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KORU Medical Systems, Inc. (symbol: KRMD) is a prominent developer and manufacturer of innovative medical devices and supplies, headquartered at 24 Carpenter Road, Chester, New York, United States. Specializing in mechanical infusion products, the company is renowned for its cutting-edge FREEDOM Infusion Systems. These systems include the FREEDOM60 and FreedomEdge Syringe Drivers, designed to provide efficient and reliable delivery of life-saving therapies.
KORU Medical Systems primarily focuses on subcutaneous infusion devices, which are essential for administering immunoglobulin therapies to patients suffering from chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Their product line features the Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets, enhancing the safety and effectiveness of home-based treatments.
The company's commitment to quality and innovation has positioned it as a leader in the medical device industry. Recent achievements include advancements in product technology and expanded partnerships aimed at enhancing patient care and expanding market reach. KORU Medical Systems continues to prioritize patient-centered solutions, ensuring their products meet the highest standards of safety and performance.
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.
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.
KORU Medical Systems (NASDAQ: KRMD) has received FDA 510(k) clearance for its FreedomEdge® infusion pump, making it the sole device authorized for administering Hizentra® prefilled syringes. Hizentra® is the leading subcutaneous immunoglobulin product with a prefilled syringe option, enhancing patient comfort and convenience. The clearance positions KORU Medical as a leader in home delivery subcutaneous immunoglobulin therapy.
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