PLG0206 has the potential to be the first approved therapy specifically indicated for the treatment of periprosthetic joint infection
Pittsburgh, PA [ July 19, 2022]:
Peptilogics, a biotech company engineering peptide therapeutics to improve the treatment landscape for patients with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead drug candidate, PLG0206, for the treatment of periprosthetic joint infection (PJI).
“Total joint replacements are the most common major surgical procedure performed annually across the globe. At any time following surgery, patients can develop PJI, a devastating and life-threatening condition with suboptimal treatment options and a high mortality rate” said David Huang, M.D., Ph.D., Chief Medical Officer of Peptilogics. “Receiving the FDA’s Fast Track designation supports our efforts to improve the standard of care for those impacted by PJI. We look forward to continuing to evaluate PLG0206’s potential to address the unique challenges of the disease and help patients in need.”
Fast Track designation is granted by the FDA to expedite the development and review of new treatments for serious or life-threatening diseases with high unmet medical need. The FDA has previously granted PLG0206 Orphan Drug Designation and Qualified Infectious Disease Product status for the treatment of PJI. According to Marc Lesnick, Ph.D., SVP of Regulatory Affairs “these designations are indicative both of the serious nature of the disease, as well as the transformative potential of our treatment.”
Peptilogics is currently evaluating the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics, and implant retention (DAIR) surgery for the treatment of PJI occurring after total knee arthroplasty (TKA). For additional information about the trial, please visit www.clinicaltrials.gov using the study identifier NCT05137314.
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.
About PLG0206
PLG0206 is an investigational, broad-spectrum, anti-biofilm, anti-infective peptide therapeutic currently in clinical development for the treatment of PJI. PLG0206 was designed with a unique mechanism of action that allows it to directly address persistent bacterial pathogens within the biofilm that evade standard-of-care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. In both in vitro and non-clinical studies, PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens including those identified by the World Health Organization and the Centers for Disease Control and Prevention as critical, urgent or high-priority targets, regardless of resistance phenotype. PLG0206 has been granted FDA Orphan Drug Designation for the treatment of PJI and has also been designated as a Qualified Infectious Disease Product (QIDP).
About Periprosthetic Joint Infection (PJI)
More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, approximately 2% of patients will develop a PJI, a serious life-threatening condition, which often necessitates continuous antibiotic usage, multiple high-risk surgical procedures and implant removal with limited ability to resolve the infection. The current standard of care has up to a 60% four-year failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate.
About Peptilogics
Peptilogics engineers peptide therapeutic candidates to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms, and purpose-built super-computing, Peptilogics is advancing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, Founders Fund, CARB-X, and Cystic Fibrosis Foundation. For more information about Peptilogics, visit www.peptilogics.com or follow the company on Twitter and LinkedIn.
Media Contact:
Cassidy McClain
Email: Cassidy.McClain@evokegroup.com
Peptilogics Contact:
Jodie Gillon
SVP Corporate Affairs & Patient Advocacy
Email:Jodie.gillon@peptilogics.com
A Pittsburgh biotech company’s developing nonantibotic treatment for the sometimes deadly impact of joint replacement surgery will have a presence this week at a global infectious disease conference that will be held in Portugal this weekend.
By Paul J. Gough – Reporter, Pittsburgh Business Times
Apr 22, 2022, 3:29pm EDT
A Pittsburgh biotech company’s developing nonantibotic treatment for the sometimes deadly impact of joint replacement surgery will have a presence this week at a global infectious disease conference that will be held in Portugal this weekend.
Peptilogics, which is based on the South Side, plans an oral presentation and a poster at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) about its latest findings on PLG0206, an investigational drug candidate that Peptilogics is in the midst of a Phase 1B clinical study. PLG0206 is a specially designed peptide that aims to treat periprosthetic joint infection (PJI), which can be a complication of the joint replacement. About 1 million joint replacements are done annually and, according to some studies, happen in as many 2% of all hip arthroplasties and total knee arthoplasties.
