Blackwerx Inc

Digital Biomarkers for Rare Diseases

About Blackwerx Inc

Blackwerx is a digital diagnostic startup focused on disrupting the diagnostic journey for patients with rare and complex diseases by developing imaging biomarkers for indications within neurology and oncology. Our platform distills unique insights from existing imaging modalities to allow for the early diagnosis and enhanced monitoring of severe diseases. The software was used in over 4,000 patients and in multiple phase 3/4 clinical trials. We are preparing to seek regulatory approval for our first indication, which assists clinicians in differentiating multiple sclerosis from neuromyelitis optical spectrum disorder. Our tool demonstrated a superior sensitivity as compared to the gold-standard blood-based assay.


Problem statement

For many diseases within neurology and oncology, clinicians, payers, and drug developers lack quantifiable tools to accurately diagnose, monitor, and treat disease. Patients with rare diseases will wait, on average, five years before they receive an accurate diagnosis, with 30% of patients waiting over a decade. For multiple sclerosis, as many as 18% of patients may actually be misdiagnosed. These incorrectly diagnosed patients maintain the incorrect diagnosis for over 3 years resulting in $41k of unnecessary costs. Drug development companies also suffer from the lack of highly sensitive and specific tools. For the rare disease neuromyelitis optica spectrum disorder (NMOSD), there are three FDA-approved therapeutics. These drugs generate as much as $640k per patient, per year. However, the gold standard for the diagnosis of NMOSD is an antibody that recognizes as little as 50% of the population, leaving the remainder of patients without access to therapy and representing a large inaccessible market.

Traction information

Before the formation of Blackwerx, our Texture technology was licensed by three manufacturers, which resulted in approximately $4 million in revenue and has been used in over 4,000 patients for diseases throughout oncology and neurology including multiple sclerosis, NMOSD, Alzheimer's, Glioblastoma, and breast cancer. We are currently engaged in discussions with two drug makers regarding collaboration agreements for our neuromyelitis optica spectrum disorder diagnostic. Furthermore, we have 4 pending patents and 1 issued patent, and our neuroimaging NMOSD biomarker pilot study, which involved 177 individuals, has been accepted for publication in the Journal of Neuroimaging on September 20, 2022. We were also the winners of the Medical device category at the UT Southwestern Pitch Competition, earning a prize of $50,000. Additionally, we have been accepted into the MassChallenge Early Stage Accelerator program.


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