AUSTIN, Texas, (October 11, 2021)—Movair, a respiratory therapy company formerly known as International Biophysics Corporation, announced the U.S. commercial launch of Luisa, an advanced ventilator intended for use in homes, institutions, hospitals or portable applications for both invasive and noninvasive ventilation. Luisa can be used through the Food and Drug Administration’s (FDA) Emergency Use Authorization in response to the increasing need for safe and effective ventilators. Luisa is a portable and compact home ventilator now available in the United States and one of the first with the added benefit of high-flow oxygen therapy.
For patients with chronic and acute respiratory conditions that require long-term ventilation, prolonged compliance is critical. Luisa was designed to help patients embrace everyday experiences and active, mobile lifestyles. Weighing only eight pounds, Luisa includes a battery run time of up to 18 hours and offers patients eight adjustable comfort settings to deliver personalized, tailored therapy.
Luisa also features a rotatable 10-inch display and flexible connectivity options so patients can integrate the ventilator into current lifestyle habits such as sleeping on a certain side of the bed. Additionally, Luisa can be programmed in multiple languages, ensuring a multitude of diverse patients, families and caregivers receive understandable alarm notifications.
"Life supporting ventilation with high-flow therapy using the Luisa device proved to be a true asset during the most recent COVID-19 surge," said Rami Arfoosh, MD, FCCP, Pulmonary and Critical Care Specialist and associate professor of Medicine at Medical College of Georgia, AU/UGA Medical Partnership. "It provided a new option to meet the high-flow needs for some patients in their home environment. Those patients would have otherwise continued to occupy hospital beds because of the lack of equipment that meets their needs at home. Luisa also provides the unique feature of switching back and forth between high-flow nasal cannula (HFNC) and noninvasive ventilator (NIV) with different mode by the push of a button."
Luisa provides respiratory support and utilizes all standard volume, pressure and mouthpiece ventilation modes with the added benefit of high-flow oxygen therapy that can support nocturnally ventilated patients during the day with a less intrusive nasal cannula. High-flow oxygen therapy delivers a blend of air and oxygen that meets or exceeds a patient's inspiratory flow demand to improve oxygenation and decrease the workload of breathing.
"Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States," said David Shockley, CEO of Movair. "We're addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany, that also provides patients with high-flow oxygen therapy. At Movair, we're committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment."
Luisa is the third-generation ventilator developed and manufactured by Lowenstein Medical in Germany and marketed in Europe since 2020. It can be prescribed to patients diagnosed with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) dependent on meeting certain qualifications. Luisa can provide high-flow therapy to patients that need at-home ventilation and offers FIO₂ and SPO₂ monitoring and ventilation from 100 milliliters tidal volume.
Movair is the exclusive U.S. dealer for Lowenstein Medical. While Luisa can be purchased through various durable medical equipment (DME) providers, normally it is provided to patients by these DMEs through private or government health insurance. In August, Movair began pre-marketing Luisa, which is already being used by thousands of patients in the U.S. Many of these patients are recovering post-COVID and were transitioned home with Luisa.
The Luisa Ventilator has not been FDA cleared or approved. The Luisa Ventilator has been authorized by FDA under an EUA and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergence use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergence use of ventilators, ventilator tubing connectors, and ventilator accessories during the COVID-19 pandemic is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Movair is in the process of filing for permanent 510k FDA clearance for the Luisa in Q4 2021.
For more information about Luisa, pulmonologists, respiratory therapists, nurses, clinical care teams, home health care providers and DMEs can contact Movair at info@movair.com.
Company Rebrand
In addition to launching Luisa, the company also announced a new name and rebrand to coincide with the company's renewed focus on strengthening and streamlining its position as an industry-leading provider of innovative respiratory therapy technologies. For nearly 30 years, Austin-based Movair, formerly known as International Biophysics Corporation, has advanced and manufactured life support equipment including heart pumps, surgical instruments, medical molding and home medical equipment. The company is best known for the development of AffloVest, a fully mobile and battery-operated respiratory airway clearance vest in the United States.
Movair is committed to advancing new respiratory solutions that provide patients with more opportunities to embrace the everyday experiences made much more difficult by their conditions. The company is poised to accelerate the growth of its respiratory therapy portfolio throughout the next 12 months.
Visit movair.com for more information.
