Suzhou Cancer-cell Secures Tens of Millions RMB in Series Angel Funding to Advance GLP-Compliant 'Gold Standard' Pathology Technology Products

VCBeat Exclusively Reports: Suzhou CCell Medical Laboratory Co., Ltd. (“Suzhou CCell”) Has Completed a Multi-Million Yuan Angel Financing Round, Solely Invested by INNOVAL CAPITAL, and Established a Production Laboratory in the Anhui Suzhou-Chuzhou Industrial Park

The proceeds from the financing will be used to standardize the production and promotion of patented technological products developed by the company over the years, such as tissue fixatives, routine and special staining solutions, hard tissue sectioning consumables, automated IHC staining systems, and intelligent diagnostic systems. This will enable the company to better provide registration-grade medical device consumables to GLP-compliant CRO organizations and healthcare institutions, thereby advancing the development of experimental and clinical pathology in China.

Suzhou CCell, founded in 2014, initially engaged in the research and development of pathology technology products before transitioning to focus primarily on pathology technology and diagnostic services.Became the sole agent for pathology technology and diagnostics at Namsa’s China laboratory in the United States in 2018., acquired by Jiangsu Biosafety Medical Technology Co., Ltd. in 2020,Provide one-stop preclinical services for medical devices under a comprehensive dual filing system for China and the United States, while continuing to offer pathology technology and diagnostic services to research institutions, CROs, and R&D-focused enterprises.

CCell boasts a highly capable pathology technology R&D team that integrates expertise in the development of patented products such as tissue fixatives and staining solutions, extensive experience in establishing standardized preclinical pathological diagnostic systems for pharmaceuticals and medical devices, and advanced capabilities in the intelligent analysis of staining results.Chief Scientist Wang ShouliHe graduated early in his career from the West China School of Clinical Medicine, Sichuan University (formerly West China University of Medical Sciences), where he studied under the renowned pathologist Professor Yang Guanghua. He has engaged in pathological diagnosis, teaching, and research at Anhui Provincial Hospital, the Affiliated Hospital of Soochow University, the Institute of Health of the Chinese Academy of Sciences, and the University of Washington in the United States. He previously served as Chief Pathologist and Toxicologist at NAMSA’s China laboratory, where he was responsible for signing off on preclinical study reports for implantable and interventional medical devices submitted to the U.S. Food and Drug Administration (FDA) for the Asia-Pacific region. Currently, Wang Shouli is a Professor and Doctoral Supervisor at the Suzhou Medical College of Soochow University and the Ningbo Institute of Biomaterials, Chinese Academy of Sciences. He also serves as a member of the Expert Committee for Medical Device Review of the National Medical Products Administration, Standing Committee Member of the Toxicologic Pathology Committee of the Chinese Society of Toxicology, and Vice Chairman of the Professional Committee on Laboratory Animal Science of the Chinese Research Hospital Association.

At the Medical Device Design and Manufacturing Forum of the 8th Future Healthcare Ecosystem Expo in 2024, Professor Wang Shouli delivered a presentation titled “How to Accelerate the Innovation and Translation Efficiency of China’s Medical Devices”

In 2018, CCell and Soochow University jointly established the “Key Laboratory of Toxicologic Pathology” to cultivate talent for its pathology technology team. Additionally, the team comprises more than ten R&D personnel holding master’s degrees or higher.To date, the team has published more than 50 SCI-indexed papers, successfully completed three National Natural Science Foundation of China (NSFC) General Program projects as principal investigators, and participated in three major research and development projects funded by the Ministry of Science and Technology. The team has established and refined preclinical evaluation protocols and pathology/toxicology assessment standards for over 40 Class III medical devices, which have been validated by the U.S. FDA., with main product categories including structural heart disease devices (vascular stents, valves, artificial blood vessels), orthopedic implants, and high-energy aesthetic medicine equipment.

With the year-on-year increase in adverse events related to medical devices, regulatory systems and enforcement by governments worldwide are being continuously improved and strengthened, while the systematic accreditation of CROs and the oversight of technical personnel qualifications are also being progressively implemented.

However, at present, compared with developed countries such as those in Europe, the United States, and Japan, China’s preclinical CRO organizations for medical devices still lag behind in infrastructure, instrumentation, staffing, and systematic standardization. Moreover, testing institutions with international recognition are extremely rare. Unlike preclinical drug evaluation, the assessment of safety and efficacy for medical devices relies heavily on histopathological techniques and diagnosis; therefore, only by improving pathological technology and diagnostic capabilities can the professionalism and authority of evaluation reports be ensured. Currently, although many CROs offer routine pathological services (H&E staining and microscopic diagnosis), the implementation of widely demanded advanced techniques—such as special staining, immunohistochemistry (IHC), image analysis, and hard tissue sectioning (as shown in the table below)—is constrained by the supply of related consumables. This round of financing for CCell aims to address this issue, thereby meeting the quality control requirements of standardized enterprises, GLP-compliant CROs, and healthcare institutions.

Common Service Types and Content in Pathology Technology and Diagnosis

Since becoming the agent for Namsa China’s laboratory pathology services in 2018, CCell has faced increased management costs and greater challenges in FDA registration due to the diversity of consumables and inconsistent quality during the implementation of its Good Laboratory Practice (GLP) system.This round of financing will standardize the production and quality control compliance of consumables for routine pathological techniques, providing a compliant supply channel for pharmaceutical and medical device CRO organizations with GLP systems, medical testing companies with CNAS accreditation, and healthcare institutions.

