Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
Field Medical Inc. continues to reap funding from investors for its pulsed field ablation (PFA) system with a $35 million oversubscribed series B financing round. With treatment of atrial fibrillation already upended by PFA technology, Field sees ventricular tachycardia as a fertile new territory for transformation.
After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. returned to buy the company. This morning, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could receive U.S. FDA approval as early as this quarter and plans to launch Globe in the U.S. this year.
Aortic valve repair and replacement continue to grab attention appropriate for the number of people affected, but the heart’s other three valves are finally gaining some respect as med-tech companies and analysts recognize the size of the potential total addressable market.
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
The rapid adoption of the Omnipod 5 answered a question automated insulin delivery system manufacturers posed for years: with clear health benefits and payer coverage, why has pump adoption been so slow? Insulet Corp.’s Omnipod 5’s rapid rise to dominance demonstrated unequivocally that people with diabetes want a stick-and-forget device. The American Diabetes Association’s 85th Scientific Sessions in Chicago on June 20-23 made just as clear that pump makers received the message with several companies outlining plans to introduce a patch system in the next two years.
Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.
