13 unchanged sentences
General economic factors
−Removed: general macroeconomic conditions, including inflationary pressures and rising interest rates, uncertainty in the global banking and financial services market, any future resurgence in the COVID-19 pandemic and responsive measures and the war between Russia and Ukraine.
+Added: general macroeconomic conditions, including inflationary pressures and rising interest rates, uncertainty in the global banking and financial services market, potential U.S.
+Added: government shutdown, global pandemics and responsive measures and the wars between Russia-Ukraine and Israel-Hamas.
Operational factors
24 unchanged sentences
Regulatory and legal factors
−Removed: healthcare reform measures;
−Removed: third-party coverage and reimbursement policies;
+Added: healthcare reform measures and changes in third-party coverage and reimbursement policies;
compliance with healthcare laws;
24 unchanged sentences
usage of our products as demand declined in elective surgeries in response to the COVID-19 pandemic, all of which have had and may continue to have a material and adverse effect on our business, future revenues and financial condition.
−Removed: We are unable to predict the extent to which any future resurgence of the COVID-19 pandemic or other public health emergencies or outbreaks and related macroeconomic impacts may continue to adversely impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives .
+Added: We are unable to predict the extent to which any future global pandemic or other public health emergencies or outbreaks and related macroeconomic impacts may continue to adversely impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives .
Our business, results of operation and financial performance were negatively impacted by the COVID-19 pandemic and related public health responses, such as travel restrictions in countries and regions in which we have operations or manufacturing partners.
Due to these impacts and measures, we have experienced and may continue to experience significant and unpredictable interruptions in the supply of raw materials, components and sub-assemblies necessary to manufacture and assemble our products and reductions in the demand for our products as healthcare customers continue to divert medical resources and priorities towards the treatment of COVID-19.
−Removed: In addition, our customers may delay, cancel or redirect planned capital expenditures in order to focus resources on any future resurgence of COVID-19 or in response to macroeconomic disruption related to any future resurgence of the COVID-19 pandemic.
+Added: In addition, our customers may delay, cancel or redirect planned capital expenditures in order to focus resources on any future outbreak of disease, global pandemic or in response to macroeconomic disruption related to any future global pandemic.
For example, during the fiscal year ended January 2, 2021, we experienced significant decline in treatment and procedure volume worldwide, as healthcare systems diverted resources to meet the increasing demands of managing COVID-19.
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assets including the rights to the PASCAL product (the “Transferred Assets”).
−Removed: We assumed only those liabilities arising after the closing in connection with the
−Removed: Transferred Assets.
+Added: We assumed only those liabilities arising after the closing in connection with the Transferred Assets.
In the Asset Purchase Agreement, our company and TMLS made certain customary representations and warranties and agreed to certain customary covenants.
34 unchanged sentences
In addition, some of our products are combined with products from other vendors, which may contain defects.
−Removed: should problems occur, it may be difficult to identify the source of the problem.
+Added: As a result, should problems occur, it may be difficult to identify the source of the problem.
If we are unable to identify and fix defects or other problems, we could experience, among other things:
8 unchanged sentences
Our ability to sell our products and generate revenues depends upon our direct and independent sales forces within the United States, direct sales force in Germany and relationships with independent international distributors.
−Removed: Currently our direct and independent sales forces within the United States consist of approximately 26 employees and two independent representatives, respectively, and our direct sales force in Germany consists of one employee.
−Removed: Our international independent distributors are managed by a team of eight people.
+Added: Currently our direct and independent sales forces within the United States consist of approximately 22 employees and one independent representatives, respectively, and our direct sales force in Germany consists of one employee.
+Added: Our international independent distributors are managed by a team of six people.
We generally grant our distributors exclusive territories for the sale of our products in specified countries and regions.
8 unchanged sentences
We derive, and expect to continue to derive, a large portion of our revenues from international sales.
−Removed: For the second fiscal quarter of fiscal year 2023, our international sales were $6.1 million, or 47.6% of total revenues.
+Added: For the third fiscal quarter of fiscal year 2023, our international sales were $6.7 million, or 52.2% of total revenues.
We anticipate that international sales will continue to account for a significant portion of our revenues in the foreseeable future.
−Removed: All of our international revenues and costs for the second fiscal quarter of 2023 have been denominated in U.S.
+Added: All of our international revenues and costs for the third fiscal quarter of 2023 have been denominated in U.S.
dollars except for sales transacted through our German subsidiary.
