Cleveland Diagnostics Inc., a clinical-stage biotechnology company in Cleveland, has raised $75 million in "growth capital financing" to accelerate its commercial and corporate development goals, especially for its novel prostate cancer test.
The financing was led by Novo Holdings A/S, the London-based life sciences investor that manages the assets of the Novo Nordisk Foundation. Existing investors also participated in the funding round along with Symbiotic Capital, which contributed a credit facility.
The company that is developing next-generation diagnostic tests for the early detection of cancers declined to disclose the debt/equity mix of the financing "due to the terms of the funding," a public relations representative said in an emailed response.
The financing is expected to help Cleveland Diagnostics, formed in 2013 by Cleveland Clinic and Cleveland biotech company Analiza, to meet growing demand for its cancer tests and achieve key clinical and regulatory milestones in 2024, Arnon Chait, Cleveland Diagnostics' CEO and co-founder, said in a statement.
Cleveland Diagnostics also expects to expand its portfolio of cancer-related tests beyond prostate cancer in 2024, the company said.
"These funds provide Cleveland Diagnostics the capital and flexibility to advance our portfolio of non-invasive tests as demonstrated by the rapidly increasing demand for our IsoPSA prostate cancer test," Chait said.
IsoPSA is a blood test used to stratify a patient's risk of prostate cancer and aid in biopsy decisions for men identified at higher risk, based on results from conventional screening methods such as PSA testing. The protein-based test differentiates cancer from benign conditions, identifying cancer at its earliest stages and minimizing the costs of overdiagnosis and overtreatment, the company said.
In the United States, prostate cancer is the second-most common cancer in men. One in every eight men is expected to be diagnosed with prostate cancer in his lifetime. In 2023, about 288,000 new prostate cancer diagnoses were made, and more than 34,000 men died from prostate cancer, according to the American Cancer Society.
Proceeds from the recent fundraising will accelerate Cleveland Diagnostics' commercial strategy for IsoPSA, expand its infrastructure and research and development pipeline development, and broaden the geographic scope of the novel prostate cancer test.
Last year, Cleveland Diagnostics expanded its facility at Tyler Village in Cleveland's Goodrich-Kirtland Park neighborhood. And in 2021, the company raised $19.4 million for its prostate cancer test.
"We believe that IsoPSA has the potential to improve treatment, reduce costs and increase quality of life for patients who may have prostate cancer," said Noel Jee, growth investments partner at Novo Holdings US, in the statement.
In connection with the recent financing, Jee will join the Cleveland Diagnostics board.
