ExThera Medical CEO, Robert Ward, Presents Keynote Address on Seraph® Filter at ACS Polymers in Medicine and Biology Forum

Martinez, Calif. – September 10, 2018 – Robert Ward, CEO of ExThera Medical Corporation, a developer of device-based therapies for removing bacteria and viruses from blood, today presented clinical results of the Seraph®100 Microbind®Affinity Blood Filter(Seraph) at the 2018 Polymers in Medicine and Biology Forum sponsored by the American Chemical Society Division of Polymer Chemistry.

Ward’s keynote presentation in a session on New Approaches in Biomaterials explained the innovative polymer technology that enables Seraph to provide effective intervention in bacterial and viral bloodstream infections. Seraph is designed to reduce the duration and intensity of infections to improve clinical outcomes. It is the first and only broad-spectrum filter that removes pathogens from whole blood. By using immobilized heparin with a unique molecular architecture, Seraph mimics the heparan sulfate binding sites on endothelial cells that are targeted by invading pathogens. Seraph’s high surface area quickly removes large amounts of drug-resistant and drug-susceptible bacteria, viruses, toxins, and sepsis mediators from flowing blood.

ExThera recently completed its CE Mark registration clinical trial, which evaluated the safety and performance of the filter in dialysis patients with bloodstream infections. Interim results from this trial, most recently presented at the Military Health System Research Symposium (MHSRS) in August, demonstrated that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures.

The U.S. Food and Drug Administration granted Seraphinclusion 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. On June 1, 2018, ExThera announced the successful completion of the CE Mark registration trial evaluating the safety and performance of Seraph in renal replacement therapy patients who developed bacteremia. ExThera will submit its EU Clinical Evaluation Report in the fourth quarter of 2018. EU product introduction is expected to begin in the first half of 2019 pending EU approval/CE Mark.

About the Seraph®Microbind®Affinity Blood Filter

As a patient's blood flows through the Seraph Microbind Affinity Blood Filter, it passes over tiny 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 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 devices to treat patients in the hospital or clinic, or on the battlefield. Led by an accomplished management team with extensive experience developing and commercializing 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 successful participation in DARPA’s Dialysis-Like Therapeutics program. For more information, visit www.extheramedical.com.

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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.

ExThera Medical Contact:

George Pitarra

george@extheramedical.com

Media Contact:

Heather Linville

media@extheramedical.com

ExThera Medical Presents Data Highlighting Key Clinical Results of Seraph®100 Blood Filter at MHSRS

Presentation marks first time Seraph 100 data presented in the U.S.

Martinez, Calif. – August 22, 2018 – ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced results from a prospective, non-randomized clinical trial evaluating the safety and performance of the Seraph®100 Microbind®Affinity Blood Filter (Seraph) in renal replacement therapy patients who developed bacteremia. The results were presented today in a session at the Military Health System Research Symposium (MHSRS). 

“These findings from the Seraph 100 trial support our belief that the Seraph filter has the potential to change the landscape for treating bloodstream infections, impacting a significant unmet need for new treatment options,” said Bob Ward, CEO, ExThera Medical. “In 2011, the federal government first envisioned that such a technology could be applicable to the military, and these efficacy and safety data support that vision for the future treatment of bloodstream infections in a multitude of settings.”

In the study, patients on renal replacement therapy who developed bacteremia had the Seraph filter included in the dialysis circuit for four hours, with regular monitoring to measure the reduction of bacteria in the blood passed through the filter (secondary outcome measure), followed by a 14-day monitoring period to assess for adverse events (primary outcome measure).

Interim safety and performance data showed that Seraph appears to be safe and effective, and compatible with widely-used dialysis equipment and procedures. In patients who exhibited measurable bacteremia at the time of treatment, despite an adequate dose of antibiotics, a decrease in bacterial count was observed by an increase in time to positivity (TTP) measured by automated blood culture, comparing contemporaneous post- to pre-Seraph blood samples. In addition, there have been no device or treatment related adverse events reported during the entire trial, with vital signs, including heart rate, blood pressure, and cardiac output, all being stable and reproducible. 

