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MAHWAH, N.J. - KORU Medical (TASE:PMCN) Systems (NASDAQ: KRMD), a medical technology firm with a market capitalization of $194 million, announced a partnership with a global pharmaceutical manufacturer to conduct a Phase III clinical trial. The trial will evaluate an expanded indication of a drug therapy for a rare renal disorder, targeting a patient population of about 30,000 and potentially 300,000 annual infusions. According to InvestingPro data, the company has demonstrated impressive momentum with an 85.7% price return over the past six months.
The collaboration is part of KORU Medical’s ongoing efforts to develop and enhance drug delivery solutions for patients with rare conditions. The trial will focus on the safety, efficacy, and performance of the drug for patients suffering from complications following kidney transplants.
Linda Tharby, President and CEO of KORU Medical, expressed optimism regarding the growth of the large volume subcutaneous market, citing the company’s established role with over 2 million infusions administered annually using the KORU Freedom Infusion System. She anticipates that successful trial results could extend the company’s reach to a new patient demographic, enhancing the treatment options for those afflicted with the rare renal disorder. The company maintains a strong financial position with a healthy current ratio of 2.99 and has achieved revenue growth of 11.6% over the last twelve months.
KORU Medical’s flagship product, the FREEDOM Syringe Infusion System, is designed for both self-administration at home and professional use in ambulatory infusion centers. The company, which received its first FDA clearance in 1994, also offers customized solutions for biopharmaceutical companies conducting clinical trials.
This press release includes forward-looking statements that involve risks and uncertainties, such as the successful outcome of the Phase III trial and regulatory clearances. While two analysts have recently revised their earnings estimates upward, as noted on InvestingPro, which offers 10+ additional exclusive insights, the company cautions against undue reliance on these statements, which are based on information available as of January 30, 2025. For further details on potential risks and uncertainties, interested parties can refer to KORU Medical’s Annual Report on Form 10-K for the year ended December 31, 2023, available on the company’s and SEC’s websites.
The information reported is based on a press release statement from KORU Medical Systems.
In other recent news, Koru Medical Systems has been making significant strides in its financial performance, as evidenced by its recent quarterly results. The company reported a 23% increase in revenues for the fourth quarter of 2024, totaling $8.9 million. This strong performance led to an annual revenue of $33.7 million, marking an 18% increase from the previous year. Analysts from Craig-Hallum and Canaccord Genuity maintained a Buy rating on the company, with the former raising the stock price target to $6.00.
In addition to its financial achievements, Koru Medical has also been making progress in its operations. The company’s contributions from its domestic core SCIg, international operations, and progress in Novel Therapies were highlighted as key drivers for the quarter. Analysts anticipate that the company will sustain above-market growth, supported by its recent launch in Japan and plans for entering new markets.
These recent developments are part of Koru Medical’s ongoing efforts to bolster its market position. The second half of 2025 is set to see the introduction of a next-generation pump and consumables, along with the anticipated approval and release of the Freedom system for a rare disease biologic into the infusion clinic space. Investors can expect to receive initial guidance for 2025 in early March, which will provide further insights into Koru Medical’s strategic direction and financial health.
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