Pure Cert Secures Over RMB 1 Billion in Series B Financing to Empower Chinese MedTech Companies' Global Expansion

VCBeat learned at the earliest opportunity，PureDiag Medical Technology (Guangzhou) Co., Ltd.(hereinafter referred to as“PureCert”）Recently announced the completion of a funding round led byLegend CapitalLead Investor, Existing ShareholdersBayland CapitalCo-investmentSuperRMB 100 millionSeries BFinancing.Probe CapitalServed as the exclusive financial advisor.

It is reported that this round of funding will be primarily used forStrategic deployment of overseas medical device resources, expansion of professional talent teams, strategic expansion in the medical device sector, and upgrading and iteration of big data information platforms.

PureReg was established in June 2020. As an industry-leading global SaaS+Data life sciences service provider, it is dedicated to enabling end-to-end digitalization of the global market entry process for medical devices. It provides comprehensive consulting services for global regulatory compliance and market access for medical devices, in vitro diagnostics (IVD), and AI-based medical software. Its full-suite services cover regulatory consulting, local authorized representation, product certification and registration, overseas clinical trials, technical documentation and quality management system guidance, and product testing.

Guided by its original mission to “facilitate the export of domestically produced medical devices and bring Chinese products to the global stage,” PureCert, after years of dedicated effort, has shone brightly at various key moments over the past two years—

• In November 2021, Ms. Meng Zhu, founder of PureDx, was selected for the “2021 Wuzhong District Dongwu Leading Talent Program for Innovation and Entrepreneurship”;

• In November 2021, PureCert was awarded the Excellence Award in the Startup Group of the Next-Generation Information Technology Sector at the China Innovation and Entrepreneurship Competition (Guangzhou Division).

• In January 2022, PureDiagnostics secured tens of millions of yuan in Series A financing, led by Bayland Capital and participated in by Probe New Medical Fund.

• In February 2022, the establishment of laboratories in Europe and the United States enriched Purey’s overseas clinical resources;

• In March 2022, the AI Builder and Scheduler modules of the big data information platform were officially launched;

• In March 2022, the clinical database of the big data informatization platform was officially launched;

• In May 2022, by the end of the IVDD era, Purui had assisted in securing nearly 100 CE certificates and thousands of EU product registrations, becoming the CRO with the highest number of List A approvals globally;

• In June 2022, PureDiagnosis received the “Weilan Award · 2022 Emerging Entrepreneur of the Year” at the 6th Future Healthcare Top 100 Conference.

• In July 2022, Ms. Meng Zhu, founder of PureDx, was selected for the “2022 Gusu Leading Talents Program for Innovation and Entrepreneurship”;

• In July 2022, PureDiagnostics was listed among “Fortune China’s Most Socially Impactful Startups of 2022”;

• In August 2022, PureCert was awarded the Second Prize nationwide in the Entrepreneurship Competition of the Digital Healthcare Track at the 2022 Digital China Innovation Competition.

• In August 2022, PureDx’s Guangzhou headquarters relocated to the Guangzhou International Bio Island;

• In September 2022, the biobank of the big data informatization platform was officially launched;

• In September 2022, PureCred officially launched the [Top 100 Main List of Overseas Expansion Index for Domestic Medical Device Enterprises] and the [Overseas Expansion Index List by Sub-sector for Domestic Medical Devices] at the 2022 China Medical Device Overseas Expansion Conference.

• ……

Since its establishment in 2020, PureCert has grown from humble beginnings into a major enterprise, becoming the first one-stop service provider for Internet-plus global medical device regulatory compliance and a leading global SaaS+Data-driven intelligent CRO platform for overseas medical devices.

Leveraging a global team of top-tier experts with extensive regulatory certification and clinical experience, PureCert provides end-to-end consulting services for global market compliance and access, as well as one-stop solutions such as overseas clinical trials for medical devices, in vitro diagnostics (IVD), and AI-based medical software. Its international team enables PureCert to gain an in-depth understanding of regulatory policies across Europe and the United States, allowing it to leverage professional expertise and superior responsiveness to help clients identify optimal solutions and enter overseas markets with maximum speed.

The company’s service network spans the globe, including the United States, Germany, Italy, Spain, Switzerland, and Poland.10countries and regions, with8Major Branch13distributed divisions. Has already exceeded100It has established business collaborations with medical and biotechnology enterprises both in China and abroad, earning widespread recognition within the industry. Purui possesses scarce clinical resources within the sector; its overseas clinical centers in Europe and the United States are accredited with CLIA, CAP, ISO 17025, and other qualifications.

Furthermore, through years of dedicated efforts, Purui has accumulated over 1,000 successful cases of overseas registration and certification, including more than one hundred certifications from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as medical product registrations in Saudi Arabia, Thailand, Colombia, and other countries. Among these 1,000+ cases, more than fifty involve approvals for overseas clinical use, such as successful Emergency Use Authorization (EUA) cases in the United States, successful certifications for medical devices in overseas clinical settings, and listings on the EU’s general whitelist.

Purui has independently developed a big data information platform empowered by next-generation information technologies such as big data and artificial intelligence, which can provide users with100+ National Market Access,600,000+Global Distributor Big Data,1M+Global Clinical Trial Data,3 Million+Global Medical Device Registration Database. From product R&D and market strategy data to regulatory consulting, we empower Chinese medical device enterprises to navigate challenges and achieve comprehensive compliance for successful global market expansion.