The injection is, in the words of a National Institutes of Health report, “one of the most devastating and costly complications,” as well as a challenge to treat. It can cause death, and antibiotics aren’t effective and treatment is expensive. With an aging population, joint replacements are only going to get more common in the years ahead.
“It’s an infection that’s catastrophic to patients who develop it. It leads to longer hospitalizations, debilitations, more surgeries and also indirect costs like loss of work and time off from work,” said Dr. David Huang, chief medical officer of Peptilogics. “It’s serious and life-threatening, and we believe we have something that could certainly help treat this devastating condition.
Peptilogics’ research finds that PLG0206 is able to tackle gram-positive and gram-negative pathogens as a bactericidal, broad-spectrum treatment.
PLG0206’s ability to be broad spectrum, both gram positive and gram negative, offer it a step up from most antibiotics, and it works against biofilm, the slime that often surrounds bacteria. Unlike antibiotics, there’s very little ability for bacteria to develop resistance to the peptides. And it can be delivered intravenously safely.
PLG0206 is in the Phase 1B trial, a 14-patient study across 10 sites in the U.S., where patients will be enrolled over the next year to confirm the safety, tolerability and efficacy of PLG0206 in people with acute knee PJIs. The U.S. Food and Drug Administration approved Peptilogics’ plan in December.
Huang said Peptilogics hopes to enroll the study by the end of 2022 and begin the next phase as early as the end of 2023 or early 2024. The earliest PLG0206 could be approved, if all went well, would be 2026.
Peptilogics in December 2020 closed on $35.4 million in Series B funding, which included Peter Thiel, the cofounder of PayPal.
The company has 31 employees, up sharply from March 2021 when it had only five.
“We’ve grown exponentially over the past year and we’re continuing to grow, especially given the progress we’re making with the platform side of the company,” Huang said.
It’s hiring more scientists, clinicians and computational biology and machine learning experts.
Ellen Sherberg, Bizwomen Contributor
Feb 4, 2022, 10:57am EST
As Omnicron continues to take a toll on the country, we’re reminded how many women are on the front lines of health care. Some in the hospital setting, some as public health leaders and others, like Teresa Whalen, in the research lab where, as CEO of CytoAgents, she leads a team of world-renowned clinical drug development experts and scientific advisory board members to find treatments for Cytokine Release Syndrome (CRS), an overreaction of the immune system causing systemic inflammation.
“An experienced CEO and a pharmacist, I was recruited by the lead investor to take over at the helm of the company when it was originally focused on treating cytokine storm triggered by infectious diseases. In addition to the infectious disease indications, I repositioned the focus of CytoAgents and evolved the company to create a foundation of science that would support a pipeline of indications across many diseases — prioritizing areas where cytokine storm is most life-threatening with a fast path to market. Right now, CytoAgents is preparing to start Phase 2 Clinical Trials in cytokine storm triggered by CAR T-Cell Therapy, where up to 70 percent of patients experience some level of cytokine storm.
With the successful completion of Phase 1 Clinical Trials, increasing funding from investors and not just one, but two National Institutes of Health grants,* I was recently selected for the EY Entrepreneurial Winning Women™ North America Class of 2021, which identifies ambitious women entrepreneurs who are leading thriving organizations and helps them scale their companies to their full potential as market-leading innovators.
The pandemic has brought the condition of ‘cytokine storm’ to the forefront. Not only does cytokine storm, more universally known in the medical community as ‘cytokine release syndrome,’ (CRS) impact mortality when it comes to Covid, it is associated with similar problems with certain cancer treatments. Interestingly, our lead drug candidate’s ability to safely modulate the cytokine response makes it an ideal solution to address CAR T-Cell therapy-related CRS in oncology.
