North American Science Associates Ltd.

Hemopurifier is a clinical stage immunotherapeutic device designed to fight cancer, life-threatening viral infections, and for use during organ transplantation A product image of Aethlon Medical’s Hemopurifier. (Credit: PRNewsFoto/Aethlon Medical, Inc.) Aethlon Medical has reported positive results for its Hemopurifier system in an in vitro binding study in removing extracellular vesicles (EVs) from plasma. Hemopurifier is a clinical stage immunotherapeutic device designed to fight cancer and life-threatening viral infections. It is also aimed to be used during organ transplantation. The system has received breakthrough device status from the US Food and Drug Administration (FDA) to treat those with advanced or metastatic cancer who either do not respond to or cannot tolerate standard therapy. It also has the same designation for cancer types where exosomes support disease progression or severity. Additionally, the Hemopurifier device has FDA breakthrough status and an open investigational device exemption (IDE) application for addressing life-threatening viruses lacking approved therapies. In human studies, the Hemopurifier has shown effectiveness in eliminating life-threatening viruses. It has also demonstrated its ability to remove detrimental exosomes from biological fluids in pre-clinical trials. According to Aethlon Medical interim CEO and chief financial officer James Frakes, the robust translational study specifically assessed the removal of EVs and EVs with PD-L1 on their surface directly from plasma. The samples were obtained from patients undergoing anti-PD-1 antibody treatment through collaboration with a third-party lab. Aethlon Medical processed the plasma samples using a miniature version of the Hemopurifier. Subsequently, the samples went for evaluation at Cellarcus Biosciences using Vesicle flow cytometry methodology. The data was then analysed at NAMSA, the medical therapeutic company’s chosen contract research organisation (CRO) for the planned Australian oncology study. Frakes said: “The positive data from this in vitro binding study of the Hemopurifier is an important step forward for Aethlon, ahead of the potential start of our planned Phase 1 oncology trials in Australia and India. “We have previously demonstrated that our Hemopurifier can reduce EVs isolated from cancer patient plasma when those EVs are placed in a buffer solution.” The translational study has generated pre-clinical evidence to back Aethlon Medical’s forthcoming Phase 1 clinical trial. The Phase 1 study is intended to assess the safety, feasibility, and dosage determination of the Hemopurifier in patients with solid tumors. It will assess patients who have stable or progressive disease while undergoing anti-PD-1 monotherapy therapies like Keytruda or Opdivo.

