News Releases

Vyaire Medical Files for Chapter 11 Protection, Markets Business Units for Sale

June 10, 2024

Chicago, June 10, 2024 – Vyaire Medical today announced Vyaire Holding Company and certain of its subsidiaries (Vyaire) have filed for Chapter 11 protection in the United States in order to obtain sufficient financing to continue business operations while Vyaire markets its business units for a value-maximizing sale. This decision follows below-plan performance in the first half of the financial year, which frustrated efforts to refinance company debt. “Chapter 11 protection will offer us the breathing room we need to explore selling our businesses to capable, well-financed buyers that have the financial ability and stability to execute on the Respiratory Diagnostics (RDx) and Ventilation business strategies delivering our vital products to customers and patients in need,” said John Bibb, Group Chief Executive Officer, Vyaire. “Our lenders continue to support our business, and we are working together to go through this process with as little disruption as possible to our customers and trusted partners.” Vyaire remains open for business and, upon court approval, will have post-petition financing in hand to continue operations while in Chapter 11. In the coming months, the company will focus on: Supporting the continuity of services to customers and honoring commitments to partners and employees, while complying with the terms of the US Bankruptcy Code. Selling Vyaire business units to stable, well-capitalized buyers that will support the growth and development of our RDx and Ventilation portfolios. “We remain committed to the success of our customers, our partners, and our employees and will continue to live out our core values in the work we do,” Bibb added. "Our plan is to maintain the team needed to operate safely and deliver effective healthcare solutions."  The Chapter 11 filing only applies to Vyaire operations in the US and one non-operational international holding company. For more information, please visit the Vyaire case website: https://omniagentsolutions.com/Vyaire. _________________________________ Vyaire remains open for business and we are committed to our partnership with you. While in Chapter 11, we will continue to serve our customers and maintain the team needed to operate safely and efficiently. Our products remain available for purchase and our team remains available to assist you and your team. Standard regional limitations, outlined below, still apply. About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 70-year history of pioneering breathing technology, the integrated solutions offered by the company’s Ventilation and Respiratory Diagnostics (RDx) businesses help enable, enhance, and extend lives. Vyaire products are available in more than 100 countries and are recognized, trusted, and preferred by specialists throughout the respiratory community worldwide.

Vyaire Medical Appoints John Bibb as Group Chief Executive Officer

May 24, 2023

CHICAGO, May 24, 2023—Vyaire Medical today announced that its Board of Directors has appointed medical device veteran John Bibb as Group Chief Executive Officer, effective immediately. Bibb has more than 20 years of experience in the medical device industry and most recently led Vyaire as Chief Legal Officer and Secretary, Human Resources. John has worked directly with Apax for more than ten years and has extensive experience advising public and private boards of directors on quarterly operational performance, material transactions and other business matters. He played a critical role in executing the recent sale of the Vyaire Consumables business to SunMed.  "We are delighted to have someone of John's caliber take the helm at Vyaire," said Steven Dyson, Partner at Apax. “John is a strong, transformational leader with two decades of medical device experience and a track record of success within the Vyaire organization. He is perfectly positioned to execute on our ambitious vision for the business.” Prior to joining Vyaire, Bibb served as Executive Vice President, General Counsel and Chief Human Resources Officer at Acelity. In more than 15 years at Acelity, he led many key business initiatives in legal, HR, commercial partnerships, joint ventures, mergers and acquisitions, and the efficient delivery of shared services to multiple business units. Bibb joined Vyaire in September 2021. “Vyaire remains focused on delivering to our customers and accelerating the strategic growth plans for our pioneering Respiratory Diagnostics and Ventilation business units,” said Bibb. “I will work closely with the leaders of the Respiratory Diagnostics and Ventilation business units to meet customer needs, build on our market leadership and create value for our employees and shareholders.” Following the sale of the Vyaire Consumables business in early May, the company established two distinct business units with dedicated teams specializing in each industry-leading portfolio. The Vyaire leadership team will ensure cohesion across business units with a focus on efficient and effective service delivery to customers and business partners. About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

