"The Histolix technology heralds a radically new approach to the preparation of the images required by pathologists to interpret biopsy specimens. Since its origins in the 19th century, pathology has been constrained by a laborious and time consuming process of fixation, dehydration, paraffinization, rehydration and staining requiring skilled technologists and expensive equipment. Histolix technology promises to dramatically reduce the time required to prepare these images, and simultaneously permit a direct-to-digital pathologic evaluation framework, enabling pathology to emulate radiology in rapid evaluation and dissemination of biopsy findings. Histolix makes preparation of digital images suitable for pathologic evaluation accessible to a wide range of users, including satellite lab facilities, veterinary laboratories, and resource constrained laboratories all over the world."
Histolix has raised $1M in SAFE funding and has completed its initial equivalency validation trial which demonstrated an FDA level of performance (under 4% discordance) as a primary diagnostic tool.* With a blinded study of 100 tissues and 22 tissue types with four third party expert readers, Histolix demonstrated its under 5 minute direct to digital imaging equivalence to standardized H&E diagnosis which takes days to weeks to complete. Histolix is now raising up to $15M in its Series A round, the funds of which will be used to finalize FDA trials in preparation for commercial launch.
* Click here to see Med Archives Publication. FDA trials will commence 2023.
Histolix Founders Receives $1.9 million in grants to initiate Histolix technology
First Histolix prototype completed at UC Davis
UC Davis Patents Filed and Histolix Incorporated
Histolix Board and Executive Team Expansion (Q1)
Rob Royea appointed as CEO (Q1)
Oran Muduroglu appointed as Chairman of the Board (Q1)
First Histolix Funds raised (Q2)
Ben Weiss, Lead Investor joins Board (Q2)
Equivalency Validation Trail (EVT) Initiates (Q2)
First Histolix office opens in Sacramento, CA (Q2)
Fourth generation Histolix prototype completed (Q3)
Dr. Allen Gown, internationally recognized pathologist joins as advisor (Q3)
3rd Party Expert Evaluation of EVT concludes (Q4)
Commercial and AI diagnostic company collaboration begins
Multiple clinical trial protocols are completed for Histolix installation in Interventional Radiology Suites
ROSE and Lumpectomy trial approvals completed
Commercial development collaboration begins
Series A Round Opens
ROSE & Lumpectomy FDA Trials Initiate
Corporate collaboration for distribution completed
Hand off to commercial manufacturing completed