https://www.newsweek.com/joe-biden-six-point-lead-donald-trump-coronavirus-poll-1501142
What is unsettling to me and should be for all Americans is the possibility that if Trump loses the Election, he will contest it even if it one sided and claim it was
rigged.
Even worse is the scary possibility that as Bill Maher has stated, he may refuse to leave if defeated, which would result in his needing to be removed by the
military, which could in turn incite his devoted followers and supporters of GAnon to resort to violence in the streets, which of course Trump would love!
What is unsettling to me and should be for all Americans is the possibility that if Trump loses the Election, he will contest it even if it one sided and claim it was
rigged.
Even worse is the scary possibility that as Bill Maher has stated, he may refuse to leave if defeated, which would result in his needing to be removed by the
military, which could in turn incite his devoted followers and supporters of GAnon to resort to violence in the streets, which of course Trump would love!
Bought a bunch of ROM at 100 bucks fool...a leveraged ETF but that shit is way over your tiny head
And yes I have a huge portion of a penny stock with a cost bass @ 22 cent's.
here's the latest update you should buy.. bread lines can only support a fool for so long.
Spectral Medical Provides Corporate Update
[*=left]The Company remains well positioned with financial strength
[*=left]COVID-19 patients using PMX in the U.S. showing positive signs in recovery
[*=left]SAMI used successfully for CRRT in COVID-19 patients
TORONTO, April 28, 2020 -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, released an update today on the impact of COVID-19 on the Company’s business, the measures it has put in place, accordingly, and its long-term strategy.
PMX COVID-19 and Tigris Trial Update
Prior to March 11, 2020, when the World Health Organization declared the novel coronavirus, which has the potential to cause severe respiratory illness (“COVID-19”), a global pandemic, the Tigris trial had nine clinical sites screening and open to enrollment of patients, with the remaining one site finalizing administrative procedures prior to its activation. The State emergency declarations combined with the subsequent decision by the U.S. and Canadian governments to close the border had an impact on Spectral’s access to Tigris site ICUs, with all ICUs diverting their resources and focus on either preparing for, or treating COVID-19 positive patients. In February, Spectral aligned its clinical resources and activities to support these trial sites in their efforts with COVID-19, while implementing strategies that would keep their clinical EAA and PMX skills active.
There is a very strong scientific case for the use of PMX in COVID-19 patients. Endotoxin is the primary driver of the cytokine storm and there is reliable evidence that removing endotoxin by the PMX cartridge, reduces circulating levels of cytokines. Increased levels of endotoxin activity as measured by Spectral’s FDA approved Endotoxin Activity Assay (EAA) have been identified in COVID-19 patients in the U.S., Italy and Asia.
PMX has been used to treat patients outside the U.S. during other analogous viral pandemics including the avian flu (H5N1) and the swine flu pandemic (H1N1) which also resulted in acute respiratory distress. In previous publications, the use of PMX in septic shock patients has resulted in decreased dependency on ventilators, which is a serious issue during this COVID-19 pandemic. The publications data showed improvement in chest x-ray results, improved lung function and successful wean from ventilator.
The Company has taken an active role in contributing to the combat of the COVID-19 pandemic, including the following specific activities:
- Since March, Spectral has fielded unsolicited inbound inquiries from hospitals in North America concerning our PMX therapy for the COVID-19 pandemic as it relates to septic shock;
- As a result of these inquiries, the Company released its PMX product to two hospitals. One site is an existing Tigris trial site, while the second site is a NY-based hospital;
- The COVID-19 positive patients were treated, with an average of approximately 2.5 PMX columns administered per treatment. While data collection is not required for the emergency access, elevated EAA levels were detected, and the majority of patients had a rapid and positive response based on lowering oxygen and vasopressor requirements;
US FDA approves Investigational Device Exemption for PMX use in patients with COVID-19 [clinicaltrials.gov: NCT04352985]
- On April 11, 2020, the US FDA approved a supplemental IDE for the use of Spectral’s PMX cartridge in the treatment of patients with COVID-19 as it relates to septic shock;
- The Company collaborated with the FDA, and with its support accelerated the approval process;
- The objective of the IDE supplement is to observe the efficacy of the PMX cartridge with a focus on safety, and allows for an initial 20 sites and 75 patient enrollment, with data collection requirements;
- Existing Tigris sites have been engaged in the supplemental IDE protocol. Participation of these sites provides for a quicker response to COVID-19 treatments, as clinical teams are already trained in administering PMX treatments. The Company is fielding unsolicited inbound inquiries from U.S. hospitals on their desire to participate in the supplemental IDE protocol, and is actively on-boarding select non-Tigris sites.
