Market Opportunity & Prevalence - The prevalence-based market opportunity for Barostim is estimated at $10.5 billion in the U S HFrEF market[8, 9] - Heart failure affects nearly 6.7 million adults in the U S [10] - The company is less than 1% penetrated into its addressable market[36] Clinical Efficacy & Safety - Barostim implantation has a 97% freedom from major complications rate[54, 56] - Barostim shows a clinically relevant 94% response rate[58] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months)[67, 68] Financial Performance & Guidance - Preliminary Q4 2025 worldwide revenue is $15 9–$16 1 million[104] - Preliminary 2025 worldwide revenue is $56 5–$56 7 million, with a gross margin of 84%-86%[104, 105] - The company expects total revenue between $63 0 million and $67 0 million for the full year of 2026[108] Growth Strategy - The company's strategy focuses on improving salesforce productivity, driving deep adoption in targeted centers, and addressing barriers to adoption[70, 71] - The company is focusing therapy awareness efforts on the clinicians and patients that surround targeted centers[84] - The company has received IDE approval for BENEFIT-HF, a potential landmark randomized controlled trial (RCT) in HF, with a trial size of 2,500 patients[94, 95]

Loan Agreements and Commitments - The Second Amendment to the Loan and Security Agreement was executed on January 9, 2026, involving CVRx, Inc. and Innovatus Life Sciences Lending Fund I, LP as the collateral agent and lender[2]. - The total commitment for Term A Loan is $15 million, with Innovatus Life Sciences Lending Fund I, LP holding a 100% commitment percentage[13]. - The Term B Loan commitment is $30 million minus the funded amount of Term A Loan, also with a 100% commitment percentage[13]. - The Term C Loan commitment is set at $20 million, with Innovatus Life Sciences Lending Fund I, LP holding a 100% commitment percentage[13]. - The Term D Loan commitment is $10 million, with Innovatus Life Sciences Lending Fund I, LP holding a 100% commitment percentage[13]. - The Term E Loan commitment is $15 million, with Innovatus Life Sciences Lending Fund I, LP holding a 100% commitment percentage[13]. - The Term F Loan commitment is $25 million, with Innovatus Life Sciences Lending Fund I, LP holding a 100% commitment percentage[13]. - The amendments to the Loan Agreement are effective upon satisfaction of specific conditions, including the execution of the amendment by all parties involved[6]. Loan Terms and Conditions - The Borrower represents that no Event of Default has occurred and that all representations and warranties are true and accurate as of the date of the amendment[6]. - The governing law for this amendment is the State of New York[9]. - The company has secured a Term A Loan of up to $15 million, with an outstanding principal amount of $15 million as of the Second Amendment Effective Date[22]. - The Term B Loan is available for up to $30 million, with an outstanding principal balance of $15 million as of the Second Amendment Effective Date[23]. - The Term C Loan can be drawn for up to $20 million, with an outstanding principal balance of $20 million as of the Second Amendment Effective Date[24]. - The Term D Loan is set at up to $10 million, with an outstanding principal balance of $10 million as of the Second Amendment Effective Date[25]. - The Term E Loan is available for up to $15 million, with no specific outstanding balance reported[26]. - The Term F Loan can be drawn for up to $25 million, with no specific outstanding balance reported[27]. - Borrower is required to make monthly interest-only payments starting from the first Payment Date following the Funding Date of any Term Loan[28]. - Upon maturity, all unpaid principal and accrued interest for the Term Loan is due and payable in full[28]. - The interest rate on the Term Loan is a floating per annum rate based on the Basic Rate, with a potential increase of 2.15% payable in-kind[33]. Financial Requirements and Covenants - Borrower must pay a commitment fee of 3.00% of the aggregate principal amount of the Term Loan Commitments for the Term E Loan or Term F Loan if certain conditions are met[42]. - The aggregate amount of the Term A Loan to be made on the Effective Date is less than or equal to 15% of Borrower's market capitalization[48]. - The market capitalization of Borrower must be greater than $190 million for the Term E Loan to be extended[51]. - The market capitalization of Borrower must be greater than $300 million for the Term F Loan to be extended[51]. - Borrower must deliver a completed Perfection Certificate for itself and each of its Subsidiaries[47]. - Borrower has good title to the Collateral, free and clear of any Liens except Permitted Liens[62]. - All consolidated financial statements for Borrower and its Subsidiaries fairly present the consolidated financial condition in conformity with GAAP[67]. - There has not been a Material Adverse Change since the date of the most recent financial statements submitted[67]. - Borrower and each of its Subsidiaries, when taken as a whole, is Solvent[68]. - The Collateral must not be in the possession of any third party bailee with components exceeding $250,000[64]. - Borrower must provide evidence that the insurance policies required are in full force and effect[48]. - Borrower and its Subsidiaries have timely filed all required tax returns and paid all taxes owed exceeding $100,000 in all jurisdictions[73]. - Borrower shall use the proceeds of the Term Loan solely as working capital and for general business requirements[74]. - Borrower must maintain its legal existence and good standing in all jurisdictions to avoid a Material Adverse Change[77]. - Borrower is required to deliver monthly financial statements within 30 days after each fiscal month and quarterly financial statements within 45 days after each fiscal quarter[79]. - Borrower must provide annual financial projections and budget to the Collateral Agent within 10 days after board approval[80]. - Borrower is obligated to keep all Inventory in good and marketable condition, free from material defects[89]. - Borrower and its Subsidiaries have complied with all material laws and regulations to avoid any Material Adverse Change[77]. - Borrower must notify the Collateral Agent of any litigation or governmental proceedings that could result in damages of $250,000 or more[81]. - Borrower is required to maintain proper books of record and allow inspections by the Collateral Agent during regular business hours[87]. - Borrower must provide