Weekly Medical Device News Roundup [Oct 28 – Nov 3]: Funding, Approvals, and IPO Filings

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Medical Robot Company "AMIT" Raises Tens of Millions of YuanSeries A Financing

MingKang Zhongjin's Non-Invasive Ventilator Passes Through the Priority Review Green Channel

Symani Surgical Robot Named One of the Best Inventions in the "Robotics Category" by U.S. TIME Magazine

Sino Medical Balloon Catheter Approved for Marketing in China

China's First Jingfeng® Single-Port Endoscopic Surgical Robot Approved for Multi-Department Clinical Applications

Shitong Medical Multi-DOF Handheld Robotic Arm ObtainsFDA Market Access

China-Made Adjustable Intracranial Thrombectomy Stent Approved for Marketing

On October 24, Shenzhen Fourth People's Hospital and Raylife Group signed a strategic cooperation agreement to jointly build a laboratory, promoting the integration of industry, academia, and research as well as the transformation of innovative achievements. The two parties will engage in long-term cooperation in areas such as technical strategic consulting, technological innovation, development of new products, and talent cultivation, driving the upgrading of healthcare technology.

On October 29, Exactech (U.S. Precision Medical), a leader in orthopedic implants, announced that it would initiate a court-supervised voluntary restructuring process (i.e., filing for bankruptcy) in collaboration with its existing group of investors, aiming to sell assets and clear legal liabilities. Exactech, a globally leading medical device company founded in 1985, is headquartered in Gainesville, Florida, USA. Exactech focuses on developing and manufacturing cutting-edge implants, precision instruments, and advanced technologies in the field of joint replacement. Its core product lines include essential surgical instruments and equipment, efficient joint revision solutions, and advanced materials that promote bone regeneration. The company not only cultivates its domestic market but has also expanded its business to over 30 overseas markets across Europe, Latin America, Asia, and the Pacific region.

Hua Rui Bo was founded in 2018 as an innovative medical device enterprise integrating the research, development, production, sales, and service of orthopedic surgical robots. The products and services it provides to medical institutions mainly cover three aspects: orthopedic surgical robots, supporting equipment and consumables, and surgical technical service management systems. To date, Hua Rui Bo has completed six rounds of financing, with Midea Investment holding a 2.68% stake.

Recently, Mindray Medical releasedThe 2024 third-quarter report shows that the company has once again achieved steady growth in the first three quarters, with operating revenue reaching 29.485 billion yuan, a year-on-year increase of 7.99%; net profit attributable to shareholders reaching 10.637 billion yuan, a year-on-year increase of 8.16%. Among them, the domestic market grew by nearly 2% year-on-year in the first three quarters, while the international market grew by more than 18%. Specifically, the European market grew by nearly 30% year-on-year in the third quarter, continuing the recovery trend seen in the first half of this year. In response, Mindray Medical stated, "All major Western European countries have shown significant growth, and it is expected that Europe will maintain rapid growth for the whole year." The developing countries market also showed rapid growth, with an increase of over 20% in the third quarter. Particularly, the Asia-Pacific region represented by India, Indonesia, and Australia showed significant growth, reaching 32%. Mindray Medical also stated, "It is expected that the developing countries market will maintain rapid growth for the whole year."

Recently, United Imaging Healthcare releasedThird Quarter Report of 2024. Third Quarter of 2024: Operating revenue was 1.621 billion yuan, a year-on-year decrease of 25%; Net profit attributable to parent company was -279 million yuan, a year-on-year decrease of 320.57%; Non-recurring net profit attributable to parent company was -334 million yuan, a year-on-year decrease of 899.46%. In the 2024 semi-annual report, accounts receivable of United Imaging Healthcare accounted for 86.52% of operating revenue. At that time, there were analysis articles pointing out that this "high accounts receivable and low growth" model was concerning. If accounts receivable could not be collected in time, it would adversely affect cash flow and financial condition. If a company has long-term negative cash flow from operating activities, it may face capital turnover pressure, affecting normal operations and future development. In the third quarter report of 2024, United Imaging Healthcare explained that due to the influence of the market environment, business volume slightly decreased during the reporting period. Meanwhile, United Imaging Healthcare continued to increase its investment in business expansion, especially overseas, resulting in an increase in sales expenses year-on-year.

