What the changes say
- Expansion strategy now emphasizes acquiring profitable U.S. fertility clinics, but targets, financing, and integration remain uncertain.
- Regulatory exposure expands around embryos, FDA quality systems, clinic liabilities, and tariffs affecting imported supplies.
- Clinic-level performance, acquisition effects, staffing competition, and internal-control weaknesses now feature more prominently.
What changed since the prior 10-K
New
- NewRisks Relating to Our Business
We may not be successful at pursuing our acquisition strategy
Growth depends on finding profitable U.S. fertility clinics, negotiating acquisitions, and obtaining financing for additional targets.
- NewRisks Relating to Our Business
We may be subject to significant liabilities arising from claims brought against our fertility clinics, affiliated physicians, and related service providers
Clinic and laboratory services could generate costly malpractice, reproductive-material handling, billing, consent, or reimbursement litigation exceeding insurance coverage.
- NewRisks Related to Our Industry
We may be subject to risks related to changes in laws regarding abortion, which can affect how a fertility clinic must treat and handle embryos
State abortion laws, including protections for stored embryos, could restrict embryo handling, fertility procedures, travel programs, or service availability.
- NewRisks Related to Our Industry
We are subject to significant domestic and international governmental regulation and if we fail to comply we could suffer penalties or be required to make significant changes to our operations
Failure to comply with extensive clinic and medical-device regulations could trigger penalties, recalls, operational changes, or cessation of operations.
- NewRisks Related to Our Industry
If we fail to comply with the FDA ’ s Quality System Regulation (“QSR”), the FDA could take various enforcement actions, including suspending our FDA clearance to market, or halting our manufacturing operations, and our business would suffer
Failure to meet FDA QSR and international quality standards could suspend marketing clearance or halt INVOcell manufacturing.
- NewRisks Related to Our Common Stock
Changes in U.S. trade policy and the imposition of tariffs could increase our operating costs and adversely affect our business
Tariffs on imported medical devices, consumables, and supplies could raise clinic costs, reduce margins, and disrupt the supply chain.
Dropped
- DroppedRisks Related to the Acquisition of NAYA Therapeutics
NAYA Therapeutics has a limited operating history and has no products approved for commercial sale, which may make it difficult for you to evaluate the success of NAYA Therapeutics business to date and to assess its future viability
- DroppedRisks Related to the Acquisition of Wisconsin Fertility Institute
The acquisition of WFI may present challenges to management, including the integration of our operations and personnel and that of WFI, continued management of the clinic and special risks, including possible unanticipated liabilities, unanticipated integration costs and diversion of management attention
- DroppedRisks Related to the Acquisition of Wisconsin Fertility Institute
If we fail to make the required $7.5 million in additional payments required in our acquisition of WFI, our business would be adversely affected
- DroppedRisks Related to the Acquisition of Wisconsin Fertility Institute
We may incur additional debt financing to provide the cash proceeds necessary to acquire WFI. If we were unable to service any such debt, our business would be adversely affected
- DroppedRisks Relating to Our Business
We are subject to significant domestic and international governmental regulation
NAYA Therapeutics’ limited history and lack of commercially approved products made its biotechnology prospects difficult to assess.
- DroppedRisks Relating to Our Business
We are subject to risks relating to federal and state healthcare fraud, waste, and abuse laws
- DroppedRisks Relating to Our Business
At present, our products and services are not reimbursable under any federal healthcare program. If, however, that changes in the future and it were determined that we were not in compliance with these federal fraud, waste, and abuse laws, we would be subject to liability
Integrating and managing Wisconsin Fertility Institute could create liabilities, costs, management distraction, and disappointing synergies.
- DroppedRisks Relating to Our Business
Additionally, to the extent that our product is sold or our services are provided in a foreign country, we may be subject to similar foreign laws
Required $7.5 million of additional Wisconsin Fertility Institute acquisition payments could strain the business.
- DroppedRisks Related to the Fertility Industry
In order to sell our products in foreign countries, generally we must obtain regulatory approvals and comply with the regulations of those countries. These regulations, including the requirements for approvals or clearances and the time required for regulatory review, vary from country-to-country
Debt used to finance Wisconsin Fertility Institute could create defaults, collateral loss, and repayment pressure.