Vyaire Medical Completes Sale of Consumables Business to SunMed

May 1, 2023

CHICAGO, May 1, 2023—Vyaire Medical today announced that it has completed the sale of the Vyaire consumables business to SunMed, a leading North American manufacturer and distributor of consumable medical devices for anesthesia and respiratory care. “We are pleased with the prompt closing of this transaction, which enables Vyaire to prioritize our pioneering respiratory diagnostics and ventilation businesses,” said Gaurav Agarwal, chief executive officer, Vyaire. “As we take this step forward in the Vyaire journey, our team remains focused on delivering for our customers and achieving our strategic plan.” Under the terms of the agreement, which were not disclosed, SunMed will acquire the Vyaire consumables business, which encompasses leading airway management and operative care technology.   Vyaire remains committed to its mission to empower the global respiratory community to enrich patients’ quality of breathing throughout their lives. About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

Vyaire Medical to Sell Consumables Business to SunMed

March 28, 2023

CHICAGO, March 28, 2023—Vyaire Medical today announced an agreement for the sale of the Vyaire consumables business to SunMed, a leading North American manufacturer and distributor of consumable medical devices for anesthesia and respiratory care. The Vyaire consumables portfolio encompasses leading airway management and operative care technology, including well-known brands such as AirLife™ oxygen therapy, Vital Signs™ anesthesia circuits and SuperNO2VA™ nasal PAP ventilation. These established products offer a differentiated portfolio of products for patients. “This divestiture allows Vyaire to focus on its industry-leading respiratory diagnostics and ventilation businesses and accelerate our strategic growth plans,” said Gaurav Agarwal, chief executive officer, Vyaire. “Uniting the industry-leading Vyaire consumables portfolio with SunMed’s compatible suite of products is a win-win for both companies, as well as customers and patients, and will enhance the potential for long-term growth of the combined consumables portfolio.” “We are extremely pleased with this transaction, which will empower Vyaire to focus squarely on its specialty in respiratory diagnostics and ventilation moving forward, cementing its position as a market leader in this space,” said Steven Dyson, Partner at Apax. “We look forward to working with the Vyaire team on this exciting new chapter for the business.”   Upon completion of the transaction, the combined businesses will create a premier dedicated manufacturer of respiratory and anesthesia consumables. Together, these complementary product lines will enhance the overall product offering for SunMed’s customers and patients globally. Terms of the agreement were not disclosed. Vyaire will continue to fully manage its consumables business and products until the transaction is finalized, with full support to customers, and will work to ensure continuity for partners and suppliers. The agreement is subject to antitrust regulatory clearance in the US. Pending such regulatory clearance and fulfillment of other conditions, Vyaire currently anticipates closing the transaction in the coming months. Vyaire remains committed to its mission to empower the global respiratory community to enrich patients’ quality of breathing throughout their lives. About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.  

Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations

February 4, 2022

CHICAGO, February 4, 2022—In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the Data Communication port set to “HL7”. Customers with software version 6.0.1600.0 or higher installed have been notified by Vyaire to immediately disable the HL7 data communication if activated. If the HL7 data communication is not disabled, such devices are at risk of the reported unintentional ceasing of ventilation. This decision is based on the receipt of reports that some bellavista™ 1000 and 1000e ventilators have unintentionally ceased ventilation during clinical use and require rebooting to resume ventilation due to a software issue. An internal investigation determined that bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed can have a conflict in memory resource allocation between software tasks when the Data Communication port is set to “HL7”. The ventilator notifies the user of the issue by triggering technical failure alarm 305 indicating an interruption in the communication between the user interface controller (EPC) and the ventilation controller (CFB). No patient harm has been reported related to this issue. If clinicians operate a bellavista™ ventilator and do not set Data Communication port to “HL7”, this error will not occur. Therefore, Vyaire supports the continued use of these devices and directs customers to follow the instructions provided in the Company’s correction notification to immediately disable the HL7 data communication if activated while the company develops and deploys a software update to address the issue, anticipated in Q1 of calendar year 2022. The affected ventilators were distributed to medical facilities in the US between 3/21/19 through 12/23/21 located in the following states: AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, PR SD, TX, VA, WA, WI and WV. US customers with questions about this correction should call 833-327-3284 between 5 am and 5 pm PST Monday through Friday, or email GMB-AMS-FSCAresponsecentre@vyaire.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 At Vyaire, patient safety is of the utmost importance, and this voluntary correction is part of our commitment to the highest quality standards for the people who rely on our technology around the world. About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

The new SuperNO2VA™ Et mask establishes a new care paradigm for surgical options by maintaining an open airway and providing real-time exhaled carbon dioxide monitoring, decreasing sedation risk before, during and after surgery

Vyaire Medical Advances Surgical Sedation Safety with Novel Airway Technology for All Patient Risk Levels

