Oncoustics – 11 August

11 Aug 2020
 

Oncoustics

Oncoustics is creating and deploying advanced and patented AI solutions for low cost, non-invasive surveillance, diagnostics, and treatment monitoring of diseases with high unmet clinical need. They offer a suite of disease and anatomy-focused apps that work on any PoC ultrasound and can be used by any MD/Nurse/Tech as a basic primary care office instrument, without the need to look at images. 

Oncoustics’ will be able to replace or pre-screen for several high-end and expensive imaging exams and procedures like CT, MR-PDFF, and biopsy. On the screening side and for their first product, Oncoustics’ main competitor is the Fibroscan system, made by Echosense. The system has become a clinical standard in hepatology clinics for assessing fibrosis. Unlike Oncoustics’ solution, the Fibroscan is an expensive (>$60k with 10k yearly maintenance), bulky device that yields non-granulated diagnosis of Fibrosis on an indirect scale that is correlated to the fibrosis stage. Nonetheless, the Fibroscan has laid the path for Oncoustics’ product adoption into hepatology, setting the stage for non-imaging ultrasound outside of radiology. Via the Fibroscan devices, clinicians have reimbursement codes (CTP codes) for a fee for services practices and government reimbursements. Having been introduced in the mid-2010s, there are 1200 Firbroscan units in the USA alone. 

Other commercial endeavors in the ultrasound machine learning space either focus on a single device, use AI to augment the acquisition process, or use traditional (and limited) images instead of RF signal. Because Oncoustics’ product has such a low upfront cost and no learning curve, unlike Fibroscan and other diagnostics modalities, they plan to expand beyond radiology and hepatology and will begin pipeline developments in endocrinology and so forth- with the end goal of being in the hands of every primary care clinician as the “stethoscope for the liver.”

 

Traction

Oncoustics has clinically-tested and deployed systems in 5 locations. They have approximately 2500 patients scanned for prostate and liver disease; that’s > 600,000 images and data points collected with a unique use of additional data streams for AI/ML biomarkers. The growth of their innovation has garnered partnerships with multiple OEMs and clinics as well as relationships with pharma partners and payers. They have IP protections in 2 issued and 2 newly filed patents. Currently, their Pre-sub is in progress and they have a regulatory path already mapped. 

Oncoustics uses a novel and innovative approach to address a huge unmet clinical need of point of care diagnosis, but the nature of their approach doesn’t have solid predicates and thus requires that they educate their partners and customers. Oncoustics plans to overcome this hurdle by providing high quality and frictionless service to their customers via a SaaS model with little to no upfront costs and expanding the market reach of their OEM partners.

 

 

Team

Ahmed El Kaffas, Ph.D., Founder – Ahmed is an Instructor at Stanford with awarded NIH grants and a lab focused on ultrasound technologies. He is equipped with well over 12+ years of experience in ultrasound,  image/signal processing, algorithm development, and cancer tissue characterization. 

Michael Weil, MD, Co-founder – Michael is a Board Certified Radiation Oncologist, a startup founder, author, and holder of 8 patents in medical devices, therapeutics, and medical processes.  

Beth Rogozinski, CXO – Beth is a serial entrepreneur with experience running several Biomedical startups. She had several exits including an IPO.

 
 

Funding

Oncoustics is currently looking to raise $11-15 million in series A funds. The purpose of the funding will allow them to not only continue their FDA application but bring their first product for detecting liver fibrosis to market which will also require funded resources to support their pipeline sales. Oncoustics’ series A milestones also include supporting their data acquisitions and having 3 additional products addressing liver disease complete and in progress of regulatory submission. 

Previously, Oncoustics had received $1.1 million in funding including additional and significant non-dilutive funding and in-kind clinical work. 

With their grand mission to transform inexpensive Point of Care Ultrasound devices into powerful diagnostic tools that provide resource-efficient care to various diseases, Oncoustics plans to expand their team to fulfill this mission. They will start off with the expansion of their product development and QA teams including adding data and AI experts to accelerate additional products in the liver and other anatomical regions. They’ll also bring on corporate development and regulatory experts to facilitate their go-to-market for their pipeline of products and commercial efforts.

 

Revenue Model

Oncoustics’ current business model is Software-As-A-Service, or SAAS. Through partnerships with the Ultrasound device companies, each device will come pre-packaged at an upfront service install fee of $5-10k dollars (that can be waived or amortized), with a per-use fee. This strategy will not require a big capital expenditure on the part of the clinic and falls well below most expenditures which have to go through budget committee reviews. Clinics and clinicians have readily available CTP codes for reimbursements and Oncoustics’ costs are a fraction of what they’ll be able to make per screening exam. Agreements are already in place with OEMs for use of their devices in data acquisition, which will allow for a smooth transition to packaging Oncousic’s detection software alongside it. 

Oncoustics also has arrangements with various hospitals that use their software for data collection. Once the product is ready for use, Oncoustics will provide codes and clinician dashboards. They expect this process to be a seamless transition from research partners to paying customers as these prospects would already be familiar with Oncoustics, their solutions, and services.

The expectation is to submit their Fibrosis/Cirrhosis detection software to the FDA by the end of the year, allowing the first iteration of the product to be on the market by 2021. Once in use, Oncoustics expect NASH and cancer detection to begin a year after, followed by other soft tissue diseases.

 

Details

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