About us

Solaris Endovascular, Inc. is a growth stage US-based medical device company developing advanced endovascular solutions for patients suffering from dialysis access challenges and peripheral artery disease.

With a proven stent platform and innovative drug-eluting technology, led by seasoned executives with extensive experience in cardiovascular MedTech, Solaris Endovascular is uniquely positioned and committed to improving long-term patient outcomes and transforming vascular health.

Endovascular focus

Groundbreaking, evidence-based solutions that extend the patency of dialysis access grafts, fistulas and peripheral arteries enabling patients to lead healthier lives with fewer interventions.

Conditions TREAted

End-Stage Kidney Disease (ESKD)

End-Stage Kidney Disease (ESKD) is a major health concern affecting approximately 10 million people worldwide with approximately 3 million people that are receiving kidney replacement therapy and relying on hemodialysis to survive. 

Over 50% of these patients experience vascular access failures within the first year and are subjected to hospital admissions and repeated costly endovascular or surgical interventions to restore their lifeline to dialysis—this drastically impacts quality of life, treatment effectiveness and survival.

Intervention (Non-surgical) options

1. Percutaneous Balloon Angioplasty, with or without a drug coating​

2. Stents (small metal mesh tubes to provide scafolding support to improve blood flow and keep vessels open and improve blood flow)​

3. PTFE Covered Stent Grafts

Peripheral Artery Disease (PAD)

Peripheral Artery Disease (PAD) is a progressive disorder that occurs when plaque builds up in the arteries, limiting blood flow to the legs and feet with 113M people effected worldwide.​

After diet and exercise, the most common treatments are​ bypass surgery and intervention.

Intervention options

1. PTA – Percutaneous Transluminal Angioplasty, with or without a drug coating​

2. Stents (small metal mesh tubes that are inserted into the artery to keep it open and improve blood flow)​

3. PTFE Covered Stent Grafts

Management team

Randy Hubbell

President & CEO

  • Randy is a proven leader in medical technologies, who has successfully commercialized multiple transformational medical devices and globalized multiple business for both Johnson & Johnson and Boston Scientific. His previous experience includes his service as: Vice President, Worldwide Marketing at Johnson & Johnson; Chairman, President and Chief Executive Officer at Carmell Corporation (NASDAQ: CTCX); and Chief Commercial Officer at Cardiva Medical, Inc. (a start-up which was acquired by Haemonetics). . Randy holds a Bachelor of Science degree in Computer Science from Tulane University and a Master of Business Administration from Loyola University of New Orleans.

Marco Costa

Chief Scientific & Medical Officer

  • Marco is a Co-Founder, Chief Medical Officer, and Director of Solaris Endovascular. An internationally recognized interventional cardiologist and medical device innovator, he is one of the world's foremost experts in drug-eluting vascular technologies, having served as Principal Investigator or Steering Committee member for numerous landmark trials that transformed treatment of coronary and peripheral vascular disease. His research includes more than 500 peer-reviewed publications, making him one of the most highly cited physician-investigators in interventional cardiovascular medicine. Prior to co-founding Solaris, Marco held leadership positions at leading academic medical centers and global medical device companies, guiding clinical development and regulatory evaluation of multiple first-in-class cardiovascular technologies. At Solaris, he leads clinical development, medical affairs, and physician engagement, and has been instrumental in conceiving the Solaris DE platform — the first sirolimus-eluting covered stent designed to address edge restenosis. His expertise shapes the Company's clinical strategy, including the DEScover clinical program and regulatory pathway toward U.S. FDA approval.

