Building on the U.S. FDA approval of its Proclaim Plus spinal cord stimulation (SCS) system in August, Abbott Laboratories notched another approval with the FDA’s greenlight of the Eterna spinal cord stimulation system.
Cofactor Genomics Inc. opened the non-small-cell lung cancer portion of its study of the Oncoprism test, which predicts response to immunotherapy. The Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies (PREDAPT) trial will study the test’s predictive ability in 11 cancers in total.
The move away from in-clinic testing continues, with another company offering a convenient, at-home sensor that gathers critical health information without requiring any change on the part of the patient, which may provide even more accurate, real-world data on patient health than the tests they replace.
Third Pole Therapeutics Inc. received a $32 million equity investment from an unnamed U.S.-based ‘large medical device innovator’ in the cardiopulmonary field. Third Pole’s lead product, the portable Enocare device, produces nitric oxide on-demand using ambiant air and electricity.
Tandem Diabetes Care Inc. entered a definitive agreement to acquire AMF Medical SA for CHF 62.4 million (US$67.1 million) in cash at closing plus future payments of as much as CHF 129.6 million (US$139.43 million) contingent on meeting certain milestones. Tandem also invested CHF 8 million (US$8.6 million) in AMF in the third quarter of 2022. The transaction is expected to close in January 2023.
Less than a month from its launch as a stand-alone business on Jan. 4, 2023, GE Healthcare Holding LLC provided a glimpse of its future plans for growth and anticipated financials for investors. The soon-to-be-launched company is hardly waiting until its spinoff to look for tuck-in acquisitions to boost sales and profitability and add new capabilities for customers and patients.
Boston Scientific Corp. offered $523 million in cash for 65% of Acotec Scientific Holdings Ltd., a manufacturer of vascular intervention devices. The acquisition would significantly expand Boston Scientific’s presence in China, which the company expects to account for about 25% of the global med-tech market by the end of the decade. The transaction is expected to close in the first half of 2023, subject to shareholder approval. The offer price of HK$20 or US$2.57 per share represents a premium of more than 31% over its close on Friday, Acotec reported.
Avenda Health Inc. secured FDA 510(k) clearance for its Iquest platform, which uses artificial intelligence to map the location of a tumor within the prostate. The visualization created provides better assessment of the extent of the malignancy and improves selection of treatments. Avenda raised $10 million in August to support development of Iquest, which guides the company’s Focalpoint laser ablation system.
Dexcom Inc. ends 2022 on a high note with broad clearance from the U.S. FDA for its G7 continuous glucose monitoring system (CGM). The long-awaited 510(k) clearance encompasses use in people with all types of diabetes age two and older, positioning Dexcom to take advantage of expanded coverage of CGMs to include individuals on basal insulin-only for Medicare beneficiaries as proposed by CMS in October.
Pancreatic cancer is the deadliest of cancers with just one in nine patients surviving five years after diagnosis. The low rate of survival largely results from the late stage at which the cancer is first detected, as 65% patients are not diagnosed until the disease has metastasized. Bluestar Genomics Inc. hopes it has developed an assay that can detect the cancer much sooner, allowing patients and their physicians to get ahead of the malignancy well before it spreads.
