ProciseDx Announces $13 Million Convertible Note Financing and Strong International Growth

SAN DIEGO, July 13, 2021 /PRNewswire/ -- ProciseDx Inc. announces a $13 million convertible note financing to support international commercialization of the ProciseDx platform and US regulatory approval. Participants in the financing round included existing major shareholders (Nestlé Heath Science, Biosynex SA) management and new investors.

The ProciseDx instrument is about the size of a shoe box and can provide diagnostics results in as little as 2 minutes from a finger prick drop of blood.

ProciseDx in San Diego, CA is producing point-of-care diagnostics which provide easy, immediate and accurate results.

"We're investing to bring the ProciseDx Point-of-Care platform to the US market and to accelerate international growth." said President and CFO, Peter Westlake, "This funding round enables us to move forward with FDA submissions for the platform and to expand our test menu for gastroenterologists."

ProciseDx has obtained CE Mark on its instrument and on four gastroenterology (GI) assays which were launched in Q3 2020. ProciseDx has established distribution relationships in more than 15 countries in Europe, Middle East and Africa (EMEA) and expects to continue its market expansion for the rest of 2021. These relationships are driving rapid growth. Already over 100 instruments have been shipped to EMEA and further growth is expected in the second half of 2021. The company expects revenues of between $2 million and $3 million for 2021.

ProciseDx has submitted a 510k application to the FDA for its instrument and Procise CRP assay.  Further submissions for additional assays are expected in 2021 and will create a compelling menu for GI's in the US.

"The ProciseDx platform has been generating impressive data in Europe and the US," noted Dr. Larry Mimms, CEO and CSO. 

So far this year, there have been three publications in ChemRxiv on the performance of ProciseDx assays for C-Reactive Protein (Procise CRP), fecal calprotectin (Procise FCP), therapeutic drug monitoring of infliximab /Remicade (Procise IFX) and adalimumab /Humira (Procise ADL).  Five scientific posters on ProciseDx assay performance were presented at the European Crohn's and Colitis Organization meeting in July.   

"ProciseDx is building a reputation for changing the course of medical care by delivering high quality results in less than 5 minutes," concluded Dr. Mimms.

About ProciseDx Inc.

ProciseDx is an in vitro diagnostics (IVD) company developing a broad portfolio of rapid diagnostic tests for the physician's office. Founded by experienced IVD specialists with a track record of successfully launching innovative Point of Care platforms, ProciseDx tests have a turn-around time of only 2-5 minutes and are easy, quantitative and accurate. ProciseDx tests use a finger prick blood sample or a stool sample and ProciseDx's first menu is focused on GI physicians (gastroenterologists).

ProciseDx occupies 30,000 sq. ft. of laboratory, manufacturing and office space in San Diego, California. ProciseDx is ISO13485 certified.

For more information about ProciseDx, please visit us at www.procisedx.com.

About Biosynex

Founded in 2005 and based in Illkirch-Graffenstaden in Alsace, a major player in public health with more than 225 employees, the French laboratory Biosynex designs, manufactures and distributes Rapid Diagnostic Tests (TDRs). In their professional version, they offer better medical care of patients thanks to the speed of their result and their simplicity of use. In their self-test version, they allow patients to self-monitor various pathologies thus ensuring better prevention and accelerating the demand for care.  Biosynex is the leader in the TDR market in France and is the only player to fully control its value chain thanks to its technology platform, which can be used in a variety of applications and is adapted to different types of users such as laboratories, hospitals, doctors and the general public.

About Nestlé Health Science (NHSc)  

Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé.  We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 7,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com  

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