For this financing round,Meng Zhu, Founder of PureCure“PureCert’s founding mission is to support Chinese medical device companies in expanding overseas by extending global clinical resources. PureCert currently operates ten major clinical centers, creating a one-stop, full-chain service ecosystem. Leveraging our accumulated expertise in computer technology and big data, we apply next-generation information technologies to empower medical innovation, with a commitment to establishing a standardized, digitalized system for the international expansion of medical devices. PureCert’s professional multi-country market access consulting services for medical devices, combined with its high-quality overseas clinical resources, can meet the needs of domestic medical device enterprises for cross-border Contract Research Organization (CRO) services covering multiple countries and product categories. The development of PureCert has been inseparable from the strong support of both new and existing shareholders as well as client partners. Following this round of financing, PureCert’s Global Regulatory Intelligence Platform will continue to undergo iterative upgrades, providing data services such as product trade analysis, overseas distributor network insights, and clinical trend research, thereby facilitating the global expansion of medical device products.”

Zhou Quan, Managing Director of Legend CapitalIt was stated that “going global has become a consensus among Chinese medical device enterprises, yet they face a series of difficulties and challenges, with pain points primarily concentrated in overseas market access and marketing. As global medical device regulations continue to tighten, it is increasingly difficult, costly, time-consuming, inefficient, and less likely to succeed for companies to independently complete overseas market access. There is therefore a strong need for CROs specializing in global expansion. However, traditional expert-led CRO services struggle to meet the diversified needs of highly fragmented downstream medical device companies for product internationalization, while CRO firms themselves encounter bottlenecks in achieving economies of scale and profitability. Leveraging extensive overseas clinical resources and data- and algorithm-driven novel digital CRO services, PureDx has successfully established cross-border, cross-specialty, and cross-category CRO capabilities, delivering significant cost reduction and efficiency improvements. It is poised to break through the bottlenecks of traditional medical device CROs and bring about disruptive change to the medical device CRO industry.”

Dai Yiren, Partner at Bayland Capital“PureReg leverages data technology to enhance the efficiency and standardization of medical device registration and clinical services. It is committed to building a commercial closed-loop ecosystem that addresses multi-country, multi-category registration needs, covering a series of business areas including R&D registration strategy, regulatory submissions, overseas clinical trials, and commercial data. As such, PureReg has established a notable influence in the field of cross-border medical device registration. As the Series A investor in PureReg, Bayland Capital has witnessed its rapid growth in business scale, overseas resources, and talent development. Looking ahead, Bayland Capital aims to continue working closely with PureReg to provide high-quality services for the cross-border registration and commercialization of medical device products.”

Yan Jingjing, Partner at Probes Capitalstated: “PureRegen possesses a dual DNA of data technology and global regulatory expertise. By integrating global regulatory big data through its self-developed SaaS platform, it significantly simplifies the regulatory registration process. Furthermore, leveraging its global organizational capabilities, PureRegen provides end-to-end services to support Chinese medical device manufacturers in expanding overseas. Amidst the current growth in global healthcare demands, PureRegen’s rapid response capability has already assisted hundreds of domestic medical device manufacturers in completing their overseas deployments and seizing the global market ahead of competitors. In 2021, Probe Capital, utilizing its proprietary industry data analysis system ‘Shennong No. 1,’ identified that the sector in which PureRegen operates was undergoing rapid change and growth. Within the following 12 months, Probe Capital successfully facilitated two rounds of financing for the company, with investment made by the Probe New Healthcare Fund. We hope that, under PureRegen’s comprehensive services, more high-quality Chinese medical device products will enter the international market.”

Legend Capital, established in April 2001, is a fund management company under Legend Holdings that specializes in early-stage venture capital and growth-stage private equity investments. Over the past two decades, Legend Capital has adhered to international standards, pioneered best practices in fund operations and management, accumulated comprehensive expertise in these areas, and built an ecosystem-based collaborative network across the entire investment value chain.

Legend Capital drives innovative corporate growth through its proactive value-added service system. While consistently delivering strong investment returns across multiple sectors, it also promotes industrial advancement and social development in China. With the vision of becoming an investment firm with global influence, Legend Capital adheres to its core value of “Wealth with Integrity” and actively fulfills its social responsibilities.

Bayland Capital, established in 2019, leverages the industrial background of Pharmaron (Stock Codes: 300759.SZ/3759.HK) to focus on equity investments in the biopharmaceutical sector. Drawing on a unique industry perspective and extensive experience in industry, scientific research, management, and capital markets, the Bayland Capital team pursues global investment opportunities, with a particular emphasis on globally leading biopharmaceutical R&D services and technology innovation platforms, biotechnology companies, and medical device manufacturers. Bayland Capital is committed to serving as a bridge linking life sciences, the health industry, and capital, and to becoming a trusted long-term partner.

Probe Capital, established in 2017, is a boutique investment bank specializing in healthcare and life sciences. Its business portfolio encompasses financial advisory, direct investment, industry consulting, and innovation incubation. The founding team hails from leading private equity firms, financial advisory institutions, management consulting companies, and vertical healthcare media outlets. Since its inception, Probe Capital has consistently completed double-digit private financing and M&A transactions annually, with a cumulative transaction value exceeding RMB 10 billion. The firm’s team also boasts extensive industry expertise in providing value-added services to portfolio companies. In 2020, Probe New Healthcare Fund was launched and has since invested in more than ten leading companies within the sector.