Medical Device Weekly Brief (July 15–21): Funding Rounds, Product Approvals, and Strategic Deals

Jul 23, 2024 08:00 CST Updated 08:00

HeartCare

Neurointerventional Medical Device Developer

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Caprico Biotechnologies Completes Pre-A+ Round Financing Worth Tens of Millions of Yuan

Recently, Caprico Biotechnologies announced the completion of a multi-million yuan Pre-A+ round of financing. This round was exclusively invested by Panlin Capital, and the funds will mainly be used for the application of Class III medical device registration certificates in China, innovative antibody research and development, optimization and production of flow cytometers, and subsidiary construction. Caprico Biotechnologies was founded in 2019, but its early technical accumulation had been completed at U.S.-based Caprico. The U.S. Caprico possesses core capabilities such as R&D of monoclonal antibody cell lines for flow cytometry, purification and preparation of flow antibodies, fluorescent dye conjugation, and production quality control of flow antibody reagents. In April 2022, Caprico Biotechnologies adjusted its equity structure to fully acquire U.S.-based Caprico. Zhengzhou serves as the headquarters, while the wholly-owned subsidiary in Atlanta functions as the innovation and R&D center for flow antibodies.

West Lake HeartCare Completes Tens of Millions in Strategic Financing

Recently, Westlake Vitech (Hangzhou) Diagnostic Technology Co., Ltd., a leading enterprise in the field of red blood cell folate mass spectrometry, announced the completion of a multi-million yuan strategic financing round. This round of financing was invested by Hongjia Fund, and the funds will be used for research and development, market expansion, and more. Westlake Vitech is committed to achieving one-stop precision medicine solutions through cutting-edge diagnostic technologies. Its business covers third-party medical testing, clinical mass spectrometry applications, mass spectrometry reagent kits, etc. The company has established third-party precision medical testing laboratories in Beijing and Hangzhou, built a GMP-standard production center, and set up a research and development subsidiary in Australia. Professor Hongjun Shi, the founder of the company and director of the Cardiac Development and Regeneration Laboratory at Westlake University School of Medicine, focuses on the pathogenic mechanisms of congenital heart disease. He made the first discovery that embryonic vitamin B3 (niacin) deficiency can lead to multi-organ malformations, while niacin supplementation during pregnancy can completely prevent the occurrence of such malformations.

China's First Femoral Artery Occluder Approved for Marketing

Recently, the HeartCare自主研发的HeartCare Pulse合封堵止血系统 received registration approval from Taiwan's Ministry of Health and Welfare. After its launch in China in February 2022, the HeartCare Pulse合封堵止血系统 quickly became an outstanding representative of domestically produced femoral artery closure devices due to its advanced concept and excellent clinical performance. The sealing and management of the femoral artery puncture site is a crucial step in concluding vascular interventional procedures. The HeartCare Pulse合封堵止血系统 provides clinical solutions for vascular access, reducing clotting time and patient bed rest duration. This successful market entry into Taiwan marks an important step for HeartCare in expanding beyond mainland China. HeartCare will be rooted in China while looking globally, providing higher-quality solutions for the worldwide stroke care industry.

Rapid Growth in Medical Device Exports to Emerging Markets like the Middle East

Recently, according to China Customs data, the export of medical devices from China to emerging markets such as the Middle East has been growing rapidly. The United Arab Emirates, Turkey, and Saudi Arabia are the three largest medical device markets in the Middle East. In the first quarter of 2024, China's medical device exports to the UAE increased by 23.41% year-on-year; exports to Turkey grew by 9.68%; and exports to Saudi Arabia rose by 8.34%. In the Middle Eastern market, medical imaging is one of the niche sectors where Chinese companies have successfully gained a foothold. For instance, multiple medical imaging products from United Imaging Healthcare have entered top hospitals in the Middle East, while Neusoft Medical has provided hundreds of large-scale medical devices to the region, covering more than 10 countries including Algeria, Egypt, and the UAE. Another key area is gene sequencing, where multiple Middle Eastern countries have launched national genome projects and are advancing precision medicine closely related to genetic testing.