Health Canada Issues an Interim Order for use of PMX
- We are reaching out to the sites involved in the Euphrates trial, and hospitals covered by our exclusive distribution partner Baxter;
- All participating sites will receive free of charge PMX cartridges and assistance with tech support to initiate.
International Use of EAA and PMX
- The Company reached out to all of its EAA distributors and requested each to provide data with respect to EAA activity levels in COVID-19 patients being treated with PMX;
- Based on feedback from hospitals and EAA distributors received to-date, increased levels of endotoxin activity as measured by Spectral’s FDA approved Endotoxin Activity Assay (EAA) has been identified in COVID-19 patients in the U.S., Italy and Asia region;
- Preliminary data from Italy suggests high incidence of endotoxin activity (EAA in the 0.6-0.9 range) in COVID-19 patients with septic shock is greater than 50%; as of today we are aware of approximately 20 COVID-19 septic shock patients that have been treated with PMX, globally.
“The Company continues to focus on finalizing the Tigris trial within the shortest timelines,” said Debra Foster, VP of Clinical Development at Spectral. “While the COVID-19 pandemic has created some unanticipated hurdles to the Tigris trial, it has also created some very positive opportunities for both the PMX product and the Tigris trial. We are observing a heightened awareness amongst ICU investigators, and clinicians of PMX, and through our recent COVID-19 FDA and Health Canada approvals, we are seeing broader utilization of PMX than we would typically see under a normalized, non-COVID-19 environment. With this increased utilization, we are now likely better positioned to benefit from supportive data collection on PMX use.”
The Company is encouraged by early results of its Tigris trial and the mortality outcome data to-date. However, the Company cautions that the existing randomized patient sample size is limited, and there is no guarantee of a positive FDA approval outcome. Tigris trial recruitment activity slowed at the beginning of March 2020, with patient enrolment mostly impacted at the three sites which had finalized training and had been activated in late 2019. The other six sites that are now open for enrolment had finalized their clinical training in late January and early February, and it typically takes three months post-clinical training for sites to enroll their first patient. Accordingly, these six sites were not projected to reach their normalized enrolment rate until May 2020. However, should the COVID-19 pandemic in the U.S. prolong limited ICU access at the Tigris sites, there could be significant risk that last patient enrolment could be delayed. Spectral has developed mitigation strategies to reduce or eliminate any timing delays, including:
- COVID-19 supplemental IDE protocol keeps current Tigris site clinician skills current for EAA and PMX;
- Spectral’s clinical team keeps weekly communication with sites and their CRAs. It has been noted by site investigators that there may be a staggered re-opening of ICUs across the U.S., as many regions and states are experiencing staggered peak COVID-19 infections and recoveries;
- Potentially increase the number of sites in the Tigris trial. Spectral is evaluating potential sites for its FDA supplemental IDE, which could subsequently be added to the Tigris trial;
- Should the data collected under the supplemental IDE protocol be robust, Spectral would propose to use the data to be supportive of the PMA for the PMX cartridge;
- The Company has developed comprehensive on-line training and site support which can be utilized until the Canada – U.S. border re-opens.
Dialco Update
Dialco, a wholly-owned subsidiary of Spectral, recently passed its one-year anniversary and many milestones have been accomplished in this short amount of time. Dialco continues its commercial activities with SAMI, Dialco’s proprietary Continuous Renal Replacement Therapy (“CRRT”) instrument. SAMI continues successful clinical evaluation in key hemodialysis centres, and building its commercial sales pipeline. With respect to DIMI, a renal replacement instrument focused on the home dialysis market, Dialco continues on its path seeking FDA regulatory approval.
“Dialco has not experienced any negative impacts due to the COVID-19 pandemic,” said Gualtiero Guadagni, President of Dialco. “Based on our interaction with the FDA, it appears the regulatory approval timelines, with respect to DIMI are status quo. In our SAMI business, we are seeing increased commercial activity in part due to the COVID-19 pandemic. As hospitals are expecting a significant shortage of CRRT machines in COVID-19 impacted ICUs, we have experienced increased activity around SAMI, including the use of SAMI in the treatment of COVID-19 positive patients.”
