MINNEAPOLIS - CVRx, Inc. (NASDAQ: CVRX), a medical device company, announced that the American Medical Association (AMA) has accepted new Current Procedural Terminology (CPT) Category I codes for baroreflex activation therapy (Barostim) to treat heart failure symptoms. The AMA CPT Editorial Panel's decision, announced today, is set to enhance reimbursement for healthcare providers and expand patient access to the Barostim procedure.
The new codes will be effective from January 1, 2026. Until then, hospitals and physicians in the U.S. are instructed to continue using the existing Category III codes for the Barostim procedures. The approval of Category I CPT codes is seen as a significant milestone for CVRx and a recognition of Barostim therapy's growing adoption and documented clinical benefits.
Barostim therapy, developed by CVRx, is a neuromodulation treatment that has been FDA-approved for use in heart failure patients within the U.S. It involves an implantable device that delivers electrical pulses to baroreceptors in the carotid artery to activate the body's baroreflex, aiming to restore balance to the autonomic nervous system and alleviate heart failure symptoms.
The effort to obtain the new CPT codes was spearheaded by the Society for Vascular Surgery (SVS) with support from the American College of Cardiology (ACC) and other organizations. Kevin Hykes, CEO of CVRx, expressed gratitude for the support from SVS and ACC during the process and highlighted the approval as an affirmation of Barostim's safety and effectiveness.
The information is based on a press release statement from CVRx, Inc. The company cautions that there are known and unknown risks and uncertainties that could affect the actual results of the CPT code implementation, including the completion of a formal survey by the AMA to determine the reimbursement level and the true impact on patient access.
In other recent news, CVRx, a medical device company, secured an additional $20 million loan tranche from Innovatus Life Sciences Fund I, LP, bringing its total outstanding term loans to $50 million. The company reported a 24% increase in Q2 revenue, reaching $11.8 million, despite a net loss of $14 million, and projects total revenue between $50 million and $53 million for 2024. Analysts have revised their outlook on CVRx, with Cantor Fitzgerald initiating coverage with an Overweight rating and a 12-month price target of $14.00, while Piper Sandler lowered its target to $13, and Canaccord Genuity raised it to $15.
CVRx also expanded its Board of Directors with the appointment of Kevin Ballinger and Mitch Hill, following the resignation of Ali Behbahani. CMS has increased the reimbursement for CVRx's Barostim implant procedure from $17,000-$23,000 to approximately $43,000, effective in 2024. Lastly, the company made key executive appointments, including a new Chief Revenue Officer and Chief Medical Officer, to enhance market development for its Barostim therapy. These are the recent developments for CVRx.
InvestingPro Insights
CVRx's recent announcement regarding the approval of new CPT Category I codes for Barostim therapy aligns with the company's strong revenue growth trajectory. According to InvestingPro data, CVRx has demonstrated impressive revenue growth of 43.94% over the last twelve months as of Q2 2024, with quarterly revenue growth of 24.28% in Q2 2024. This growth trend suggests that the expanded reimbursement opportunities from the new CPT codes could further accelerate the company's financial performance.
However, investors should note that despite the positive news, CVRx faces some financial challenges. An InvestingPro Tip indicates that the company is "quickly burning through cash," which is reflected in its operating income margin of -124.78% for the last twelve months. This suggests that while the new CPT codes may improve future revenue prospects, the company is currently operating at a loss.
Another relevant InvestingPro Tip mentions that "3 analysts have revised their earnings upwards for the upcoming period," which could be interpreted as a positive signal in light of the CPT code approval. This analyst optimism might be factoring in the potential for increased adoption of Barostim therapy and improved reimbursement rates.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 7 more InvestingPro Tips available for CVRx, which could provide further context to the company's financial health and market position.
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