Aerobiotix Announces FDA 510(k) Clearance of Medical Ultraviolet Air Filtration System

Jan 25, 2021 | News, News and Events

L: Illuvia, non-turbulent air system, R: Aerocure-MD medical air purification system (Photo: Business Wire)
 

MIAMISBURG, Ohio–(BUSINESS WIRE)–Aerobiotix, Inc., a leading manufacturer of air treatment devices for hospitals and healthcare, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Aerocure-MD medical air purification system. This system joins an expanding line of Aerobiotix technologies which utilize patented simultaneous mechanical and ultraviolet filtration to eliminate airborne contamination in clinical environments. Aerobiotix submitted independent data demonstrating effectiveness against viral and bacterial aerosols, as well as particulate contamination to support clearance.

“This clearance represents an important regulatory validation of our technology as we expand our footprint to cover all areas of healthcare. The growing challenge of airborne healthcare-acquired infections, including SARS-CoV-2, underscores the need for medical devices with rigorously investigated, peer-reviewed performance against airborne organisms in real-world clinical environments”

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The Aerocure-MD platform is unique in that it has FDA labeling to both destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles from the air via HEPA filtration. The system is designed for mobile, high-volume air decontamination applications in healthcare spaces such as acute care areas, contaminated storage and handling areas, and long-term health care facilities. Unlike other ultraviolet technologies, Aerobiotix uses a shielded internal ultraviolet system, preventing potentially hazardous exposure of personnel and material to ultraviolet rays.

“This clearance represents an important regulatory validation of our technology as we expand our footprint to cover all areas of healthcare. The growing challenge of airborne healthcare-acquired infections, including SARS-CoV-2, underscores the need for medical devices with rigorously investigated, peer-reviewed performance against airborne organisms in real-world clinical environments,” stated Dr. David Kirschman, MD, CEO of Aerobiotix, Inc.

Aerobiotix products, including the Illuvia® nonturbulent air system for operating rooms, are used globally by leading medical centers and are supported by multiple published clinical studies.

About Aerobiotix, Inc.

AEROBIOTIX® is a global medical device company improving patient outcomes by transforming the airborne environment of care. The company uses proprietary technologies to remove airborne microorganisms within clinical environments and deliver measurable, data-driven, and peer-supported improvements to patient outcomes. More information can be found at www.aerobiotix.com

 

Contacts

Ann Dunham
Marketing Manager
Aerobiotix, Inc.
adunham@aerobiotix.com
888-978-7087, ext. 103

 

JASON-TODD-VP-SALES-AEROBIOTIX

JASON TODD

Vice President of Global Sales

Jason leads our global sales team and brings over 18 years of Medical Device experience to Aerobiotix. Jason has led top performing National and Regional Sales teams, selling disruptive technology in the Cardiovascular space with Getinge, Surgical Robotics at Hansen Medical and most recently in the Biologics space with Axogen. Jason received his Bachelor of Science Degree from the University of Indianapolis.

MELISSA-GIETZEN-VP-GLOBAL-MARKETING-AEROBIOTIX

MELISSA GIETZEN, MBA

Vice President of Global Marketing

Melissa Gietzen, MBA is a highly skilled strategic marketing professional with over 20 years’ experience in the healthcare industry. She has significant expertise in strategic planning, capital budgeting, service improvement projects, and creating strong successful brands in the orthopedic, cardiac & ophthalmology markets. Melissa holds a undergraduate degree in Management and Organization Development and a masters degree in Business Administration.

DAVID KIRSCHMAN, M.D. President and CEO

DAVID KIRSCHMAN, M.D.

President and CEO

The founder and CEO is David Kirschman, M.D., a former physician with extensive experience as CEO, Director, Chief Scientific Officer and operator in the orthopedic and biologic medical device space. Dr. Kirschman holds 55 issued US Patents for a wide range of medical devices. He received his BS in Biological Science cum laude from Colorado State University and M.D. from University of Colorado School of Medicine.

GREGORY CARROLL PH.D. Director Scientific Affairs

GREGORY CARROLL PH.D.

Director Scientific Affairs

Dr. Carroll has extensive experience in ultraviolet and photonic science. Prior to joining Aerobiotix, he led the research and development group at Sunstar Engineering. He has a Ph.D. in chemistry from Columbia University and did his postdoctoral fellowship under Nobel laureate Prof. Ben Feringa at the University of Groningen, Netherlands, and Lawrence Berkeley National Laboratory.

TONY EMBREE Chief Commercial Officer

TONY EMBREE

Chief Commercial Officer

Tony leads our global sales organization and commercialization strategy. Prior joining Aerobiotix, he was Senior Manager of Strategy at Stryker. He has led sales and marketing teams in multiple organizations including SurgiCount Medical, part of Patient Safety Technologies, INC (PSTX) as it expanded from 8 hospitals in 2008 to user base of 330 hospitals at time of acquisition in 2013.

COURTNEY ADAMS, Ph.D. VP of Clinical and Medical Affairs

COURTNEY ADAMS, Ph.D.

VP of Clinical and Medical Affairs

Dr. Adams leads our global clinical research and education initiatives as well as developing key opinion leaders to support our clinical mission. Prior to joining Aerobiotix, she held leading research and medical affairs roles at Biogen, Axogen, and MedPace. Dr. Adams holds Ph.D. in Pharmacology from University of Cincinnati.

ANTHONY DEFALCO Vice President of Engineering

ANTHONY DEFALCO

Vice President of Engineering

Anthony is a topflight medical device product development engineer and leader, experienced in the development and implementation of orthopedic, environmental, and electromechanical systems.

NATHAN UTZ Vice President of Client Services

NATHAN UTZ

Vice President of Client Services

Nathan brings a high level of commitment to servicing and building client relations. Nathan has previously held leadership roles in the medical device industry.

MICHAEL SCHMITZ Chief Financial Officer

MICHAEL SCHMITZ

Chief Financial Officer

Mr. Schmitz is a highly experienced financial practitioner with financial leadership roles in diverse industries including manufacturing and technology as well as a background in public accounting. He received his BS in accounting, cum laude, from the Miami University of Ohio. Mr. Schmitz is a certified public accountant and certified management accountant.