Partner with Us

Whether you’re looking for a turn-key system or a customized solution, we can help!

Delivering the Future of Large Volume Drug Therapy

36 COUNTRIES

with regulatory clearance

13 DRUGS

including 9 subcutaneous drugs on label

59K PATIENTS

active globally

15 YEARS

of commercial and clinical experience

KORU is the Leader in Large Volume Subcutaneous Drug Administration¹

KORU Medical is uniquely positioned to assure your large volume subcutaneous drug’s success.

No other partner in the large volume drug delivery space fulfills all delivery needs like KORU Medical.
59,000 active patients performing over 2 million subcutaneous infusions annually.
Commercialized over 15 years with 13 drugs [including 9 subcutaneous drugs] on label.
Clearances in 36 countries, and an established global distribution network.
Platform infusion system capable of being clinically or commercially ready in 4-6 months.

Partnered with leading pharmaceutical companies.
Strong strategic partnerships with the Subcutaneous Drug Delivery Development Consortium, Cambridge Designs Partnership, and Schott Pharma.
ISO 13485/MDSAP/EU MDR Certified Quality Management Systems, in-house expertise in device manufacturing, and a highly sustainable system.

Drug development is challenging – de-risk and heighten the chances of your drug's commercial success. Partner with KORU Medical.

We De-risk Drug Development from Clinical to Commercialization

CLINICAL TRIALS

Capable of being clinically ready in 3-6 months

TRANSITION TO COMMERCIAL

Supporting independent 510k or combination product

COMMERCIALIZATION

Established manufacturing and distribution channels

Providing Clinical Development Value

The FreedomEDGE® is 510(k) cleared and CE Mark approved, which reduces regulatory burden for sponsors integrating the device into their IND/CTA submissions
Variable delivery volume (20 mL and 30 mL syringe compatibility) gives trial designers flexibility to accommodate different dose volumes without device changes
“Off-the-shelf” availability allows sponsors to access devices quickly for early-phase studies without custom procurement timelines
Variable flow rate capability supports protocol flexibility across different drug viscosities and patient tolerances

Speeds up Road to Commercialization

Our technology supports:

Wearable development programs that need a validated subcutaneous delivery reference platform during development
A device-agnostic labelling strategy at commercialization: Sponsors can reference a generic device category such as “mechanical infusion pump” in their label rather than a named device, avoiding a combination product designation and its associated regulatory obligations. Our technology allows sponsors to preserve labelling flexibility while still having a clinically validated delivery system behind the language

Applications

Home

In-Clinic

Rare Disease

Oncology

Freedom Platforms

Supports Large Volume Subcutaneous Infusions from 5 mL to 50+ mL of immunoglobulins, monoclonal antibodies, and other biologics.

FreedomEDGE®

Our FreedomEDGE® supports 20mL and 30mL syringe compatibility.

Freedom60®

Next Generation Infusion Set*

Next Generation Pump*

*Under development- not available for commercial sale

1. Based on KORU sales data.
2. Rutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIG
Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease.
Poster presented at: National Home Infusion Association Annual Conference; March 23-27, 2024; Austin TX.