Cleveland Diagnostics, Inc., a Cleveland, OH-based clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, closed a Series D round of $17.4m.
The round was led by LYFE Capital, with participation from existing investors including Cleveland Clinic and others. Following the close of the round, the company received a term sheet for a $2M convertible note, expected to close shortly.
Funds raised will be used to expand commercialization of IsoPSA—the company’s first diagnostic test, designed to enhance early detection of prostate cancer—as well as to expand internal infrastructure and operations to support platform development for other tests, including breast and lung cancer.
Led by Arnon Chait, CEO and co-founder, Cleveland is a commercial-stage diagnostics company developing lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level (as opposed to overall biomarker concentration in blood), providing direct insights regarding the protein origin on the cellular level, thus improving test specificity to the underlying disease process. Its portfolio of non-invasive cancer diagnostics will be expanding from prostate cancer to breast cancer and lung cancer, infectious diseases, and certain neurological diseases, such as Alzheimer’s disease.
In 2019, the company received FDA Breakthrough Device designation for its IsoPSA test, which has allowed the company to work more closely with FDA to ensure it obtains the appropriate regulatory approvals. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test (LDT) conducted through its high-complexity, CLIA-certified lab in Cleveland, Ohio. It is now expanding its operations and has begun to broaden test availability across the country.