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ICU Medical, Inc.

ICUI
MedTech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$157.18
▲ +1.15 · +0.74%

Financials

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52W LOW $112.5052W HIGH $192.85
Volume
220.61 K
Value Traded
87.39 M
Short % Float
6.17%
-1.38%Week
-2.37%1 Month
+1.79%3 Month
+25.06%6 Month
-34.04%5 Year
+2,399.54%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
3.93 B
EPS (TTM)
1.84
P/E Ratio
85.44
Ent. Value
4.86 B
Total Shares
25.00 M
Float Shares
24.56 M
Insiders
1.77%
Institutions
104.52%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ICUI Catalyst Timeline

Dated clinical, regulatory and corporate events for ICU Medical, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for ICU Medical, Inc.

5Total events
0Upcoming
1Tier-1 (high impact)
2025 to 2026Coverage

Event history 4

▼RecallCMC / Inspection
Otsuka ICU Medical issues voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP 100 mL due to potential mix-up with 10 mEq Potassium Chloride Injection
●Manufacturing MilestoneCMC / Inspection
End of US distribution period for affected lot of 0.9% Sodium Chloride Injection, USP
●Manufacturing MilestoneCMC / Inspection
Affected lot of 0.9% Sodium Chloride Injection, USP distributed in the United States
●Manufacturing MilestoneCMC / Inspection
Affected lot 1042188 of 0.9% Sodium Chloride Injection, USP manufactured
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How ICUI actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2020-04-29Mannitol 15% In Plastic Container (mannitol) PDUFA Date ApprovedPDUFA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D22 / 100
Pipeline Score
$0M
Pipeline Value
Not rated
Valuation Signal
1
Drugs Scored
-
rNPV / MCap
Top 91%
Small Cap
(rank 599 of 658)
Percentile Rank
ICU Medical, Inc. faces pipeline headwinds (22/100), with 1 assets in development.
Showing 0 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
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Clinical Trial Results

Readouts, endpoints and source filings for every ICUI program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Example Drug Example indication for clinical evaluationPhase 32025-12-01The study met its primary endpoint demonstrating statistically significant improvement.Read MorePhase 3 Study Results AnnouncementRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Sanzone Virginia RuthOfficer (VP, General Counsel)Sell -2,202 17,258 held$167.67 09/03/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
PROSIGHT MANAGEMENT, LP 1.3 % (116.7 %) 7.48 M 51.00 K 85.79% ( 23.55 K)
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Shares held by hedge funds each quarter, and who bought or sold.

ICUI Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2027-02-19
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How ICUI ranks across every disease it competes in

Competitive Position is a premium feature
See how ICUI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ICUI News

ICUI
Sep 17, 2026
ICUIFDA Updates

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

Otsuka ICU Medical LLC has issued a voluntary recall for a lot of 0.9% Sodium Chloride Injection due to a labeling mix-up that may result in the product containing Potassium Chloride instead. This poses significant health risks, particularly for vulnerable populations. The recall affects products distributed in the U.S. between December 2025 and June 2026, and customers are advised to quarantine the affected products and return them.

Read more →
ICUI
Aug 27, 2026
ICUIConferences/Events

ICU Medical to Participate in Upcoming Investor Conferences

ICU Medical, Inc. announced its participation in two upcoming investor conferences. The company will engage in one-on-one meetings and fireside chats at the Wells Fargo 21st Annual Healthcare Conference and the Morgan Stanley 24th Annual Global Healthcare Conference. Live audio webcasts of these discussions will be available on their website.

Read more →
ICUI
Aug 6, 2026
ICUIGeneral
▲ +10.9%on this news

ICU Medical Announces Second Quarter 2026 Results and Updates its Fiscal Year 2026 Guidance

ICU Medical reported a 1% increase in GAAP revenue for Q2 2026, with adjusted diluted earnings per share rising to $2.37. The company updated its fiscal year 2026 guidance, projecting higher net income and earnings per share. However, the divestiture of the IV Solutions business has affected year-over-year comparisons.

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ICUI
Jul 23, 2026
ICUIConferences/Events

ICU Medical Announces Time of Second Quarter 2026 Earnings Conference Call

ICU Medical, Inc. has announced the schedule for its second quarter 2026 earnings release and conference call. The earnings will be released on August 6, 2026, at 4:00 p.m. ET, followed by a conference call at 4:30 p.m. ET. The call will be accessible via phone and webcast, ensuring investor engagement.

Read more →
ICUI
Jul 9, 2026
ICUIGeneral

Otsuka ICU Medical LLC Announces Over $500M Expansion of IV Solutions Manufacturing in North America

Otsuka ICU Medical LLC has announced a significant expansion of its IV solutions manufacturing, investing over $500 million in a new facility in Austin, Texas. This expansion aims to improve supply chain resiliency and accelerate the development of non-DEHP products. It marks a key milestone in the joint venture's commitment to enhance IV solutions manufacturing in North America.

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ICUI
May 7, 2026
ICUIGeneral

ICU Medical Announces First Quarter 2026 Results

ICU Medical reported its first quarter 2026 financial results, showing a 12% decline in GAAP revenue to $530.2 million compared to the previous year. However, non-GAAP organic revenue increased by 1% when excluding the impact of the IV Solutions divestiture. The company achieved a GAAP net income of $30.1 million, a significant turnaround from a loss in the prior year. The gross margin improved to 39%, indicating better operational efficiency.

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ICUI
Apr 23, 2026
ICUIConferences/Events

ICU Medical Announces Time of First Quarter 2026 Earnings Conference Call

ICU Medical, Inc. has announced the timing for its first quarter 2026 earnings release and conference call. The earnings report will be available on May 7, 2026, followed by a conference call at 4:30 p.m. ET. This call will allow stakeholders to discuss the results and gain insights into the company's performance.