- DroppedRisks Related to the Fertility Industry
If third-party payers do not provide adequate coverage and reimbursement for INVOcell and the IVC procedure, we may be unable to generate significant revenue
- DroppedRisks Related to Our Therapeutics Business and Industry
Our ability to develop proprietary technology platforms and products and our future growth depend on retaining NAYA Therapeutics’ key personnel and recruiting additional qualified personnel
- DroppedRisks Related to Our Therapeutics Business and Industry
The regulatory processes that will govern the approval of our product candidates are complex and changes in regulatory requirements could result in delays or discontinuation of development or unexpected costs in obtaining regulatory approval
- DroppedRisks Related to Our Therapeutics Business and Industry
Additionally, any delay in, or termination of, our future clinical trials will delay the submission of a BLA to the FDA or other equivalent applications with other relevant foreign regulatory authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenue
Broad domestic and international government regulation could cause penalties, product recalls, or cessation of operations.
- DroppedRisks Related to Our Therapeutics Business and Industry
Our fully integrated product candidates represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical development or delays in or our inability to achieve regulatory approval, commercialization, or payor coverage of our product candidates
Healthcare fraud, waste, and abuse laws could expose the company to enforcement and liability.
- DroppedRisks Related to Our Therapeutics Business and Industry
Even if any of our product candidates receive marketing approval, we may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success
Future federal reimbursement could make noncompliance with federal fraud, waste, and abuse laws actionable.
- DroppedRisks Related to Our Therapeutics Business and Industry
Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities
Foreign healthcare laws, HIPAA, HITECH, and protected-health-information breaches could harm the business.
- DroppedRisks Related to Our Therapeutics Business and Industry
Any delay or difficulties in the manufacturing and/or clinical supply of NY-303 and NY-338, or any of our other current or future product candidates would adversely affect our therapeutics business and operations
- DroppedRisks Related to Our Therapeutics Business and Industry
Clinical product candidate development involves a lengthy and expensive process and involve uncertain outcomes. We may incur additional costs and encounter substantial delays or difficulties in our therapeutics clinical trials
- DroppedRisks Related to Our Therapeutics Business and Industry
If we encounter difficulties in enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected
- DroppedRisks Related to Our Therapeutics Business and Industry
We may not be able to file Investigational New Drug Applications to commence future clinical trials on the timelines it expects, and even if it is able to, the FDA or comparable foreign authority may not permit us to proceed
- DroppedRisks Related to Our Therapeutics Business and Industry
Interim, “top-line” and preliminary data from our clinical trials that it announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
- DroppedRisks Related to Our Therapeutics Business and Industry
We face significant competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing, or commercializing products before or more successfully than we do
- DroppedRisks Related to Our Therapeutics Business and Industry
We face substantial competition from multiple sources, including large and specialty pharmaceutical, biopharmaceutical and biotechnology companies, academic research institutions and governmental agencies and public and private research institutions
- DroppedRisks Related to Our Therapeutics Business and Industry
NY-500 may not surpass the current standard of care or that sales of NY-500, if ever approved, will approach or surpass the market leader
- DroppedRisks Related to Our Therapeutics Business and Industry
We may not identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success
- DroppedRisks Related to Our Therapeutics Business and Industry
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
- DroppedRisks Related to Our Therapeutics Manufacturing
The manufacturing of our product candidates will be very complex. We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates
- DroppedRisks Related to Our Therapeutics Manufacturing
As a result, we may not be able to conduct these corporate collaborations in the manner or on the time schedule it currently contemplates, which may negatively impact our therapeutics business operations
- DroppedRisks Related to Our Therapeutics Manufacturing
We work with several third-party manufacturers and suppliers for the production of our antibody and cell product candidates. We have a long-term relationship with STC Biologics for the manufacturing of our NY-303 and NY-338 products
- DroppedRisks Related to Our Therapeutics Manufacturing
Our product candidates rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all
- DroppedRisks Related to Our Therapeutics Manufacturing
We also face competition for supplies from other cell therapy companies. Such competition may make it difficult for us to secure raw materials or the testing of such materials on commercially reasonable terms or in a timely manner
- DroppedRisks Related to Our Therapeutics Manufacturing
If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement its strategies
- DroppedRisks Related to Our Therapeutics Manufacturing
We may seek to form collaborations in the future with respect to our product candidates, but may not be able to do so, which may cause us to alter our development and commercialization plans
- DroppedRisks Related to Our Therapeutics Manufacturing
Our business involves the use of hazardous materials which requires that we, and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict or interrupt its business
- DroppedRisks Related to Our Therapeutics Manufacturing
Furthermore, if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed or we could lose potential revenue
Foreign sales required country-specific medical-device approvals, including European certification and CE marking.