Proprietary special staining reagents demonstrate heart valves (Movat stain, upper image) and blood vessels (Masson stain, lower image).

Through technological innovations in our products, such as the universal tissue fixative (Patent No. 201911335152.6), brain tissue fixative (Patent No. 201911335152.6), and bone tissue decalcification solution (Patent No. 201911335152.6), we have not only eliminated the irritancy and toxicity associated with traditional formalin fixatives but also reduced tissue processing steps during subsequent analyses (e.g., immunohistochemistry), thereby lowering the difficulty of antigen retrieval and ensuring the reliability of test results.

HE-stained intestinal mucosa (top), cardiac valve vegetations (middle), and immunohistochemical staining (bottom) prepared using the company’s patented technology (tissue fixative)

With the development and application of new materials in China, more than 100 hard tissue sectioning technology platforms have been introduced from Germany in recent years. However, due to the high cost of imported consumables and the substantial expenses associated with technical training, many of these platforms have experienced operational stagnation.The light-curing embedding agents and adhesives, jointly developed by the CCell team and international experts in the field, have been validated over the long term. Results demonstrate stable and reliable quality, holding promise for import substitution.Meanwhile, the UV-curing coverslip sealer developed based on achievements in photoinitiators is expected to address issues associated with current neutral balsam mounting, such as toxicity, flammability, and prolonged drying time.

Dental and Bone Tissue Implants Visualized via Hard Tissue Sectioning Using a Proprietary Light-Curing Embedding Agent

Furthermore, leveraging extensive data resources from animal pathological diagnoses, CCell is poised to pioneer the rollout of an intelligent diagnostic system for the preclinical pathological evaluation of pharmaceuticals and medical devices.

Looking ahead, CCell will dedicate itself to the research, development, and production of novel histopathological technologies and diagnostic products, driving the standardization and internationalization of preclinical pathological evaluation for pharmaceuticals and medical devices. As the brand enhances its product specialization and standardizes its diagnostic systems, CCell is poised to leverage its remote pathology technology platform to establish a networked, multi-center service model that radiates across China. This initiative will bolster China’s capacity for translating scientific and technological achievements and strengthen its international influence in the field of preclinical pathological evaluation.

INNOVAL CAPITAL“With the acceleration of independent innovation and domestic substitution in China’s medical device industry, coupled with growing patient demand for healthcare services, the medical device sector is experiencing rapid development, thereby generating an urgent need for related Contract Research Organizations (CROs). Currently, CROs in China are predominantly focused on drug safety assessment, clinical research, and regulatory registration services, while those specializing in medical devices are relatively scarce. In particular, CROs capable of conducting preclinical biological evaluations and large-animal studies are even rarer. Following this round of investment, we aim to accelerate the commercialization and implementation of CCell’s years of R&D achievements in pathology technologies, filling the gap in non-systematized quality control of consumables used by CROs. Meanwhile, innovative R&D in pathology-related consumables is expected to increase the market share of domestically produced supplies in pathology departments. By establishing its operations in the Zhongxin Suchu Industrial Park in Anhui Province, CCell will help build a specialized medical device industrial cluster in the Chuzhou region, serving as a practical and innovative case study in the integration of the Yangtze River Delta.”

Anhui Innoval Private Equity Funds Management Co., Ltd. (hereinafter referred to as “Innoval Capital”) was established in December 2017. It is a market-oriented fund management company jointly initiated by Anhui High-Tech Investment Co., Ltd. and its management team, founded on the successful reform experiences of leading domestic state-owned investment institutions. The company was set up by Anhui Provincial Investment Group to implement the “Comprehensive Innovation Reform” plan and meet the requirements for constructing a provincial-level private equity investment fund system.Adhering to the overarching principle of “prioritizing practice and achieving new accomplishments,” Innoval Capital focuses on high-quality development, leverages high-efficiency coordination, bases its operations on high-standard selection, and pursues high-level expansion. In response to the new landscape where Anhui’s government-guided fund system is transitioning from “predominantly state-owned enterprise management” to “diversified institutional management,” Innoval Capital has secured mandates for the parent funds of the Smart Home Appliances Special Plan and the “Young Eagles” Special Plan. By embracing the new development philosophy and activating sources of competitive advantage, the company has established dedicated task forces, recruited professional composite talent, and rigorously conducted sub-fund selection. It has optimized its organizational structure, cultivated core personnel to leverage their strengths, and allocated human resources rationally. Committed to market-oriented reforms, Innoval Capital has formulated governance systems aligned with market practices and continuously improved its operational mechanisms. Upgrades to both hardware and software facilities have ensured steady progress.To date, Innoval Capital manages 29 funds with a planned scale of RMB 18.9 billion and a paid-in capital of nearly RMB 8.9 billion. It has invested in over 200 projects, with a total investment exceeding RMB 7 billion (including 20 listed companies). More than 80 portfolio companies have achieved subsequent financing rounds. Innoval Capital effectively fulfills its mission of implementing comprehensive innovation reforms, serving technological innovation and entrepreneurship, and promoting industrial upgrading in Anhui Province, making solid strides toward becoming a “brand investment institution representing Anhui’s image.”