ADDED
trade, tax or other policies that restrict imports or increase import tariffs for certain countries, particularly Mexico and Costa Rica; continuing pressures to reduce healthcare costs and inadequate coverage and reimbursement; our ability to comply with applicable laws, rules and regulations, including, without limitation, matters raised in a warning letter issued by the FDA in 2025, regarding modifications to our cleared MedFusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump that could impact our continued commercial activity.
Principal risks and uncertainties include: We derive a significant portion of our revenues from non-U.S.
We are therefore subject to risks of doing business in other countries, including those related to tariffs, retaliatory counter measures and further escalation of trade tensions.
Continuing pressures to reduce healthcare costs and inadequate coverage and reimbursement may adversely affect our prices and volume.
ICU's product portfolio includes ambulatory, syringe, and large volume IV pumps and safety software; dedicated and non-dedicated IV sets, needlefree IV connectors, peripheral IV catheters, sharps safety products, and sterile IV solutions offered on behalf of our joint venture; closed system transfer devices and pharmacy compounding systems; as well as a range of respiratory, anesthesia, patient monitoring, and temperature management products.
( OPF ), a global IV solutions manufacturing subsidiary of Otsuka Holdings Co., Ltd., to divest a controlling interest in our IV Solutions business.
In April 2025, pursuant to the Agreement, ICU Medical Pearl LLC (n/k/a Otsuka ICU Medical LLC (the "joint venture")) was formed, and the assets, liabilities and operations comprising the IV Solutions product line were transferred to the joint venture.
In May 2025, upon the closing under the Agreement, we sold a 60% ownership interest in the joint venture to OPF and the Company retained a 40% ownership interest in the business.
Pursuant to commercial agreements, a services agreement and a license agreement, we sell and distribute products to customers on behalf of the joint venture.
Our primary Infusion System products are: Large Volume Pump ("LVP") Hardware: Plum Duo and Plum Solo precision infusion pumps (together, the "Plum precision pumps") are single-channel and dual-channel infusion pump systems that received FDA 510(k) clearance in April 2025.
REMOVED
trade, tax or other policies that restrict imports or increase import tariffs for certain countries, particularly Mexico, will escalate trade wars and will have a material adverse effect on our results of operations.
Continuing pressures to reduce healthcare costs and inadequate coverage and reimbursement may adversely affect our prices.
In particular, if we are unable to resolve or close-out the Warning Letter dated October 1, 2021, received by Smiths Medical ASD, Inc.
from the Minneapolis, Minnesota Facility following a February to March 2021 inspection, we could suffer significant sanctions which may impact our ability to sell products globally.
ICU's product portfolio includes ambulatory, syringe, and large volume IV pumps and safety software; dedicated and non-dedicated IV sets, needlefree IV connectors, peripheral IV catheters, sharps safety products, and sterile IV solutions; closed system transfer devices and pharmacy compounding systems; as well as a range of respiratory, anesthesia, patient monitoring, and temperature management products.
( 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.
Our primary Infusion System products are: Large Volume Pump ("LVP") Hardware: Plum 360 infusion pumps feature a unique delivery system that helps to enhance patient safety and workflow efficiency.
Plum Duo infusion pumps with LifeShield safety software are dual channel devices capable of delivering up to four compatible medications at independent rates with a single pump.