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ICUI
Feb 19, 2026
ICUIGeneral

ICU Medical Announces Fourth Quarter 2025 Results and Provides Fiscal Year 2026 Guidance

ICU Medical, Inc. reported its financial results for the fourth quarter of 2025, revealing a revenue decline to $540.7 million compared to $629.8 million in the previous year. Despite a minor improvement in gross margin to 38%, the company experienced a GAAP net loss of $(15.7) million. Looking forward, the company has provided guidance for fiscal year 2026, estimating net income between $26 million and $44 million, alongside adjusted EBITDA projections of $400 million to $430 million. Vital Care revenue suffered a significant drop, highlighting challenges within specific product lines.

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ICUI
Feb 5, 2026
ICUIConferences/Events

ICU Medical Announces Time of Fourth Quarter 2025 Earnings Conference Call

ICU Medical, Inc. has announced the schedule for its fourth quarter 2025 earnings release and conference call. The results will be disclosed on February 19, 2026, at 4:00 p.m. ET, followed by a conference call at 4:30 p.m. ET. The call will be accessible via phone and webcast, ensuring broad participation.

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ICUI
Dec 31, 2025
ICUIConferences/Events

ICU Medical to Present at the 44th Annual J.P. Morgan Healthcare Conference

ICU Medical, Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference in January 2026. The presentation is scheduled for January 14 at 1:30 p.m. PT. Additionally, the company will hold one-on-one meetings with investors on the same day. The event will be webcast live and available for replay.

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ICUI
Nov 20, 2025
ICUIConferences/Events

ICU Medical to Participate at the Piper Sandler 37th Annual Healthcare Conference

ICU Medical, Inc. will participate in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025. The company's management will host a fireside chat on December 4 at 10:00 a.m. PT and will also hold one-on-one meetings with investors. The event will be webcast live, with a replay available afterward.

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ICUI
Nov 6, 2025
ICUIGeneral
▲ +8.1%on this news

ICU Medical Announces Third Quarter 2025 Results and Updates its Fiscal Year 2025 Guidance

ICU Medical reported its third quarter 2025 financial results, showing a revenue of $537 million, down from $589.1 million year-over-year. Despite a GAAP net loss of $3.4 million, the company improved its adjusted diluted earnings per share to $2.03. ICU Medical has updated its fiscal year 2025 guidance, projecting a reduced net loss and increased adjusted EBITDA.

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ICUI
Oct 23, 2025
ICUIConferences/Events

ICU Medical Announces Time of Third Quarter 2025 Earnings Conference Call

ICU Medical, Inc. has announced the timing for its third quarter 2025 earnings release and conference call. The earnings results will be released on November 6, 2025, at 4:00 p.m. ET, followed by a conference call at 4:30 p.m. ET. The call will be accessible via phone and webcast, ensuring investor participation.

Read more →
ICUI
Aug 7, 2025
ICUIGeneral

ICU Medical Announces Second Quarter 2025 Results and Updates its Fiscal Year 2025 Guidance

ICU Medical Inc. announced its second quarter 2025 financial results, revealing revenues of $548.9 million, a decline compared to last year's $596.5 million. However, the company experienced a favorable net income of $35.3 million this quarter, a notable contrast to a loss in the same period last year. Additionally, the gross margin improved to 38%. The company has also updated its fiscal year 2025 guidance, adjusting its estimates for GAAP net loss and diluted earnings per share.

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ICUI
May 8, 2025
ICUIGeneral

ICU Medical Announces First Quarter 2025 Results

ICU Medical, Inc. reported its financial results for Q1 2025, showing a revenue increase to $604.7 million compared to $566.7 million in Q1 2024. The gross profit also rose, leading to an improved gross margin of 35%. Despite these gains, the company faced a net loss of $(15.5) million. The CEO noted that results were generally in line with expectations.

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ICUI
May 1, 2025
ICUIGeneral

ICU Medical, Inc. and Otsuka Pharmaceutical Factory, Inc. Complete Joint Venture to Bolster IV Solutions Manufacturing and Innovation in North America

ICU Medical, Inc. and Otsuka Pharmaceutical Factory, Inc. have successfully formed a joint venture named Otsuka ICU Medical LLC. This partnership aims to enhance the IV solutions manufacturing capabilities in North America, combining OPF's global manufacturing expertise with ICU Medical's local production. The collaboration is expected to improve supply chain resiliency and introduce innovative technologies.

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ICUI
Apr 7, 2025
ICUIFDA Updates

ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo™ and Plum Duo™ Precision IV Pumps

ICU Medical has received FDA clearance for its new Plum Solo and Plum Duo precision IV pumps, enhancing its IV Performance Platform. These devices aim to reduce infusion delivery variability and provide accurate data for patient care. The Plum Solo is a single-channel pump complementing the dual-channel Plum Duo, both ensuring ±3% accuracy in various conditions. This launch marks a significant advancement in infusion therapy technology.

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ICUI
Mar 24, 2025
ICUIConferences/Events

ICU Medical to Present at the 24th Annual Needham Virtual Healthcare Conference

ICU Medical will present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025. The presentation is scheduled for 8:00 a.m. PT and will be available via live webcast. Additionally, company management will hold one-on-one meetings on the same day, providing opportunities for direct engagement with investors.

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About ICU Medical, Inc.

San Clemente, CA 13,000 employees icumed.com
Headquarters951 CALLE AMANECER, SAN CLEMENTE, CA, 92763-6212
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