Welcome to our dedicated page for Koru Med Sys news (Ticker: KRMD), a resource for investors and traders seeking the latest updates and insights on Koru Med Sys stock.
KORU Medical Systems Inc (KRMD) specializes in innovative subcutaneous infusion systems for critical therapies. This hub provides authorized updates about the company's medical device developments, regulatory milestones, and strategic initiatives.
Investors and healthcare professionals will find timely announcements including product launch details, financial disclosures, and manufacturing updates. Our curated collection ensures access to verified information about FREEDOM infusion systems and related technologies.
Key updates cover FDA clearances, partnership announcements, clinical application insights, and operational developments. All content maintains strict compliance with financial disclosure regulations and medical device reporting standards.
Bookmark this page for streamlined access to KRMD's latest advancements in immunoglobulin therapy delivery systems. Check regularly for official updates directly impacting the medical device sector and chronic care treatment landscapes.
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.
KORU Medical Systems (NASDAQ: KRMD) is set to participate in two significant healthcare conferences. The company will present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on November 18, 2021, at 11:00 AM EST. Additionally, management will engage in 1x1 investor meetings at the 33rd Annual Piper Sandler Healthcare Conference on December 1, 2021, and a pre-recorded fireside chat available from November 22. Interested parties can access the live broadcast through KORU Medical’s investor page.
KORU Medical Systems (NASDAQ: KRMD) has announced a collaboration with Gilero, a medical device design and manufacturing company, aimed at enhancing its home infusion product line. This partnership focuses on the advancement of large-volume subcutaneous infusion technology, allowing KORU Medical to innovate and expand its offerings in the growing home infusion market. The collaboration is expected to leverage Gilero's expertise in drug delivery systems to improve patient comfort and convenience in infusion processes.
KORU Medical Systems (NASDAQ: KRMD) announced the appointments of Rob Cannon as Vice President of Sales and Brian Hertzog as Vice President of BioPharma Business Development. Cannon will focus on U.S. sales and enhancing subcutaneous therapy penetration, while Hertzog will drive biopharmaceutical business development and new drug integration. CEO Linda Tharby emphasized the company's growth potential and expertise in large-volume subcutaneous infusion solutions, backed by FDA and CE regulatory clearances. This leadership expansion aims to accelerate growth and meet the significant unmet needs in the biopharmaceutical market.
KORU Medical Systems (NASDAQ: KRMD) will report its third quarter 2021 financial results on November 10, 2021. Management will host a conference call at 4:30 p.m. ET to discuss the results and provide a corporate update. Participants can access the call via designated phone numbers based on location or via the company's Investor section. The archived webcast will be available for six months post-event, allowing stakeholders to stay informed about KORU Medical's performance and updates.
Repro Med Systems, Inc., operating as KORU Medical Systems (NASDAQ: KRMD), announced the appointment of Chris Pazdan as Vice President of Quality Assurance and Regulatory Affairs. Mr. Pazdan brings over 16 years of experience from notable companies such as Hillrom and Abbott Laboratories. His expertise in quality and regulatory strategy aims to strengthen KORU Medical's Quality Management System to meet global standards. CEO Linda Tharby emphasized Mr. Pazdan's strategic and operational skills as key assets for the company's growth in meeting biopharmaceutical customer needs.
KORU Medical Systems (NASDAQ: KRMD) reported second-quarter 2021 results with net revenue of $5.5 million, reflecting a 28.3% decline year-over-year but a 2% sequential increase. The gross margin was 58.1%, down 5.6 percentage points from last year, influenced by lower volumes. The company reported a net loss of $1.1 million or $(0.03) per diluted share, unchanged from Q2 2020. Despite these challenges, CEO Linda Tharby noted a rebound in the subcutaneous immunoglobulin market and a focus on growth strategies for their SCIg therapy franchise.
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