CVRx Announces Implementation of New Category I CPT Codes for Barostim Therapy

Rhea-AI Summary

CVRx (NASDAQ: CVRX) confirmed that Category I CPT codes for baroreflex activation therapy using its Barostim device replaced Category III codes effective Jan 1, 2026. Category I CPT codes indicate an established procedure and can support broader adoption, coverage, and reimbursement across the U.S. healthcare system.

CVRx said U.S. hospitals and physicians should update billing systems and begin using the new codes for procedures performed on or after Jan 1, 2026. The company stated it believes the change will enable more predictable and consistent reimbursement for Barostim patients and providers.

Positive

• Category I CPT codes effective Jan 1, 2026
• Category I designation supports adoption, coverage, reimbursement
• Billing update required for procedures on or after Jan 1, 2026

Negative

• None.

Key Figures

Category I CPT effective date Jan. 1, 2026 New Category I CPT codes for Barostim procedures became effective

Shelf capacity $150,000,000 Maximum amount under Form S-3 shelf registration

Q3 2025 revenue $14.7M Quarter ended Sept. 30, 2025; up 10% year over year

Q3 2025 gross margin 87% Improved from 83% on higher pricing and efficiencies

Q3 2025 net loss $12.9M Quarterly net loss; $0.49 basic and diluted loss per share

Cash & equivalents $85.1M Balance as of Sept. 30, 2025

Long-term debt $50.0M Innovatus loan outstanding as of Sept. 30, 2025

ATM shares issued 543,462 shares for $9.5M Shares sold via ATM during nine months ended Sept. 30, 2025

Market Reality Check

$7.92 Last Close

Volume Volume 274,698 is 1.49x the 20-day average of 184,273 ahead of this news. normal

Technical Shares at $7.67 are trading below the 200-day MA of $8.04 and 58.65% under the 52-week high.

Peers on Argus

CVRX gained 8.03% with elevated volume, while peers showed mixed moves: BSGM up 39.91%, ELMD up 3.44%, SGHT and STIM down modestly. This points to a stock-specific reaction rather than a broad medical devices move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 22	Conference appearance	Neutral	-2.6%	Announcement of presentation at the J.P. Morgan Healthcare Conference.
Nov 19	Conference appearance	Neutral	-1.1%	Participation in Piper Sandler healthcare conference fireside chat.
Nov 05	Earnings results	Positive	-2.0%	Q3 2025 revenue growth, high margins, and updated guidance.
Nov 04	Conference appearance	Neutral	-3.6%	Presentation plans for Jefferies Global Healthcare Conference in London.
Oct 22	Earnings preview	Neutral	+1.5%	Scheduling of Q3 2025 results release and conference call.

Pattern Detected

Recent news, including positive earnings and conference appearances, often saw flat-to-negative reactions, with only one clear divergence on a fundamentally positive earnings release.

Recent Company History

Over the last few months, CVRx has mainly issued conference and earnings updates. An Oct. 22, 2025 results-call announcement saw a modest 1.51% gain, while subsequent conference appearances on Nov. 18 and at the Piper Sandler and J.P. Morgan events all coincided with small declines. The Q3 2025 earnings release, which reported revenue of $14.7M and improved margins, still saw a -2% move, indicating past positive fundamentals did not consistently translate into immediate upside.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-06

$150,000,000 registered capacity

CVRx has an active Form S-3 shelf filed on Nov. 6, 2025, allowing the company to offer up to $150,000,000 of various securities in the future via prospectus supplements. The shelf had not been used yet, with 0 recorded takedowns in the provided data.

Market Pulse Summary

This announcement highlighted the transition of Barostim procedures to Category I CPT codes effective Jan. 1, 2026, which signals recognition as an established therapy and can support nationwide reimbursement. It followed Q3 2025 results showing $14.7M revenue and an 87% gross margin, alongside an unused $150,000,000 Form S-3 shelf filed on Nov. 6, 2025. Investors may watch how procedure volumes, reimbursement trends, and any future use of the shelf evolve.

