KORU Medical Systems (KRMD) Company Report

KORU Medical Systems announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli).
This clearance expands the FreedomEDGE® label to include administration by a healthcare professional, increasing flexibility and access for patients with generalized myasthenia gravis (gMG).
This marks the ninth subcutaneous drug clearance for KORU Medical, reinforcing its leadership in the large-volume subcutaneous infusion market.

Jan 29, 2026, 9:05 PM

Press Release

KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results

KRMD

Earnings

Guidance Update

Revenue Acceleration/Inflection

KORU Medical Systems announced preliminary unaudited net revenues for Q4 2025 are expected to be $10.9 million, representing 23% growth over the prior year period.
Preliminary unaudited net revenues for full year 2025 are expected to be $41.1 million, representing 22% growth over the prior year.
The company achieved an ending cash balance of $8.9 million, indicating positive cash flow in Q4 and positive cash flow from operations for the full year 2025.
KORU Medical Systems submitted a 510(k) for clearance of the Freedom Infusion System for use with Phesgo®, marking a key milestone in expanding beyond Ig into oncology.
The company plans to release its final Q4 and full year 2025 financial results and 2026 guidance in early March 2026.

Jan 12, 2026, 3:25 PM

8-K

KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results

KRMD

Earnings

Revenue Acceleration/Inflection

New Projects/Investments

KORU Medical Systems announced preliminary unaudited net revenues of $10.9 million for the fourth quarter of 2025, representing 23% growth over the prior year period, and $41.1 million for the full year 2025, representing 22% growth over the prior year.
The company achieved record revenue and positive operating cash flow for the full year 2025, ending the year with an $8.9 million cash balance.
KORU Medical Systems submitted a 510(k) for clearance of the Freedom Infusion System for use with Phesgo®, marking a key milestone in expanding beyond immunoglobulin into oncology.

Jan 12, 2026, 1:00 PM

Press Release

KORU Medical Systems Submits 510(k) for FreedomEDGE® System with Oncology Biologic

KRMD

Product Launch

New Projects/Investments

KORU Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for clearance of its FreedomEDGE® infusion system to administer PHESGO®, a co-formulated therapy for HER2+ breast cancer.
This submission represents a key milestone in the company's strategy to expand the use of the FreedomEDGE® system beyond its current immunoglobulin indications and into the broader oncology infusion center market.
KORU Medical anticipates market entry upon FDA 510(k) clearance, aiming to address unmet needs related to nursing satisfaction and workflow complexity in oncology infusion centers.

Dec 30, 2025, 9:05 PM

Press Release

KORU Medical Highlights Strong 2025 Growth and Outlines 2026 Expansion Plans

KRMD

Revenue Acceleration/Inflection

Product Launch

New Projects/Investments

KORU Medical reported over 20% year-to-date growth in 2025, driven by international expansion (more than doubling) and U.S. business growth of 10-15%, outperforming the market, and expects to maintain 20%+ revenue growth in 2026.
Key growth drivers for 2026 include projected over 30% international segment growth, the addition of four new drugs to its label (with the first approval hoped for in Q1 2026), and the anticipated launch of a new pump in the first half of 2026, which is expected to offer a higher average selling price.
The company achieved cash flow positive and positive EBITDA in 2025 and is targeting gross margins of 65%+ from the current 61-63% through increased capital allocation for margin improvement.

Dec 2, 2025, 2:30 PM

Transcript

KORU Medical Discusses 2025 Growth, 2026 Outlook, and Margin Expansion

KRMD

Revenue Acceleration/Inflection

Product Launch

New Projects/Investments

KORU Medical is experiencing over 20% growth year-to-date in 2025, driven by international expansion (more than doubling its business and increasing market share from 10% to 20%) and its U.S. business outperforming the market by growing 10-15% compared to the market's 8-10%.
For 2026, the company anticipates adding four new drugs to its label, filing for a new pump in the first half, and expects international growth to exceed 30% with five new markets converting to prefills.
KORU Medical aims to launch its new pump, which is expected to be priced between $1,000 and $1,500 (compared to current pumps in the $300-$500 range), and is targeting gross margins of 65%+ as part of its five-year strategy, up from the current 2025 guidance of 61-63%.
The company achieved cash flow positive and positive EBITDA in the current quarter.

