July Sees Approval of 272 Medical Devices, Johnson & Johnson Expands Cardiovascular Portfolio, and First At-Home Syphilis Test Launches

On August 20, Johnson & Johnson announced a major acquisition plan to acquire V-Wave, a heart failure treatment company, with a total transaction value potentially reaching $1.7 billion. This strategic acquisition will enhance Johnson & Johnson's innovation capabilities in the cardiovascular medical device field and is expected to bring breakthrough treatments to patients.

According to the agreement, Johnson & Johnson will pay V-Wave an upfront payment of $600 million and may pay up to an additional $1.1 billion based on future regulatory and commercial milestones. V-Wave will be integrated into Johnson & Johnson's medical technology division, and the transaction is expected to be completed by the end of 2024.

Johnson & Johnson stated in a press release that the addition of V-Wave will solidify its position as an innovation leader in the field of cardiovascular disease treatment and accelerate the company’s strategic transformation towards high-growth and high-opportunity markets. Furthermore, this acquisition will deepen collaboration with structural heart disease and heart failure specialists, providing patients with more comprehensive treatment options.

V-Wave's flagship product, the Ventura Interatrial Shunt (IAS), is an innovative implantable device designed to reduce left atrial pressure in patients with congestive heart failure by creating a shunt between the left and right atria of the heart, thereby decreasing cardiovascular events and heart failure hospitalizations. The device is implanted through a minimally invasive procedure, offering patients a treatment option that lies between medication therapy and highly invasive cardiac surgery.

This deal is expected to be completed by the end of 2024, marking another significant expansion for Johnson & Johnson in the cardiac device market. Since 2022, Johnson & Johnson has successfully acquired leading companies such as Abiomed, Laminar, and Shockwave Medical, continuously expanding its premium medical product portfolio and demonstrating its firm commitment to medical technology innovation and market expansion.

What "medical device" news is worth paying attention to in the medical device industry this week? Insights into new industry policies, observations of corporate developments, and a review of market investments and financing, all tracked and reported by the Pharmaceutical Economy News!

NMPA: 272 Medical Device Products Approved in July

Recently, the National Medical Products Administration (NMPA) announced that in July 2024, the NMPA approved the registration of 272 medical device products, a significant increase compared to 134 in June. Among them, there were 192 Class III medical devices produced in China (109 approved in June), 44 imported Class III medical devices, 35 imported Class II medical devices, and 1 medical device product from Hong Kong, Macao, or Taiwan.

The executive meeting of the Shanghai Municipal Government has preliminarily approved the "Action Plan for Enhancing the International Competitiveness of Biomedical Enterprises in Shanghai (2024-2027)"

Recently, Gong Zheng, Deputy Secretary of the Shanghai Municipal Committee and Mayor of Shanghai, presided over a meeting of the Standing Committee of the Shanghai Municipal Government. The meeting gave preliminary approval to the "Shanghai Action Plan for Enhancing the International Competitiveness of Biomedical Enterprises (2024-2027)" and noted:

To support more locally innovated pharmaceuticals and medical device products from Shanghai to go global, promote multi-dimensional international expansion, and encourage group-based, collaborative, and independent overseas ventures;

To expand into diversified markets, we must deepen our presence in the mature markets of Europe, America, and Japan while actively exploring emerging markets, and promote the recognition of more innovative pharmaceuticals and medical device products by foreign regulatory authorities;

Efforts should be made to strengthen the empowerment of the entire chain, support enterprises in establishing global innovation networks such as overseas R&D and clinical trials, cultivate international professional service agencies, and accelerate integration into the global regulatory standards mutual recognition and cooperation system.

Jiangxi Strengthens Regulation of Medical Device Transportation and Storage Service Enterprises

Recently, the Jiangxi Provincial Drug Administration released the "Regulations on Quality Management for Enterprises Specializing in Transportation and Storage Services of Medical Devices," which will come into effect on January 1, 2025. The new regulations aim to strengthen the supervision of medical device operations, standardize market order, and promote the high-quality development of third-party logistics enterprises.

The regulations specify requirements for personnel allocation, area, shelving, transport vehicles and equipment, warehouse management, unique identification collection and reading, video surveillance, computer information systems, cross-regional warehouse setup, and information reporting to ensure the quality and safety of medical device transportation and storage services. The regulations state that specialized operating enterprises providing medical device transportation and storage services must be equipped with unique identification collection and reading devices to achieve full traceability.

SonoWe 7mm Ultrasonic Scalpel Approved for Class III Medical Device Registration Certificate

Recently, the 7mm ultrasonic scalpel (disposable ultrasonic high-frequency surgical integrated equipment ultrasonic scalpel head) independently developed by Sinowave has been officially approved for a Class III medical device registration certificate by the National Medical Products Administration (NMPA), becoming the first approved domestically produced 7mm ultrasonic scalpel in China.

