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Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

Genius AI Detection Receives FDA Clearance – New Deep Learning-based Software Designed to Help Radiologists Detect Subtle Potential Cancers in Breast Tomosynthesis Images

This new technology, represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius® 3D Mammography™ exam.

Passio Pump Drainage System Granted 510(k) for Additional Indication for Home Use

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion.

Boston Scientific Signs Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific notes SERB, backed by private equity firm Charterhouse Capital Partners since 2017, owns a diversified portfolio of prescription medicines focused on rare and life-threatening diseases.

CytoSorbents Awarded $4.4 Million Contract by the U.S. Department of Defense

CytoSorbents today that the Assistant Secretary of Defense for Health Affairs, endorsed by the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP), has awarded the Company a three-year contract valued at up to $4,421,487 as part of a Peer-Reviewed Medical Research Program Technology/Therapeutic Development Award to complete preclinical development of the HemoDefend™-BGA plasma and whole blood adsorber.

The HemoDefend-BGA filter is designed to enable “universal plasma”, or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products.

This award augments the previously awarded Defense Health Agency Small Business Technology Transfer (STTR) Phase 3 contract of $2,897,172. Funds provided by the CDMRP award will be allocated to complete preclinical development (e.g. final device design, device verification and validation testing, biocompatibility, and sterilization validation testing), the establishment of quality documentation in conformity with CytoSorbents’ certificated, full quality management and quality assurance system, and building clinical inventory.  The goal of the program is to obtain an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to move forward with clinical studies.

Dr. Maryann Gruda, Ph.D., Principal Investigator and Director of Biology of CytoSorbents stated, “We are grateful for the U.S. Army’s strong support and funding of our HemoDefend-BGA technology, which will help us advance it more rapidly to commercialization.  We believe the BGA adsorber will have a momentous impact on the availability of universal plasma and low titer O whole blood (LTOWB) to prevent unnecessary loss of warfighter and civilian life.”

Dr. Phillip Chan, MD, Ph.D., Chief Executive Officer of CytoSorbents, “Hemorrhage from battlefield injuries and civilian trauma is a leading cause of preventable death.  The broader availability of safe blood products that can help resuscitate patients is a key to survival.  Our goal is to leverage this new award to rapidly bring the HemoDefend-BGA anti-A and anti-B adsorber to the markets globally to help save lives.”

The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. The U.S. Army Medical Research Acquisition Activity (USMRAA), 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office for this Award (No. W81XWH2010712). This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Material Command (USAMRMC).

The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Army and the Department of Defense.

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