Veritas In Silico Conducts Preparatory Meeting with PMDA for Commercialization of "Perfusio" Drug Delivery System

Our company is engaged in drug discovery research for mRNA-targeting small molecule drugs and nucleic acid drugs, which is our core business, utilizing our AI drug discovery platform "aibVIS". In addition to this, we have conceived a drug delivery system*1 (hereinafter "DDS"; product name "Perfusio") applicable to various pharmaceuticals including nucleic acid drugs. As announced on December 15, 2025, in our notice 'Patent Granted and Rights Secured for Our Drug Delivery System "Perfusio"', we have completed the patent rights acquisition. We established a New Business Development Office on January 1 of this year and have been promoting efforts toward the commercialization of "Perfusio", with a sales launch targeted within our mid-term management plan (FY2026-27). We are pleased to announce that we have conducted a preparatory meeting for a face-to-face consultation on medical devices and in-vitro diagnostics with the Pharmaceuticals and Medical Devices Agency (PMDA)*2, which is a prerequisite for obtaining regulatory approval as a medical device for this commercialization. "Perfusio" can create a state where the target organ is independent of systemic blood flow within the body by placing catheters on both the venous and arterial sides of the treatment target organ to occlude the vessels. In this state, it is possible to deliver the drug reliably to the target organ while avoiding systemic drug exposure by administering the drug from one catheter and collecting it from the other. This method is characterized by not requiring chemical modifications to the drug for DDS purposes and being applicable to various target organs. Until now, the intended use of existing catheters did not explicitly include such drug administration or collection. To clarify the approval process for combining multiple such catheters with a new intended use, we have been in discussions with the PMDA through general consultations since March of this year, and based on the results, we held a preparatory meeting with the PMDA on May 14. Through this preparatory meeting, we have decided on a policy for "Perfusio" to obtain approval as a general medical device with a new intended use without conducting trials to acquire new data. We will now proceed to pre-development consultations with the PMDA and steadily advance the necessary processes to obtain approval for a market launch at the targeted time. ● Comment from Jun Sasaki, Head of New Business Development Office: Since this January, our company has been promoting the commercialization of "Perfusio" as a new business, and by conducting this preparatory meeting with the PMDA, we have clearly demonstrated that these efforts are progressing smoothly. The greatest value of "Perfusio" lies in its ability not only to deliver drugs directly to the target organ but also to retrieve them afterward. In parallel with our efforts to obtain regulatory approval as a medical device, we are also building partnerships with companies in the catheter business. We expect to collaborate with partner companies to expand the applications of their respective catheters and contribute to their sales growth. Meanwhile, it has become clear that "Perfusio" has high versatility and can be applied to a wide range of drugs. Particularly, because of its high potential to avoid systemic toxicity, even for compounds where systemic toxicity was observed in Phase I clinical trials, switching to a delivery-and-retrieval type clinical trial using "Perfusio" could lead to regulatory approval without discontinuing development. Our company will not only use this for our own pipeline development but will also propose licensing out "Perfusio" to pharmaceutical companies as a means to resume suspended projects. By doing so, we aim to deliver new medicines to society quickly and meet unmet medical needs. [Glossary] 1 Drug Delivery System: A system for delivering the active ingredients of a drug to a target (mainly an organ). Usually, this involves chemically attaching molecules to the drug that selectively target an organ or encapsulating the drug in a lipid bilayer. However, our company considers physically approaching the target organ with an arterial catheter and also approaching from the venous side with a catheter to physically deliver the drug as one form of a drug delivery system. 2 Pharmaceuticals and Medical Devices Agency (PMDA): An independent administrative agency responsible for ensuring the efficacy, safety, and quality of pharmaceuticals and medical devices. [Contact] Veritas In Silico Website Contact Form: https://www.veritasinsilico.com/contact/