A new endovascular catheter, recently approved by the U.S. Food and Drug Administration (FDA), is paving the way to more effective and safe treatment for acute pulmonary embolism. Already shown to be effective for reducing blockages in lung arteries, new research shows that this catheter also reduces blockages in the smaller segmental pulmonary artery branches. These branches are ultimately responsible for oxygenating the blood in the lungs. The new study, which was part of the National Institutes of Health-sponsored multicenter RESCUE clinical trial, further showed a correlation between decreased numbers of blockages in the small lung arteries and functional recovery of the right ventricle of the heart, which pumps blood into the main pulmonary artery of the lungs. Compared to other devices, the BASHIR™ catheter also had significantly lower bleeding rates, a key advance in acute pulmonary embolism treatment. The findings are described in JACC: Advances. The BASHIR™ Endovascular Catheter (THROMBOLEX, Inc.), recently approved by the U.S. Food and Drug Administration (FDA), is paving the way to more effective and safe treatment for acute pulmonary embolism. Already shown to be effective for reducing blockages in lung arteries, new research at the Lewis Katz School of Medicine at Temple University shows that the BASHIR™ catheter also reduces blockages in the smaller segmental pulmonary artery branches. These branches are ultimately responsible for oxygenating the blood in the lungs. The new study, which was part of the National Institutes of Health-sponsored multicenter RESCUE clinical trial, further showed a correlation between decreased numbers of blockages in the small lung arteries and functional recovery of the right ventricle of the heart, which pumps blood into the main pulmonary artery of the lungs. Compared to other devices, the BASHIR™ catheter also had significantly lower bleeding rates, a key advance in acute pulmonary embolism treatment. The findings are described in JACC: Advances. "Blockages in these smaller, distal pulmonary arteries have never previously been explored in patients treated for acute pulmonary embolism," explained Riyaz Bashir, MD, FACC, Professor of Medicine, Director of Vascular and Endovascular Medicine in the Section of Cardiology, Department of Medicine at the Lewis Katz School of Medicine and Temple University Hospital, co-inventor of the BASHIR™ Endovascular Catheter, and first author on the new report. The BASHIR™ catheter is a small tube-like device that consists of a helical basket with six mini-infusion catheters at its farthest end. When the infusion basket is expanded within a clot in a large blood vessel, new channels open, enabling blood to flow through the clot. Blood that flows through carries the body's clot-dissolving chemicals into the channels, accelerating clot breakdown. Researchers at THROMBOLEX™ Inc. were involved in developing and commercializing this platform technology. The occlusion of small lung arteries is the major reason for the reduction in blood flow in patients with acute pulmonary embolism. "The more occlusions a patient has, the lower their survival," Dr. Bashir said. "Among the treatment goals is relieving obstructions in both large and small arteries." Patients who survive may, over more extended periods, be at high risk of developing chronic thromboembolic pulmonary hypertension (CTEPH), which is a life-threatening condition caused by increased blood pressure in the lungs. In the new study, Dr. Bashir and colleagues observed reductions in occlusions in segmental and proximal branches of the pulmonary artery 48 hours following treatment with the BASHIR™ catheter. The blockages decreased even in those arteries that were distant from where the infusion basket was located, enabling improved blood flow and healing of the right ventricle. "We suspect that the improvements in blood flow are due to both the expansion of the basket and the flow of the body's clot dissolving molecules into the clot, which cause the blockage to shrink," Dr. Bashir said. "As the volume of blood flow improved, right ventricular function also improved, which could translate to better survival." In future work, Dr. Bashir and colleagues plan to investigate mechanisms behind the observed reductions in arterial blockage. More extensive trials are also needed to understand better the impact of treatment with the BASHIR™ catheter on patient survival and incidence of CTEPH. Other researchers who contributed to the new study were Gregory Piazza, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston; Brian Firth, Thrombolex Inc, New Britain, Pennsylvania; Kenneth Ouriel, NAMSA (SYNTACTX), New York; Akhilesh Sista, Division of Interventional Radiology, Department of Radiology, Cornell University School of Medicine, New York; Parth Rali, Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University; Anthony Comerota, Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, Virginia; Vladimir Lakhter, Division of Cardiovascular Diseases, Lewis Katz School of Medicine, Temple University; Ayman Iskander, Division of Cardiology, St Joseph's Hospital, Syracuse; Malcolm Foster, Department of Cardiology, East Tennessee Heart, Turkey Creek, Knoxville; Ripal Gandhi, Division of Interventional Radiology, Miami Cardiac and Vascular Institute, Miami, Florida; Amir Darki, Department of Cardiology, Loyola University Medical Center, Maywood, Illinois; Robert Lookstein, Department of Radiology, Mount Sinai Hospital, New York; and Kenneth Rosenfield, Department of Cardiology, Massachusetts General Hospital, Boston. Dr. Bashir is a co-founder and has an equity interest in Thrombolex, Inc., a medical device company developing interventional catheter-based therapies for the rapid and effective treatment of acute venous thromboembolic disorders. Temple University also holds financial interests in the BASHIR™ Endovascular Catheter and other Thrombolex products pursuant to the license granted to Thrombolex for the University's interest in patents co-invented by Dr. Riyaz Bashir. As a result of these interests, Temple University could ultimately potentially benefit financially from the outcome of this research. These interests have been reviewed and approved by Temple University in accordance with its Institutional Conflict of Interest policy.

North American Science Associates (NAMSA) recently opened its expanded preclinical lab near Minneapolis. It is “the biggest worldwide preclinical facility dedicated to medical medtech services,” NAMSA CEO Christophe Berthoux said in a promotional video by Medical Alley. The facility — at 8945 Evergreen Boulevard in Coon Rapids, Minnesota — now has six cath labs and three operating rooms. The company said it added one more of each in the expansion to reduce wait times for procedures. “We can do all sorts of different development studies for medical device manufacturers, all the way from very basic interventional procedures such as stent placement to highly complex studies” such as extracorporeal membrane oxygenation (ECMO), NAMSA SVP of Global Laboratory Operations Lisa Olson said in the video. Toledo, Ohio-based NAMSA also expanded the facility’s lobby, break room, and locker space. NAMSA announced the expansion in November 2021, saying it would add 55,000 ft² to the campus, which totaled 130,000 ft² at the time. The medtech contract research organization said wait times were as long as nine months at competitors. Berthoux became NAMSA’s CEO in March 2021 after his private equity firm, ArchiMed, took a majority stake in the organization in September 2020. Since then, NAMSA has completed at least eight acquisitions, including American Preclinical Service, Syntactx and — most recently — The Clinical Research Institute.