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Hemolung® RAS Used to Treat More than 75 COVID-19 Patients(Photo: ALung Technologies, Inc.)

PITTSBURGH–(BUSINESS WIRE)–ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that it has now treated more than 75 COVID-19 patients, and that it is experiencing increasing demand for the Hemolung® Respiratory Assist System (RAS) as a result of the current pandemic. The Food and Drug Administration (FDA) granted the Company Emergency Use Authorization (EUA) designation to the Hemolung RAS for the treatment of COVID-19 patients in the second quarter of 2020. The Hemolung is the only ECCO2R device currently granted an EUA for the treatment of COVID-19.

“The Hemolung RAS has enabled us to recover patients with COVID pneumonia during the pandemic. In select patients where there is a selective issue with hypercarbic respiratory acidosis while their oxygen requirements have normalized post-Veno-Venous ECMO cannulation, we have utilized Hemolung as a bridge in their recovery. We have noticed that these patients are able to wean off mechanical circulatory support in a gradual manner. Additionally, at a time when there was a shortage of ECMO circuits, our program has relied on utilizing this technology in stabilizing patients with severe hypercarbic respiratory acidosis while providing lung protective ventilation,” stated Dr. Bindu Akkanti, MD, Associate Professor of Medicine, Divisions of Critical Care, Pulmonary and Sleep Medicine, McGovern Medical School, and Director of Heart and Vascular Critical Care, Memorial Hermann – Texas Medical Center.

“The Hemolung RAS has given us a new tool during the current pandemic, to safely and easily treat our COVID-19 patients. We were able to rapidly introduce the Hemolung RAS to our staff and start treating patients under Emergency Use Authorization. As a smaller community hospital without an ECMO program, the ease of use of the Hemolung has played a large role in the successful deployment of ECCO2R for the treatment of COVID-19 at Palm Beach Gardens Medical Center,” stated Ribal Darwish, MD, Medical Director Critical Care Medicine, Palm Beach Gardens Medical Center.

“We are pleased to be able to assist in this fight against the COVID-19 viral disease by providing the use of the Hemolung RAS as a 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). We are treating COVID-19 patients in greater than 20 hospitals worldwide,” said Mr. Peter M. DeComo, Chairman and CEO of ALung Technologies.

In its EUA approval letter to ALung 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.

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 on the use of the Hemolung RAS for COVID-19 patients, please visit https://www.alung.com/covid-19/covid-19-us/

*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.

KDKA:  https://pittsburgh.cbslocal.com/2020/12/09/pittsburgh-based-cytoagents-drug-trial-coronavirus-treatment/.

Pittsburgh Post-Gazette: New COVID-19 treatment shows encouraging early results, North Shore biotech company says

Pittsburgh Business Times: How CytoAgents’ plans for growth run far beyond Covid crisis

WTAE Pittsburgh: Pittsburgh-based company behind ‘promising’ new COVID-19 treatment

Fox 43 News: Pennsylvania biotechnology company testing new drug that could change the way COVID-19 patients are treated

WPXI Wolf Administration Highlights CytoAgents New Therapy Development  

New C360 CEO Howard Wright Sees Broadcast Tech Putting Fans on the Field of Play

The technology evangelist will focus on relationships and strategy in his new role

Howard Wright is not a new face in the industry — he was VP of global business development for Intel Sports and, prior to that, at Qualcomm — but he does have a new role: CEO, C360 Technologies, the Pittsburgh-based company whose technology has been used for such events as the Super Bowl, ESPN’s MNF, and major college football games. At both Qualcomm and Intel Sports, he honed his skills as a technology evangelist and also had a chance to develop relationships with some of the world’s top CTOs, league commissioners, and broadcasters.

C360’s Howard Wright: “We’re going up the stack and becoming an immersive-media–creation engine for the most valuable partners and teams and leagues in the world.”

“That takes a very special set of skills, and I am lucky to have learned them,” he says. “Some of those skills have been instilled in me by some of the greatest minds in telecommunications or mentors or friends to this day.”

Wright likes to refer to himself as a wannabe engineer going all the way back to his days at Stanford University, where he graduated with a bachelor’s degree in qualitative economics.

“I like to see how something goes from an idea on a whiteboard, into a patent pool, and then becomes something that permeates every part of our lives,” he says. “That fourth-dimension chess game has been what has kept me in high tech all these years.”

Evan Wimer, co-founder/CBO, C360, says that Wright’s skills will allow Wimer to focus on product development and other initiatives while Wright zeros in on relationships and strategy. He adds that Wright’s joining the company coincides with the closing of a round of financing with SeventySix Capital and that Wayne Kimmel, managing partner, SeventySix Capital, is now on the C360 board of directors.

