ProciseDx Inc. has raised $10.5m through $8.5m of equity and $2m of debt, to fund ongoing development and commercialization of its point-of-care (POC) diagnostic platform. The investment round was led by Biosynex, S.A., a French diagnostics company, and included management and private investors.

Biosynex will now own 37% and will join the board. Nestlé Health Science, which previously owned 100% of ProciseDx, remains an active supporter and significant minority shareholder. CoView Capital, Inc. and, their life science consultants, The Channel Group, acted as advisors to ProciseDx.

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 that have successfully launched innovative POC platforms worldwide, ProciseDx is developing and commercializing POC tests with a turn-around time of only 2-5 minutes that are easy, immediate and accurate. These tests use finger prick blood or stool samples and ProciseDx’s first menu is focused on GI physicians (gastroenterologists) and includes inflammatory and drug monitoring tests.

The investment from Biosynex, a leader in European POC diagnostics in infectious disease and women’s health, reinforces a relationship established in May 2020, when Biosynex became the distribution partner for ProciseDx gastrointestinal diagnostics in France.

“We are delighted with this significant investment from our European partner, Biosynex. This is an important synergistic and strategic transaction that will help us generate immediate revenues, scale up instrument production, launch our products internationally and fund our US clinical trials,” said Larry Mimms CEO and Chief Scientific Officer of ProciseDx.

Larry Abensur, CEO, Biosynex, commented “We are pleased to make this investment in ProciseDx which adds capability of quantitative rapid instrument based immunoassays to our strong portfolio of lateral flow tests marketed in France and Europe. Our partnership with ProciseDx will also accelerate our commercial development in the US for some of our key products, thanks to the tremendous experience of the ProciseDx team and their track record of FDA approvals.”

In addition to the investment and European distribution relationship, ProciseDx will serve as the US FDA agent and US distributor for the Biosynex COVID-19 BSS Antibody test for which an Emergency use Authorization (EUA) file has been submitted. On behalf of Biosynex, ProciseDx has initiated clinical trials to obtain a finger prick blood claim. The Biosynex test is a highly sensitive and highly specific 10-minute blood test detecting anti-SARS Cov-2 antibodies to the viral spike protein.

“These strategic investments are critical in our evolution from a technology company to a commercial operation. Our diagnostic technology platform has significant international potential and ProciseDx will be launching in France, Switzerland, Italy and Spain in Q3 2020. We look forward to realizing ProciseDx’s potential, with support from Biosynex,” said Peter Westlake, President and CFO of ProciseDx.

ProciseDx’s launch menu includes Therapeutic Drug Monitoring of Infliximab and Adalimumab as well as CRP, each test from fingerstick whole blood. ProciseDx will also offer a Fecal Calprotectin assay with simple and reliable sample collection. All ProciseDx assays run on the same instrument in less than 5 minutes with very easy workflow. ProciseDx believes that real-time measurement of Infliximab and Adalimumab will dramatically improve the monitoring of IBD patients under biotherapy and will generate significant drug cost savings.

ProciseDx is also pleased to announce that Dr. Magda Marquet will serve as ProciseDx Board Chair. Dr Marquet has a distinguished career as co-founder of Althea Technologies in San Diego and is an investor, scientist, entrepreneur and board member of a number of biotech companies. She also serves on the California governor’s select advisory committee to address the COVID crisis. “Dr. Marquet has been advising us for the last year and we’re very happy that she has agreed to help guide ProciseDx through this exciting next phase of international commercialization,” said Mimms.

About ProciseDx Inc.

ProciseDx is a diagnostics company committed to the development and commercialization of a broad portfolio of point-of-care diagnostic tests for use in physician offices, retail clinics and urgent care. ProciseDx currently has 25 employees, 30,000 sq. ft. of laboratory, manufacturing and office space and is ISO13485 certified. ProciseDx is headquartered in San Diego, California.

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

About Biosynex

Founded in 2005 and based in Illkirch-Graffenstaden in Alsace, a major player in public health with more than 180 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-monitoring 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 Nestle Health Science

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow.

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