Preliminary data from the trial were presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels, and MHSRS marks the first time these findings have been presented in the U.S.

The U.S. Food and Drug Administration granted Seraphinclusion 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. On June 1, 2018, ExThera announced the completion of the CE Mark registration trial evaluating the safety of the Seraph® 100 Microbind®Affinity Blood Filter (Seraph) in renal replacement therapy patients who developed bacteremia. 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.

 

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

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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.

 

Media Contact:

Heather Linville

media@extheramedical.com

ExThera Medical Contact:

George Pitarra

george@extheramedical.com

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

Trial Provides Foundation for Submission for European CE Mark Application

Martinez, Calif. – June 11, 2018 – 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 Seraphinclusion 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.

 

ExThera Medical Contact:

George Pitarra

george@extheramedical.com

 

Media Contact:

Heather Linville

media@extheramedical.com

ExThera Medical Announces Creation of European Subsidiary

Carla Kikken-Jussen Appointed as Managing Director to Oversee the Strategic Direction of ExThera Medical’s Operations in Europe

Martinez, Calif. – March 18, 2018 – ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced the company’s plan to create ExThera Medical Europe and appointed Carla Kikken-Jussen as managing director of the new wholly-owned subsidiary.

Carla brings more than 30 years of experience in clinical research and the commercialization of new medical devices in the European market to ExThera Medical, where she will oversee the strategic direction for ExThera’s European operations.

“The establishment of our European subsidiary is an exciting milestone as we prepare for commercialization,” said Robert Ward, President and CEO of ExThera Medical. “Carla has a distinguished track record in medical device development and commercialization, including overseeing clinical research, regulatory affairs, quality assurance, and operations. As CEO of her company, Meditech, she successfully supported the rapid clinical adoption of many new medical devices. Carla’s strategic leadership will be invaluable as we continue our clinical research in Europe and build our operations and infrastructure for commercialization.”

Carla was most recently interim CEO and board chairwoman of Vimecon GmbH, which provides laser-based treatment of atrial fibrillation. In 2000, she founded MediTech Strategic Consultants in the Netherlands, a contract research organization for medical devices, and served as the company’s CEO until the company was acquired by MedPace in 2012.  She has served as a board director for Shape Memory Therapeutics, Replication Medical, and as advisor to Greenhills Ventures. Carla has also been active in the EU Commission and Dutch Standardization Institute and has received several industry awards recognizing her accomplishments including the Next Women 100 Award in 2013, recognizing her as one of the 100 most influential business women in the Netherlands, and the Federation Businesswomen Award, as the best international female entrepreneur in 2010.

“Seraph holds incredible promise to transform the treatment of potentially lethal bloodstream infections,” said Kikken-Jussen. “Traditional treatments are costly and often result in poor outcomes, while contributing to drug resistance. They can also require lengthy hospital stays, and frequently fail to prevent patients from developing sepsis. I am eager to drive the completion of ongoing clinical trials in Europe and prepare for the commercialization of Seraph.”

Interim safety and performance data from the ongoing European clinical trial of the ‘Seraph® 100’ Blood Filter will be presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels by Prof. Jan Kielstein of Academic Teaching Hospital in Braunschweig, Germany.

ExThera Medical is focused on developing easy-to-use devices for the rapid treatment of life-threatening/drug-resistant bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide. The company’s Seraph® Microbind® Affinity Blood Filters can remove a broad range of sepsis-causing bacteria, viruses and toxins from whole blood. The technologies are currently under evaluation in a promising European clinical trial and recently designated by FDA for inclusion in their Expedited Access Pathway (EAP) program (Seraph 100). EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases. 

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.