October 29, 2021

The new SuperNO2VA™ Et mask establishes a new care paradigm for surgical options by maintaining an open airway and providing real-time exhaled carbon dioxide monitoring, decreasing sedation risk before, during and after surgery CHICAGO, October 29, 2021—Vyaire Medical, the world’s largest medical device maker fully dedicated to improving breathing for every person around the world, today announced the availability of SuperNO2VA™ Et, a mask that utilizes breakthrough technology to stent the airway open, thus avoiding airway collapse while accurately monitoring end tidal carbon dioxide (EtCO2), which is particularly important for high-risk patients. It uniquely maintains airway patency while delivering precise and consistent oxygenation to patients during deep sedation procedures, helping reduce hypoxemia and hypoventilation. SuperNO2VA™ Et provides increased flexibility by providing continuous patient oxygenation before, during and after surgery, and transforms surgical practice by allowing more patients to have procedures under sedation. “At Vyaire, we are committed to imagining new possibilities in the ways we can support breathing. SuperNO2VA™ Et does just that by removing some of the tangible risks of deep sedation through proprietary airway management technology and real-time clinical measurements to reduce complications,” said Gaurav Agarwal, chief executive officer, Vyaire. “Through this innovation, we envision reducing the need for general anesthesia and the associated complications, including extended procedure times, hospital stays and their burdens on healthcare systems.” SuperNO2VA™ Et reduces hypoxemia by 75 percent and airway intervention by 65 percent compared to current standard of care.i ii It also allows for effective pre-oxygenation and rescue ventilation without the need for additional equipment, and eliminates the use and associated costs of a separate mask, endotracheal tube, laryngoscope and intubation. “SuperNO2VA™ Et brings a new standard to the way surgeries can be performed for patients,” said Steven H. Cataldo, MD, director of anesthesiology at CareMount Medical and director of anesthesia services at Yorktown Center for Specialty Surgery. “With this technology, we are able to rethink how and where we operate, with decreased risks, procedure times and associated costs. Even high-risk patients can have reduced recovery times, providing them a safer and better overall care experience.” “As the company inspired and empowered to elevate the quality of breathing, SuperNO2VA™ Et is an obvious yet critical piece of our innovation strategy and evolution,” said Agarwal. “We will continue to bring new-to-world technology to market to advance breathing solutions on behalf of customers and patients.” About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.   i Bai Y, Xu Z, Chandrashekar M, at al. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019;36(9):633-640. ii Dimou F, Huynh S, Dakin G, et al. Nasal positive pressure with the SuperNO2VA™ Et device decreases sedation-related hypoxemia during pre-bariatric surgery EGD. Surg Endosc. 2019;33(11):3828-3832.

Vyaire Medical Advances the Standard of Care in Low-Flow Oxygen Delivery

July 28, 2021

The new AirLife™ Open oxygen mask provides the benefits of traditional cannula, mask and non-rebreather devices into a single revolutionary solution for low-flow oxygen therapy CHICAGO, July 28, 2021—Vyaire Medical, the world’s largest medical device maker fully dedicated to improving breathing for every person around the world, today announced the availability of AirLife™ Open oxygen mask, a revolutionary new low-flow oxygen therapy device designed to advance the standard of care and improve the satisfaction of patients receiving low-flow oxygen therapy. The AirLife™ Open oxygen mask combines the best elements of traditional nasal cannula, oxygen mask and non-rebreather benefits in a single device that is revolutionary for low-flow oxygen therapy. This is achieved through the patented design and unique geometry of the mask openings that maintain higher oxygen concentrations without obtrusive structures. The mask’s design distributes oxygen flow through unique jet orifices, creating a soft curtain of oxygen around the nose and mouth, reducing the risk of rebreathing carbon dioxide resulting in a more comfortable patient experience. The AirLife™ Open mask is designed to allow patients to drink, eat and easily communicate without removing the mask, while delivering uninterrupted oxygen therapy. For clinicians, AirLife™ Open provides the ability to adjust oxygen delivery from 1—15 LPM without disturbing the patient. What’s more, the unique design of AirLife™ Open allows access for certain procedures and the easy transfer of patients between areas of care. AirLife™ Open reduces the need to change out interfaces, improving workflow, reducing waste and cost while effectively delivering continuous oxygen therapy without compromising safety or quality.   “Vyaire is leveraging our rich history of innovation and expansive knowledge in respiratory care to bring to market revolutionary devices like the AirLife™ Open mask that will advance patient comfort and care while reducing the burden on clinicians,” said Gaurav Agarwal, chief executive officer, Vyaire. “We incorporated feedback from customers and patients from across the world and we are thrilled that the results we have seen confirm that the new design delivers the revolutionary benefits AirLife™ Open provides.” “The novel design of AirLife™ Open is the culmination of customer inputs and extensive benchtop testing,” said Michael Pedro, M.D., chief medical officer, Vyaire, and board-certified anesthesiologist. “The feedback from our limited commercial release exceeds our initial expectations as AirLife™ Open is delivering superior results both in maintaining oxygen concentrations and reducing the risk of rebreathing while providing patients with an enhanced, updated and more comfortable method of oxygen therapy.” “We believe that when it comes to compliance and comfort, there shouldn’t be a tradeoff. AirLife™ Open is the first of many new innovations Vyaire will introduce that are patient-centric and improve the standard of care,” added Agarwal. “For far too long, innovation within the respiratory space has been dormant, and Vyaire is working to fill that void, bringing meaningful new consumable products to market that will help everyone breathe better.” About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

