Company: MLSS
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001437749-25-012050
Chunk: 3

Company: MILESTONE SCIENTIFIC INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 3
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 foreign currency exchange rates, could increase the end user cost for instruments;                                 
  restrictions on, or difficulties and costs associated with, the currency exchange from foreign countries to obtain U. S. dollars;  
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  difficulties and costs associated with complying with a wide variety of complex laws, treaties, and regulations;                   
  unexpected changes in political or regulatory environments;                                                                        
  political and economic instability;                                                                                                
  import and export control restrictions and other trade barriers such as tariffs; and                                               
  difficulties in obtaining approval for significant transactions.                                                                   

11

If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired.

There is no assurance that physicians, hospitals, clinics, and other health care providers will accept and use the CompuFloEpidural System. Acceptance and use of the CompuFloEpidural System will depend on many factors including:

  perceptions by members of the health care community, including physicians, about the safety and effectiveness of our product.  
  cost-effectiveness of our product relative to competing products and systems;                                                  
  convenience, ease of use and reliability of our product relative to competing products and systems                             
  patient satisfaction;                                                                                                          
  product availability as well as, manufacturer warranty, maintenance, and customer and technical support;                       
  availability of reimbursement for our product from government or other healthcare payers; and                                  
  effectiveness of marketing and distribution efforts by us and our licensees and distributors.                                  

Because we expect sales of the CompuFloEpidural Computer Controlled Anesthesia System to generate substantially all our medical product revenues in the near-term, the failure of this product to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.

Developments by competitors may render our products or technologies obsolete or non-competitive.

The medical device industry is intensely competitive and subject to rapid and significant technological change. We expect that other companies (or individuals), whether located in the United States or abroad, will pursue the development of alternative injection-based or imaging-based systems that will compete with our products. Many of these potential competitors have substantially greater capital resources, larger research and development staffs and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These companies also compete with us to attract qualified personnel and parties for