Nufactor, Inc.

COLUMBIA, Md., Aug. 28, 2023 /PRNewswire/ -- The Myositis Association announces its 2023 Annual Patient Conference: Celebrating YOU Our Myositis Heroes taking place at the Sheraton San Diego Hotel & Marina from September 7-10. It brings together patients, care partners, and healthcare professionals from around the world for a unique educational and empowering experience. Myositis, a group of rare autoimmune disorders, causes muscle weakness, pain, fatigue, and disability. This conference helps attendees learn about the latest advances in myositis research, treatment options, and coping strategies, as they share personal experiences and connect with others. Event Highlights: Celebrated speakers from the myositis community and beyond provide attendees with renewed hope and motivation on their myositis journey. Renowned myositis experts present the latest breakthroughs in research, diagnostic techniques, and management strategies. Interactive workshops offer attendees practical tools for managing myositis in their daily lives. Real-life stories from individuals living with myositis inspire and empower attendees. Networking opportunities connect attendees with others navigating similar challenges. Exhibitor hall showcases a diverse range of pharmaceutical companies, medical device manufacturers, and support organizations. As a special event, TMA also hosts its annual Heroes in the Fight Awards Ceremony on Saturday evening. The ceremony celebrates the extraordinary individuals and organizations making strides in the battle against myositis. Among the heroes being recognized are myositis researcher Dr. Rohit Aggarwal, the ALS and Neuromuscular Center at the University of California at Irvine, and pharmaceutical company Octapharma. Grammy Award-winning musician Peter Frampton will also be there to receive TMA's Patient Ambassador Award. This conference is made possible by the generous support of our sponsors. TMA extends its heartfelt gratitude to the following: Platinum Sponsors: Octapharma Pfizer Gold Sponsors: Mallinckrodt Pharmaceuticals Silver Sponsors: Abcuro argenx Horizon Therapeutics NuFactor Bronze Sponsors: Alexion Pharmaceuticals BioTek reMedys Boehringer Ingelheim CSI Pharmacy IndeeLift Janssen Global Services Myositis Support and Understanding Optum Priovant Therapeutics Soleo Health Whether you are seeking knowledge, support, or connections, TMA encourages members of the myositis community to attend this exceptional conference. Registration information and conference details can be found at . About The Myositis Association: The Myositis Association is a leading nonprofit organization dedicated to improving the lives of individuals affected by myositis through education, support, advocacy, and research. TMA is committed to fostering a sense of community that empowers individuals to live their best life. Contact: Linda Kobert, Communications Specialist; [email protected]; 434-882-2189. SOURCE The Myositis Association

KORU Medical claims that its Freedom Edge is the only device specifically approved for the delivery of subcutaneous Ig prefilled syringes FreedomEdge infusion pump delivers Hizentra in prefilled syringes. (Credit: Arek Socha from Pixabay.) Repro Med Systems, doing business as KORU Medical Systems, has secured the US Food and Drug Administration (FDA) 510k approval for the use of its FreedomEdge infusion pump. The infusion pump was indicated for delivering Hizentra [immune globulin subcutaneous (human) 20% liquid] in 20 mL prefilled syringes. According to speciality infusion pharmacy NuFactor, the device simplifies the infusions as it requires patients to simply place the syringes in the pump and infuse, eliminating the difficult drug transfer process. Hizentra is a sterilised solution made from human plasma, containing antibodies that help the body to protect itself against infection from various diseases. It is manufactured and distributed by CSL Behring, a biopharmaceutical company focused on plasma-derived and recombinant therapeutic products. The prescription medicine is currently used for treating chronic inflammatory demyelinating polyneuropathy (CIDP), and primary immunodeficiency (PI) diseases. CIDP is an autoimmune disorder where the immune system attacks the nervous system, which causes muscle weakness and numbness. The PI diseases include a humoral immune defect in congenital agammaglobulinemia, X-linked agammaglobulinemia, and Wiskott-Aldrich syndrome. According to the company, Hizentra is the most prescribed subcutaneous Ig product and is the first to be offered in a prefilled syringe format. KORU Medical is engaged in developing, manufacturing, and marketing advanced speciality infusion solutions to improve the quality of life for patients. Its FREEDOM Syringe Infusion System includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, precision flow rate tubing and HIgH-Flo needle sets. KORU Medical chief executive officer Linda Tharby said: “As the leader in home delivery of subcutaneous immunoglobulin therapy, we are thrilled to add Hizentra prefilled syringes to our label. “KORU Medical is committed to improving the patient home infusion experience. The KORU Medical FreedomEdge is the only infusion pump specifically indicated for delivery of a subcutaneous immunoglobulin prefilled syringe product. “We will continue to innovate to improve patient comfort and support the innovations developed by our biopharmaceutical relationships such as CSL Behring.”

KORU Medical’s Freedom Edge becomes the only device specifically cleared for delivery of subcutaneous Ig prefilled syringes CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion pump to deliver Hizentra® [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra® is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format. “Our patients who use prefilled syringes tell us that their infusions are significantly easier. With the FreedomEdge® they simply place syringes in the pump and infuse, avoiding the drug transfer process that many patients find difficult and stressful. We’re excited to see KORU Medical’s commitment to improve patient satisfaction by getting this important FDA clearance,” said Amy Ehlers, Senior Director of Clinical Programs at NuFactor, a leading specialty infusion pharmacy. “As the leader in home delivery of subcutaneous immunoglobulin therapy, we are thrilled to add Hizentra® prefilled syringes to our label,” said Linda Tharby, KORU Medical’s Chief Executive Officer. “KORU Medical is committed to improving the patient home infusion experience. The KORU Medical FreedomEdge is the only infusion pump specifically indicated for delivery of a subcutaneous immunoglobulin prefilled syringe product. We will continue to innovate to improve patient comfort and support the innovations developed by our biopharmaceutical relationships such as CSL Behring.” About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit . Trademark Statement The trademark is property of CSL Behring. Forward-looking Statements This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements can be identified by words such as “will”, “seeks to”, and “trend”. Actual results may differ materially from the results predicted. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, actual performance of the parties under the collaboration, patient demand for new in-home infusion products, and those risks and uncertainties included under the captions “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, which is available on the SEC website at and on our website at . All information provided in this release and in the attachments is as of November 10, 2021 and based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.