In the news release, Valcare Medical, Inc. Announces Corporate
Restructuring and Appointment of New CEO, issued 24-Apr-2024 by Valcare Medical over PR Newswire,
we are advised by the company that there have been edits in first,
third, and fourth paragraph. The complete, corrected release
follows:
Valcare Medical, Inc. Announces Corporate Restructuring and
Appointment of New CEO
TAMPA,
Fla., April 24, 2024 /PRNewswire/ -- Valcare
Medical, Inc., a leading innovator in transcatheter-based mitral
solutions, today announced a comprehensive corporate restructure by
a group of investors led by Techwald Next, aimed at accelerating
the company's plans to initiate the AMEND mitral annuloplasty
clinical studies in Europe and
the United States.
As part of the restructuring, TechWald has appointed
Steve Sandweg to serve as Chief
Executive Officer. Sandweg brings a successful 25-year history in
the medical device space having worked for both Fortune 500 and
startup companies in the cardiovascular and structural heart space.
Sandweg most recently served as Chief Commercial Officer for EBR
Systems, Inc, developer of the world's only wireless cardiac pacing
system for heart failure. Prior to that, Sandweg worked for
Keystone Heart where he served as General Manager, and Direct Flow
Medical serving as Director, US Clinical Field Operations.
Sandweg began his cardiovascular and structural heart career
with Medtronic Corp. in 2006 where he held positions of increasing
responsibility with Medtronic's peripheral vascular, coronary, and
structural heart business units. While with Medtronic, Sandweg
played a key role in helping execute several strategic product
launches including Endeavor and Resolute, the company's first drug
eluting stents and Corevalve/EVOLUT, the company's first
transcatheter aortic valve devices.
"I'm excited and honored to be joining such a remarkably
talented team," Sandweg said. "The corporate restructure offers a
unique opportunity for us to increase focus and accelerate
performance. Following the success of our first in human experience
in which 33 patients were treated with AMEND and showed
promising results (17 treated under clinical protocol and followed
out to 6 months), we are eager to now begin enrolling
patients in the AMEND Plus European pilot study and continuing our
work with the FDA on a future IDE submission."
In addition to the appointment of Sandweg, the company also
appointed a new Board of Directors led by Executive Board Chair,
Chris Richardson. Richardson has
over 30 years of experience in the medical device industry, and an
extensive record of successfully leading medtech startups from
clinical study phase through regulatory approval, commercial
launch, and acquisition.
Prior to joining the Valcare Medical Board, Richardson served as
President and CEO of Keystone Heart which was acquired by Venus
Medtech in 2018. He also served as International President and
Chief Commercial Officer of Direct Flow Medical, a transcatheter
aortic valve company, and General Manager of Evalve (MitraClip),
which was acquired by Abbott Vascular in 2009.
"We're fortunate to have Steve come on board at this important
stage in Valcare's development," said Chris
Richardson. "Steve has the experience and operational track
record the company needs at this time to execute on its ambitious
plan to transform the standard of care for patients suffering from
severe mitral regurgitation."
Valcare's AMEND mitral valve repair device is an innovative,
clinically proven, D-shaped, semi-rigid closed ring with
proprietary anchoring capabilities. AMEND is designed to provide
clinical standard-of-care surgical treatment via a
transcatheter-based procedure. The AMEND platform also serves as
the foundation for Valcare's future mitral replacement and
tricuspid repair solutions.
The AMEND device is limited to investigational use and is not
commercially available.
For more information, contact:
info@valcaremedical.com
About Valcare Medical:
Valcare Medical is dedicated to providing innovative minimally
invasive technologies for the treatment of mitral
regurgitation.
www.valcaremedical.com
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SOURCE Valcare Medical