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

Manchester United and True Religion Launch Denim Range19.10.2018 17:37Pressemelding

Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion

Arch Insurance Announces Strategic Leadership Changes19.10.2018 13:10Pressemelding

Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These

Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 12:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 11:54Pressemelding

Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr

Schlumberger Announces Third-Quarter 2018 Results19.10.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the third quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2018 Jun. 30, 2018 Sept. 30, 2017 Sequential Year-on-year Revenue $8,504 $8,303 $7,905 2% 8% Pretax operating income $1,152 $1,094 $1,059 5% 9% Pretax operating margin 13.5% 13.2% 13.4% 36 bps 15 bps Net income - GAAP basis $644 $430 $545 50% 18% Net income, excluding charges & credits* $644 $594 $581 8% 11% Diluted EPS - GAAP basis $0.46 $0.31 $0.39 48% 18% Diluted EPS, excluding charges & credits* $0.46 $0.43 $0.42 7% 10% North America revenue $3,189 $3,139 $2,602 2% 23% International revenue $5,215 $5,065 $5,147 3% 1% North America revenue, excluding Cameron $2,572 $2,546 $2,086 1% 23% International revenue, excluding Cameron $4,559 $4,387 $4,430 4% 3% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commented, “Our third

Tradeshift Announces Q3 2018 Results19.10.2018 11:00Pressemelding

Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the third quarter of 2018, marking the tenth quarter in a row of successive growth and beating targets. Tradeshift’s third quarter growth stats announced today include: YoY revenue grew 400 percent (trailing 12 months) YoY new bookings grew 284 percent YoY gross merchandise volume (GMV) grew 262 percent New total contract value grew by $47M in Q3 Tradeshift’s customer roster continued strong growth this quarter adding 27 new customers, including Hertz, Shiseido, ECU, and Fortune 500 leaders in retail apparel, agriculture, engineering and construction, hospitality, travel and food delivery. Tradeshift also expanded its app ecosystem by adding a key partnership with Coface, a global credit insurer. Coface has announced a new app solution on the Tradeshift platform offering risk and business information services to help businesses make decisions by ensuring greater financial transparency between