No one is looking in the rearview mirror at Medtronic plc as a fresh U.S. FDA approval for the next generation version of its intrathecal drug delivery system allows the company to leave behind a spate of problems associated with its Sychromed II device. The device delivers medication directly to the fluid surrounding the spinal cord via a small catheter positioned to deposit the drug at the site of most severe pain. The targeted delivery improves management of chronic and cancer-related pain as well as management of severe spasticity without use of systemic opioids.
AOA Dx Inc. closed an oversubscribed $17 million seed round to expand the clinical trial for its ovarian cancer diagnostic test, build out new lab facilities and explore applications of its Glycolocate platform in other cancers. The platform uses tumor marker gangliosides to enable early cancer. A recent study demonstrated that the test had more than 90% sensitivity and specificity for ovarian cancer detection across all stages.
Precede Biosciences Inc. emerged from stealth having raised $57 million in seed and series A financing to fund its genome-wide platform. The blood-based platform detects and provides critical insight into the biological activity of genes and pathways in diseased tissue to improve care and development of new therapeutics.
At its annual investor day at the American Society for Radiation Oncology meeting in San Diego, Accuray Inc. reported that its Tomo C radiation therapy system obtained approval from the Chinese National Medical Products Administration for the country’s type B market. The system will be made in China through the company’s joint venture, CNNC Accuray (Tianjin) Medical Technology Co. Ltd.
Providing the right therapy at the right time has proven more difficult in the world of cancer than in other disease areas thanks to the variability in treatment response, but a new study hints that this problem may be at least partly solved for non-small cell lung cancer (NSCLC). A study presented at this year’s meeting of the American Society for Radiation Oncology (ASTRO) in San Diego shows that circulating tumor DNA (ctDNA) can provide therapeutic guidelines for oligometastatic forms of the disease, including when high-dose radiation therapy may or may not be indicated.
Patients with metastatic brain tumors are among the most desperate of patients for at least a modestly effective treatment let alone a cure, and GT Medical Technologies Inc., of Tempe, Ariz., reported the interim findings from a study of 48 patients suffering from a total of 51 brain metastases. Four-month data from this study demonstrate that implant of the Gammatile device is safe as demonstrated by the lack of adverse events, and these results combined with other data suggest that this device can offer this patient population real hope of surviving one of the deadliest series of afflictions known to humankind.
The receipt of a reimbursement code for the Episwitch Prostate Screening (PSE) test developed by Oxford Biodynamics plc, following its recent launch, is good news for men frustrated with the inaccuracies in prostate-specific antigen (PSA) tests and the lack of alternatives, Jon Burrows, CEO of Oxford Biodynamics told BioWorld.
U.S. researchers reported seeking patent protection for methods to neutralize circulating tumor cells (CTCs) during hemodialysis to prevent cancer metastasis and reduce cancer-related deaths.
In a positive sign for its future success, Harbinger Health Inc. closed a $140 million series B fundraising round, bringing total funds raised since its founding in 2020 to $190 million. The new funds will be used to support completion of the company’s CORE-HH 10,000 participant study of its blood-based multicancer early detection (MCED) test. The company expects to complete enrollment in CORE-HH, a three-part case control, adaptive study with development, validation and longitudinal cohorts in 2024.
Mission Bio Inc. released its Tapestri single-cell minimal residual disease (MRD) assay for acute myeloid leukemia (AML) on September 26, with the goal of enabling greater personalization of care for patients with blood cancers. The test can provide insights into the progression of AML and help identify targets for treatment in addition to identifying patients truly experiencing relapse as distinct from having pre-leukemic or precursor clones.