The FDA granted breakthrough device designation to Histosonics Inc. for the first system to harnesses microbubbles created by pulsed ultrasound waves to wreak very targeted cellular destruction, with real-time visualization and control. The therapy, called histotripsy, destroys tissue in the liver without heat, radiation or surgery. The technology was developed at the University of Michigan.
Genome sequencing initiated to investigate how chronic liver disease leads on to hepatocellular carcinoma has instead uncovered mutations that impact fat metabolism and reduce the sensitivity of hepatocytes to insulin.
LONDON – Following on from the $25 million up-front payment received on sealing their recent research collaboration, Mina Therapeutics Ltd. is now in line for a $15 million equity investment from Eli Lilly and Co. Inc.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment. The small-molecule drug, independently developed by Zelgen, is a multitarget kinase inhibitor.
HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform.
Sporos Bioventures LLC closed a $38.1 million series A financing to develop a pipeline of therapies for treating cancer and immune diseases through four companies with a business structure that its chief financial officer, Michael Wyzga, described as a hub-and-spoke model that leans on diversification.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