SIDHI Medical: "World's First" Smartphone Capsule Gastroscope, Creating a One-Stop Innovative Solution for Gastric Disease Screening

Recently, Sidahui Medical Released the World’s First Smartphone-Based Capsule Gastroscope to Improve Early Gastric Cancer Screening Rates. The system consists of a capsule gastroscope, a portable recorder, an app, and image analysis software. It operates without a main unit or wearable devices, supports multi-scenario applications, and achieves a diagnostic consistency rate of 96.8%. It has obtained Class III medical device registration and manufacturing licenses.

Boston Scientific Announces Agreement to Acquire SilkRoad Medical, Inc. Medical Device Company

Recently, Boston Scientific announced that it has signedSilkRoadMedical,Inc.The final agreement of the acquisition.SilkRoadMedical,Inc.It is a medical device company that has developed an innovative platform product to provide stroke prevention for carotid artery patients through minimally invasive surgery — Transcarotid Artery Revascularization (TCAR). The acquisition price was $27.5 per share, with an equity value of approximately $1.16 billion.

AccuMed-Ruiya Li Strategic Cooperation Agreement Successfully Signed

Recently, the strategic cooperation agreement signing ceremony between SEKISUI Medical Technology (China) Co., Ltd. ("SEKISUI Medical") and Shenzhen Raylio Group Co., Ltd. ("Raylio") was successfully held in Shenzhen. Mr. Qiang Gao, General Manager of SEKISUI Medical, and Mr. Shaobo Su, Chairman of Raylio, attended the ceremony and signed on behalf of both parties.

Medical Device Solutions Provider UFP Technologies Announces Acquisition of Marble Medical

Recently, UFP Technologies, a designer and manufacturer of medical device solutions, announced the acquisition of Marble Medical, a company specializing in adhesive-based medical components and disposable devices. The CEO of UFP stated that this acquisition complements their surgical robotic drapes and wearable device platform, offering a broader range of innovative solutions and incorporating specialized adhesive technology. Joe Audie, President of Marble Medical, expressed excitement about joining UFP and accelerating growth.

Medical Device Developer Autonomix Reaches Agreement with RF Innovations to Obtain IP License for Innovative Radiofrequency Ablation Technology

Recently, Autonomix has been granted the intellectual property rights of RF Innovations' Apex 6 radiofrequency generator, which has received FDA approval for ablation technology used in pain management. The agreement provides Autonomix with a permanent, non-exclusive, global royalty-free license, with plans to initially apply the technology for treating pancreatic cancer-related pain.

GE Healthcare Announces Agreement to Acquire Clinical AI Business from Intelligent Ultrasound

Recently, GE HealthCare has agreed to acquire Intelligent Ultrasound's clinical AI software business for approximately $51 million. Intelligent Ultrasound specializes in AI-driven image analysis tools to enable smarter and more efficient ultrasound.

Shukun Technology's Self-Developed Chest CT Image Processing and Analysis Software Officially Approved for NMPA Class III Medical Device Registration Certificate

Recently, the chest CT image processing and analysis software (Lungdimension Doc) independently developed by Shukun Technology has officially been approved for the NMPA Class III medical device registration certificate, becoming the 13th Class III medical AI certificate obtained by the company.

Tellgen Life's Fully Automatic Chemiluminescence Immunoassay Analyzer Obtains Medical Device Registration Certificate

Recently, Tellgen Corporation announced that its wholly-owned subsidiary, Jiangxi Tellgen, obtained a medical device registration certificate for its fully automatic chemiluminescence immunoassay analyzer (model and specifications: TESMIi50, TESMIi50Pro). The fully automatic chemiluminescence immunoassay analyzer is a Class II in vitro diagnostic instrument. This product uses the direct chemiluminescence method based on acridinium ester and is used together with matching test reagents. In clinical settings, it is used for qualitative or quantitative detection of analytes in human serum and plasma samples, including proteins and peptides, vitamins, amino acids and blood drug levels, hormones, immune function, autoantibodies, infectious diseases, tumor-associated antigens, and enzyme-related tests.

Huarun Pharmaceuticals Obtains Medical Device Registration Certificate for "Disposable Nasal Oxygen Tube"

Recently, Huaren Pharmaceutical announced that its wholly-owned subsidiary, Qingdao Huaren Medical Products Co., Ltd., has received the "Medical Device Registration Certificate" for the "Disposable Nasal Oxygen Tube" issued by the Shandong Provincial Drug Administration. The disposable nasal oxygen tube, which obtained the Class II medical device registration certificate, is used for direct oxygen delivery or humidified delivery between the oxygen source and the oxygen user during oxygen inhalation. The product includes 21 model specifications to meet diversified clinical needs. Currently, there are 202 companies in China with similar marketed products of disposable nasal oxygen tubes.