- DroppedRisks Related to Our Therapeutics Manufacturing
The Chinese government also exercises significant control over Chinese economic growth through the allocation of resources, controlling payment of foreign currency-denominated obligations, setting monetary policy and providing preferential treatment to particular industries or companies
Insufficient payer coverage or reimbursement for INVOcell and the IVC procedure could limit revenue.
- DroppedRisks Related to Our Intellectual Property
Any failure to obtain, maintain, protect, or enforce our intellectual property and proprietary rights, or if the scope of intellectual property protection we obtain are not sufficiently broad, that could impair our ability to compete or protect its proprietary technology and brand
NAYA Therapeutics depended on retaining key personnel, particularly co-founder and CEO Daniel Teper.
- DroppedRisks Related to Our Intellectual Property
We have entered into license agreements with third parties and may need to obtain additional licenses from our existing licensors and others to advance our research or allow commercialization of product candidates and technologies we may develop
Changing and complex approval requirements for NAYA’s cellular product candidates could delay development or increase costs.
- DroppedRisks Related to Our Intellectual Property
Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts
- DroppedRisks Related to Our Intellectual Property
We may be subject to claims asserting that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
- DroppedRisks Related to Our Intellectual Property
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court
- DroppedRisks Related to Our Intellectual Property
Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates
- DroppedRisks Related to Our Intellectual Property
Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. If we or our licensors do not obtain patent term extension for our product candidates, our business may be materially harmed
- DroppedRisks Related to Our Intellectual Property
We may not be able to protect our intellectual property rights throughout the world
- DroppedRisks Related to Our Intellectual Property
We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope, or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture, and eventually market product candidates
- DroppedRisks Related to Our Intellectual Property
Obtaining and maintaining our patent rights 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 noncompliance with these requirements
- DroppedRisks Related to Our Intellectual Property
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
- DroppedRisks Related to Our Intellectual Property
Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business
- DroppedRisks Related to Our Intellectual Property
Intellectual property rights do not necessarily address all potential threats to our business
- DroppedRisks Related to Our Common Stock
On November 4, 2024, we received a notice from Nasdaq’s Listing Qualifications Staff stating that we had determined that we have demonstrated compliance with the equity requirement of the Equity Rule but that we will be subject to a Mandatory Panel Monitor for a period of one year from October 14, 2024
- DroppedRisks Related to Our Common Stock
On March 25, 2025, we were notified by the Staff that because we did not evidence compliance with the Minimum Bid Rule by March 17, 2025, the Staff determined that our securities should be delisted from Nasdaq
- DroppedRisks Related to Our Common Stock
The letter had no immediate effect on the listing of our common stock
- DroppedRisks Related to Our Common Stock
Our business may be affected by new tariffs, U.S. trade policy, and trade wars
Reworded
- 100% rewrittenRisks Relating to Our Business
We may not be able to successfully manage current and future acquisitions and to achieve the benefits expected to result from the acquisitions
The discussion now covers current and future acquisitions, adds unanticipated integration risks, and identifies existing clinic joint ventures as important.
Was: We may not be able to successfully manage Wisconsin Fertility Institute and to achieve the benefits expected to result from the acquisition
- 88% rewrittenRisks Related to Our Common Stock
If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock will be delisted from Nasdaq
Specific Nasdaq equity-rule delisting details were removed; the risk now focuses on potential delisting and reduced over-the-counter liquidity.