prompt notice of any Event of Default or events that could constitute an Event of Default within three business days[81]. - Borrower must achieve TTM Revenue of at least 50% of projections for the 12-month period ending on the last day of each quarter starting from September 30, 2025[102]. - If TTM Revenue for the previous quarter exceeds $100 million, Borrower is not obligated to comply with the revenue requirement for the current quarter[103]. - Borrower must maintain a cash balance of at least 5% of the aggregate principal amount of Term Loans in Collateral Accounts[104]. - Borrower is required to notify Collateral Agent of any new offices or business locations if the assets exceed $250,000[107]. - Borrower must provide written notice to Collateral Agent before establishing any Collateral Account[93]. - Borrower must execute further instruments as requested by Collateral Agent to perfect or continue the security interest in the Collateral[99]. - Borrower is restricted from paying dividends exceeding $100,000 per fiscal year, except under specific employee stock plans[112]. - Borrower cannot make any investments outside of permitted investments as defined in the agreement[113]. - Any material transaction with affiliates must be conducted at fair and reasonable terms, ensuring no less favorable conditions than arm's length transactions[115]. - Borrower must comply with various financial covenants, including maintaining minimum liquidity levels and submitting acceptable financial plans if breaches occur[121]. Events of Default and Remedies - A material adverse change may trigger an event of default, allowing the collateral agent to declare all obligations immediately due[122]. - Borrower is prohibited from engaging in transactions with blocked persons or entities listed on OFAC lists[118]. - Any judgments against Borrower exceeding $250,000 that remain unsatisfied for ten days may constitute an event of default[123]. - Borrower must maintain valid ownership of intellectual property critical to its business, free from any liens[125]. - Delisting of Borrower's common stock from its primary exchange without immediate listing on another recognized exchange may trigger default[126]. - Borrower is subject to regulatory actions that could result in liabilities exceeding $250,000, which may lead to material adverse changes[124]. - Upon the occurrence of an Event of Default, the Collateral Agent has the right to settle disputes directly with Account Debtors without notice[129]. - The Collateral Agent may appoint a receiver to manage and realize any of the Collateral, with authority granted by a competent court[131]. - Borrower waives the right to direct the application of any payments received by the Collateral Agent, who has exclusive rights to apply payments against Obligations[135]. - Collateral Agent may obtain insurance on behalf of the Borrower if they fail to do so, with all costs being immediately due and payable[134]. - The Collateral Agent and Lenders are not liable for any loss or damage to the Collateral as long as they comply with reasonable banking practices[137]. - The Borrower irrevocably appoints the Collateral Agent as its attorney-in-fact to endorse checks and settle disputes with Account Debtors upon an Event of Default[133]. Notices and Legal Provisions - All notices and communications must be in writing and are deemed validly served upon actual receipt or after a specified period if sent via mail or email[140]. - The governing law for this agreement is the internal laws of the State of New York, excluding conflict of laws principles[144]. - The Collateral Agent has the right to apply proceeds from the sale of Collateral first to Lenders' Expenses, then to accrued interest, and finally to principal amounts[135]. - Borrower bears all risk of loss, damage, or destruction of the Collateral[137]. - The Borrower irrevocably accepts the jurisdiction of New York courts for any legal actions related to the Loan Documents[146]. - The Borrower waives personal service of legal documents and consents to service by mail to the specified address[147]. - The Borrower agrees to indemnify the Collateral Agent and Lenders against all claims and liabilities arising from the Loan Documents[151]. - The Borrower must not transfer rights or obligations under the Agreement without prior written consent from the Collateral Agent[150]. - The Collateral Agent may correct errors in the Loan Documents consistent with the parties' agreement[153]. - All covenants and representations made in the Agreement continue until all obligations are satisfied[159]. - Confidential information handling requires the same degree of care as proprietary information, with specific disclosure conditions[160]. - The Borrower grants a lien and right of set-off to the Collateral Agent and Lenders against all deposits and property[162]. - The Borrower agrees to cooperate in executing documents for assignments of Term Loan Commitments[163]. - The Collateral Agent and Lenders may publicly announce the transactions contemplated by the Agreement[164]. Financial Metrics and Definitions - Adjusted EBITDA for the Borrower is calculated as net income from continuing operations plus interest expense, income taxes, depreciation, amortization, and non-cash stock-based compensation[168]. - The Basic Rate for each Term Loan is the greater of the Prime Rate or 6.75% plus 2.65%, which will reduce to 2.00% after achieving two quarters of positive Adjusted EBITDA[171]. - The Final Fee Percentage is set at 4.50% of the aggregate amount of the Term Loans funded[192]. - The Facility Fee is 0.75% of the total principal amount for each Term Loan funded on the Funding Date[188]. - Cash Equivalents include marketable direct obligations with maturities of not more than one year, commercial paper with the highest rating, and certificates of deposit with similar maturity[176]. - The Amortization Date is February 1, 2030, unless the Interest-Only Extension occurs, in which case it will be February 1, 2031[170]. - The Borrower's Books include all financial records, tax returns, and information regarding assets and liabilities[173]. - The definition of Indebtedness includes obligations for borrowed money, capital lease obligations, and Contingent Obligations[200]. - The term "Blocked Person" refers to individuals or entities subject to anti-terrorism laws, including those listed in Executive Order No. 13224[172]. - The term "Affiliate" includes any person that owns or controls the Borrower or is under common control with the Borrower[169].