With the positive Phase 1 trial results, an oversubscribed equity round, solid scientific and business strategies, and the addition of preeminent oncology and venture capital experts to our board, CytoAgents has built tremendous momentum in a relatively brief time. I am driven by knowing that we can make a difference on mortality, economic burden and strain on our overall healthcare system as a consequence of CRS and that our therapeutic is positioned to be a new, breakthrough therapy to meet this threat head-on.
How am I making that ambitious mission happen?
It’s a 24/7 effort with operations that span the globe and are firing on all cylinders. The team I have built is composed of world-renowned clinicians and scientists, clinical drug development and regulatory experts, as well as those skilled in the areas of patent law, business development and finance. Together we have built a culture of collaboration, excellence, and urgency. We have great momentum built through value creation in a very rapid period of time. My leadership style is to build a team with the best minds capable of hitting milestones and executing on the strategic plan in a capital efficient manner.
Working with my robust, national, and international network has also proved valuable. Being recently selected by the EY Entrepreneurial Winning Women program is an incredible honor and validates the strength of our business, forging connections with the vast EY network will help propel our business to even higher levels.
As an angel investor myself, I also try to make time to mentor female-led startups and speak at events that can help entrepreneurs by sharing my experiences and lessons learned. Fostering a strong ecosystem of innovation is critical for breakthrough technology and economic growth and innovation.
What have I learned from the age of the coronavirus?
This is a time for virtual community and sharing. If you would like to contribute to this ongoing narrative on the impact of the pandemic on women’s lives, please send an e-mail to esherberg@bizjournals.com.
*NIH Award Numbers 1R44AI152726-01 and 1R44AI157719-01
Industries:
By Alex Kreisman, Media Center of Excellence, IRI, and Marc Guldimann, CEO, Adelaide
Marketers have an ever-growing selection of metrics to measure digital media at their disposal. But not all of them use the rigor of evidence-based methodologies to prove effectiveness.
Take viewability, for instance. According to the standards of the Interactive Advertising Bureau (IAB), a digital ad is considered viewable if 50% of the ad’s pixels are visible in the browser window for one second. It’s clearly valuable for marketers to know whether the audiences they are trying to reach can see their digital ads. But viewability, like other KPIs used in isolation, has limitations. And it’s a metric that can lead marketers astray when misapplied.
Marketers who use viewability to chase the lowest possible cost per thousand impressions (CPM) can end up wasting money on tiny ads on big screens that, in practice, rarely capture attention. To give brands a more transparent measure of ad quality, IRI has started working with Adelaide, which has devised a way to move beyond viewability and take media quality measurement to the next level using its metric, AU.
AU is an omnichannel media quality score proven to predict the likelihood and quality of attention and the probability of subsequent outcomes. Signals used to calculate AU are captured through Javascript, web scanning, eye-tracking panels and third-party data.
Advertisers who optimize their campaigns with AU can see up to an 80% improvement in ad impact.
IRI Lift™ can incorporate Adelaide AU into the final sales measurement deliverable. This functionality gives marketers the ability to test and learn by comparing the sales lift achieved from AU-optimized media and other optimization tactics, like viewability. IRI uses a forensic test and control method to ensure tightness of fit to accurately measure incrementality against various test groups.
Danone, a mutual client of IRI and Adelaide, has started using this approach as it is searching for media metrics that are predictive of KPIs across the entire marketing funnel. Initial results were successful, finding a correlation between AU-optimized media and sales lift. This combination of Adelaide AU Measurement with IRI Sales Lift Measurement is helping to provide Danone with the tools it needs to maximize every media dollar and improve sales results.
With consumer attention at a premium in our distracted world, marketers need proven tools that maximize their campaign results. This is another one that can get them closer to success.
by Allison Schiff //
The National Basketball Association is scoring higher tune-in for live games by optimizing its media planning using attention, including on connected TV.
The league has been on the hunt for a more effective real-time optimization metric tied to larger business goals, like brand lift and tune-in, said Larisa Johnson, VP of paid and CRM media at the NBA.