Key Terms

Category I CPT codes regulatory

"confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex"

Category I CPT codes are standardized numeric labels used by doctors and hospitals to describe common medical procedures and services for billing and insurance purposes. Think of them like a universal price tag and barcode for a medical service: having a Category I code makes it easier for providers to bill insurers and for payers to decide coverage, which directly affects how reliably and quickly a procedure generates revenue and is adopted across the health system.

Category III codes regulatory

"Barostim device replaced the Category III codes as of Jan. 1, 2026."

Category III codes are temporary medical billing codes used to identify and track new, experimental or emerging procedures, technologies and services that do not yet have permanent billing codes. They matter to investors because obtaining one can help providers bill and collect data on a new product or treatment, which can speed clinical adoption and provide evidence needed for permanent reimbursement—much like a trial label that lets a new gadget be tested in the marketplace.

Current Procedural Terminology (CPT) regulatory

"Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy"

Current Procedural Terminology (CPT) is a standardized set of codes used to describe medical procedures and services for billing and record-keeping, maintained by a professional medical body. For investors, CPT codes matter because they determine how healthcare providers and companies get paid by insurers and government programs, influence revenue recognition, pricing and billing clarity, and can affect reimbursement rates and regulatory compliance — think of CPT like the universal barcode for medical services.

baroreflex activation therapy medical

"CPT codes for baroreflex activation therapy using its Barostim device replaced the"

An implantable device therapy that sends gentle electrical signals to the body’s blood‑pressure sensors to trigger a natural reflex that lowers blood pressure and eases strain on the heart—think of it like a thermostat that nudges the body to steady its pressure. It matters to investors because its commercial success depends on clinical effectiveness, regulatory clearance, reimbursement and adoption, which together determine the size and predictability of device sales and follow‑on service revenue.

AI-generated analysis. Not financial advice.

MINNEAPOLIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using its Barostim device replaced the Category III codes as of Jan. 1, 2026. In the U.S. healthcare system, Category I CPT codes signify established procedures, supporting adoption, coverage, and reimbursement nationwide.

The new CPT codes for use with Barostim procedures are available in the reimbursement guide here, and on CVRx’s website.

U.S. hospitals and physicians performing Barostim procedures should update their billing systems and start using these new codes for all procedures performed on or after Jan. 1, 2026.

“We believe the new Category I CPT codes will enable more predictable and consistent reimbursement for Barostim patients and healthcare professionals,” said Kevin Hykes, President and Chief Executive Officer of CVRx, “and validate the important role of Barostim therapy in the heart failure treatment continuum.”

About CVRx, Inc.
CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding the anticipated effect the new codes will have on Barostim’s adoption are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about the future and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause actual results to differ from our expectations, including the actual impact the new codes have on reimbursement and patient access. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
ir@cvrx.com

Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
emeyers@cvrx.com

FAQ

What change did CVRx (CVRX) announce about Barostim CPT codes on Jan 6, 2026?

CVRx confirmed that Category I CPT codes for Barostim replaced Category III codes effective Jan 1, 2026.

How do the new Category I CPT codes affect reimbursement for CVRX Barostim procedures?

Category I codes indicate an established procedure and can support broader coverage and reimbursement nationwide.

When should hospitals and physicians start using the new Barostim CPT codes for CVRX procedures?

Hospitals and physicians should update billing systems and use the new codes for procedures performed on or after Jan 1, 2026.

Where can providers find the new Barostim CPT codes for CVRX procedures?

The new CPT codes are available in the company's reimbursement guide and on the CVRx website.

Will the new CPT codes guarantee payment for CVRX Barostim procedures?

The company said the Category I codes should enable more predictable and consistent reimbursement, but actual payment depends on payer policies.

What does Category I designation mean for Barostim from CVRX (CVRX)?

Category I designation means the procedure is considered established in the U.S. coding system, which supports adoption and reimbursement.