3 unchanged sentences
A fully government-run healthcare system would likely eliminate healthcare consumer choice as well as commercial incentives for innovation.
−Removed: Restrictions on “nonessential” medical procedures during a pandemic reduce the demand for certain of UTMD’s medical devices.
Increasing regulatory burdens, including premarketing approval delays, may result in significant loss of revenue, unpredictable costs and loss of management focus on developing and marketing products that improve the quality of healthcare:
1 unchanged sentence
Premarketing submission administrative burdens, and substantial “user fees” or notified body review fees, represent a significant non-clinical and/or non-scientific barrier to new product introduction, resulting in lack of investment or delays to revenues from new or improved devices.
−Removed: The risks associated with such circumstances relate not only to substantial out-of-pocket costs, including potential litigation in millions of dollars, but also loss of business and a diversion of attention of key employees for an extended period of time from managing their normal responsibilities, particularly in new product development and routine quality assurance activities.
+Added: The risks associated with such circumstances relate not only to substantial out-of-pocket costs, including potential litigation in millions of dollars, but also loss of business and a diversion of attention of key employees for an extended period of time from managing normal responsibilities, particularly in new product development and routine quality assurance activities.
Group Purchasing Organizations (GPOs) in the U.S.
2 unchanged sentences
GPOs have been granted an antitrust exemption by the U.S.
−Removed: Otherwise, their business model based on “kickbacks” would be a violation of law.
−Removed: Despite rhetoric otherwise, these bureaucratic entities do not recognize or understand the overall cost of care as it relates to safety and effectiveness of devices, and they create a substantial administrative burden that is primarily driven by collection of their administrative fees.
+Added: In other industries their business model based on “kickbacks” would be a violation of law.
+Added: Despite rhetoric otherwise, these bureaucratic entities do not recognize or understand the overall cost of care as it relates to safety and effectiveness of devices, and they create a substantial administrative burden that is primarily driven by collection of administrative fees.
The Company’s business strategy may not be successful in the future:
1 unchanged sentence
As the healthcare industry becomes increasingly bureaucratic it puts smaller companies like UTMD at a competitive disadvantage:
−Removed: An aging population is placing greater burdens on healthcare systems, particularly hospitals.
+Added: An aging population and uncontrolled immigration is placing greater burdens on healthcare systems, particularly hospitals.
The length of time and number of administrative steps required in adopting new products for use in hospitals has grown substantially in recent years.
19 unchanged sentences
made raw materials and components are likely being purchased in fixed USD.
−Removed: Trade restrictions and /or tariffs resulting from changing government trade policies have the potential to disrupt UTMD’s supply chain.
−Removed: Lack of predictability of a major OEM customer currently representing over 20% of UTMD’s sales.
−Removed: ITEM 1B – UNRESOLVED STAFF COMMENTS
+Added: Trade restrictions and /or tariffs resulting from changing government geopolitical trade policies have the potential to disrupt UTMD’s supply chain.
+Added: Current lack of predictability of demand from a major OEM customer representing 17% of total consolidated sales in 2023.
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.