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Overview of KORU Medical Systems Inc
KORU Medical Systems Inc is a specialized manufacturer and developer of medical devices, with particular emphasis on mechanical infusion products designed to enhance patient care. The company has established a niche in the development of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies, addressing chronic conditions such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Utilizing innovative engineering and precision manufacturing techniques, KORU Medical Systems Inc offers a range of devices that support accurate and safe administration of critical therapies.
Core Product Lines and Technologies
The primary product suite includes the FREEDOM Integrated Infusion System, which incorporates models such as the FREEDOM60 and FreedomEdge Syringe Drivers. Additionally, the company provides specialized components like Precision Flow Rate Tubing and High-Flo Subcutaneous Safety Needle Sets that are integral in ensuring that patients receive precise and safe subcutaneous infusions. These intertwined product categories highlight KORU Medical Systems Inc’s commitment to safety, precision, and user-friendly design.
Industry Position and Market Context
Operating within the medical device and healthcare equipment manufacturing sector, KORU Medical Systems Inc occupies a significant position by offering solutions tailored to the administration of immunoglobulin therapies. The company’s products are crucial for patients who require regular, controlled drug delivery, making these devices essential in both outpatient and specialized clinical settings. By focusing on reliability and innovation, the company differentiates itself in a competitive market that values stringent regulatory adherence, technical expertise, and proven operational safety.
Product Innovation and Quality Assurance
Innovation is a key pillar of KORU Medical Systems Inc. The company leverages advanced manufacturing processes and stringent quality control measures to ensure that each device meets high standards reflective of current industry practices. The integration of precise control mechanisms in its infusion systems not only enhances patient safety but also improves the overall therapy management process. Medical device innovation and a rigorous commitment to quality underscore the company’s approach to addressing complex healthcare needs.
Operational Excellence and Customer Impact
KORU Medical Systems Inc prides itself on operational excellence, a quality that is essential in the design and manufacture of medical devices. The seamless integration of product design, manufacturing processes, and safety protocols ensures that the devices are both reliable and effective. Hospitals, clinics, and home care settings benefit from devices that facilitate the accurate administration of therapies, thus contributing to improved patient outcomes in chronic disease management. The company’s unwavering focus on reliability and functionality is rooted in its deep understanding of the rigorous demands of the healthcare industry.
Market Dynamics and Competitive Landscape
The competitive landscape in medical device manufacturing demands not only innovation but also adherence to strict industry regulations. KORU Medical Systems Inc differentiates itself through specialized product offerings and a commitment to quality, placing emphasis on the intricate aspects of infusion device engineering. This strategic focus, combined with precise market positioning, allows the company to maintain relevancy in a sector that values both technological advancement and operational consistency. Industry stakeholders and healthcare professionals recognize the company’s ability to provide specialized solutions designed for a critical segment of patient care.
Concluding Insights
In summary, KORU Medical Systems Inc is a robust entity in the medical device manufacturing sphere, dedicated to developing infusion systems that play a vital role in patient care. The company’s product range—spanning integrated systems and accessory components—demonstrates a high degree of technical sophistication and a commitment to addressing complex healthcare challenges. This comprehensive approach underlines the company’s significance as a trusted manufacturer of devices that facilitate the accurate and safe delivery of subcutaneous therapies.
KORU Medical Systems (NASDAQ: KRMD), a leading medical technology company, announced its participation in the 8th Annual Lake Street Best Ideas Growth Conference on September 12, 2024, in New York. The company, which specializes in developing and manufacturing innovative large volume subcutaneous infusion solutions, will be engaging in investor meetings during the event.
This conference participation highlights KORU Medical's commitment to investor relations and showcases its position in the medical technology sector. The Lake Street conference is known for featuring promising growth companies, suggesting that KORU Medical's attendance may indicate positive momentum and potential investment opportunities in the subcutaneous infusion market.
KORU Medical Systems (NASDAQ: KRMD) announced a record second quarter for 2024, achieving 22% revenue growth. The company's net revenues hit $8.4 million, driven by a 20% growth in core business and geographic expansion. Gross profit increased by 41% to $5.5 million with a gross margin of 65%, showing a year-over-year improvement of 890 basis points. Ending cash balance was $10.5 million with a quarterly cash usage of $0.3 million.
KORU raised its full-year 2024 revenue guidance to $32.0-$32.5 million, representing a growth of 12-14%, and gross margin guidance to 61-62%. Business highlights include regulatory clearance for the FreedomEdge® Infusion System in Japan, progress in oncology biologics, and entry into a Phase III clinical trial for nephrology. Despite the positive earnings, the company reported a net loss of $1.0 million or ($0.02) per diluted share, a significant reduction from the previous year's loss of $2.5 million.