Recent Dialco Highlights:
- SAMI instrument was successfully used to treat a young patient with COVID-19 under an Emergency access request for the PMX cartridge;
- Recently deployed SAMI devices utilized at a prominent U.S. university in the treatment of COVID-19 positive patients with renal failure. The U.S. university decided to move forward with the implementation of SAMI to address the increase in AKI patients in view of a shortage of CRRT machines due to COVID-19;
- Successful remote installation, set-up and high-level training on-line of SAMI. While COVID-19 has negatively impacted the ability of our field resources to access ICUs, Dialco was able to successfully ship and set-up five SAMI machines without major issues;
- Presently, Dialco is corresponding with the FDA, concerning DIMI‘s 510k application which includes the needs for further biocompatibility and electromagnetic capability analysis which are being conducted by certified labs. While a competitive device was recently approved for home hemodialysis use by the FDA, the Company believes this event continues to validate Dialco’s decision to enter the dialysis market. Additionally, to the Company’s knowledge DIMI remains the only machine capable of both PD and HD for home use.
Corporate Activities Update
- Exploration of a senior U.S. listing: The Company has been studying the potential benefits of a secondary listing on a senior U.S. exchange. Based on the stage of development of the Company, management’s observations regarding the market for peers of the Corporation whose securities are listed on a stock exchange in the U.S., the Company believes that there are potential benefits of a U.S. listing, including a potential increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players. The Company will determine if and when to apply for a listing on a U.S. exchange, and when it is considered in the best interests of Spectral.
- Financial Update: The Company has ample liquidity to weather the COVID-19 pandemic, and execute on its 2020 business plan goals. The Company continues to operate at full staffing levels, and does not anticipate any changes to current staffing levels. Additionally, the Company has not, nor does it intend to avail itself of any COVID-19 government subsidies.
Spectral Outlook
“I am proud of Spectral’s contribution to combat COVID-19. Our entire product portfolio has been utilized during this pandemic, and we will continue to deploy our products until the COVID-19 pandemic ends. We are very pleased with the progress made on both the development of our renal support products and the use of the PMX cartridge in the IDE studies. In addition, we have realized early commercial success with SAMI and have completed a comprehensive distribution agreement for PMX/EAA. I feel we are well positioned to make significant corporate progress in 2020,” said Dr. Paul Walker, President and CEO of Spectral. “While COVID-19 has altered some of Spectral’s short-term priorities, our long-term strategy remains unchanged. Regardless of short term data points, our focus has not changed on obtaining the required approvals and commercialization of our products. The significant clinical unmet need that our products address, and the size of those patient populations have not changed. The value of our greatest assets remain unchanged.”
About Spectral
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
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Baxter and Spectral Medical Announce Exclusive Distribution Agreement for Blood Filter in U.S. and Canada
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Press Release
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PDF
DEERFIELD, Ill. and TORONTO, ON - February 4, 2020
Baxter International Inc. (NYSE:BAX), a leading global medical products company, and Spectral Medical Inc. (TSX:EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced a distribution agreement for TORAYMYXIN™ PMX-20R (PMX), a hemoperfusion filter, and the Endotoxin Activity Assay™ (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. PMX is an investigational device in the U.S. that removes endotoxin, which contributes to sepsis, from the bloodstream.
As part of the agreement, Baxter has agreed to pay Spectral a series of milestone payments including a US$5 million upfront rights payment. Baxter will be Spectral's exclusive distributor of the PMX filter in the U.S. and Canada and has non-exclusive rights to distribute the EAA globally. Spectral will receive access to Baxter's market capabilities while retaining control over the PMX regulatory approval process. Baxter has the option to maintain exclusive rights for PMX through future milestone payments and maintaining certain performance obligations.
"Spectral believes that Baxter is the best industry partner to commercialize the PMX product within the U.S. and Canada," said Dr. Paul Walker, CEO of Spectral. "This agreement provides Spectral access to Baxter's large installed base of critical care devices in hospitals across the U.S. and Canada, and Spectral believes this partnership significantly accelerates the company's commercialization efforts for PMX."
"This agreement provides an opportunity to broaden our portfolio and expand Baxter's offering in sepsis management," said Reaz Rasul, general manager, Baxter's Acute Therapies business. "We are partnering with Spectral to advance purposeful innovation to help clinicians address a serious issue in critical care."
