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Cleveland Diagnostics Closes $75M Private Financing

NEW YORK — Cleveland Diagnostics said Wednesday that it has closed $75 million in a private financing.

The company said it plans to use the funds to support development and commercialization of its portfolio of cancer early detection tests, including its lead product, the IsoPSA test for prostate cancer.

The financing was led by Novo Holdings with participation from existing investors as well as a credit facility from Symbiotic Capital. It follows a $19.4 million Series D round the company closed in 2021.

The IsoPSA test measures the levels of different protein isoforms in patient samples to assess an individual's risk of having prostate cancer and is intended to aid doctors in making decisions about whether to perform a biopsy. The test received breakthrough device designation from the US Food and Drug Administration in 2019 and is currently available from Cleveland Diagnostics as a laboratory-developed test.

The IsoPSA test is based on Cleveland Diagnostics' Solvent Interaction Analysis (SIA) technology, which detects disease by looking at the behavior of different protein isoforms in two-phase aqueous solutions. The company is now looking to apply the technology to other areas including breast and lung cancer.

"We believe that IsoPSA has the potential to improve treatment, reduce costs, and increase quality of life for patients who may have prostate cancer," Noel Jee, partner on the growth investments team at Novo Holdings, said in a statement. "The company’s differentiated blood-based approach presents an opportunity to further improve diagnostics for other cancers and diseases."

Concurrent with the financing, Jee is joining Cleveland Diagnostics' board of directors.

"We are pleased to have secured this growth capital and support from a mix of new and existing investors, exhibiting their confidence in our company’s growth potential and our ability to execute financial discipline as we anticipate increased test utilization and achievements of key clinical and regulatory milestones in 2024," Cleveland Diagnostic Cofounder and CEO Arnon Chait said in a statement. "These funds provide Cleveland Diagnostics the capital and flexibility to advance our portfolio of noninvasive tests as demonstrated by the rapidly increasing demand for our IsoPSA prostate cancer test."