Dec 2, 2025, 2:30 PM

Transcript

KORU Medical Highlights Strong 2025 Performance and Outlines 2026 Growth Strategy

KRMD

Revenue Acceleration/Inflection

Product Launch

Guidance Update

KORU Medical reported over 20% year-to-date growth in 2025, primarily due to international expansion (more than doubling its business and increasing European market share from 10% to 20%) and 10%-15% growth in its U.S. business.
Key growth drivers for 2026 include the anticipated addition of four new drugs to its label, the filing for a new pump in the first half of the year, and the conversion of five new international markets to prefills.
The company achieved cash flow positive and positive EBITDA in a recent quarter of 2025.
KORU Medical targets increasing gross margins from the current 61%-63% to 65%+ within its five-year strategy, supported by new products like a new pump expected to be priced between $500 and $1,500.
Clinical trials for secondary immunodeficiency are projected to conclude in late 2026 to early 2027, which could more than double the U.S. patient population opportunity from 300,000.

Dec 2, 2025, 2:30 PM

Transcript

KORU Medical Systems Reports Record Q3 2025 Revenue and Raises Full-Year Guidance

KRMD

Earnings

Guidance Update

Revenue Acceleration/Inflection

KORU Medical Systems reported record Q3 2025 revenues of $10.4 million, marking a 27% growth over the prior year period, primarily driven by strength in the Core SCIg business and international expansion.
For Q3 2025, the company achieved a gross profit of $6.3 million (a 21% increase year-over-year) and a positive adjusted EBITDA of $0.09 million, while generating $0.4 million in cash, bringing the cash balance to $8.5 million as of September 30, 2025.
The company raised its 2025 revenue guidance to $40.5-$41.0 million, representing 20%-22% growth, and reiterated its gross margin guidance of 61%-63% and positive cash flow from operations for the full year.
Strategic advancements include two new Pharma Services and Clinical Trials collaborations and the successful completion of an oncology pilot site study, with a 510(k) application submission for an oncology drug anticipated by the end of 2025.

Nov 12, 2025, 9:30 PM

Presentation

KORU Medical Systems Reports Strong Q3 2025 Results and Raises Full-Year Revenue Guidance

KRMD

Earnings

Guidance Update

Revenue Acceleration/Inflection

KORU Medical Systems reported Q3 2025 revenue exceeding $10 million, marking a 27% year-over-year growth, primarily driven by a 30% increase in its core subcutaneous immunoglobulin (SCIG) business.
The company achieved positive adjusted EBITDA and generated positive cash flow in Q3 2025, ending the quarter with $8.5 million in cash. Year-to-date, net losses were cut in half to $2.2 million.
KORU raised its full-year 2025 revenue guidance to $40.5-$41 million, representing 20%-22% growth, and reaffirmed its gross margin guidance of 61-63% and positive cash flow from operations.
Strategic progress includes successful completion of a U.S. oncology study with 100% administration success and high nurse/patient satisfaction, leading to an anticipated 510(k) filing by Q1 2026. International expansion continues to be a significant growth driver, with market share growing to 15%-20% in the OUS SCIG market.

Nov 12, 2025, 9:30 PM

Transcript

KORU Medical Systems Reports Strong Q3 Revenue Growth and Raises 2025 Guidance

KRMD

Earnings

Guidance Update

Revenue Acceleration/Inflection

KORU Medical Systems reported net revenues of $10.4 million for the third quarter ended September 30, 2025, marking a 27% increase over the prior year period.
The company achieved a gross profit of $6.3 million (60.2% gross margin) and a net loss of ($0.8) million, representing a 51% improvement compared to the prior year.
Adjusted EBITDA was positive at $0.09 million, a 121% improvement over the prior year period, and the company generated $0.4 million in cash during the quarter, ending with $8.5 million in cash and cash equivalents.
KORU Medical Systems raised its full year 2025 revenue guidance to a range of $40.5 million to $41.0 million, indicating year-over-year growth of 20% to 22%.
The company also reiterated its full year 2025 gross margin guidance of 61% to 63% and expects positive cash flow from operations with an ending cash balance greater than $8.2 million.