NIA Small Business Showcase: WellSIM Biomedical Technologies, Inc.

Alzheimer’s disease (AD) is the world’s most widespread neurodegenerative disorder and is a major global health concern as the population ages. More than 6 million Americans are suffering from AD, and this number is predicted to increase to approximately 14 million by 2050. Despite the severity of the disease, early diagnosis of AD is still challenging due to the low accuracy or high cost of neuropsychological tests and neuroimaging. Development of a precise, cost-effective technology for noninvasive early diagnosis and monitoring of AD before irreversible brain damage or mental decline is critical for timely intervention, symptomatic treatment, and improved patient function.

WellSIM has developed ExoDot, a platform that consists of an all-in-one microfluidic device, a sample-to-answer benchtop instrument, a validated composite biomarker panel, and a machine learning-enabled diagnostic model, for quantification of AD core biomarkers from plasma extracellular vesicles (EVs). With the advantages of good accuracy, high speed, low cost, and noninvasiveness, this platform could be used in conjunction with other diagnostic tools as an aid to detect AD and establish a clinical diagnosis.

According to the World Health Organization, an estimated 50 million people worldwide currently have dementia, and there are nearly 10 million new cases every year, 60% to 70% of which are Alzheimer’s disease. Driven by the rapidly aging population, the global market for AD is expected to reach $25 billion by 2027, with a compound annual growth rate of 17.5%. There is an urgent demand for technologies that can provide low-cost, noninvasive early diagnosis and monitoring of AD.

Compared with the detection of soluble protein biomarkers in blood, WellSIM’s EV-based approach can enrich neural cell-derived extracellular vesicles from plasma for more specific detection of AD biomarkers to improve the diagnostic accuracy. Moreover, WellSIM’s low-cost integrated system, which enables an automatic workflow, will allow broader screening of high-risk population at various clinical settings.

Company Milestones

Scientific

• 2019: Developed a novel platform for EV isolation, purification, and enrichment
• 2020: Applied its platform for on-site rapid and sensitive detection of SARS-CoV-2 viral antigens in the NIH Rapid Acceleration of Diagnostics (RADx) program
• 2021: Developed a highly sensitive assay for multiplex detection of EV surface markers
• 2022: Validated its technology for AD detection with clinical samples
• Q2 2023: Fabricate and optimize a fully integrated prototype system
• Q4 2023: Finish assessment of the clinical validity of the prototype system in AD diagnostics
• Q2 2024: Seek Section 510(k) approval of the device in AD diagnostics
• Q1 2025: Initiate product launch and mass production

Business

• 2019: Raised $250,000 through equity investment
• 2020: Joined Illumina Accelerator and received $200,000 in convertible notes
• 2020: Received $260,000 in research grants from the NIH RADx program in response to COVID-19
• 2021: Received $450,000 in research grants from the NIH Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs
• 2022: Received $2.4 million in research grants from the NIH SBIR/STTR programs
• 2023: Raise $5 million in Series A funding
• 2024: Raise $9 million in Series B funding

Financial Overview

To date, WellSIM has raised $250,000 from equity investment, $200,000 in convertible notes from venture capitals, and more than $3 million from NIH SBIR/STTR research grants. WellSIM is seeking approximately $5 million for clinical validation of AD diagnostic device and regulatory preparation in Q2 2023 and $9 million for Section 510(k) approval, product manufacturing, and sales in Q3 2024.

Intellectual Property

WellSIM has three granted patents and another three pending applications for the company’s EV isolation and molecular analysis methods. The company also has multiple provisional and Patent Cooperation Treaty applications covering its core technologies.

Product Development and Regulatory Strategy

WellSIM is currently developing an integrated system for its plasma EV-based AD biomarker detection. The company plans to apply for Section 510(k) approval after clinical validation of the platform, which is estimated to prepare for regulatory submission at the end of 2023. WellSIM will also seek breakthrough device designation to speed up the review of submission.

Commercialization Strategy

WellSIM intends to sell its high-speed, low-cost, and compact system to clinics and hospitals as an aid for AD detection in conjunction with other diagnostic tools (e.g., positron emission tomography [PET] imaging) to establish a clinical diagnosis. This prescreening approach will help reduce total AD diagnostic costs by more than 80%. The company will seek reimbursement coverage for the test from Medicare and private health insurers.

Company Details

WellSIM Biomedical Technologies, Inc. website
160 E. Tasman Drive
San Jose, CA 95134

Industry: Diagnostics

Management Team:

• Chief Executive Officer: Yuchao Chen
• Chief Scientific Officer: Fei Liu

Point of Contact:

Yuchao Chen
Email Yuchao Chen
814-777-8586