ExThera Medical Gains MDSAP Certification, ISO 13485 Recertification

ExThera Medical Corporation has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.

“Receiving certification from these organizations demonstrates ExThera’s commitment to regulatory and quality standards that not only healthcare providers and patients require but is also an important milestone in our global development strategy,” said Sallie Coviello, Head of Quality and chief operating officer at ExThera. “With these approvals, ExThera is well-positioned to move forward with its plans toward global commercialization.”

MDSAP certification confirms the comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers that want to sell products in the United States (U.S. Food and Drug Administration), Canada (Health Canada), Japan (Ministry of Health, Labor and Welfare), Australia (Therapeutic Goods Association), and Brazil (ANVISA). MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies. The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

As a company in extracorporeal therapies to remove pathogens and circulating tumor cells from the blood, achieving these regulatory and quality standards is paramount for success. “We continue to make rapid progress in our efforts to bring life-saving extracorporeal products to the market, with both our Seraph 100 Microbind Affinity Blood Filter (Seraph 100) for pathogen removal, and OncoBind Cancer Procedure,” ExThera Medical Founder/CEO Robert Ward, Ph.D. 
 
To date, the Seraph 100 has received both Medical Device Designation (MDD) CE Mark certification in the European Union, and FDA Emergency Use Authorization (EUA) to treat COVID-19 in the United States and Canada. Over the summer, ExThera also announced FDA approval of a recently submitted Investigational Device Exemption (IDE) application for its OncoBind Procedure to remove metastatic pancreatic cancer cells from blood.

As a patient’s blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph 100 Microbind Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the United States, the European Union, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100 attained CE Mark and is commercially available in the EU. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treating COVID-19.