KORU Medical Systems develops, manufactures, and commercializes large-volume subcutaneous infusion solutions for drug delivery in home and ambulatory care settings. Its Freedom Syringe Infusion System includes Freedom60 and FreedomEDGE syringe infusion drivers, Precision Flow Rate Tubing, and HigH-Flo Subcutaneous Safety Needle Sets.
Company updates commonly cover quarterly results, revenue guidance, cash flow trends, FDA 510(k) clearances, EU MDR certification, and label expansions, including FreedomEDGE use for RYSTIGGO delivery. News also addresses pharma services and clinical-trial collaborations with biopharmaceutical companies, customization of the Freedom System across drug categories, and governance or leadership succession matters.
KORU Medical Systems (NASDAQ: KRMD) reported a strong first quarter of 2022, achieving a 15% year-over-year net sales growth to $6.2 million. This marks the second consecutive quarter of double-digit growth, driven by domestic core sales increasing by 13.2% to $5 million. The company received its fourth FDA clearance in five months and expanded its pipeline for novel therapies. However, operating expenses rose to $6.7 million, leading to a net loss of $2.5 million or $(0.06) per diluted share. KORU reaffirms guidance for full-year revenues of $26.5 to $27.0 million.
KORU Medical Systems (NASDAQ: KRMD) has received 510k clearance for its FreedomEdge infusion system, which will now deliver pegcetacoplan (EMPAVELI®/Aspaveli®) in the U.S. This drug treats paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder affecting about 15,000 patients globally. The company's President emphasized the expansion of their infusion technology to enhance patient care and emphasized their online training support for healthcare providers. This development aligns with KORU's strategy to broaden its infusion solutions.
KORU Medical Systems (NASDAQ: KRMD) will release its first quarter 2022 financial results on May 4, 2022, at 4:30 p.m. ET. Management will host a conference call to discuss these results and provide a corporate update. Interested parties can join the call by dialing (877)-407-0784 for U.S. participants or (201)-689-8560 for international callers, using conference ID: 13728821. A live and archived webcast will also be available on the company's website.
KORU Medical Systems (NASDAQ: KRMD) has appointed Brian Case as its new Chief Technology Officer. With over 20 years in R&D, including roles at Fresenius Kabi and Cook Medical, Case will lead product development and innovation. He aims to enhance KORU's technology strategy to support a global drug delivery portfolio. CEO Linda Tharby expressed confidence in Case's ability to drive value through his extensive experience. This leadership change comes at a vital time for KORU, as it seeks to innovate in home infusion solutions.
KORU Medical Systems (NASDAQ: KRMD) reported a 60% increase in fourth-quarter net revenues, reaching $6.5 million, driven by growth in all business areas. For the full year, revenues were $23.5 million, a 2.8% decline from last year due to reduced novel therapies revenue. The company achieved three new 510(k) clearances and announced a five-year strategic plan aiming for $60 million in revenues by 2026. Despite a net loss of $4.6 million in 2021, cash reserves stand at $25.3 million as they prepare for 2022 revenue growth projected at $26.0 to $27.0 million.
KORU Medical Systems (NASDAQ: KRMD) will report its fourth quarter and full year 2021 financial results on March 2, 2021. The company will hold a conference call and webcast at 4:30 p.m. ET to discuss these results and provide a corporate update. Investors can access the call by dialing the designated numbers, with an archived webcast available for six months on their website. The company specializes in innovative home infusion solutions aimed at improving patients' quality of life.
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KORU Medical Systems (NASDAQ: KRMD) has received FDA 510(k) clearance to expand the on-label use of its FREEDOM60 Infusion System. The new clearance includes two additional subcutaneous Ig medications: Cutaquig® from Octapharma and Xembify® from Grifols. This move enhances KORU Medical's position in the home infusion market, providing patients and providers with more options for immunoglobulin therapy. The FREEDOM60 is now cleared for use with more SCIg drugs than any other system, reaffirming the company's leadership in this growing market.
KORU Medical Systems (NASDAQ: KRMD) has announced an upcoming investor day designed to update stakeholders on its strategic plan. The event is set for December 9, 2021, at 10:00 AM EST. Interested parties can access the live and archived webcast on the company's website.
KORU Medical specializes in developing innovative home infusion solutions, including the FREEDOM Syringe Infusion System, which enhances patient quality of life.
KORU Medical Systems (NASDAQ: KRMD) reported third-quarter 2021 financial results, achieving net revenue of $6.0 million, a 9% sequential increase from Q2 2021, highlighting three consecutive quarters of growth. Compared to Q3 2020, net revenue decreased slightly by 0.7%. Gross margin declined to 57.9% from 64.8% due to manufacturing transition delays and material scrap. Operating expenses rose to $4.8 million from $3.6 million, influenced by strategic initiatives. The company reported a net loss of $1.1 million, or $(0.02) per diluted share.