- 80% rewrittenRisks Related to Our Common Stock
We have broad discretion over the use of our cash and cash equivalents and may not use them effectively
The unchanged cash-use discussion now adds identified material weaknesses and ineffective internal control over financial reporting.
- 76% rewrittenRisks Relating to Our Business
We may not be able to develop or continue our business if we fail to recruit and/or retain key personnel
The risk now includes clinic physicians, lab directors, embryologists, and staff, plus recruitment competition and physician-employment regulation.
Was: We may not be able to develop or continue our business if we fail to retain key personnel
- 70% rewrittenRisks Related to Our Industry
Improper marketing and promotion or off-label use of our product could lead to investigations and enforcement by governmental bodies including product recalls or market withdrawal, may harm our reputation and business, and could result in product liability suits
The INVOcell off-label marketing and physician-use discussion is substantively unchanged.
- 64% rewrittenRisks Related to Our Common Stock
Our revenue and operating results could fluctuate from quarter to quarter, which may cause our stock price to decline
Operating volatility is now tied to individual clinic performance and acquisitions, in addition to INVOcell ordering cycles.
Was: Our revenue and operating results could fluctuate significantly from quarter to quarter, which may cause our stock price to decline
- 62% rewrittenRisks Related to Our Industry
Changes in the healthcare industry may require us to decrease the selling price for our services or products or could result in a reduction in the available market size
The risk now expressly covers pricing and market effects on services as well as products.
Was: Changes in the healthcare industry may require us to decrease the selling price for our products or could result in a reduction in the available market size
- 35% rewrittenRisks Related to Our Common Stock
An active trading market for our common stock may not be sustained. If an active trading market is not sustained, our ability to raise capital in the future may be impaired
The active-trading-market risk is substantively unchanged, including capital-raising constraints and stock-price volatility.
- 34% rewrittenRisks Relating to Our Business
Currency exchange rate fluctuations may affect the results of our operations
- 25% rewrittenRisks Relating to Our Business
Our products incorporate intellectual property rights developed by us that may be difficult to protect or may be found to infringe on the rights of others
- 24% rewrittenRisks Relating to Our Business
We need to manage growth in our fertility operations, and we may not be successful in implementing our growth strategy
- 23% rewrittenRisks Relating to Our Business
Our business is subject to significant competition
Was: Our fertility business is subject to significant competition
- 20% rewrittenRisks Related to Our Common Stock
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
All 52 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Condition and Our Need for Additional Capital
- 01Our financial situation creates doubt whether we will continue as a going concern
- 02We have substantial indebtedness outstanding, and our operations are significantly leveraged. If we were unable to service our indebtedness, our business would be adversely affected
- 03We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate operations
- 04Even if we can raise additional funding, we may be required to do so on terms that are dilutive to you
Risks Relating to Our Business
- 05Our business has posted net operating losses, has a limited operating history, and needs additional capital to grow and finance its operations
- 06Our business is subject to significant competition23% rewritten
- 07We need to manage growth in our fertility operations, and we may not be successful in implementing our growth strategy24% rewritten
- 08We may not be successful at pursuing our acquisition strategyNew
- 09We may not be able to develop or continue our business if we fail to recruit and/or retain key personnel76% rewritten
- 10We may not be successful at managing clinics
- 11We may not be able to successfully manage current and future acquisitions and to achieve the benefits expected to result from the acquisitions100% rewritten
- 12We may be subject to significant liabilities arising from claims brought against our fertility clinics, affiliated physicians, and related service providersNew
- 13We face potential liability as a provider of a medical device. These risks may be heightened in the area of artificial reproduction
- 14If we fail to maintain adequate quality standards for our services and products, our reputation and business may be adversely affected and harmed
- 15We heavily rely on third party package delivery services, and a significant disruption in these services or significant increases in prices may disrupt our ability to import or export materials, increase our costs and negatively affect our ability to achieve and maintain profitability
- 16Our products incorporate intellectual property rights developed by us that may be difficult to protect or may be found to infringe on the rights of others 25% rewritten