3 unchanged sentences
Our international operations and sales are subject to a number of risks and potential costs, including:
−Removed: macroeconomic conditions, including the impact of any future resurgence of the COVID-19 pandemic on the global economy and financial markets;
+Added: macroeconomic conditions, including the impact of any future global pandemic on the global economy and financial markets;
fluctuations in foreign currency exchange rates;
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These or other similar risks could adversely affect our revenues, profitability and the price of our common stock.
+Added: Our operating results may be adversely affected by uncertainty regarding healthcare reform measures and changes in third-party coverage and reimbursement policies.
+Added: Our products are typically purchased by doctors, clinics, hospitals and other users, which bill various third-party payers, such as governmental programs and private insurance plans, for the health care services provided to their patients.
+Added: Changes in government legislation or regulation or in private third-party payers’
+Added: policies toward reimbursement for procedures employing our products may prohibit adequate reimbursement.
+Added: There have been a number of legislative and regulatory proposals to change the healthcare system, reduce the costs of healthcare and change medical reimbursement policies.
+Added: Doctors, clinics, hospitals and other users of our products may decline to purchase our products to the extent there is uncertainty regarding reimbursement of medical procedures using our products and any healthcare reform measures.
+Added: Further proposed legislation, regulation and policy changes affecting third-party reimbursement are likely.
+Added: Among other things, Congress has in the past proposed changes to and the repeal of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, collectively, the “Affordable Care Act”, and the current U.S.
+Added: presidential administration has announced certain policy changes that could impact the availability of benefits under the Affordable Care Act.
+Added: For example, tax reform legislation enacted at the end of 2017 eliminated the tax penalty for individuals who did not maintain sufficient health insurance coverage beginning in 2019 (the “individual mandate”).
+Added: We anticipate continued Congressional interest in modifying provisions of the Affordable Care Act.
+Added: At this time, it remains unclear whether there will be any changes made to or any repeal of the Affordable Care Act, with respect to certain of its provisions or in its entirety or related administrative policies.
+Added: Various healthcare reform proposals have also emerged at the state level.
+Added: We are unable to predict what legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted in the future at the state or federal level, or what effect such legislation or regulation may have on us.
+Added: Furthermore, existing legislation and regulation related to the health care industry and third-party coverage reimbursement, including the Affordable Care Act, has been subject to judicial challenge, and may be subject to similar challenges from time to time in the future (such as the California v.
+Added: In June 2021, the U.S.
+Added: Supreme Court held that Texas and other challengers had no legal standing to challenge the Affordable Care Act, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the Affordable Care Act.
+Added: Denial of coverage and reimbursement of our products, or the revocation or changes to coverage and reimbursement policies, could have a material adverse effect on our business, results of operations and financial condition.
+Added: Third-party payers are increasingly scrutinizing and continue to challenge the coverage of new products and the level of reimbursement for covered products.
+Added: Doctors, clinics, hospitals and other users of our products may not obtain adequate reimbursement for use of our products from third-party payers.
+Added: While we believe that the laser procedures using our products have generally been reimbursed, payers may deny coverage and reimbursement for our products if they determine that the device was not reasonable and necessary for the purpose used, was investigational or was not cost-effective.
+Added: As discussed above, the MACs have published “Local Coverage Determination L39620 Micro-Invasive Glaucoma Surgery (MIGS)”
+Added: in October and November 2023.
+Added: Based on our initial analysis, this LCD imposes additional requirements for reimbursement, which will likely materially limit the types of patients for which WPS will reimburse cyclophotocoagulation procedures after the effective date.
+Added: A number of physicians have expressed concerns regarding the potential restriction on their patients’
+Added: access to transscleral cyclophotocoagulation laser therapy (“TLT”) under this LCD.
+Added: Although this LCD does not deny coverage, it is unclear how this LCD will be interpreted or applied by the MACs in practice, or how our customers will interpret or perceive this LCD when
+Added: making purchasing decisions.
+Added: As such, the full impact of this LCD on our glaucoma business in the United States is unclear.
+Added: We and other stakeholders intend to challenge the scope of this LCD.
+Added: Additionally, we plan to work with participating physicians to collect additional data to demonstrate the value of the MicroPulse technology to patients.
+Added: We can provide no assurance that the level of coverage or reimbursement, market share and demand, and/or revenues for any of our products will be maintained.
+Added: We will continue to assess and adjust our domestic glaucoma operations as appropriate in response to any changes in reimbursement policies that materially impact our ability to maintain and expand our glaucoma business in the United States.