“That gives us another weapon and insights at our disposal, which is tremendous and benefits our company,” Wimer adds.

He notes that innovation at C360 has always been about bringing a level of quality that fits into a production and, at the same time, brings a whole new set of opportunities to personalize the fan experience.

For C360, that innovation is a 10K camera system small enough to be mounted on a football yardage marker. Coupled with a wide-angle lens, it allows an operator to remotely pan, tilt, and zoom within the image, offering dynamic replays that can ensure a key moment isn’t missed.

That same system can also be tied into a live OTT or VR experience to allow the viewer to do their own pan, scan, and zoom.

“With betting,” Wimer points out, “the ability to select a particular player and track them throughout the whole game is where the future of sports is going. We can leverage the linear and OTT experience at the same time, and we continue to do things like add more digital zoom. That and color matching are two things we are [focusing on].”

Wright says that the evolution of consumer technologies coupled with broadcast technologies is creating the ability for fans to be on the field of play or follow players the way Wimer mentions.

“We want to create an option value for the broadcasters, for social, linear, and digital, and that is the part where Evan and I spend most of our time,” Wright says. “C360 isn’t just a pylon-cam company. It’s not a VR company. It’s not an AR company. The idea is that we’re going up the stack and becoming an immersive-media–creation engine for the most valuable partners and teams and leagues in the world. That’s the unapologetic goal.

“What we have at C360,” he continues, “is a very simple weapon to be utilized by the broadcasters and, ultimately, by OTT players. And what we’re trying to do is increase the efficiency, increase the efficacy, increase the horsepower of our solution so that it can service this industry and the other industries that we service.”

To help get to those goals, Wright says, he follows the Servant Leadership principles.

“You need to take and close action items as much as you need to give them,” he says. “You need to be an active listener and not a dictator. And you need to be a trusted member of the team that is working alongside the rest of the team, regardless of status, regardless of equity, regardless of title. The goal is to harness and galvanize the collective IQ of our staff and investment community. That’s going to propel us as forward.”

Adds Wimer, “Howard is the kind of person that we really needed and have looked for to lead the company. There couldn’t be a better person paired for the next growth cycle of the company.”

Local Biotech Firm Develops Drug For Respiratory Distress In COVID-19 Patients

  10 HOURS AGO

Pittsburgh-based biotech company CytoAgents is launching into phase one of clinical trials this month on a drug designed to treat people with COVID-19 who develop serious respiratory distress when their immune system overreacts to the virus.

According to CytoAgents CEO Teresa Whalen, severe illness in some patients is triggered by a cytokine storm which is an excessive immune response that attacks the body. She said the drug could be particularly helpful for someone hospitalized with COVID-19.

“Our drug will be used as soon as the patient enters the hospital to keep the patient from progressing to the ICU and avoiding the need for ventilators,” Whalen said.

The drug, GP 1681, is given orally and Whalen said that makes it more affordable than traditional immunotherapy treatments known as biologics which are often administered intravenously.

“Biologics are more than $10,000 for one course of therapy and we would likely be in the hundreds, possibly low one thousands, so there is a significant difference,” Whalen said.

In addition to COVID-19, Whalen said the drug is designed to combat cytokine storm in other infectious diseases like influenza.

“We are really excited by the potential of the science and the fact that we could be therapeutically helpful for not only this pandemic but many future pandemics,” Whalen said. She also noted her company is working with partners to conduct drug trials to treat people who have suffered intense respiratory failure and lung damage caused by vaping.

In July, CytoAgents announced it received an investment of $250,000 from the Richard King Mellon Foundation to support its first phase of clinical trials. The funding is part of the foundation’s $25 million Pandemic Solutions package to help local organizations respond to the coronavirus crisis.

CREDIT CYTOAGENTS

Other pandemic assistance from RK Mellon includes $2.5 million to help colleges and universities in western Pennsylvania cover additional expenses they will incur as they reopen for the fall semester.

Debut on NFL Kickoff Game – Thurs., Sept. 10, 8:20 p.m. ET on NBC – Marks First NFL Broadcast with Immersive Replays from Overhead

STAMFORD, Conn. – August 27, 2020 – NBC’s Sunday Night Football, primetime television’s #1 show for an unprecedented nine consecutive years, will present viewers with a unique overhead replay perspective this season with the innovative C360 camera, which is expected to yield looks at everything from the techniques of linemen along the line of scrimmage to plays along the sidelines.

Beginning with the NFL Kickoff Game on Thurs., Sept. 10 at 8:20 p.m. ET on NBC, and continuing throughout the NBC SNF season, the camera will provide for the first time on an NFL broadcast an immersive overhead replay experience.

