Vivifi Medical Selects Panama for First-in-Human Trial of Revolutionary Varicocele Treatment, Reinforcing Latin America as Premier Destination for MedTech Innovation
December 10, 2024. Panama's emergence as a strategic hub for medical device clinical trials has attracted another groundbreaking medical innovation, as Vivifi Medical has selected the country for first-in-human clinical trials of its revolutionary Calexis-Lap device. This decision reinforces Latin America's rapidly growing reputation as the preferred destination for innovative MedTech startups seeking efficient pathways to market while maintaining rigorous clinical standards.
Pioneering Minimally Invasive Treatment for Varicocele
Founded in 2019 by Dr. Tushar Sharma, Vivifi Medical is developing the world's first suture-less, minimally invasive solution for varicocele treatment. The Calexis-Lap device represents a paradigm shift in varicocele treatment by using minimally invasive vascular procedures rather than traditional surgical approaches.
"Panama offers the ideal environment for our first-in-human studies," said Dr. Tushar Sharma, CEO of Vivifi Medical. "The combination of modern healthcare infrastructure, favorable regulatory framework, and strategic geographic location in the Eastern Time Zone makes Panama a compelling choice for innovative medtech companies like ours seeking to accelerate the path to market while maintaining the highest clinical standards."
With NSF SBIR grants totaling over $1.25 million, Vivifi Medical is positioned to transform care for the approximately 30 million men in the US affected by varicocele, a condition that causes over 1.5 million cases of infertility.
Technology That Transforms Laparoscopic and Robotic Surgery
Vivifi Medical's Calexis-Lap technology changes the way laparoscopic and robotic surgery is performed for vascular procedures2. The company's minimally invasive approach aims to provide immediate and long-lasting reversal of varicocele, addressing a significant unmet need in male urological health.
The innovative nature of the Calexis-Lap device aligns with the cutting-edge medical technologies increasingly finding their first clinical applications in Latin America. By selecting Panama for its first-in-human studies, Vivifi Medical joins a growing trend of MedTech innovators recognizing the region's unique advantages.
Latin America's Emergence as a Clinical Trial Powerhouse
The decision to conduct first-in-human trials in Panama aligns with broader trends across Latin America, where clinical research has seen remarkable growth. The region has experienced a 138% increase in medical device trials from 2017-2020, with projections indicating the market will reach $4.08 billion by 2032.
This growth is driven by several key advantages that Latin American countries offer:
Diverse patient populations that enhance study representativeness
Improved regulatory frameworks with streamlined approval processes
Lower operational costs compared to traditional research locations
Higher patient retention rates
Eastern Time Zone compatibility for efficient communication
Modern healthcare infrastructure supporting complex research
Panama: A Strategic Hub for Medical Innovation
Panama specifically has positioned itself as a pivotal player in medical device clinical trials thanks to its strategic location, modern infrastructure, and supportive economic landscape. The country's regulatory framework for medical research is designed to uphold ethical standards and international compliance, ensuring that studies are conducted with the utmost regard for participant safety and rights.
The National Directorate of Health acts as the regulatory body, managing the approval procedure for research studies through thorough evaluation of documentation and ethical assessments before any investigation starting. This demonstrates Panama's dedication to ethical principles that are vital for comprehensive research management.
Strategic Partnerships Driving Innovation
Vivifi Medical's potential collaboration with bioaccess®, the leading Medtech contract research organization (CRO) specializing in Latin American clinical research, exemplifies the strategic partnerships driving innovation in the region. By leveraging local expertise and established clinical networks, innovative medtech startups can navigate regulatory requirements efficiently while accessing diverse patient populations.
This announcement adds to a growing list of innovative medtech companies selecting Latin America for first-in-human and early feasibility studies. Recent examples include Axoft's brain implant study at The Panama Clinic, which marked the first time bio-inspired material was authorized for human use3, and Protaryx Medical's transseptal puncture device trial.
Conclusion
Vivifi Medical's selection of Panama for first-in-human trials of their revolutionary Calexis-Lap device exemplifies Latin America's emergence as the premier destination for breakthrough medical device development. This strategic decision leverages Panama's streamlined regulatory framework, diverse patient population, and cost advantages while maintaining the highest clinical standards.
As Latin America continues its extraordinary growth in medical device trials, innovative MedTech startups increasingly recognize the region's unique combination of scientific excellence, operational efficiency, and strategic advantages. This trend establishes a new paradigm for bringing life-changing medical technologies to market faster while maintaining rigorous clinical standards.
For medical device companies interested in exploring clinical trial opportunities in Latin America or learning more about Vivifi Medical's groundbreaking work, please contact bioaccess® for strategic guidance and support.
