Bio-safety secures Series A funding to build intelligent preclinical pathology platform for medical devices

Jiangsu Bio-safety Medical Technology Co., Ltd. ("Bio-safety") has recently completed a Series A financing round totaling 15 million RMB. This round was exclusively invested by Kunshan Hi-Tech Group.

The proceeds will be primarily allocated to intelligent experimental pathology technology R&D, recruitment of high-end talent, expansion of its nationwide service network, and upgrading of standardized preclinical evaluation services. This funding will further consolidate the company's leading position in the field of medical device pathology technology and diagnostic services, while driving the industry toward digitalization, standardization, and internationalization.

Initially focusing on pathology technology product development, Bio-safety established a solid technical foundation by creating over 20 patented products including tissue fixatives and special staining solutions. In 2018, leveraging its leading technical capabilities and toxicology/pathology diagnostic qualifications, the company became the exclusive Chinese laboratory partner for NAMSA – a globally leading medical device testing organization – introducing international GLP management systems and achieving a significant leap in service capabilities toward international standards.

In 2020, the company completed the acquisition of Suzhou CancerCell, integrating resources to establish a comprehensive preclinical CRO platform covering large animal studies, pathology technologies, and diagnostic services. Following this expansion, Bio-safety secured tens of millions of RMB in angel funding in 2022, continuously advancing the development of its CNAS and GLP systems while strengthening its medical device "Dual Submission to China and U.S." service capabilities.

Today, Bio-safety has established a full-cycle preclinical service system for medical devices, spanning from biological evaluation and animal studies to pathological diagnosis, supported by standardized evaluation frameworks and service protocols.

In recent years, as Chinese medical device companies accelerate their global expansion, international regulatory agencies like the FDA have increasingly stringent requirements for preclinical CROs. Bio-safety has proactively adjusted its strategy by continuously strengthening its large animal study capabilities while strategically focusing on productizing its experimental pathology technology platform and enhancing its service system.

In June 2024, its subsidiary CancerCell completed an angel funding round totaling tens of millions of RMB to support the development of conventional pathology technology products, addressing quality control needs for both GLP-compliant CROs and healthcare institutions.

Following this Series A round, Bio-safety will leverage its accumulated case studies and data resources to establish a "Medical Device Preclinical Evaluation Intelligent Database," enhance the automation and intelligence of pathological diagnostics, and utilize remote pathology technologies and management systems to build a multi-regional, multi-disciplinary collaborative network for experimental pathology technology diagnosis and services.

Bio-safety's core team is led by Professor Wang Shouli, former Chief Scientist of NAMSA's China Laboratory. Professor Wang has presided over four General Programs of the National Natural Science Foundation of China, participated in three Key R&D Programs of the Ministry of Science and Technology, and published over 50 SCI papers in international journals including Biomaterials and Oncogene. He possesses profound expertise in implantable/interventional medical devices, biomaterial evaluation, and international standards research.

Since founding their venture in 2014, the team has cultivated over a decade of deep expertise in experimental pathology technology and diagnostics. To date, they have issued preclinical evaluation reports covering more than 40 categories of medical devices—including cardiovascular, orthopedic, aesthetic material, and high-energy devices—which have been successfully submitted to both the U.S. FDA and China's NMPA. Leveraging extensive client resources and a robust service framework, the company has established deep collaborations with multiple animal testing centers. These partnerships effectively help clients shorten R&D cycles, reduce costs, and enhance both regulatory compliance and report quality.

In preclinical evaluation of medical devices, the pathology diagnosis phase demands exceptionally high qualifications and expertise. Bio-safety addresses this critical industry challenge by leveraging its team of professional pathologists and toxicologists to provide authoritative histopathological diagnoses and signing endorsements for various innovative devices. This capability effectively resolves the pain point faced by comprehensive CROs regarding access to high-end pathology talent, making Bio-safety an indispensable partner.

Amid intensifying competition in the CRO industry, Bio-safety has consistently pursued a development path characterized by specialization and refinement. Leveraging its advanced histopathological technologies and internationally compliant diagnostic systems, the company has established a comprehensive preclinical evaluation service chain that spans the entire medical device lifecycle. From early-stage R&D support to late-phase systematic evaluation, it provides clients with efficient, compliant, one-stop solutions.

As one of China's earliest teams engaged in international medical device preclinical evaluation, Bio-safety holds distinct advantages in technical expertise, resource integration, and standard alignment. The company not only helps enterprises accurately interpret international submission requirements and anticipate R&D directions but also provides critical support during project攻坚 and implementation phases. This approach has enabled Bio-safety to build differentiated competitive barriers within a highly homogenized market.

Looking ahead, Bio-safety will continue to expand its business boundaries around the "Three Products and One Device" framework, deepening multi-dimensional collaborations. The company plans to extend its animal study consulting and histopathology technical services into the safety and efficacy evaluation of pharmaceuticals, food, and cosmetics, thereby broadening the application scenarios for its pathology technologies.

Concurrently, the company will prioritize developing its intelligent data resource library and deploying remote experimental pathology and intelligent diagnostics. Through technological iteration and business model innovation, Bio-safety is committed to establishing itself as the benchmark for preclinical pathology evaluation services in China, providing more efficient and intelligent support for global medical device innovation.