, particularly for the electrode stent and subcutaneous signal transmission systems. Xinwei Medical's experience over the past nine years provides a competitive edge in overcoming these barriers [8][9]. 9. Future Adaptations: - The initial focus is on stroke patients, but there is potential for expanding indications based on technological advancements and market needs [16][17]. 10. Surgical Considerations: - The surgical procedure is complex, positioned between interventional and surgical methods, with neurosurgery being the most suitable field for these operations [21]. Additional Important Insights - The current prototype has a high domestic production rate, with core components being locally sourced, indicating a robust domestic supply chain [11]. - The industry is still in its nascent stages, with significant time required for product validation and market introduction, potentially taking 3 to 5 years for mature products to emerge [25][26]. - The impact of national medical insurance policies on neuro-interventional products is evolving, with a focus on maintaining competitive pricing while ensuring quality care [27].
心玮医疗20250724