▸ Because we are a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting in order to comply with Section 404 of the Sarbanes-Oxley Act of 2002 (the· · · · ● 1 ▸ We cannot assure you that we will be successful in addressing these or other risk factors that might affect the market acceptance of our products. If we are unsuccessful in achieving and maintaining market acceptance of our· · · · ● 1 ▸ We maintain product liability insurance, but this insurance is subject to deductibles, limits, and exclusions and may not fully protect us from the financial impact of defending against product liability claims or the potential loss· · · · ● 1 ▸ We may pursue additional arrangements regarding the sales, marketing, and distribution of one or more of our products and our future revenue may depend, in part, on our ability to enter into and maintain successful· · · · ● 1 ▸ Changes in the state and local regulatory environment could limit our business activities or increase our operating costs.· · · ● ● 2 ▸ Our future capital needs are uncertain and we may need to seek additional financing in the future, which we may not be able to secure on favorable terms, if at all.· · ● ● ● 3 ▸ If we are unable to manufacture or ship our products to meet demand, our operating results will suffer.· ● ● ● ● 4 rw ▸ Our customers' research and development, and the clinical and market success of their products, may significantly influence our business, financial condition, and results of operations.· ● ● ● ● 4 ▸ We may become the subject of various claims, litigation or investigations which could have a material adverse effect on our business, financial condition, results of operations, or stock price.· ● ● ● ● 4 ▸ The Second Amended and Restated Credit Agreement contains a number of requirements, including a covenant regarding minimum cash and revenue amounts as well as other restrictive covenants that impose· · · ● · 1 ▸ We are subject to environmental, health, and safety laws and regulations, incur costs to comply with such laws and regulations, and could be exposed to liabilities or other obligations imposed under such laws or regulations. The· · · ● · 1 ▸ We have invested a significant amount of capital in our new and legacy manufacturing facilities in both equipment and infrastructure to substantially increase the effective manufacturing capacity at our facilities, improve· · · ● · 1 ▸ We are highly dependent, and our success depends largely, upon the continued service of our management, technical, and other staff and our ability to attract, retain, and motivate highly skilled personnel who deliver· · ● · · 1 ▸ We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a· · ● · · 1 ▸ We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.· · ● · · 1 ▸ Any such non-compliance, even if prohibited by our internal policies, could have an adverse effect on our business and result in significant fines or penalties.· ● · · · 1 ▸ If we fail to comply with Nasdaq listing rules or California laws governing the diversity of our board of directors, we could be exposed to financial penalties and suffer reputational harm.· ● ● · · 2 ▸ Natural disasters (including earthquakes, fire, and drought), geopolitical unrest, war (including the war in Ukraine), terrorism, public health issues (including the ongoing COVID-19 pandemic) or other catastrophic· ● · · · 1 ▸ Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.· ● · · · 1 ▸ Our internal computer systems, or those of our suppliers, customers, or contractors, have been and may in the future be subject to cyberattacks or security breaches, which could result in a material disruption of our· ● · · · 1 ▸ Any breach of our confidentiality agreements or our failure to enforce such agreements effectively would have a material adverse effect on our business and competitive position.● ● · · · 2 rw ▸ As of December 31, 2021, we had $13.7 million of U.S. federal and $11.7 million of state net operating loss (NOL) carryforwards available to reduce taxable income in future years. Our ability to utilize those NOLs may be● · · · · 1 ▸ Changes in economic conditions could negatively impact our revenue and earnings.● · · · · 1 ▸ Even if we successfully innovate and develop new products and product enhancements, we may incur substantial costs in doing so, and our profitability may suffer.● · · · · 1 ▸ If the quality or delivery of our products does not meet regulatory requirements or our customers’ expectations, our reputation could suffer and ultimately our sales and operating earnings could be negatively impacted.● · · · · 1 ▸ If we are unable to manufacture in specific quantities, our operating results will be harmed.● · · · · 1 ▸ It may be difficult for us to implement our strategies for revenue growth in light of competitive challenges.● · · · · 1 ▸ Material weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our financial statements.● ● ● · · 3 ▸ Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of our products, which could negatively affect our operations and performance.● · · · · 1 ▸ Our business, financial condition, and results of operations may be materially adversely affected by global epidemics, including, but not limited to, the ongoing COVID-19 pandemic and resulting unfavorable economic conditions.● ● · · · 2 rw ▸ Our future capital needs are uncertain and we may need to raise additional funds in the future.● ● · · · 2 ▸ Our investments in significant information technology infrastructure may cause disruptions to or failure of our systems and may interfere with our operations.● · · · · 1 ▸ Our long-term results depend upon our ability to improve existing products and introduce and market new products and services successfully.● ● · · · 2 ▸ Our management has limited experience in operating a public company.● ● ● · · 3 ▸ Shares of common stock are listed on the Nasdaq Global Market, and we are a "controlled company" within the meaning of the rules and listing standards of The Nasdaq Stock Market LLC (NASDAQ). As● · · · · 1 ▸ The market may not be receptive to our new products and services upon their introduction.● ● · · · 2 ▸ The phase-out of the London Interbank Offered Rate (LIBOR), or the replacement of LIBOR with a different reference rate, may adversely affect interest rates.● · · · · 1 ▸ The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business, particularly after we are no longer an “emerging growth company”.● ● · · · 2 ▸ These factors, among others, may enable our competitors to market their products and services at lower prices or on terms more advantageous to customers than we can offer. Competition may result in price reductions, reduced● · · · · 1 ▸ We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations.● ● · · · 2 ▸ We may be unable to successfully expand our operations or manage our growth effectively.● ● · · · 2 ▸ We may become subject to greater financial, operating, legal, and compliance risk associated with global operations.● ● · · · 2 rw ▸ We rely on confidentiality agreements that may be difficult to enforce and the breach of which could have a material adverse effect on our business and competitive position.● ● · · · 2 rw ▸ We rely upon our internal manufacturing, packaging and distribution operations to produce many of the products we sell and our warehouse facilities to store products pending sale. Our primary manufacturing and storage● · · · · 1 ▸ We use third-party credit card processors to process payments from our customers. Through our agreements with our third-party credit card processors, we are subject to payment card association operating rules, including the● · · · · 1 ▸ We are also a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing● · · · ● 2 ▸ An active, liquid trading market for our common stock may not be sustained, which may limit your ability to sell your shares.● ● ● ● ● 5 ▸ Changes in accounting principles and guidance could result in unfavorable accounting charges or effects.● ● ● ● ● 5 ▸ Changes in political, economic, or governmental regulations may reduce demand for our products or increase our expenses.● ● ● ● ● 5 rw ▸ Claims for indemnification by our directors and officers may reduce our funds available to satisfy successful third-party claims against us and may reduce the amount of money available to us.● ● ● ● ● 5 rw ▸ Despite current indebtedness levels, we may incur substantially more indebtedness, which could further exacerbate the risks associated with our substantial indebtedness.● ● ● ● ● 5 ▸ Fluctuations in our effective tax rate may adversely affect our results of operations and cash flows.● ● ● ● ● 5 ▸ Future acquisitions, if any, may expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.● ● ● ● ● 5 rw ▸ Future strategic investments or transactions may require us to seek additional financing, which we may not be able to secure on favorable terms, if at all.● ● ● ● ● 5 ▸ Given the foregoing factors, comparing our revenue and operating results on a period-to-period basis may not be meaningful, and our past results may not be indicative of our future performance.● ● ● ● ● 5 ▸ If our customers do not qualify our quality systems, or if we are unable to maintain our ISO certification, our operating results could suffer.● ● ● ● ● 5 rw ▸ If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business, financial condition, results of operations, cash flows, and prospects may be adversely affected.● ● ● ● ● 5 rw ▸ If we are unable to continue to hire and retain skilled personnel, we will have trouble developing and marketing our products.● ● ● ● ● 5 ▸ If we cannot provide quality technical and applications support, we could lose customers and our business and prospects would suffer.● ● ● ● ● 5 ▸ Intellectual property litigation and other proceedings could cause us to expend substantial resources and distract our personnel from their normal responsibilities.● ● ● ● ● 5 rw ▸ Intellectual property rights do not necessarily address all potential threats.● ● ● ● ● 5 ▸ Our ability to use net operating loss carryforwards to reduce future tax payments may be limited.● ● ● ● ● 5 ▸ Our business is subject to risks relating to environmental, health, and safety laws and regulations.● ● ● ● ● 5 rw ▸ Our corporate culture has contributed to our success, and if we cannot maintain this culture as we grow, we could lose the innovation, creativity, and teamwork fostered by our culture and our business may be harmed.● ● ● ● ● 5 rw ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● ● ● 5 ▸ Our employees, consultants, distributors, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading.● ● ● ● ● 5 rw ▸ Our estimates of market sizes and opportunity 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.● ● ● ● ● 5 rw ▸ Our existing indebtedness could adversely affect our business and growth prospects.● ● ● ● ● 5 ▸ Our operating results may fluctuate significantly in the future, making them difficult to predict, and they could fall below expectations or any guidance we may provide.● ● ● ● ● 5 ▸ Our products are highly complex and are subject to quality control and assurance requirements.● ● ● ● ● 5 rw ▸ Our revenue recognition and other factors may impact our financial results in any given period and make them difficult to predict.● ● ● ● ● 5 ▸ Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products, and limit commercialization of any products that we may develop.● ● ● ● ● 5 rw ▸ Provisions of our corporate governance documents could make acquiring us more difficult and may prevent attempts by our stockholders to replace or remove our current directors or management, even if beneficial to our stockholders.● ● ● ● ● 5 rw ▸ group Risks Related to Our Business and Strategy● ● ● ● ● 5 ▸ group Risks Related to Our Common Stock● ● ● ● ● 5 ▸ group Risks Related to Our Indebtedness● ● ● ● ● 5 ▸ group Risks Related to Our Intellectual Property● ● ● ● ● 5 ▸ Should any of these events occur, they could significantly harm our business, financial conditions, results of operations, cash flows, and prospects.● ● ● ● ● 5 rw ▸ Telegraph Hill Partners Management Company LLC, through its affiliates THP IV LP, THP IV LLC, THP V LP, and THP V LLC controls us, and its interests may conflict with ours or yours in the future.● ● ● ● ● 5 rw ▸ Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our operating results and financial condition.● ● ● ● ● 5 ▸ We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.● ● ● ● ● 5 ▸ We are dependent upon information technology systems, which are subject to disruption, damage, and failure.● ● ● ● ● 5 ▸ We have incurred operating losses in the past and may incur losses in the future.● ● ● ● ● 5 ▸ We may be required to record a significant charge to earnings if our intangible or long-lived assets, or other investments become impaired.● ● ● ● ● 5 rw ▸ We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common stock, which could depress the price of our common stock.● ● ● ● ● 5 ▸ We may need or may choose to obtain licenses from third parties to allow commercialization of our current or future products, and we cannot provide any assurances that we would be able to do so.● ● ● ● ● 5 rw ▸ We rely on assumptions, estimates, and data to calculate certain of our key metrics, and real or perceived inaccuracies in such metrics may harm our reputation and negatively affect our business.● ● ● ● ● 5 rw