Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 4

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 4
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.S. market. We are growing our presence in Australia and New Zealand and are seeking a new presence in the Middle
East and Europe. As decisions are made at a system level, we intend to highlight the clinical, economic, and safety benefits of AEM technology.

The Technology

Stray Electrosurgical Burn Injury to the
Patient

Electrosurgical technology is a valuable and
prevalent resource for surgeons. Since its introduction in the 1930s, electrosurgical technology has continually evolved and is estimated
to be used in over 75% of all surgeries.

The primary form of electrosurgery, monopolar
electrosurgery, is a standard tool for general surgeons throughout the world. In monopolar electrosurgery, the surgeon uses an instrument
(typically scissors, grasper/dissectors, spatula blades or suction-irrigation electrodes) to deliver electrical current to patient tissue.
This “active electrode” provides the surgeon with the ability to cut, coagulate or ablate tissue as needed during the surgery.
With the advent of MIS procedures, surgeons have continued using monopolar electrosurgery as a primary tool for hemostatic incision, coagulation
of bleeding tissues, excision and ablation. Unfortunately, conventional laparoscopic electrosurgical instruments from competing manufacturers
are susceptible to emitting stray electrical currents during the procedure. This risk is exacerbated by the fact that laparoscopic camera
systems limit the surgical field of view. Ninety percent of the instrument may be outside the surgeon's field of view at any given time
during the surgery.

The dangers of stray energy are twofold. Not
only is there the danger created by the burn injury itself, but there is the compounding danger that the burn will go unnoticed during
the surgery and be allowed to manifest post-operatively as fecal peritonitis or other potentially deadly and devastating outcomes. In
many cases, the surgeon cannot detect stray electrosurgical burns at the time of the procedure because it is out of their field of visualization.
The resulting complication usually presents itself days later in the form of a severe infection or sepsis, which often results in a hospital
readmission and a difficult course of remedial surgeries and prolonged hospital recovery for the patient. This situation has even resulted
in fatalities.

Stray electrosurgical burn injury can result
from two causes – instrument insulation failure and capacitive coupling. Instrument insulation failure can be a common occurrence
with laparoscopic instruments. Con