- 17We may be forced to defend our intellectual property rights from infringement through expensive legal action
- 18We are subject to risks in connection with changes in international, national, and local economic and market conditions
- 19If we are unable to effectively adapt to changes in the healthcare industry, our business may be harmed
- 20Social media platforms present risks and challenges
- 21We are susceptible to cybersecurity breaches and cyber-related fraud
- 22We are subject to risks associated with doing business globally
- 23Currency exchange rate fluctuations may affect the results of our operations34% rewritten
- 24Failure to comply with the United States Foreign Corrupt Practices Act or similar laws could subject us to penalties and other adverse consequences
- 25We will need additional, qualified personnel in order to expand our fertility business. Without additional personnel, we will not be able to expand our fertility business
Risks Related to Our Industry
- 26We may be subject to risks related to changes in laws regarding abortion, which can affect how a fertility clinic must treat and handle embryosNew
- 27We are subject to significant domestic and international governmental regulation and if we fail to comply we could suffer penalties or be required to make significant changes to our operationsNew
- 28The FDA regulatory review process for medical devices is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products
- 29Improper marketing and promotion or off-label use of our product could lead to investigations and enforcement by governmental bodies including product recalls or market withdrawal, may harm our reputation and business, and could result in product liability suits70% rewritten
- 30If we fail to comply with the FDA ’ s Quality System Regulation (“QSR”), the FDA could take various enforcement actions, including suspending our FDA clearance to market, or halting our manufacturing operations, and our business would sufferNew
- 31We are subject to continuing regulation by the FDA, and failure to comply may materially harm our business
- 32Changes in the healthcare industry may require us to decrease the selling price for our services or products or could result in a reduction in the available market size62% rewritten
- 33Recent economic trends could adversely affect our financial performance
Risks Related to Our Common Stock
- 34Our secured debt instruments contain numerous restrictive covenants that limit management’s discretion to operate our business
- 35If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock will be delisted from Nasdaq88% rewritten
- 36Our common stock is subject to risks arising from restrictions on reliance on Rule 144 by shell companies or former shell companies
- 37Our directors have the right to authorize the issuance of shares of our preferred stock and additional shares of our common stock
- 38The indemnification rights provided to our directors, officers and employees may result in substantial expenditures by us and may discourage lawsuits against its directors, officers and employees
- 39We have a trading symbol for our common stock (“IVF”) and our common stock is currently listed on the Nasdaq Capital Market
- 40We do not expect to pay any dividends to shareholders
- 41Our revenue and operating results could fluctuate from quarter to quarter, which may cause our stock price to decline64% rewritten
- 42We may have difficulty raising the necessary capital to fund operations because of the thin market and market price volatility for our shares of common stock
- 43An active trading market for our common stock may not be sustained. If an active trading market is not sustained, our ability to raise capital in the future may be impaired35% rewritten
- 44Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price20% rewritten
- 45Changes in U.S. trade policy and the imposition of tariffs could increase our operating costs and adversely affect our businessNew
- 46Our business is affected by macroeconomic conditions, including rising inflation, interest rates and supply chain constraints
- 47We are a Smaller Reporting Company, or SRC, and the reduced disclosure requirements applicable to SRCs may make our common stock less attractive to investors
- 48We have broad discretion over the use of our cash and cash equivalents and may not use them effectively80% rewritten
- 49If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline
- 50Stockholders may be diluted significantly through our efforts to obtain financing and from issuance of additional shares of our common stock, including such issuances of shares for services
- 51We are subject to the reporting requirements of U.S. federal securities laws, which can be time consuming and expensive
- 52Failure to comply with internal control attestation requirements could lead to loss of public confidence in our financial statements and negatively impact our stock price
Other INVO Fertility 10-Ks
- FY2024 10-K risk factors99 risks
INVO Fertility faces substantial accumulated net losses, ongoing liquidity concerns, and a high degree of operational leverage tied to debt and acquisitions like WFI and NAYA Therapeutics. Regulatory compliance across FDA medical device standards and healthcare fraud laws significantly impacts commercialization efforts and clinical trials.
Filed Apr 30, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.