Pure Global Secures Tens of Millions in Series A Funding to Empower Chinese Medical Device Companies' Global Expansion

VCBeat (WeChat: vcbeat) has learned that PureReg MedTech (Guangzhou) Co., Ltd. (“PureReg”) announced today the completion of its RMB tens of millions Series A financing round. The round was led by Bayland Capital, with participation from Probe New Healthcare Fund, and Probe Capital served as the exclusive financial advisor. The proceeds will be used to support the research and development of PureReg’s global regulatory intelligence platform, further expand overseas clinical laboratory resources, and continue to strengthen its professional team by recruiting more outstanding technical talent.

PureCert was established in June 2020 as China’s first “Internet+” one-stop service provider for global medical device regulatory compliance qualifications, and a globally leading SaaS+Data-enabled intelligent CRO platform for overseas medical devices.

As a medical technology company founded during the COVID-19 pandemic, PureCert is dedicated to streamlining the entire process for global market entry of medical devices, facilitating industrial informatization and digital transformation, and helping enterprises in sectors such as medical devices, in vitro diagnostics (IVD), and AI-powered medical software achieve compliant global expansion across the full value chain.

China’s healthcare industry is currently experiencing a surge in R&D and global expansion. The country’s robust, full-supply-chain industrial system provides a solid foundation for Chinese medical device manufacturers to enter international markets. Amid the ongoing global trend of digital transformation, every link within this comprehensive supply chain requires integration with technology and information systems. Enhancing industrial efficiency and optimizing collaborative development have become key challenges that the entire industry chain must address.

With multiple patents in computer software services and digital technologies, along with exclusive self-developed SaaS platforms backed by big data infrastructure, PureDiagnostics has gained a unique industry perspective. As a tool, SaaS connects with data; their integration holds significant commercial value in the field of medical innovation.

PureDiag’s service network spans nine countries and regions worldwide. Its overseas clinical centers in Europe and the United States hold accreditations such as CLIA, CAP, and ISO 17025, and possess exclusive clinical resources that are scarce within the industry. Leveraging its unique intelligent service platform oriented toward global regulatory compliance and highly customized clinical services, PureDiag has carved out a distinctive niche in this specialized sector.

PureDiagnostics CEO Meng Zhu

Ms. Meng Zhu, Founder and Chief Executive Officer, holds degrees from prestigious universities both in China and abroad. Her Bachelor of Science in Biomedical Engineering from Shanghai Jiao Tong University and Master of Science in Computer Science from Carnegie Mellon University have equipped her with a cross-disciplinary expertise at the intersection of healthcare and information technology. Prior to returning to China to establish PureDx, Ms. Meng held key positions at Google and Citadel Securities, the world’s largest market maker, where she accumulated over a decade of deep experience in big data and artificial intelligence.

Other core members of the PureCert team possess decades of extensive experience in technology consulting, product development, medical certification, and global medical registration. The team comprises multidisciplinary experts who have served as senior advisors to multiple Fortune 500 companies, authorized signatories for various international and domestic medical standards committees, and senior executives overseeing product research and development at publicly listed groups. More than 50% of the company’s team members are returnees from overseas, including talent from prestigious institutions such as Columbia University and Johns Hopkins University.

The expert team at the Purui Medical Technology Research Institute comprises a distinguished group of professionals, including pioneers in the first generation of global medical device certification, experts with over three decades of experience in the medical device certification industry, a Ph.D. in Molecular Pathology from the United States, cellular and molecular biology experts from Yale University, former auditors from European CE Notified Bodies, industry specialists from top-ten U.S. medical device companies, directors of national diagnostic laboratories in the United States, heads of medical regulatory affairs at leading U.S. biotechnology firms, renowned frontline physicians from various countries, and several holders of the Regulatory Affairs Certification (RAC) for international medical device certification.

Since its establishment in June 2020, PureDx has collaborated with over 100 domestic and international medical and biotechnology enterprises, earning widespread industry recognition. In 2021, PureDx secured tens of millions in angel-round funding, and within a year, it successfully closed its Series A financing round.

Ms. Meng Zhu, Founder and CEO of PureDxHe stated, “Pure’s development to date would not have been possible without the strong support of both new and existing shareholders and customer partners. We are deeply grateful to our investors for their backing and to our extensive client base for their trust and recognition. Returning to China to start a business amid the pandemic brought both pressure and high expectations. My original aspiration was to establish a global enterprise capable of empowering innovation in the healthcare sector. Our vision is to leverage our industry expertise in computer technology and big data to drive medical innovation through next-generation technologies. Following this round of financing, Pure’s proprietary information and big data platform will continue to undergo iterative upgrades, delivering more comprehensive and disruptive SaaS+Data services that will bring about transformative changes to the industry. Meanwhile, Pure’s overseas clinical resources will also be upgraded in tandem, providing clients with richer, one-stop global clinical trial solutions. At the same time, I would like to take this opportunity to thank my team; their excellence has enabled Pure to advance with greater stability and confidence. Post-financing, we also aim to recruit more seasoned industry professionals to join the Pure team, working together to help Chinese healthcare companies fulfill their globalization missions, enabling more outstanding enterprises to expand beyond China’s borders and tap into the vast potential of the global market.”

Dai Yiren, Partner at Bayland Capital, the Lead Investor in This Round“It has become evident that the COVID-19 pandemic has served as a catalyst for reshaping the global landscape of the medical device industry. Chinese enterprises are progressively enhancing their willingness and capability to expand into overseas markets, leading to surging demand for cross-border regulatory Contract Research Organizations (CROs) that offer multi-country, multi-category, one-stop services with access to overseas clinical resources. PureRegen, with its inherent global orientation, leverages data technology to improve the efficiency and standardization of regulatory services. It is committed to building a closed-loop business ecosystem encompassing strategy formulation, regulatory submissions, overseas clinical trials, and commercial data analytics. The company has already accumulated a portfolio of leading clients and gained industry recognition. Bayland Capital is honored to participate in this financing round. We look forward to working closely with PureRegen to provide high-quality services that support the global expansion of Chinese medical device products.”

Yan Jingjing, Partner at Probe Capital, the investor in this round and exclusive financial advisor“Probe New Medical Fund is honored to participate in this round of financing. BT/IT has always been a key focus area for Probe. PureCert leverages data capabilities and its global organizational structure to enter the healthcare industry, significantly accelerating clinical trials and regulatory approval processes for medical device and IVD products. Industry progress often stems from cross-disciplinary technological innovations. We look forward to PureCert, under the leadership of its CEO, transforming the current R&D models in the medical device and IVD sectors and contributing to the industry’s better development.”

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 R&D service providers and technology innovation platforms in biopharmaceuticals, 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 being a trusted long-term partner.

Founded in 2017, Probes Capital 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 agencies, management consulting companies, and vertical healthcare media outlets. Since its inception, Probes Capital has consistently completed double-digit private financing and M&A transactions annually, with a cumulative transaction value approaching RMB 10 billion. The firm’s team also brings extensive industry expertise to corporate value-added services. In 2020, Probes New Healthcare Fund was established and has since invested in more than ten leading companies within the sector.