Rowan Hettel

Chief Technology Officer

  • Rowan serves as Chief Technology Officer of Solaris Endovascular, leading the Company's technology strategy, product development, manufacturing, and engineering. He is a recognized medical device innovator with 20 years of experience developing and commercializing breakthrough cardiovascular and endovascular technologies, with a career spanning roles at Stryker, Inari Medical, LimFlow SA, Boston Scientific, Johnson & Johnson, and Boeing. Most recently, Rowan served as Director of R&D at Stryker Peripheral Vascular, leading the Emerging Therapies franchise (LimFlow and Artix) and Concept Teams responsible for organic pipeline development. As part of the original LimFlow SA startup, he led engineering of the novel venous arterialization technology for patients with chronic limb-threatening ischemia, including development of the first FDA-approved endovascular implant utilizing electrospun PTFE — the same material technology that forms the foundation of the Solaris SX and Solaris DE platforms. LimFlow SA was acquired by Inari Medical in 2023, then by Stryker in 2024. He holds a BS in Mechanical Engineering from Stanford University, an MS in Mechanical Engineering from UCLA, and is named on more than 95 granted patents worldwide.

Janet Vargo, PhD

Head of Regulatory

  • Janet serves as Head of Regulatory & Clinical Sciences at Solaris Endovascular, leading the Company's global regulatory strategy, clinical development, and regulatory authority interactions. She brings more than 30 years of experience in medical device and combination product development, with expertise spanning regulatory affairs, clinical strategy, quality systems, and product approvals across cardiovascular, vascular, and interventional medicine. Before joining Solaris, Janet held senior regulatory and clinical leadership positions at leading medical device companies, directing regulatory submissions, clinical trial strategy, and approvals for numerous Class II and Class III devices. Her experience spans IDE applications, PMA submissions, Breakthrough Device Designation strategies, international approvals, and post-market clinical evidence generation. At Solaris, Janet leads regulatory and clinical strategy for the Solaris DE and Solaris SX programs, including securing FDA Breakthrough Device Designation for Solaris DE and establishing the regulatory pathway for the Company's U.S. clinical development program. She also oversees clinical trial design, regulatory submissions, and compliance activities supporting the Company's global development efforts.

Matthew Head

Chief Financial Officer

  • Matthew is the Chief Financial Officer of Solaris Endovascular, where he leads the company’s financial strategy and operations as it advances innovative technologies for the treatment of dialysis access disease and peripheral artery disease. He brings more than 25 years of executive finance and operational leadership experience across the medical device, biotechnology, and healthcare industries, with a proven track record of helping growth-stage organizations scale, secure capital, and execute strategic initiatives.
    Before joining Solaris Endovascular, Matthew served as Chief Financial Officer for OncoNano Medicine, where he played a key role in supporting the development of the company’s platform technology, fundraising efforts, and corporate growth. Earlier in his career, he held senior finance leadership positions at ZS Pharma (acquired by AstraZeneca) and at Alcon Laboratories (acquired from Nestlé by Novartis), building deep expertise in financial planning, business strategy, mergers and acquisitions, product launches and operational excellence.
    Matthew holds a BS in Economics from The University of the South (Sewanee) and an MBA from the M.J. Neeley School of Business at Texas Christian University. Matthew is recognized for combining financial discipline with a collaborative, business-focused leadership style.

Board

Randy Hubbell

President & CEO

  • Randy is a proven leader in medical technologies, who has successfully commercialized multiple transformational medical devices and globalized multiple business for both Johnson & Johnson and Boston Scientific. His previous experience includes his service as: Vice President, Worldwide Marketing at Johnson & Johnson; Chairman, President and Chief Executive Officer at Carmell Corporation (NASDAQ: CTCX); and Chief Commercial Officer at Cardiva Medical, Inc. (a start-up which was acquired by Haemonetics). . Randy holds a Bachelor of Science degree in Computer Science from Tulane University and a Master of Business Administration from Loyola University of New Orleans.

Marco Costa

Chief Scientific & Medical Officer

  • Marco is a Co-Founder, Chief Medical Officer, and Director of Solaris Endovascular. An internationally recognized interventional cardiologist and medical device innovator, he is one of the world's foremost experts in drug-eluting vascular technologies, having served as Principal Investigator or Steering Committee member for numerous landmark trials that transformed treatment of coronary and peripheral vascular disease. His research includes more than 500 peer-reviewed publications, making him one of the most highly cited physician-investigators in interventional cardiovascular medicine. Prior to co-founding Solaris, Marco held leadership positions at leading academic medical centers and global medical device companies, guiding clinical development and regulatory evaluation of multiple first-in-class cardiovascular technologies. At Solaris, he leads clinical development, medical affairs, and physician engagement, and has been instrumental in conceiving the Solaris DE platform — the first sirolimus-eluting covered stent designed to address edge restenosis. His expertise shapes the Company's clinical strategy, including the DEScover clinical program and regulatory pathway toward U.S. FDA approval.

