CryoLife, Inc. has acquired Ascyrus Medical LLC which is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent (AMDS™), the world’s first aortic arch remodeling device used for the treatment of acute Type A aortic dissections. The addition of the AMDS to CryoLife’s product portfolio further strengthens the Company’s position as a leader in the growing aortic repair market.
Strategic Rationale for the Transaction
Provides CryoLife with:
- AMDS, the first aortic arch remodeling system for use in the repair of acute Type A aortic dissections
- Significant cross-selling opportunities with CryoLife’s existing JOTEC® portfolio, BioGlue®, and On-X®
- Access to an estimated $540 million incremental global market opportunity pending regulatory approvals
- Positions the Company for high single-digit revenue growth beginning in 2021 and non-GAAP earnings growth over the next five years
- Leverages CryoLife’s existing world-wide direct sales organization calling on cardiac surgeons
“We believe the addition of the AMDS to our product offerings will make a meaningful contribution to our future growth as it gives us immediate access to the combined $100+ million EU and Canadian markets and has the potential to expand our worldwide addressable market by approximately $540 million,” said Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife. “AMDS is another highly differentiated device that, when included in our commercial channel, will further solidify our position as a global leader in aortic repair, as it will immediately strengthen our highly competitive product portfolio in Europe.”
Globally, approximately 48,000 patients suffer from acute Type A aortic dissections. Aortic dissection occurs when the innermost layer of the aorta tears and blood surges through the tear separating the layers of the aorta. In acute Type A aortic dissections, the tear in the wall of the aorta originates in the ascending aorta and continues down into the descending thoracic aorta. Left untreated, aortic dissections can lead to death. The current standard of care for repairing acute Type A aortic dissections is a hemiarch repair which involves open surgery during which the ascending thoracic aorta is replaced. Hemiarch repair typically addresses the most critical and pressing issues resulting from acute Type A dissections. However, stand-alone surgical repair is often not enough, as it does not address downstream re-entry tears or treating the false lumen beyond the ascending aorta, which could lead to issues such as continued blood flow in the false lumen, an enlarged aorta, and malperfusion with subsequent end-organ ischemia resulting from a lack of blood-flow – complications that result in costly and dangerous re-interventions, and often times, death.
Ascyrus has developed the AMDS, the world’s first aortic arch remodeling device for use in the treatment of acute Type A aortic dissections. It is used as a complement to, and in conjunction with, hemi-arch 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 less than five minutes to the procedure time. The deployment of the AMDS preserves the native arch, potentially allowing for the minimally invasive re-interventions, including the repair of additional entry tears, rather than an invasive arch repair. In the clinical trial supporting the CE Mark and Health Canada approvals, the AMDS was shown to reduce mortality, complications and reoperations compared to the standard of care, thereby improving the care of patients and offering significant cost savings for the health care system.
Michael Andrew Borger, MD, PhD, 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.”
Terms of the Agreements
Under terms of the agreements, CryoLife will acquire Ascyrus Medical for up to $200 million, consisting of:
- $80 million upfront payment, consisting of $60 million in cash and $20 million in CryoLife common stock
- Up to $120 million in milestone payments, consisting of:
- $20 million upon U.S. IDE approval, consisting of $10 million in cash and $10 million in CryoLife common stock
- $25 million upon U.S. PMA
- $10 million upon Japan approval on or before June 30, 2027
- $10 million upon China approval on or before June 30, 2027
- Up to $55 million (or up to $65M-$75M if Japanese or Chinese approval are not secured on or before June 30, 2027) based on 2 times non-European based incremental sales in the 36 months subsequent to U.S. FDA approval
Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. CryoLife markets and sells products in more than 100 countries worldwide. For additional information about CryoLife, visit www.cryolife.com.
About Ascyrus Medical
Privately held Ascyrus Medical, headquartered in Florida, has developed the AMDS, the world’s first aortic arch remodeling device for use in the repair of acute Type A aortic dissections. It is used as a complement to, and in conjunction with, hemi-arch replacement which is the current standard of care. Ascyrus received CE-Mark to commercialize in Europe the AMDS, and received Health Canada approval allowing for distribution in Canada. For additional information about Ascyrus, visit www.ascyrus.com.