NPCE on Nasdaq

NeuroPace Inc

Logo: neuropace.com3

American surgical and medical instruments and apparatus company1

In its 2026 annual report the company says: “We are a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Our novel and differentiated RNS System is the first and only commercially available, brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source.”5 It is headquartered in Mountain View.1 Its shares trade on Nasdaq under the symbol NPCE.1

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Last updated Oct 21, 2026.

Overview

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  • TickerNPCE on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersMountain View1
  • Websitewww.neuropace.com
  • Legal formcorporation1
  • Incorporated inDE4
  • Business address455 N. Bernardo Avenue, Mountain View, Ca 940434
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company4
NeuroPace Inc image from its website
Image: neuropace.com3

We are a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Our novel and differentiated RNS System is the first and only commercially available, brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source. By continuously monitoring and analyzing the brain’s electrical activity, recognizing patient-specific abnormal electrical patterns, and responding in real time with imperceptible electrical pulses to prevent seizures, our RNS System is programmed by clinicians to deliver the precise amount of therapy when and where it is needed and provides exceptional clinical outcomes with approximately three minutes of stimulation on average per day. Our RNS System is also the only commercially available device that records continuous brain acti…5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

77.2%Gross margin6
-16.3%Operating margin6
-21.5%Net margin6
25.1%Revenue growth, 20256
-112.8%Return on equity6
3.09×Debt to equity6
-$11.3MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue23¢$22.8M
  • Research and development28¢$27.9M
  • Other costs49¢$49.3M

Out of $100.0M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$100.0M in 2025+143% since 2020
0$25.0M$50.0M$75.0M$100.0M2020: $41.1M$41.1M20202021: $45.2M$45.2M2021+10%2022: $45.5M$45.5M2022+1%2023: $65.4M$65.4M2023+44%2024: $79.9M$79.9M2024+22%2025: $100.0M$100.0M2025+25%
Gross profit789106$77.2M in 2025+155% since 2020
0$20.0M$40.0M$60.0M$80.0M2020: $30.3M$30.3M20202021: $33.4M$33.4M2021+10%2022: $32.5M$32.5M2022−3%2023: $48.1M$48.1M2023+48%2024: $59.1M$59.1M2024+23%2025: $77.2M$77.2M2025+31%
Operating income789106-$16.3M in 2025+25% since 2020
-$60.0M-$40.0M-$20.0M02020: -$13.1M-$13.1M20202021: -$23.7M-$23.7M2021+82%2022: -$40.8M-$40.8M2022+72%2023: -$27.2M-$27.2M2023−33%2024: -$21.7M-$21.7M2024−20%2025: -$16.3M-$16.3M2025−25%
Net income789106-$21.5M in 2025−12% since 2020
-$60.0M-$40.0M-$20.0M02020: -$24.3M-$24.3M20202021: -$36.1M-$36.1M2021+49%2022: -$47.1M-$47.1M2022+30%2023: -$33.0M-$33.0M2023−30%2024: -$27.1M-$27.1M2024−18%2025: -$21.5M-$21.5M2025−21%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Revenue$100.0M$79.9M
Cost of goods sold$22.8M$20.8M
Gross profit$77.2M$59.1M
Sales and marketing$46.6M$39.7M
Research and development$27.9M$23.7M
General and administrative$19.1M$17.4M
Total operating expenses$93.6M$80.8M
Loss from operations-$16.3M-$21.7M
Interest income$2.8M$3.0M
Interest expense-$7.5M-$8.8M
Other income (expense), net-$486.0K$304.0K
Net loss and comprehensive loss-$21.5M-$27.1M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$0.66-$0.93
Net loss per share attributable to common stockholders, diluted (in dollars per share)-$0.66-$0.93
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic (in shares)32.7M shares29.1M shares
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted (in shares)32.7M shares29.1M shares

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Corporate structure

NeuroPace Inc sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of NeuroPace Inc

  • NeuroPace Inc Mountain View

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What NeuroPace Inc reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$9.3M6 Dec 31, 2025$9.0M6 Dec 31, 2024+3.4%
Accumulated depreciation$8.2M6 Dec 31, 2025$8.0M6 Dec 31, 2024+2.9%
Property and equipment, net$1.1M6 Dec 31, 2025$1.1M6 Dec 31, 2024+6.9%
Operating-lease assets (leased space)$10.1M6 Dec 31, 2025$11.8M6 Dec 31, 2024−14.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$21.7M6 Dec 31, 2025$13.4M6 Dec 31, 2024+61.5%
Marketable securities, current$39.4M6 Dec 31, 2025$39.3M6 Dec 31, 2024+0.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$16.9M6 Dec 31, 2025$13.4M6 Dec 31, 2024+26.3%
Raw materials$6.2M6 Dec 31, 2025$3.9M6 Dec 31, 2024+60.4%
Work in process$2.8M6 Dec 31, 2025$2.2M6 Dec 31, 2024+29.0%
Finished goods$7.9M6 Dec 31, 2025$7.4M6 Dec 31, 2024+7.5%

