CryoLife to Host Webcast Discussing PROACT Xa Clinical Trial on December 7, 2020

Rhea-AI Summary

CryoLife, Inc. (NYSE: CRY) will host a webcast on December 7, 2020, at 4:00 p.m. EST, to discuss progress in its PROACT Xa clinical trial. This randomized trial examines the safety and efficacy of apixaban versus warfarin for patients with On-X mechanical aortic valves. Enrollment began earlier this year, targeting around 1,000 participants across 60 sites. The trial’s primary endpoints focus on valve thrombosis and safety outcomes. The aortic surgical valve market is valued at approximately $1.2 billion.

Positive

• Webcast scheduled for December 7, 2020, to discuss PROACT Xa trial progress.
• PROACT Xa trial involves approximately 1,000 participants, indicating strong investor interest.
• Clinical trial targets significant market, estimated at $1.2 billion.

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• None.

ATLANTA, Nov. 19, 2020 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it will host a webcast for investors and analysts to discuss progress with the Company's ongoing PROACT Xa trial on December 7, 2020 at 4:00 p.m. EST.

The webcast will include brief remarks by Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife Inc. followed by a presentation from Dr. John H. Alexander, Steering Committee Co-Chair of the PROACT Xa trial and Professor of Medicine at Duke University, and a Q&A session.

The PROACT Xa clinical trial is a prospective, multicenter, randomized, clinical trial to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban (Eliquis^®) rather than on warfarin.  Patient enrollment in the trial began earlier this year and is expected to continue through 2021.

To listen to the live teleconference and participate in the Q&A session, please dial 201-689-8261 a few minutes prior to 4:00 p.m. ET.  A replay of the teleconference will be available December 7 through December 14, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13713375.

The listen-only live webcast and replay can be accessed in the Investor Relations section of the CryoLife website at www.cryolife.com and selecting Webcasts & Presentations. 

About the PROACT Xa Clinical Trial
The PROACT Xa trial is a prospective, multicenter, randomized clinical trial that will include approximately 1,000 participants (500 participants in each arm) at up to 60 sites in the U.S., who are 18 years of age or older and have been implanted with the On-X Aortic Valve.  Participants will be randomized to either continue warfarin or switch to apixaban.  Each participant will be followed for at least 2 years.  The co-primary efficacy endpoints are to (1) determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X Aortic Valve for the primary composite outcome of valve thrombosis and valve-related thromboembolism and (2) determine if apixaban provides acceptable anticoagulation for patients with an On-X Aortic Valve for the primary composite outcome of valve thrombosis and valve-related thromboembolism as compared with objective performance criteria.  The primary safety endpoint is to determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) in the safety outcome of major bleeding in participants with an On-X Aortic Valve.

Worldwide, there are approximately 340,000 surgical aortic valves replaced annually placing the worldwide aortic surgical valve market at approximately $1.2 billion.

ELIQUIS is a registered trademark of Bristol-Myers Squibb Company.  Neither CryoLife nor the PROACT Xa Trial are affiliated with, sponsored, or endorsed by the Bristol-Myers Squibb Company.

The PROACT Xa rationale and study design manuscript was published by Jawitz et al. in the American Heart Journal (September 2020).

About CryoLife
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 our website, www.cryolife.com.

Contacts:

CryoLife        D. Ashley Lee                                                 Executive Vice President, Chief Financial Officer and Chief Operating Officer  Phone: 770-419-3355

Gilmartin Group LLC Brian Johnston / Lynn Lewis Phone:  631-807-1986 investors@cryolife.com

 

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SOURCE CryoLife, Inc.

FAQ

What is the purpose of the PROACT Xa trial?

The PROACT Xa trial aims to determine if apixaban is a safe and effective alternative to warfarin for patients with On-X mechanical aortic valves.

When will the webcast discussing the PROACT Xa trial be held?

The webcast will take place on December 7, 2020, at 4:00 p.m. EST.

How many participants are involved in the PROACT Xa trial?

The trial plans to enroll approximately 1,000 participants.

What are the primary endpoints of the PROACT Xa trial?

The co-primary endpoints are evaluating valve thrombosis rates and major bleeding incidents between apixaban and warfarin.

What is the market size for surgical aortic valves?

The global market for surgical aortic valves is approximately $1.2 billion.