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Today’s latest medical device information includes:
policy information
● Jiangxi Provincial Food and Drug Administration issued medical device registrant system work implementation plan
corporate news
● Corfu Medical plans to acquire Jirui Medical Devices (Shanghai) Co., Ltd. has approximately 54% equity
● Medtronic announced early clinical data of the Intrepid transcatheter mitral valve replacement system
investment and financing
● Jingfeng Medical completed the signing of a Series C financing of over US$200 million, and the old shareholder Sanzheng Health followed up with investment
● Dongyun Medical received nearly 10 million US dollars in strategic investment from ISKCO
regional news
● Hubei plans to build a "government, industry, academia, research and medical" collaborative innovation platform to help the medical device industry high-quality development
1. Policy information
, Jiangxi Provincial Pharmaceutical The Supervisory Bureau issued an implementation plan for the medical device registrant system
A few days ago, in order to promote the in-depth advancement of the biopharmaceutical industry chain in Jiangxi Province and serve the high-quality development of the medical device industry, according to the "Regulations on the Supervision and Administration of Medical Devices", Jiangxi Pharmaceutical The Supervision Bureau has issued the "Implementation Plan for the Medical Device Registrant System in Jiangxi Province" (hereinafter referred to as the "Plan") based on actual conditions, strengthening the registrant's performance to ensure the quality of medical devices, marketing and services, monitoring and evaluation of adverse events of medical devices, and medical treatment. Supervision and management of obligations such as device recalls, strengthening registrants’ full life cycle management responsibilities and full-chain management capabilities for medical devices, and urging trustees to strictly manage and standardize production. (Source: Jiangxi Provincial Food and Drug Administration)
Highlights
The registrant system is a system based on the registrant taking the main responsibility for the quality of the entire life cycle of the medical device. Its core essence is to combine the original registration certificate holder with the production license The license holder needs to unbundle the model of the same company entity into two different company entities, thereby realizing the "unbundling" of medical device product registration and production license.
The implementation of the "Plan" will bring new opportunities for the development of the medical device industry in Jiangxi Province: changing the original production-research integration model of the medical device industry, and further forming the industry segmentation pattern. Encourage scientific research units and scientific research-based enterprises to focus on R&D. R&D institutions do not have to invest in building factories themselves, but can put products on the market through commissioned production. This will help speed up the transformation of scientific research results and the launch of innovative medical devices, and will help encourage enterprise innovation, transformation and upgrading. Medical device registrants can entrust the production of samples and products to avoid problems such as duplication of construction, waste of funds and idle equipment. Mergers, acquisitions and reorganizations between enterprises are more flexible, and cooperation models are more diverse, which is conducive to promoting the division of labor and cooperation between medical device R&D institutions and the manufacturing industry. Optimize the reasonable allocation of resources.
The registrant system is a modern medical device management system commonly used internationally. The launch of the registrant system will also help Jiangxi enterprises to connect with international medical device manufacturing rules and promote the localization of high-end medical device products. The overall goal is to promote the compliant and rapid launch of innovative medical devices and urgently needed clinical medical devices to meet the people's increasingly urgent needs for high-quality health services.
2. Corporate News
. Corfu Medical intends to acquire about 54% of the equity of Jirui Medical Equipment (Shanghai) Co., Ltd.
Corfu Medical announced on the evening of November 7 that the company plans to share trust with the transferors Chen Jianguo and Ningbo Huaige Equity Investment Partnership (Limited Partnership), Niu Qiaoli, Shanghai Jizhong Enterprise Management Partnership (Limited Partnership), and Jirui Investment Management (Shanghai) Co., Ltd. signed the "Equity Transfer Agreement", and the company used its own funds to acquire the shares held by Ningbo Huaige Jirui Medical Equipment (Shanghai) Co., Ltd. acquired approximately 16.27% equity interest in the company, and acquired approximately 37.79% equity interest in Jirui Medical Devices held by Chen Jianguo and other unrelated parties. (Source: Daily Economic News)
Highlights
By acquiring the controlling stake of Jirui Medical, it has supplemented the vacancies in Corfu Medical's independent research and development and production capabilities of wheelchairs, mobility assistive devices and other products. It complements the company's advantages and has good The synergistic effect will help increase the overall revenue scale and comprehensive strength of the company's rehabilitation assistive products, increase the proportion of self-owned brands and self-manufactured products, and further consolidate and enhance the company's core competitiveness. After the completion of this transaction, Jiri Medical will become a holding subsidiary of the company and be included in the scope of consolidated statements, and will become one of the company's new revenue and profit growth points in the future.
. Medtronic announced early clinical data of the Intrepid Transcatheter Mitral Valve Replacement System.
