KORU Medical Systems, Inc.

KORU Medical Systems develops, manufactures, and commercializes portable large-volume subcutaneous infusion solutions used to deliver drugs under the FREEDOM Infusion System brand. Its products are designed for home and specialty-care administration of therapies such as immunoglobulin for PIDD and CIDP, and the company also supports pharma clinical trials and customization work for biopharmaceutical customers.

−5,3 %

62,3 %

−6,4 %

+22,2 %

2.44

1.99

— KORU Medical Systems, Inc.
%
Mechanical infusion systems55% Portable syringe drivers and related devices used to infuse subcutaneous therapies.
Consumables35% Needle sets and tubing used with the FREEDOM System for recurring patient use.
Pharma services and clinical trials10% Product supply and support for feasibility studies and clinical trial programs.

KORU sells mainly to specialty pharmacies, home infusion providers, pharmaceutical companies, and medical device...

  • Specialty pharmaciesprimary

    Buy drivers, tubing, and needle sets for patients receiving immunoglobulin at home; they value one-stop purchasing and inventory management.

  • Home infusion providersprimary

    Purchase the FREEDOM System for subcutaneous drug administration in home-care settings where portability and patient convenience matter.

  • Medical device distributorsprimary

    Resell KORU products and account for a large share of revenue; they matter because purchasing patterns can swing quarterly results.

  • Pharmaceutical and biopharma companiessecondary

    Buy product supply and engineering support for feasibility studies, clinical trials, and commercialization readiness.

  • Hospitals and ambulatory service providerssecondary

    Use the system for subcutaneous drug delivery in clinical settings and outpatient care.

KORU’s core business is split between domestic core revenue, which includes the U.S. and Canada, and international core...

  • •Domestic core covers the U.S. and Canada
  • •International core provides meaningful non-U.S. growth
  • •Mahwah, New Jersey is the main manufacturing site
  • •Nicaragua contract manufacturing supplies consumables
  • •Distributor concentration makes regional execution important

KORU’s strategy centers on expanding adoption of the FREEDOM System in subcutaneous drug delivery while broadening its...

01
Broaden distribution and reduce concentrationshort-term

A few distributors drive most revenue, so expanding channels lowers dependency and improves resilience.

02
International expansionmedium-term

Non-U.S. growth can diversify the business and increase the installed base of the FREEDOM System.

03
Product innovation and clinical customizationmedium-term

New devices and services help defend against competition and support biopharma commercialization.

KORU is exposed to customer concentration, distributor dependence, and competitive pressure in a medical-device market...

high

Distributor concentration

A small number of distributors account for most net revenue, so order timing and purchasing patterns can swing results.

Scope
Three U.S. and six non-U.S. distributors represented about 77% of net revenues.
Materiality
high
high

Manufacturing and supply chain disruption

Production is split between Mahwah and Nicaragua, and any site outage or border/logistics issue could delay shipments.

Scope
Needle sets and tubing rely on contract manufacturing in Nicaragua.
Materiality
high
high

Regulatory and reimbursement changes

Demand depends on FDA clearance, payer coverage, and reimbursement for the therapies delivered with the system.

Scope
Subcutaneous drug delivery and immunoglobulin therapy markets.
Materiality
high
medium

Competitive and pricing pressure

Consolidation among medical device buyers and suppliers can increase bargaining power and force price reductions.

Scope
Specialty pharmacy, distributor, and healthcare-system channels.
Materiality
medium
medium

Technology obsolescence

If KORU fails to introduce new products or keep pace with infusion technology, customers may switch to alternatives.

Scope
Mechanical infusion systems and accessories.
Materiality
medium
Revenue recognition at shipment
Quarterly comparability
Warranty accruals
Gross margin and operating expense
Inventory valuation
Working capital and cost of sales
Liquidity and financing assumptions
Capital structure and dilution risk

InfuSystem Holdings, Inc

INFU · Surgical & Medical Instruments & Apparatus

Corbus Pharmaceuticals Holdings, Inc.

CRBP · Pharmaceutical Preparations

Korro Bio, Inc.

KRRO · Pharmaceutical Preparations

ORAMED PHARMACEUTICALS INC.

ORMP · Pharmaceutical Preparations

IRADIMED CORP

IRMD · Surgical & Medical Instruments & Apparatus

ORASURE TECHNOLOGIES INC

OSUR · Surgical & Medical Instruments & Apparatus

: 28/04/2026