Michael R. Minogue
Chairman, President and Chief Executive Officer at Abiomed
Thanks, Nicole, and good morning, everyone. Abiomed delivered record revenue of $261 million in the quarter, up 14% year-over-year in constant currency. Despite its lower start in October due to the COVID resurgence and hospital labor shortages, Abiomed achieved directive revenue. These results were driven by patient utilization records in both the U.S. and Japan up 10% and 35% year-over-year, respectively. Even with the headwinds, our Abiomed 2.0 playbook allowed us to adapt and execute, grow sequentially and support the most patients ever in a quarter. These results will not have been possible without the dedication of our customers and employees supporting critically ill patients, 24/7 on site, online and in the cloud with Impella Connect. From a financial perspective, we achieved a 25% operating margin while investing $41 million in research and development as we remain fanatical and focused on creating breakthrough technologies, advancing clinical research and guidelines and improving real-world outcomes by supporting hospitals with a premier clinical team. And our long-term outlook is robust and strengthened by our balance sheet with $932 million in cash and 0 debt, with over 1,300 patents and over 1,300 patents pending. On today's call, I will highlight how we are executing our Abiomed 2.0 playbook in the current COVID environment and provide updates on our patented breakthrough technologies. Abiomed 2.0 is helping our hospital partners by supporting their staff to improve patient outcomes for many of the sickest heart and lung patients. Our company provides a unique and exclusive service with a premier clinical field team, educating, training and supporting hospitals 24/7. This support is even more critical as hospitals today struggle with labor shortages. COVID impact or reinfection rates and ICU capacity, all impacting procedural volume. For Protected PCI today, the majority of our patients transition to the non-ICU unit after the procedure.
This compares to a majority of our past high-risk PCI patients before COVID that routinely went to the ICU post procedure. To improve physician access and closure outcomes or single access procedure for Protected PCI has grown with education and training. In Q3, 55% of our high-risk PCI patients received single access and strong clinical signal now exists for lower bleeding rates and quicker recovery. This 55% single access, so a single hole for both the PCI Procedure and the Impella, compares to 4% of our high-risk PCI patients with single access before COVID. These new high-risk protocols help open beds in the ICU for emergency shock patients who tend to be younger and higher priority for treatment. Our ability to share Impella and cardiogenic shock best practices has improved real-world outcomes, validated in multiple studies from the U.S., Japan, Italy and Germany. Recently, a cardiogenic shock, 24-hospital multicenter U.S. observational study published in JACC demonstrated that centers with shock teams were more likely to obtain invasive hemodynamics, use advanced types of mechanical circulatory support like Impella and less IABP, resulting in lower risk-adjusted mortality for patients. Our hub-and-spoke strategy continues to demonstrate that community spoke hospitals are growing their Impella patient volume. This shift to treatment in outline centers allows scheduling availability and flexibility for referring physicians and patients when large transplant hospitals get overwhelmed with COVID patients. As a result, we've seen community volume growth both sequentially and year-over-year. COVID has also accelerated the rollout of Impella Connect, our remote monitoring technology. Today, this technology is now available in 1,564 hospitals worldwide and approximately 90% of weekly U.S. patients are monitored in the cloud. This allows our field team to support our patients 24/7 even with COVID hospital restrictions and labor shortages which helps ease patient management and optimize care in the ICU.
