6 unchanged sentences
Risks Relating to Our Business and Financial Condition
−Removed: ● The COVID-19 pandemic or other public health crises.
+Added: ● Pandemic or other public health crises.
● Our dependence on a limited number of products, and disruptions in our ability to sell these products.
56 unchanged sentences
Risks Relating to Our Business and Financial Condition
−Removed: Our business, financial condition and operations has been and may be in the future, materially adversely affected by the COVID-19 pandemic or other public health crises.
−Removed: The COVID-19 pandemic, and the resulting restrictions intended to slow the spread of COVID-19, including stay-at-home orders, business shutdowns and other restrictions, has and may continue to adversely affect our business in a number of ways.
−Removed: To respond to the demands of managing COVID-19 and the resulting economic uncertainties, healthcare organizations may be forced to adjust spending priorities by increased spending related to COVID-19, which may have a significant effect on the demand and available budget for our products and related services.
−Removed: The financial strains on healthcare systems may also lead to an increased risk of delays in customer payments.
−Removed: In addition, a recession resulting from the spread of COVID-19 could materially affect our business, especially if a recession results in higher unemployment causing potential patients to not have access to health insurance.
−Removed: Our ability to generate sales may be further disrupted by hospitals restricting access to hospital workers only.
−Removed: A decline in operating results has limited and could further limit our generation of capital resources and cause financial stress if we are unable to increase revenues or adjust our costs appropriately to changes in revenue.
−Removed: We believe that COVID-19’s adverse impact on our operating results, cash flows and financial condition will be primarily driven by the severity and duration of the pandemic and its impact on the U.S.
−Removed: and global economy.
−Removed: In addition to adversely impacting demand for our products, COVID-19 or other public health crises could have an adverse impact on our manufacturing capacity, supply chains, and distribution systems as we and other businesses and governments take preventative and precautionary measures designed to slow the spread of COVID-19.
−Removed: We could experience other negative impacts of COVID-19 relating to lack of availability of our key personnel or temporary closures of our office or the facilities of our suppliers or third-party service providers.
−Removed: The future progression of the COVID-19 pandemic and its resulting impacts on our customers, sales activity, supply chain and distribution networks are uncertain at this time.
−Removed: However, the foregoing and other disruptions as a result of COVID-19 could have a material adverse effect on our business, operating results and financial condition, especially to the extent these impacts persist or exacerbate over an extended period of time.
Our financial performance is significantly dependent on a limited number of products, and disruptions in our ability to sell these products may have a material adverse effect on our business.
3 unchanged sentences
The FDA could require us to cease shipment of our products, notify health professionals and others that the devices present unreasonable risk or substantial harm to public health, order a recall, repair, replacement, or refund of the devices, detain or seize adulterated or misbranded medical devices, or ban the medical devices.
−Removed: The FDA may also issue further warning letters or untitled letters, refuse future requests for 510(k) submission or premarket approval, revoke existing 510(k) clearances or premarket approvals previously granted, impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees, or us.
+Added: The FDA may also issue further warning letters or untitled letters, refuse future requests for 510(k) submission or premarket approval, revoke existing 510(k) clearances or premarket approvals
+Added: previously granted, impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees, or us.
+Added: As inflationary measures have affected the greater market in 2022, we have considered the effects of inflation on our business operations and financial results.
+Added: We have assessed that inflation has not had a material impact on our revenues, expenses, assets, liabilities, or cash flows for the current reporting period.
+Added: We have also evaluated our exposure to future inflationary risk and concluded that it is not significant based on our current business model, market conditions, and hedging strategies.
+Added: We have mitigated the impact of inflation on our cost of goods sold by continued operational efficiency.
Our products could be rendered obsolete or economically impractical by numerous factors, many of which are beyond our control, including but not limited to:
10 unchanged sentences
We have significant international sales as well as international supply chain links and we face risks related to health epidemics that could adversely affect our revenue.
−Removed: Our business could be adversely impacted by the effects of COVID-19 or other epidemics.
−Removed: The COVID-19 pandemic has negatively impacted our revenues, particularly in 2020, and may do so again in the future.
+Added: Our business could be adversely impacted by the effects of various health epidemics.
With respect to our sales, in the past, some customers implemented heightened security policies that inhibited the ability of our domestic sales force and international distributors to access hospitals for purposes of selling our products.
1 unchanged sentence
These heightened security policies and delays of orders may be reinstated or continue.
