MEDINET Japan and Stempeutics India, a part of the Manipal Education & Medical Group, have announced the signing of an option license agreement granting MEDINET the rights to enter into an exclusive license agreement for Stempeucel in Japan, specifically for the treatment of Critical Limb-Threatening Ischemia (CLTI).
If exercised, the option will allow MEDINET to exclusively develop and commercialize the Stempeucel product in Japan. Stempeutics has received an upfront payment under this agreement and will be eligible for additional licensing fees, milestone-based payments, and royalties upon execution of the full license. The product will be manufactured at Stempeutics’ cGMP-certified facility in Bengaluru and shipped to Japan for clinical trials and potential commercial use, as per the agreed transfer pricing terms.
CLTI, an advanced stage of peripheral arterial disease, occurs due to severe arterial blockages that restrict blood flow to the limbs, often resulting in chronic wounds and a high risk of amputation. Current treatment options provide satisfactory outcomes in only about 25% of patients. Stempeucel offers a breakthrough regenerative therapy designed to enhance the body’s ability to restore blood flow to ischemic tissues.
Developed using a patented process that pools bone marrow-derived mesenchymal stromal cells (MSCs) from healthy donors, Stempeucel ensures consistency and potency by minimizing donor variability. Research at Stempeutics demonstrates that this pooling process enhances the product’s immunomodulatory properties, cytokine expression, and clinical performance.
Stempeucel acts through anti-inflammatory and immunomodulatory mechanisms, promoting angiogenesis in ischemic muscles and leading to improved clinical outcomes in CLTI patients. Real-world evidence from practicing physicians supports its efficacy and therapeutic potential.