Encision Profile
Encision Inc. operates as a medical device company. The company develops and markets innovative technology that provides unprecedented outcomes and patient safety in minimally-invasive surgery.
The company addresses 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.
The company’s patented AEM technology provides surgeons with the desired tissue effects of cutting and coagulating tissue in laparoscopic procedures, while preventing stray electrosurgical energy that can cause complications and even death. AEM Surgical Instruments are equivalent to conventional instruments in size, shape, ergonomics and functionality, but they incorporate a proprietary shield and electrically connect to an Active Electrode Monitor to dynamically and continuously monitor the flow of electrosurgical current, thereby preventing patient injury from stray monopolar energy. With the company’s shielded and monitored instruments, surgeons are able to perform electrosurgical procedures more safely, effectively and economically than is possible using conventional instruments.
The company has developed and launched patented AEM Surgical Instruments and Monitors that enhance patient safety and patient outcomes in laparoscopic surgical procedures. The company has been issued 16 unexpired patents relating to AEM technology from the United States Patent and Trademark Office, each encompassing multiple claims, and which have between two and eighteen years remaining. The company also has patents relating to AEM technology issued in Europe, Japan, Canada and Australia.
The company’s AEM Surgical Instruments and Monitors have been engineered to provide a seamless transition for surgeons switching from conventional laparoscopic instruments. The AEM product line encompasses a full range of instrument sizes, types and styles favored by surgeons. While always quality-centric, the company added a new level of customer-centricity with increased marketing focus on its reposable AEM EndoShield 2 Burn Protection System (EndoShield 2). The EndoShield 2 can be used for a number of surgical procedures without reprocessing.
The company’s proprietary AEM technology enhances patient safety in MIS, especially in light of laparoscopic instruments being in closer proximity with single-port and reduced-port approaches. The company’s AEM technology, in the hands of a sales network with broad access to the surgery marketplace, will help to increase utilization and market share.
Products
The company produces and markets a full line of AEM Instruments, which are shielded and monitored to prevent stray electrosurgical burns from insulation failure and capacitive coupling. Its product line includes a broad range of endo-mechanical instruments (scissors, graspers and dissectors), fixed-tip electrodes and suction-irrigation electrodes. These AEM Instruments are available in a wide array of reusable and disposable options. Also, the company has a line of handles that are used for advanced laparoscopic procedures that incorporate stiffer shafts and ergonomic features. In addition, the company markets an AEM monitor product line that is used in conjunction with AEM Instruments. The company introduced its AEM EndoShield 2 Burn Protection System during its fiscal year ended March 31, 2018. The EndoShield 2 integrates the company’s patented AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor.
The introduction of the company’s AEM 2X enTouch Scissors (2X Scissors) brings new levels of performance and economy to the surgical scissor market by combining the best in class performance of its enTouch Disposable Scissors with the value and economy of a multi-use device. 2X Scissors are a game-changing product that will have a significant impact on the disposable laparoscopic scissor market. The company’s enTouch Disposable Scissors have long been the surgeon preferred product because of their sharpness and micro-serrations. 2X Scissors will open new use segments for the company and create an opportunity for customers to standardize on its entire portfolio of Active Electrode Monitoring (AEM) products.
Sales and Marketing
The company’s marketing efforts are focused on building awareness by providing technical education for Health Care Providers on the dangers of stray electrosurgical energy and in providing clinical and economic evidence to substantiate the value of AEM technology to Hospitals, their Staff, and their patients.
In addition to the efforts to broaden market acceptance in the United States, the company has contracted with independent distributors in Australia and New Zealand to market its products internationally.
Research and Development
For the year ended March 31, 2021, the company’s research and development expenses were $569,542.
Patents, Patent Applications and Intellectual Proprietary Rights
The company has been issued 16 unexpired relevant patents that together form a significant intellectual property position. Its patents relate to the basic shielding and monitoring technologies that the company incorporates into its AEM products. As of March 31, 2021, the company had 16 unexpired United States patents relating to specific implementations of shielding and monitoring in instruments. As of March 31, 2021, there are between two and eighteen years remaining on the company’s AEM patents. The company has five patent applications in process; and it has four trademarks.
Competition
The company competes directly for customers with those companies that make conventional electrosurgical instruments. Larger competitors include Advanced Surgical Technologies Group (a division of Medtronic plc) and Ethicon Endo-Surgery (a division of Johnson & Johnson).
Government Regulation
The company is subject to the rules and regulations of the United States Food and Drug Administration (FDA). The FDA regulates the company and its products under a number of statutes, including the Federal Food, Drug and Cosmetics Act (the FDC Act).
The FDA regulates the company’s quality control and manufacturing procedures by requiring it and its contract manufacturers to demonstrate compliance with the Quality System Regulation (QSR) as specified in published FDA regulations.
History
Encision Inc. was founded in 1991 as a Colorado corporation.
