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Cardiva Medical Awarded Internationally Recognized Shingo Bronze Medallion From the Shingo Institute for Operational Excellence

SANTA CLARA, Calif.–(BUSINESS WIRE)–#ShingoPrize–Cardiva Medical, Inc., an innovator in the field of vascular closure,
today announced that the company has been recognized for Operational
Excellence from The
Shingo Institute
, part of the Jon
M. Huntsman School of Business
at Utah State University. Based on a
thorough assessment of organizational culture and operations, Cardiva’s
manufacturing facility in Guaymas, Mexico was awarded the Bronze
Medallion as recognition of the site’s ongoing commitment to operational
excellence throughout all levels of the organization.

“Receipt of the Shingo Bronze Medallion signifies an organization’s
mastery of fundamental tools and techniques for improving an
organization’s operations,” said Ken Snyder, executive director at the
Shingo Institute. “Organizations such as Cardiva that receive the Bronze
Medallion are making great progress on their journey to achieving
enterprise excellence.”

Built in 2014 to support growing sales volume of Cardiva’s vascular
closure technologies, the Guaymas, Mexico facility is dedicated to
manufacturing Cardiva’s VASCADE® Vascular Closure System and
CATALYST® Closure Wire. Led by plant manager Jesus Beltran,
the facility started implementation of the Shingo Principals as it was
being designed and staffed, and since opening has grown the number of
employees by over 700 percent. The plant has also supplied product for
the recently completed AMBULATE
Clinical Trial
and will be the future manufacturing site of VASCADE®
MVP – a first-of-its-kind mid-bore venous vascular closure device
designed for multi-access electrophysiology procedures.

“True to the Shingo principles, Cardiva is committed to creating value
for our customers by driving quality and delivering innovative vascular
closure devices that help patients receive the best care possible,” said
Justin Ballotta, Cardiva’s chief operating officer. “Implementing the
Shingo principles has helped us create a culture committed to growth,
continuous improvement, and lean processes, and we are grateful for the
recognition and guidance from the Shingo Institute throughout this
process.”

By implementing the Shingo Principals, Cardiva’s manufacturing facility
has been able to support a three-year growth rate of 183 percent – a
sales growth that recently earned Cardiva recognition on Inc.
Magazine’s Inc. 5000
list as one of the fastest growing
private companies in the United States.

Cardiva Medical, Inc. designs and develops vascular access management
products that facilitate rapid hemostasis following diagnostic and
interventional endovascular procedures. Since its founding, Cardiva has
introduced a series of advanced vascular access management technologies
that have been adopted by hundreds of leading medical centers.

Cardiva Medical will receive Shingo’s Bronze Medallion award during the
Awards Gala at the 31st Shingo Conference held April 28–May 3, 2019, in
Cincinnati, Ohio.

About the VASCADE Vascular Closure Systems

VASCADE is a fully integrated, extravascular, bioabsorbable femoral
access closure system that is easy to use, leaves no permanent
components behind, and has demonstrated safety and efficacy in a wide
range of patients. The system combines Cardiva’s proven proprietary
collapsible disc technology and a thrombogenic resorbable collagen patch
in an integrated design. For patients and healthcare providers, VASCADE
enables secure and rapid hemostasis while minimizing complications,
including bleeding at the access site.

VASCADE works by placing a small, collapsible mesh disc against the
inside of the vessel wall to temporarily stop the bleeding, releasing a
collagen patch into the tissue and then removing the mesh disc. The
collagen patch expands, providing a mechanical and physiological seal to
stop the bleeding, and then absorbs into the body, leaving nothing
behind and allowing further access to the vessel if additional
procedures are required.

The VASCADE MVP System is a new, investigational device built upon the
established and clinically proven VASCADE system.

About Cardiva Medical, Inc.

Cardiva Medical, Inc. is a privately held medical device company focused
on developing and commercializing innovative vascular closure
technologies. The company is headquartered in Santa Clara,
California. For further information, visit our website at www.cardivamedical.com and
follow us on Twitter at @CardivaMedical.

VASCADE® and Cardiva Catalyst® are registered
trademarks of Cardiva Medical®, Inc.

About the Shingo Institute

The Shingo Institute is home of the Shingo Prize, an award that
recognizes organizations that demonstrate an exceptional culture that
fosters continuous improvement. Part of the Jon M. Huntsman School of
Business at Utah State University, the Shingo Institute is named after
Japanese industrial engineer and Toyota advisor, Shigeo
Shingo
. Dr. Shingo distinguished himself as one of the world’s
thought leaders in concepts, management systems, and improvement
techniques that have become known as the Toyota Production System.

Drawing from Dr. Shingo’s teachings and years of experience working with
organizations worldwide, the Shingo Institute developed the Shingo
Model™ which is the basis for its several educational offerings,
including workshops, study tours, and conferences. Workshops
are available in multiple languages through the Institute’s licensed
affiliates
. For more information on workshops, affiliates, or to
register to attend the International Shingo Conference, please visit www.shingo.org.

Contacts

for Cardiva Medical, Inc.
Sierra Smith, 408-540-4296
sierra@healthandcommerce.com