KORU Medical Systems (KRMD) investor relations material

Business overview and market position

• Specializes in large-volume subcutaneous drug delivery, supporting the shift from IV hospital settings to home and clinic-based SC therapy.

• Freedom Infusion System serves approximately 60,000 chronic SCIg therapy patients globally, with 2.7M+ annual infusions.

• Holds 9 drug clearances across 30+ countries, with first subcutaneous drug clearance in 2010.

• Expanding beyond SCIg through 8 collaborations with pharmaceutical companies for new drug therapies.

• Leverages a low-cost go-to-market model targeting pharma, specialty pharmacies, home care, and distributors.

Product portfolio and innovation

• Freedom Infusion System includes mechanical pumps and customizable consumables, with 97% patient adherence rate.

• 80% of revenues come from consumables, 20% from mechanical pumps.

• First devices 510(k) cleared for use with prefilled syringes, simplifying home therapy.

• Ongoing development of next-generation Freedom360™ pump, with 510(k) submission planned for 2H26.

• Acquired connected monitoring technology to provide real-time data insights for pharma and specialty pharmacy partners.

Market opportunity and growth drivers

• Large and growing LVSC market, with <20% SCIg penetration and 95+ new drugs in development over 10mL.

• Oncology market opportunity with 8 subcutaneous oncology drugs available and $138M TAM by 2030.

• Pipeline includes 8 active opportunities for new drugs and indications, with 9 drugs currently on label.

• Strategic growth pillars: protect and grow domestic business, expand internationally, enable more drugs and reach more patients.

• International expansion includes top-10 market entries and new drugs on label.