NEW YORK ─ ProciseDx on Tuesday announced it has closed a $13 million convertible note financing to support the commercialization of its ProciseDx platform and US regulatory approval.
Current shareholders Nestlé Heath Science and French diagnostics firm Biosynex participated in the financing round along with new investors.
The firm's point-of-care platform is based on time-resolved measurement of fluorescence with fluorescence resonance energy transfer technology. Using fingerstick blood or a stool sample, its tests have a turnaround time of between two and five minutes, ProciseDx said.
"We're investing to bring the ProciseDx point-of-care platform to the US market and to accelerate international growth," Peter Westlake, the firm's president and CFO, said in a statement. The financing round enables it to move forward with US Food and Drug Administration submissions for its point-of-care platform and expand its test menu for gastroenterologists, he said.
ProciseDx, which has a 30,000-square-foot laboratory, manufacturing, and office space in San Diego, has submitted a 510(k) application to the FDA for its instrument and Procise c-reactive protein assay. Further submissions for additional gastrointestinal assays are expected in 2021.
The company has obtained the CE mark for its instrument and four gastroenterology assays, which it launched in the third quarter of 2020. It has shipped more than 100 instruments to the Europe, Middle East, and Africa, or EMEA, region and expects revenues of between $2 million and $3 million this year. ProciseDx said it has also established distribution relationships in more than 15 countries in the EMEA region and expects to continue its market expansion this year.
In February, the company announced it had obtained CE marking for its Procise FCP point-of-care test for inflammatory bowel disease, and last July it raised $10.5 million in a Series A financing round led by Biosynex.