On November 6, Medtronic announced at the 33rd Transcatheter Cardiovascular Therapy (TCT) Conference that data from 15 patients who participated in the early feasibility study of the Intrepid Transfemoral System were announced. Clinical data. Data show that the survival rate of the 15 patients participating in the clinical study was 100% and they did not suffer from symptoms such as stroke . All implanted patients had no symptoms such as mitral regurgitation (MR) at 30 days. (Source: PR Newswire)
Points to Watch
The Intrepid TMVR System received Breakthrough Device Designation from the FDA, which combines self-expanding dual-stent technology with replacement tissue heart valves to facilitate catheter-based implantation. The valve is inserted into the heart using a delivery catheter, and the new replacement valve expands directly into the failed mitral valve . The external stent frame is designed to connect and conform to the natural valve, eliminating the need for additional sutures, tethers or anchors to secure the prosthesis. The stent is equipped with valves, made from cow tissue, that maintain blood flow.
3. Investment and Financing
. Edge Medical completed the signing of Series C financing of more than US$200 million. The old shareholder Sanzheng Health pursued investment
Edge Medical, the world's leading surgical robot platform company, recently announced that it has completed the completion of more than US$200 million. Series C financing was signed, Boyu Investment led the investment, Temasek and Sequoia China jointly led the investment, Sanzheng Health Investment, LYFE Capital (Zhouling Capital), National Policy Investment and other old shareholders added additional investment, Chinese state-owned enterprise mixed ownership reform Fund, OrbiMed, Chenyi Investment, Greater Bay Area Fund, Octagon Capital, Sage Partners, Lingang Blue Bay Capital, Mirae Asset and other well-known investors at home and abroad participated in the investment. (Source: Arterial Network)
Highlights
Jingfeng Medical is committed to creating innovative solutions for future surgeries. It currently masters both multi-port surgical robot and single-port surgical robot technologies, and has applied for and authorized more than 400 patents. This round of funding will help the company comprehensively improve its business and rapidly commercialize its core products, deeply expand product research and development, build large-scale production bases and training centers, and implement comprehensive commercialization layout.
. Dongyun Medical received a strategic investment of nearly 10 million US dollars from ISKCO
On November 6, ISKCO (Jiangsu) Biotechnology Co., Ltd. announced at the 4th China International Import Expo that it had completed the nearly 10 million-dollar investment in Dongyun Medical Technology (Shanghai) Co., Ltd. Ten million US dollars of strategic investment, and an on-site signing ceremony was held. In the future, the two parties will deeply integrate resources, and the funds will be used to comprehensively deploy assisted reproductive medical devices.(Source: Dongyun Medical)
Highlights
Dongyun Medical is a domestic supplier of independent research and development and innovation, providing a full set of domestic embryo culture media, egg and sperm processing reagents. Dongyun Medical has a complete production system and quality control management system for embryo culture fluids and micromanipulation products, and has built production facilities including high-standard clean production workshops, automated production lines, quality control workshops, cold chain warehousing and R&D laboratories. Testing R&D base.
ISKCO and Dongyun Medical will comprehensively promote the full range of upstream assisted reproductive products. The two parties will deeply integrate domestic and foreign advanced technical resources and market resources to rapidly promote the localization of assisted reproductive technology products and assisted reproductive laboratory reagents and consumables.
4. Regional dynamics
. Hubei plans to build a collaborative innovation platform for "government, industry, academia, research and medicine" to help the high-quality development of the medical device industry
On November 4, the Hubei Provincial Food and Drug Administration held a symposium on collaborative innovation of "government, industry, academia, research and medicine" for medical devices. meeting. It is reported that the Hubei Provincial Food and Drug Administration has officially submitted an application to the State Food and Drug Administration to establish the "State Food and Drug Administration Medical Device Review Center Medical Device Innovation Hubei Service Station" in Wuhan, Huazhong University of Science and Technology , Wuhan University applied to the State Food and Drug Administration as the "National Medical Device Supervision Scientific Research Base", which will play a major positive role in Hubei Province's independent innovation of medical devices and the high-quality development of the industry, and further strive for Hubei's efforts to obtain approval for drugs and medical devices. Lay the foundation for the evaluation of national sub-centers. (Source: Hubei Daily)
Highlights
Hubei Province has 45 drug clinical trial institutions with qualifications to conduct clinical trials of drugs and medical devices. The rich clinical resources can provide professional and professional services for clinical trials and evaluation of innovative medical devices. High-quality, full-chain services. Four key laboratories of the State Food and Drug Administration can provide technical support to R&D enterprises in the province. In the next step, Hubei Province will also increase support for market innovation entities, continue to introduce practical and feasible policies and measures, encourage green channels for medical device innovation, and make new contributions to promoting a strong province in medical device manufacturing.
Daily investment and financing news
(Collection date: November 8, 2021)
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