SciBase is active within both skin cancer detection and skin barrier assessment. SciBase’s Nevisense platform addresses multiple sizeable clinical application areas.
Skin Cancer
Skin cancer can be divided into two main types: non-melanoma skin cancer and melanoma.
Skin cancer, particularly melanoma, poses a significant public health challenge. Approximately 2.2 percent of the US population will face a melanoma diagnosis in their lifetime. The incidence of melanoma has surged by over 300 percent between 1975 and 2016, with projections indicating further increases by 2030.
Survival rates for melanoma are closely tied to early detection. Stage 0 (in situ melanoma) has the highest survival rates, while stage IV carries the highest mortality risk. Early detection is key to improving survival rates. However, melanoma's early stages are often challenging to identify visually, leading to misdiagnoses.
Currently, an estimated 50–60 million formal skin cancer screenings occur globally, primarily in SciBase's target regions. These screenings involve General Practitioners (GPs) or dermatologists who visually examine skin lesions, sometimes aided by dermatoscopes or digital tools. Visual inspection relies on assessing size, shape, color, and borders, but it has limitations, particularly in detecting early-stage melanomas. Visual screenings result in biopsies or excisions for about 10 percent of cases, with the majority proving benign upon further examination.
The skin serves as a crucial protective barrier with two main mechanical components: the outermost stratum corneum and ""tight junctions"" sealing epithelial cells in the stratum granulosum beneath it.
These tight junctions selectively control the passage of water, ions, and solutes between epithelial cells, serving as an essential defense mechanism.
A compromised stratum corneum or malfunctioning tight junctions can impair the skin's barrier function, allowing irritants and allergens to penetrate. This vulnerability can lead to cutaneous allergen sensitization, a factor in the development of allergies and atopic diseases.
Understanding the skin's barrier function is vital not only for dermatology but also for broader health contexts, including the airway and gastrointestinal system.
SciBase's innovative approach to skin diagnostics aims to address the challenges of early detection, potentially transforming the landscape of skin cancer diagnosis as well as assessment of the skin barrier function to help patients suffering from atopic dermatitis and other skin disorders.
Need for improved diagnostic accuracy in dermatology
There is a pressing need to enhance diagnostic accuracy in dermatology, particularly in the case of melanoma. The effectiveness of melanoma treatment is highly dependent on the stage at which it is detected. Early detection is not only vital for improving survival rates but also for reducing the overall cost of treatment. When melanoma is detected at an early stage, it is easily treatable through biopsy, and the risk of it spreading is significantly diminished. Conversely, treating later-stage melanomas is associated with substantially higher costs.
In SciBase's pivotal trial, Nevisense demonstrated remarkable accuracy in identifying small and early-stage melanomas. The broader trend in skin cancer detection emphasizes the importance of early identification through methods or systems that can detect skin cancers in their early stages. High sensitivity, or the ability to detect melanoma and skin cancers, is especially critical during the early stages of disease progression.
Currently, visual diagnostic methods in dermatology are subjective and exhibit relatively low sensitivity. This often leads to unnecessary biopsies and, in the worst-case scenario, the missed diagnosis of melanomas or other skin cancers. SciBase estimates that this poor diagnostic accuracy results in approximately $2 billion in unnecessary costs each year for public health and private insurers, primarily due to biopsy expenses.
Results from SciBase's pivotal study indicate that Nevisense can reduce unnecessary biopsies by 34 percent. Additionally, a recently published article demonstrated a 47 percent reduction in biopsies at a clinic that implemented Nevisense.
SciBase's objective is to enhance the precision of clinicians evaluating atypical skin lesions where there is a risk of melanoma or non-melanoma skin cancer (NMSC) using Nevisense. This approach can decrease the likelihood of missed melanomas and skin cancers while reducing the number of unnecessary biopsies for benign lesions. Nevisense serves as an objective tool that elevates the overall standard of clinical melanoma detection, as its accuracy is not contingent on the user's level of experience. Furthermore, Nevisense often surpasses the sensitivity of even seasoned clinicians, offering a promising solution for more accurate and efficient skin cancer diagnosis.
