CSA Medical Inc | October 22, 2020
CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University. Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th. "We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life," said Dr. Criner. "RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis."
Porton Advanced | April 25, 2022
Suzhou Porton Advanced Solutions Ltd. and Guizhou Sinorda Biomedicine Co. Ltd. announced a long-term strategic relationship in cell and gene therapy research and development and platform development.
Porton Advanced provides plasmids, cell therapy, gene therapy, oncolytic virus, mRNA treatment, and bacterial therapy as part of an end-to-end gene and cell therapy CDMO service platform. Sinorda Biomedicine focuses on the R&D of revolutionary drugs for digestive tract disorders, tumor immunotherapy, and oncolytic virus therapy and has multiple new drug projects in the clinical stage, thanks to its extensive expertise in domestic and international new drug filing. Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., a subsidiary, conducts pre-clinical and clinical research on tumor immune pharmacology and efficacy.
Under the terms of the agreement, Porton Advanced will help Sinorda Biomedicine speed up the development, production, and registration of breakthrough cell therapies, such as its T-cell immunotherapy product for colorectal cancer, SND002 and other pipelines. Sinorda Biomedicine will partner with Porton Advanced to support its cell and gene therapy R&D and production.
The first collaborative initiative, SND002, has been approved for Phase II clinical trials in Europe. The product had previously been recognized by the Chinese National Science and Technology Major Project for "the Breakthrough New Drugs." The beginning of this key initial initiative allows Porton Advanced and Sinorda to combine resources and expertise, promising increased synergy in the clinical development and approval of Sinorda's SLN-T program.
"Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda's pipeline. Supporting Sinorda's development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally."
Dr. Yangzhou Wang, CEO of Proton Advanced
International Medical Industries, Inc. | February 28, 2022
IMI bolsters expertise in secure drug delivery products with the release of new Prep-Lock Tamper Evident Cap for ENFit® and Oral Syringes with incorporated Radio Frequency Identification (RFID) technology.
IMI's Prep-Lock line of Tamper Evident Products helps ensure medication safety from pharmacy to patient. The DoseID certified RFID Technology presents an opportunity to augment the proven benefits of tamper-evident products. "RFID technology represents the future of inventory management and medication safety. This technology aligns perfectly with IMI's core business strategy of providing drug security solutions to healthcare institutions worldwide," says Bryan McGurn IMI Senior Vice President of Sales & Marketing.
Prep-Lock Tamper Evident Caps are an established method for providing safeguards to ensure medication safety. Tamper Evident Caps for ENFit and Oral Syringes offer the same high-value risk mitigation as the IV Caps utilized by 84% of the top outsource compounders in the US. RFID technology enables real-time scanning that optimizes inventory management, efficiency, and medication safety while creating quantifiable pharmaceutical supply chain benefits by providing item-level inventory visibility. Every drug secured with a Tamper Evident Cap featuring RFID is trackable throughout its entire lifecycle. These two powerful technologies in combination enhance workflow efficiencies, eliminate time-consuming manual inventory control processes, provide assistance with growing regulatory demand, and supply a comprehensive strategy to prevent, detect, and resolve drug diversion events. In addition, Tamper Evident Caps with incorporated RFID technology offer a significant reduction in RFID implementation costs.
IMI joined DoseID, a consortium of RFID proponents in 2020 to support the interoperability, quality, and performance of RFID tagged products. The DoseID RFID tag, now incorporated in the Prep-Lock Tamper Evident Cap, is certified by Auburn University RFID Lab's ARC Program to ensure the high standards set by the DoseID consortium are met and that those standards meet the needs of the healthcare industry.
"We're using RFID tags to automate some of our inventory management and get better insight into inventory movement," says Dr. Paul Stranges, PharmD, BCACP, AE-C Clinical Assistant Professor at the Department of Pharmacy Practice at The University of Chicago's College of Pharmacy. "It really helps our efficiency." Incorporating RFID technology in IMI's Tamper Evident Cap delivers a significant advantage in supply chain management. They offer both hospitals and outsource compounding operations an efficient and cost-saving method for applying RFID benefits to their drug preparations.