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KORU Medical's (KRMD) FreedomEdge Gets Regulatory Nod in Japan

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KORU Medical Systems, Inc. (KRMD - Free Report) recently announced that its state-of-the-art FreedomEdge System had received regulatory clearance in Japan for the delivery of multiple drugs.

The regulatory clearance covers the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).

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The FreedomEdge System is known for its reliability, precision, and patient-friendly design and offers convenient and efficient administration of large-volume subcutaneous therapies at home and in the clinic. The FreedomEdge System provides adjustable features to individualized treatment experiences to cater to the various demands of patients and healthcare providers. Patients can efficiently manage their therapy in a variety of locations because of its compact and portable design, which permits flexibility in treatment administration.

The regulatory clearance marks a significant advancement in patient care in Japan, providing patients and healthcare providers with access to cutting-edge treatment options for SCIg and PNH. KORU Medical is likely to expand access to essential therapies with the approval of the FreedomEdge System in Japan, providing patients and healthcare professionals with a dependable and easy-to-use drug delivery platform.

More on KORU’s Freedom System

KORU Medical’s FREEDOM Syringe Infusion System, or the Freedom System, received its first FDA clearance in 1994. The system is used for self-administration in the home by the patient or delivered in an ambulatory infusion center by a healthcare professional.

The Freedom System currently includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.

The Freedom Integrated Syringe Infusion System with the FREEDOM60 Syringe Driver and Precision Flow Rate Tubing is specifically indicated for the intravenous infusion of antibiotics like Ertapenem, Meropenem, Oxacillin and Tobramycin when used according to the FDA-approved drug product labeling.

Industry Prospects

Per a report by Grand View Research, the global intravenous infusion pump market size was valued at $5.3 billion in 2022 and is expected to witness a growth rate of 8.3% from 2023 to 2030.

The key factors driving the growth of the market include increased incidences of chronic diseases, rapid escalation seen in the geriatric population, rising surge for ambulatory infusion pumps, and the burgeoning number of people undergoing surgical procedures. 

Price Performance

In the past six months, KRMD’s shares have lost 7.5% against the industry’s 3.4% growth. The S&P 500 has increased 16.1% in the same time frame.

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Zacks Rank & Stocks to Consider

KRMD presently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space that have announced quarterly results are DaVita (DVA - Free Report) , Ecolab (ECL - Free Report) and Universal Health Services (UHS - Free Report) .

DaVita, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DaVita’s shares have gained 44% compared with the industry’s 20.4% growth in the past year.

Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 1.7%.

Ecolab’s shares have gained 33.8% against the industry’s 9.3% decline in the past year.

Universal Health Services has an Earnings ESP of +2.91% and a Zacks Rank of 2, at present. UHS has an estimated earnings growth rate of 30.5% for 2024.

UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.12%.


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