SciBase's Addressable Market for Melanoma Detection
SciBase has identified a substantial addressable market with the key estimates being the following:
In SciBase's addressable geographies, the company estimates that approximately 50 million formal melanoma screenings are conducted annually.
Of these screenings, SciBase estimates that at least 10-15 percent, or more than 7 million lesions, are deemed suspicious enough to warrant excision and examination for melanoma.
Additionally, SciBase believes there are approximately 1-2 million lesions that, while not suspicious enough for immediate excision or biopsy, are still of concern. These lesions could potentially contain melanomas and represent a significant market opportunity.
Combining the 7 million lesions currently excised with the additional 1-2 million lesions of concern, SciBase estimates the total addressable market potential for melanoma detection to be around $400 million USD per year, or approximately BSEK 3.7.
Of the seven million estimated annual excisions performed in SciBase’ s target markets around 86-97% are later found to be benign. Uncertainty in the detection of melanoma due to inexperience and limitations of visual screening methods leads physicians to excise many lesions ‘just in case’, as physicians do not want to risk missing a melanoma. Despite this over-excision as many as 13% of all melanomas are missed. The excision and biopsy of benign (harmless, i.e., not skin cancers) lesions due to uncertainty of visual screening methods is estimated to cost payers around USD 1.5 billion annually. SciBase estimates that Nevisense could reduce the number of benign lesion excisions by 34-50%.
Market estimate Non-melanoma skin cancer
The population of non-melanoma skin cancer patients includes more than ten times the number of patients compared to the melanoma patient population though the need for testing is not so acute.
SciBase estimates that the potential for the use of Nevisense amounts to at least 4 million examinations or tests annually. Given this, non-melanoma skin cancer is estimated to have a total market potential of approximately SEK 1.4 billion annually. Although non-melanoma skin cancer is less harmful than melanoma, SciBase sees the addition of the indication as important for users and necessary to increase market penetration, especially in Germany. Dermatologists see many times more patients with suspected non-melanoma skin cancer than with suspected melanoma, which means that the potential for performing tests with Nevisense is significantly increased.
US the largest market
The United States represents the single largest market in the world for melanoma detection. In total, there are approximately 6,500–7,000 private dermatology clinics in the US of which around 6,000 are likely relevant for SciBase. There are currently just over 20 larger practice groups on the American market, with an average of 40 clinics per group and the number is growing. The continued consolidation of individual independent dermatology practices or small groups into larger practice groups has been central to SciBase strategy and has enabled a relatively cost-effective introduction in the USA. The Company’s strategy also includes further developing existing networks of Key Opinion Leaders (KOLs) in the United States to spread knowledge and experience about Nevisense and help support the reimbursement process.
Skin barrier market
An exciting new application area is skin barrier assessment. The skin barrier stops irritants, allergens etc. entering, and water from leaving the body. An impaired skin barrier at birth can be a predictor of the development of Atopic Dermatitis (AD) or eczema. The development of AD often precedes the development of other atopic diseases such as food allergies, allergic rhinitis and allergic asthma. The ability to easily detect an impaired skin barrier can help detect, manage and treat atopic diseases before the development of AD. There is a high interest from the research community and this group is the short-term sales target within the barrier area.
In the application area of the skin’s barrier assessment, prediction of disease onset and improving the management of atopic dermatitis are considered to be the largest potential markets. The application area includes disease development prediction in infants, diagnostic and therapy selection tests in a clinical setting, and regular tests in the home in order to monitor and manage the disease. Furthermore, there are many areas within research where the ability to evaluate the skin barrier in a clinical environment or at home has significant value and potential. Given this, the total number of measurements for all patients with atopic dermatitis could potentially exceed the tens of millon per year. In the market estimates for skin barrier assessments, the Company expects lower electrode prices. Even so, and only based on two sub-groups (patients with chronic severe recurring eczema episodes and prediction of AD in infants) the total addressable market for the application area skin barrier function is estimated at approximately SEK 3 billion annually.