That need became imperative coming out of 2020. The NBA knew it possessed a strong brand that was highly relevant culturally, with players pushing for social justice reforms after the murder of George Floyd and following the successful completion of an entire playoff season in a bubble with only minimal setbacks.
But ratings were down. So the NBA was looking to shake things up in its channel mix and choose placements that were more predictive of positive outcomes.
“With business metrics only being available post-flight, we were previously operating in the dark while the campaign was live,” Johnson said.
With help from its media buying partner, IPG-owned Mediahub, the NBA started experimenting with a new CTV product from Adelaide, a startup that’s developing an attention-based ad currency it calls the “attention unit” (AU).
“Advertisers need an omnichannel metric that’s more broadly applicable than viewability,” said Marc Guldimann, Adelaide’s CEO and founder. “Viewability only makes sense in scrolling environments.”
Media placements are given quality scores that rate how likely they are to capture attention. If you capture attention, positive business outcomes follow. Adelaide uses a mix of different machine learning algorithms depending on the channel to analyze whichever signals are the likeliest predictors of quality and attention.
On the web, those signals usually include the position of a media placement, the duration of exposure and the amount of clutter on a page. But it’s a completely different story on CTV, where attention-grabbing signals include the ad pod, the genre and the time of day when an ad runs.
When Mediahub started looking at CTV media quality through the AU lens as part of the planning process for the NBA last year, it noticed a massive spread between what Adelaide characterized as low-attention versus high-attention placements.
“That gave us a clear, tactical way to optimize our plan by moving money from low to high attention media,” said Ed McElvain, EVP for digital platforms and data-driven media at Mediahub.
By focusing its media budget on high-attention placements across both CTV and digital, the NBA saw a 36% higher tune-in rate for live games compared to when it bought against placements with a lower AU score.
The NBA now uses AU as its main optimization metric, Johnson said, which “helped justify that the cost of certain premium placements really are worth the price tag.”
Adelaide and Mediahub are in the process of working together to co-develop media buying and planning technology that bakes in attention-based media quality metrics.
Although startups like Adelaide have been trying to make attention metrics happen for years, it’s been slow going. Ad buyers are accustomed to their familiar proxy metrics, and they’ve been loath to change, even though most know they could be getting more out of their media.
But the end of third-party cookies and the general move toward more privacy-protective technologies is making advertisers more amenable to trying a different approach, Guldimann said.
“They’ve always known that not all impressions are the same, but they’ve been able to rely on attribution systems to see where they’re getting value,” he said. “As that becomes less tenable, there’s more of a desire to understand the quality of the media they’re buying.”
The fact is, attribution is turning into “swiss cheese,” McElvain said.
“We may or may not be able to know the action someone took based on the device or the preferences of an individual, but we can use attention to influence our buying without having to rely on a workaround,” he said. “We’re seeing a lot more clients open to having that conversation this year than last year.”
By Nate Doughty – Reporter
December 09, 2021, 11:28am EST
Strip District-based Niche, a company that provides users with a platform of rankings on schools, colleges and places to live, announced two new executive team appointments following a year-long hiring spree that has increased employee count by more than half.
Andra Smith joins the company as its first general counsel and corporate secretary. With more than 15 years of experience running legal departments, Smith has worked at companies like KAYAK, OpenTable and TicketNetwork. As general counsel and corporate secretary, Smith will be tasked with crafting privacy and compliance initiatives in new markets, overseeing the company’s corporate governance and internal processes and developing a series of best practices aimed at continuing to scale the quickly growing company. Smith will also serve as lead counsel for all of Niche’s commercial and financial transactions and will serve as secretary on the company’s board.
