CVRx is a commercial-stage medical device company that develops, manufactures, and commercializes neuromodulation solutions for cardiovascular diseases, notably its Barostim device for heart failure patients.
What is the promise of neuromodulation, and could you introduce us to Barostim?
Neuromodulation is not a new concept; it has been used for over 20 years in conditions like chronic pain, epilepsy, and Parkinson’s disease. Barostim, however, is the first neuromodulation therapy specifically targeting heart failure. This makes it unique in the field, as other approaches have not succeeded in addressing heart failure with neuromodulation. Heart failure is a significant global issue, affecting six million Americans and projected to cost $70 billion annually by 2030. Barostim offers a novel approach to improving symptoms for a subset of these patients, significantly enhancing their quality of life.
CVRx was founded in 2001, and the initial focus was on hypertension—a related condition often present alongside heart failure. The shift to heart failure began around 2010, leading to the launch of Barostim in Europe in 2014 and FDA approval in the U.S. in 2019. However, launching in February 2020 amidst the pandemic presented challenges. Despite this, Barostim has been in the U.S. market for four years now and continues to show strong promise.
What updates have been made to the Barostim technology, and how does it compare to similar devices like pacemakers?
Barostim has undergone several refinements over time, including improvements in battery longevity, size, programmability, and lead design. It now boasts a 94% responder rate, with 97% of patients free from complications. Unlike pacemakers or defibrillators, Barostim does not involve placing leads inside the heart, which reduces the risk of complications like infections and mechanical stress. The implant procedure is minimally invasive, making it a safer and more predictable option.
How many patients have been treated with Barostim, and why is adoption still below 2%?
Over 5,000 patients worldwide have been treated with Barostim across its indications, with the U.S. penetration at less than 2%. This is typical for new medical technologies, where adoption is gradual due to physician conservatism and challenges in obtaining insurance coverage. Even widely accepted devices like defibrillators see limited adoption despite decades of availability. Barostim’s adoption trajectory aligns with these industry norms, and progress is being made.
Does Barostim face competition, and what is its place in the treatment continuum?
Barostim primarily addresses heart failure patients who do not respond adequately to standard drug therapies. These patients often fall into the “forgotten middle,” where options are limited to end-stage therapies like transplants or left ventricular assist devices. While some pacemaker-like therapies exist, they target narrower populations, leaving Barostim as the only neuromodulation solution for broader heart failure treatment.
What strategies are you using to accelerate market adoption of Barostim?
Raising awareness among healthcare providers is key to increasing adoption. This involves educating cardiologists and nurses about Barostim’s benefits and its place alongside traditional therapies.
Generating more evidence to validate the therapy’s outcomes is also critical, as is improving insurance coverage to make the device accessible. Recent Medicare advancements, including increased inpatient and outpatient reimbursements, have significantly improved the economic viability of Barostim for hospitals.
What are your objectives for the future, and do you plan to expand beyond heart failure?
While neuromodulation holds potential for other conditions, the focus remains on establishing Barostim as a standard of care for heart failure. With less than 2% of eligible U.S. patients currently treated, there is immense room for growth. The near-term priority is expanding this number to 10%, and eventually higher, to make a profound impact on patients’ lives. Exploration of other indications will continue, but the primary emphasis will stay on addressing the massive unmet need in heart failure.
