Tivic Health and Feinstein Institute Present New Data Showing Personalized Vagus Nerve Stimulation Method Optimizes Impact on Autonomic Nervous System
The data were presented in a poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' at the Sixth Bioelectronic Medicine Summit, March 4 & 5. The findings were based on Tivic's collaboration with The Feinstein Institute of Medicine, one of the global scientific leaders in bioelectronic medicine.
'These promising findings reinforce Tivic's premise that non-invasive bioelectronic devices can effectively treat inflammatory, cardiac and neurologic disorders without invasive surgeries or pharmaceuticals - both of which carry burdensome side effects,' said Jennifer Ernst, CEO of Tivic Health. 'With these new data secured with pending patents, we believe that we have demonstrated the potential for developing personalized, scalable bioelectronic therapies to treat patients in need.'
Tivic Health's poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' highlighted a novel ncVNS approach and its ability to modulate autonomic nervous system (ANS) function and brain activity. Key results included:
Personalized stimulation approach for optimal autonomic modulation:
No single stimulation frequency had a universally dominant effect on HRV, highlighting the need for personalized neuromodulation strategies.
Choosing the optimal ncVNS stimulation frequency for each study subject resulted in a meaningful increase in effect size of HRV change, paving the way for patient-specific therapy.
Significant increase in heart rate variability (HRV), indicating enhanced parasympathetic activity:
In 60% of participants (responders), raw HRV nearly doubled on average following ncVNS stimulation.
Normalized HRV increased 2.67x post-stimulation, suggesting a strong activation of vagal tone and improved autonomic balance.
The data presented resulted from Tivic's ongoing collaboration with the Feinstein Institute of Bioelectronic Medicine to advance high-precision vagus nerve stimulation in a non-invasive form factor.
About The Bioelectronic Medicine (BEM) Summit
The BEM Summit is a premier gathering of industry leaders, researchers, and clinicians exploring cutting-edge neurotechnologies and neuromodulation therapies. Hosted by the Feinstein Institutes for Medical Research, the event brings together experts in bioelectronic medicine, autonomic neuroscience, and inflammation research to discuss the latest advancements in the field.
About Tivic Health Systems, Inc.
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. Tivic Health's biopharma division's lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™.
Tivic Health already has an FDA-approved over-the-counter device, ClearUP™ that treats sinus pain and pressure and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com
Forward-Looking Statements
This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to
future events that may not prove to be accurate, including as a result of changes to the company's relationship with the Feinstein Institute, future development of the company's ncVNS treatment, changes to the company's business strategy, clinical trial and study results, consummation of any strategic transactions, the company's need for, and ability to secure when needed, additional working capital, and the company's ability to maintain its Nasdaq listing. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading 'Risk Factors'; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
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SOURCE: Tivic Health Systems, Inc.
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PUB: 03/06/2025 08:15 AM/DISC: 03/06/2025 08:17 AM
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Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Balance Sheets (In thousands except par values, unless otherwise indicated) June 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents, including restricted cash of $152 for both periods presented $ 60,474 $ 44,660 Trade receivables, net of allowances of $199 and $95, respectively 9,656 7,768 Inventories 14,406 9,192 Prepaid expenses and other assets 2,143 2,482 Total current assets 86,679 64,102 Leasehold improvements and equipment, net 1,632 1,719 Intangible assets, net 284 359 Right-of-use assets 2,525 1,730 Other long-term assets 405 368 Total assets $ 91,525 $ 68,278 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 13,680 $ 8,526 Accrued expenses 7,381 7,817 Current maturities of operating lease obligations 957 982 Current maturities of finance lease obligations 6 12 Customer deposits 303 611 Total current liabilities 22,327 17,948 Deferred revenue 2,674 2,579 Operating lease obligations, less current maturities 2,329 1,657 Total stockholders' equity 64,195 46,094 Total liabilities and stockholders' equity $ 91,525 $ 68,278 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Statements of Cash Flows Six Months Ended June 30, (In thousands) 2025 2024 Net cash provided by / (used in): Operating activities $ 9,133 $ 31 Investing activities (167 ) (53 ) Financing activities 6,848 582 Net increase in cash and cash equivalents 15,814 560 Cash and cash equivalents beginning of period 44,660 27,325 Cash and cash equivalents at end of period $ 60,474 $ 27,885 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Reconciliation of Non-GAAP Financial Measures Reconciliation of Net Income (Loss) to Adjusted EBITDA (In thousands) Q2 2025 Q1 2025 Q4 2024 Q3 2024 Q2 2024 Net income (loss), as reported $ 3,609 $ 5,063 $ 7,179 $ 1,878 $ (15 ) Adjustments: Interest income, net (552 ) (459 ) (373 ) (276 ) (241 ) Provision for income taxes 128 168 305 — — Depreciation 158 158 151 164 170 Amortization of intangibles 38 37 38 38 37 Noncash lease expense 159 173 169 164 163 Share-based compensation 1,488 1,075 752 735 1,185 Severance and restructuring 21 4 (4 ) 185 276 Reversal of previously accrued royalties and license maintenance fees (1) — — (3,521 ) — — Recovery of credit losses related to legal settlement (2) — (1,325 ) (1,325 ) — — Adjusted EBITDA $ 5,049 $ 4,894 $ 3,371 $ 2,888 $ 1,575 Expand (1) The reversal of previously accrued royalties and license maintenance fees related to a supplemental agreement with Dartmouth, which waived certain obligations under the exclusive license agreements. (2) The recovery of credit losses relates to the 2024 legal settlement with Elysium Health, LLC, paid in two installments, reversing a bad debt write-off from 2019. Expand Non-GAAP Financial Information: To supplement Niagen Bioscience's unaudited financial data presented in accordance with generally accepted accounting principles (GAAP), the Company has presented Adjusted EBITDA, a non-GAAP financial measure. Niagen Bioscience believes the presentation of this non-GAAP financial measure provides important supplemental information to management and investors and enhances the overall understanding of the Company's historical and current financial operating performance. The Company believes disclosure of the non-GAAP financial measure has substance because the excluded expenses are infrequent in nature, are variable in nature or do not represent current cash expenditures. Further, such non-GAAP financial measure is among the indicators the Company uses as a basis for evaluating the Company's financial performance as well as for planning and forecasting purposes. Accordingly, disclosure of this non-GAAP financial measure provides investors with the same information that management uses to understand the Company's economic performance year-over-year. Adjusted EBITDA is defined as net income (loss) before (a) interest, (b) provision for income taxes, (c) depreciation, (d) amortization, (e) non-cash share-based compensation costs, (f) severance and restructuring expense and (g) other infrequent items, including the reversal of previously accrued royalties and license maintenance fees, and the recovery of previously recognized credit losses from a legal settlement. While Niagen Bioscience believes that this non-GAAP financial measure provides useful supplemental information to investors, there are limitations associated with the use of such measure. This measure is not prepared in accordance with GAAP and may not be directly comparable to similarly titled measures of other companies due to potential differences in the method of calculation. Management compensates for these limitations by relying primarily on the Company's GAAP results and by using Adjusted EBITDA only supplementally and by reviewing the reconciliation of the non-GAAP financial measure to its most comparable GAAP financial measure. Non-GAAP financial measures are not prepared in accordance with, or an alternative for, generally accepted accounting principles in the United States. The Company's non-GAAP financial measure is not meant to be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP.
