Mauna Kea Technologies (Paris), inventor of Cellvizio, the unique trans-disciplinary optical biopsy platform, reported a new collaboration with Siemens Healthcare to evaluate the clinical benefits of Cellvizio in interventional radiology procedures. Cellvizio's needle-based optical biopsy technology will be used in combination with Siemens Angiography & Interventional X-ray (AX) and Computed Tomography (CT) imaging systems in two clinical studies taking place at the Hôpital Européen Georges Pompidou (HEGP) in Paris and the University Hospital in Strasbourg, France.
Doctors will use the Cellvizio and Siemens AX and CT technologies combined in a range of interventional radiology procedures, which is a growing field in medicine, representing a potential multimillion procedure volume in the world each year. In this process, doctors insert a small needle, guided by X-ray, into tissue to perform biopsy or ablation. The two clinical trials will focus on procedures involving the lungs, liver and kidneys. Patients will receive a full examination using a combination of Cellvizio and Siemens imaging and guiding technologies.
"We strongly believe that real-time cellular information can enhance reliability and efficiency of biopsies and treatments by providing feedback on the adequacy of the location targeted, and streamline patient management," said Afshin Gangi, Interventional Radiologist and chairman of Radiology at University Hospital in Strasbourg.
"We are very interested in pioneering the evaluation of Optical Biopsy in Interventional Radiology procedures as the HEGP is a center of excellence in Interventional Oncology and has always been at the forefront of innovation, added Marc Sapoval, chairman of the Cardiovascular Radiology department at HEGP.
Both studies will provide quantitative and qualitative results on the feasibility and effectiveness of the device combination. Several additional teams around the world are also evaluating the benefits of Cellvizio in interventional radiology under their own study protocols.
Cellvizio is currently not approved for interventional radiology applications and is considered experimental in these protocols.
Biocon expands with CytoSorbents for cytokine reduction
Biocon (Bangalore, India), and U.S.-based CytoSorbents (Monmouth Junction, New Jersey) reported that they have expanded the scope of their strategic partnership for CytoSorbents' CytoSorb cytokine reduction therapy to treat patients experiencing severe whole body inflammation, often called a Systemic Inflammatory Response Syndrome (SIRS). SIRS is caused by a wide range of life-threatening conditions seen in the intensive care unit and can also be caused by surgical interventions, particularly cardiac surgery.
Biocon says it will now have the exclusive, region-wide rights to distribute CytoSorb for all critical care applications in the intensive care unit (ICU) as well as cardiac surgery applications for India and select emerging countries. As part of the expanded agreement, Biocon will also play a prominent leadership role in the generation of new clinical evidence to support the adoption and usage of CytoSorb. This includes commitments to conduct and publish results from multiple Investigator Initiated Trials (IITs) and patient case studies.
So far, the response to CytoSorb for the management of sepsis has been very encouraging, according to the compnay, with hundreds of patients in India having benefitted from this novel therapy. The expanded usage of CytoSorb in other applications could improve patient outcomes and save precious lives.
Abhijit Barve, president, R&D, Biocon, said, "While our initial focus has been on sepsis, physicians are increasingly identifying conditions where very high levels of cytokines are known to cause multiple organ failure. We also believe there is a significant unmet medical need to manage high risk patients undergoing cardiac surgery by using CytoSorb to control inflammation. We are excited about working together with CytoSorbents and look forward to playing an important role in advancing the clinical development of this product."
Biocon partnered with CytoSorbents in 2013 to launch CytoSorb, a 'first-in-class' therapy to enable physicians to treat sepsis, the overactive immune response to a serious infection. Over the past year, Biocon has created a dedicated sales force that is solely focused on promoting CytoSorb across multiple cities in India. CytoSorb, an extracorporeal cytokine filter, has been enthusiastically embraced by physicians as a safe and well–tolerated therapy for managing sepsis in critically-ill patients. By reducing toxic levels of cytokines, CytoSorb targets the modulation of the body's excessive immune response and the prevention or treatment of organ failure, the cause of nearly half of all deaths in the ICU.
Severe sepsis and septic shock are major causes of morbidity and mortality worldwide. It is a leading cause of death in non-coronary ICUs and the 11th leading cause of death overall. Over a third of patients who develop sepsis die globally, even when the best standard of care is available. In India, more than one million estimated new cases of severe sepsis are treated in the Indian ICUs each year, accounting for one out of every four patients in the ICU. According to a recent nationwide study of Indian Intensive Care Case Mix and Practice Patterns involving more than 124 ICUs across 17 states in India, mortality was found to be as high as 46% in patients with septic shock and 42.2% overall in septic patients, compared with 17.8% mortality for ICU patients who did not develop sepsis.
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