Pathware — Providing Patients With Point-Of-Care Diagnostics
A real-time tissue imaging and diagnostic platform to standardize sample collection quality control
The Problem
One in five biopsies fail to make a diagnosis, resulting in thousands of procedures being repeated at a direct expense to the hospital. While there is a manual technique to verify sample quality, its implementation is limited because it requires on-site pathology services. This requirement is impossible for the vast majority of hospitals who physically ship their samples to off-site pathology services like Quest and Lab Corp. This failure of our modern diagnostic workflow results in thousands of patients left in limbo as they wonder what might be happening inside their bodies.
What The Company Does
Pathware is creating a digital link between the lab and the bedside with point-of-care, whole-slide imaging. Their system will immediately image and verify that a sample is of diagnostic quality to eliminate the risk of repeated procedures. The digital image is then transmitted to the offsite pathologist for remote interpretation services. Pathware plans to iteratively add software enhancements to highlight key regions of interest, recommend ancillary testing, generate preliminary reports, and ultimately recommend treatment regimens based on a given patient’s cytological profile. The company’s ultimate goal is to achieve same-day diagnostics to give patients the peace of mind that they deserve.
Market
Pathware’s initial market is targeting biopsy sample quality. Based on current biopsy volumes in the U.S., this presents a $2B recurring revenue opportunity. The company’s platform is specifically designed to image a wide range of sample types and seamlessly expand into adjacent markets such as hematology ($5.4B), urine cytology ($1.6B), and veterinary samples ($1.5B). Pathware is ultimately positioning its system to serve as the first checkpoint that all samples must pass through, enabling them to capture the majority share of a $22.9B total market opportunity.
Business Model
Every sample processed by Pathware’s system generates new reimbursement revenue for client institutions that otherwise would be left on the table. Pathware makes money by sharing this new reimbursement revenue with monthly billing based on the hardware’s utilization. Pathware will generate additional revenue by expanding its platform’s applications and working with third-party app developers to create an application marketplace built on their proprietary imaging technique.
Traction
Pathware got its start in accelerator programs such as NSF I-Corps, VentureWell, and Valley Venture Mentors. In 2019, the company received its first institutional financing from UnityPoint Health, an Iowa-based health system, who had firsthand experience with the challenges of the manual pathology workflows that are currently the gold standard. The company has since completed its first clinical study with Old Dominion Pathology and is currently drafting a multi-site trial with the FDA that will take place with support from Michigan Medicine, the University of Washington, and UnityPoint Health. The Pathware team was also nationally recognized as the number one medtech company at South-By-Southwest.
Founding Team Background
CEO Michael Moore has spent the last nine years building teams at for-profit and non-profit organizations to improve the accessibility, efficiency, and quality of diagnostic services. He left medical school at the University of Michigan in 2017 to co-found Pathware and grow it to where it is today. CTO Jaron Nix is a chemical engineer by training, but his skillset places him at the crossroads of graphic design, engineering, and team building. He is a three-time biotech founder that has participated in entrepreneurial training programs such as NSF I-Corps. He left his graduate-level economics program to co-found Pathware. Chief Product Officer Alan Michelich is a medical device professional who built out his skill set working in the R&D departments of Novo Nordisk and Boston Scientific. Thus far in his career, he has guided four medical devices through regulatory clearances in the U.S. and the EU.
What They Need Help With
The company is beginning to have discussions around its next funding round that it will use to clear the FDA and launch its product into their partner hospitals. Pathware would appreciate any introductions to VCs and family offices that support the development of hardware and software medical devices. Specifically, the company is looking for investors that have shown interest in machine learning, digital pathology, and point-of-care diagnostic systems. Connect with the Pathware team.
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