Kehua Bioengineering Receives Medical Device Registration Certificate for "Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Kit"

Recently, Kehua Bio-engineering announced that the company has received the Medical Device Registration Certificate (In Vitro Diagnostic Reagents) issued by the National Medical Products Administration. The product name is Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method).

Two Departments Issue Management Requirements for Temporary Import and Use of Clinically Urgently Needed Medical Devices by Medical Institutions

Recently, to further meet the urgent clinical needs for medical devices, the National Medical Products Administration (NMPA), in conjunction with the National Health Commission, formulated and released the "Management Requirements for Temporary Import and Use of Clinically Urgent Medical Devices by Medical Institutions." The Requirements fully consider patients' needs for medical devices under special circumstances, defining the scope of products and medical institutions; clarifying the responsibilities of medical institutions, distributors, overseas manufacturers, and agents; stipulating application materials, procedures, review methods, and timelines; and outlining requirements for record-keeping, discontinuation, analysis reports, and continued use of corresponding medical devices by medical institutions. The Requirements apply to Class II and Class III medical devices that are temporarily imported for urgent clinical use in patients when such devices are already approved abroad but no equivalent product is yet approved in China, excluding equipment subject to large-scale medical device allocation licensing.

NMPA: Increase Support for the Development of Innovative Drugs and Medical Devices

Recently, the National Medical Products Administration held an enlarged meeting of the Party Leadership Group to convey and study the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party of China, and to research and deploy measures for implementation. The meeting required systematic planning of policies and measures to deepen the reform of the entire process of drug regulation, promoting a positive interaction between high-level drug safety and high-quality development of the pharmaceutical industry. Efforts should be focused on improving the drug safety responsibility system, promoting the integration and linkage of departmental regulatory responsibilities, local management responsibilities, and corporate primary responsibilities, achieving shared responsibilities, joint problem-solving, and coordinated efforts. It is necessary to continuously deepen the reform of the review and approval system, increase support for the research and development of innovative drugs and medical devices, and fully support the high-quality development of the biopharmaceutical and medical equipment industries. Strengthen the supervision of selected drugs and medical devices in centralized procurement, enhance the supervision of the operation and use of drugs and medical devices in medical institutions, and better serve the overall situation of healthcare system reform.

Hunan Province Biomedical and Medical Device Industrial Park Symposium Convened

Recently, the Hunan Province Biomedical and Medical Device Industry Park Symposium was held in Changsha. The development of Hunan's biomedical and medical device industry continues to improve, with the industry scale constantly expanding. As of the end of June, the province had 249 pharmaceutical manufacturing enterprises, 1,300 medical device manufacturing enterprises, and 68 cosmetic manufacturing enterprises. The meeting emphasized the need to continuously promote the growth and strengthening of the industry by focusing on addressing weaknesses and strengthening areas of deficiency. It stressed the importance of enhancing a sense of crisis and urgency to further foster an innovative ecosystem for the industry. The meeting also highlighted the importance of adhering to the "one chessboard" thinking across China, adapting measures to local conditions, fully leveraging the initiative and creativity of biomedical and medical device industry parks in various regions, tapping development potential, forming agglomeration effects, and improving the scale, quality, and efficiency of park development.

Regulations on the Management of Importing Pharmaceuticals and Medical Devices from Hong Kong and Macao into Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area Under Review for Public Comments

Recently, the "Draft Amendment of the Regulations on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area in Guangdong Province (Draft for Public Comment)" was published on the Guangdong People's Congress website and is currently open for public comments until July 28. The draft proposes that medical institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area that meet the following conditions may apply to the health authority of the municipal government at or above the prefecture level where they are located. After evaluation, they must be reviewed and confirmed by the provincial health authority as designated medical institutions for the import and use of urgently needed drugs and medical devices from Hong Kong and Macao. For applications to import and use urgently needed drugs and medical devices within the designated list, the provincial health authority should issue an audit opinion within five working days of receiving the application. If the requirements are met, the provincial drug regulatory department should issue the approval document within five working days.

Note: The information in this article is compiled based on online news.

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