KORU Medical Systems (NASDAQ: KRMD), a leading medical technology company specializing in large volume subcutaneous infusion solutions, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event is scheduled for August 14, 2024, with KORU Medical's management set to present at 8:30 am ET.
Interested parties can access both the live and archived webcast of the presentation through the News/Events page in the Investors section of KORU Medical's official website at www.korumedical.com. This conference provides an opportunity for KORU Medical to showcase its innovative and patient-centric solutions to a wider audience of investors and industry professionals.
KORU Medical Systems (NASDAQ: KRMD) announces the promotion of Christopher Pazdan to Chief Operating Officer, effective July 18, 2024.
Pazdan, with KORU since 2021, was previously Senior Vice President of Operations. He will now oversee Research and Development, product development, and innovation efforts. CEO Linda Tharby commends Pazdan for his transformative leadership and familiarity with the company's culture.
Brian Case, Chief Technology Officer, will depart on September 16, 2024. Tharby thanks him for his contributions to the R&D team and product development process.
KORU Medical Systems (NASDAQ: KRMD), a leading medical technology company specializing in large volume subcutaneous infusion solutions, has announced its plans to report second quarter 2024 financial results on August 7, 2024. The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.
Interested parties can access the conference call by dialing (877)-407-0784 for U.S. or Canada participants, and (201)-689-8560 for international callers. A live and archived webcast will be available on the company's investor relations website for six months following the event.
KORU Medical Systems (NASDAQ: KRMD) has secured regulatory clearance for its FreedomEdge® Infusion System in Japan. This approval includes the delivery of multiple drugs such as CSL Behring’s Hizentra, Takeda Pharmaceutical’s Cuvitru, and Sobi’s Aspaveli for conditions like Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH).
This clearance marks a significant milestone for KORU Medical, expanding its international market reach and enhancing patient care in Japan. The FreedomEdge® System, known for its reliability and patient-friendly design, allows for convenient at-home or clinical administration of large volume subcutaneous therapies.
CEO Linda Tharby highlighted this regulatory success as a testament to KORU’s commitment to improving global healthcare solutions. The system’s customizable features and portable design offer flexible and effective therapy management for patients and healthcare providers alike.
SCHOTT Pharma and KORU Medical Systems (NASDAQ: KRMD) announced a collaboration to advance large-volume subcutaneous infusion. KORU Medical, known for its Freedom Infusion System, and SCHOTT Pharma, known for its TOPPAC® prefillable polymer syringes, aim to optimize drug delivery in large-volume subcutaneous infusion markets. The collaboration seeks to simplify and de-risk drug administration for both healthcare professionals and patients. The focus is on therapies requiring large volumes and recurring dosing, such as chronic diseases and cancer. Their joint solution promises improved time-to-market for infusion therapies and a streamlined drug development process. SCHOTT's prefillable syringes, available in 5mL to 50mL formats, are compatible with KORU's Freedom System, enhancing ease of use and reducing administration errors.
KORU Medical Systems (NASDAQ: KRMD) announced a collaboration with a global pharmaceutical company to initiate a feasibility study for their Freedom Infusion System. This system, designed for subcutaneous administration, will be tested with an FDA and EMA approved oncology biologic drug currently administered manually by healthcare professionals. The Freedom System, a mechanical ambulatory drug delivery device, can deliver large volumes of medications from 2mL to over 100mL. If successful, the study could lead to the commercialization of the system within 12 months, addressing a growing trend in oncology for subcutaneous drug administration.
KORU Medical Systems (NASDAQ: KRMD) has signed a Phase III clinical supply agreement for a new enzyme replacement therapy targeting a rare endocrinological disease. This follows the successful validation of the KORU Medical Freedom System for subcutaneous infusion. The trial will evaluate bi-weekly infusions, with potential treatment impact for 10,000 patients globally. The experimental drug has been granted Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the FDA and in Europe.
KORU Medical President and CEO, Linda Tharby, expressed pride in their device development for large volume subcutaneous delivery and emphasized the company's expanding role in administering rare disease drugs.
KORU Medical Systems, Inc. (NASDAQ: KRMD) reported Q1 2024 financial results with net revenues of $8.2 million, an 11% increase YoY. Gross profit increased by 23% to $5.1 million. The company reaffirmed its full year 2024 revenue guidance of $31.2-$32.2 million, reflecting growth of 10-13% YoY. KORU Medical continues to expand its Core business and Novel Therapies collaborations, aiming for increased value for customers, patients, and shareholders.
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