The C360 camera will fly attached to the bottom of SkyCam to provide up-close and intimate replays of the game inside the tackle box, illuminating the talents of stars like Los Angeles Rams defensive tackle Aaron Donald and Dallas Cowboys guard Zach Martin in a way not previously seen on NFL telecasts. In addition, because the camera shoots in 8K and records in a 180-degree immersive field of view, production can go back in time to reframe a play to better provide definitive views from C360.

If there’s a question about a receiver catching a pass on the sideline, the technology can freeze the entire image, zoom in and focus on the player’s hands to confirm possession, before panning down to the player’s feet and zooming in to confirm both touched the ground before going out of bounds.

“We are excited to provide some of the most compelling overhead replays that football fans have ever seen, and look forward to working with C360 Technologies on this presentation,” said Fred Gaudelli, executive producer of NBC Sunday Night Football.

“We’re thrilled to be working with NBC Sports and to provide this novel immersive capability.  As a secondary camera on SkyCam, we anticipate capturing a fresh perspective of the game over the trenches,” said Evan Wimer, co-founder of C360 Technologies.

The C360 camera technology has previously been used in car on NASCAR on NBC broadcasts, and was nominated for a 2019 Sports Emmy for its use while embedded within line-to-gain pylons and first-down markers last season.

ABOUT C360 TECHNOLOGIES, INC.

C360® is personalizing the sports viewing experience. We’ve entertained millions of viewers worldwide while working with the largest sports broadcasters and Fortune 500 companies across the globe. Our platform integrates the smallest, most innovative cameras and patented software with v-commerce, sports betting and player/object tracking.  C360 is leading the personalized viewing revolution across every streaming channel, device and social media service allowing unlimited viewers to control their own fully immersive viewing experience.

– NBC SPORTS –

3 months in a coma, local man beats COVID

Vlad Laroche is going home on Friday

The steps were slow and shuffling, but they were steps.

And for Vlad Laroche, that means recovery.

“I’m thankful to God,” he said. “He made it happen. He brought me back.”

Laroche is a physician in West Palm Beach.

In April, he was admitted to Palm Beach Gardens Medical Center with COVID-19.

He spent months in a coma on life support.

Now, he’s awake and on Friday, he’s going home.

“God touched him, picked him up with his own hands and got him home,” said Paul Laroche, Vlad’s brother.

Doctors at the hospital said they had to be creative as they worked for months to keep Laroche alive.

“We just kept faith,” said Dr. Ribal Darwish. “We just kept facing challenges, and every time we had a new challenge, we had to come up with a new solution.”

Darwish said one of those solutions was is something called a Hemolung, a machine that removes carbon dioxide from the blood and replaces it with oxygen.

It allows the lungs to rest and heal.

Doctors also used a medication called Dornase Alpha, normally only prescribed for patients with cystic fibrosis.

Darwish said Palm Beach Gardens Medical Center is the only place using it to fight COVID-19, and he hopes other hospitals are paying attention.

“I think many lives can be saved if they are going to utilize some of the treatments that we are utilizing here at Palm Beach Gardens,” he said.

Vlad Laroche said there’s no question it definitely saved his life.

“They were guided, you know?” he said about his doctors. “I would not have made it if I was in any other setting.”

Paul Laroche compared his brother’s recovery to the feeling he got holding his newborn children.

“I don’t know if there’s anywhere beyond that in terms of happiness,” he said. “But whatever that is, utopia, I’m there.”

Laroche has no plans to go back to work any time soon.

He said he will just spend the next few months regaining his strength and reminding people that COVID-19 is not something to take lightly.

“People have to wear masks, socially isolate, maintain your distance,” he said. “If you don’t have to go out, stay in your place.”

Richard King Mellon Foundation boosts funding for COVID-19 aid to $25 million

Among recipients: colleges adapting for fall; Wilkinsburg small business incubator; and public art for riverfront trails

JOYCE GANNON
Pittsburgh Post-Gazette
jgannon@post-gazette.com

JUL 2, 2020

The Richard King Mellon Foundation is adding $10 million to its commitment to help the Pittsburgh region deal with the fallout from the COVID-19 pandemic.

The new funding — which includes money for economic and health initiatives and support for the arts — follows a $15 million commitment that the city’s largest philanthropy made in April for COVID-19 relief.

The April pledge came “with the real clear understanding this crisis wasn’t going to subside in the short term,” said Sam Reiman, foundation director.

As the unemployment rate skyrocketed and disproportionate effects of the pandemic on the Black community and other groups became more pronounced, “We realized this is something you couldn’t just finish with one level of investment,” he said.

The foundation, created from the fortunes of Pittsburgh’s Mellon banking family, had an endowment of $2.7 billion in 2019.

Its new package for COVID-19 aid includes $2.5 million to help colleges and universities in Western Pennsylvania cover additional expenses they will incur to reopen for the fall semester such as virus testing.

