A Week in Review of the Medical Device Industry
July 25 - July 31
01
Centralized procurement
Country: Carry out the filling of procurement needs of medical institutions for spinal consumables
On July 27, the National Organization of High-value Medical Consumables Joint Procurement Office issued the "Notice on Carrying out the Procurement Demand Filling of Spinal Consumables Medical Institutions", announcing the variety, time, method and requirements for the procurement of spinal consumables. The variety of this report is orthopedic spine medical consumables, including 14 product system categories, the filling time is from 12 o'clock on August 1, 2022 to 17 o'clock on August 14, 2022.
Hunan: It is planned to carry out low-value consumables procurement in the province
On July 28, the Zhuzhou Alliance Pharmaceutical Centralized Price Limit Procurement Platform issued the "Notice on Inviting and Declaring the Product Information of Low-value Medical Consumables Procurement Enterprises in Hunan Province". According to the notice, Hunan plans to carry out low-value consumables procurement in the province, and the product scope covers disposable nebulizer inhalers, disposable light-proof infusion sets, sterile dressings (special for indwelling needles), disposable vacuum blood collection tubes, disposable nasal oxygen tubes (with humidification), disposable medical laryngeal masks, medical polymer splints (orthopedics), and medical polymer bandages (orthopedics). Enterprises that have sold related products in public medical institutions in Hunan Province since 2021 are required to fill in relevant information before 17:00 on August 7.
Jiangxi: Carry out the procurement of liver function and biochemical reagent alliance
Recently, the procurement of liver function biochemical reagents led by Jiangxi was officially launched, and the 21 provinces and cities include: Jiangxi Province, Hebei Province, Shaanxi Province, Inner Mongolia Autonomous Region, Liaoning Province, Jilin Province, Heilongjiang Province, Fujian Province, Henan Province, Hubei Province, Hunan Province, Guangdong Province, Guangxi Zhuang Autonomous Region, Hainan Province, Chongqing Municipality, Guizhou Province, Shaanxi Province, Gansu Province, Qinghai Province, Ningxia Hui Autonomous Region, Xinjiang Uygur Autonomous Region, and Xinjiang Production and Construction Corps.
Jilin: Maintain the procurement information of orthopedic trauma products
Recently, according to the requirements of the Jilin Provincial Medical Insurance Bureau's "Notice on the Implementation of the Results of the Beijing-Tianjin-Hebei "3+N" Alliance Orthopedic Trauma Medical Consumables with Volume Linkage", the results of the purchase of orthopedic trauma medical consumables will be implemented on August 1, and our center will adjust the online procurement price of the selected products. All relevant medical institutions are requested to maintain the procurement information of trauma consumables products before August 1, improve the platform procurement process, and avoid price differences caused by delayed maintenance information for products purchased before the implementation of volume results.
02
Policy supervision
Shenzhen issued the "Several Measures to Promote the High-quality Development of High-end Medical Device Industry Clusters in Shenzhen"
On July 26, Shenzhen issued a policy to promote the development of high-end medical devices, "Several Measures to Promote the High-quality Development of High-end Medical Device Industry Clusters in Shenzhen", which mentioned that the support areas cover medical imaging, in vitro diagnostics, high-value consumables, genetic testing, surgical robots and other subdivisions. The issuance of the "Notice" is conducive to accelerating the cultivation of local high-end medical device industry clusters, effectively seizing the commanding heights of a new round of industrial development, and enhancing the core competitiveness of local industries.
Guangdong Provincial Drug Administration issued the "Guangdong Provincial Drug Administration Regulations on the Administration of Extended Inspection of Medical Device Registrants and Filing Persons" (Draft for Comments)
On July 27, the Guangdong Provincial Drug Administration issued the "Guangdong Provincial Drug Administration Regulations on the Administration of Extended Inspection of Medical Device Registrants and Record Holders" (draft for comments) to ensure the quality and safety of medical devices, protect human health and life safety, and promote the development of the medical device industry. The extended inspection referred to in the "Provisions" refers to the inspection activities carried out by the drug regulatory department to comprehensively evaluate the compliance and effectiveness of the quality management system of medical device registrants and filing persons, and to provide products or services for the development and production of medical devices. The "Provisions" are applicable to the extended inspection activities in the field of medical devices carried out by drug regulatory departments at all levels in Guangdong Province.
