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FDA Grants the Hemolung® De Novo Clearance

PITTSBURGH – (BUSINESS WIRE) – November 15, 2021 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System.

The Hemolung System is the first and only ECCO2R device cleared by the FDA. The Hemolung is indicated for respiratory support that provides extracorporeal carbon dioxide (CO2) removal from the patient’s blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.

“The FDA De Novo review process is designed to determine that the clinical benefits outweigh the clinical risks associated with a medical device when there is not a substantially equivalent predicate device. As a result, the De Novo process is quite rigorous. In order to demonstrate benefit over risk, ALung submitted data to FDA from over 1,000 Hemolung patient treatments on clinical safety and over 230 Hemolung patient treatments on clinical performance outcomes. This clinical data along with all of our pre-clinical data demonstrated to the FDA that the clinical benefits of the Hemolung for ECCO2R therapy has been substantiated. We look forward to introducing this new and valuable technology to the clinical market,” stated Peter M. DeComo, Chairman and CEO.

“The Hemolung will be an important new treatment modality for acute respiratory failure to avoid or mitigate the harms from invasive mechanical ventilation. FDA clearance of the Hemolung is a game-changer for the treatment of these critically ill patients and will usher in a new era of extracorporeal lung support,” said Steven Conrad, MD, PhD, MCCM, Medical Director at ALung and Professor of Medicine at Louisiana State University Health Sciences Center.

The Hemolung is a first of its kind, comprehensive, all-in-one system intended to provide minimally invasive, low-flow ECCO2R. Low-flow ECCO2R with the Hemolung is a lung-independent ventilatory support therapy for removal of CO2 waste molecules from venous blood via extracorporeal circulation through a single, 15.5 French, central venous catheter at blood flows of 350 – 550 mL/min. Respiratory failure patients often experience the need for CO2 removal without the need for supplemental oxygen.  Historically, when extracorporeal therapy was indicated for the removal of CO2,extracorporeal membrane oxygenation (ECMO) devices were utilized because other alternatives were not available. ECMO is typically necessary when respiratory failure patients have a significant oxygenation issue. ECMO systems are complex, invasive, require high blood flows and as a result, require specialty personnel to monitor both the technology and the patient. The Hemolung offers ICU physicians, nurses, respiratory therapists and perfusionists a new tool to treat respiratory failure patients in a less complex, costly, and invasive manner.

ALung has been conducting the VENT-AVOID pivotal clinical trial for the treatment of Chronic Obstructive Pulmonary Disease (COPD) exacerbations and providing the Hemolung for the treatment of COVID-19 patients under an Emergency Use Authorization (EUA) granted by the FDA. The objective of the VENT-AVOID trial is to demonstrate that the Hemolung can avoid or minimize the need for invasive mechanical ventilation. The trial sites have enrolled 111 subjects making VENT-AVOID the largest ECCO2R trial ever conducted for this indication.  The Company has also been working with numerous hospitals to treat COVID-19 patients with acute respiratory failure requiring CO2 removal. To date, the Hemolung has been utilized in the treatment of greater than 120 patients suffering from severe COVID-19 respiratory failure. In its EUA approval letter to ALung, the FDA stated that it believes the Hemolung has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to reduce hypercapnia and hypercapnic acidosis due to COVID 19, and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved and, in turn, may provide clinical benefit, and that there is no adequate, approved and available alternative to the emergency use of the Hemolung RAS to treat lung failure caused by COVID 19.

About ALung Technologies

ALung Technologies, Inc. is a privately held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.

For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.

For more information on the use of the Hemolung RAS for COVID-19 patients, please visit www.alung.com/covid-19

*The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA.

*This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung RAS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.

Contact:

ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO

+1-412-697-3370 ext. 207
pdecomo@alung.com

FDA Grants ALung Emergency Use Authorization (EUA) to the ALung for the Treatment of COVID-19

PITTSBURGH – (BUSINESS WIRE) – April 24, 2020 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company Emergency Use Authorization (EUA) designation to the Hemolung® Respiratory Assist System (RAS) for the treatment of Coronavirus Disease 2019 (COVID-19) patients. ALung has treated numerous COVID-19 patients in the U.S. under existing FDA Emergency Use Provisions, and in the European Union, where the Company is approved having been granted their CE Mark in 2013.

