Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
Continuing its aggressive buying spree, Bruker Corp. entered into a definitive share purchase agreement with Tecfin S.à r.l. to acquire molecular diagnostics (MDx) company Elitechgroup SAS for €870 million (US$943.5 million), excluding the Elitech clinical chemistry business. The deal is expected to close in the second quarter of 2024 and will be funded with a mix of cash on hand and debt financing.
Alamar Biosciences Inc.’s substantially oversubscribed series C pushed the company’s total funds raised to $250 million. The company closed the first $100 million on Feb. 26 and expects to close an additional $28 million within 30 days. The target for the series C was $100 million. The funds will be used to drive market adoption of its Argo HT system and nucleic acid linked immune-sandwich assay sequencing (NULISAseq) inflammation panel 250 for deep profiling of immune response.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.
Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).
Reprieve Cardiovascular Inc. landed $42 million in its first fundraising round out of stealth to fund development of its acute decompensated heart failure treatment. The series A round will support clinical and development programs, including the ongoing FASTR trial and Reprieve’s upcoming pivotal trial.
Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
The slow pace of financing in med-tech appears to have stimulated cardiac arrhythmia technology developer Adagio Medical Inc. to turn to a special purpose acquisition company (SPAC) in a type of deal that has all but vanished in the last year. The company signed an agreement with Arya Sciences Acquisition Corp. IV to combine in a reverse merger deal that will result in Adagio’s listing on Nasdaq under “ADGM.”
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”