Veracyte Inc. reported that its Prosigna breast cancer assay significantly reduced the use of chemotherapy in patients with high-risk, early-stage disease at the European Society for Medical Oncology 2023 in Berlin this week. The findings came from the EMIT study, a prospective, multi-year, population-based study in women in Norway that is assessing the impact of the Prosigna test on treatment decisions and outcomes.
In February, Viewray Inc. said it expected to post 25% to 40% revenue growth this year. By April, the company said delays in installations would cut growth to 0% to 15% and it announced it was pursuing strategic alternatives with Goldman Sachs. Less than a month later, on May 10, the company withdrew its guidance entirely citing “the current market conditions and ongoing strategic process.”
Presentations at the Digestive Disease Week 2023 conference highlighted the strong performance of non-invasive tests for early-stage colorectal cancer. Both Guardant Health Inc. and Exact Sciences Corp. aim to increase acceptance of their tests for CRC to drive higher screening rates, as the preparation and invasive nature of colonoscopy continue to depress participation, even as rates of CRC are rising sharply among younger adults.
Baxter International Inc. agreed to divest its Biopharma Solutions (BPS) business to private equity firms Advent International and Warburg Pincus for $4.25 billion. Baxter expects to net approximately $3.4 billion from the transaction, which it will use to pay down debt. The deal is anticipated to close in the second half of 2023.
Citing significant concerns of bacterial contamination, the FDA urged consumers and health care providers to stop using specific lots of SD Biosensor Inc.’s Pilot COVID-19 At-Home Tests, which were distributed by Roche Diagnostics Systems Inc. The agency warned that direct contact with the contaminated liquid solution could pose safety issues as well as impair the test’s performance.
Insulet Corp. once again broke records with a nearly 50% increase in Omnipod revenues in U.S. in the first quarter and a 32% increase in revenue from the tubeless insulin delivery device worldwide. In an unusual move following such positive quarterly results, the company simultaneously announced a major shake-up in the leadership team, with multiple senior members moving to new positions starting July 1. The latest round of musical chairs comes almost exactly a year after the last at the Insulet, when Founder, President and CEO Shacey Petrovic stepped down and Jim Hollingshead assumed the top spot.
In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials to advance research in medical devices, drugs and biologics.
In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials (DCTs) to advance research in medical devices, drugs and biologics. This week’s announcement responds to the Food and Drug Omnibus Reform Act, signed into law late last year, which required the agency to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices.”
Patient Square Capital bankrolled a new portfolio company, Elevage Medical Technologies, with $300 million to provide capital and strategic expertise to promising medical device companies. Evan Melrose, founding managing director of Spindletop Capital and a practicing family medicine physician, will lead Elevage.
Avertix Medical Inc. signed a definitive merger agreement with Bios Acquisition Corp., a special purpose acquisition company (SPAC), in a deal that will take the company public on the Nasdaq. The deal will establish the combined entity, which will continue under the Avertix name and trade as AVRT, with an estimated enterprise value of $195 million. The transaction is expected to close in the second half of the year.