Core Insights - CVRx, Inc. reported preliminary unaudited revenue results for Q4 and full year 2025, indicating growth and strategic progress in the commercialization of its neuromodulation solutions for cardiovascular diseases [1][2][18] Financial Performance - Q4 2025 revenue is expected to be between $15.9 million and $16.1 million, reflecting a growth of approximately 4% to 5% compared to Q4 2024 revenue of $15.3 million [3][8] - Full year 2025 revenue is projected to be between $56.5 million and $56.7 million, representing an increase of approximately 10% to 11% over 2024 revenue of $51.3 million [4][8] - For Q1 2026, the company anticipates total revenue between $13.7 million and $14.7 million [6] Business Outlook - The company expects full year 2026 revenue to be between $63 million and $67 million, indicating growth of 11% to 18% [8] - The transition to Category I CPT codes effective January 1, 2026, is expected to enhance reimbursement dynamics and support commercial efforts [2][8] Operational Highlights - As of December 31, 2025, CVRx had 252 active implanting centers, up from 250 as of September 30, 2025 [4] - The number of sales territories in the U.S. increased to 53, adding three territories during Q4 2025 [4] Debt Facility - On January 9, 2026, the company amended its term loan agreement, increasing the facility by $50 million to a total of $100 million, with an additional $10 million borrowed at closing [11] - The amended loan has an interest rate of 9.40% or prime plus 2.65%, with an extended interest-only period [11] Clinical Development - The FDA approved the BENEFIT-HF trial design in November 2025, which aims to evaluate Barostim's impact on heart failure patients [10] - The trial is set to randomize 2,500 patients across 200 centers in the U.S. and Germany, with expected costs of $20 million to $30 million over five to seven years [10]

Core Insights - CVRx, Inc. has transitioned to Category I Current Procedural Terminology (CPT) codes for its Barostim device, effective January 1, 2026, replacing the previous Category III codes, which is expected to enhance adoption, coverage, and reimbursement for the therapy [1][2][3] Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - The Barostim device is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim functions by delivering electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Regulatory and Market Impact - The new Category I CPT codes are anticipated to provide more predictable and consistent reimbursement for healthcare professionals and patients using Barostim therapy [3] - The Barostim device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3]

