The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use. Fresenius expects Novalung will be available in the U.S. by the middle of the year.

“We are working diligently to ensure we have a strong supply and can fulfill all orders for the U.S. market when we begin shipping later this year,” company spokesman Brad Puffer told BioWorld when asked about more specifics related to the launch.

Upon launch, the offering will aim help patients in acute respiratory or cardiopulmonary failure get oxygen into their bloodstream or expel carbon dioxide from their bodies. Recent research tied a significant increase in the use of ECMO with evidence of improved survival rates and no increase in hospitalization costs.

Additionally, Novalung offers an alternative to the need for invasive mechanical ventilation, which can cause additional lung injury because of the air pressure required. Novalung offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs and emergency departments.

"Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before," said Mark Costanzo, president of renal therapies group, the technologies and pharmaceuticals division of FMCNA. "We've applied our leadership and technical expertise in renal medical devices to elevate standards for acute respiratory and cardiopulmonary failure treatments and technologies. We're proud to broaden our care offerings to provide new therapies for patients with acute cardiopulmonary conditions."

Robert Bartlett, professor emeritus, section of general surgery, division of acute care surgery, University of Michigan School of Medicine, expressed enthusiasm about the system, saying it will go a long way toward helping patients heal. "The system's pressure sensor technology ensures continuous monitoring and accurate flow control of each patient's blood, allowing the care team the flexibility needed to treat the underlying health issues."

Indeed, its use minimizes the need for invasive ventilation, provides support after multi-organ injuries, and gives better survival outcomes for patients in cardiac arrest.

And the company appears to be well-positioned. “We believe the indications for use granted by the FDA, which allow for more than six hours of extracorporeal life support, put us in a strong competitive position,” Puffer responded when asked if any competition was expected in the near term. “The critical care market has been waiting for a product that can deliver heart and lung therapy for long-term use, and we are proud to be the first ECMO system in the U.S. with this designation.”

He also noted that a retrospective analysis of clinical outcomes highlighted that the system did well in terms of giving heart and lung support, demonstrating its effectiveness for long-term use.

The company does have experience in other markets. “Different versions of the Novalung system, known as the Xenios Console, have been approved for use in Europe, which is why we had significant history around the success of this device,” Puffer said. He reiterated that this system is the only version of this ECMO system with an FDA nod.

Xenios

Parent company Fresenius Medical Care AG & Co. KGaA, of Bad Homburg, Germany, obtained the technology through its 2016 buy of Heilbronn, Germany-based Xenios AG, a specialist in the treatment of lung and cardiac failure.

In 2013, Novalung GmbH and Medos Medizintechnik AG established Xenios AG as a common holding company. On Aug. 30, 2019, Novalung GmbH, was absorbed into Xenios. The goal was to help the company become more closely aligned with the parent company Fresenius Medical Care.

When Xenios was absorbed, Fresenius executives saw great potential. Rice Powell, CEO of Fresenius Medical Care and chairman of management board, said during the company’s Capital Markets Day 2017 that the organization was looking to identify new opportunities.

“We are getting much better, at FMC [Fresenius Medical Care], of not being trapped in that not-invented-here syndrome. And what I mean by that specifically is that we're branching out. We are looking at new technologies that we think we can add value to. Xenios is one of those,” he added.

That buy was followed by the bigger Nxstage Medical for $30 per share, or $2 billion. Given Fresenius Medical Care’s focus on dialysis products and services, Margaret Kaczor of William Blair saw the Nxstage deal as making sense. “We believe the acquisition was driven by a desire to drive adoption of home dialysis, moving patients into a lower-cost environment,” she added.

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