MiCardia® Announces Issuance of 18th US Patent in Structural Heart Disease – “Adjustable Annuloplasty Ring with Subcutaneous Activation Port”

MiCardia Corporation – September 8, 2014 – (Irvine, California) today announced that The United States Patent Office granted patent number 8,821,570, “Adjustable Annuloplasty Ring with Subcutaneous Activation Port”, on September 2, 2014.

This patent and its execution can allow for minimally invasive or percutaneous access to activate a device implanted into the cardiovascular system. MiCardia developed this vascular access delivery system to use with its’ enCorSQ Mitral Valve Repair SystemTM. This access port may also be clinically beneficial for the delivery and use of a number of other implantable cardiovascular devices.

The MiCardia Dynaplasty Technology and the enCorSQ Mitral Valve Repair System
MiCardia has developed the world’s first clinically proven dynamic technology, “DynaplastyTM”, designed to optimize mitral valve repair, during and after surgery. Managing mitral regurgitation remains a significant problem for people with mitral valve disease. Left untreated or under managed, it can lead to more significant problems, including heart failure and death.

Currently, mitral valve regurgitation (MVR) is repaired surgically with the implantation of annuloplasty rings. However, some patients have residual MVR post‐surgery and for 15‐20% of patients, MVR significantly returns (3+ to 4+) within 6 to 12 months.

MiCardia’s Dynaplasty technology is unique and is the basis for the Company’s innovative enCorSQ. The enCorSQ can be dynamically adjusted under beating‐heart conditions to reduce the shape of the valve annulus to improve coaptation of the leaflets and reduce or eliminate regurgitation. To see an illustrated product animation, please visit the Company website at www.MiCardia.com.

The enCorSQ has received CE Mark and the annuloplasty adjustment procedure has also received reimbursement in select European countries. Using the proprietary Dynaplasty technology, this device addresses recurrent mitral regurgitation, days, weeks, months or years after the surgical procedure. The enCorSQ technology allows recurrent mitral regurgitation to be managed on an out‐patient basis, without the risk and cost of another cardiac surgery.

MiCardia is conducting a clinical registry study in a number of European hospital centers to prove the potential clinical value of the enCorSQ. Currently, over 140 patients have had the enCorSQ implanted and a number of them have had minimally invasive adjustments following recurrent mitral regurgitation both immediately after implant and up to 2 years after implantation. MiCardia’s immediate goals are to build upon this clinical success by expanding these trials to broaden the number of centers implanting the enCorSQ.

Commenting on the most recent patent issuance, Mr. Jeff DuMontelle, Vice President and General Manager said, “The issuance of this patent enhances our extensive intellectual property portfolio and further demonstrates MiCardia’s commitment to developing percutaneous solutions to resolve recurrent regurgitation in patients with mitral valve disease.”

MiCardia is a privately held Company, and is developing a completely unique treatment technology that will allow adjustment of cardiac anatomy both intra‐operatively and post‐ operatively. Surgical and percutaneous activation platforms are in advanced development.

For further information, please visit www.micardia.com or contact:
Tracy Pearson
Director of Administration
+949‐951‐4888
tpearson@micardia.com

The MiCardia enCor Mitral Valve Repair SystemTM and the enCorSQ Mitral Valve Repair SystemTM are not currently available for sale in the USA. MiCardia, Dynaplasty, enCor and enCor Mitral Valve Repair System, enCorSQ and enCorSQ Mitral Valve Repair System are registered trademarks of MiCardia Corporation. All rights reserved.

NOT AVAILABLE FOR SALE.
MICARDIA®, MICARDIA CORPORATION®, The M Logo®, ENCORSQ™, ENCORSQ MITRAL REPAIR SYSTEM™, DYNAPLASTY™ and DYNAPLASTY SYSTEM™ are trademarks of MiCardia Corporation. The ® symbol indicates that it is registered in the U.S. The ™ symbol indicates that the mark is not registered in the U.S.