Your Trusted Cardiovascular Device CRO
From Concept to Commercialization
Powering cardiovascular device innovation with $3B+ enterprise value delivered for MedTech leaders in the last 5 years.
Cardiovascular CRO expertise driving device innovation
At Veranex, cardiovascular device innovation isn’t just a focus—it’s our passion. With over $3B in enterprise value created for our partners, we bring unparalleled expertise to every project. Backed by 20+ years of experience supporting MedTech leaders, we’ve played a pivotal role in advancing groundbreaking cardiovascular devices that save lives and shape the future of healthcare. From first-in-class innovations to next-generation improvements, we’ve partnered with sponsors across every stage of development, ensuring success from concept to commercialization.
Living and breathing
cardiovascular innovation
every day
Product Design & Engineering Projects
Patents Secured for Cardio Clients
Completed Preclinical Service Projects
%
of All TAVI/TAVR Valves Validated with Veranex
Clinical Investigations from Pilot to Pivotal
Regulatory & Quality Projects
What clients say
Seamless solutions for every stage of your cardiovascular device journey
From Generation 1 to Generation 3 and Beyond, We’re Your Partner at Every Milestone.
Veranex is the only MedTech CRO that integrates design, manufacturing, preclinical, and clinical investigation capabilities—guided by regulatory & commercialization expertise—to advance your cardiovascular device from concept to commercialization.
By offering seamless transitions within a single partner, we eliminate inefficiencies, save valuable time, and reduce costs—enabling our sponsors, like you, to focus on innovation that transforms patient care.
Product Design & Engineering
From idea to market-leading solution, our Product Design & Engineering team delivers innovative cardiovascular solutions, seamlessly integrating the disciplines of research, industrial design, human factors, and manufacturing to transform your healthcare innovation into reality.
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Preclinical Solutions
Building on our innovative designs, Veranex’s world-class preclinical facilities in Atlanta, Worcester, and Paris set the gold standard in cardiovascular research and histopathology—delivering insights that drive success and accelerate your path to market.
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Regulatory & Quality Systems
Serving at the hub of Veranex’s integrated approach, our Regulatory & Quality Systems team provides strategic value at every stage of development. From regulatory consultations and submissions to streamlining compliance, we ensure your cardiovascular device reaches the market with confidence and precision.
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Clinical Investigations
Bridging innovation to evidence, our Clinical Investigations CRO team supports every stage of cardiovascular medical device trials. From delivering high-quality data to flawless execution, we advance your device towards regulatory approval and transformative patient impact.
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Commercial Strategy & Market Access
From early development to launch, our Commercial Strategy & Market Access team identifies pathways to success. By aligning product design with market needs, regulatory goals, and clinical milestones—including pricing and reimbursement strategies—we help position your cardiovascular device for optimal success in competitive markets.
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Your partners in cardiovascular device innovation
Silvia Anghel
Luc Behr, DVM, MsC, PhD
Bob Bouthillier
Nicolas Borenstein, DVM, MsC, PhD
Taras Bouzakine
Lisa Boyle
Irena Brants
Olivier Chevènement, DVM, PhD
Joseph Ferrara
Ramona Field
Dustin Gaidos
Genice Gallegos
Joe Gordon
Danita Harris
Greg Johnson
Robert Kieval, VDM, PhD
Valentina Lintas
Cinzia Metallo
Alexis Morlet, DVM, PhD
Michael Neidert
Jérôme Randall
Cédric Razaname
Timothy Sheflin
Brad Solberg
Michael Sweet
TAVI Delivery System
Case Study: TAVI Delivery System
Situation
In response to evolving market demands due to increasing prevalence of aortic stenosis disorder, our client was determined to improve their transcatheter aortic valve implantation device (TAVI) to become the preferred standard by surgeons.
Successes
- 175 initial concepts generated, reduced to 5 compelling directions that lead to the 1 selected delivery system.
- We harvested thought leader and end user feedback from multiple geographies (US, Germany, and Netherlands) to inform sponsor and solution positioning to drive market competitiveness.
- Veranex produced rapid prototypes with benchtop testing, to expedited development of final fit and form, leading to best-in-class solution that is gaining market share today.
- 16 months from project initiation to design freeze
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Product design refinement
Pulse Field Ablation Preclinical Study
Case Study: Pulse Field Ablation Preclinical Study
Situation
A large-animal model GLP preclinical study was needed to support a 510(k) submission for the next generation of an electrophysiology (EP) device, specifically with pulsed field ablation (PFA).
Successes
- The sponsor leveraged Veranex’s PFA expertise to design and execute a large-animal GLP study.
- We leveraged our in-house DVM to guide execution and delivery of the PFA in model supporting sponsor’s staff.
- Safety criteria was met and summarized into a report after a 30-day checkup and histopathology results.
Services by Veranex
- Preclinical Services | Paris, France
- Preclinical Services | Atlanta, GA
- Histology | Worcester, MA
TAVR Preclinical Study
Case Study: TAVR Preclinical Study
Situation
TAVR is known to migrate in animals, we created an ovine model of aortic calcification to support TAVR.
Successes
- The team leveraged their expertise to execute a cardiopulmonary bypass open-heart approach to perform annuloplasty that spared the native aortic leaflets. Two weeks later the TAVR was successfully completed.
- Leveraged in house DVM to support the Sponsor’s staff to execute study.
- The data collected demonstrated chronic performance of the valve and the acute performance of the delivery system to support an FDA submission.
Services by Veranex
- Preclinical Services | Paris, France
Your partner in cardiovascular medtech innovation & development
From groundbreaking designs to flawless clinical trials and optimized market strategies, Veranex unites world-class expertise across the entire lifecycle. Discover how we’ve helped innovators achieve faster approvals, reduced costs, and transformative patient outcomes.
