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) 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.
KORU Medical Systems (NASDAQ: KRMD) will participate in Canaccord Genuity’s 41st Annual Growth Conference on August 12, 2021, at 3:00 PM EDT. The event highlights the company’s focus on developing specialty infusion solutions aimed at improving patient quality of life.
Management's presentation can be accessed live or in archive for six months via the Investors section of KORU Medical’s website.
KORU Medical Systems (NASDAQ: KRMD) plans to report its second quarter 2021 financial results on August 11, 2021. The management will hold a conference call and webcast at 4:30 p.m. ET on the same day to discuss the financial outcomes and present a corporate update. Interested parties can participate via a U.S. toll-free number or an international line, using conference ID 13721184. A webcast will be available on KORU Medical's website for six months post-event.
KORU Medical Systems (NASDAQ: KRMD) reported its Q1 2021 results, revealing net revenue of $5.4 million, a 14% decline from $6.3 million in Q1 2020, attributed mainly to decreased sales in novel therapies and pandemic impacts. Gross margin stood at 59.5%, consistent with last year. The company incurred a net loss of $1.3 million, or $(0.03) per diluted share, primarily due to leadership change expenses. Total operating expenses rose to $5.4 million, up from $3.2 million the previous year. Adjusted EBITDA was $(0.4) million, a decrease from $1.3 million in Q1 2020.