+Added: If we are unable to obtain or maintain adequate levels of third-party coverage and reimbursement for the procedures using our products, if third parties rescind or modify their coverage or impose greater restrictions reimbursement criteria, or if patients are left with significant out-of-pocket costs, it would have a material adverse effect on our business, financial condition and results of operations.
If we fail to develop and successfully introduce new products and applications or fail to improve our existing products, our business prospects and operating results may suffer.
2 unchanged sentences
Due to the complexities and uncertainties associated with ophthalmic research and development, products we are currently developing may not complete the development process or obtain the regulatory approvals required to market such products successfully.
−Removed: In addition, our research and development process was delayed due to the impact of the COVID-19 pandemic, and should the current macroeconomic conditions worsen, it could delay and disrupt our research and development processes even further.
+Added: Should the current macroeconomic conditions worsen, it could delay and disrupt our research and development processes even further.
Successful commercialization of new products and new applications will require that we effectively transfer production processes from research and development to manufacturing and effectively coordinate with our suppliers.
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Concerns about consumer and investor confidence, volatile corporate profits and reduced capital spending, uncertainty in the global banking and financial services market, international conflicts, terrorist and military activity, civil unrest and pandemic-related illness could reduce customer orders or cause customer order cancellations.
−Removed: For example, any future resurgence of the COVID-19 pandemic or other public health emergencies may cause adverse impacts on global economic activity which could negatively impact our business.
−Removed: In addition, political and social turmoil related to international conflicts, such as that occurring in Russia and Ukraine, and terrorist acts may put further pressure on economic conditions in the United States and abroad.
+Added: For example, any future global pandemic or other public health emergencies may cause adverse impacts on global economic activity which could negatively impact our business.
+Added: In addition, political and social turmoil related to international conflicts, such as that occurring in Russia-Ukraine and Israel-Hamas, and terrorist acts may put further pressure on economic conditions in the United States and abroad.
Weak economic conditions and declines in consumer spending and consumption may harm our operating results.
16 unchanged sentences
Factors contributing to these fluctuations include the following:
−Removed: general macroeconomic conditions, including inflationary pressures and rising interest rates, uncertainty in the global banking and financial services market, any future resurgence of the COVID-19 pandemic and responsive measures and the war between Russia and Ukraine;
+Added: general macroeconomic conditions, including inflationary pressures and rising interest rates, uncertainty in the global banking and financial services market, potential federal government shutdown, global pandemics and responsive measures and the wars between Russia-Ukraine and Israel-Hamas;
changes in the prices at which we can sell our products, including the impact of changes in foreign currency exchange rates;
14 unchanged sentences
In addition to these factors, our quarterly results have been, and are expected to continue to be, affected by seasonal factors.
−Removed: For example, our European sales during the third quarter are generally lower due to many businesses being closed for the summer vacation season.
Our expense levels are based, in part, on expected future sales.
8 unchanged sentences
We believe that continued and increased sales, if any, of these medical laser systems is dependent upon a number of factors including the following:
−Removed: the impact of any future resurgence of the COVID-19 pandemic or other public health emergencies on timing of ophthalmic treatment procedures;
+Added: the impact of any future resurgence any future global pandemic or other public health emergencies on timing of ophthalmic treatment procedures;
acceptance of product performance, features, ease of use, scalability and durability, including with respect to our MicroPulse laser photocoagulation systems, and our PASCAL product;
22 unchanged sentences
Some companies also have greater name recognition than us and long-standing customer relationships.
−Removed: In addition, other medical device companies, academic and research institutions, or others, may develop new technologies or
−Removed: therapies, including medical devices, surgical procedures or pharmacological treatments and obtain regulatory approval for products utilizing such techniques that are more effective in treating the conditions targeted by us, or are less expensive than our current or future products.
+Added: In addition, other medical device companies, academic and research institutions, or others, may develop new technologies or therapies, including medical devices, surgical procedures or pharmacological treatments and obtain regulatory approval for products utilizing such techniques that are more effective in treating the conditions targeted by us, or are less expensive than our current or future products.
Our technologies and products could be rendered obsolete by such developments.
8 unchanged sentences
We can provide no assurance that such capital will be available or available on terms that are acceptable to us.
−Removed: We cannot assure you that we will be successful in managing these or any other significant risks that we encounter in divesting a business or product line, and any divestiture we undertake could materially and adversely affect our business, financial condition, results of operations and cash flows, and may also result in a diversion of management attention, operational difficulties and losses.
−Removed: Our operating results may be adversely affected by uncertainty regarding healthcare reform measures and changes in third-party coverage and reimbursement policies.
