Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 5

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 5
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ventional active electrodes for laparoscopic surgery are designed with the same basic construction –
a single conductive element and an outer insulation coating. This insulation can fail during the course of normal use during surgery.
One university study found insulation defects in new disposable instruments before they were used or after limited surgical use. It is
also possible for instrument insulation to become flawed during the handling, cleaning and sterilization process. This common insulation
failure can allow electrical currents to "spark" from the instrument to unintended and unseen tissue with potentially serious
consequences for the patient, such as bowel perforations. Four different studies indicate that the insulation failure rate in reusable
instruments can be as high as one in five. Capacitive coupling is another way stray electrosurgical energy can cause unintended burns
during laparoscopy. Capacitive coupling is an electrical phenomenon that occurs when current is induced from the instrument to nearby
tissue or another instrument despite intact insulation. This potential for capacitive coupling is present in all laparoscopic surgeries
that utilize monopolar electrosurgery devices and are likely to occur outside the surgeon’s field of view.

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Conventional, “non-shielded, non-monitored”
laparoscopic instruments are susceptible to causing unintended, unseen burn injuries to the patient in MIS. Instrument insulation failure
and capacitive coupling are the primary causes of stray electrosurgical burns in laparoscopy and are the two events over which the surgical
team has traditionally had no control. Although alternative forms to monopolar electrosurgery energy exist, these alternative energies
tend to be less effective, take longer to achieve the desired surgical effect and are costlier.

Encision’s AEM Surgical Instruments

AEM technology eliminates the risk of stray electrical
energy caused by instrument insulation failure and capacitive coupling, and thus prevents unintended burn injuries to patients.

AEM Surgical Instruments are an innovative solution
to stray electrosurgical burns in laparoscopic surgery and are designed with the same look, feel and functionality as conventional instruments.
They direct electrosurgical energy where the surgeon desires, while continuously monitoring the current flow to prevent stray electrosurgical
energy from instrument insulation failure or capacitive coupling.

Whereas conventional instruments are simply a
conductive element with a layer of insulation coating, AEM Surgical Instruments have a patented, multi-layered design with a built-in
“shield,” a concept much like the third-wire ground in standard electrical cords. The shield in these instruments is electrically
connected and referenced