By Laura Serrano / January 5, 2022
2021 was a transformational year for Nuwellis. We began the year as CHF Solutions, and ended as Nuwellis — a new name that represents our commitment to treating all patients with fluid overload. Together, we achieved several major milestones and grew as a team. As the COVID-19 pandemic continued, we adapted, adjusted and never lost sight of our mission to transform fluid management care through the development of solutions that are clinically proven, safe, and reliable. As one year ends and a new one begins, we want to reflect on our accomplishments and achievements, which were all made possible by our courageous employees and the dedication of resilient healthcare workers around the world, all working with the best interest of patients in mind.
To kick off the year, on January 19, we announced the appointment of Nestor Jaramillo, Jr. as President and Chief Executive Officer. Throughout the year, we continued to grow and expand our leadership team. George Montague was named our Chief Financial Officer; Al Saalabi was appointed Vice President of Quality and Regulatory; Neil P. Ayotte became our Senior Vice President General Counsel and Chief Compliance Officer; and Megan Cease as the Director of Clinical Research and Reimbursement. We are grateful for their leadership and look forward to growing further under their leadership in 2022.
In January, we also held a physician-led webinar to discuss real-world experience using ultrafiltration in the management of heart failure patients. Panelists discussed results from the real-world retrospective study of 335 consecutive patients treated with the Aquadex FlexFlow® System, published in the Journal of Cardiac Failure Supplement, which demonstrated that ultrafiltration compares favorably in reducing heart failure rehospitalizations, renal function response, and weight/volume loss.
In April, we announced our rebranding and new name to better reflect our core therapeutic focus areas: pediatric (20 kgs or more), critical care, and heart failure fluid imbalance. The Nuwellis name reflects the “new well” that signifies better tomorrows for patients, their families, and their healthcare providers and caregivers.
We were also awarded a three-year national contract with Premier, Inc. in June. This collaboration has provided Nuwellis with the opportunity to expand into many of the thousands of hospitals with which Premier holds relationships and it allows Premier members to take advantage of special pricing and terms pre-negotiated by Premier for the Aquadex SmartFlow System.
In an effort to increase the availability of life-saving ultrafiltration therapy to people experiencing fluid overload, the American Medical Association issued a new Category III Current Procedural Terminology (CPT) for Therapeutic Ultrafiltration. The new CPT code was announced in July 2021 and came into effect on January 1, 2022. Providers can utilize the code when using Aquadex® to deliver ultrafiltration to adults and children (20 kg or more). Reimbursement is an integral aspect of hospital administration decision-making and can play a huge role in whether patients will have access to life-saving technologies. We are confident the code will enable patient access through adoption by providers who prescribe ultrafiltration for their fluid-overloaded patients.
In August, the National Institutes of Health awarded a $1.7 million grant to develop a fully integrated pediatric CRRT. We partnered with Minneapolis-based research and development firm Koronis Biomedical Technologies, the grant recipient, to begin designing and developing a custom pediatric product that will enable clinicians to better care for babies with limited kidney function.
We also received CE Mark Certification for our 24-Hour Blood Circuit Set in September. The CE marking allows Nuwellis to market the 24-hour Blood Circuit in the European Union and all other countries that recognize this certification. This can expand access to ultrafiltration among patients who need no more than 24 hours of Aquadex therapy in the inpatient setting. Additionally, this circuit can provide a more economical solution for hospitals to treat patients in the outpatient/ambulatory setting, where therapy can be delivered for up to 8 hours.
Our efforts from the year were later recognized as we were honored in awards ceremonies in the fall. In October, Nuwellis was selected as a recipient of the Governor’s International Trade Award. This award honors Minnesota companies that are developing and continuing to grow a significant part of their business in foreign markets, increasing or maintaining jobs in Minnesota, and developing novel approaches for competing globally. In addition, the Aquadex SmartFlow system was a winner in the Analytical/Test category of the 2021 R&D 100 Awards, which recognize commercial products, technologies and materials for their technological significance that are available for sale or license.
There’s no question that 2021 was a year of accomplishments, challenges, and growth for all at Nuwellis. We are looking forward to building upon the progress from the last year as we begin 2022.