Vyaire Medical Expands Ability to Streamline Respiratory Care Through Portable Remote Monitoring and Connectivity Capabilities

June 28, 2021

Vyaire signals significant strategic investment in digital technology and data management capabilities with launch of new tool that helps clinicians provide life-saving care CHICAGO, June 28, 2021—Vyaire Medical, the world’s largest medical device maker fully dedicated to improving breathing for every person around the world, today announced the development of a new comprehensive digital tool designed to arm clinicians with the data and insights they need to better manage breathing for critically ill patients. Vyaire Messenger is a novel mobile application that securely provides patient status information and meaningful clinical insights directly to the respiratory therapist via their mobile devices. Vyaire Messenger is intended to reduce the burden on clinicians by providing visibility to all ventilated patients simultaneously so that they can prioritize and coordinate care. In addition, Vyaire Messenger will proactively notify clinicians should a patient experience a change in ventilation therapy, simplifying processes and prioritizing patients who need the most care. “Vyaire is leveraging digital and connectivity technology to reimagine the needs of our customer base,” said Gaurav Agarwal, chief executive officer of Vyaire. “Our collective experience with COVID-19 has taught us that care must be delivered differently, such as the ability to better triage patients or monitor them outside the hospital room. We are committed to taking those lessons learned and delivering meaningful solutions that help clinicians provide care to those who need it most.” Vyaire Messenger works seamlessly with the bellavista™ and Avea™ ventilation platforms via the Respiratory Knowledge Portal, a data application system released by Vyaire in 2015. The Vyaire Messenger is unique to market in that it is portable on mobile devices and gathers data from compatible IV pumps providing important clinical insights in sedation. Developed in partnership with customers on the front lines, Vyaire Messenger has the potential to significantly reduce the cost of care in the ICU by improving protocol adherence and coordination of clinical functions in order to reduce the amount of time patients spend on a ventilator. The Company released Vyaire Messenger last summer to a limited market and developed the current version based on customer testing and feedback. Clinical data gathered from that period enhances the Company’s thesis that Vyaire Messenger has the potential to improve multiple metrics & outcomes, including[1]: 78% of clinicians who agree that Vyaire Messenger has the potential to improve protocol adherence resulting in an improvement in ventilated patient outcomes; 83% of clinicians who agree that Vyaire Messenger has the potential to improve coordination of care between clinical functions resulting in the reduction of the incidences of ventilator associated events (VAE).  “Monitoring and prioritizing ventilated patients without these advanced technologies requires frequent bedside visits and coordination of care between various clinical specialties is a challenge,” said Tom Cahill, Respiratory Director at St. Elizabeth Healthcare in Kentucky. “Now, our clinicians can get real-time clinical insights for their patients right at their fingertips and improved communication within our care teams, which helps prioritize patient care and provide optimal patient management.” “With the availability of Vyaire Messenger, we are embarking on an exciting digital transformation journey,” continued Agarwal. “Vyaire engineers are hard at work contemplating how we will leverage digital and connectivity technology across sedation, diagnostics and ventilation platforms. We see exciting potential in this space that will help patients around the world take better breaths.” About Vyaire Medical Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what's possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.   [1] Vaire Messenger Pilot Study Report, Integritas Analytics, 2021

1 of 4