US pulsed field ablation market revenue exceeds $500m in 2024

PFA has a lower chance of damaging surrounding structures than methods used before. Credit: Touchr / Shutterstock

Pulsed field ablation (PFA) is a treatment for atrial fibrillation, an irregular heartbeat disorder that can lead to blood clots in the heart and increase the risk of developing other heart problems. PFA has a lower chance of damaging surrounding structures than previous methods. It uses electrical pulses for a targeted approach at destroying abnormal tissue. PFA revenue exploded in the first quarter (Q1) of 2024 following the US Food and Drug Administration (FDA) approvals of Boston Scientific’s FARAPULSE and Medtronic’s PulseSelect. Over the last year, the PFA market has grown to over $500m, reveals GlobalData, a leading data and analytics company.    

In Q4 2024, Medtronic launched its new PFA device, Affera Sphere-9, after receiving FDA approval in late October. In its first month, Sphere-9 made about half of the revenue that FARAPULSE made in its first month after approval, according to GlobalData’s US Healthcare Facility Invoicing Database. In December, two months after approval, Sphere-9’s revenue was at about a quarter of FARAPULSE’s revenue at the same point in its launch cycle.   

Medtronic’s Sphere-9 launched at a lower price than Boston Scientific’s FARAPULSE originally did. It appears that Medtronic is intending to be price competitive with Boston Scientific in order to gain market share. 

Boston Scientific and Medtronic are currently the two major players in the PFA market. Boston Scientific dominated the market with the release of FARAPULSE in Q1 2024, despite PulseSelect’s earlier approval.   

Despite accumulating less revenue than FARAPULSE, Sphere-9 doubled its sales in the second month after its launch. GlobalData notes that Medtronic is threatening to take market share from Boston Scientific if it can build on its current momentum, but the situation may be complicated by new players such as Johnson & Johnson’s Varipulse, which has the potential to shake up the market.

Taking top spot in biotech IPOs this year is CG Oncology – the cancer drug specialist raised $380m when it hit the NASDAQ trading boards in January. This increased to $437m at IPO close after the underwriters exercised the option to purchase additional shares.

Funds raised are going towards CG’s lead asset, cretostimogene grendenorepevec, an oncolytic virus immunotherapy, which is in development for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer.

GlobalData’s business fundamentals senior analyst Ophelia Chan says: “Oncology continued to dominate as the leading therapeutic area for IPOs this year, highlighted by CG Oncology’s $437m upsized IPO—the largest and first of the year. The company’s robust clinical data and ability to secure substantial capital have contributed to its strong performance in 2024.”

After a quiet summer, the IPO market reached full swing in autumn when Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences all opened on the NASDAQ on the same Friday in September. The ‘triple-header event’ saw the three companies pull in over $700m combined. It was no surprise that the surge in activity came after the Federal Reserve’s decision to lower interest rates for the first time in years, ushering in a more inviting funding environment. This fruitful month was a stark contrast to August, which saw a significant global stock market dip amid fears of a US recession.

In June, Telix Pharmaceuticals – an emerging player in the fast-growing radiopharmaceutical space – pulled a last-minute plug on its IPO. The Australian company had been planning to list on NASDAQ and was on course to raise $232m – a value that would have placed it high on the list of biotech IPO sizes this year. Telix cited that its board did not move forward with the plans due to market conditions at the time.

Numb feet, bleeding legs and dehydrated bodies mark their journeys – not to mention infectious diseases and psychological trauma. Studies have identified outbreaks of measles, diphtheria and malaria across Venezuela, while tuberculosis, typhoid and HIV, are also resurgent.

Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.

The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.