Company: ICUI
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0000883984-25-000007
Chunk: 3

Company: ICU MEDICAL INC/DE
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1A
Chunk 3
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 ambulatory infusion devices, vascular access, and vital care products, and we believe has significantly strengthened and expanded our global market reach.

In November 2024, we entered into a purchase agreement with Otsuka Pharmaceutical Factory America, Inc. (“Otsuka”), a global IV solutions manufacturing subsidiary of Otsuka Holdings Co., Ltd. Under the agreement, a joint venture will be formed among the Company and ICU Medical Sales, Inc., a wholly owned subsidiary of the Company (collectively, the “ICU Medical Entities”), and Otsuka, to provide additional supply chain resiliency and innovation to our North American IV solutions market under commercial agreements, a services agreement and a license agreement. The transaction is expected to be completed during the second quarter of 2025.

Products

Our primary product offerings are described below.

Consumables

Our Consumables business unit includes Infusion Therapy, Oncology, Vascular Access and Tracheostomy products.

Infusion Therapy

Our Infusion Therapy products include non-dedicated infusion sets, extension sets, needle-free connectors, and disinfection caps. Infusion sets used in hospitals and ambulatory clinics consist of flexible sterile tubing running from an IV bag or bottle containing a drug product or solution to a catheter inserted in a patient’s vein that may or may not be used with an infusion pump. Disinfection caps are used to actively disinfect access points into the infusion sets and catheters. Our primary Infusion Therapy products are:

1

•Clave™ needlefree products, including the MicroClave, MicroClave Clear, and NanoClave™ brand of connectors, accessories, extension and administration sets used for the administration of IV fluids and medications;

•Neutron™ catheter patency device, used to help maintain patency of central venous catheters;

•Tego™ needlefree connector utilized to access catheters for hemodialysis and apheresis applications; and

•ClearGuard™, SwabCap™ and SwabTip™ disinfection caps.

Oncology

Closed System Transfer Devices ("CSTD") and hazardous drug compounding systems are used to prepare and deliver hazardous IV medications such as those used in chemotherapy, which, if released, can have harmful effects on the healthcare worker and environment. Our primary Oncology products are:

•ChemoLockTM CSTD (“ChemoLock”), which utilizes a proprietary needlefree connection method, is used for the preparation and administration of hazardous drugs. ChemoLock is used to limit the escape of hazardous drug or