SoniCure® Ultrasonic Scalpel by Sinowave relies on powerful algorithm capabilities to develop two core technologies: Adaptive Tissue Technology and High-Speed Frequency Tracking. Both technologies have previously been recognized as "Key Core Technologies of Medical Devices in China." The Adaptive Tissue Technology intelligently adjusts output energy based on differences in tissue characteristics and the cutting process, achieving precise and efficient cutting and hemostasis while reducing thermal damage and eschar. The High-Speed Frequency Tracking technology allows for maximum energy conversion through high-speed frequency modulation, maximizing the transformation of mechanical energy at the ultrasonic blade tip into thermal energy, thereby achieving vessel coagulation and closure.

First At-Home Syphilis Test Kit Receives FDA Approval

Recently, the U.S. FDA approved the marketing authorization of NOWDiagnostics' syphilis testing product, which is the first over-the-counter home test for detecting antibodies to Treponema pallidum in human blood. The test provides results in approximately 15 minutes, offering individuals a convenient way to preliminarily understand their condition.

Clinical studies show that the test can correctly identify 99.5% of negative samples and 93.4% of positive samples, significantly improving syphilis screening. Syphilis, a sexually transmitted infection once thought to be on the decline, is now resurging globally. Between 2017 and 2021, reported cases in the United States increased by 74%. The CDC reports that congenital syphilis cases have risen tenfold in the past decade, potentially leading to miscarriages, stillbirths, infant deaths, and lifelong medical issues.

FDA Approves: Multi-Application Radiofrequency Skin Platform Expands Indications

Recently, Candela Corporation (Syneron), a global leader in medical aesthetic devices, announced that its Matrix™ system, the first radiofrequency (RF) platform for comprehensive skin treatment, has received U.S. FDA 510(k) clearance for the transcutaneous treatment of facial wrinkles in patients with Fitzpatrick skin types (FST) I-IV.

The Matrix™ system is the only device on the market today capable of delivering multiple energy levels at various depths in a single treatment. It utilizes the finest microneedle array available, allowing for more precise and smoother delivery of short-pulse radiofrequency energy to the skin, effectively enhancing patient comfort and minimizing recovery time. As a new energy-based device launched by Candela Medical in Australia and New Zealand, the Matrix™ system, powered by Dimensional RF™, aims to stabilize, repair, and regenerate the skin at all stages of the aging process.

Maivision Medical Completes Nearly 100 Million Yuan in Series A Financing

Recently, Shenzhen Maiwei Medical Technology Co., Ltd. (hereinafter referred to as "Maiwei Medical") has completed nearly 100 million yuan in A-round financing, led by Tasly Capital, with Delian Capital and Tianfeng Capital participating. This round of financing will be used for the registration clinical trials, commercialization, and new product layout of core products.

Founded in July 2021, Maiwei Medical is a national high-tech enterprise that owns industry-leading multi-modal energy platforms and key technologies, including pulsed electric fields, ultrasound, radiofrequency, and plasma. Currently, Maiwei Medical has developed a range of innovative cardiovascular treatment devices and solutions for indications such as cardiac electrophysiology (atrial fibrillation) and refractory hypertension. Based on the team's over 20 years of research accumulation, the company has overcome several critical industry challenges, achieving better clinical efficacy and safety.

730 Million! Ultrasonic Tumor Treatment Platform Completes D Round Financing

Recently, HistoSonics, a medical technology company focused on developing sonic technology for tumor treatment, announced the completion of an oversubscribed $102 million (approximately 730 million RMB) Series D financing round. This round was led by Alpha Wave Ventures, with participation from new investors Amzak Health and HealthQuest Capital, as well as existing investors.

HistoSonics, founded in 2009, is a medical device company dedicated to the use of sonic technology for tumor treatment. It develops non-invasive platforms and proprietary sonic beam therapies using tissue fractionation technology. The company's tissue fractionation technology is a novel mechanism of action that utilizes focused ultrasound to mechanically disrupt and liquefy unwanted tissue and tumors. HistoSonics is currently focused on commercializing its Edison platform in the United States, targeting the global liver treatment market while expanding the application of tissue fractionation technology to other organs such as the kidneys and pancreas. HistoSonics has offices in Ann Arbor, Michigan, and Minneapolis, Minnesota.

Sijie Medical Announces Completion of Tens of Millions in Series A+ Financing

Recently, Sijie Medical Technology (Guangzhou) Co., Ltd. ("Sijie Medical" for short) announced the completion of a multi-million A+ round of financing. This follows the successful completion of Shandong Hexin’s A round of financing in February 2023, with Sijie Medical once again receiving additional investment from the well-known angel investment institution Wuming Investment. This round of financing will strongly support Sijie Medical's R&D innovation and market expansion in the field of transradial neurointerventional devices, accelerating the commercialization process of the company's core product pipeline.

Suitable介入医疗科技（广州）有限公司 was founded in October 2021. It is a high-tech enterprise focusing on the research, production, and sales of vascular interventional devices. The company aims to become a global leader in transradial neurointerventional devices and has innovatively developed multiple transradial neurointerventional products.

Editor: Wu Yun