SafeMargin
Soteria Medical Solutions produces SafeMargin, the first device developed specifically to help surgeons determine tumor-free margins during head and neck cancer removal. It eliminates the inaccuracies and inefficiencies associated with currently available methods for determining cancer margins during surgery.
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The Problem
Head and Neck Cancer
Head and neck cancer encompasses tumors in the oral cavity, pharynx, larynx, and nasal sinuses, representing some of the most devastating forms of cancer. Worldwide, there are 1.1 million new cases and more than 350,000 deaths related to head and neck cancer reported annually.
The effects of head and neck cancer are profound, spanning physical, emotional, social, and economic challenges. Physically, patients may endure pain, functional impairment, and disfigurement resulting from the tumor itself, as well as from surgical, radiological, and chemotherapeutic treatments. Emotionally and psychologically, the condition can precipitate depression, anxiety, diminished self-esteem, and issues with body image, which may impair social interactions and lead to isolation.
The Solution
Impact of Positive Margins
Complete surgical resection is the preferred method for treating most types of head and neck cancer. During this process, surgeons aim to remove the entire tumor by excising tissue around its margins and conducting ‘frozen section analysis’—a technique where biopsies are examined during surgery to ensure cancer-free edges.
The objective is to achieve clean margins, as confirmed by a pathologist, indicating no residual cancer cells at the edges of the removed tissue. However, this method is time-intensive, prolongs surgery duration, and is susceptible to errors, such as mistakenly identifying margins as cancer-free when they contain cancer cells (‘positive margins’). The result is cancer remaining in the surgical site associated with treatment failure in up to 40% of cases. Patients face the risk of cancer recurrence, significantly lower survival rates, and the increased necessity for aggressive and often debilitating treatments like radiation and chemotherapy.
The Technology
SafeMargin
SafeMargin allows surgeons to analyze cancer margins during surgery in a fundamentally different way. The underlying process is quite complex, but essentially consists of shining a laser light on the tissue and looking at the character of the scattered light to determine the tissue type. Cancer and non-cancer tissue scatter light from the laser differently.
SafeMargin uses a specific type of light analysis, a form of Raman spectroscopy adapted to tissue sampling in the operating room and advanced artificial intelligence to classify the tissue. The analysis detects the differences in cancer and non-cancer tissue and allows the surgeon to map the cancer margins accurately and in real time. SafeMargin eliminates the difficulties associated with the standard practice of taking biopsies during surgery as described
above.
Value Proposition
A Wide Range of Benefits
Surgeons
Improved Outcomes
Shorter Operating Times
Hospitals
Improved Reimbursement
Reduced Costs
Patients
Less Cancer Recurrence
Live Longer, Less Pain
Investors
The Market
This market represents a substantial opportunity, with a total addressable market (TAM) valued at an impressive $45 billion, underscoring the extensive need and potential for innovative solutions. The serviceable addressable market (SAM) for SafeMargin is estimated at $1 billion. And our serviceable obtainable market (SOM) is projected at $32 million, highlighting the tangible opportunity SafeMargin has to capture market share.
Our Team
Michael Dunham, MD, FACS
Co-Founder and CEO
LSU School of Medicine
Jian Xu, PHD
Co-Founder and CTO
LSU College of Engineering
Jian Zhang, PhD
Co-Founder and CSO
LSU College of Engineering
SafeMargin will fundamentally change the way cancer surgery is performed.
The technology is safe, precise, and fast. Once developed for head and neck cancer, SafeMargin’s technology can be expanded to other forms of cancer including breast, lung, and colon. It represents substantial cost savings compared to current alternatives and will be lifesaving for many cancer patients.