Biopsee Secures Tens of Millions in Series A+ Funding to Accelerate Clinical Adoption of Confocal Laser Endomicroscopy in Respiratory and Gastrointestinal Fields

VCBeat has learned at the earliest opportunity that,viestarMedical Technology (Suzhou) Co., Ltd.(hereinafter referred to as“viestar”) announced completionTens of millions of yuanA+Series Round Financing, this round is byEzhou Changda、Under SND Venture CapitalSuzhou JuyiFund、Suzhou Science and Technology TownThe fund and those under the SND GroupSuzhou Medtronic No. 1FundJoint investment completed, funds willForConfocal MicroendoscopeContinuous R&D of the Product- ScalabilityProduction、Promotion of Clinical Application.

Founded in 2014, viestar is a high-tech enterprise dedicated to the R&D, manufacturing, and promotion of innovative medical devices. The company remains committed to providing clinically valuable, advanced technologies for the early precise diagnosis and treatment of tumors. Its product portfolio spans three core technological areas: minimally invasive diagnostic and therapeutic access technologies for tumors, real-time visualized biopsy technologies, and minimally invasive tumor treatment technologies.

Viestar is the lead organization for national-level major science and technology projects and a key participant in advancing national medical strategic planning. Committed to its mission of continuous innovation for better quality of life, Viestar has long collaborated closely with numerous authoritative medical and research institutions across China. With the goals of improving prognoses for cancer patients and reducing healthcare expenditures, Viestar strives to become a core force in innovative cancer diagnosis and treatment, leveraging technological advancements to benefit human health and well-being.

In 2019, viestar obtained the world’s second and China’s first medical device registration certificate for confocal laser endomicroscopy. This milestone signifies that China’s technological capabilities in confocal laser endomicroscopy imaging have reached an internationally leading level, filling a domestic gap in this field. It holds landmark significance for the development of China’s domestically produced endoscope industry, marking the entry of China’s endoscopic technology into a new era of real-time, in vivo, cellular-level visualized biopsy.

In 2021, the second-generation confocal laser endomicroscopy system independently developed by viestar, the Beixi® Confocal Microscopic Imager, received approval for market launch. To date, the Beixi® Confocal Microscopic Imager has been implemented in more than 30 Grade A tertiary hospitals across 16 provinces in China, including renowned institutions such as Beijing Friendship Hospital, Shanghai Changhai Hospital, Beijing Changgung Hospital, Nanjing Drum Tower Hospital, Nanjing Zhongda Hospital, Wuhan Union Hospital, and Wuhan Zhongnan Hospital.

Source: viestar

Persistence and focus are the keys to innovative exploration. As one of the earliest teams globally engaged in related technological research, the viestar team has been deeply rooted in this field for 13 years, establishing a solid technical reserve and accumulating extensive clinical data. Meanwhile, by relying on independent R&D and the domestic production of key components, viestar has significantly reduced manufacturing costs and greatly enhanced the potential for widespread adoption of its technology, truly embodying the notion that “the swallows that once graced the halls of nobility now fly into the homes of ordinary people.”

Confocal Laser Endomicroscopy (CLE) is an endoscopic technology that generates real-time, in vivo optical histological sections, also known as visual biopsy. Leveraging the principles of confocal microscopy, it magnifies tissue up to 1,000 times, enabling clinicians to perform real-time, in vivo cellular-level pathological observations during endoscopy. In preoperative diagnosis, CLE facilitates targeted and precise biopsies, reducing trauma and missed diagnoses. Intraoperatively, it provides a basis for surgical decision-making, allowing for accurate determination of resection margins, complete removal of multifocal lesions, and minimized residual disease and recurrence. Postoperatively, it supports regular patient follow-up.

Source: Official Website of the 2022 Chinese Digestive Physicians Conference

However, due to the extremely high technical barriers, only a handful of companies worldwide possess this technology and are capable of product development. Meanwhile, the high product cost has severely limited its application, making clinical adoption in China particularly challenging. In 2017, viestar was approved to lead the National Key R&D Program project titled “Research and Development of Confocal Endoscopy” under the 13th Five-Year Plan. Two years later, viestar’s product received regulatory approval, making it the second company globally and the only company in China capable of commercializing confocal laser endomicroscopy products.

Source: viestar

Probe-based Confocal Laser Endomicroscopy (pCLE) is compatible with the biopsy channels of any conventional endoscope and has extensive clinical applications. Visualized biopsy can be employed in nearly all scenarios requiring tissue sampling. For instance, in the early diagnosis of gastric cancer, studies have shown that combining CLE with traditional endoscopic forceps biopsy achieves a detection accuracy of 98% and reduces the number of biopsy samples by 68%.