Robert Ward, CEO of ExThera Medical, Elected to Prestigious National Academy of Engineering

Designation is Among Highest Professional Distinctions Awarded

Martinez, Calif. – February 26, 2018. – ExThera Medical Corporation, a developer of therapies for removing bacteria and viruses from blood, today announced the election of the company’s president, Robert Ward, into the prestigious National Academy of Engineering (NAE), recognizing his accomplishments in the commercialization of biomedical devices and prosthetic implants. Ward will be formally inducted at the NAE’s annual meeting in Washington, D.C., on September 30, 2018.Election to the National Academy of Engineering (NAE) is among the highest professional distinctions accorded to an engineer. Academy membership honors those who have made outstanding contributions to engineering research, practice, or education. This includes pioneering new fields of technology, making major advancements in traditional fields of engineering, and developing innovative approaches to education. Bob will be part of the 2018 class of 83 new U.S. members and 16 foreign members to join the academy from many different engineering fields.

“It is a tremendous honor to be recognized by this historic academy for our work over the past 47 years.  Since 1971 I have been lucky to be continuously involved in the development and application of new biomaterials and medical devices.  Working as contract product developers for medical device companies from 1989 to 2010 our talented team of scientists and engineers used vertical integration of R&D/Manufacturing, from the design of biomedical polymers to their scale up and translation to the manufacturing of medical devices and implants,” Ward said. “It is gratifying that our contributions have helped improve clinical outcomes for many patients.”

Founded in 1964, the National Academy of Engineering is a private, independent, nonprofit that provides engineering leadership in service to the nation. The NAE operates under the same congressional act of incorporation that established the National Academy of Sciences, signed in 1863 by President Lincoln. Under this charter the NAE is directed whenever called upon by any department or agency of the government, to investigate, examine, experiment and report upon any subject of science or art. 

About ExThera Medical

Based in Martinez, Calif., ExThera Medical is a privately-held medical device company developing blood filters capable of capturing and removing bacteria, viruses, parasites, from whole blood. www.extheramedical.com.

ExThera’s products are undergoing pre-clinical and clinical evaluations and are not available for commercial sale.

ExThera Medical's 'Seraph' Blood Filter Successfully Completes Pre-Clinical Testing in Final Phase of DARPA's DLT Program

Technology Could Address Significant Need for
Better Treatment of Bloodstream Infections Caused by Drug-resistant Microbes

Martinez, CA. – January 25, 2018 – ExThera Medical Corporation, the leading developer of innovative therapies for removing bacteria and viruses from blood, today announced that the safety and effectiveness of its Seraph® 200 Microbind® Affinity Blood Filter (Seraph 200) has been demonstrated in pre-clinical testing. The fourth phase of DARPA’s Dialysis-Like Therapeutics (DLT) program was successfully completed in November by Battelle scientists. This final phase of testing employed Good Laboratory Practices to produce results for submission to the U.S. Food and Drug Administration (FDA).  The written report, which is pending, confirms safety and efficacy of Seraph in the removal of drug-resistant pathogens from whole blood.

Seraph is a unique production-ready device that is capable of removing a broad range of sepsis-causing bacteria, viruses, toxins, and pro-inflammatory cytokines from whole blood. Validated in preclinical studies and currently under evaluation in a promising European clinical trial, a related device (Seraph 100) promises to address the significant unmet need for rapid treatment of bloodstream infections caused by a long list of pathogens, including many that are drug-resistant. Seraph 100 was recently designated by FDA for inclusion in the 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.  

Although similar in appearance, Seraph is very different from other blood filters, which are offered for the treatment, but not the prevention, of bacterial sepsis. Whereas other devices can remove only cytokines or endotoxins, and in one case viruses, Seraph quickly removes many bacteria, bacterial toxins, viruses, fungi and cytokines simultaneously, using a blood-compatible surface that does not injure the blood. As such, Seraph is designed to treat bloodstream infections quickly to prevent their progression to life-threatening sepsis and septic shock. Seraph 200 also binds endotoxins created by gram-negative bacteria.

ExThera Medical is focused on developing easy-to-use devices for the rapid treatment of life-threatening bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide.

