Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers identified through its blood-based multi-cancer early detection (MCED) test remained cancer-free more than four years after diagnosis. Half of all the participants with cancer detected remained alive at four years, notable because most of the detected cancers had no recommended screening tests or standards. The results will be presented at the American Society of Clinical Oncology meeting June 2-6.
Medtronic plc agreed to acquire Eoflow Co. Ltd., the manufacturer of Eopatch, a tubeless, wearable and fully disposable insulin delivery service, for $738 million. The deal, which is expected to provide a significant boost to Medtronic’s beleaguered diabetes unit, is slated to close in the second half of 2023. The deal announcement coincided with Medtronic’s release of its fourth quarter results for fiscal 2023.
Artivion Inc. (formerly Cryolife Inc.) received U.S. FDA premarket application (PMA) approval of its Perclot absorbable hemostatic system and promptly sold the product line to Baxter International Inc., in keeping with the terms of an agreement announced in July 2021. Artivion will begin shipping Perclot product to Baxter following receipt of a milestone payment of $18.75 million in cash, of which $4.5 million will go to Artivion’s former partner Starch Medical Inc.
Beta Bionics Inc. received U.S. FDA clearance for its Ilet Bionic Pancreas, an automated insulin-delivery (AID) system that calculates 100% of insulin doses without requiring carb counting or manual boluses. The system—a pump plus dosing decision software—is indicated for people aged six years and up with type 1 diabetes.
A collaboration between Aegis Ventures LLC and Northwell Holdings invested $12 million to launch New York-based Optain Inc., an artificial intelligence company created to enable early identification and disease prevention through retinal imaging. Retinal imaging is well known for identifying eye diseases including diabetic retinopathy, age-related macular degermation and glaucoma, but it can also provide insight into cardiovascular and neurological conditions.
Shockwave Medical Inc. enrolled the first patient in its EMPOWER CAD study, the first prospective, all-female study of percutaneous coronary intervention (PCI). The study seeks to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions. Women have historically been underrepresented in cardiovascular trials and have had less favorable outcomes in response to therapies.
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
Ravgen Inc.’s patent litigation strategy could add another $100 million to the company’s coffers, assuming enhanced damages in its suit against Laboratory Corp. of American Holdings (Labcorp) awarded on May 12 are sustained on appeal. The additional damages are on top of the $272.5 million awarded in September for “egregious” violations of Ravgen’s patents on non-invasive prenatal testing methods.
The U.S. Securities and Exchange Commission (SEC) reported that Royal Philips NV will pay more than $62 million in connection with “irregularities in the medical device industry” related to its Chinese subsidiaries. The charges arise from actions that occurred between 2014 and 2019 from sales of medical diagnostic equipment in China.
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.
