Martinez, Calif. – January 10, 2020 – ExThera Medical has commenced commercial sales in the European Union (EU) of its revolutionary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) by establishing strategic distributors in Italy, Germany, and the Benelux countries.
In October, soon after receiving CE Mark approval in late July 2019, over 100 devices were shipped to Europe. The first post-CE Mark clinical treatment occurred in November 2019, with promising results. ExThera is now preparing for increased sales in anticipation of positive early results. “This is a monumental step in the company’s history” says Dr. Keith McCrea, Vice President Research & Development/CSO of ExThera Medical. “We look forward to more clinical results to be presented in upcoming medical congresses, in published case studies, and from our large company-sponsored Post Market Study”.
In 2019, ExThera established three new partnerships with TOP Medical, Burke & Burke, and Heinz Meise GmbH for exclusive distribution rights in Benelux, Italy and Germany, respectively. Agreements were signed shortly after ExThera’s CE Mark approval of Seraph 100 for the broad indication of pathogen reduction during bloodstream infections (BSI) in adjunction with antibiotic therapy.
With a shared interest in bringing breakthrough medical technology to patients in need, these commercial partners, TOP Medical, Burke & Burke and Heinz Meise GmbH have worked closely with ExThera to introduce a revolutionary therapy to address bloodstream infections, which affect over 1 million people in Europe every year.
The Seraph 100 blood filter provides a new option for treating bloodstream infections with its unique technology. Whereas, existing hemoperfusion devices remove only molecules, the Seraph 100 can also quickly lower the concentration of bacteria, viruses and fungi in whole blood. In pre-clinical and clinical testing, Seraph 100 was able to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance.
“We are excited to work with TOP Medical, Burke & Burke and Heinz Meise GmbH to bring Seraph to important EU countries. These organizations have long, established commitments to offering healthcare providers and patients quality options, and we’re happy to support their efforts to address a serious, global medical need,” commented Bob Ward, NAE President/CEO of ExThera Medical.
Headquartered in Maastricht, The Netherlands and founded in 2003, TOP Medical has a strong track record enabling new and breakthrough medical device technologies to enter the Benelux market to improve the quality of patient care. TOP Medical is ISO 13485:2016 certified.
Burke & Burke SpA is a private company established in 1967 with headquarters in Assago–Milan, and several regional offices throughout the country. They are a leader in ICU and NICU with a presence in all Italian hospitals and are recognized for their ability to introduce innovative Intensive Care products.
Heinz Meise GmbH Medizintechnik is based in Nordrheinwestfalen Germany and was established in 1983. The company, which is ISO 13485 certified, develops, manufactures and distributes sterile disposables and devices for acute dialysis, apheresis and transfusion medicine.
Additional distribution partnerships will be announced in 2020.
About the Seraph® 100 Microbind® Affinity Blood Filter
As a patient’s blood flows through the Seraph, it passes over spheres coated with molecular receptor sites that mimic the receptors on human cells that pathogens use when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface and are thereby reduced in concentration in the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells intact. The adsorption media is a flexible platform using chemically bound, immobilized heparin for its blood compatibility, and its unique capacity to bind a long list of pathogens.
About ExThera Medical
Based in Martinez, California, and in Vaals, The Netherlands, ExThera is a privately held medical device company developing innovative, single-use blood filters capable of capturing a broad range of bacteria, viruses, parasites, toxins or other harmful substances from whole blood. The company develops therapeutic products to treat patients in the hospital or clinic, during epidemics, or on the battlefield. Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has strong patent protection and a growing body of data from independent laboratory studies, from its participation in DARPA’s Dialysis-Like Therapeutics program and from a successful EU clinical trial.
Disclaimer: All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release. Seraph is not approved for use by the FDA.