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 p.m. (PT) [1] - Barostim™ is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - Barostim has received FDA Breakthrough Device designation and is approved for heart failure patients in the U.S., as well as certified under EU Medical Device Regulation [3] Event Information - A live webcast of the J.P. Morgan Healthcare Conference presentation will be available at ir.cvrx.com, with an archived version accessible for a limited time [2]

Summary of CVRx Conference Call Company Overview - **Company**: CVRx - **Industry**: Medical Technology (Med Tech) Key Points and Arguments Financial Guidance and Sales Performance - The company is guiding for an incremental revenue increase of only $1 million in Q4, compared to over $2 million in the same period last year, indicating a conservative approach to forecasting [1][2] - Sequential growth has been approximately 8%-10% since a business reset earlier in the year, which involved a deeper transformation of the sales force [2][3] Sales Force Transformation - The sales force has undergone significant changes, with many new hires coming from established companies like Abbott and J&J, focusing on a more systematic approach to therapy adoption [4][5] - The productivity of new sales representatives is expected to ramp up over a period of 6 to 12 months, depending on their prior experience and the territories they inherit [10] Revenue Targets and Cash Flow - Each sales representative is targeted to generate approximately $1.8 million in annual revenue, with the current average territory producing about $1 million [11][12] - The company aims to achieve cash flow break-even by increasing the productivity of existing territories and adding new ones [19][20] Market Adoption Barriers - The company identifies three main barriers to therapy adoption: awareness among clinicians, the need for more clinical evidence, and reimbursement issues [34] - The company is investing in new randomized controlled trials (RCTs) to generate additional evidence and address these barriers [34][50] Clinical Trials and Evidence Generation - A new RCT is planned with 2,500 randomized patients, which is expected to take 4-6 years to enroll and follow up, with an estimated cost of $20 million-$30 million [50][53] - The trial aims to expand the indication for the therapy, potentially tripling the total addressable market (TAM) [51] Reimbursement Landscape - The company has successfully secured permanent inpatient reimbursement rates, increasing from $17,000 to $45,000, and is working towards a permanent level six code for outpatient procedures [108][110] - The transition from Category III to Category I codes is expected to improve prior authorization processes and reduce friction in therapy adoption [112][113] Gross Margin and Cash Position - The gross margin in Q3 was reported at 87%, with expectations to maintain margins in the 85%-86% range moving forward [116] - The company has $85 million in cash, with a burn rate of $10 million per quarter, indicating at least three years of cash runway [118] Competitive Landscape - The company does not view competitors like Impulse Dynamics as direct threats, emphasizing that both companies can coexist and grow within the same market [106][107] - The recent approval and reimbursement updates for competitors are seen as potentially beneficial for the overall market [101][104] Additional Important Insights - The company is focused on deepening relationships with high-potential accounts, with only 20% of accounts currently performing at least one implant per month [92] - The company is actively working to improve the productivity of its sales force and the adoption rates within existing accounts [93][96]

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The Barostim™ device is the first FDA-approved technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim™ is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3] Event Details - The fireside chat is scheduled for December 3, 2025, at 2:00 p.m. (ET) and will be available via webcast on the company's investor relations page [1][2]

CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Cardiovascular medical devices - **Product**: Barostim, a neuromodulation therapy for heart failure - **Annual Total Addressable Market (TAM)**: $2.2 billion [1][5] Key Points and Arguments Heart Failure Market - Heart failure leads to over 1 million hospitalizations, 1.3 million emergency room visits, and 8 million physician office visits in the U.S. annually, with spending projected to reach approximately $70 billion by the end of the decade [1] - Heart failure is a progressive disease with significant mortality rates, exceeding those of the top five cancers [1] Treatment Landscape - Current treatment involves quad therapy (four Class I drugs), but only 1% of patients reach therapeutic doses, and 40% discontinue at least one drug within the first year [3] - Patients express a preference for a higher quality of life over mere life extension [4] - Barostim targets the "forgotten middle" of heart failure patients, aiming to restore quality of life [4] Clinical Evidence and Efficacy - Barostim has shown a 68% improvement in New York Heart Class functional status and a 94% response rate among patients [10] - A real-world study indicated an 85% reduction in hospitalization rates post-implantation of Barostim [11] - The therapy operates by restoring signaling from baroreceptors to the brain, effectively reducing sympathetic tone and neurohormonal toxicity [8][9] Go-to-Market Strategy - CVRx is focusing on building a specialized sales organization and deepening adoption in targeted accounts rather than broad distribution [12][13] - The company has identified 300-400 centers in the U.S. with the highest potential for Barostim adoption based on patient volume and experience with similar devices [15][16] Barriers to Adoption - Key barriers include therapy awareness, clinical evidence, patient access, and reimbursement issues [18][19] - Significant outreach efforts are being made to educate referral physicians and advanced practice providers [20] Reimbursement Developments - Secured a permanent inpatient DRG reimbursement of $43,000 and an outpatient code at $45,000 [24] - Transitioning to a permanent category one procedural code on January 1, which will enhance payment certainty for surgeons and reduce prior authorization denials [25][26] Financial Performance - Reported Q3 revenue of $14.7 million, with guidance for Q4 revenue between $15 million and $16 million [27] - Gross margin reported at 87%, with a cash balance of $85 million [27] Additional Important Information - The therapy has a remarkable 97% freedom from complications during implantation [9] - The company is actively generating further clinical evidence to support the therapy's efficacy and safety [21][22][23]

Revenue Performance - Revenue for the three months ended September 30, 2025, was $14.7 million, an increase of $1.3 million, or 10%, compared to the same period in 2024[86] - Revenue for the nine months ended September 30, 2025, was $40.6 million, an increase of $4.7 million, or 13%, compared to the same period in 2024[99] - Revenue generated in the U.S. was $36.9 million for the nine months ended September 30, 2025, an increase of $4.1 million, or 13%, over the prior year[100] - Revenue generated in Europe was $3.7 million for the nine months ended September 30, 2025, a $0.5 million increase, or 17%, compared to the same period in 2024[101] Gross Profit and Margins - Gross profit increased to $12.8 million for the three months ended September 30, 2025, a rise of $1.6 million, or 15%, with a gross margin of 87% compared to 83% in the prior year[91] - Gross profit for the nine months ended September 30, 2025, was $34.5 million, reflecting a $4.3 million increase, or 14%, over the prior year[103] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $25.0 million, an increase of $0.9 million, or 4%, compared to the same period in 2024[85] - SG&A expenses decreased by $4.6 million, or 6%, to $66.5 million for the nine months ended September 30, 2025, primarily due to a decrease in non-cash stock-based compensation[107] Research and Development - Research and development expenses rose to $3.1 million, an increase of $0.6 million, or 26%, primarily due to higher compensation and consulting costs[92] Net Loss - Net loss for the nine months ended September 30, 2025, was $41.4 million, a decrease of $7.9 million, or 16%, compared to the net loss of $49.3 million in the same period in 2024[111] - The company anticipates continued net losses in the coming years due to planned investments in commercialization efforts[72] Cash and Financing - The company had cash and cash equivalents of $85.1 million as of September 30, 2025, down from $105.9 million at the end of 2024[111] - Cash used in operating activities for the nine months ended September 30, 2025, was $30.4 million, slightly lower than $31.1 million in the same period in 2024[118] - The company issued 543,462 shares of common stock under the ATM offering for gross proceeds of $9.5 million during the nine months ended September 30, 2025[113] - Interest expense increased by $1.5 million for the nine months ended September 30, 2025, driven by higher levels of borrowings under the Loan Agreement[108] Market Expansion and Strategy - U.S. sales accounted for $13.5 million, reflecting a 10% increase, driven by growth in the heart failure business and expansion into new sales territories[87] - The company had 250 active implanting centers in the U.S. as of September 30, 2025, up from 208 in the previous year[88] - The company plans to expand its U.S. commercial organization and increase awareness among physicians and patients to drive future revenue growth[77] Regulatory and Economic Factors - The Centers for Medicare & Medicaid Services released new Category I CPT codes for Barostim, expected to improve reimbursement predictability starting January 1, 2026[73] - Inflationary factors may adversely affect operating results, with potential impacts on gross margin and operating expenses if product selling prices do not increase accordingly[129] - Revenue and operating expenses incurred outside the U.S. are subject to foreign currency exchange rate fluctuations, particularly with the Euro, but realized gains and losses have not been material to financial statements[128] - The company is exposed to interest rate risk primarily related to cash equivalents and debt under the Loan Agreement, with no current plans to use financial derivatives[127]

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