Company: SNWV
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001628280-25-014141
Chunk: 48

Company: SANUWAVE Health, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1A
Chunk 48
---
 raise additional capital, the timing of any required financing and the amount of such financings. Factors that may cause our future capital requirements to be greater than anticipated or could accelerate our need for funds include, without limitation:

•unanticipated expenditures in research and development or manufacturing activities;

•unanticipated expenditures in the acquisition and defense of intellectual property rights;

•the failure to develop strategic alliances for the marketing of some of our products;

•unforeseen changes in healthcare reimbursement for procedures using any of our approved products;

•inability to train a sufficient number of physicians to create a demand for any of our approved products;

•lack of financial resources to adequately support our operations;

•difficulties in maintaining commercial scale manufacturing capacity and capability;

•unforeseen problems with our third-party manufacturers, service providers or specialty suppliers of certain raw materials;

•unanticipated difficulties in operating in international markets;

•unanticipated financial resources needed to respond to technological changes and increased competition;

•unforeseen problems in attracting and retaining qualified personnel;

•the impact of changes in U.S. health care law and policy on our operations;

•enactment of new legislation or administrative regulations;

•the application to our business of new court decisions and regulatory interpretations;

•claims that might be brought in excess of our insurance coverage;

•delays in timing of receipt of required regulatory approvals;

•the failure to comply with regulatory guidelines; and

•the uncertainty in industry demand and patient wellness behavior.

In addition, although we have no present commitments or understandings to do so, we may seek to expand our operations and product line through acquisitions. Any acquisition would likely increase our capital requirements.

The medical device/therapeutic product industries are highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products that are safer and more effective than any products we may develop, our commercial opportunities will be reduced or eliminated.

Our success depends, in part, upon our ability to maintain a competitive position in the development of technologies and products. We face competition from established medical device, pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies, and private and public research institutions in the United States and abroad. Many of our principal competitors have significantly greater financial resources and expertise than we do in research and development, manufacturing, pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements, or mergers with, or acquisitions by