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September 2, 2020

CryoLife Acquires Ascyrus Medical

September 2, 2020—CryoLife, Inc. announced that it has acquired Ascyrus Medical LLC, a privately held developer of the Ascyrus Medical dissection stent (AMDS), an aortic arch remodeling device used for the treatment of acute type A aortic dissections.

CryoLife will acquire Ascyrus Medical for up to $200 million, consisting of upfront payment in $60 million cash and $20 million in CryoLife common stock; and up to $120 million in milestone payments upon various regulatory approvals in the United States, Japan, and China.

According to CryoLife, the AMDS is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity. The design of the AMDS allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, adding < 5 minutes to the procedure time. Deployment of the AMDS preserves the native arch, potentially allowing for the minimally invasive reinterventions, including the repair of additional entry tears, rather than an invasive arch repair.

In February 2019, Ascyrus announced that the AMDS received European CE Mark approval, which was based on data from the prospectively controlled DARTS I trial. In the clinical trial, which also supported approval from Health Canada, the AMDS was shown to reduce mortality, complications, and reoperations compared with the standard of care, thereby improving the care of patients and offering significant cost savings for the health care system.

In August 2019, the company announced that the AMDS had received FDA Breakthrough Device Designation for the treatment of acute type A aortic dissections.

In CryoLife's announcement, Michael Andrew Borger, MD, Professor of Cardiac Surgery, University of Leipzig, Director of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany, commented, "Based on our experience with the AMDS and the published data, I believe the addition of this simple and elegant device to the standard surgical procedure for patients with acute aortic dissection will actually simplify the operation, reduce early and late complications requiring reintervention, and possibly improve survival. It is likely to become the standard of care because of its ease of adoption, simplicity, safety, and effectiveness, particularly with the sickest patients."

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