The money, to be distributed to about a dozen schools through grants that will average $200,000 to $250,000, could also help students fill financial gaps and be used for faculty needs such as transitioning to remote learning, said Mr. Reiman.

Providing funds to higher education institutions was a priority for the foundation, he said, because especially in smaller, rural communities, colleges “play an outsized role in the local economy.”

Also included in the new round is $3.3 million to continue an economic impact and recovery initiative the foundation launched as part of its April commitment to COVID-19 relief.

It recently awarded 37 grants totaling more than $5 million from its first round of funds.

The board approved another 24 grants because “there were so many worthy ideas” among the submissions it received from the community, said Mr. Reiman.

Among the new allocations is $175,000 to Locally Grown, a nonprofit trying to jump-start small businesses in Wilkinsburg through an incubator program based at the former Johnston Elementary School.

Others include $175,000 to Community Human Services Corp., a Strip District nonprofit, to expand telehealth access for behavioral health services for vulnerable people such as the homeless; $100,000 to the Westmoreland County Community College Education Foundation for job training and job placement programs; $150,000 to the Center that Cares in the Hill District for digital literacy programs; and $100,000 to the Mediation Council of Western Pennsylvania to reduce an expected surge in evictions linked to job losses among renters.

Some of the economic recovery grants will boost arts and recreation organizations that have seen revenues practically dry up since shelter-in-place orders were issued in March.

A grant of $100,000 to the Pittsburgh Symphony, for instance, will fund a new marketing initiative to attract people back to Downtown, said Mr. Reiman.

“If you’re in the business of generating revenues through large gatherings, there’s been virtually no improvement in your business since the economy shut down,” he said.

Riverlife, a nonprofit that promotes reuse of the city’s riverfronts, received $200,000 for a program to install public art along riverfront trails.

Some of the $10 million will go to health-related initiatives.

In its earlier round, the foundation supported vaccine research at the University of Pittsburgh and local production of protective face shields.

The new funding includes $250,000 in North Side biotech firm CytoAgents to fund clinical trials of a drug that could reduce the severity of human response to the coronavirus.

Some of the new funding has yet to be committed to specific initiatives, said Mr. Reiman, because, “We don’t really know when this will end.”

Another surge of cases could result in shortages of personal protective equipment and more funds may be needed for vaccine development.

“We’re really trying to keep our powder dry,” he said.

https://www.post-gazette.com/business/career-workplace/2020/07/02/Richard-King-Mellon-Foundation-COVID-19-relief-recovery-Pittsburgh/stories/202007010154

ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung
The next generation Hemolung RAS was developed by Bioengineering Professor William Federspiel and was partially funded by the Coulter Program

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.

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

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.

5/14/2020

Contact: Peter M. DeComo

Pittsburgh biotech company receives $1.6 million grant to develop drug to treat COVID-19

The Pittsburgh company, CytoAgents, received a $1.6 million grant to develop a drug that could help treat COVID-19

https://www.wtae.com/article/coronavirus-what-we-know-and-what-we-don-t-explained/32493740

The Pittsburgh company, CytoAgents, received a $1.6 million grant to develop a drug that could help treat COVID-19.

The biotech company is located on Pittsburgh’s North Side.

The CEO of CytoAgents, Teresa Whalen, said: “It’s certainly a validation of our science and the potential of our drug.”

CytoAgents was awarded a National Institutes of Health grant for the drug called GP1618.

“This is so exciting. This is a critical milestone for CytoAgents and an excellent example between a collaboration between the National Institute of Health and the private sector to accelerate innovation,” said Whalen.

Scientists said when a person gets sick from viruses, their symptoms are triggered by a cytokine storm.

Whalen said, “The cytokine storm is an overreaction of our immune system, driving severe illness. Our drug calms that cytokine storm, reducing inflammation and restoring balance and allowing our patients to recover.”

Whalen said the drug would help with COVID-19, influenza and other respiratory illnesses.

“We have incredible trust in the promise of our drug. Pittsburgh has such a long history of excellence with health care system and world renown academic institutions and it’s really a privilege to be part of that ecosystem,” said Whalen.

She said the drug could also stop overcrowding at hospitals by getting patients off ventilators and out of the ICU.

Whalen said clinical trials could start in August and the drug could be available by the beginning of next year.

ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung

https://www.businesswire.com/news/home/20200505005548/en/ALung-Announces-Commercial-Development-Breakthrough-Generation-Artificial

(Photo: Business Wire)

(Photo: Business Wire)

PITTSBURGH–(BUSINESS WIRE)–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.

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

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

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BlueTree Venture Fund
P.O. Box 1323
Wexford, PA 15090
724-475-4538
info@bluetreeventurefund.com