Properties, in its own words

We currently lease approximately 53,000 square feet for our corporate headquarters and manufacturing facility located in Mountain View, California under a lease agreement which terminates in 2030 and we have an option to extend for another five years. We believe that this facility is sufficient to meet our current and anticipated needs in the near term and that suitable additional or alternative space can be obtained in the future on commercially reasonable terms, as needed.

Item 2 of the 10-K filed Mar 3, 2026.5

Leadership

Who has led NeuroPace Inc, and when. Pick a name to see everywhere that person has worked.

Chief financial officer

  1. Rebecca Kuhn2021–now
2025
Board members and other officers (12)

Timeline

  1. Aug 11, 20268-K Results of operations26
  2. Jul 28, 20268-K Regulation FD disclosure27
  3. Jun 8, 20268-K Shareholder vote28
  4. May 12, 20268-K Results of operations29
  5. Mar 3, 20268-K Results of operations30
  6. Nov 4, 20258-K Results of operations31
  7. Aug 12, 20258-K Results of operations32
  8. Jun 24, 20258-K Executive or director change; Regulation FD disclosure33
  9. Jun 12, 20258-K Shareholder vote34
  10. Jun 4, 20258-K Entered a material agreement; Ended a material agreement; New debt or obligation35
  11. May 27, 20258-K Regulation FD disclosure; Other events36
  12. May 13, 20258-K Results of operations37
  13. Apr 20, 2021New chief executive Michael Favet becomes CEO13

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.11) a share, on Nov 4, 2025.38

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results26
  2. May 12, 2026Reported quarterly or annual results29
  3. Mar 3, 2026Reported quarterly or annual results30
  4. Nov 4, 2025Reported quarterly or annual results31
  5. Aug 12, 2025Reported quarterly or annual results32
  6. May 13, 2025Reported quarterly or annual results37
  7. Mar 4, 2025Reported quarterly or annual results39
  8. Jan 28, 2025Reported quarterly or annual results40

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

284 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 46 major events, 150 insider forms, 33 large holders, 35 other. The latest 20:

  1. Sep 25, 20264 EDGAR
  2. Sep 21, 20264 EDGAR
  3. Sep 4, 2026SCHEDULE 13G/A EDGAR
  4. Sep 4, 20264 EDGAR
  5. Aug 28, 20264 EDGAR
  6. Aug 28, 20264 EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 11, 202610-Q EDGAR
  9. Aug 11, 20268-K EDGAR
  10. Jul 28, 20268-K EDGAR
  11. Jun 25, 20264 EDGAR
  12. Jun 22, 20264 EDGAR
  13. Jun 22, 20264 EDGAR
  14. Jun 22, 20264 EDGAR
  15. Jun 8, 20268-K EDGAR
  16. Jun 5, 20264 EDGAR
  17. Jun 5, 20264 EDGAR
  18. Jun 5, 20264 EDGAR
  19. Jun 5, 20264 EDGAR
  20. Jun 5, 20264 EDGAR

The 284 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

70 open-market trades by officers, directors and large owners since October 2021: 2 buys and 68 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 15, 2025Morrell MarthaCHIEF MEDICAL OFFICERSale25,000$15.97$399.2KForm 4
May 14, 2025ORBIMED ADVISORS LLC10% ownerSale168,136$15.85$2.7MForm 4
Feb 21, 2025Morrell MarthaCHIEF MEDICAL OFFICERSale78,334$13.72$1.1MForm 4
Feb 20, 2025KCK LTD.10% ownerSale5,270,845$9.40$49.5MForm 4
Jan 30, 2025Morrell MarthaCHIEF MEDICAL OFFICERSale200$15.00$3.0KForm 4
Jan 29, 2025Morrell MarthaCHIEF MEDICAL OFFICERSale100$15.00$1.5KForm 4
Jan 24, 2025Morrell MarthaCHIEF MEDICAL OFFICERSale3,200$15.01$48.0KForm 4
Oct 25, 2024KCK LTD.10% ownerSale223,991$5.45$1.2MForm 4
Oct 23, 2024KCK LTD.10% ownerSale147$6.02$885Form 4
Oct 22, 2024KCK LTD.10% ownerSale4,082$6.09$24.9KForm 4
Oct 21, 2024KCK LTD.10% ownerSale3,720$6.10$22.7KForm 4
Oct 18, 2024KCK LTD.10% ownerSale4,878$6.29$30.7KForm 4
Oct 17, 2024KCK LTD.10% ownerSale3,294$6.28$20.7KForm 4
Oct 16, 2024KCK LTD.10% ownerSale6,900$6.57$45.3KForm 4
Oct 15, 2024KCK LTD.10% ownerSale4,017$6.50$26.1KForm 4
Oct 14, 2024KCK LTD.10% ownerSale4,031$6.54$26.4KForm 4
Oct 11, 2024KCK LTD.10% ownerSale2,572$6.35$16.3KForm 4
Oct 10, 2024KCK LTD.10% ownerSale2,504$6.12$15.3KForm 4
Oct 9, 2024KCK LTD.10% ownerSale3,123$6.10$19.1KForm 4
Oct 8, 2024KCK LTD.10% ownerSale6,000$6.43$38.6KForm 4