"Effective treatments for preventing and treating sepsis are critically needed, especially for members of our military for whom risk of exposure is significant. We are pleased to have been chosen for this important final phase of DLT testing, and to contribute to the collective efforts to save lives and healthcare dollars,” said Robert Ward, CEO of ExThera Medical.

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 will be useful in bloodstream infections that progress to endotoxemia. The Seraph filters have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory, and which has been demonstrated to be safe in other medical devices and implants.

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.

 

ExThera Medical Contact:
Robert S. Ward
robert.ward@extheramedical.com

Media Contact:
Sierra Smith
(408) 540-4296
sierra@healthandcommerce.com

 

Approved for Public Release, Distribution Unlimited

FDA Grants ExThera Medical’s Seraph® 100 Blood Filter Expedited Access Pathway (EAP) Designation

The EAP should make Seraph available to clinicians more quickly, satisfying the ‘unmet need’ for improved treatments for drug-resistant infections

Martinez, CA. – August 30, 2017 – ExThera Medical Corporation, the leading developer of innovative filtration devices for removing pathogens from whole blood, today announced that the U.S. Food and Drug Administration (FDA) has granted ExThera’s Seraph® 100 Blood Filter (Seraph) the agency’s Expedited Access Pathway (EAP) designation. Seraph’s initial indication for use will be ‘as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is a heparin- or heparan sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE, and MRSE.’

As explained on the FDA web site and in a guidance document issued by FDA:

“The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. The program is detailed in the FDA's guidance Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.

“Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence.  Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager.” 

“The EAP designation for Seraph gives us the opportunity to accelerate the approval process in the United States while still maintaining the high standards of safety, efficacy and scientific rigor required by the program,” commented Dr. Robert Ward, ExThera’s President and CEO.  It has been said that ‘Speed is life’ in the effective treatment of blood stream infections (BSI). Seraph can potentially save thousands of lives now lost to infections for which there are no available drugs.”

According to Kathleen White, ExThera’s COO, “We submitted our EAP application in late June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation within the accelerated timeframe FDA set for itself. The support we received from FDA was very helpful.”

Although similar in appearance, Seraph is different from other blood filters.  Seraph removes many different pathogens simultaneously using a blood-contacting surface that does not injure the blood. As such, Seraph is designed to quickly treat blood stream infections to prevent them from becoming life-threatening.

“ExThera Medical is focused on developing simple devices for the rapid treatment of bloodstream infections, especially in the face of rising incidence rates and the worldwide spread of drug-resistant pathogens. Effective treatments for potentially lethal BSIs are also needed for members of our military for whom the risk of exposure is significant,” said Dr. Ward. 

 

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 field or hospital, and devices that can purify transfused blood prophylactically.  Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has a well-protected set of patents and a growing body of data from independent laboratory studies, including testing within DARPA’s Dialysis-Like Therapeutics program. For more information, visit www.extheramedical.com.

 

# # #

Disclaimer: This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements include any related to the FDA approval process for the company’s products, including Seraph, and any related to the actual efficacy of Seraph if it is approved.  These statements are subject to risks and uncertainties that could cause events and our actual results and financial position to differ materially from those currently anticipated.  Such risks and uncertainties include the possibility that FDA approval will not be forthcoming on a prompt basis, or at all, or that the actual efficacy of Seraph will not be as currently projected or indicated by testing to date. 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.

 

ExThera Medical Contact:

Robert S. Ward

robert.ward@extheramedical.com

 

Media Contact:

Jessica Volchok,

310-849-7985

jessica@healthandcommerce.com


DARPA funds ExThera Medical’s ‘Seraph’ Blood Filter for Pre-Clinical Testing

ExThera Medical Announces Updates on Seraph™ Development Program to be Presented at the 2016 Military Health System Research Summit (MHSRS)

ExThera Medical Closes Financing Led by Fresenius Medical Care Ventures to Support Commercialization of Innovative Technology to Remove Pathogens from Whole Blood