KORU Medical Systems Announces Second Quarter 2026 Results and Updates Full Year 2026 Guidance

KORU Medical Systems, Inc. (KRMD) filed an SEC Form 8-K — Results of Operations and Financial Condition. EXHIBIT 99.1 KORU Medical Systems Announces Second Quarter 2026 Results and Updates Full Year 2026 Guidance MAHWAH, NJ – August 5, 2026 – KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development,

Original reporting
Published Aug 5, 2026, 8:04 PM UTC
Analysis
AlphAI AI DeskAI-generated
Added to AlphAI Aug 5, 2026, 8:06 PM UTC. Informational, not investment advice.
How this was made
AlphAI summarizes source reporting and applies a structured AI analysis for relevance, timing, sentiment and ticker impact. Always verify material claims with the original publisher.
AlphAI market briefEarnings
Primary signal
$KRMD
Bullish
high confidence
Mentioned
$KRMD
Relevance
7/10
AlphAI data visualization · based on SEC EDGAR 8-K
Decision brief

The 30-second read

$KRMDBullishMed
01

Why it matters

Traders can update valuation and positioning based on the narrowed revenue and gross margin targets, improved gross margin and net income, and management’s stated strategic shift in U.S. oncology regulatory approach.

02

Market read

The filing provides fresh, quantitative guidance and profitability updates that can drive near-term repricing and trading decisions.

03

What to watch

Pharma services and clinical trials revenue fell 35% YoY, and international growth is expected to moderate due to European launch conversion timing, which could cap upside if execution slips.

Relevance 7/10Novelty 8/10Timing: after-hours/filing today, guidance update for FY 2026

Background

This is an SEC 8-K with the company’s Q2 2026 financial results and an updated full-year 2026 guidance range.

Company-level read

Ticker impact

$KRMDBullishHigh confidence
Context

KORU Medical reported Q2 2026 results and narrowed FY 2026 guidance, including revenue $47.5-$48.5M and gross margin 62%-64%.

Expected impact

Moderate positive bias for the next few sessions as traders price in the updated FY revenue and margin outlook.

Evidence & confidence

The filing is a primary-source earnings and guidance update with specific quantitative targets and profitability improvements, which typically drives immediate repricing for small/mid-cap biotech/medtech names.

Market effects

Signals demand strength in subcutaneous infusion and SCIg-related volumes, potentially supportive for peers focused on large-volume subcutaneous delivery.

International core revenue growth (up 59.1% YoY) highlights Europe conversion dynamics as a key driver.

Limited broader macro relevance; primarily company-specific medtech execution and regulatory strategy (510(k) withdrawal).

Counterpoint

Withdrawing the U.S. 510(k) for FreedomEDGE with Phesgo could be viewed as a near-term setback to U.S. oncology growth plans despite the shift to alternative higher-volume molecules.

Key entities

  • KORU Medical Systems, Inc.

    NASDAQ-listed medical technology company reporting Q2 2026 results and updating FY 2026 guidance.

  • FreedomEDGE

    U.S. oncology device referenced in the company’s decision to withdraw a 510(k) application.

  • Phesgo

    Referenced in the withdrawn 510(k) application tied to FreedomEDGE.

Related articles

$KRMDMed

KORU Medical Systems Announces Third Quarter 2026 Results Including Second Consecutive Quarter of Positive Net Income and Adjusted EBITDA

KORU Medical Systems, Inc. (KRMD) filed an SEC Form 8-K — Results of Operations and Financial Condition. EXHIBIT 99.1 KORU Medical Systems Announces Third Quarter 2026 Results Including Second Consecutive Quarter of Positive Net Income and Adjusted EBITDA MAHWAH, NJ – November 10, 2026 – KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical t

$KRMDMed

KORU Medical Systems Q2 Earnings Call Highlights

KORU Medical Systems (KRMD) reported Q2 PST revenue of $0.6M, down 35% year over year, citing lower clinical-trial orders and timing. Gross margin rose to 65.1% from 63.5%. The company narrowed full-year revenue guidance to $47.5M-$48.5M, raised gross-margin guidance to 62%-64%, ended with $8.3M cash, and expects positive adjusted EBITDA. It acquired a connected monitoring technology asset and shifted some FDA oncology timing.

$KRMDMedAI 8/10

KORU Medical Systems, Inc. Q2 2026 Earnings Call Summary

KORU Medical Systems reported Q2 2026 revenue up 18% and first positive net income since 2019, with domestic revenue up 12% and international revenue up 59%. It withdrew a US FDA 510(k) for Phesgo, narrowed FY revenue guidance to $47.5M-$48.5M, raised gross margin to 62%-64%, and expects positive adjusted EBITDA in 2026.