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Digital Biopsy Platform ‘cCeLL’

Real-time testing using a miniaturized microscope

Certified with NET in Korea and FDA-approved in the US

Two out of five men and one out of three women.
This is the likelihood of developing cancer if a person lives to their expected lifespan. Fortunately, thanks to pharmaceutical research, post-diagnosis survival rates for cancer are improving. VPIX Medical is one of the companies driving this transformation. They have developed a real-time, non-invasive digital biopsy platform called ‘cCeLL’ to address the limitations of traditional surgical biopsies.

Using advanced microscope technology, ‘cCeLL’ allows non-invasive observation of affected areas and transmits data in real time to pathology departments, minimizing patient discomfort.

The platform has received the New Excellent Technology (NET) certification in Korea and FDA approval in the US. It has also received significant support from the Health Industry Startup Innovation Center, which fosters and develops bio-health companies from their early stages.

We met with Kyungmin Hwang, CEO of VPIX Medical, to discuss their technological innovations and future plans.

What inspired you to start the company?

“While studying at the Korea Advanced Institute of Science and Technology (KAIST), I researched miniaturized microscopes in brain engineering. My co-founder, Dr. Shin-Hyuk Kang, a professor of neurosurgery at Korea University, suggested applying this miniature microscope technology in clinical settings. Hoping that my graduate research could offer hope to cancer patients, I founded the company while still a student.”

How does ‘cCeLL’ improve upon traditional biopsy methods?

“Traditional biopsies involve extracting tissue samples during surgery, which takes 30 minutes to an hour. In areas with vital structures like blood vessels, biopsies may not be possible. ‘cCeLL’ addresses these limitations with a 3mm-diameter miniaturized confocal microscope that provides real-time cellular-level fluorescence imaging. Surgeons can immediately examine high-resolution images of organs during surgery, accurately distinguishing cancerous tissue from normal tissue. This reduces surgical time and allows biopsies even in inaccessible areas, greatly enhancing surgical efficiency.”

Which types of surgeries can benefit from ‘cCeLL’?

“With its compact design—3mm in diameter and 3cm in length—‘cCeLL’ can function as a handheld device, eliminating the need for extensive tissue excision. It is also compatible with laparoscopic and robotic surgeries, making it suitable for brain tumors and most types of cancer.”

What is the principle behind the miniaturization of ‘cCeLL’?

“‘cCeLL’ utilizes the principles of a confocal fluorescence microscope, widely used in bio labs for high-resolution imaging. Precise surface observation requires laser scanning technology, where a laser is used as the light source to evenly illuminate the cellular surface. VPIX Medical developed a technology to miniaturize the laser scanner, enabling compact and portable device design.”

When will the product be commercially available?

“Both Korean and US regulatory approvals are complete, meaning ‘cCeLL’ can legally be used for patients. However, to alleviate concerns about new technologies among patients and doctors, we aim to gather more clinical data. Clinical trials are currently underway at major hospitals, including Korea University Anam Hospital, Seoul National University Hospital, and Samsung Medical Center.”

What was the most significant achievement this year?

“We obtained the NET certification from the Ministry of Health and Welfare and received FDA approval in August last year. To expand into global markets, we are actively participating in exhibitions and other international activities.”

Reported by Jinhan Lee (likeday@donga.com)
The Dong-A Ilbo (January 8, 2025)