−Removed: Our products are typically purchased by doctors, clinics, hospitals and other users, which bill various third-party payers, such as governmental programs and private insurance plans, for the health care services provided to their patients.
−Removed: Changes in government legislation or regulation or in private third-party payers’
−Removed: policies toward reimbursement for procedures employing our products may prohibit adequate reimbursement.
−Removed: There have been a number of legislative and regulatory proposals to change the healthcare system, reduce the costs of healthcare and change medical reimbursement policies.
−Removed: Doctors, clinics, hospitals and other users of our products may decline to purchase our products to the extent there is uncertainty regarding reimbursement of medical procedures using our products and any healthcare reform measures.
−Removed: Further proposed legislation, regulation and policy changes affecting third-party reimbursement are likely.
−Removed: Among other things, Congress has in the past proposed changes to and the repeal of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, collectively, the “Affordable Care Act”, and the current U.S.
−Removed: presidential administration has announced certain policy changes that could impact the availability of benefits under the Affordable Care Act.
−Removed: For example, tax reform legislation enacted at the end of 2017 eliminated the tax penalty for individuals who did not maintain sufficient health insurance coverage beginning in 2019 (the “individual mandate”).
−Removed: We anticipate continued Congressional interest in modifying provisions of the Affordable Care Act.
−Removed: At this time, it remains unclear whether there will be any changes made to or any repeal of the Affordable Care Act, with respect to certain of its provisions or in its entirety or related administrative policies.
−Removed: Various healthcare reform proposals have also emerged at the state level.
−Removed: We are unable to predict what legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted in the future at the state or federal level, or what effect such legislation or regulation may have on us.
−Removed: Furthermore, existing legislation and regulation related to the health care industry and third-party coverage reimbursement, including the Affordable Care Act, has been subject to judicial challenge, and may be subject to similar challenges from time to time in the future (such as the California v.
−Removed: In June 2021, the U.S.
−Removed: Supreme Court held that Texas and other challengers had no legal standing to challenge the Affordable Care Act, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the Affordable Care Act.
−Removed: Denial of coverage and reimbursement of our products, or the revocation or changes to coverage and reimbursement policies, could have a material adverse effect on our business, results of operations and financial condition.
−Removed: Third-party payers are increasingly scrutinizing and continue to challenge the coverage of new products and the level of reimbursement for covered products.
−Removed: Doctors, clinics, hospitals and other users of our products may not obtain adequate reimbursement for use of our products from third-party payers.
−Removed: While we believe that the laser procedures using our products have generally been reimbursed, payers may deny coverage and reimbursement for our products if they determine that the device was not reasonable and necessary for the purpose used, was investigational or was not cost-effective.
+Added: We cannot assure you that we will be successful in managing these or any other
+Added: significant risks that we encounter in divesting a business or product line, and any divestiture we undertake could materially and adversely affect our business, financial condition, results of operations and cash flows, and may also result in a diversion of management attention, operational difficulties and losses.
If we fail to comply with healthcare laws, we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.
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We file patent applications to protect technology, inventions and improvements that are significant to the development of our business.
−Removed: As of July 1, 2023, our patent portfolio includes 64 active United States patents and 83 active international patents on the technologies related to our products and processes.
−Removed: In addition, as of July 1, 2023, we have 13 patent applications pending in the United States and 21 international patent applications pending.
+Added: As of September 30, 2023, our patent portfolio includes 62 active United States patents and 85 active international patents on the technologies related to our products and processes.
+Added: In addition, as of September 30, 2023, we have 11 patent applications pending in the United States and 21 international patent applications pending.
Our patent applications may not be approved.
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There are risks associated with the use of independent manufacturers, including the following:
−Removed: the impact of macroeconomic conditions, including any future resurgence of the COVID-19 pandemic and inflationary pressures on global supply chains and market stability;
+Added: the impact of macroeconomic conditions, including any future global pandemic and inflationary pressures on global supply chains and market stability;
unavailability of shortages or limitations on the ability to obtain supplies of components and products in the quantities that we require, or that satisfy the environmental requirements to which we are subject;
136 unchanged sentences
On March 22, 2019, we provided the FDA with a request for termination of Recall Number Z-1075-2018.
−Removed: We submitted follow up requests for termination on September 29, 2021 and October 17, 2022.
−Removed: Our termination request is pending.
−Removed: We obtained FDA clearance for an updated TruFocus LIO Premiere ® device.
