Medical technology company Abiomed acquired an artificial breathing device designed by Breethe to work with its Impella heart pump and treat patients whose lungs can no longer oxygenate the body, including those who suffer from cardiogenic shock or respiratory failure due to SARS, H1N1, ARDS, or COVID-19. Breethe is the developer of the extracorporeal membrane oxygenation (ECMO) system that is designed to expand Abiomed’s product portfolio. Abiomed has been in communication with Breethe for years. It finally invested in the startup company in the middle of 2019, according to CEO Mike Minogue.
Currently, Abiomed is waiting for the artificial lung device to receive 510(k) clearance from the FDA before it can be used in hospital settings. Abiomed posted its fourth-quarter earnings, indicating that Impella revenue came in at approximately $197 million, which was down 1% from the year before. Abiomed stated that the impact of COVID-19 on procedures was mostly to blame as the company lost approximately $17 in sales. Additionally, two studies published last year determined that using the Impella heart pump with the ECMO system was beneficial for recovery rates among patients.
Key highlights of Abiomed’s recent activity includes the following:
Before acquiring Breethe’s sleep ECMO machine, Abiomed stated that approximately 10,000 cases of cardiogenic shock patients received both the Impella heart pump and the ECMO within the last decade. Abiomed refers to these patients as “ECpella” cases. This term has been documented in the European Journal of Heart Failure and the Journal of the American College of Cardiology.
Out of the combined 4,126 patients tested, results found that the use of ECPella was linked to better survival rates than patients who were treated with ECMO only. Along with a better survival rate, the study published in the European Journal of Heart Failure found that patients had better heart recovery with the ECPella treatment than the ECMO only.
What is the Breethe ECMO System?
The Breethe ECMO system is similar to a set of artificial lungs. It uses tubes and takes venous blood, removes the carbon dioxide from it, adds oxygen, and returns the oxygenated blood to the patient. The machine was founded by the University of Maryland’s cardigan surgeon Bartley Griffith, who also served as the lead investigator of Abiomed’s RECOVER I study for the Impella 5.0 pump. There are several versions of the pump currently available, including the following:
Patients who need ECMO therapy are diagnosed with severe, life-threatening illnesses that prevent their lungs from working properly, such as COVID-19. Every year, over 20,000 patients in the United States receive ECMO therapy. In a recent press release, Abiomed stated that they recognize the need for ECMO therapy to treat patients that need oxygen assistance. Breethe’s device is a one-of-a-kind, easy to use ECMO system and a sleek design that uses an integrated oxygen concentrator to promote patient ambulation.
Its novel design is easy for healthcare providers to set up, monitor, and manage. Dr. Griffith has partnered with Abiomed for several years and brings decades of experience to the system’s background. The device provides cutting-edge technology to improve patient’s outcomes and quality of life while reducing the cost of care by altering the way oxygen is administered. Dr. Griffith stated that Abiomed is the best company to build the legacy of what Breethe has stated. He believes that adding Breethe’s technology to Abiomed’s already well-established portfolio will improve patient’s outcomes and serve a new generation of patients, including those affected by the coronavirus.
Breethe plans to integrate with Abiomed and combine their quality, sales, manufacturing, research and engineering capabilities, including Abiomed’s clinical support center. According to Abiomed’s Chairman, President, and CEO, Michael Minogue, both companies strive to put patients first and improve outcomes. He stated that doctors have asked the company to bring the new technology on board because of the company’s ability to support patients, collect critical data for research, and teach best practices. The ECMO device will allow doctors to treat cardiogenic shock patients while adding pediatric offerings and addressing a new population of patients with respiratory failure.
For patients in cardiogenic shock, the Impella heart pump is ideal because it unloads the left ventricle, allows the heart to rest and recover, and perfuses end organs. However, these patients may also need oxygen support. ECMO helps by perfusing the end organs but does not unload the left ventricle, which is needed to increase oxygen demand of the heart muscle. Impella heart pumps are FDA approved and will be used with Breethe’s new technology once it is also cleared by the FDA.
In addition to helping patients cope with breathing problems, Abiomed’s latest move could help improve their bottom line. Like most medtech companies affected by the COVID-19 pandemic, Abiomed saw a decrease in numbers during the last quarter. The company is preparing for the worst yet hoping for the best as it begins to integrate its new technology into healthcare systems.
The company has also suffered from delayed elective procedures. During the last quarter, Impella revenue in the United States declined 3% year over year. Patient use of Impella products was down 5%. However, overall for the year, Impella sales reached nearly $807 million, which was an increase of 9%.
According to a recent guidance on healthcare systems in different parts of the world, the ramp up of elective procedures will help increase device sales in the summer. This would result in a stronger second half of the year and prompt companies to make more devices, especially at facilities in the United States and Germany. To help navigate through the decline in sales, Abiomed is implementing alternative work schedules at production sites. It’s also reducing executive salaries, halting hiring, and taking other measures to cut costs.
In late March, the company stated that it paused its STEM-DTU clinical trial, which was designed to assess the Impella CP circulatory assist device. The company has not given any future financial guidance for the upcoming year due to the uncertainty that the COVID-19 pandemic brings. However, with the improvements and additions Abiomed has recently added to its team, the company could expect to see better numbers in the future.