IRVINE, Calif., (Sept. 15, 2015)—Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced today that the Centers for Medicare and Medicaid Services (CMS) has assigned two Healthcare Common Procedure Coding System (HCPCS) codes for the Company's Life2000 Ventilation System.
"Breathe Technologies recognizes the assignment of these codes as a significant advancement in addressing an unmet need for individuals living with respiratory insufficiency and neuromuscular diseases," said Larry Mastrovich, president and CEO of Breathe Technologies. "We look forward to continue fulfilling our mission to empower healthcare providers and patients with novel, reliable and accessible solutions for respiratory needs."
The Breathe Technologies Life2000 Ventilation System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June and is indicated for adult patients who require positive pressure ventilation delivered invasively or non-invasively. The device, classified by FDA as a continuous ventilator, can treat both acute and chronic respiratory failure and is suitable for use in home and institutional settings under the direction of a physician by qualified, trained personnel.
"These reimbursement codes further substantiate Breathe Technologies as a leader in developing new, life-enabling technologies for patients suffering from severe respiratory and neuromuscular diseases," said Beth Seidenberg, M.D., general partner, Kleiner Perkins Caufield & Byers, and member of Breathe Technologies' board of directors. "Since its inception, the Company has demonstrated an ongoing commitment to the clinical and patient communities it serves and we are gratified to now have a clearly defined channel in place to ensure widespread patient access and coverage."
The Company anticipates that the Breathe Technologies Life2000 Ventilation System will be commercially available in the United States in late 2015.
For more information, please visit www.breathetechnologies.com.