−Removed: Our materials suppliers could also be disrupted by conditions related to COVID-19, or other epidemics, possibly resulting in disruption to our supply chain.
+Added: Our materials suppliers could also be disrupted by epidemic related conditions, possibly resulting in disruption to our supply chain.
If our suppliers are unable or fail to fulfill their obligations to us for any reason, we may not be able to manufacture our products and satisfy customer demand or our obligations under sales agreements in a timely manner, and our business could be harmed as a result.
−Removed: At this point in time, there remains uncertainty relating to the ongoing or possible renewed effects of COVID-19 on our business.
−Removed: Infections from new or existing variants may become widespread or may recur at a later time, there may be variations in the global response to future outbreaks, and inefficiencies of testing and vaccination programs, and should any one of these limit our ability to timely sell and distribute our products or cause supply disruptions, it would have a negative impact on our business, financial condition and operating results.
In addition, a significant health epidemic could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could affect demand for our products which could have a material adverse effect on our business, operating results and financial condition.
21 unchanged sentences
● discovery of previously unknown or undetected imperfections in raw materials or components;
−Removed: ● labor disputes or shortages, including from natural disasters and the effects of health emergencies such as COVID-19;
+Added: ● labor disputes or shortages, including from natural disasters and the effects of health emergencies or pandemics;
● political instability and actual or anticipated military or political conflicts.
28 unchanged sentences
Our competitors may have certain advantages, which include the ability to devote greater resources to the development, promotion, and sale of their products.
−Removed: Consequently, we may need to increase our efforts, and related expenses for research and development, marketing, and selling to maintain or improve our position.
+Added: Consequently, we may
+Added: need to increase our efforts, and related expenses for research and development, marketing, and selling to maintain or improve our position.
We may not realize the per unit revenue we have planned for and expect.
10 unchanged sentences
If a major customer experiences financial difficulties, the effect on us could be material and have an adverse effect on our business, financial condition, and results of operations.
−Removed: Additionally, COVID-19 has and may continue to cause delays in payments from customers, which may adversely impact our future results of operations and liquidity.
+Added: Additionally, the recent health pandemic has and may continue to cause delays in payments from customers, which may adversely impact our future results of operations and liquidity.
If we fail to maintain relationships with integrated delivery healthcare systems and Group Purchasing Organizations, sales of our products could decline.
10 unchanged sentences
Cost-containment efforts of our customers and purchasing groups could adversely affect our sales and profitability.
−Removed: Our MRI compatible medical devices are considered capital equipment by many potential customers, and hence changes in the budgets of healthcare organizations and the timing of spending under these budgets and conflicting spending priorities, such as spending related to COVID-19, may have a significant effect on the demand for our products and related services.
+Added: Our MRI compatible medical devices are considered capital equipment by many potential customers, and hence changes in the budgets of healthcare organizations and the timing of spending under these budgets and conflicting spending priorities, such as spending related to the recent health pandemic, may have a significant effect on the demand for our products and related services.
Any decrease in expenditures by these healthcare facilities could decrease demand for our products and related services and reduce our revenue.
5 unchanged sentences
The decision-making process of customers is often complex and time-consuming.
−Removed: Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our products have varied widely and have historically ranged between three and six months in duration, with more recent cycles lengthening beyond this historical range due to COVID-19.
+Added: Based on our experience, we believe the period between initial discussions with customers regarding our products and a customer’s purchase of our products have varied widely and have historically ranged between three and six months in duration.
Sales cycles can also be delayed because of capital budgeting procedures.
19 unchanged sentences
We believe that Mr.
−Removed: Susi will play a significant role in the development of new products.
+Added: Susi will continue to play a significant role in the development of new products.
Our current and future operations could be adversely impacted if we were to lose his services.
4 unchanged sentences
Our future success will also depend in part on our ability to identify, hire and retain additional personnel, including executives, skilled engineers to develop new products and sales and production staff.
−Removed: We may not be successful in attracting, integrating, or retaining qualified personnel to meet our current growth plans or future needs.
+Added: We may not be successful in attracting, integrating, or retaining qualified
+Added: personnel to meet our current growth plans or future needs.
Our productivity may be adversely affected if we do not integrate and train our new employees quickly and effectively.
11 unchanged sentences
If we are unable to respond to and manage changing business conditions, or the scale of our products, services, and operations, then the quality of our services, our ability to retain key personnel and our business could be harmed.
