[Edaily Reporter KIM SAE-MI ] IMGT, a developer of focused ultrasound-based cancer treatment medical devices, is set to embark on a large-scale confirmatory clinical trial following its designation as a Breakthrough Device (BDD) by the U.S. Food and Drug Administration (FDA). Securing funding is crucial, as the confirmatory clinical trial is expected to cost approximately 40 billion won.

Lee Hak-jong, CEO of IMGT, recently met with E-Daily and stated, “Confirmatory clinical trials for cancer treatment are particularly difficult because they require long-term follow-up of patients to evaluate survival rates,” adding, “It is a major challenge for a venture company to see this through to the end.”

IMGT received a Biologics Device Designation (BDD) from the FDA for its cancer treatment medical device “IMD10” in February of last year. According to the company, this marks the first such designation in the field of cancer treatment medical devices in South Korea. In November of the same year, the company obtained an Investigational Device Exemption (IDE) for a U.S. confirmatory clinical trial. Based on this, the company plans to begin enrolling the first patients and performing procedures for the U.S. confirmatory clinical trial shortly.

CEO Lee confided, “To be honest, from the company’s perspective, we didn’t want to conduct clinical trials because they are both time-consuming and costly,” adding, “We asked the FDA if we could obtain U.S. approval based on existing clinical data, but the answer was ‘no.’” He further explained, “The FDA told us to focus not on how much the tumor size had shrunk, but on how long patients survived.”

Nevertheless, CEO Lee explained that the FDA appears to highly value the innovative nature of IMGT’s technology. He emphasized, “Although the FDA stated it could not grant approval based solely on existing data, it highly valued the technology’s innovation and recommended applying for BDD designation,” adding, “After receiving BDD designation, we communicated closely with the FDA representative and were able to obtain IDE approval in about nine months.”

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S. FDA: “Survival Period Must Be Demonstrated”… Pushing Ahead with a 360-Patient Confirmatory Clinical Trial

IMD10 is a medical device that uses focused ultrasound to enhance drug delivery within tumors while administering existing anticancer drugs. It works by inducing cavitation through ultrasound—without the need for separate microbubble injection—to facilitate the penetration of anticancer drugs into tumors. It is designed to be administered at the patient’s bedside for approximately 40 minutes while the patient is receiving anticancer treatment.

CEO Lee explained, “While previous research focused on using ultrasound to generate heat and destroy cancer cells, we have focused on ensuring that drugs are delivered more effectively to the tumor,” adding, “The concept is not to require a separate procedure room, but rather to bring the machine to the patient’s bedside to administer additional ultrasound during chemotherapy.”

Positive results were observed in early clinical trials. In a researcher-initiated clinical trial at Seoul National University Hospital, the median overall survival (OS) for 56 pancreatic cancer patients treated with a combination of IMD10 and FOLFIRINOX was 24 months—7 months longer than the 17 months observed in a control group of 56 patients. The objective response rate (ORR) was also higher at 64.3%, compared to 35.7% in the control group.

In a subsequent randomized exploratory trial involving 30 patients, the 2-year survival rate was 64.29% in the combination group and 40% in the control group. Although the hazard ratio (HR) was 0.44, the p-value was 0.13, so statistical significance was not achieved.

CEO Lee stated, “Since there were only 30 patients and they were divided into two groups, we cannot say the results are statistically significant,” but added, “We observed a positive trend in survival time, and based on this, we were able to calculate the number of patients needed for a confirmatory clinical trial.”

IMGT plans to conduct a confirmatory clinical trial involving approximately 360 pancreatic cancer patients at about seven medical institutions in the U.S. and South Korea. The company plans to recruit approximately 65% of the patients from the U.S. and 35% from South Korea. The domestic clinical trial is scheduled to begin in the first quarter of next year, with the final data analysis targeted for 2030.

CEO Lee emphasized, “Ultimately, the most important factor in cancer treatment is how long patients survive,” adding, “To assess survival duration, we must follow patients for several years. This is why confirmatory clinical trials for cancer treatments are far more challenging than other clinical trials.”

Confirmatory Trial Costs 40 Billion Won… Considering KOSDAQ Listing and Strategic Investment

The challenge lies in securing funding to conduct the long-term

confirmatory

trial. The company estimates that even with a conservative calculation, a total of 40 billion won will be required. With no revenue from commercialized products at present and annual expenses of approximately 5 billion won, the company is in need of additional funding.

IMGT is pursuing clinical funding support from the U.S.-based Focused Ultrasound Foundation and seeking external financing. As a KONEX-listed company, IMGT is also considering a transfer listing to KOSDAQ under the technology exception category in 2027.

The company is also keeping the door open for potential collaborations with global firms. In particular, it expects that once confirmatory clinical trials in the U.S. are in full swing and additional evidence of efficacy is secured, this will help expand global partnerships.

Following commercialization, the company plans to focus on revenue from consumables used in repeat procedures rather than equipment sales. This is the so-called “printer and toner” model, in which equipment is supplied to hospitals at a relatively low cost, and disposable kits are used each time a patient undergoes cancer treatment.

CEO Lee hinted, “The business model we envision isn’t simply about how many machines we sell,” adding, “Although it takes the form of a medical device, we are envisioning a business model similar to that of anticancer drugs, given that it can be used repeatedly every time a patient undergoes anticancer treatment.”

The initial target market is major cancer specialty hospitals in the United States. The company views the approximately 72 National Cancer Institute (NCI)-designated cancer centers as its primary sales targets. Even if two units are supplied to each large cancer center, the initial number of installations may not reach 200. Therefore, revenue is expected to be driven not only by the number of installations but also by the number of procedures per patient and the price of consumables.

IMGT plans to expand its scope of application beyond pancreatic cancer to include other solid tumors, such as bile duct cancer and sarcomas, and is also pursuing combination therapy with antibody-drug conjugates (ADCs) and immunotherapy.

CEO Lee stated, “Although we started with pancreatic cancer, we intend to expand our scope to other solid tumors,” adding, “We expect to enhance efficacy not only when used with chemotherapy but also when combined with ADCs or immunotherapy.”

The vision CEO Lee envisions is to establish focused ultrasound as a standard adjuvant therapy that enhances the effectiveness of existing cancer treatments. Finally, he said, “Ultimately, I hope we will reach a time when receiving ultrasound therapy alongside anticancer treatment becomes a natural choice.”