Recruiting for Spectral's Tigris clinical trial for PMX (www.clinicaltrials.gov: NCT03901807) is underway in the U.S., and the trial is expected to be completed in late 2021. Tigris is a follow-on study that builds on knowledge gained from the EUPHRATES trial, a large prospective randomized blinded trial performed in North America and completed in 2018. Tigris is a prospective randomized, open labelled trial of 150 patients with a 2:1 randomization favoring the treatment arm. The end point remains a reduction in the 28-day mortality using the PMX filter versus the standard of care.
The EAA™, which is the only commercially available, FDA cleared test to measure endotoxin activity in whole blood, is a semi-quantitative test for the measurement of endotoxin activity and allows for rapid measurements to obtain results in approximately 30 minutes. While Spectral's EAA™ is currently cleared by the FDA, Baxter plans to commercialize the EAA™ and PMX filter together following successful completion of the Tigris trial and subsequent FDA approval. Baxter plans to market the diagnostic tool in some countries in Europe, where the EAA™ is currently CE marked, alongside the company's Oxiris blood purification set.
Oxiris is a 3-in-1 set for continuous renal replacement therapy (CRRT)-sepsis management to help simplify multiple treatment challenges for critically ill patients. The Oxiris set is designed to combine three functionalities in a single device: endotoxin removal, cytokine removal, and fluid/uremic toxin removal. Oxiris is not approved for use in the United States.
The Impact of Sepsis and the Role of Endotoxin
Globally, a recent study estimated that 48.9 million incident cases of sepsis were recorded in 2017, resulting in 11 million sepsis-related deaths.[SUP]1[/SUP] In the U.S. alone, sepsis has a high cost of hospitalization consuming more than $27 billion per year[SUP]2[/SUP] with an estimated 1.5 to 2 million new cases diagnosed each year[SUP]3[/SUP]. Septic shock, the most severe form of sepsis, is predominantly treated in the ICU.
The use of blood purification filters to remove cytokines and endotoxin from the blood represents a promising approach to treat patients with conditions where excessive levels of those inflammatory mediators are often seen, including sepsis. Additional research is ongoing to understand the potential of blood purification to help address sepsis and other conditions.
PMX is not approved for use in the United States.
Rx Only. For safe and proper use of the devices mentioned, refer to the full Instructions for Use.
Intended Use Information for EAA
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
The information, when used in conjunction with other clinical information and other relevant diagnostic tests, aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.
Intended Use Information for Oxiris
The Oxiris set is indicated for use only with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). It is intended for patients in need of blood purification, including continuous renal replacement therapy, and in conditions where excessive endotoxin and inflammatory mediator levels exist.
This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris set must be prescribed by a physician. It is contra-indicated to use the Oxiris set where patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II).
About Spectral Medical
Spectral is a late stage theranostic company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 170,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc.(“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit spectraldx.com.
About Baxter
Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Baxter: This release includes forward-looking statements concerning a distribution agreement entered into by Baxter and Spectral Medical, including expectations regarding the financial impact and other benefits of such agreement for Baxter. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: Baxter's ability successfully commercialize the product and realize the benefits of the agreement; demand for and market acceptance of new and existing Spectral products; the ability of Baxter to develop, manufacture and commercialize, as applicable, new and existing products; product quality or patient safety concerns; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on its website. Baxter does not undertake to update its forward-looking statements.
Spectral Medical: Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
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Baxter and Spectral Medical Announce Exclusive Distribution Agreement for Blood Filter in U.S. and Canada
</header>
Press Release
- Agreement will enable Baxter to expand its Acute Therapies portfolio to address unmet needs
- Agreement provides Spectral with a strategic commercialization partner and their access to a large number of hospitals
- Spectral to receive upfront exclusive rights payment
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DEERFIELD, Ill. and TORONTO, ON - February 4, 2020
Baxter International Inc. (NYSE:BAX), a leading global medical products company, and Spectral Medical Inc. (TSX:EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced a distribution agreement for TORAYMYXIN™ PMX-20R (PMX), a hemoperfusion filter, and the Endotoxin Activity Assay™ (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. PMX is an investigational device in the U.S. that removes endotoxin, which contributes to sepsis, from the bloodstream.
As part of the agreement, Baxter has agreed to pay Spectral a series of milestone payments including a US$5 million upfront rights payment. Baxter will be Spectral's exclusive distributor of the PMX filter in the U.S. and Canada and has non-exclusive rights to distribute the EAA globally. Spectral will receive access to Baxter's market capabilities while retaining control over the PMX regulatory approval process. Baxter has the option to maintain exclusive rights for PMX through future milestone payments and maintaining certain performance obligations.
