AIVIS, a company specializing in AI-based digital pathology solutions, has been officially selected as a beneficiary of the Ministry of SMEs and Startups' Scale-up TIPS program. Through this selection, AIVIS will receive up to 1.2 billion KRW in funding for research and development (R&D) and commercialization over three years. The company will also gain access to various forms of support, including mentorship for global expansion, IR opportunities, customized consulting, and participation in overseas events. This achievement brings AIVIS's total accumulated investment to 5.8 billion KRW. Following an initial 300 million KRW in seed funding, AIVIS successfully secured a 4.3 billion KRW Pre-A investment round in December 2024 from major institutions including Intops Investment, Nextrans, HG Initiative, and the Seoul Business Agency (SBA). The selection for the Scale-up TIPS program was based on the growth potential of AIVIS's Pan-Cancer Multi-Biomarker Quantitative Analysis AI Platform, which is currently under development. AIVIS is accelerating the development of this next-generation bio-platform to overcome the limitations of existing AI solutions that analyze only specific cancer types or a small number of biomarkers. The company is focused on advancing a universal technology that can integrally analyze multiple cancer types (such as thyroid, lung, and gastric cancer) and multiple biomarkers within a single platform. About AIVIS and its Technology Established in 2021, AIVIS is a digital pathology solution company that precisely analyzes pathology images by combining Artificial Intelligence (AI) and Visualization. The company is dedicated to developing AI-based solutions that visualize and quantify vast amounts of pathology big data to support the cancer diagnosis and treatment decision-making processes. AIVIS's core service, Qanti® is a solution that converts cancer tissue slides into high-resolution digital images. Its AI precisely analyzes the presence, distribution, staining intensity, and proportion of cancer cells within billions of pixels, providing objective diagnostic data to medical professionals. It particularly excels in the precise analysis of HER2, Ki-67, and hormone receptor (ER/PR) expression rates, which are essential for predicting prognosis and determining treatment policies for breast cancer patients. Through this, Qanti® plays a key role in realizing precision medicine by accurately selecting patients who are highly likely to respond to specific therapies. Based on this technology, Qanti® has obtained two product licenses as a Software as a Medical Device (SaMD) from the Korean Ministry of Food and Drug Safety (MFDS). AIVIS has also secured 8 patents related to digital pathology image analysis and global quality management certifications, including GMP and ISO 13485. The company recently launched Qanti® Micro, which enables AI analysis using only microscope images, for small and medium-sized medical institutions that face challenges in adopting digital scanner infrastructure. Currently, AIVIS supplies its solutions to over 10 major general hospitals in Korea and is expanding its business by strengthening partnerships with domestic and international companies. This includes signing an official licensing agreement with Philips and promoting a joint clinical study and diagnostic collaboration for the HER2 biomarker with AstraZeneca. Daehong Lee, CEO of AIVIS, stated, "Our ultimate goal is to become a game-changer that transforms the paradigm of cancer diagnosis and treatment. This selection for Scale-up TIPS is another official recognition of AIVIS's technology and vision. With the secured resources, we will complete our platform technology, accelerate regulatory approvals such as European CE marking and key Asian market licenses, and create tangible results in the global market, thereby contributing to elevating the status of Korea's bio-health industry." Q&A with Daehong Lee, CEO of AIVIS Q. What was your strategy for securing this competitive grant? "We emphasized our deep technical expertise and, more importantly, our objective, real-world market performance," Lee noted. "We proved that our AI technology, which is capable of analyzing multiple cancer types and resolving data variance between hospitals, is not just an idea but a commercially viable solution already trusted by global leaders." Q. How will the new funding be deployed? The new funding will be strategically deployed to enhance the company’s Pan-Cancer Multi-Biomarker Platform, with a focus on expanding its portfolio to include key immuno-oncology biomarkers and developing AI-driven tools for discovering novel biomarkers. A significant portion of the funds is earmarked for global expansion, including: • Clinical validation for US FDA clearance and European CE MDR certification. • Hiring global sales and marketing talent. • Strengthening international partnerships and customer support systems. Q. What are AIVIS's short-term goals and long-term vision? "We are targeting a Series A funding round in late 2025 or early 2026 to fuel our next stage of growth," Lee said. "The company aims to expand its domestic footprint to over 30 major hospitals by next year while laying the groundwork for a major push into the European and North American markets." "In the long term, our vision is to complete an AI-powered companion diagnostics (CDx) platform that connects patients with personalized therapies from the earliest stages of drug development," he continued. "We believe we have the passion and the technology to solve one of the most difficult challenges in medicine." Q. Any words of advice for startups in related fields or those preparing for the TIPS program? "I want to emphasize that an attitude of genuine immersion in your field is essential. It goes beyond simply liking what you do; you must have the confidence and passion to solve the problem better than anyone else. The bio-health sector, in particular, is a series of unimaginable hardships and a continuous death valley, and the strength to endure it ultimately comes from a deep sense of mission for the problem you are trying to solve. In our early days, AIVIS also went through a period of trial and error where we were too engrossed in the technology and failed to listen to the market. However, we arrived at our current position by not fearing change and making bold attempts. The moment a product, created through an arduous process, contributes to patient treatment in a real hospital is the greatest reward for an entrepreneur. If you have a good idea and the will to change the world, I encourage you to challenge yourself without hesitation."