Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 12

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 12
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. What clearly
differentiates us from the competition is that while competitive technologies may somewhat reduce the risk of stray energy burns, only
AEM Technology completely eliminates it.

We also believe that manufacturers of products
based on alternative technology to monopolar electrosurgery are our competitors. These alternative technologies include other “advanced
energy” technologies such as bipolar electrosurgery, laser surgery and ultrasonic dissector sealers. Leading manufacturers in these
areas include Advanced Surgical Technologies Group, Gyrus/ACMI (a division of Olympus Corporation and a leader in bi-polar electrosurgery),
Lumenis (laser surgery) and Ethicon Endo-Surgery (a division of Johnson and Johnson, manufacturers of the harmonic scalpel). We believe
that monopolar electrosurgery offers substantial competitive, functional and financial advantages over these alternative energy technologies
and will remain the primary tool for the surgeon, as it has been for decades. However, the risk exists that these alternative technologies
may gain greater market share and that new competitive techniques may be developed and introduced.

As mentioned in the Sales and Marketing discussion,
the competitive issues involved in selling our AEM product line do not primarily revolve around a comparison of cost or features, but
rather involve generating an awareness of the inherent hazards of electrosurgery and the potential for injury to the patient. This involves
conceptual selling, rather than just product selling, which results in a longer sales cycle and generally higher sales costs. Independent
endorsements of AEM technology have greatly enhanced the credibility of AEM Instruments. However, our efforts to increase market awareness
of this technology may not be successful, and our competitors may develop alternative strategies and/or products to counter our marketing
efforts.

Many of our competitors
and potential competitors have widely-used products and significantly greater financial, technical, product development, marketing and
other resources. In addition to our direct sales force, we utilize a network of independent distributor representatives in selected areas.
In some cases, our options for independent distribution have conflicting and competing product interests which compromise our ability
to make market advances in certain areas. We may not be able to compete successfully against current and future competitors, and competitive
pressures faced by us may have a material adverse impact on our business, operating results and financial condition.

8 

Government
Regulation

Government regulation in the United States and
other countries is a significant factor in the development and marketing of our products and in our ongoing manufacturing, research, and
development activities. The