NIA Small Business Showcase: Medical Care Corporation
Traditional approaches to assessing cognitive health are not sensitive enough to detect presymptomatic cognitive changes caused by emerging medical conditions like Alzheimer’s disease (AD). Because of this, clinical trial sponsors cannot identify suitable subjects to test new AD therapies, and physicians cannot intervene with current AD therapies in a timely manner prior to irreversible disease progression.
Medical Care Corporation (MCC) has applied sophisticated analytical methods to a proprietary dataset of more than 1 million subjects assessed with a standardized cognitive battery and, from this work, has developed digital cognitive biomarkers that quantify the unobservable processes of storage and retrieval that underlie learning and memory. In subjects with AD, these processes change in presymptomatic stages, prior to significant neurodegeneration. MCC has deployed an electronic system that uses a brief 10-minute cognitive assessment, automatically quantifies these processes, and enables pragmatic identification of potential AD trial candidates and AD patients who might benefit from timely treatment.
Approximately 200 annual AD trials at FDA are increasingly recruiting asymptomatic candidates and experiencing high screen fail rates in the enrollment process. MCC’s technology can efficiently qualify subjects with subtle cognitive changes who are more likely to “screen pass,” thereby reducing trial costs and accelerating drug development timelines. Reducing screen fail rates from the current range of about 80% to MCC’s demonstrated range of 57% would reduce the estimated cost of enrolling a single 2,000-subject trial by more than $50 million. MCC estimates a $2.6 billion market opportunity from clinical trials in the United States alone.
MCC’s competitive advantage is built upon the company’s massive proprietary database, algorithms for extracting signals from standard cognitive assessment protocols, and six patents protecting novel applications of those algorithms in various health and research settings. The company’s digital cognitive biomarkers are more accurate than traditional cognitive assessment batteries, less invasive than physical biomarkers, and infinitely scalable with high margins.
Company Milestones
Scientific
- 2005: Launched electronic system with 10-minute assessment that distinguishes “normal aging” from “mild cognitive impairment” with 97% accuracy. Published validation study in Proceedings of the National Academy of Sciences
- 2015: One-millionth assessment completed by clients, establishing a massive, one-of-a-kind database for ongoing research and development (R&D) in the cognitive health field
- 2019: Received sixth patent, covering application of proprietary algorithms to particular cognitive health challenges
Business
- 2007: Signed $1.5 million licensing deal making the 10-minute cognitive assessment available to the long-term care insurance field
- 2015: MCC’s cognitive assessment technology adopted into Japan’s National Dementia Prevention Program
- 2018: Signed marketing and distribution agreement with Hoag Hospital to co-market cognitive assessment technology in the clinical care channel. Completed 50,000th clinical assessment on MCC’s platform.
Financial Overview
MCC has raised approximately $6.5 million in debt ($500,000) and equity ($6 million). One strategic investor contributed $500,000 of the equity; certified individual investors and one small venture fund contributed the remaining $5.5 million.
The company anticipates that approximately $5 million more will be required to establish meaningful adoption of its methods in the drug development space. Once established there, cash flow from those operations would fund further expansion into clinical and insurance channels. MCC is optimistic that a portion of future funding may come from grants, including a recently scored NIH application that may be funded in the near term.
Intellectual Property
MCC has collected item-level responses to a battery of six well-validated neuropsychological assessments on more than 1 million subjects. The data, which include subjects spanning the adult human life cycle as well as demographics (education, gender, race), form a proprietary R&D dataset that is unrivaled in this field. Using this dataset, MCC has developed multiple proprietary algorithms for quantifying specific cognitive processes, and the company has received six patents for applying those algorithms to specific scenarios in the brain health field.
Product Development and Regulatory Strategy
One of the commercial strengths of MCC’s technological approach is that its products do not require regulatory approval, as MCC merely provides additional analysis of data that is already collected using widely adopted and well-validated instruments. MCC’s product development strategy is to expand from detection of “abnormal” signals in the underlying cognitive processes of memory and learning to classification of those signals into diagnostic categories. The company’s massive proprietary database and expanding capabilities in machine learning and AI will enable such diagnostic classification and facilitate entry into a broader set of commercial markets. MCC also intends to migrate its electronic assessment system onto a mobile platform and incorporate voice recognition capabilities to make its technologies available in a “self-assessment” form.
Commercialization Strategy
MCC’s client universe consists of a relatively small set of drug developers who attend the same conferences, read the same journals, and contract with the same clinical research organizations. MCC is well-introduced into this research ecosystem, regularly presents new research at industry events, and has direct relationships with many of our potential clients. In 2021, MCC will launch an academic initiative making the system freely available to the academic research community. The company will also publish normative values for all of the parameters that MCC’s models generate in order to provide context for interpreting each parameter in any given study. This will increase research adoption, raise visibility, and contribute to even stronger validation of MCC’s ability to precisely characterize cognitive health.
Company Details
Medical Care Corporation website
Newport Beach, CA
Industry: Digital Health
Management Team:
- Chief Executive Officer: Dennis Fortier, M.A., M.B.A.
- Chief Medical Officer: William Shankle, M.D., M.S.
- Chief Scientific Officer: Junko Hara, Ph.D.
- Chief Technology Officer: Tushar Mangrola, M.S.
Point of Contact:
Dennis Fortier
Email Dennis Fortier
(949) 637-6407
Showcase selected for: RESI Boston