Morry Mitrani will serve as Niche’s first vice president of growth and lifecycle, a role he’ll take on following previous work at online dating platform Bumble Inc. (NASDAQ: BMBL). Mitrani joined Bumble during the company’s early stage period and led its global user acquisition teams through an acquisition by Blackstone Inc. (NYSE: BX) and Bumble’s eventual IPO. He’s logged more than 10 years of experience in digital marketing, working at other companies like IT networking platform Spiceworks and advertising agency GSD&M, both based in Austin, Texas. At Niche, Mitrani will oversee the growth, lifecycle and brand marketing teams that support the company’s scaling efforts, implementing new strategies that aim to retain and grow the user base.
“I’m incredibly excited to have Andra and Morry onboard at such a pivotal moment for the company,” Luke Skurman, CEO and co-founder of Niche, said in an email statement. “Andra brings invaluable legal and corporate expertise that will allow us to scale effectively and adopt best practices in contracts, compliance, user privacy and more. Morry’s previous successes using newer platforms to engage a similar audience will help expand our reach and build our brand in the next phase of our business. I’m very much looking forward to working closely with each of them.”
The two new appointments come after a year-long effort of significant employee onboarding for the Pittsburgh company.
At the start of 2021, Niche had 156 full-time employees. Now, it’s at 241 full-time workers across 27 states, a 54% increase in headcount from less than 12 months ago. It’s also now up 20% in workers since September, which is when the company first surpassed employing more than 200 workers.
“The headline with Niche right now is that we have happy users, we have happy clients, we’re a successful Pittsburgh company that’s scaling and growing right now and really hitting the stride right now,” Skurman said in September. “And yes, we are hiring aggressively right now. We anticipate hiring another 100 people over the next year in all facets of the business — engineering, product, design, sales, marketing, all across the board — it’s a really exciting time in the company right now.”
Founded in 2002 and initially named CollegeProwler by then-Carnegie Mellon University Tepper School of Business students Skurman and Joey Rahimi, the company has since evolved from its original form of publishing print guidebooks on U.S. colleges to one that posts online rankings of K-12 schools, colleges, cities, neighborhoods and companies throughout the nation. In April 2020, it raised $35 million in Series C funding led by Radian Capital and with participation from Salesforce Ventures, as well as the company’s existing investors; Allen & Co. LLC and Tim Armstrong.
By Jordyn Hronec – Digital Producer, Pittsburgh Business Times
Sep 22, 2021, 12:28pm EDT
Peptilogics, a biotech company based on the South Side, will be presenting data it collected from the first-in-human Phase 1 of its lead investigational therapy for the treatment of prosthetic joint infection (PJI). The presentation will take place at the IDWeek 2021 conference.
The company, which engineers peptide therapeutics in order to change the treatment landscape for patients with life-threatening diseases, has optimized the therapy, known as PLG0206, for both safety and broad-spectrum activity against biofilms, which are produced by bacteria that harbor and protect bacteria from most antibiotics.
The PLG0206 therapy has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for the treatment of PJI. It targets and disrupts bacterial membranes, thus leading to the rapid killing of bacterial cells. It was announced in February of 2020 that Peptilogics would receive funding for clinical studies of the treatment from CARB-X, or Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, a global nonprofit partnership based at Boston University School of Law.
Following joint replacement procedures, 1-2% of patients will develop a PJI. These infections are serious and life-threatening, and often require major surgeries to resolve, which carry a 60% failure rate. The mortality rate for surgeries intended to resolve PJIs over a five year period is 25%.
At the IDWeek 2021 conference, Peptilogics will present data from three accepted abstracts:
IDWeek is the joint annual meeting of several organizations: the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). IDWeek 2021 is a virtual conference taking place from Sept. 29 through Oct. 3.
SUNNYVALE, CA and PITTSBURGH, PA – August 18, 2021 – Cerebras Systems, the pioneer in high performance artificial intelligence (AI) compute, and Peptilogics, a biotechnology platform company and an emerging leader in leveraging computation to design novel therapeutics, today announced a collaboration to accelerate the development cycle of peptide therapeutics through AI.
