PharmaBio Corporation
Transforming Vision Care with Breakthrough Technology

PharmaBio Corporation is pioneering regenerative medicine in severe myopia and related eye conditions. By 2050, over 50% of the world’s population is expected to be affected by myopia, with pathological cases leading to complications like myopic chorioretinal atrophy (mCRA), a progressive condition lacking effective treatments. PharmaBio’s PAL-222 is an implantable, human (allogeneic) subcutaneous adipose tissue-derived mesenchymal stem cell sheet that aims to repair retinal damage by multiple actions that are superior to current technology.

Developed using the patented technology of Dr. Tsutomu Yasukawa from Nagoya City University, PAL-222 targets retinal pigment epithelial (RPE) impairments. Ongoing clinical trials have demonstrated its potential to restore retinal function.

PharmaBio’s founder, clinician Dr. Kusano, witnessed how elderly and frail patients struggled with conventional therapies. Driven by compassion and innovation, he pioneered gentler treatments through regenerative medicine, such as PAL-222.

“Our mission is to restore retinal function and improve lives for those suffering from severe ocular conditions,” says Dr. Hitoshi Kusano, CEO of PharmaBio. This groundbreaking approach underscores PharmaBio’s commitment to advancing ophthalmic care.

Today, PharmaBio excels in advanced cell manufacturing, cell sheet technologies, and drug discovery in regenerative medicine. Initially recognized for contract material-processing by the Johnson & Johnson Group, PharmaBio built on this trust, advancing its expertise in cell sheet manufacturing.

By overcoming challenges like cell sheet fragility, PharmaBio enhanced functionality and adherence rates, cementing its position as a leader in regenerative medicine innovation.
PAL-222 is a groundbreaking therapy offering two key benefits: 1) the risk of immune rejection is low, eliminating the need for immunosuppressants, and 2) seamless transplantation with a shape-memory feature that allows undamaged removal from its container, simplifying surgical procedures.

One of PAL-222’s key innovations lies in its composition. Unlike traditional cell suspension or sheet therapies that rely on artificial scaffolds and face issues such as low engraftment rates and immune reactions, PAL-222 consists of cell sheets with a basement membrane containing extracellular matrix made by the cells themselves. This organic design enhances biocompatibility, ensuring higher therapeutic success rates while reducing adverse reactions—a critical advancement in cell-based medical treatments.

The therapy’s shape-memory capability further distinguishes it. PAL-222 can be effortlessly peeled from its culture container without damage, using only a gentle flow of water and a standard injection needle. Its structural integrity and ability to return to its original form streamline transplantation procedures, significantly improving the practicality and reliability of its surgical applications.
Beyond its structural innovations, PAL-222 holds promise as a precision medicine, as this mesenchymal stem cell sheet enables precise delivery of genes or viral agents to specific body sites. By minimizing systemic side effects and enhancing localized efficacy, PAL-222 represents a paradigm shift, offering unparalleled potential for personalized treatments that advance the boundaries of regenerative medicine.

Already showing exceptional potential in clinical trials for mCRA in Japan, plans are underway to expand into the global market including the U.S. Early discussions with pharmaceutical partners give PhamaBio confidence about an accelerated path to global distribution. PharmaBio’s advanced GMP cell manufacturing facility is strategically located near Haneda airport, enabling efficient support for time-sensitive treatments including future overseas clinical trials.

PharmaBio’s expertise in regenerative medicine extends beyond ophthalmology, with plans to address conditions like diabetic ulcers in dermatology. Collaborations with leading institutions such as Kyoto University are producing promising results. The adaptability of PharmaBio’s cell sheet technology to various cell types underscores its vast business potential. As the clinical pipeline progresses, PharmaBio is preparing for an IPO, poised to scale its innovative technology and drive growth.