SurgiVance is developing a point of care Surgical Pathology Solution, effectively a histopathology “lab in a box” for pathology markets including specialty surgery.

• Our new biospecimen processing platform will enable improved diagnosis in dermatology, surgical, and pathology specialties.
• Mohs Surgery, our beachhead market, demands accurate margin status + rapid pathology.
• Our technology addresses the global dermatology device $5.7B market.

There are 5.4 million new cases of skin cancer per year in the USA, with an associated 25 million biopsies, each taking 7-10 business days to yield a diagnosis. The major limitation is limited access to rapid histopathology for Mohs surgeons and dermatologists. SurgiVance takes 17 seconds to scan a typical specimen, which is faster than the 30minutes-2weeks for the current standard of care, and enables instant, 3D, digital pathology AI analysis.

• Geographic: We will create a direct sales force, leveraging proximity to cities of Mohs surgeons. We will partner for international distribution.
• Psychographic: Our customers, Mohs Surgeons, will offer shorter turnaround times and enhanced patient experience, driving demand.

• Our target customers are the 2.2K Mohs surgeons in the US, a beachhead clientele of early-adopters in a key position to validate the technology. 

• This validation will facilitate rapid takeover of the general dermatology market, with 19K US general practice dermatologists, and all pathology markets.

• Patented hardware (the only solid-state confocal microscope) and software (AI diagnostic and interpretation) enable the only rapid surgical pathology solution that looks and feels like standard histopathology.

• Competitors suffer the need to re-train the physician where SurgiVance technology allows the physician to utilize our 3D surgical pathology solution that improves workflow on day one. 

Providers excising tissue specimens buy a SurgiVance imager and pay for supplies and services to achieve rapid bedside pathology. Potential revenue streams include:

• 1-time capital equipment purchase of imager
• Disposable tissue compression chambers
• Supply of tissue-staining solution
• Per-click fee for digital staining and analytics

In our beachhead market, Mohs surgery, there are 2,000 physician surgeons in the U.S. in which a direct sales force can be deployed initially in major metropolitan centers.  We will look to license the technology to companies that market outside the U.S. As SurgiVance expands outside of Mohs surgery to other solid tumor types, our strategy will be to license the technology.

The existing alternative is the standard histopathology, which is comparatively slow and cumbersome. Novel UV LED imaging by MUSE Microscopy Inc. is non-confocal (therefore not 3D), offering limited performance in highly scattering tissue like skin. Point-scanning confocal microscopy devices by Caliber ID Inc. and Samantree require more re-training to use, are less stable, are mechanically complex, and more expensive.