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SynCardia Systems, Inc.

Press Release:

SynCardia Artificial Heart to Emerge from Chapter 11 Reorganization With New Owner on September 16, 2016

French artificial heart maker Carmat’s chief executive officer, Marcello Conviti, was quoted regarding SynCardia and the SynCardia temporary Total Artificial Heart (TAH-t) in an August 3, 2016 article published by Seeking Alpha. This response from SynCardia is to correct erroneous information in the article.

At 16-years-old Lexi Henderson became the youngest patient to be discharged from the hospital with the SynCardia temporary Total Artificial Heart (TAH-t), powered by Freedom® portable driver. She received a donor heart transplant after 386 days of SynCardia TAH-t support. At 16-years-old Lexi Henderson became the youngest patient to be discharged from the hospital with the SynCardia temporary Total Artificial Heart (TAH-t), powered by Freedom® portable driver. She received a donor heart transplant after 386 days of SynCardia TAH-t support. TUCSON, Ariz. – August 16, 2016 – “SynCardia’s machine works quite well, but it’s a very old machine with a big air compressor … I’m not surprised that they’re heading out of the market,” said Marcello Conviti.

SynCardia states it is not heading out of the market that it dominates through superior clinical results.

Here are specifics on SynCardia’s reorganization:

On August 2, 2016, the judge overseeing the Chapter 11 reorganization approved the following:

  1. The court approved for SynCardia the retention of its professionals, debtor in possession financing and bid procedures.
  2. The second order provides SynCardia with access to money to continue to make purchases and operate in its normal course.
  3. The last order entered provides for the sale of the business to Sindex. The court, after hearing all the arguments, granted a workable and reasonable time table for the business to be marketed and sold in the near term (sale date is September 16, 2016).

SynCardia is on track to serve SynCardia Certified Centers for years to come. SynCardia’s plans include the following initiatives:

  1. Complete the next generation of Freedom® portable driver, which will be smaller, lighter and virtually silent. The Freedom® driver powers SynCardia Total Artificial Hearts and provides patients with nearly unlimited mobility.
  2. Complete the FDA-approved 50cc TAH-t clinical study in the United States. The 50cc is a smaller version of SynCardia 70cc TAH-t and fits women, adolescents and men of smaller stature. The 50cc TAH-t has already been approved for use in Europe.
  3. Complete the FDA-approved destination therapy clinical study in the United States for patients who are not transplant eligible.
  4. Expand the availability of the SynCardia Total Artificial Heart to underserved populations and geographies.

Clinical Success

SynCardia agrees with Conviti’s quote that the SynCardia Total Artificial Heart “works quite well.”[1] From 1969 through August 5, 2016 there have been 1,688 implants of many different Artificial Heart designs in people. The SynCardia accounts for 1,625 of those artificial hearts implanted. There are 113 SynCardia Certified Centers worldwide, 13 of which are located in France.[2] There are more than 400 SynCardia implants for each one Carmat implant. SynCardia patients have over 550 patient years of support and Carmat has less than two patient years.

The International Society for Heart and Lung Transplantation (ISHLT) recently issued the first annual report of its Mechanically Assisted Circulatory Support (IMACS) registry. The global registry monitors the outcomes of patients receiving durable mechanical circulatory support (MCS) devices in all countries and hospitals wishing to participate.

According to the latest statistics in the IMACS report, 73.5% of patients implanted with the SynCardia Artificial Heart were either alive on the device (26.3%) or were transplanted (47.2%) at six months. This is the highest bridge to transplant rate for any durable device.[3]

New Technology

According to SynCardia, Conviti’s quote, “But it’s a very old machine with a big air compressor,” is outdated. The SynCardia Artificial Heart is powered by precisely calibrated pulses of air produced by SynCardia drivers. The drivers that powered the SynCardia Artificial Hearts have come a long way since the large first-generation drivers.

Over the last six years SynCardia has received regulatory approval by the CE Mark for Europe, Health Canada, and FDA in the U.S., for both the new Companion 2 hospital driver and Freedom® portable driver. The 50cc SynCardia Heart was approved for use in Europe on December 24, 2014.

During the same time period, over 200 clinically stable SynCardia Artificial Heart patients have benefited from the nearly unlimited mobility offered by the SynCardia Freedom® portable driver. These patients have been discharged from the hospital to enjoy life at home and in their communities. This helps patients get in better shape for their eventual donor heart transplant.[4]

Sources: http://seekingalpha.com/article/3995140-carmats-heart-approaches-market-rival-hits-buffers http://seekingalpha.com/article/3995140-carmats-heart-approaches-market-rival-hits-buffers

[1] http://www.uab.edu/medicine/intermacs/images/Federal_Quarterly_Report/Federal_Partners_Report_2016_Q1.pdf http://www.uab.edu/medicine/intermacs/images/Federal_Quarterly_Report/Federal_Partners_Report_2016_Q1.pdf

[2] http://www.syncardia.com/2016-multimedia-release/worlds-leading-artificial-heart-center-la-pitie-hospital-paris-celebrates-30-years-and-249-implants-of-the-syncardia-total-artificial-heart/itemid-1768.html

[3] http://www.jhltonline.org/article/S1053-2498(16)00049-8/pdf http://www.jhltonline.org/article/S1053-2498(16)00049-8/pdf

[4] http://www.syncardia.com/2015-multimedia-releases/1st-us-patient-discharged-from-the-hospital-without-a-human-heart-celebrates-5th-anniversary-of-going-mobile-with-the-freedom-portable-driver/itemid-1753.html

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About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is a medical technology company focused on developing and manufacturing the SynCardia temporary Total Artificial Heart (TAH-t). The SynCardia TAH-t is an implantable system designed to assume the full function of a failed human heart in patients suffering from end-stage biventricular (both sides) heart failure.

The SynCardia Total Artificial Heart is the only artificial heart that is commercially available in the United States, European Union and Canada for use as a bridge to donor heart transplantation.

More than 1,625 implants of the SynCardia Total Artificial Heart account for over 550 patient years of life on the device. Since January 2012 more than 600 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart and received a successful donor heart transplant was nearly four years (1,373 days).

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom® portable driver has been used by more than 290 patients, accounting for over 190 patient years of support.

About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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