+Added: In February 2023, we purchased 26 acres of land in which we plan to build an expanded facility to increase capacity.
+Added: Any failure to successfully construct and operate such a facility expand might limit our ability to grow as we expect.
We engage in related party transactions, which result in a conflict of interest involving our management.
3 unchanged sentences
Related party transactions could also cause us to become materially dependent on related parties in the ongoing conduct of our business, and related parties may be motivated by personal interests to pursue courses of action that are not necessarily in the best interests of our company and our stockholders.
+Added: The purchase of land and the planned expanded facility will reduce related party transaction exposure by the eventual termination of the lease with Susi, LLC.
Any acquisitions of technologies, products, and businesses may be difficult to integrate, could adversely affect our relationships with key customers, and/or could result in significant charges to earnings.
−Removed: We plan to periodically review potential acquisitions of technologies, products and businesses that are complementary to our products and that could accelerate our growth.
+Added: We periodically evaluate potential acquisitions of technologies, products and businesses that are complementary to our products and that could accelerate our growth.
However, our company has never completed an acquisition and there can be no assurance that we will be successful in finding any acquisitions in the future.
3 unchanged sentences
The environment in which we operate makes it difficult to accurately forecast our business performance.
−Removed: Significant changes and volatility in most aspects of the current business environment, including financial markets, consumer behavior, speed of technological, regulatory, and competitive changes, and the continued impact of COVID-19, make it increasingly difficult for us to predict our revenues and earnings into the future.
+Added: Significant changes and volatility in most aspects of the current business environment, including financial markets, consumer behavior, speed of technological, regulatory, and competitive changes, and the recent health pandemic, make it increasingly difficult for us to predict our revenues and earnings into the future.
Our quarterly sales and profits depend substantially on the volume and timing of orders fulfilled during the quarter, and such orders are difficult to forecast.
23 unchanged sentences
Although we take steps to protect the security of our customers’ personal information, we may be required to expend significant resources to comply with data breach requirements if third parties improperly obtain and use the personal information of our customers or we otherwise experience a data loss with respect to customers’ personal information.
−Removed: A breach of our network security and systems could have negative consequences for our business and future prospects, including possible fines, penalties and damages, reduced customer demand for our products, and harm to our reputation and brand.
+Added: A breach of our network security
+Added: and systems could have negative consequences for our business and future prospects, including possible fines, penalties and damages, reduced customer demand for our products, and harm to our reputation and brand.
Risks Related to Our Industry
114 unchanged sentences
Even if we are able to obtain approval for introducing new products to the market, we and our suppliers may not be able to remain in compliance with applicable FDA and other material regulatory requirements once clearance or approval has been obtained for a product.
−Removed: These requirements include, among other things, regulations regarding manufacturing practices, product labeling, off-label marketing, advertising and post-marketing reporting, adverse event reports and field alerts.
+Added: These requirements include, among other things, regulations regarding manufacturing practices, product labeling, off-
+Added: label marketing, advertising and post-marketing reporting, adverse event reports and field alerts.
Compliance with these FDA requirements is subject to continual review and is monitored through periodic inspections by the FDA.
1 unchanged sentence
The FDA issued a Form 483 on July 18, 2016 resulting from an inspection of our facility between July 11 and July 18, 2016 that identified three observations.
−Removed: These observations were related to procedural and documentation issues associated with the CAPA system, vendor requirements and complaint investigation.
+Added: These observations were related to procedural and documentation issues associated with the CAPA (Corrective and Preventive Action) system, vendor requirements and complaint investigation.
We submitted responses to the Form 483 in August 2016 and October 2016 in which we described our proposed corrective and preventative actions to address each of the observations.
2 unchanged sentences
In addition, manufacturing flaws, component failures, design defects, off-label uses, or inadequate disclosure of product related information could result in an unsafe condition or the injury or death of a patient.
−Removed: All of these events could harm our sales, margins and profitability in the affected periods and may have a material adverse effect on our business.
+Added: All these events could harm our sales, margins and profitability in the affected periods and may have a material adverse effect on our business.
Any adverse regulatory action or action taken by us to maintain appropriate regulatory compliance, with respect to these laws and regulations could disrupt our business and have a material adverse effect on our sales, profitability, and financial condition.
104 unchanged sentences
Our Board of Directors has historically authorized stock repurchase programs and, pursuant to these authorizations, we have used a significant amount of cash to repurchase shares of common stock of our company.