All 70 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Joel BeckerPresident and Chief Executive Officer58$567.6K$2.4M52
2025Patrick WilliamsChief Financial Officer53$263.5K$1.6M52
2025Martha Morrell, M.D.Chief Medical Officer70$489.8K$1.0M52
2025Rebecca KuhnFormer Chief Financial Officer, Vice President, Finance and Administration$268.2K$846.3K52
2024Joel BeckerPresident and Chief Executive Officer58$528.7K$3.0M52
2024Martha Morrell, M.D.Chief Medical Officer70$486.7K$1.2M52
2024Rebecca KuhnFormer Chief Financial Officer, Vice President, Finance and Administration$416.2K$1.1M52

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Polar Capital Holdings Plc3,298,104$52.4M0.1%No change
Soleus Capital Management, L.P.2,911,122$46.3M1.6%−21,085
First Light Asset Management, LLC2,861,167$45.5M2.8%+401,201
Morgan Stanley2,654,391$42.2M0.0%+87,552
BlackRock, Inc.2,477,603$39.4M0.0%+131,270
Orbimed Advisors LLC1,505,125$23.9M0.5%−591,402
Driehaus Capital Management LLC1,447,391$23.0M0.1%−4,220
Vanguard Capital Management LLC1,227,072$19.5M0.0%+103,361
Deutsche Bank Ag\938,919$14.9M0.0%+6,829
Armistice Capital, LLC692,000$11.0M0.3%No change
Geode Capital Management, LLC666,300$10.6M0.0%+48,181
Fmr LLC554,771$8.8M0.0%+1,242
State Street Corp550,132$8.7M0.0%+52,586
Silvercrest Asset Management Group LLC344,124$5.5M0.0%−15,941
Northern Trust Corp260,025$4.1M0.0%+20,185
Qube Research & Technologies Ltd221,237$3.5M0.0%+35,048
Vanguard Portfolio Management LLC220,371$3.5M0.0%+32,942
Palumbo Wealth Management LLC209,199$3.3M0.7%−1,270
Essex Investment Management Co LLC208,703$3.3M0.4%−9,035
Algert Global LLC184,774$2.9M0.0%+5,218
Vanguard Fiduciary Trust Co182,534$2.9M0.0%+3,888
Jpmorgan Chase & Co173,311$2.9M0.0%+32,170
HighMark Wealth Management LLC163,000$2.6M0.9%+100,000
Russell Investments Group, Ltd.162,164$2.6M0.0%−16,857
D. E. Shaw & Co., Inc.161,081$2.6M0.0%+117,456

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How NeuroPace Inc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARNeuroPace Inc2
  • CIK0001528287
  • Employer ID (EIN)22-35502305
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address455 N. Bernardo Avenue, Mountain View, CA 940432
  • Phone65023727002
  • Shares outstanding34,324,274 as of Aug 7, 202612
  • Public float$306.2M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers, San Jose, California PCAOB ID 238; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 30, 20112
  • Filings353 in all: 4 (163), 8-K (50), 3 (18), 10-Q (17), SC 13G/A (12), 144 (11), SCHEDULE 13G/A (11), CORRESP (7)2
    All 33 form types

    S-8 (7), SC 13G (7), 10-K (5), DEF 14A (5), DEFA14A (5), 4/A (4), ARS (4), D (4), EFFECT (3), SCHEDULE 13G (3), 424B5 (2), UPLOAD (2), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), FWP (1), POS AM (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3 (1), SC 13D (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 3, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareNPCEThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 3, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks NeuroPace Inc names in Item 1A of its 10-K filed Mar 3, 2026: 72 risks under these headings, as written.5

