Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 9

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 9
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rosurgery and have accepted AEM technology as the way to eliminate those risks. In other instances, we have found selling
the concept behind AEM technology more difficult. This difficulty is due to several factors, including the necessity to make surgeons,
nurses, and hospital risk managers aware of the potential for unintended electrosurgical burns (which exists when conventional instruments
are used during laparoscopic monopolar electrosurgery) and the resulting increased patient injury and medicolegal liability exposure.
Additionally, we must contend with the overall lack of single purchasing points in the industry (surgeons, hospital personnel, and value
analysis committees have to be in substantial agreement as to the benefits of new technology), and the resulting need to make multiple
sales calls on personnel with the authority to commit to hospital expenditures. Other challenges include the fact that many hospitals
have exclusive contractual agreements with manufacturers of competing surgical instruments.

6 

Our goal is to optimize a network that has experience
selling into the hospital operating room environment. We believe that improvement in this network offers us the best opportunity to cost-effectively
broaden acceptance of our product line and generate increased and recurring sales. Additionally, we are pursuing supplier agreements with
the major selected GPOs, hospital systems, and integrated delivery networks.

In addition to the efforts to broaden market
acceptance in the United States, we have contracted with independent distributors in Australia and New Zealand to market our products
internationally. We have achieved Conformité Européene (“CE”) marking for our products so that we may sell into
the European marketplace. The CE marking indicates that a manufacturer has conformed to all of the obligations imposed by European health,
safety and environmental legislation. While CE certification opens up incremental markets in Europe, our distribution options in the European
marketplace are developing, and sales in international markets are small.

We believe that the expanding awareness for AEM
technology through education and the improved sales network of independent representatives will provide the basis for increased sales
and continuing profitable operations. However, these measures, or any others that we may adopt, may not result in increased sales or profitable
operations.

Research
and Development

We aim to continually expand our AEM Instrument
product line to satisfy the evolving needs of surgeons. For AEM technology to fully become a standard of care, we must satisfy surgeons’
preferred instrument shapes, sizes, styles, and functionality with integrated AEM technology. This commitment includes expanding the styles
of electrosurgical instruments available for MIS applications