Business Wire

ExThera Medical Announces Completion of CE Mark Registration Trial Evaluating the Safety of Seraph® 100 Blood Filter

Del

ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced that it completed its CE Mark registration trial evaluating the safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph) in renal replacement therapy patients who developed bacteremia. The prospective, non-randomized study enrolled 15 patients across four trial sites in Germany and the final follow-up day for the last patient enrolled in the trial was June 7, 2018. ExThera Medical expects to move forward with the regulatory submission of CE Mark data in the European Union (EU) in the fourth quarter of 2018.

“The completion of the European trial represents an exciting step forward in our effort to make a simple, device-based treatment like Seraph, available for bloodstream infections,” said Bob Ward, CEO, ExThera Medical. “With the lack of effective antibiotics for many bloodstream infections and limited new anti-infectives in development, there is a significant unmet need for new approaches that can help treat drug-resistant infections, especially in patients at high risk like those undergoing dialysis.”

The primary outcome measure of the study is to demonstrate the safety of Seraph in a hemodialysis circuit assessed by rate of adverse events (time frame: 14 days). The secondary outcome measure is the reduction of bacteria in blood passed through the Seraph filter (time frame: 4 hours). In the study, patients on renal replacement therapy who developed bacteremia had the Seraph filter included in the dialysis circuit for 4 hours, with hourly monitoring. Patients were monitored for 14 days following treatment.

Interim safety and performance data from the trial was presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels and showed that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures. Final results from the trial are currently being analyzed and are expected to be available in October 2018. To date, there have been no device or treatment related adverse events reported during the trial.

“Our preclinical studies and the interim data from this study suggest that Seraph is well tolerated when used during dialysis as a treatment to quickly reduce the level of blood-borne pathogens in bacteremia patients,” said Kathleen White, VP and COO, ExThera Medical. “We look forward to analyzing the complete study results as we continue our work on making this novel device, that uses biomimetic adsorption media to treat bloodstream infections, available in Europe.”

The U.S. Food and Drug Administration granted Seraph inclusion in its Expedited Access Pathway (EAP) program. EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases.

About the Seraph ® Microbind ® Affinity Blood Filter

As a patient's blood flows through the Seraph Microbind Affinity Blood Filter, it passes over proprietary microspheres 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 proprietary surface and are thereby removed from the bloodstream without adding 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 binding capacity for pathogens.

Seraph may be configured with optional supplemental adsorbents to remove other toxins and evolved pathogens. For example, ‘Seraph 200’ adds endotoxin binding to Seraph 100, which may be useful in certain bloodstream infections that progress to endotoxemia. The Seraph filters have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory.

About ExThera Medical

Based in Martinez, Calif., ExThera Medical is a privately held medical device company developing innovative, single-use blood filters capable of capturing and removing 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, 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, in addition to its participation in DARPA’s Dialysis-Like Therapeutics program. For more information, visit www.extheramedical.com.

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.

Caution: The Seraph® Microbind® Affinity Blood Filter is currently undergoing clinical evaluation and is not available for commercial sale.

Contact information

ExThera Medical Contact:
George Pitarra
george@extheramedical.com
or
Media Contact:
Heather Linville
media@extheramedical.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Tory Burch Names Pierre-Yves Roussel Chief Executive Officer11.12.2018 21:26Pressemelding

Tory Burch, LLC, today announced it has named Pierre-Yves Roussel Chief Executive Officer, starting early 2019. A longtime LVMH executive, Mr. Roussel will be based out of Tory Burch’s New York headquarters; he will join and report to the Company’s board of directors. In partnership with Ms. Burch, he will lead and implement the company’s global strategy with a focus on operations. “There are very few leaders in the industry who have both a commercial track record and a deep admiration for the creative process. I respect what he has built at LVMH and value the way he thinks about business, luxury and the fashion industry as a whole. He also shares my belief in the importance of a culture-led company. We have a strong management team in place and Pierre-Yves is a natural fit as we continue to focus on long-term growth and global expansion,” said Tory Burch, who is currently Chief Executive Officer and will assume the role Executive Chairman and Chief Creative Officer. “I’m very excited

