Daehong Lee, CEO of AIVIS
Further strengthening its three core pillars of ‘accuracy,’ ‘speed,’ and ‘clinical usability’
Focusing on expanding biomarker quantitative diagnostic technology and developing additional biomarker quantification solutions
While AIVIS initially focused on the development and regulatory approval from the Ministry of Food and Drug Safety for four key breast cancer biomarkers (ER, PR, HER2, and Ki-67), the company is now leveraging this proven technology to aggressively expand its product lineup.
Specifically, AIVIS is focusing on expanding its biomarker quantitative diagnostic technology to gastric, thyroid, and lung cancers, while also developing additional biomarker quantification solutions. This reflects the company’s commitment to assisting pathologists in providing accurate and consistent diagnoses across various cancer types and connecting patients to the most effective treatment options.
AIVIS has further strengthened its three core pillars of ‘accuracy,’ ‘speed,’ and ‘clinical usability,’ along with its ‘HER2 ultra-low expression detection technology.’ Among them, the greatest strength is ‘accuracy.’ By combining its proprietary AI technology with high-quality data built over more than a year by nine in-house pathology specialists, the company has secured technology capable of precisely distinguishing cancer cells and accurately quantifying staining intensity at the cellular level, setting itself apart with exceptional precision. As a result, the company has minimized variations caused by the subjective interpretation of pathologists and established objective and consistent diagnostic standards for all patients.
The second is ‘speed.’ A single digital pathology slide (WSI, Whole Slide Image) is an ultra-high-resolution dataset composed of hundreds of thousands of small images. The AIVIS solution analyzes entire tissue slides efficiently, taking about one minute for small tissue samples and approximately five minutes even for large surgical specimens. This represents an exceptional speed that can be seamlessly integrated into the actual workflow of busy clinical environments.
The third is ‘clinical usability.’ Pathologists from within the company participated directly in every stage of the process, from product planning and development to validation. In particular, the company has clearly identified the functions most needed by pathologists and the areas they found inconvenient in real clinical settings (unmet needs) and immediately integrated them into its solutions, creating essential diagnostic tools that are not just technological demonstrations but are actually used in daily practice.
AIVIS’s partnerships with global companies are evolving beyond simple licensing agreements, leading to stronger and more tangible outcomes. The company is currently forming joint sales networks in Korea with Philips and AstraZeneca, accelerating collaboration with tertiary general hospitals and major medical institutions. Furthermore, the company is focusing on building trust within the medical field through active participation in academic societies and support for research initiatives.
“The biggest change is that we are now proving the clinical usefulness of our technology with objective data and actively utilizing it in marketing. We recently supported a large-scale clinical study involving 38 specialists from about 30 institutions affiliated with the Breast Pathology Study Group under the Korean Society of Pathologists. As a result, the study clearly demonstrated that the concordance rate among pathologists significantly improved when using AIVIS’s AI solution. The findings are scheduled to be presented at ESMO Asia 2025, which will be held in December this year.”
AIVIS successfully completed its Pre-A funding round in December 2024, raising 4.3 billion KRW. The company is currently planning to raise approximately 10 billion KRW in a Series A funding round, targeted for the first half of 2026. This investment focuses not merely on securing R&D funds but on establishing and executing concrete plans for a full-scale business expansion. The secured funds will be strategically allocated to △ achieving a dominant expansion of domestic market share, △ advancing the product lineup for follow-up items such as lung and gastric cancer, and △ most importantly, obtaining overseas certifications (including U.S. FDA and European CE) and conducting international clinical validations for global market entry.
AIVIS has a team of 35 members. In addition to its core AI research team, which includes co-founders from Korea University, AIVIS has strengthened its technological depth with the addition of master’s and doctoral-level experts in artificial intelligence. Moreover, three pathologists and several clinical laboratory technologists are directly building datasets for AI training, enhancing product completeness and accelerating the expansion of the product lineup.
Regarding future plans, CEO Lee said, “Our goal has become even clearer,” adding, “In the short term, we aim to expand the domestic market share of our already approved breast cancer solution and quickly complete regulatory approvals for our lung, thyroid, and gastric cancer solutions currently under development, so that we can supply them to major hospitals in Korea.”
Founded: January 2021
Main Business: Provider of AI-based digital pathology analysis solutions for cancer diagnosis and treatment
Achievements: Possesses a proprietary AI-based biomarker quantification solution capable of identifying even HER2 ultra-low expression, obtained MFDS approval, GMP, and ISO 13485 certification, introduced to more than 20 medical institutions in Korea and abroad, and established licensing agreements and strategic partnerships with global healthcare companies such as Philips and AstraZeneca
reporter jinho lee
jinho2323@hankyung.com
© 한경매거진&북, 무단전재 및 재배포 금지