  • Risks related to operational, regulatory, commercial and manufacturing matters
  • We currently rely on our RNS System, which can only be marketed in the United States for use in adults with drug-resistant focal epilepsy, as our primary source of revenue. If we fail to successfully market and sell our RNS System cost effectively and maintain and expand our market share, our sales, business, financial condition and results of operations will be negatively affected.
  • Our commercial success will continue to depend on attaining significant market acceptance of our products and increasing the number of patients treated. If we are unable to successfully achieve substantial market acceptance and increase adoption of our RNS System both within Level 4 CECs and in the community, our sales, business, financial condition and results of operations would be harmed.
  • Our commercial success will depend on a continued flow of patient referrals to CECs from treating primary care physicians, neurologists, and other healthcare providers and from caregiver support of such referrals. If we are unable to successfully expand our referral pathways to achieve an increased patient referral pipeline into CECs or develop opportunities outside of Level 4 CECs, in the community setting, our sales, business, financial condition and results of operations would be harmed.
  • Various factors outside our direct control may negatively impact our manufacturing of our RNS System, which could harm our business, financial condition, and results of operations.
  • We depend on a limited number of single-source suppliers and vendors in connection with the manufacture of our RNS System, which makes us vulnerable to supply shortages and price fluctuations that could harm our business, financial condition, and results of operations.
  • Our results of operations may be harmed if we are unable to accurately forecast customer demand for our products.
  • If we fail to optimize our sales and marketing capabilities and develop widespread brand awareness cost-effectively, our growth will be impeded and our business may suffer.
  • We may be unable to compete successfully with other treatment options for drug-resistant focal epilepsy, which could harm our sales, business, financial condition and results of operations.
  • Adoption of our RNS System depends on positive clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians would harm our sales, business, financial condition, and results of operations.
  • If adequate reimbursement becomes unavailable for the procedures to implant our RNS System and for clinicians to provide ongoing care for patients treated with our RNS System, it could diminish our sales or affect our ability to sell our RNS System profitably.
  • Use of our RNS System requires appropriate neurosurgeon training for implantation and epileptologist training for prescribing, programming and ongoing patient care, and inadequate training may lead to negative patient outcomes, which could harm our business, financial condition, and results of operations.
The other 61 risks
  • We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
  • We expect to increase the size of our organization in the future, and we may experience difficulties in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of our business, our future revenue and operating results may be harmed.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our RNS System, which could harm our business and results of operations.
  • The current administration’s new and changing tariff framework could inhibit our ability to maintain the RNS System’s gross margin at the historical rates, which could negatively impact our long-range revenue forecast, and the results of operations. In addition, trade restrictions or other political tensions may exacerbate unfavorable macroeconomic conditions, which could adversely affect our business, results of operations, financial condition and prospects.
  • We are seeking expanded FDA labeling for our RNS System to be able to treat patients with generalized drug-resistant epilepsy as well as patients between the age of 12 and 17 with drug-resistant focal epilepsy, but if we are unable to broaden the indications for our RNS System to include these patients, or if the recent FDA staffing changes delay reviews of our applications for indication expansion, our growth potential could be harmed.
  • Our growth prospects may be harmed if we are unable to successfully use our unique data asset and analysis capabilities, either internally or through collaboration, or if our expectations with respect to our ability to leverage our unique data asset prove to be incorrect.
  • We may expand sales of our RNS System internationally in the future, but we may experience difficulties in obtaining regulatory clearance or approval or in successfully marketing our RNS System internationally even if
  • approved. A variety of risks associated with marketing our RNS System internationally could harm our growth potential.
  • Risks related to government regulation and our industry
  • If we fail to comply with U.S. federal and state laws and regulations, including fraud and abuse and other healthcare laws and regulations, such as those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business, financial condition and results of operations could be harmed.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business, financial condition and results of operations.
  • Regulatory compliance is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
  • Our operations are subject to pervasive and continuing FDA regulatory requirements, and failure to comply with these requirements could harm our growth potential, and our business, financial condition and results of operations.
  • Modifications to our products or products we sell may require new 510(k) clearances or PMAs or may require us to recall or cease marketing these products until clearances or approvals are obtained, which could harm our business, financial condition and results of operations.
  • Our products or products we distribute may be subject to recalls after receiving FDA approval or clearance, which could divert managerial and financial resources, harm our reputation and our business.
  • If any of our products or products that we distribute cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations which can result in voluntary corrective actions or agency enforcement actions and harm our reputation, business, financial condition and results of operations.
  • From time to time, we engage outside parties to perform services related to certain of our clinical studies. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to complete our clinical studies on our planned timelines, or at all, and may incur significant additional costs.
  • Healthcare reform initiatives and other administrative and legislative proposals may harm our business, financial condition, results of operations and cash flows in our key markets.
  • Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability.