Anhui Food and Drug Administration issued the "Measures for the Supervision and Administration of the Use of Drugs and Medical Devices in Anhui Province"
On July 29, the Anhui Food and Drug Administration issued the "Measures for the Supervision and Administration of the Use of Drugs and Medical Devices in Anhui Province", which basically established a regulatory system covering the whole field and all aspects of the supervision of drugs, devices and cosmetics. Anhui blood products, biological products, large-volume injections, national centralized procurement of selected drugs and Class III medical devices and other key product manufacturers, special drug production and operation enterprises to implement annual full coverage supervision and inspection. A total of 4,388 cases of illegal drug and device use were investigated and dealt with, a year-on-year increase of 54.8%, achieving a "double improvement" in the number and quality of cases investigated and handled, and significantly enhancing the pertinence and effectiveness of supervision.
National Health Commission: Since the 18th National Congress of the Communist Party of China, positive progress and remarkable results have been achieved in promoting the task of deepening medical reform
On July 28, the Secretariat of the Leading Group for Medical Reform of the State Council and the National Health Commission held a press conference on the progress and effectiveness of deepening medical reform in various places since the 18th National Congress of the Communist Party of China. Xu Shuqiang, director of the Department of Institutional Reform of the National Health Commission, said that since the 18th National Congress of the Communist Party of China, all localities have vigorously promoted the system integration and implementation of the task of deepening medical reform, and have achieved positive progress and obvious results. First, local party committees and governments attach great importance to deepening medical reform; the second is to promote the experience of Sanming medical reform according to local conditions, and make new breakthroughs; the third is to accelerate the construction of an orderly new pattern of medical treatment and diagnosis and treatment; fourth, promote the comprehensive reform and high-quality development of public hospitals; fifth, to promote the high-quality development of medicine and medical insurance; Sixth, we will coordinate and promote reforms in relevant fields.
03
Investment and financing
Flint created and completed 100 million yuan in Series B financing
On July 28, Firestone recently announced the completion of a round B financing of 100 million yuan, which was jointly invested by the new shareholders of the Ministry of Industry and Information Technology's SME Development Fund Puhua (Hangzhou) Fund, Liandong Group, and the old shareholder Wangmei Investment. Jin Xia, chairman of Firestone Creation, said that this round of financing will be used for continuous exploration of industrial data intelligent services, and Firestone Creation and Liandong will also increase collaboration at the business level such as industrial services and park operations.
Yuan Guji received tens of millions of yuan in financing
On July 29, Guangzhou Yuanguji Technology Co., Ltd. announced the recent financing progress, and signed a new round of capital increase agreement with the Yangtze River Delta Capital, Danlu Capital, and Convergence New Star Fund, and the old shareholder Danlu Capital continued to make additional investments. The investment is mainly used to focus on the construction of respiratory specialties in Yuanguji, promote the transformation of production, education and research, and create a full life cycle solution for respiratory diseases. Yuanguji is an innovative enterprise guided by the development of respiratory specialties, committed to the transformation of scientific and technological achievements and serving clinical needs, continuously broadening the diagnosis and treatment path of respiratory diseases, and creating the first brand of auxiliary respiratory specialty construction and development.
Astor completed nearly 200 million yuan in Series B financing
On July 29, Astor (Chengdu) Biopharmaceutical Co., Ltd. recently completed nearly 200 million yuan in Series B financing, led by Shenyin Wanguo, followed by Gree Financial Investment, Guanghua Wutong, Kangju Venture Capital, Mingcheng Ruiying, Chengdu Daopu, etc. This round of financing will be mainly used for the expansion and renewal of R&D facilities in Wenjiang and the construction of production bases in Yibin, Jinchang and Guang'an. Astor is a high-tech enterprise dedicated to providing customized research and development (CRO), customized research and development and production (CDMO), customized manufacturing (CMO), API process development (CMC) and chemical process safety assessment services for global pharmaceutical companies, and is the world's leading green chemical reaction technology platform company.
Youwei Medical completed Series A financing
Recently, Youwei Medical has recently completed the A round of financing, led by Hengxu Capital, and its partner Yahong Pharmaceutical also participated in the investment. Youwei Medical has 4 disposable endoscope products approved by FDA, including 3 disposable cystoscopes and 1 disposable hysteroscope, all of which have been marketed in the United States.
Kna Medical has recently raised nearly 100 million yuan
Recently, Kna Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as "Kna Medical") announced the completion of the B2 round of financing, with a financing amount of nearly 100 million yuan. This round of financing was invested by Qianfeng Financing Co., Ltd., and Walden International continued to follow. Kona Medical will use the funds from this round of financing to quickly launch its self-developed high-frequency ultrasound imaging system to the global market on the one hand, and on the other hand, it will develop a new generation of CMUT chips and innovative ultrasound imaging products with the help of the core patents of semiconductor ultrasound CMUT chips.