Needle-based confocal laser endomicroscopy (nCLE) can be used in conjunction with cholangioscopes and puncture needles. When ERCP is combined with nCLE, sensitivity increases from 38.5% to 84.2%. In pancreatic puncture procedures, combining nCLE with standard biopsy raises sensitivity to 100% and reliability to 93%. Furthermore, nCLE can improve the diagnostic rate of pulmonary nodules to 90%.

Visualized biopsy has a wide range of applications. It demonstrates significant clinical value in the esophagus, stomach, intestines, biliary tract, pancreas, respiratory system, gynecology, oncology, surgery, stomatology, and urology.

Source: Official Website of the 2022 Chinese Gastroenterologist Conference

As of August 2022, three clinical trials on visualized biopsy were underway, led by nationally renowned Grade A tertiary hospitals including Beijing Friendship Hospital, Capital Medical University; Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; Zhongda Hospital Southeast University; and Zhongnan Hospital of Wuhan University. By the end of 2022, an additional 12 clinical trials are scheduled to be initiated.

With the accumulation of relevant clinical studies, the clinical value of visualized biopsy has been further confirmed, leading to its inclusion in related guidelines and widespread anticipation for consensus statements.

Wan Libo, Executive Director of Ezhou Fund of FundsHe stated, “State-owned capital needs to empower enterprises and accelerate the rapid development of innovative companies. As the only enterprise in China that has achieved the production and sales of confocal laser endomicroscopy systems, viestar adheres to its mission of continuous innovation for better quality of life and has been committed to providing clinically valuable advanced technologies for the early precise diagnosis and treatment of tumors. The visualized biopsy technology focused on by the company has already undergone multiple clinical studies, and its clinical value has been fully validated. I believe that, through the relentless efforts of the viestar team, this technology will provide greater convenience for physicians and bring health benefits to patients.”

Suzhou New District Venture CapitalHe stated, “As the second company globally and the first in China to achieve clinical application of confocal laser endomicroscopy (CLE), viestar has always adhered to national policy guidance, with improving patients’ quality of life as its ultimate goal. By continuously deepening its expertise in the field of CLE, we have ultimately broken the monopolistic advantage held by foreign companies in this technology, truly placing mastery of CLE into Chinese hands. I believe that, driven by this sense of social responsibility and a spirit of relentless pursuit of cutting-edge technology, viestar will surely promote this innovative endoscopic technology in the future, benefiting both patients and society.”

Wang Ping, Chairman of Suzhou Medical Device Industrial Parkstated: “As a pioneer of innovative endoscopic technologies in China, viestar leverages its cutting-edge innovations to focus on the endoscopy sector within the healthcare industry, actively developing top-tier technologies urgently needed for the high-quality development of the medical field. Chairman Wang Ping affirmed the clinical value of viestar’s confocal laser endomicroscopy for visualized biopsy in the field of digestive diseases, expressed strong confidence in the company’s growth prospects, and looked forward to future collaboration to benefit patients.”

Changda Industrial Fund is a fund of funds established by Ezhou Changda Company to support the development of key municipal industries. Leveraging the resource advantages of this municipal-level platform company, the fund collaborates with various social capital partners to establish specialized sub-funds for investing in the city’s priority industries.

Suzhou Juyi Venture Capital Partnership (Limited Partnership) and Suzhou Science & Technology City Gaochuang Venture Capital Partnership (Limited Partnership) are subsidiaries of SND Venture Capital. As the equity investment platform of SND Financial Holdings, a state-owned financial holding group directly under the administration of Suzhou New District (SND), SND Venture Capital has long been committed to supporting the development of SND by continuously promoting the deep integration of financial innovation with corporate and technological innovation. Leveraging extensive investment management experience, a high-caliber management team, and rigorous management systems, SND Venture Capital has continued to expand its scale and capabilities. It has established a comprehensive fund investment system covering the entire corporate lifecycle—including angel investment, venture capital (VC), private equity (PE), industrial investment, and mergers, acquisitions, and private placements—thereby fostering an investment ecosystem characterized by multi-party win-win outcomes and multidimensional empowerment. The firm is striving to advance into the top tier of China’s private equity and venture capital institutions.

Suzhou Medtech No. 1 Equity Investment Fund Partnership (Limited Partnership) was jointly established by Suzhou Hi-Tech Private Equity Fund Management Co., Ltd. and Suzhou Hi-Tech Life Science Investment Development Co., Ltd. The fund focuses on equity investments in medical industry projects within the Suzhou High-Tech Zone, aiming to support local enterprises, facilitate the clustering of the medical industry in the zone, foster the growth of high-quality medical companies, establish Suzhou as a landmark for the medical industry, and boost regional economic development.