The Hemolung® RAS is currently being used in the FDA approved VENT-AVOID trial for the study of ECCO2R in the treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AE-COPD). In addition, the Hemolung RAS and ECCO2R have been studied for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS) in the just concluded UK REST trial, which enrolled 412 patients.

A public health emergency related to COVID-19 was declared by the Secretary of Health and Human Services (HHS) on February 4, 2020. The FDA has issued an EUA for the Hemolung RAS to treat lung failure caused by COVID-19. As indicated in the FDA’s EUA letter to ALung, the Hemolung RAS is not FDA-cleared or approved, and there are no FDA-approved or cleared device treatments for lung failure caused by COVID-19. ALung submitted and the FDA reviewed in vitro and in vivo information in support of ALung’s ongoing U.S. VENT-AVOID clinical trial for the Hemolung RAS as well as additional information about clinical use of the Hemolung RAS outside the U.S., and additional biocompatibility, cytotoxicity, and performance testing.

Based on the information submitted, the FDA stated that it believes the Hemolung RAS has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to reduce hypercapnia and hypercapnic acidosis due to COVID-19, and/or to maintain normalized levels of partial pressure of carbon dioxide(PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved and, in turn, may provide clinical benefit, and that there is no adequate, approved and available alternative to the emergency use of the Hemolung RAS to treat lung failure caused by COVID-19.

“We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of COVID-19 by removal of CO2 directly from the blood during extracorporeal therapy,” said Mr. Peter M. DeComo, Chairman and CEO of ALung Technologies.

Mr. DeComo further stated, “With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as Ventilator Induced Lung Injury (VILI). Many of the academic medical centers involved with our clinical trial have already requested the use of the Hemolung RAS for treatment of their COVID-19 patients.”

About ALung Technologies

ALung Technologies, Inc. is a privately held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.

For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.

*The Hemolung RAS has not been FDA cleared or approved.

*The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA.

*This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung RAS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.

Contact:

ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO
+1-412-697-3370 ext. 207
pdecomo@alung.com

ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung

PITTSBURGH–(BUSINESS WIRE)– April 4, 2020 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent initiation of commercial development of its next generation artificial lung, which expands the Company’s focus on highly efficient gas exchange devices and also broadens its applicable market.

The Company’s current product, the Hemolung® Respiratory Assist System (RAS), is the only fully comprehensive extracorporeal carbon dioxide removal (ECCO2R) system specifically designed and manufactured for this therapy, as compared to complex competitive products that are modifications of existing technologies designed for other purposes. The Hemolung continues to be the most highly efficient and simple to use ECCO2R system on the market today.

The next generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh. Developed by Professor William Federspiel, PhD and colleagues at the Swanson School of Engineering and the McGowan Institute for Regenerative Medicine, this new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. The licensed research was supported in part by the National Institutes of Health and the Coulter Translational Research Partners II Program at the University of Pittsburgh. Dr. Federspiel has an equity holding in the company and is compensated as an advisory board member.

“The next generation Hemolung RAS is a direct result of the continued collaboration between the University of Pittsburgh and ALung Technologies. This collaboration, spanning 20+ years, has resulted in a rich pipeline of innovation for ALung that will accelerate the development of highly efficient, simple to use artificial lung devices for the treatment of acute respiratory failure. The foundation of our next generation system is an integrated artificial lung cartridge/blood pump that will be unparalleled in the industry as the most efficient carbon dioxide removal and oxygen delivery system, which will address the needs of acute respiratory failure patients that require ECCO2R and/or ECMO (extracorporeal membrane oxygenation). All of this will again be consolidated in a comprehensive, easy to use system without all of the complexities represented in competitive systems,” stated Peter M. DeComo, Chairman and CEO of ALung Technologies.

Jeremy Kimmel, PhD, Vice President of New Technology at ALung Technologies stated, “Professor Federspiel and colleagues at the University of Pittsburgh have rapidly advanced this technology toward commercial readiness through state of the art computational, in vitro and in vivo testing, including successful 7-day and 30-day large animal studies. ALung has initiated commercial development of the next generation Hemolung RAS to provide clinicians with the flexibility to support patients across the full spectrum of acute and acute-on-chronic respiratory failure using a single integrated device. The system design will accommodate bedside therapy as well as portability and wearability, further enhancing device usability and expanding potential clinical indications.”

