Company: ECIA
Filing Date: 2025-08-15
Form Type: 10-Q
Source: 0001079973-25-001326
Chunk: 13

Company: ENCISION INC
Filing Date: 2025-08-15
Form: 10-Q
Item: Item 8
Chunk 13
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 Program. The
program has begun to levy as much as a 1% penalty on Medicare reimbursements to hospitals in the lower quadrant of performance for selected
quality indicators, including accidental puncture and laceration (“APL”). Examples of APL include the use of a cautery device
(electrosurgery) or scissors to dissect a tissue plane that errantly causes an injury to underlying bowels.

We address market opportunities created by the increase
in minimally invasive surgery (“MIS”) and surgeons’ use of electrosurgery devices in these procedures. The product opportunity
exists in that monopolar electrosurgery instruments used in laparoscopic procedures provide excellent clinical results but are also susceptible
to causing inadvertent collateral tissue damage outside the surgeon’s field of view due to insulation failure and capacitive coupling.
The risk of unintended electrosurgical burn injury to the patient in laparoscopic surgery has been well documented. This risk poses a
threat to patient safety, including the risk of death, and creates liability exposure for surgeons and hospitals, as well as increased
and preventable readmissions.

Our patented AEM technology provides surgeons with
the desired tissue effects while capturing stray electrosurgical energy that can cause unintended and unseen tissue injury that may result
in death. AEM Surgical Instruments are equivalent to conventional instruments in size, shape, ergonomics, functionality, and competitive
pricing, but they incorporate “Active Electrode Monitoring” technology to dynamically and continuously monitor the flow of
electrosurgical current, thereby helping to prevent patient injury. With our “shielded and monitored” instruments, surgeons
can perform electrosurgical procedures more safely, effectively, and economically than is possible using conventional instruments or alternative
energy sources.

The AEM system consists of shielded 5mm AEM Instruments
and an AEM monitor. The AEM Instruments are designed to function identically to the conventional 5mm instruments that surgeons are familiar
with, but with the added benefit of enhanced patient safety. Our entire line of laparoscopic instruments has an integrated AEM design
and includes the full range of instruments that are common in laparoscopic surgery today. The AEM monitor is compatible with most electrosurgical
generators and can also be adapted for use in robotic systems. AEM Surgical Instruments provide enhanced patient safety, require no change
in surgeon technique, and are cost-competitive. Thus, conversion to AEM Surgical Instruments is easy and economical.

AEM technology has been recommended and endorsed by
many groups