BioCardia Says Morph AccessPro Receives FDA Clearance

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SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia, Inc., a cardiovascular products company developing and commercializing innovative interventional treatments for vascular and cardiac disease, has expanded its product portfolio with the 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Morph® AccessPro™ steerable introducer system.

The Morph® AccessPro™ system was developed to simplify procedures associated with peripheral access, enhance physician control, and thereby help improve clinical outcomes in treating peripheral artery disease or PAD. Between 8 and 12 million Americans suffer from PAD, which is caused by the accumulation of plaque in leg or foot arteries, reducing blood flow. Symptoms include leg pain when walking or at rest. PAD can lead to tissue loss and eventually limb amputation. The Morph® AccessPro™ system is believed to be the world’s only arterial access steerable conduit with a profile small enough to be used in routine PAD procedures and an inner lumen large enough to deliver the equipment used in treating PAD such as stents, atherectomy devices, laser systems, and balloons.

For PAD procedures, the AccessPro™ system is designed to act as a steerable introducer, guide, and interventional sheath. It has potential to enable the first steps in a standard PAD limb access procedure to be performed more quickly with less equipment with the goal of reducing procedure costs. The AccessPro™ system is intended to be shaped in real time by the physician to conform more closely to the patient anatomy during the procedure and to provide greater back up support than standard fixed guides and sheaths. This device includes a soft dilator, a smooth transition from dilator to catheter tip, and a trackable and kink-resistant hybrid catheter shaft intended to optimize flexibility and torque transmission.

Based on experience from thousands of clinical cases with the company’s Morph® Universal Deflectable Guide catheter platform, the Morph® AccessPro™ system has been developed to address a real clinical need for enhanced control and back up support in therapeutic PAD procedures. Product line extensions are planned for additional clinical applications.

About BioCardia

Founded in 1999 and headquartered in San Carlos, privately held BioCardia, Inc. is a leader in cardiac regeneration therapies and vascular access technologies. BioCardia is the corporate sponsor of the TAC-HFT and TABMMI stem cell trials to treat heart failure and provides Helix™ and Morph® catheter systems to partners for other leading biological based therapies to treat cardiovascular disease. BioCardia markets the Morph® catheter and soon the Morph® AccessPro™ system at more than 200 hospitals in the United States. More information is available on the company’s website at: www.biocardia.com. Contact: Miranda Peto, 650-226-0120, mpeto@biocardia.com

Contact:

BioCardia, Inc. Miranda Peto, 650-226-0120 mpeto@biocardia.com

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