Recently, Autobio Diagnostics released its Q3 report for 2024, achieving a total operating revenue of 3.38 billion yuan, a year-on-year increase of 4.24%, and a net profit attributable to shareholders of 956 million yuan, a year-on-year increase of 6.13%. In terms of assets, Autobio Diagnostics reported total assets of 11.389 billion yuan at the end of the period, with accounts receivable amounting to 1.224 billion yuan. Regarding cash flow, the net cash flow generated from operating activities was 949 million yuan, while the cash received from sales of goods and provision of services amounted to 3.588 billion yuan. Autobio Diagnostics focuses on the research, development, manufacturing, integration, and service of in vitro diagnostic reagents and instruments. Its product portfolio covers testing areas such as immunoassay, microbiology, biochemistry, molecular diagnostics, and coagulation, and it has already established a presence in precision testing fields like sequencing and mass spectrometry, providing comprehensive product solutions and holistic services to medical laboratories.

On October 24, the National Medical Products Administration (NMPA) and the Danish Medicines Agency signed a letter of intent for cooperation. The aim is to strengthen exchanges and cooperation between the two parties in the field of pharmaceuticals and medical device regulation, and jointly promote the second phase of the China-Denmark strategic cooperation project on pharmaceuticals and medical devices.

Recently, the National Medical Products Administration released the "Tissue Engineering Medical Devices "Fibroin Protein" Pharmaceutical Industry Standard Provides Clear Technical Specifications for the Application of Fibroin Protein in the Medical Device Field. This standard covers the physical and chemical performance requirements of fibroin protein, as well as regulations on labeling, packaging, transportation, and storage, ensuring its safe and effective application in medical devices. The release of this standard fills an industry gap and establishes new norms for the application of fibroin protein in the fields of medical aesthetics and regenerative medicine.

Recently, the General Office of the Ministry of Industry and Information Technology released"Notice on the Launch of a Campaign to Collect Typical Application Cases of Intelligent Technologies in the Field of Biomanufacturing"

Recently, the Culture, Health, and Sports Committee of the Shanghai Municipal Committee of the Chinese People's Political Consultative Conference (CPPCC) held a legislative consultation seminar. At the meeting, the Education, Science, Culture, and Health Committee of the Shanghai Municipal People's Congress and the Shanghai Drug Administration introduced the legislative work related to the "Shanghai Pharmaceutical and Medical Device Management Regulations (Draft)" and listened to the opinions and suggestions of the attending CPPCC members on the "Regulations (Draft)." In recent years, the situation regarding pharmaceutical and medical device safety in Shanghai has been stable, orderly, and controllable, with active technological innovation, continuously improving industrial levels, and an optimized innovation ecosystem. During the research, enterprises acknowledged that Shanghai has made significant achievements in innovating regulatory methods, addressing difficulties in the production and operation processes of enterprises, and promoting industrial development in recent years. Currently, the "Regulations (Draft)" focus on..."Four Highs" Development: Encourage Original Innovation and Accelerate Market Entry, Enhance Accessibility, and Focus on Ensuring High-Quality Living Standards.

Recently, the Inspection Center of Jiangsu Provincial Drug Administration held a meeting on carbon ions/Key Points Seminar on Proton Therapy System Inspection. Carbon ion/proton therapy is an external radiation therapy technology that utilizes ionizing radiation, taking advantage of the Bragg peak characteristics of ion beams to better concentrate the energy of ionizing radiation on the lesion, reducing damage to normal tissues along the beam's path, thereby treating tumor lesions more precisely and minimizing toxic side effects for patients. Carbon ion/proton therapy equipment is an ultra-large active device, classified as a Class III medical device. Unlike other medical devices mass-produced by enterprises, this type of equipment covers a large area, has complex and numerous components, requires significant investment, and often needs customized configurations. It is generally designed and installed on-site at medical institutions and must undergo inspections and checks by regulatory authorities, posing a considerable challenge to the capabilities of inspection agencies. In recent years, with the accelerated development of domestically produced equipment in Jiangsu Province, there is an urgent need for regulatory and inspection agencies to intervene early, strengthen technical reserves, and train personnel in preparation for future registration inspections and routine supervision.

