Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 6

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 6
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 back to an AEM Monitor at the electrosurgical generator. In the event of a harmful level of stray electrical
energy, the monitor shuts down the power at the source, assuring patient safety. If instrument insulation failure should occur, the AEM
system, while continually monitoring the instrument, immediately interrupts monopolar output from the electrosurgical generator and alerts
the surgical staff. The AEM system protects against capacitive coupling by providing a neutral return path for “capacitive”
electrical energy. Capacitive energy is continually drained away from the instrument and away from the patient through the protective
shield built into all AEM instruments and the connected AEM Monitor.

The AEM system comprises 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 the integrated AEM design
and includes the full range of instruments common in laparoscopic surgery today. The AEM monitor is compatible with most electrosurgical
generators and can be adapted for robotic systems. AEM Surgical Instruments provide enhanced patient safety, require no change in surgeon
techniques, and are cost-competitive. Thus, conversion to AEM Surgical Instruments is easy and economical.

Historical
Perspective

We were
organized as a Colorado corporation in 1991 and spent several years developing the AEM monitoring system and protective sheaths to adapt
to conventional electrosurgical instruments. During this period, we conducted product trials and applied for patents with the United States
Patent and Trademark Office and International patent agencies. Our patents relate to
the basic shielding and monitoring technologies we incorporate into our AEM products. As of March 31, 2025, we have 21 unexpired United
States patents relating to specific implementations of shielding and monitoring in instruments, and we continue to add patents as we further
develop our proprietary technology and its applications.

As we evolved, it was clear to us that our “active
electrode monitoring” technology needed to be integrated into the standard laparoscopic instrument design. As the development program
proceeded, it also became apparent that the merging of electrical and mechanical engineering skills in the instrument development process
for our patented, integrated electrosurgical instruments was a complex and difficult task. As a result, instruments with integrated AEM
technology were not completed for several years.