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Fortuna Devices In The News

PRESS RELEASE:   -----  January 2, 2024,  Birmingham, AL.

Fortuna Devices Inc officially opens the first round of financing.

 

The aim of the first financing round is to accomplish device freeze stage, further engage FDA towards 510(k) clearance, and complete First In Man (FIM) clinical study. The round is being opened to private investors and other companies.

PRESS RELEASE:   -----  December 1, 2023, Birmingham, AL.

Fortuna Devices announces creation of Company Advisory Board.

Fortuna Devices is pleased to announce agreements with world clinical & business leaders to serve on company Advisory Board.

Dr. Zvonimir Krajcer, Marv Woodall, and Marvin Slosman are considered Key Thought Leaders in Endovascular Medicine and graciously agreed to serve on our Advisory Board.

 

  • Dr. Krajcer is an interventional cardiologist at The Texas Heart Institute Center for Cardiovascular Care and a member

of Texas Heart Institute’s Professional Staff. He is an active member of the Texas Heart Institute Cardiovascular Disease Fellowship Program at Baylor St. Luke’s Medical Center teaching staff, training our next generation of physician-scientist and interventional cardiologists. His leadership and commitment to important international research and education collaborations is impacting the care of patients suffering from vascular diseases worldwide.

Dr. Krajcer is an internationally recognized pioneer in his field and is the immediate past President of the International Society for Endovascular Specialists dedicated to the advancement of vascular and endovascular therapies. He serves as the Editor in Chief of Texas Heart Institute Medical Journal.

Since 1996, Dr. Krajcer has participated as a co-investigator and principal investigator in many clinical trials for the treatment of peripheral arterial disease, abdominal and thoracic aortic aneurysms, and carotid artery stenosis including: Corvita AAA trial, Hemobahn Trial, AneuRx AAA Trial, AneuRx Thoracic trial, Wallgraft Trial, Carotid Wallstent Trial, Sapphire Carotid Stent Trial, BEECH Carotid Trial, Sapphire World Registry Trial, Archer Carotid Stent Trial, Choice Carotid stent Trial, Capture I & II Carotid Stent Trials, Endologix EVAR Trials, Valor I and Valor II Trial, Captivia Thoracic Trial, Captivia Acute Dissection Trial, and Excluder Original Design vs. Low Permeability Design study.

 

  • Mr. Woodall’s distinguished career at Johnson & Johnson spanned nearly 37 years, where he retired in 2001.

He served as the President of Johnson & Johnson Interventional Systems, Inc., leading the team responsible for pioneering its multibillion-dollar cardiovascular franchise. His tenure at J&J included the development and launch of the transformational PALMAZ-SCHATZ® Coronary Stent and development of the world’s first drug eluting stent. Mr. Woodall, while at Johnson & Johnson, was subsequently responsible for Health Economics Worldwide, for the Cordis circulatory disease business franchise.

He has served as the Chairman, or CEO or Board member of the Lehigh Valley Hospital and Health Network, Doylestown Hospital, the Cardiovascular Research Foundation, the International Society of Endovascular Specialists, Spectranetics, CardioMEMs, Inc., Contego Medical, LLC, and Percutaneous Valve Technologies, Inc. plus several community based non-profit entities, including the Free Clinic of Doylestown, the Heritage Conservancy, and the Playhouse Artists of the Bucks County Theater. Currently he serves as The Chairman of the Board of Thrombolex, Inc.

He received his undergraduate degree with a B.B.A. in Management and Finance from the University of Oklahoma and he completed graduate studies at Harvard, Columbia, and Duke Universities

 

  • Marvin L. Slosman is the CEO of InspireMD (Nasdaq: NSPR), a commercial-stage medical device company

with proprietary and innovative stent designs with integrated embolic prevention systems (EPS) delivering neurovascular protection and stroke prevention. InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for sustained embolic protection, neurovascular protection and stroke prevention. InspireMD is focused on changing the carotid/neurovascular market through expanding its portfolio of solutions and indications to advance patient outcomes.

Marvin has 34 years as a medical technology executive, with global experience, broad medical segment expertise (Cardiovascular, Peripheral Vascular, Diagnostic Imaging, Sleep, Neuro Surgery and Orthopedics), Blue-chip pedigree (GE, J&J, Baxter) combined with early-stage (Emerge, Phormax, Ovalum, Itamar) leadership. Broad technology category expertise (major capital, small capital, devices, implantable devices, disposables and supplies).

Achievements include an IPO, multiple funding tranches, and M&A transactions; operating leadership , investor, consultant, and board member.

PRESS RELEASE:   -----  October 5, 2023, Birminham, AL.

FDA Confirms Fortuna Devices Inc 510k designation, and offers guidance regarding further testing.

 

In their letter dated October 5, 2023 FDA agreed with Fortuna Devices Inc 510(k) Pathway Notification, and predicates submitted by the company. It also offered guidance regarding further testing, including interaction with other devices, and benchtop tests regarding specific anatomies.

PRESS RELEASE:   -----   September 18, 2022,  Houston, TX

Fortuna Devices Inc conducts successful Porcine Clinical Study at Texas Heart Institute Animal Lab.

 

In September 2022 Fortuna Devices successfully conducted live animal study in Houston, testing the devices in different porcine anatomies.

Please watch the testimony of Dr Zvonimir Krajcer, MD, PhD, 

Co-Director, Peripheral Interventions, Texas Heart.

Editor In Chief, Texas Heart Institute Journal

Professor of Medicine, Baylor College of Medicine

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