United Nations Climate Action Award Goes to Germany for the First Time11.12.2018 19:00Pressemelding

Within the context of the United Nations Framework Convention on Climate Change, two ProVeg projects were awarded the Momentum for Change Climate Action Award 2018 in the category Planetary Health. One of these is the health promotion project Aktion Pflanzen-Power, jointly initiated with BKK ProVita. ProVeg and its partner received the award for their work in schools. It marks the first time that this award has gone to Germany. The award ceremony took place yesterday in the Polish city of Katowice as part of the 24th UN Climate Change Conference. ProVeg and BKK ProVita promote children’s health and climate action Aktion Pflanzen-Power aims to improve the availability and quality of vegan and vegetarian dishes in schools. Together with BKK ProVita, ProVeg has so far reached 24,800 students at 41 schools throughout Germany on the subject of wholesome, plant-based nutrition as part of the health promotion project. Healthy nutrition with Aktion Pflanzen-Power Andreas Schöfbeck, member of t

Thales and Gemalto are granted regulatory clearance by the European Commission11.12.2018 17:01Pressemelding

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto announce today that they have been granted merger control Regulatory Clearance by the European Commission, following Thales’s commitment to divest its general purpose hardware security modules (GP HSM) business globally1 to a suitable purchaser. This clearance is effective immediately. Together with the merger control clearances obtained in China, Israel, South Africa and Turkey, and clearances relating to f

Starr Insurance Companies Expands Aviation Insurance Operations to Brazil11.12.2018 15:43Pressemelding

Starr Insurance Companies today announced that Starr International Brasil Seguradora S.A. (“Starr Brazil”) has been granted a local license to offer aviation insurance. “We are thrilled to be adding aviation capability in an important, growing economy like Brazil,” stated Steve Blakey, president and chief executive officer for Starr Insurance Holdings, Inc. “As a worldwide leader in aviation insurance solutions, we are constantly seeking new opportunities and markets to meet the growing needs of the aviation and aerospace industry around the globe.” Fernanda Strachino, aviation specialist underwriter, has joined Starr Brazil to head the new aviation division. Fernanda brings more than 16 years’ of experience in the aviation and insurance market. Starr Brazil will offer a variety of aviation coverages, including: Aircraft Hull & Liability; Spare Parts; Third-Party Legal Liability; Corporate Non-Owned Aircraft Liability; General Liability; RETA Insurance (Mandatory Liability), Hangarkeep

Andersen Global Continues Growth in United Kingdom With Claritas Tax Limited11.12.2018 14:30Pressemelding

Today, Andersen Global expanded its reach in the United Kingdom with the addition of Claritas Tax Limited, a tax advisory and compliance services firm based in Birmingham, the second largest city in the country. Claritas is the fourth firm collaborating with Andersen Global in the UK. “Adding a sought-after firm like Claritas is not only a logical extension for Andersen Global, but it broadens our offering in the UK. Their practice focuses on corporation tax, R&D tax reliefs, mergers and acquisitions, private equity and venture capital in addition to serving individuals,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “Iain Wright and his team enhance our already robust core competences in the UK, a critical market for our clients, and we look forward to working with Claritas on a number of upcoming corporate opportunities.” Founded in 2012, Claritas Tax Limited is an advisory led business that provides a full range of tax advisory and compliance services to entr

Seoul Semiconductor Wins Patent Litigation against Everlight in Germany and Is Awarded Statutory Litigation Costs11.12.2018 14:00Pressemelding

Seoul Semiconductor Co., Ltd. (KOSDAQ:046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it won a patent litigation against Everlight Electronics Co., Ltd. (“Everlight”) in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005233/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) The patent involved in this litigation relates to an LED package structure for thermal dissipation. Everlight purchased this patent from a U.S. company in 2017, and subsequently brought a patent lawsuit against Seoul in the Manheim Court of Germany. In December 2018, however, the Manheim Court ruled in favor of Seoul and ordered that Everlight, as the losing party, should bear the statutory costs of the court proceeding. In the United Kingdom, Seoul had already won a patent litigation against Everlight earlier this year. At that time, the UK Patent Court also ordered that Ever