(Press Release)Finding a solution to inefficient century-old biopsy methods

- Source: Finding a solution to inefficient century-old biopsy methods in KAIST’s innovative technology, HelloDD, 2021.11.05

KAIST graduate Hwang Kyung-min, founder of VPIX Medical introduces “Full digitization” of cancer screening with an ultra-compact microscope

"The goal of listing in 2024 ... to lead the digital biopsy field."

In 2016, Hwang Kyung-min was a doctoral student in the Department of Bio and Brain Engineering at KAIST and introduced the “ultra-compact microscope” in her thesis. It is a technology that dramatically shortens the cancer surgery time. "If the microscope you introduced is developed, it will be a great help to cancer patients," the professor's words deeply engraved themselves in her mind. It was the beginning of her second life as CEO of VPIX Medical. To put the theoretical technology into practice and lay the foundation for VPIX Medical, she often worked 15-hour days, using only two desks borrowed from a shared school office.

In 2021, it is now a full-fledged five-year healthcare startup. The headquarters office recently moved to a four-story building near Oryong Station in Daejeon. The total investment came to about 7.2 billion won. And it has gained marked recognition as an emerging powerhouse in the healthcare field since its selection as a “Baby Unicorn 200” by the Ministry of SMEs and Startups and one of “12 K-Innovative Companies.

VPIX Medical's handheld device that reads a microscopic tissue image as a real-time digital image, without sectioning.

VPIX Medical is pioneering an unprecedented venture. The primary focus features real-time biopsy equipment based on a subminiature microscope, as opposed to the less efficient frozen biopsy method that takes on average 30-40 minutes. This method provides a high-resolution tissue image by directly contacting the lesion with a microscope after dyeing the affected tissue from the patient's body. This method is a significant progression from the traditional methods of transferring the tissue to the pathology department, freezing it, cutting it thinly, and looking through the microscope.

CEO of VPIX Medical, Hwang Kyung-min said, "We will pioneer a new path in the healthcare field with unprecedented technology. By converting a series of cancer biopsy procedures into a digital solution, we will be able to provide optimal solutions for both patients and doctors."

◆ “Total Digitization” of Cancer Biopsy Equipment

VPIX Medical’s digital biopsy equipment for real-time tissue diagnosis during cancer surgery.

It is known that the recurrence rate of most cancers is usually 20-30%. This is typically due to cancerous tissue that may remain after cancer surgery, among other reasons. To prevent recurrence, any cancerous tissue must be completely removed. Current methods involve removing cancer tissue and performing a biopsy during surgery to check whether there are any remaining cancer cells. However, this biopsy method is very time-consuming, and since all work is done in analog, it is inefficient. In addition, current medical technology only examines selectively cut cancerous tissue, causing some cancerous tissue to remain or, conversely, for some healthy tissues to be cut further.

VPIX Medical's ultra-compact microscope can check the image of cancerous tissue anywhere in the human body immediately by injecting fluorescent medical dyes during surgery. With this advancement, the entire process from tissue image acquisition to digital image storage can be performed in real time supporting communication between medical staff participating in the cancer surgery. This great innovation converts the existing inefficient analog biopsy process into a digital one.

The shortened biopsy process, which previously took 30 to 40 minutes, has proven more beneficial to both patients and doctors. Now doctors can perform more surgeries with shorter surgery times, allowing more cancer patients access to life-saving surgery. And as a high-resolution tissue image can now be acquired with only one device, the cost of biopsy can also be reduced, while increasing profit margins.

CEO Hwang said, "About 40,000 out of 140,000 major cancer surgeries in Korea do not perform frozen biopsy. If the time is shortened, there will be no reason not to perform the biopsy for those 40,000 cases. Then, the remaining cancer cells that could be missed can be found.”

◆ Regulatory hurdles… VPIX Medical will lead the digital biopsy industry.

Hwang Kyung-min, CEO of VPIX Medical.

As a startup in the medical device field, VPIX Medical must overcome its fair share of regulatory hurdles. According to CEO Hwang, licensing and regulation starts with “whether there is an equivalent product already commercially available.” If not, the race to clear each regulatory hurdle will commence. VPIX Medical's ultra-compact microscope is no exception.

CEO Hwang said, "When it comes to regulation, basically, it starts with safety tests, technical documentation approval for products, and verification of the medical device quality management system. After that, the first license for the device to be sold to hospitals is obtained. Next comes insurance stipulations, such as the price charged to patients for use of the product in hospitals and the efficiency of its application. In insurance protocol, new procedures are often checked against similar medical practices of the past, and if no comparable procedures or devices are found, the price is set based on the verification of the new technology’s effectiveness in comparison to conventional practices.”

Clinical trials are also essential. VPIX Medical recently conducted a safety test for a first-class in vitro diagnostic device and obtained certification for the medical device quality management system. In the process, VPIX Medical received support for prototype production, clinical trial plans, and consulting from Daejeon Technopark (Daejeon TP). Regarding the use of external parties for commercialization, VPIX Medical was also benefitted.

CEO Hwang said, "We are expecting the first sales since the establishment with the market launch of the in vitro diagnostic device next year." "In the case of in vitro diagnostic devices, we plan to proceed with licensing and approval for manufacturing quality tests by the end of next year. It will take a longer time for commercialization in the domestic market than the overseas market,” she added.

"Furthermore, we are considering the concept of an AI assistant advising on the possibility of cancer cells based on critical data and in-depth learning. Next year, we will formulate a strategy for entering the US market and completing the approval process for technical documents for in vitro devices. With the goal of listing on the KOSDAQ by the end of 2024, we aim to become a leader in the digital biopsy field that ventures beyond the existing limits of histopathology,” she said.

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