−Removed: Historically, we have opportunistically repurchased additional shares of common stock from time to time at prices that we believe are attractive.
−Removed: While our stock repurchase program has expired, should our Board of Directors authorize another stock repurchase program, there can be no assurance that we will be able to repurchase shares on favorable terms or, if we do repurchase shares, that such repurchases will increase shareholder value.
−Removed: In February 2022, our Board of Directors declared a special cash dividend of $1.00 per common share, which reduced our cash balance by approximately $12.6 million.
+Added: During 2016 and 2017, we repurchased 779,135 shares of our common stock for approximately $11.8 million.
+Added: While those stock repurchase programs have expired, should our Board of Directors authorize another stock repurchase program, there can be no assurance that we will be able to repurchase shares on favorable terms or, if we do repurchase shares, that such repurchases will increase shareholder value.
+Added: Stock repurchases now are burdened with a Federal excise tax which diminishes their attraction to deliver returns to shareholders.
+Added: In February 2023, our Board of Directors declared and paid a special cash dividend of $1.05 per common share, which reduced our cash balance by approximately $13.2 million.
+Added: Similarly, in 2022 we paid a cash dividend of $1.00 per share which reduced our cash balance by approximately $12.6 million.
In the future, the Board of Directors may elect to allocate capital based on our continued ability to generate cash from operations, our capital needs to support normal operations, and making investments that are aimed at supporting growth, rather than paying cash dividends.
These capital allocation decisions could have a material adverse effect on our stock price.
−Removed: If the Board of Directors elects to retain all future earnings for the operation and expansion of our business, realization of a gain on your investment will depend solely on the appreciation of the price of our common stock, which may never occur.
+Added: If the Board of Directors chose to omit a dividend and retained future earnings for the operation and expansion of our business, realization of a gain on your investment will depend solely on the appreciation of the price of our common stock, which may never occur.
Additionally, if we use a significant portion of our capital to repurchase shares or pay cash dividends, our financial flexibility will be reduced, and we may not be able to execute on other strategic initiatives or tolerate periods of operating losses.
2 unchanged sentences
While we believe that our cash and investment balances and prospective cash flow from our operations will provide us with adequate capital to fund operations for at least the next 12 months from the date of the issuance of the financial statements included herein, we may need or choose to raise additional funds prior to that time.
−Removed: We may seek to sell additional equity or debt securities or
−Removed: to obtain a credit facility, which we may not be able to do on favorable terms, or at all.
+Added: We may seek to sell additional equity or debt securities or to obtain a credit facility, which we may not be able to do on favorable terms, or at all.
The sale of additional equity or convertible debt securities could result in additional dilution to our stockholders.
If additional funds are raised through the issuance of debt securities or preferred stock, these securities could have rights that are senior to holders of common stock and any debt securities could contain covenants that would restrict our operations.
−Removed: The sale of such securities could hurt demand for our common stock and lead our share price to decline.
+Added: The sale of such securities could hurt demand for our common stock and cause our share price to decline.
Roger Susi, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, owns a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
−Removed: Susi, our founder, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, and his affiliates, beneficially own a significant percentage of our outstanding common stock.
+Added: Susi, our founder, who serves as our Chairman of the Board of Directors, President and Chief Executive Officer, and his affiliates, beneficially own approximately 43 percent of our outstanding common stock.
Susi may be able to significantly influence matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions, or other extraordinary transactions.
He may also have interests that differ from yours and may vote in a way with which you disagree, and which may be adverse to your interests.
−Removed: This concentration of ownership may have the effect of delaying or deterring a change of control of our company.
+Added: This concentration of ownership may have the effect of promoting, delaying or deterring a change of control of our company.
The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.
19 unchanged sentences
Our remediation efforts may not enable us to avoid a material weakness in the future.
−Removed: Our business practices have become more visible as a public company, and this could impact our competitive environment and our risk of potential litigation.
−Removed: As a result of disclosure of information in filings required of a public company, our business and financial condition have become more visible potentially exposing us to new competition and threatened or actual litigation, including by competitors and other third parties.
+Added: Our business practices are more visible as a public company, and this could impact our competitive environment and our risk of potential litigation.
+Added: As a result of disclosure of information in filings required of a public company, our business and financial condition are more visible than a privately-held company, potentially exposing us to new competition and threatened or actual litigation, including by competitors and other third parties.
New competition could result in reduced sales of our products and adversely impact our profitability.
22 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.