Encision Inc. develops and markets innovative active electrode monitoring surgical instruments to enhance patient safety during minimally invasive surgeries.

# Encision Inc. Company Summary

## Business Overview
- **Industry:** Medical Devices
- **Location:** Boulder, Colorado
- **Core Technology:** Active Electrode Monitoring (AEM®) Surgical Instruments
- **Purpose:** Enhance patient safety in minimally invasive surgery (MIS) by preventing stray electrosurgical energy that can cause tissue burns, injuries, or fatalities.
- **Market Focus:** Increase in MIS procedures (laparoscopy and robotic-assisted surgeries) and use of monopolar electrosurgery devices.
- **Key Benefits:** Innovative, same size and functionality as conventional instruments, but incorporate patented shield and monitoring technology to continuously prevent unintended tissue damage.

## Products
- **AEM Surgical Instruments:** Full range of laparoscopy tools (scissors, graspers, dissectors, forceps, suction/irrigation devices) available in reusable and disposable formats.
- **AEM Monitors:** Devices that connect with instruments to monitor electrical current flow and shut down energy if hazards are detected.
- **EndoShield® 2:** Burn protection system, disposable and reprocessable, compatible with existing electrosurgical generators.
- **enTouch® Disposable Scissors:** High-performance scissors with integrated AEM technology.
- **2X enTouch® Scissors:** Cost-effective, multi-use scissors with thermochromic indicators for usage tracking.
- **Accessories:** Handles, tips, and other surgical components.

## Market & Adoption
- **Market Size:** Over 4.4 million laparoscopic procedures annually in the U.S.
- **Market Share Goals:** Targeting a growing share in monopolar electrosurgical instrument market (~$500 million annual sales in the U.S.).
- **Adoption Path:** Aiming to become a standard of care similar to pulse oximetry; endorsed by surgeons, nurses, insurers, legal, and medical communities.
- **Distribution:** U.S. direct and independent sales reps, expanded hospital GPO agreements, and international distributors. CE marking obtained for European sales; expanding presence in Australia, New Zealand, Middle East, and Europe.
- **Customer Base:** Hospitals, surgical centers, and healthcare providers implementing monopolar electrosurgery.

## Employees and Financials
- **Employees:** 22 full-time, 2 part-time (as of March 31, 2025).
- **Annual Revenue:** Not explicitly provided.
- **Net Income:** Not explicitly provided.
- **Research & Development Expenses:** Approximately $593,152 in FY 2025, and $621,894 in FY 2024.
- **Funding & Capital:** Primarily financed through stock offerings, options, loans; cash and equivalents of $257,433 as of March 31, 2025.

## Regulation & Patents
- **Regulatory Status:** Products are Class II medical devices (FDA) with a pending or existing approval process.
- **Patents:** 21 active U.S. patents and additional patents internationally, protecting shielding and monitoring technologies.
  
## Competitive Position
- **Differentiation:** Only company offering a continuous solution that completely eliminates stray electrical energy risks.
- **Main Competitors:** Larger medical device firms like Medtronic and Johnson & Johnson, plus alternative energy technologies such as bipolar electrosurgery, lasers, and ultrasonic devices.
- **Industry Challenges:** Market acceptance, regulatory approvals, competition from well-established firms, and technological advancements.

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> Note: Specific revenue, profit, or customer numbers are not provided in the document.  
> The summary is based solely on the detailed information given in the provided excerpt.

Encision Inc. is a medical device company based in Boulder, Colorado, specializing in innovative technologies for minimally invasive surgeries, particularly through its patented Active Electrode Monitoring (AEM®) Surgical Instruments.

# Encision Inc. Overview

### Company Profile
- **Name:** Encision Inc.
- **Location:** Boulder, Colorado
- **Type:** Medical device company
- **Founded:** 1991
- **Number of Employees:** 22 full-time, 2 part-time

### Business Focus
Encision Inc. specializes in developing and marketing innovative technologies that improve patient safety and outcomes in minimally invasive surgeries (MIS). The company's primary product line revolves around its patented **Active Electrode Monitoring (AEM®)** Surgical Instruments designed to mitigate the risks associated with monopolar electrosurgery, particularly unintended patient burns caused by stray electrosurgical energy.

### Key Products
- **AEM Surgical Instruments:** A full range of laparoscopic instruments (including scissors, graspers, dissectors, fixed-tip electrodes, and suction-irrigation devices) that incorporate AEM technology.
- **AEM Monitors:** Devices that work in conjunction with AEM instruments to monitor electrosurgical current flow and ensure patient safety.

### Market and Customers
- **Target Market:** The market for laparoscopic monopolar electrosurgical instruments, estimated at approximately **$500 million** in annual sales.
- **Annual Laparoscopic Procedures:** Over **4.4 million** procedures performed annually in the U.S., with about **75% of surgeons** utilizing monopolar electrosurgery.
- **Current Customers:** Includes hospitals and surgical facilities, with a notable focus on gaining contracts with Group Purchasing Organizations (GPOs) and hospital systems. The company has been recognized by the U.S. Department of Veterans Affairs, expanding its customer base into VA Medical Centers.

### Sales and Financial Performance
- **Sales Impact:** Sales generated from hospitals using reusable and disposable AEM products accounted for over **90%** of total sales in the fiscal year ended March 31, 2024.
- **Revenue:** Specific revenue figures for the most recent fiscal year are not provided, but previous losses are noted at approximately **$22 million** since inception.
- **Cash Position:** As of March 31, 2024, the company had cash and equivalents totaling **$43,000** with cash provided by operations amounting to **$144,000** for the fiscal year 2024.

### Research and Development
- **R&D Investment:** Encision allocates resources towards expanding its product line in response to surgeon needs, with expenditures on research and development reported at **$621,894** for fiscal year 2024, down from **$816,119** in fiscal year 2023.

### Regulatory Compliance
- **FDA Regulation:** The company’s AEM products are classified as Class II medical devices and have received 510(k) pre-market clearance from the FDA.

### Challenges and Risks
- **Market Adoption:** As Encision seeks to educate the healthcare community about the benefits of AEM technology, there are challenges associated with market acceptance and competition with established players in the electrosurgical device market.
- **Financial Viability:** The need for continual financial support to sustain operations is crucial, with significant reliance on stock and warrants since establishment.

### Conclusion
Encision Inc. continues to focus on advancing the safety of laparoscopic surgery via its AEM technology, with an emphasis on broadening market acceptance and developing innovative surgical instruments to meet evolving healthcare needs. The company is poised for growth but faces competitive and operational challenges in the medical device landscape.

ENCISION INC

10-K / July 10, 2025

10-K / July 15, 2024

10-K / July 10, 2025

Encision Inc. Company Summary

Business Overview

Products

Market & Adoption

Employees and Financials

Regulation & Patents

Competitive Position