Melchiades Cunha

Board Member

David M. Stack

Independent Director

  • David is a proven healthcare executive, investor, and public company leader with more than three decades of experience building, financing, commercializing, and scaling innovative life sciences companies. Most recently, he served as Chairman and CEO of Pacira Biosciences from 2007 to 2024, transforming it into a leading commercial-stage biopharmaceutical company focused on non-opioid pain management, leading it through its IPO, multiple FDA approvals, and international expansion while building an intellectual property portfolio extending into 2041. His previous experience includes his service as President, CEO, and Director of The Medicines Company, where he helped build one of the era's most successful cardiovascular specialty pharmaceutical companies. There, he raised more than $300 million in financings and grew it to a market capitalization exceeding $1.3 billion. He also served as Managing Director of Commercial Operations at MPM Capital, a leading healthcare venture capital firm. A recipient of the Ernst & Young Entrepreneur of the Year Award for Healthcare, David currently serves on multiple public and private company boards. He holds a Bachelor of Science in Pharmacy from Albany College of Pharmacy and a Bachelor of Science in Biology from Siena College.

Alex Moreira

Board Member

scientific/ Medical Advisors

Dr. Peter Schneider

Senior Medical Advisor

  • Peter is a nationally recognized vascular surgeon, clinical investigator, and educator with more than three decades of experience advancing endovascular therapies for peripheral vascular disease and complex aortic interventions. As a Medical Advisor to Solaris Endovascular, he provides strategic guidance on clinical development, physician adoption, trial design, and commercialization strategy. Internationally regarded as one of the pioneers of modern endovascular surgery, Peter has served as Principal Investigator and Steering Committee member for many multicenter clinical trials that helped establish new standards of care in peripheral artery disease, dialysis access, aortic aneurysm repair, carotid disease, and complex endovascular interventions. A prolific author, he has published hundreds of peer-reviewed articles and is a frequent invited faculty member at major international vascular meetings, having trained thousands of vascular surgeons and interventional specialists worldwide. At Solaris, Peter advises on clinical strategy, physician engagement, market development, and the design of U.S. clinical programs for the Solaris DE and Solaris SX platforms.

Dr. Ziv Haskal

Senior Medical Advisor

  • Ziv's research has spanned the breadth of interventional radiology, from foundational work in TIPS and complex portal hypertension — including preclinical and human studies leading to the TIPS endograft used by the majority of the world — to interventional trans-arterial gene vector studies, the first demonstration of IR radiation eye injury risks at occupational levels, and advances in dialysis access care, including the first randomized (‘NEJM ‘FLAIR’) trial establishing covered stents as a superior to angioplasty for AV graft stenosis. He has published more than 400 manuscripts, chapters, and books in journals including the New England Journal of Medicine, Circulation, Hepatology, Radiology, CVIR, and JVIR; the AHA/ACC PAD Guideline he co-chaired has been cited over 7000 times, and his H-index exceeds 60. He has led or participated in more than 50 human and animal research studies, led multiple PMAs resulting in devices used across more than 80% of the world, and has consulted for organizations from startups to large companies on strategy, device design, and trial design. Ziv has given more than 700 invited lectures worldwide and received numerous national and international awards for innovation, leadership, and research excellence. He served as Deputy Editor-in-Chief of CVIR, doubling its Impact Factor, then as two-term Editor-in-Chief of JVIR, tripling its submissions and raising its Impact Factor to 3.037. He has founded or led several national and international scientific congresses, including the SIR annual meeting, and SIR EDGE, and has mentored hundreds of trainees over nearly 30 years.

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Contact Us

Partner with us to redefine patient outcomes for hemodialysis access and PAD.

randy@solarisendovascular.com

3232 McKinney Ave., Suite 500
Dallas, TX 75204