Identafi DEN1129 - Oral Cancer Detection

Identafi DEN1129

Need for Early Detection

• Importance: The Identafi DEN1129 is a vital tool for oral health professionals, including Dentists, Dental Hygienists, and Surgeons, as it aids in early detection of oral cancers, which can significantly impact patient management and outcomes.

Purpose

• Protection Against Oral Cancer: The primary goal of the Identafi is to protect patients from the devastating effects of oral cancer by facilitating early diagnosis, which is crucial for improving survival rates.

• First Line of Defense: It serves as the first line of defense against this potentially deadly disease, enabling healthcare providers to take timely action and implement necessary treatments.

Enhancing Surgical Ability

Benefits for Surgeons:

• Biopsy Site Selection: The device assists surgeons in selecting the most appropriate biopsy sites based on the visualization of oral lesions.

• Incision Margin Determination: Aids in determining the suitable margin for surgical incisions, which can lead to better patient outcomes by ensuring complete removal of cancerous tissue while preserving surrounding healthy tissue.

Multi-spectral Cancer Screening

Features:

• Deep Penetrating Power: The device is equipped with technology that allows for deeper visualization of mucosal abnormalities, which can often go unnoticed during standard examinations.

• High Sensitivity Detection: It is capable of identifying premalignant dysplasia that is not visible to the naked eye as well as detecting established cancerous lesions, enhancing diagnostic accuracy.

Screening Steps

1. Step 1: White Light

   • Utilizes three distinct color wavelengths to improve visibility of lesion morphology and details, enabling better assessment of oral lesions.

2. Step 2: Violet Light

   • Utilizes patented 405-nanometer violet light which enhances the fluorescence of healthy tissue. This contrast makes suspicious areas appear darker, aiding in prompt identification of potentially malignant changes.

3. Step 3: Green-Amber Light

   • Activating the amber light allows for visualization of blood vessels within the oral tissues. Areas with increased diffuse and dilated vasculature are often indicative of higher likelihood of cancerous conditions, providing critical diagnostic information.

Oral Cancer Facts & Figures

• Prevalence: Oral cancer results in approximately one death per hour in the United States, underscoring the urgency for effective screening and detection techniques.

• HPV Link: Approximately 20 million Americans are infected with HPV, a significant risk factor that is strongly linked to the development of oral cancer.

• Trends: There is a concerning rise in HPV-related oral cancers among individuals under the age of 40, with a noticeable shift away from traditional risk factors such as tobacco and alcohol use.

• Survival Rates: Early detection through screenings can lead to a remarkable 90% survival rate for patients diagnosed with oral cancer, emphasizing the importance of regular monitoring.

• Screening Recommendations: It is recommended that all patients over the age of 17 undergo annual screenings to facilitate early detection and intervention.

Identafi Features and Benefits

Design:

• Compact Size: The Identafi's compact size, combined with an angled disposable examination mirror, allows for easy access to hard-to-reach areas of the oral cavity such as the tongue, hard and soft palate, and the back of the pharynx.

• Space-Saving Design: The device is designed to be space-efficient, making it suitable for various clinical environments.

Procedure:

• User-Friendly Operation: Eliminates the need for messy and unpleasant-tasting dyes or solutions, making the procedure more comfortable for patients and easier for practitioners.

Impact:

• Expanded Practice Offerings: The Identafi expands practice offerings and significantly enhances the perception of the practice, establishing it as one that adheres to the highest standard of care.

Financials:

• Dental Reimbursement Code: The presence of the dental reimbursement code (DO431) allows for effective cost recovery, enabling practices to recoup expenses in as few as eight weeks.

Uniqueness:

• Exclusive Technology: The Identafi is the only handheld intraoral device available on the market specifically designed for cancer screening, giving practices a unique diagnostic tool to enhance patient care.