Key features and benefits of the next generation Hemolung RAS will include:

  • Patent-pending technology that generates superior blood flow uniformity to maximize gas exchange efficiency.
  • A custom designed centrifugal pump integrated with a low surface area (0.65 m2) gas exchange membrane without the need for additional components (e.g. heat exchanger, pressure ports) that will reduce operational complexity of the system.
  • Low flow ECCO2R (250 – 700 mL/min) as well as full ECMO (2 – 4 L/min) using a single integrated pump and gas exchange membrane.
  • The highest efficiency oxygenation of any ECMO device on the market providing full oxygen saturation at ≤4 L/min blood flow with membrane surface area of 0.65 m2.

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. ARDS is estimated to affect more than 10% of intensive care unit patients globally, has a mortality rate as high as 45% and requires invasive mechanical ventilation in the majority of cases.3,4 Combined, these disorders represent a significant need and a global market for innovative respiratory assist devices. The COVID-19 pandemic is a recent example of such a dramatic need.

Currently, the Hemolung RAS has European marketing clearance (CE Mark). In addition, it is the only system that has been studied for safety and efficacy in two large landmark pivotal trials; the FDA approved VENT-AVOID trial and the U.K. REST trial. The Hemolung RAS was recently granted Emergency Use Authorization (EUA) by FDA for the treatment of acute respiratory failure caused by COVID-19.

About ALung Technologies

ALung Technologies, Inc. is a privately held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.

For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.

For more information about the REST Trial, please visit UK National Institute for Health Research (NIHR) – REST Trial Project Website.

CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.

This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.

References

1. https://www.copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx

2. http://www.lung.org/assets/documents/research/copd-trend-report.pdf

3. Bellani. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788-800.

4. Walkey A. Acute respiratory distress syndrome: epidemiology and management approaches. Clinical Epidemiology 2012:4 159–169.

Contacts

ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO
+1-412-697-3370 ext. 207
pdecomo@alung.com

ALung Announces that the Independent Data and Safety Monitoring Board (DSMB) Recommends Continuation of VENT-AVOID Trial and Reports that Significant Progress Continues with their Clinical Trial Programs

PITTSBURGH – (BUSINESS WIRE) May 9, 2019 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today the achievement of a major milestone in its U.S. based VENT-AVOID clinical trial and reports continued progress in its clinical trial programs. The independent Data and Safety Monitoring Board (DSMB) of the VENT-AVOID trial recommended continuation of the trial without modification following its first scheduled review of safety data from the initial 31 subjects enrolled.

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. The VENT-AVOID Trial is the world’s first pivotal study of ECCO2R in the AE-COPD population. The study aims to validate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) for COPD patients experiencing acute exacerbations requiring ventilatory support. Nearly thirty hospitals have been brought online and are screening patients for ALung’s VENT-AVOID Trial of the Hemolung RAS.

In the United Kingdom, the REST Trial, a landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome (ARDS), has enrolled greater than 360 patients. Significant progress continues to be made enrolling patients in this landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome, and it is now the largest prospective clinical study of extracorporeal lung support ever conducted. ALung’s Hemolung RAS is the exclusive ECCO2R technology being used in the trial. The research is jointly led by Queen’s University and Belfast Health and Social Services Trust under the direction of investigators Professor Danny McAuley and Dr. James McNamee of the Centre for Experimental Medicine at Queen’s University Belfast.

“The attainment of this significant VENT-AVOID milestone is gratifying, and we look forward to the continuation of these pivotal trials, both of which hold the promise that the Hemolung RAS and ECCO2R therapy will provide a new tool in the treatment of acute respiratory failure,” stated Peter DeComo, Chairman and CEO of ALung.

The Hemolung RAS has European marketing clearance (CE Mark) and is the world’s only fully integrated Respiratory Dialysis® system. ALung is the only company pursuing two major pivotal trials to validate the safety and efficacy of extracorporeal carbon dioxide removal therapy.

About ALung Technologies

ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.

For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.

For more information about the REST Trial, please visit UK National Institute for Health Research (NIHR) – REST Trial Project Website.

CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.

This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.

Reference

1. https://www.copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx
2. http://www.lung.org/assets/documents/research/copd-trend-report.pdf

Contact:

ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO
+1-412-697-3370 ext. 207
pdecomo@alung.com