Leading Pharma LLC

UPPSALA, SWEDEN / ACCESSWIRE / March 7, 2024 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica, active in blood-based cancer monitoring, has signed a master service agreement with a leading tier-1 pharmaceutical company, enabling Biovica to provide its TKa testing assay and testing services. The agreement holds room for several expected work orders, the first of which is 1.7 MSEK. This service agreement enables the evaluation of cell proliferation activities in pivotal drug development studies. The test service is focused on the use of the Biovica's TKa assay and expertise within the interpretation of TKa measurement dynamics. "This agreement confirms the Pharma interest in using our assay to measure changes in tumor cell proliferation during drug development activities and potentially further leading into the development of a Companion Diagnostic (CDx) product. It is an important step for Biovica to support pharma in the development of new improved cancer therapies that benefit cancer patients," said Anders Rylander, CEO of Biovica. Contact Anders Rylander, CEO Phone: +46 76 666 16 47 E-mail: anders.rylander@biovica.com Anders Morén, CFO Phone: +46 73 125 92 46 E-mail: anders.moren@biovica.com Biovica - Treatment decisions with greater confidence Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: Attachments Biovica signs master service agreement for TKa testing with leading pharma company SOURCE: Biovica International View the original press release on accesswire.com

MAHWAH, N.J.--( BUSINESS WIRE )-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”) , a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce a clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials. The custom product developed for this clinical trial under a prior agreement was built off the foundation of the KORU Medical Freedom System and tailored to meet the unique subcutaneous infusion administration specifications of this novel drug. This significant milestone represents an essential advancement in developing novel therapies for patients with immunological disorders. The Phase 3 trial aims to assess the safety, efficacy, and performance of the SCIg drug in treating various medical conditions, including autoimmune diseases, primary immunodeficiency disorders, and neurological disorders. The newly developed custom device, designed by KORU Medical's team of experts, includes advanced technology and user-friendly interfaces to enhance patient comfort and ensure precise therapy delivery. “We are proud of our role in developing devices that meet large volume subcutaneous delivery needs, demonstrating KORU Medical’s ability to support our pharmaceutical partners’ drug development process and patient needs,” said Linda Tharby, President and CEO of KORU Medical. "We are excited to announce the execution of this Phase 3 clinical supply agreement, marking a critical step forward in our commitment to advancing healthcare through innovation. Assuming successful completion and results of the Phase 3 trial, we expect to file a 510k and commercialize with this novel SCIg drug." About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom 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 www.korumedical.com . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to those relating to the Company’s development of a customized Freedom System, submission of a device for FDA clearance, entry into AICs and AISs, and continuing leadership in large volume subcutaneous infusion. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, success of the feasibility study, agreement with the pharmaceutical manufacturer with respect to customization of the system, successful development of the system, obtaining regulatory clearances, and by those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, which are on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov . All information provided in this release and in the attachments is as of March 11, 2024. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

SANTA CLARA, Calif., May 23, 2023 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. For more information, visit . Further Information Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, 359269@email4pr.com View original content to download multimedia: SOURCE ValGenesis Inc.