In addition, we adapted our business model to include more online training and education by launching our password-protected user community called CAMP PCI. CAMP is an online and interactive education and training endeavor that hosts live cases, allows for confidential user interaction and has a dedicated clinical research community for our STEMI DTU and PROTECT IV studies. CAMP PCI is led by a faculty of experts in the field of cardiology, creating a virtual platform for experts to share live cases, best practices and techniques. For ICU nurses and CAF and surgery technologies, in addition to on-site training and education, we offer online training modules and credits at our Abiomed Academy Heart Recovery website. Now turning to our innovation update. The Impella 5.5 with SmartAssist received a Japanese PMDA approval. We are excited to bring this game-changing technology to Japan, a country where we recently hit our 5,000th patient milestone. Culturally, the Japanese are averse to heart transplants and invasive sternotomies. This makes Japan ideal for Impella 5.5, given the pump's ability to provide minimally invasive longer-term unloading heart support, enabling native heart recovery. We expect this first Japanese Impella 5.5 patient to be treated this spring. The Impella ECP received Category B status from the FDA, and we established our pivotal protocol. We also received FDA approval for the Impella BTR early feasibility IDE Study clearing the way for their first patient in the world. The Impella BTR will provide patients a home discharge option with over one year on full hemodynamic support. In the early feasibility study, 10 patients will be enrolled at up to five hospitals and supported by Impella BTR for up to 28 days. The first Impella BTR patient is expected to be treated in March or April this year in the U.S. Abiomed has also entered the ECMO space with our innovative breed technology. During our initial limited market release and study, we have treated 61 patients, have a 71% survival for respiratory failure and have logged 873 patient days.
The average duration of use is 14 days and 80% of patients have been for VV-ECMO, a majority with COVID complications. We worked closely with these leading hospitals to provide support, gather feedback and learn best practices on every patient. In general, we are pleased with overall survival, blood compatibility, durability of the pump lung unit, hemodynamic flow rates and ease of patient ambulation. Based on our early patient study and analysis, we've identified areas of improvement around electronics of the console and have implemented a voluntary recall at our seven hospitals. Until this field corrective action is completed, we are not expanding our number of patients or new centers. The console upgrades may require a 510(k) clearance, and so we're working with the FDA on the next steps. We also announced the successful results of the first-in-human early feasibility study of the preCARDIA system published in circulation heart failure. The multicenter prospective single-arm study examined 30 patients with acutely decompensating heart failure or ADHF, who were assigned pre cardiotherapy for 12 or 24 hours. The study met its safety and feasibility endpoints and documents that preCARDIA system can rapidly reduce cardiac filling pressures and augment urine output by intermittently including the superior vena cava. This product has also been awarded Category B designation by the FDA. This technology may enable the heart and kidneys to work more effectively, potentially providing therapy for patients nonresponsive to diuretics estimated to be approximately 300,000 of the one million U.S. ADHF admissions per year. We summarized all of these studies for our shareholders and posted on our quarterly slide deck. Our leading in innovation and technology principle to be smaller, smarter and more connected remains a cornerstone of our sustainable success. At the JPMorgan Healthcare Conference, I gave more detail about our innovation and the presentation is available on our investor website.
Before concluding, I'd like to highlight a patient story. John Cupolosis 85, is a husband, father and retired attorney from Jacksonville, Florida. John previously had mitral valve replacement, but was living an active lifestyle and enjoying retirement. When John began experiencing shortness of breath and intermittent chest pain in August 2021, he went to see his cardiologist who diagnosed John with heart failure. Tests also revealed multivessel disease and a lesion in his left interior descending artery. John was evaluated for CABG or open heart surgery, but due to his age and previous surgery, was deemed too high risk for another surgery. John was referred to Dr. Sam Garis, who identified John as a candidate for a Protected PCI procedure with Impella. Dr. Garis inserted the Impella heart pump pre-PCI to provide hemodynamic support while placing stents and performing a complete revascularization. The Impella heart pump was removed in the cath lab, and John was transferred to the CCU unit for overnight observation. John left the hospital the following morning and was home in time for lunch. Today, John has a normal heart function and feels better than he has in years. He and his wife Ann plan to travel, resume their passion for gardening and spend time with their six grandchildren. In conclusion, our focus on extending our lead in innovation, advancing clinical evidence and building a premier core commercial team enables the pursuit of becoming the global standard of care for hemodynamics support. We are now in the final stretch of our fiscal year 2022. As we cross the $1 billion revenue threshold, we know it is our commitment to patients first that has inspired our innovation, improved our outcomes and led to our success. I'd like to thank our employees, customers and shareholders for their continued support.
I will now turn the call over to Todd.