Completed the first round of financing of tens of millions of yuan with Rui Innovation
Recently, the new force of smart surgery and Rui Innovation announced the completion of the first round of financing of tens of millions of yuan, which was exclusively invested by Yuanyi Capital. This round of funds will be mainly used for the continuous research and development of SurgSmart, an intelligent minimally invasive series of products, to make it suitable for more types of surgery, and at the same time actively promote the nationwide market layout to help the company seize the leading position in the global field of smart surgery 4.0.
Mozhuo Biotech completed nearly 100 million yuan in Series A+ financing
Recently, Mojo Biotechnology (Zhejiang) Co., Ltd. (hereinafter referred to as "Mozhuo Biotech") announced the completion of nearly 100 million yuan in Series A+ financing, which was led by LYFE Capital and followed by the old shareholder Source Code Capital and the local government guidance fund Yunxiang Fund to fully support the company's development. It is reported that the funds raised in this round of financing will be mainly used to further expand the company's single-cell product R&D pipeline, vigorously promote the R&D and promotion of the world's unique high-throughput microbial single-cell genomics platform (MobiMicrobe™), and continue to promote the R&D, production, commercialization and market development of various products, and strive to accelerate the creation of a diversified and efficient single-cell ecosystem with other industry practitioners.
Zhongguancun Shuimu Medical completed the A+ round of financing of 100 million yuan
Recently, Beijing Zhongguancun Shuimu Medical Technology Co., Ltd. (hereinafter referred to as Zhongguancun Shuimu Medical) completed a 100 million yuan A+ round of financing, with investors Yijing Capital and Songhe Capital. This round of funds is mainly used to lay out CDMO and animal experiment services of Zhongguancun Shuimu Medical Devices, and build a one-stop service platform for the whole industrial chain of medical devices.
Haihe Biotech completed the B round of financing of over 100 million yuan
On July 30, Haihe Biomedical Technology Group Co., Ltd. recently completed a Series B financing of over 100 million yuan, which was exclusively invested by Legend Capital, and the funds obtained will be used to further expand testing facilities, develop medical device CDMO business and expand the talent team. Haihe Biotech is a platform company specializing in providing product life cycle services for medical device and drug-related research institutions, R&D and manufacturing enterprises, as well as relevant regulatory agencies, and has a high industry position in the field of biomedical CRO. Its business covers product life cycle services, service-oriented manufacturing, intelligent creation and third-party testing and certification.
Ribo Biotech completed a $40 million Series E1 financing
Recently, Ribo Biotech announced that it has recently completed a $40 million E1 round of financing. This round of financing is mainly completed by existing shareholders such as Panlin Capital and Sany Innovation Fund, as well as new institutional and individual investors in this round. According to the press release of Ribo, the funds raised in this round will continue to support the company's global development of multiple varieties in different stages of research and development, as well as the iteration of existing small nucleic acid technologies, especially the research of non-liver targeted delivery technology.
Stranawave Biotech completed tens of millions of Series A financing
Recently, Layer Wave Biotech announced the completion of tens of millions of yuan in Series A financing. This round of financing is invested by IDG Capital, and the funds will be used for the research and development and marketing of the company's flow cytometry products. Focusing on the field of flow cytometry, Lamina Biotech is committed to realizing the automation and routine of flow cytometry technology, and the application of analysis is foolish and intelligent, and has launched a variety of flow cytometry products. At present, the main product 2-laser 8-color flow cytometer MateCyteTM successfully obtained the NMPA registration certificate in January 2021, and the high-end product 3-laser 14-color flow cytometer LongCyteTM 26 models have obtained CE certification and are applying for the NMPA registration certificate. In the second half of the year, we will successively launch reagents such as flow cytometry sample preparation instrument FA3000L, flow cytometry detection antibodies, etc.
04
other
Huawei released the WATCH 3 Pro new with ECG analysis and obtained the medical device registration certificate
On July 27, at the HarmonyOS 3 and Huawei all-scenario new product launch conference, HUAWEI WATCH 3 Pro new was officially released, equipped with HarmonyOS 3, supporting eSIM independent networking communication, and rich application apps, covering common use scenarios in life, allowing users to fully enjoy smart life; At the same time, it supports ECG analysis, Huawei ECG analysis prompt software, and obtained the registration certificate of Class II medical devices from the Medical Products Administration. In addition, HUAWEI WATCH 3 Pro new also participates in the vascular health research initiated by the China Association for the Promotion of International Exchange in Healthcare, which supports screening for the risk of arteriosclerosis, provides professional health advice, and realizes active vascular health management at home. Committed to creating an interactive center, a smart center and a health center around the wrist.
