Investors in Cathvision ApS are backing the company with an additional $7.2 million to accelerate U.S. commercialization of its electrophysiology (EP) recording system, Ecgenius. The ECG support technology is designed to detect cardiac electrograms with minimal baseline noise so electrophysiologists can accurately interpret complex arrhythmias, including atrial fibrillation (AF). In May, the U.S. FDA granted the Copenhagen-based company 510(k) clearance for the system.
Nanodx Inc. is readying for a U.S. pivotal trial of its nanowire biosensor technology. The company’s flagship product is designed to detect and quantify biomarkers proteins from a small fluid specimen of blood or saliva in less than four minutes and was developed in partnership with Skywater Technology Inc. and IBM Research. The privately held company is focusing on two clinical indications: traumatic brain injury (TBI) and COVID-19.
Moximed Inc. has received $40 million in series C financing to pursue regulatory approval for its implantable shock absorber (ISA) for knee osteoarthritis (OA). Fremont, Calif.-based Moximed secured backing from investors including Advent Life Sciences, New Enterprise Associates, Future Fund, Vertex Healthcare and Runway Growth Capital to advance the Misha knee system. The company is touting the technology as the world’s first implantable shock absorber for OA.
Monod Bio Inc. raised a $25 million seed financing round to advance its protein-based biosensor technology. The round was led by Matrix Capital, with participation from the Global Health Investment Corp., Cercano Management, the Washington Research Foundation, Boom Capital Ventures, Sahsen Ventures, and Pack Ventures. The funds will be used to create protein biosensors for rapid point-of-care medical diagnostics and biotechnology applications.
The U.S. FDA granted Preceptis Inc. an expanded clearance for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube procedures. The device was previously cleared in children 6-24 months, but the new clearance allows in-office procedures in all children six months and older. The minimally invasive device is designed to create an incision so the ear tube can be delivered using a single pass down the ear canal, without the use of general anesthesia.
Integrated Graphene Ltd. is partnering with a team of scientists at the University of Edinburgh to develop a point-of-care biomedical test for liver transplants. The Sensibile project team is working to develop a prototype electrochemical biosensor that can detect biliary complications’ biomarkers in donor livers. Sterling, Scotland-based Integrated Graphene’s 3D graphene foam electrode will help to assess the viability of the biliary compartment, and the quality of the donor liver prior to transplantation.
Investors are backing Levita Magnetics International Corp. with $26 million to advance its new Magnetic-Assisted Robotic Surgery (MARS) platform. The series C financing round was led by Ballast Capital, with participation from Medtex Ventures, Invermaster and Carao Ventures. The new platform builds on the company’s first commercial device, the Levita Magnetic Surgical system which received U.S. FDA approval in 2015. The system enables reduced-port laparoscopic surgical procedures and consists of an external magnet that is placed on the skin and controls a magnetic grasper inside the abdomen during surgery.
Dartmouth College spinoff Nanopath Inc. closed a $10 million series A funding round to commercialize a point-of-care biosensing platform with ultrasensitive optical detection. The startup is developing a rapid test that provides genetic information in less than 15 minutes without the need for nucleic amplification. To date, the company has generated preliminary data in two clinical indications focused on women’s health: human papillomavirus genotyping and urinary tract infection characterization.
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.