Cleveland Diagnostics, Inc. Raises Over $19 Million in Financing

Company to Expand Infrastructure and R&D, and Broaden Availability of Its Novel IsoPSA® Prostate Cancer Test

CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that it has closed a Series D round of $17.4 million. 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.

Published studies from two, large multicenter prospective clinical trials conducted with well over 1,000 patients evaluated by clinician investigators from Cleveland Clinic and other leading hospitals and community clinics internationally and across the U.S. demonstrated that the non-invasive, blood-based IsoPSA test has significantly superior diagnostic accuracy when compared to traditional prostate specific antigen (PSA) tests in the detection of high-grade prostate cancer. In addition, a recently published economic study has demonstrated that IsoPSA can provide these benefits in a highly cost-effective manner. The combination of excellent clinical performance for patients with cost efficiency for payers is a cornerstone of the healthcare system, and IsoPSA meets both of these criteria to enable lasting commercial success.

In July 2020, Cleveland Diagnostics initiated commercial and clinical operations, offering IsoPSA on a limited basis through physicians in Cleveland Clinic’s Glickman Urological and Kidney Institute. Early results from an ongoing clinical utility study are highly promising, with IsoPSA leading to a significant reduction in unneeded prostate biopsies, providing the downstream benefits of avoiding patient discomfort and potential complications and significant cost savings associated with the avoidance of unnecessary biopsies. Cleveland Diagnostics is now expanding its operations and has begun to broaden test availability across the country.

“The clinical utility of traditional serum total PSA is limited by its relatively poor specificity for high grade disease,” said Eric A. Klein, M.D., Chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. “Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s risk of prostate cancer and decision to proceed with prostate biopsy. IsoPSA has the potential to substantially improve our ability to limit biopsy to those at highest risk of having a cancer that requires treatment and to avoid biopsy in those who do not. Our past experience in the published clinical studies of IsoPSA and, more recently, during the clinical launch of the test, have been very encouraging.”

“We are inspired by our clinical study results as well as early clinical utility data that indicate that IsoPSA could and will be a transformative tool in the diagnostic workflow of prostate cancer,” said Arnon Chait, Cleveland Diagnostics’ CEO and co-founder. “The current round of funding allows us to broaden access of this game-changing test into the hands of physicians, and expand our platform into other disease states. We are thrilled to be working alongside of LYFE Capital, an international venture fund with wide reach in the U.S. and abroad, to make this a reality.”

In 2019, Cleveland Diagnostics 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.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a commercial-stage diagnostics company developing highly efficacious, 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 better and more 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. Visit us at ClevelandDx.com and IsoPSA.com.

Cleveland Diagnostics, Inc.
Bob Rochelle
Phone: 216 432-2700, Ext. 2119
Bob.Rochelle@ClevelandDx.com