Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 19

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 19
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 devices must receive clearance from the Food and Drug Administration through the
Section 510(k) pre-market notification process or through the lengthier pre-market approval process before they can be sold in the United
States. The process of obtaining required regulatory approvals is lengthy and has required the expenditure of substantial resources. There
can be no assurance that we will be able to continue to obtain the necessary approvals. As part of our strategy, we also intend to pursue
commercialization of our products in international markets. Our products are subject to regulations that vary from country to country.
The process of obtaining foreign regulatory approvals in certain countries can be lengthy and require the expenditure of substantial resources.
We may not be able to obtain necessary regulatory approvals or clearances on a timely basis or at all, and delays in receipt of or failure
to receive such approvals or clearances, or failure to comply with existing or future regulatory requirements would have a material adverse
effect on our financial position, results of operations and cash flows. Tariffs may increase our material costs and, if they are fully
absorbed by us, then they will negatively affect our gross profit margins.

If we fail to comply with the extensive regulatory
requirements governing the manufacturing of our products, we could be subject to fines, suspensions or withdrawals of regulatory approvals,
product recalls, suspension of manufacturing, operating restrictions and/or criminal prosecution. The manufacturing of our products
is subject to extensive regulatory requirements administered by the Food and Drug Administration and other regulatory agencies. Inspection
of our manufacturing facilities and processes can be conducted at any time, without prior notice, by the Food and Drug Administration
and such regulatory agencies. In addition, future changes in regulations or interpretations made by the Food and Drug Administration or
other regulatory agencies, with possible retroactive effect, could adversely affect us. Changes in existing regulations or adoption of
new regulations or policies could prevent us from obtaining, or affect the timing of, future regulatory approvals or clearances. We may
not be able to obtain necessary regulatory approvals or clearances on a timely basis in the future, or at all. Delays in receipt of, failure
to receive such approvals or clearances, and/or failure to comply with existing or future regulatory requirements would have a material
adverse effect on our financial position, results of operations, and cash flows.

Our current patents, trade secrets and know-how
may not provide a competitive advantage, the pending applications may not result in patents being issued, and our competitors may design
around any patents issued to us. Our