−Removed: The updated device includes expanded user instructions and minor design changes.
−Removed: Use of the updated LIO may result in adverse events, including those observed with the prior LIO device.
−Removed: If physician use of our updated LIO results in serious adverse events, we may have to initiate another recall or utilize additional resources to further evaluate the design of the LIO device.
−Removed: Furthermore, in light of the recall, we cannot provide any assurance that the updated LIO, will achieve market acceptance.
−Removed: We will be required to devote significant resources to launch and market the updated LIO and cannot provide any assurance that these activities will generate revenue as anticipated.
−Removed: If our revenue grows more slowly than we expect because of a delay in or a lack of market acceptance for our updated LIO, our business and financials will be adversely affected.
+Added: On September 22, 2023, the FDA notified the Company that the FDA concluded that the recall has been completed, there has been proper disposition of the recalled product, and, therefore, FDA considers the recall terminated.
If product liability claims are successfully asserted against us, we may incur substantial liabilities that may adversely affect our business or results of operations.
22 unchanged sentences
Furthermore, changes in United States trade policy have resulted and could result in additional reactions from United States trading partners and other countries, including adopting responsive trade policies that make it more difficult or costly for us to export our products to those countries.
−Removed: We sell a significant majority of our products into countries outside the United States and we purchase a significant portion of equipment
−Removed: and supplies from suppliers outside the United States.
+Added: We sell a significant majority of our products into countries outside the United States and we purchase a significant portion of equipment and supplies from suppliers outside the United States.
These measures could also result in increased costs for goods imported into the United States or may cause us to adjust our worldwide supply chain.
1 unchanged sentence
We cannot predict future trade policy or the terms of any renegotiated trade agreements and their impacts on our business.
−Removed: The adoption and expansion of trade restrictions, the occurrence of a trade war, or other governmental action related to tariffs or trade agreements or policies has the potential to adversely impact demand for our products, our costs, our customers, our suppliers, and the United States economy, which in turn could adversely impact our business, financial condition and results of operations.
+Added: The adoption and expansion of trade restrictions, the occurrence of a trade war, or other governmental action related to tariffs or trade
+Added: agreements or policies has the potential to adversely impact demand for our products, our costs, our customers, our suppliers, and the United States economy, which in turn could adversely impact our business, financial condition and results of operations.
Changes in U.S.
8 unchanged sentences
Based on our net operating loss carryovers and valuation allowance, there is no impact to its consolidated financial statements as a result of the accounting for the tax effects of the Tax Act.
−Removed: Subsequent legislations, guidance, regulations or audits that differ from our prior assumptions and interpretations, or other factors which were not anticipated at the time we estimated our tax provision could have a material adverse effect on our business, cash flow, results of operations or financial condition.
+Added: Subsequent legislation, guidance, regulations or audits that differ from our prior assumptions and interpretations, or other factors which were not anticipated at the time we estimated our tax provision could have a material adverse effect on our business, cash flow, results of operations or financial condition.
We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties.
23 unchanged sentences
We may sell shares or other securities in any offering at a price per share that is less than the price per share paid by existing investors, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
−Removed: price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by existing investors.
+Added: The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by existing investors.
If we fail to comply with environmental requirements, our business, financial condition, operating results and reputation could be adversely affected.
10 unchanged sentences
Our stock price has been and may continue to be volatile and an investment in our common stock could suffer a decline in value.
−Removed: The trading price of our common stock has been subject to wide fluctuations in response to a variety of factors, some of which are beyond our control, including changes in foreign currency exchange rates, quarterly variations in our operating results, announcements by us or our competitors of new products or of significant clinical achievements, changes in market valuations of other similar companies in our industry and general market conditions, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine.
−Removed: During the second quarter of fiscal year 2023, the trading price of our common stock fluctuated from a low of $1.76 per share to a high of $2.43 per share.
+Added: The trading price of our common stock has been subject to wide fluctuations in response to a variety of factors, some of which are beyond our control, including changes in foreign currency exchange rates, quarterly variations in our operating results, announcements by us or our competitors of new products or of significant clinical achievements, changes in market valuations of other similar companies in our industry and general market conditions, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia-Ukraine and Israel-Hamas.
+Added: During the third quarter of fiscal year 2023, the trading price of our common stock fluctuated from a low of $1.33 per share to a high of $2.54 per share.
There can be no assurance that our common stock trading price will not suffer declines.
15 unchanged sentences
As a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting.
−Removed: We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.
+Added: We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls
+Added: may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.
We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting.
28 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.