Ostial Corporation Reaches 15,000 FLASH™ System Units Sold


May 12, 2020

CAMPBELL, Calif., — Ostial Corporation (Ostial), a private medical technology company focused on addressing the clinical challenges of aorto-ostial interventions, today reached a new milestone, passing the mark of 15,000 commercial units sold of its FLASH™ Aorto-Ostial Angioplasty System (FLASH System) in over 300 hospitals across the United States. FLASH is the first and only dual balloon-based system designed for use in aorto-ostial angioplasty in coronary and peripheral cases.

"Aorto-ostial lesions are notoriously difficult vascular interventions due to their challenging location and complex vessel morphology," stated William Lombardi, MD, Clinical Professor of Medicine, Director of Complex Coronary Artery Disease Therapies and Attending Physician at the University of Washington Medical Center in Seattle, Washington. "FLASH is an optimal treatment for these high-risk lesions as it allows me to confidently treat the entire diseased area, while maintaining access for future interventions."

The FLASH System is an innovative dual-balloon angioplasty catheter designed to help overcome challenges of aorto-ostial stenting by delivering true 360° stent apposition at the ostium. The novel technology employs a non-compliant distal balloon that post-dilates and anchors the system while an outer compliant contouring proximal balloon allows the operator to precisely position the catheter at the aorto-ostium, gently flaring the stent to the ostium wall. Total stent apposition with FLASH optimizes patient outcomes while improving reaccess for future interventions.1

"This is a significant achievement for our company, and I would like to thank our small yet growing team for reaching this important milestone," stated Jon Bohane, General Manager and Chief Operating Officer of Ostial. "We are pleased to offer physicians and their patients the only aorto-ostial balloon that achieves complete and efficient lesion coverage."

About Ostial Corporation
Ostial Corporation (Ostial) is a private medical technology company focused on addressing the clinical challenges of aorto-ostial interventions. The company, headquartered in Campbell, California, owns and distributes the novel FLASH Aorto-Ostial Angioplasty System. For more information, visit www.ostialcorp.com.

INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND POTENTIAL ADVERSE EVENTS
The FLASH™ Ostial System should only be used by and under the prescription of physicians who have received appropriate training in percutaneous transluminal angioplasty techniques for addressing coronary and peripheral lesions. For complete product information, including the full indications for use, warnings, precautions, and harms, see the IFU included in the product packaging or visit the following link: ostialcorp.com

1 Data on file at Ostial Corporation.

Indications, Contraindications, Warnings & Precautions

The FLASH™ Ostial system in a specialty balloon device and should only be used by physicians who are trained to use it.
To request a complete copy of the IFU or user training, please contact customer service at customerservice@ostialflash.com.