Recently, Pure Pure Medical Technology Co., Ltd. completed the B round of financing of over 100 million yuan. This round of financing was led by Legend Capital, and the old shareholder Kangjun Capital followed. This round of funds will be mainly used for the construction of overseas medical device resources, the expansion of professional talent teams, the strategic expansion of the medical device field, and the upgrading and iteration of the big data informatization platform.
Pure Pure was established in June 2020. As an industry-leading global SaaS+Data life science service provider, it is based on the informatization of the whole process of medical devices going overseas to open up the global market, helping medical devices, in vitro diagnostics, and medical software AI. We provide full-process consulting services for global market compliance and access, covering device regulations consulting, local authorized representatives, product certification and registration, overseas clinical trials, technical documentation and system guidance, product testing and other full-process services.
At present, Purui has more than 1000 overseas registration/certification successful cases, including hundreds of British Medicines Regulatory Agency (MHRA) certification, Saudi Arabia, Thailand, Colombia and other countries medical registration certification. Among the more than 1,000 cases, there are more than 50 cases of overseas clinical certification, including successful cases of EUA emergency in the United States, successful cases of overseas clinical medical device certification, and cases of EU general whitelist certification.
Meng Zhu, founder of PureCare, said: “The original intention of PureCare is to help Chinese medical device companies go overseas and expand overseas clinical resources. At present, PureCare has 10 major clinical centers, creating one-stop, full-chain services. Ecology. Through the accumulation of experience in the field of computer technology and big data, we use a new generation of information technology to empower medical innovation, and we are committed to establishing a standardized and digitalized medical device overseas system. Purui Pure Certified professional multinational medical device market access consulting services And high-quality overseas clinical resources, it can meet the needs of domestic medical device companies for cross-border registration of CROs in multiple countries and categories. The development of the company is inseparable from the strong support of new and old shareholders and customer partners, and the global regulatory intelligence platform of Pure Pure. After this round of financing, it will continue to complete iterative upgrades, and provide data services such as product trade analysis, overseas dealer network, clinical trend research, etc., to help medical device companies go overseas.”
Zhou Wei, managing director of Legend Capital, said: “Going overseas has become a consensus for the development of Chinese medical device companies, but it also faces a series of difficulties and challenges. The pain points are mainly concentrated in the two links of overseas access and marketing. Regulations are becoming more and more strict, and it is difficult, expensive, long-term, low-efficiency and low-successful for enterprises to independently complete overseas access, so it is very necessary to assist CRO service providers who focus on going overseas. However, traditional expert CRO services are difficult to meet the high requirements. Due to the diversified demands of scattered downstream device companies for their products to go overseas, the scale effect and profitability of CRO companies themselves have also encountered bottlenecks. With its rich overseas clinical resources and new digital CRO services driven by data and algorithms, PureCare has successfully achieved It has achieved CRO capabilities across countries and regions, departments and categories, and has significant advantages in cost reduction and efficiency enhancement, which is expected to break the bottleneck of traditional device CRO companies and bring disruptive changes in the device CRO industry.”
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- 2022-10-18 “Pure Pure Securities” completed the B round of financing of over 100 million yuan, led by Legend Capital
- 2022-08-02Haihe Bio completed the B round of financing of over 100 million yuan
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