Recently, the United StatesFDA Special Topic: Hengjian Biotech Obtains De Novo for Combined At-Home Test for Flu and Coronavirus, Announces on LinkedIn and Other PlatformsHengjian Biotech USA, a wholly-owned subsidiary of Orient Gene Biotech in Texas, USA, announced that the U.S. Food and Drug Administration (FDA) has officially granted marketing authorization for the Healgen Rapid Check COVID-19/Flu (Type A & B) Antigen Test Kit. This product is an over-the-counter medication that can be used without a doctor's prescription and is suitable for patients with respiratory symptoms. Using a nasal swab for easy sample collection, users can independently perform rapid testing for COVID-19 and flu (Type A & B) at home, obtaining accurate results in approximately 15 minutes.

Recently, the Anhui Provincial Drug Administration revealed at the Anhui Provincial Press Conference that during the meeting,At the 2024 Yangtze River Delta Drug Regulation Integration Cooperation Conference, four agreements will be signed, including the cross-regional cooperation on drug evaluation for the integrated development of the Yangtze River Delta. Three achievements will be announced, such as the shared recognition of processing standards for Chinese herbal pieces in the Yangtze River Delta region. Additionally, five consensuses will be reached, including a unified system in the drug regulation field for minor violations to be exempt from penalties in the Yangtze River Delta region. The Anhui Provincial Drug Administration stated in a press release...BuhuiAs introduced, in the aspect of deepening the reform of the review and approval system, Anhui has opened a green channel for the prioritized approval of Class II medical devices, established a consultation mechanism for the classification of medical devices, implemented a dossier review for the first registration projects of Class II active medical devices, and provided early intervention, tracking services, and list-based support for innovative drug and device projects under research.

Recently, the Tianjin Municipal Medical Products Administration issued the "Several Measures on Deeply Implementing the Spirit of the Third Plenary Session of the 20th CPC Central Committee to Further Comprehensively Deepen the Reform in the Field of Drug Regulation." The Several Measures aim to better protect and promote people's health, with a total of27 Specific Measures for Deepening Reform in Four Aspects of Drug Regulation. Establish a Full-Chain Support Mechanism for the Development of Innovative Drugs, Medical Devices, and Cosmetics. Actively Seek National Pilot Policies to Promote the Implementation of Optimized Drug Supplemental Application Review and Approval Reform Pilots, and Explore Cosmetic Personalized Customization Service Pilots. Enhance the Level of Review and Approval Services, Establish a Guidance and Service Mechanism for Drug Research and Innovation, Strengthen Institutional Supply for New Areas and Tracks in Biomedical Science, Reinforce Rule Leadership and Standards Improvement, and Optimize the Drug and Device Registration Review and Approval Service Mechanism. Foster the Construction of an Innovative Ecosystem and Industrial Ecosystem, Improve Public Platforms for Medical Device Innovation Transformation and Industrialization, and Build a Shared Cosmetic R&D Platform.

Recently, it was learned from the Municipal Economic and Information Technology Bureau that Beijing is about to release the "Beijing Medical Device Industry Quality Improvement and Upgrade Action Plan (2024-2026)" The "Action Plan" is guided by clinical needs, led by the integration and innovation of technology, focused on promoting collaboration among medical research, industry, academia, and application, and supported by strengthening regional synergy as the overall strategy. It proposes specific goals such as exceeding an overall scale of 50 billion yuan by 2026, establishing more than five specialized industrial parks, and introducing over 100 innovative products. Efforts will be made to build a world-class innovative medical device industry cluster by the end of the "15th Five-Year Plan." Beijing will implement the "Digital Intelligence Engine Upgrade Project," promoting the construction, iteration, and application of large-scale medical models, accelerating the compliant circulation of healthcare big data like medical imaging; encouraging medical institutions to participate in the "Medical-Engineering Integration Demonstration Project," creating demonstration applications and training centers, and establishing a collaborative innovation system.