"Spectral believes that Baxter is the best industry partner to commercialize the PMX product within the U.S. and Canada," said Dr. Paul Walker, CEO of Spectral. "This agreement provides Spectral access to Baxter's large installed base of critical care devices in hospitals across the U.S. and Canada, and Spectral believes this partnership significantly accelerates the company's commercialization efforts for PMX."
"This agreement provides an opportunity to broaden our portfolio and expand Baxter's offering in sepsis management," said Reaz Rasul, general manager, Baxter's Acute Therapies business. "We are partnering with Spectral to advance purposeful innovation to help clinicians address a serious issue in critical care."
Recruiting for Spectral's Tigris clinical trial for PMX (www.clinicaltrials.gov: NCT03901807) is underway in the U.S., and the trial is expected to be completed in late 2021. Tigris is a follow-on study that builds on knowledge gained from the EUPHRATES trial, a large prospective randomized blinded trial performed in North America and completed in 2018. Tigris is a prospective randomized, open labelled trial of 150 patients with a 2:1 randomization favoring the treatment arm. The end point remains a reduction in the 28-day mortality using the PMX filter versus the standard of care.
The EAA™, which is the only commercially available, FDA cleared test to measure endotoxin activity in whole blood, is a semi-quantitative test for the measurement of endotoxin activity and allows for rapid measurements to obtain results in approximately 30 minutes. While Spectral's EAA™ is currently cleared by the FDA, Baxter plans to commercialize the EAA™ and PMX filter together following successful completion of the Tigris trial and subsequent FDA approval. Baxter plans to market the diagnostic tool in some countries in Europe, where the EAA™ is currently CE marked, alongside the company's Oxiris blood purification set.
Oxiris is a 3-in-1 set for continuous renal replacement therapy (CRRT)-sepsis management to help simplify multiple treatment challenges for critically ill patients. The Oxiris set is designed to combine three functionalities in a single device: endotoxin removal, cytokine removal, and fluid/uremic toxin removal. Oxiris is not approved for use in the United States.
The Impact of Sepsis and the Role of Endotoxin
Globally, a recent study estimated that 48.9 million incident cases of sepsis were recorded in 2017, resulting in 11 million sepsis-related deaths.[SUP]1[/SUP] In the U.S. alone, sepsis has a high cost of hospitalization consuming more than $27 billion per year[SUP]2[/SUP] with an estimated 1.5 to 2 million new cases diagnosed each year[SUP]3[/SUP]. Septic shock, the most severe form of sepsis, is predominantly treated in the ICU.
The use of blood purification filters to remove cytokines and endotoxin from the blood represents a promising approach to treat patients with conditions where excessive levels of those inflammatory mediators are often seen, including sepsis. Additional research is ongoing to understand the potential of blood purification to help address sepsis and other conditions.
PMX is not approved for use in the United States.
Rx Only. For safe and proper use of the devices mentioned, refer to the full Instructions for Use.
Intended Use Information for EAA
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
The information, when used in conjunction with other clinical information and other relevant diagnostic tests, aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.
Intended Use Information for Oxiris
The Oxiris set is indicated for use only with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). It is intended for patients in need of blood purification, including continuous renal replacement therapy, and in conditions where excessive endotoxin and inflammatory mediator levels exist.
This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris set must be prescribed by a physician. It is contra-indicated to use the Oxiris set where patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II).
About Spectral Medical
Spectral is a late stage theranostic company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 170,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc.(“Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit spectraldx.com.
About Baxter
Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Baxter: This release includes forward-looking statements concerning a distribution agreement entered into by Baxter and Spectral Medical, including expectations regarding the financial impact and other benefits of such agreement for Baxter. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: Baxter's ability successfully commercialize the product and realize the benefits of the agreement; demand for and market acceptance of new and existing Spectral products; the ability of Baxter to develop, manufacture and commercialize, as applicable, new and existing products; product quality or patient safety concerns; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on its website. Baxter does not undertake to update its forward-looking statements.
Spectral Medical: Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
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instead of inside herHi i am bozzie, a mom jean wearing fairy and i got money. Look at me, look at me, look at me
Just like your lover savage. Brag about what you got to make yourself feel better. Shit stain left wingers like you do it oftenointer:
funny you would know about my investments or would take an interest...stock much?