Kangtu Medical Polyetheretherketone Prefabricated Skull Plate obtained the medical device registration certificate
Recently, Kangtu Medical announced that the company recently obtained the third class of "Medical Device Registration Certificate" issued by the State Drug Administration, and the product name is polyetheretherketone prefabricated skull plate, which is suitable for surgical treatment of skull defect repair and reconstruction. Founded in 2005, Xi'an Kangtuo Medical Technology Co., Ltd. (hereinafter referred to as "Xi'an Kangtuo") focuses on neurosurgery, cardiovascular surgery, craniomaxillofacial surgery, stomatology and other professional fields, and is a high-tech enterprise integrating R&D, production and sales services of three types of implantable medical devices.
Philips Medical (Suzhou) domestic high-end flagship ultrasound collar/preview series was approved for marketing
On July 26, the new ultrasound product of Guochuang Intelligent Manufacturing - Lingjian/Pre-Appraisal series, developed and produced by Philips Medical (Suzhou) Co., Ltd. in conjunction with global resources, has been officially approved for listing through NMPA registration, and has obtained the registration certificate of Class III medical devices. As a new high-end flagship ultrasound product of Philips, the Lingjian/Preview series of ultrasound includes a total of 12 products. The new domestic series of ultrasound inherits the excellent image quality and advanced technical advantages of Philips, which not only covers a variety of clinical applications such as systemic application, tumor intervention, maternal and child care, cardiovascular and cerebrovascular care, but also brings precision ultrasound diagnosis and treatment.
Beixin Life Sciences' intravascular ultrasound diagnostic system was approved for marketing
On July 27, the official website of the State Food and Drug Administration (NMPA) of China announced that the intravascular ultrasound diagnostic system (referred to as the IVUS system, including two innovative products, the intravascular ultrasound diagnostic instrument and the disposable intravascular ultrasound diagnostic catheter) developed by Shenzhen Beixin Life Science Co., Ltd. obtained the registration certificate of Class III medical devices. According to a press release, the system is China's first self-developed 60MHz high-definition IVUS product, and it is also the world's fastest imaging IVUS product.
Boston Scientific released its 2022 Q2 earnings report
On July 27, Boston Scientific announced its financial results for the second quarter of 2022. According to the data, the company's Q2 revenue was $3.244 billion, with an expectation of $3.216 billion, a net profit of $246 million, an expectation of $450 million, and earnings per share of $0.44 and an expected earnings per share of $0.42. Q3 adjusted earnings per share are expected to be $0.43-$0.45 versus $0.45 expected. Third-quarter revenue growth of 6%-8% is expected, compared to the consensus of $3.2 billion. Adjusted 2022 earnings per share from $1.74 to $1.79 to $1.74 to $1.77. The 22-year revenue forecast was lowered to 6%-8% from 7%-9% growth, with the consensus estimate of $12.82 billion.
Sino Medical released its 2022 H1 earnings forecast
On July 27, Sino Medical announced that the company expects a loss of 71.2348 million yuan in the first half of 2022, a year-on-year increase of 12.64%. During the reporting period, the company's new generation of coronary drug-eluting stent HT Supreme in the sales of coronary products increased significantly compared with the same period last year, and this reporting period is the second year of the implementation of the national centralized procurement policy for coronary stents, the company's coronary stent products are still outside the scope of centralized procurement, and due to the outbreak of the epidemic in many places in China, the company's coronary business growth has slowed down compared with the first quarter.
Jianfan Biotech (300529.SZ) subsidiary "hemodialysis concentrate" obtained the medical device registration certificate
Recently, Jianfan Biotech (300529.SZ) announced that Tianjin Standard Biologics Co., Ltd. (hereinafter referred to as "Tianjin Standard"), a holding subsidiary of the company, recently received the "Medical Device Registration Certificate" issued by the State Drug Administration.
3M, an international manufacturer of integrated products, will spin off its healthcare business
Recently, 3M, an international integrated product manufacturer, announced on Tuesday local time that it would spin off its healthcare business and create two publicly traded companies to pursue its growth plans. The spin-off is expected to close by the end of 2023. The new 3M company will reportedly serve as a global materials science company across a range of industrial and consumer markets, while the nutraceutical company will focus on wound care, medical information technology, oral care and biopharmaceutical filtration products. The former had sales of $26.8 billion in 2021 and health supplements at $8.6 billion.
The new industry obtained 1 medical device registration certificate
Recently, New Industry announced that the company received a "Medical Device Registration Certificate" issued by the Guangdong Provincial Drug Administration, and the product name is: Total Type I Collagen Amino Terminal Elongated Peptide Assay Kit (Chemiluminescence Immunoassay).
END
Source: Health Circles