27 July 2020
Palm Beach, Florida
Excerpt from our “Melanoma Development Report”
Submitted by: Elora Mesa, Research information officer
Signet is moving forward with its melanoma detection device, the Sniffer™, a patented, scientifically proven and verified technology. “The CPT application process is underway to ensure insurance reimbursement for physician use of the Sniffer™ technology,” CEO Ernest Letiziano said in prepared remarks.

The Process:
• The purpose of this step is to understand the current reimbursement environment in the US, relevant for our medical device, and develop an initial reimbursement strategy. To do so, we will:
• Clarify the relevant type of procedure coding systems (CPT, HCPCS or ICD-10-PCS); identify relevant coverage policies by public or commercial payers; relevant type of payment mechanisms (MS-DRG, APC and different fee-for-service fee schedules); and payment rates applicable for the specific device or to any comparable products.
• Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and, if so, which mechanisms (e.g., a new CPT or HCPCS code, a new coverage policy, or a modified payment rate).
• Identify the main decision makers, lay out the typical path towards obtaining public payer (Medicare, Medicaid) or commercial payer reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in the USA.

• Depending upon the existence or the lack of, of applicable reimbursement mechanisms (as identified in the prior Reimbursement step), we will conduct the following activities:
• Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
• Reimbursement Applications: Work with the relevant medical societies to apply for new reimbursement mechanisms, such as CPT, HCPCS or ICD-10-PCS codes and inclusion in the relevant public/commercial payer’s coverage policies.
• Pilot Projects: Initiate pilot projects with local payers or Medicare contractors.
• Other Funding Options: Apply for other or interim funding options such as New Technology Add-On Payment and Pass-Through Payments under the hospital outpatient prospective payment system (OPPS).


Melanoma Medical Statistics:
• Melanoma is the deadliest of skin cancers. Rates of diagnosis for the disease have increased dramatically over the past three decades, outpacing almost all other cancers. Today, it is one of the most common cancers found among young adults in the United States. The following information provides key facts regarding risk and incidence of melanoma. Related infographics can be found here.

Melanoma Risk:
• According to the CDC, the incidence of melanoma has doubled during the past three decades in the United States.
• One person dies of melanoma every hour, every day.
• Your risk of melanoma is higher if one or more of your first-degree relatives (parents, brothers, sisters, or children) had melanoma. Around 10% of all people with melanoma have a family history of the disease.
• Melanoma is more than 20 times more common in whites than in blacks. Overall, the lifetime risk of getting melanoma is about 2.5% (1 in 40) for whites, 0.1% (1 in 1,000) for blacks, and 0.5% (1 in 200) for Hispanics.
• 100,350 people in the United States are expected to be diagnosed with new melanomas in 2020.
• On age related cancers, melanoma is the #1 most diagnosed cancer among 25 to 29 year olds in the United States. For 15 to 29 year olds, it is the 3rd most common for men and 4th most common for women.
• The average age of people diagnosed with melanoma is 63. But melanoma is not uncommon even among those younger than 30. In fact, it’s one of the most common cancers in young adults (especially young women).
• An estimated 6,850 people in the United States are expected to die of melanoma in 2020— about 4,610 men and 2,240 women.

Tanning and Sun Damage:
• In addition to the risk of melanoma increasing by 75 percent with tanning bed use before the age of 35, there is also an association between UV-emitting tanning devices and cancer of the eye (ocular melanoma).
• Tanning beds increase your risk of melanoma by 75%.
• Melanoma, the deadliest form of skin cancer, in most cases, is related to UV-induced damage. Sources of UV include tanning beds and the sun. Severe sunburns, especially at a young age, are also linked to melanoma.
• The international Agency for Research on Cancer (IARC) concluded that UV-A and UV-B rays cause DNA damage, which can lead to skin cancer in laboratory animals and humans.

Treatment and Clinical Trials:
• The 5-year relative survival rate from diagnosis for localized, early melanoma is over 98%, but only about 25% for melanoma that has spread to distant sites.
• Since 2007, 12 new FDA-approved melanoma therapies have been developed for treatment of the disease.
• 100% of treatments and medications currently available for melanoma were first rigorously tested in clinical trials.
• 1 in 4 clinical trials fail because they don’t enroll enough patients; lack of enrollment in clinical trials is one of the biggest obstacles to bringing new, potentially life-saving therapies to market.
• Of all clinical trial participants in the U.S., 80-90% are white.
• Almost half of all people who participate in a clinical trial do so to help advance science and the treatment of their condition.
• Today there are more than 400 melanoma-focused clinical trials currently recruiting patients.
• Only 15% of patients in North America have been asked to participate in a clinical research study.
• Over half of clinical trial participants would recommend participation to family and friends.
• Today, only 1 out of 20 cancer patients enroll in a clinical trial.