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February 09, 2016 1:24 AM ET

Healthcare Equipment and Supplies

Company Overview of SynCardia Systems, Inc.

Company Overview

SynCardia Systems, Inc., a medical technology company, focuses on developing, manufacturing, and commercializing the SynCardia temporary Total Artificial Heart (TAH-t) in the United States, European Union, and Canada. Its SynCardia TAH-t is an implantable system designed to assume the full function of a failed human heart in patients suffering from advanced heart failure. The company was founded in 2001 and is headquartered in Tucson, Arizona.

1992 East Silverlake Road

Tucson, AZ 85713

United States

Founded in 2001

116 Employees

Phone:

520-545-1234

Fax:

520-903-1783

Key Executives for SynCardia Systems, Inc.

Chief Executive Officer, President and Director
Age: 60
Co-Founder and Director
Age: 72
Co-Founder, Chief Scientific & Medical Officer and Chairman of Science Advisory Board
Age: 59
Chief Financial Officer
Age: 52
Senior Vice President of Regulatory Affairs and Quality
Age: 68
Compensation as of Fiscal Year 2015.

SynCardia Systems, Inc. Key Developments

SynCardia Hires Canaccord To Consider Strategic Alternatives

SynCardia Systems, Inc. has initiated a process to explore and evaluate all potential strategic alternatives to maximize stakeholder value, including a possible sale of the business. Michael Garippa, SynCardia Chief Executive Officer, said "SynCardia develops and manufactures the only FDA and CE Mark Total Artificial Heart, an implantable system designed to assume the full function of a failed human heart in patients suffering from advanced heart failure. The SynCardia Board of Directors has retained Canaccord Genuity to evaluate and identify strategic alternatives aimed at optimizing the value of our business and technology, which have resulted in over 1,500 implants of our Total Artificial Heart in patients globally.” Conaccord Genuity Inc. has been hired by SynCardia to explore and evaluate all potential strategic alternatives.

SynCardia Systems Seeks Acquisitions

SynCardia Systems, Inc. is seeking acquisitions. SynCardia Systems, Inc. has filed an IPO in the amount of $40.00 million, the net proceeds of which will be used to in-license, acquire, or invest in complementary businesses, technologies, products or assets.

SynCardia Systems, Inc. Receives FDA Approval to Conduct an Investigational Device Exemption Clinical Study on the Effective Use of 50cc SynCardia Temporary Total Artificial Heart

SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart. The FDA approval will allow SynCardia to launch the study with as many as 30 heart failure patients. Patients enrolled in this study will receive the 50cc SynCardia Total Artificial Heart as a bridge to a donor heart transplant. Under the study, the 50cc SynCardia Total Artificial Heart initially will be available for implantation in - 10 pediatric patients 10-18 years old - 10 adult patients 19-75 years old - 10 patients who would not otherwise qualify under the study criteria. This secondary arm is expected to further characterize the use of the 50cc SynCardia Heart. All patients in the study must be eligible for donor heart transplant. As part of the study and to better understand the patient populations that can benefit from the 50cc SynCardia Heart, images of the patients' chest cavities will undergo 3D modeling. Study data through the first six months of patient use will be provided to the FDA as part of its review and approval process. Patients will be followed for up to two years to report on their experiences.

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