A biomarker found in spinal fluid can detect Parkinson’s disease in individuals with the disease and may flag those at risk years before symptoms develop, a study published in The Lancet Neurology found. The breakthrough, which could enable diagnosis of the disease for the first time in patients who do not exhibit a movement disorder, was achieved by an international coalition of scientists led by the Michael J. Fox Foundation (MJFF) as part of its landmark clinical study, the Parkinson’s Progression Markers Initiative (PPMI).
Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory greenlight for the durable medical equipment component received, the company is now pursuing coverage by the CMS for the entire Freestyle Libre 3 system. The system’s sensor received FDA clearance in May 2022.
Motus GI Holdings Inc. undertook further lifesaving measures to survive into 2024 as it continues to seek strategic and financial alternatives that will enable the company to accelerate commercialization of its Pure-Vu endoscopy system. CEO Tim Moran became chairman of the board as former CEO—and current President, Chief Operating Officer and director—Mark Pomeranz added the CEO position to his portfolio.
Viewray Inc., the manufacturer of the Mridian MR-guided radiation therapy system, released disappointing preliminary first quarter 2023 results and shareholders braced for more bad news as the company reported it engaged Goldman Sachs to evaluate strategic alternatives including corporate sale, merger or business combination.
Function Oncology Inc. emerged from stealth on April 12 with the announcement of a $28 million series A financing that will continue support development of its CRISPR-enabled platform to profile cancer in patient-specific detail. The platform goes beyond next-generation sequencing to measure gene function, potentially allowing identification of new therapeutic targets and better matching of available therapies to vulnerabilities in an individual’s tumors.
Becton, Dickinson and Co. (BD) tackled the persistent issue of missed vessels for intravenous (IV) placement with the goal of enabling hospitalized patients to have a ‘one-stick stay.’ The Prevue II system uses the BD Cue needle tracking-enabled system, which offers a high-quality ultrasound image of the needle trajectory in conjunction with real-time needle depth markers.
Pear Therapeutics Inc. filed for bankruptcy protection under chapter 11 to buy time to sell its assets. The company was the first-to-market for prescription digital therapies, with three PDTs gaining regulatory nods from the FDA: Reset for substance use disorder, Reset-O for opioid use disorder and Somryst for insomnia. Reset-A received breakthrough device designation in 2021. The Reset therapies are approved for use in conjunction with medication therapy or other outpatient therapy for substance use.
Heartflow Inc. is feeling the love of investors again as it closed a $215 series F financing round led by Bain Capital Life Sciences. The round marks a return to the equity markets after several years away; the company closed its series E in 2017 and a $65 million venture round in 2019. In early 2022, Heartflow scrapped its plans to go public through a special purchase acquisition company (SPAC) merger with Longview Acquisition, citing what both companies called “current unfavorable market conditions.” Longview had offered $690 million in July 2021, in a deal that implied an enterprise value of $2.4 billion at the time.
Medtronic plc and Davita Inc. launched a new company this week centered on the assets and capabilities of Medtronic’s former Renal Care Solutions (RCS) division. Mozarc Medical US LLC brings Medtronic’s strategic plan to streamline its operations by spinning off several divisions one step closer to fruition.
Mercy Bioanalytics Inc. stepped into the increasingly competitive early cancer detection field with a $41 million series A financing round to support its Halo liquid biopsy platform. Novalis Lifesciences led the oversubscribed round with participation from Sozo Ventures, Hatteras Venture Partners, Iselect Fund, American Cancer Society BrightEdge and Broadway Angels, an all-women venture capital group. Laboratory Corp. of America Holdings, Bruker Corp. and existing investors also contributed to the round.