  • Clinical studies may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to support label expansion for additional indications.
  • We may become subject to numerous laws and regulations related to anti-bribery and anti-corruption laws, such as the FCPA and the U.K. Bribery Act, in which violations of these laws could result in substantial penalties and prosecution.
  • Risks related to privacy, information technology and cybersecurity
  • reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences, which could have a material and adverse impact on our business, financial condition and results of operations.
  • We face potential liability related to the privacy of health information we obtain.
  • Risks related to our intellectual property
  • If we are unable to obtain, maintain, protect, enforce and defend patent or other intellectual property protection for our products, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, or as a result of our existing or any future out-licenses of our intellectual property, our competitors could develop and commercialize products similar to or competitive with our products, our ability to continue to commercialize our RNS System, or our other products, may be harmed.
  • We may not be successful in obtaining necessary rights to any products or processes we may develop through acquisitions and in-licenses.
  • Patents covering our products, including our RNS System could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, which could harm our business, financial condition and results of operations.
  • The medical device industry is characterized by patent litigation and in the future we could become subject to patent or other intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages or prevent us from marketing our existing or future products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Certain of our patents are, and our future owned and in-licensed patents may be, discovered through government funded programs and thus may subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • If we fail to comply with our obligations in any current or future agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • If we are unable to obtain patent term extension under the Hatch-Waxman Amendments, our business may be materially harmed.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world, which could harm our business, financial condition and results of operations.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims, including third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators, challenging the ownership or inventorship of our intellectual property and, if unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, or to cease the development, manufacture and commercialization of one or more of our products.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed.
  • Intellectual property rights do not necessarily address all potential threats, and limitations in intellectual property rights could harm our business, financial condition and results of operations.
  • If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed.
  • Our inability to use software licensed from third parties, or our use of open-source software under license terms that interfere with our proprietary rights, could disrupt our business.
  • Risks related to financial matters
  • We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we do achieve profitability, we may not be able to sustain it.
  • Our MidCap Term Loan contains restrictive covenants as well as financial maintenance covenants, and if we are unable to comply with these covenants then the lenders could declare an event of default and we may need to immediately repay the amounts due under the MidCap Term Loan.
  • With the expiration of our exclusive distribution agreement with DIXI Medical, our revenue growth, financial condition and results of operations may be materially affected.
  • Our actual operating results may differ significantly from any guidance provided.
  • Our operating results may fluctuate across periods, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • To support our continued operations and the growth of our business, we may need to seek additional capital through new equity or debt financings, which sources of additional capital may not be available to us on acceptable terms or at all. If we are unable to obtain, if needed, adequate financing or financing on terms satisfactory to us, it could harm our business and growth prospects.
  • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
  • If we identify any material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations.
  • Our history of recurring losses and anticipated expenditures as well as the significant amount of debt that we have incurred may affect our ability to operate our business and secure additional financing in the future.
  • Other risks facing our company
  • Our estimates of market opportunity and forecasts of market and revenue growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar rates, if at all.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our products. The expense and potential unavailability of insurance coverage for liabilities resulting from our products could harm our business and our ability to sell our products, including our RNS System.
  • The failure of third parties to meet their contractual, regulatory and other obligations could adversely affect our business.
  • Future legislation, potential changes in federal regulatory agency leadership, and new policies and priorities under the current Administration may adversely impact our company.
  • Risks related to ownership of our common stock
  • If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
  • Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to decline.
  • Concentration of ownership of our common stock among our executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
  • Our stock price has been volatile, an active or liquid market in our common stock may not be sustainable and the value of our common stock may decline.
  • We are an emerging growth company and a smaller reporting company, and our compliance with the reduced reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companies could make our common stock less attractive to investors.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware or, under certain circumstances, the federal district courts of the United States of America be the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • General risk factors
  • Disruptions at the FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages or governmental shutdowns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Legal proceedings

Legal Proceedings

From time to time, we may be subject to litigation and claims arising in the ordinary course of business. While the results of any litigation or other legal proceedings are uncertain, we are not currently a party to any material legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, financial position, results of operations or cash flows.

The opening of Item 3, Legal Proceedings.5

Sources

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