Leveraging the revolutionary Cerebras CS-2 system – powered by the world’s fastest AI processor – Peptilogics will be able to push the boundaries of innovation in drug design and novel peptide therapeutics. This cutting-edge exploration of innovation is a scientific game changer with the potential to meaningfully reduce the time from bench to bedside.
“Our mission at Peptilogics is to radically alter drug development and realize the full potential of peptides as therapeutics,” said Nick Nystrom, PhD, SVP and Head of Computation and Data, Peptilogics. “By partnering with Cerebras, we will be able to accelerate our research by orders of magnitude for important areas such as membrane proteins, including G protein coupled receptors (GPCRs). Traditional drug discovery operates on the time scale of one new drug in ten years. We aim to flip that to ten new leads in one year.”
Peptides are sequences of amino acids, essentially small proteins, that play critical roles in how our bodies operate. They offer relatively unexplored opportunities for therapeutics, conferring potential advantages over other types of drugs. The “design space,” or number of possible peptide structures, is vastly larger than could be explored through traditional drug discovery. AI – specifically deep learning – is well-suited to identify ideal peptide structures as drug candidates.
Through this collaboration, Cerebras and Peptilogics scientists will use the CS-2 system to develop and run advanced models to identify novel peptide therapeutics that meet specific biological activity and biophysical criteria. By accelerating the slowest step of the research cycle and training deep learning models on big data, Peptilogics with Cerebras will be positioned to deliver better therapeutics sooner. Peptilogics joins other life science leaders, including GSK and AstraZeneca, in leveraging Cerebras’ industry-leading AI technology to advance drug discovery.
“Peptilogics is operating at the forefront of AI-enabled drug design. With Cerebras, they are part of a select group of partners that share similar interests in pushing the boundaries of scientific research and AI computing to radically accelerate innovation for better healthcare outcomes,” said Andy Hock, VP of Product at Cerebras. “Cerebras Systems makes world-leading AI compute accessible and easy to use so that our partners at Peptilogics can test more ideas quickly, reduce the cost of curiosity, and achieve their mission of discovering peptide therapeutics in record time.”
For more information, please visit https://cerebras.net/industries/health-and-pharma/.
About Cerebras Systems
Cerebras Systems is a team of pioneering computer architects, computer scientists, deep learning researchers, and engineers of all types. We have come together to build a new class of computer to accelerate artificial intelligence work by three orders of magnitude beyond the current state of the art. The CS-2 is the fastest AI computer in existence. It contains a collection of industry firsts, including the Cerebras Wafer Scale Engine (WSE-2). The WSE-2 is the largest chip ever built. It contains 2.6 trillion transistors and covers more than 46,225 square millimeters of silicon. By comparison, the largest graphics processor on the market has 54 billion transistors and covers 815 square millimeters. In artificial intelligence work, large chips process information more quickly producing answers in less time. As a result, neural networks that in the past took months to train, can now train in minutes on the Cerebras CS-2 powered by the WSE-2.
About Peptilogics
Peptilogics is a clinical-stage biotechnology platform company that designs and develops novel peptide therapeutics. The company is supported by investors including Presight Capital, Founders Fund, and Peter Thiel, who are known for their investments in companies such as AbCellera (NASDAQ: ABCL), Compass Pathways (NASDAQ: CMPS), SpaceX, and Synthego. Through its computational platform, Peptilogics is advancing drug discovery to uncover new, previously unexplored chemical design space, while ensuring biological viability and scalable manufacturing. Peptilogics’ anti-infectives pipeline includes a novel clinical stage anti-infective, PLG0206, that has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for its initial focus on the treatment of prosthetic joint infections, an urgent unmet medical need. More information on Peptilogics can be found at www.peptilogics.com as well as on Twitter and LinkedIn.
Cerebras Media Contact:
Kim Ziesemer
Email: pr@zmcommunications.com
Peptilogics Contact:
Jodie Gillon
SVP Corporate Affairs & Patient Advocacy
Email: jodie.gillon@peptilogics.com
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.
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