ADM Tronics Unlimited Inc. (ADMT) announces that Ventis Medical Inc. (VMI), has entered into an agreement for ADMT to provide regulatory support and manufacturing for VMI’s portable ventilator technology, the Ventis VM-2000 Ventilator.
VMI was founded under the clinical guidance of Glenn W. Laub, MD, a cardiac surgeon and medical technology developer who recognized the need for a low-cost, simple-to-use ventilator based on his experiences witnessing certain patients critically deteriorate while waiting for a ventilator to be applied, as well as ventilation being delayed in emergency scenarios due to the complexity of deploying standard ventilators.
After completing extensive development efforts and qualifications of the Ventis VM-2000 Ventilator, VMI sought a U.S. FDA-registered and ISO-13485 certified medical device manufacturer to bring the device into production. After reviewing potential companies, VMI selected ADMT.
VMI President Karen Laub spoke out about this process, commenting: “We are pleased to be working with ADM Tronics to bring our Ventis VM-2000 Ventilator into volume production. There is a significant need for a low-cost, easy-to-use ventilator for emergency use with improved functionality. We believe the VM-2000 fills that need, and I am confident ADMT can help us to produce it for the marketplace.”
ADMT will meet regulatory requirements for quantity manufacturing of the Ventis Ventilator in ADMT’s FDA-registered medical device manufacturing facility in Northvale, N.J. Moreover, ADMT will support VMI in regulatory manufacturing requirements for the FDA and international authorities.
“We are honored and pleased that VMI has chosen our company for this important technology that can help so many people around the world,” says Andre’ DiMino, president and CEO of ADMT. “Our regulatory and manufacturing teams look forward to working with Dr. Laub and the development team at VMI to bring the Ventis ventilator into production for the medical marketplace.”