To the Organ Transplantation Community,
In our last Newsletter, we shared our exciting clinical data news from the World Transplant Congress (WTC) in San Francisco, where we presented our pivotal 12-month follow-up on our Bridge to HOPE (Hypothermic Oxygenated Perfusion) trial with VitaSmart™ and the 13th Congress of the International Pediatric Transplant Association (IPTA) in Berlin, Germany, where we presented the results of the first-ever multicenter study of HOPE with VitaSmart™ in pediatric liver transplants.
The cumulative outcome of those research trials of Hypothermic Oxygenated Perfusion (HOPE) with Bridge to Life’s innovative VitaSmart™ perfusion technology is a trajectory that has led to the company’s current FDA review and the potential clearance of its application by early 2026.
In short, we’re on the cusp of bringing this innovative technology to the U.S. transplant community.
Our next phase centers on aligning critical organizational developments across the company and streamlining our supply chain to better and more efficiently serve you. Our goal here is simple: to ensure Bridge to Life continues to be your trusted partner for innovative and reliable organ preservation solutions.
Based on our discussions with clinicians, the impact of VitaSmart™ on the transplant ecosystem has the potential to be nothing short of transformative, and we look forward to building a commercial strategy and organization that fully realizes that opportunity.
With Bridge to Life’s enhanced solutions supply chain and the imminent FDA clearance of our VitaSmart™ perfusion system, Bridge to Life leadership is transforming and relaunching Bridge to Life as the preeminent organ preservation company for all your organ preservation needs.
Following are company enhancements we hope will reinforce your confidence in Bridge to Life as we prepare for an exciting 2026.
And as the holidays are fast approaching, we at Bridge to Life want to wish you the healthiest, happiest and most joyous holiday season and New Year! Here’s to an exciting 2026!
Bridge to Life Strengthens Leadership Team
Meet David A. Castiglioni, our new Chief Commercial Officer
As Chief Commercial Officer, Dave is responsible for all global commercial operations, with an immediate focus on preparing for the U.S. launch of the VitaSmart™ Hypothermic Oxygenated Perfusion System upon FDA clearance.
As demonstrated by his nearly three decades of leadership experience in healthcare, medtech, and biotechnology, Dave has a proven record of building high-performing commercial teams, scaling early-stage ventures into global businesses, and driving transformative growth. He was one of the early-stage leaders that brought da Vinci Surgery to the world. He has served as CCO at Hyperfine, MediGO (acquired by CareDx), and Siren Care, where he consistently delivered rapid revenue growth and successful go-to-market strategies across the U.S., Europe, and Asia-Pacific.
Dave’s track record of building world-class commercial organizations-highlighted by his years at Intuitive-combined with his deep experience bringing creative product offerings to customers, makes Dave a great fit to guide the U.S. launch of VitaSmart™, and the next wave of growth for Bridge to Life’s complete transplantation solutions offerings.
Most importantly, Dave will be focused on you and how Bridge to Life can support your lifesaving efforts and, frankly, simplify your operations and make the organ preservation process easier for you.
New Role for Brian Lenz as Chief Financial Officer
Life sciences industry veteran Brian Lenz, our newly appointed Chief Financial Officer, brings more than 20 years of leadership experience as a CFO, along with serving in other senior executive capacities at several life sciences companies. Over the course of his career, he has raised over $1 billion in equity and debt financings, including successfully taking two companies public.
As CFO, he was also an integral contributor at the various companies he served in the areas of mergers and acquisitions, licensing transactions, and guiding companies from research and development through to commercialization and profitability, resulting in exponential market capitalization growth from less than $100 million in value to greater than $1 billion in value.
Over the past two and a half years, Brian has served as a highly engaged member of our Board of Directors, and in that time, Bridge to Life has developed a strong working relationship built on shared vision and trust. His excitement about Bridge to Life’s future prospects-particularly the expected future FDA clearance of VitaSmart™-has only grown stronger. Combined with his proven ability to drive growth, implement financial discipline, and build high-performing teams, we are confident Brian will help us scale and deliver on our mission.
Brian will continue to serve as a member of the Board of Directors.
Prior to joining Bridge to Life, Brian spent 12 years at ADMA Biologics, where he served as Chief Financial Officer and General Manager of its subsidiary ADMA BioCenters. Previous to ADMA he was the CFO and COO at CorMedix, and prior, served as CFO in several other biotechnology companies. Brian began his professional journey in audit with KPMG. He is a licensed CPA, earned his bachelor’s degree from Rider University, and received his MBA from St. Joseph’s University.
Bridge to Life Receives FDA 510(k) Clearance for Multi-Sourced Belzer UW® and MPS® Solutions with Expanded Labeling for MPS® Across All Abdominal Organs
Bridge to Life is excited to share that we have received FDA 510(k) clearance for its multi-sourced Belzer UW® and MPS® organ preservation solutions. Notably, this clearance includes expanded labeling for Belzer MPS® UW Machine Perfusion Solution to cover all abdominal organs - a first-of-its-kind milestone in the field of transplantation.
Customer Assurance and Supply Continuity
Bridge to Life’s solutions are utilized daily by Organ Procurement Organizations (OPOs) and transplant centers throughout the United States and internationally. To ensure uninterrupted access, the company maintains a minimum 60-day global inventory buffer and has established multiple exclusive supplier agreements across key regions. This approach enhances operational resilience and mitigates supply chain risks, while also enabling the delivery of highly customizable solutions to meet the evolving needs of our customers.
Advancing Global Regulatory Approvals
In parallel, Bridge to Life is pursuing CE Marks for its preservation solutions, with approvals anticipated in 2026. These efforts highlight BTL’s commitment to global access and compliance with evolving regulatory standards.
From Distributor to Industry Leader
With longstanding exclusive rights to Belzer UW® and MPS® from the University of Wisconsin and the addition of BTL-owned EasiSlush®, the company has built a portfolio of trusted brands that have supported transplants for more than a decade. In addition to solutions, Bridge to Life continues to invest in engineering and next-generation product development, positioning itself as the only company offering both foundational preservation solutions and innovative perfusion technologies.
Upcoming Clinical Conferences
Bridge to Life is proud to share that we are Platinum Sponsors of this year’s Donate Life Egypt 2025, to be held in Cairo, Egypt during International Transplantation Week, November 12-15, 2025. This global conference will join representatives from around the world.
Bridge to Life wholly supports the DLE Cairo Charter: One Vision, One Hope, One Heart. Further, Bridge to Life will be participating at DLE 2025 in a machine perfusion wet lab.
Bridge to Life is also excited to participate in the 2025 Congress of the International Society for Organ Donation Professionals (ISODP), a partner of The Transplantation Society (TTS).
ISODP has an important role in bringing together clinicians, managers, administrators, researchers and others with leading roles and a commitment to improving quality of life for organ transplant patients.
The 2025 Organ Donation Congress/17th Biennial Congress of International Society for Organ Donation Professionals will be held this year in Kyoto International Conference Center, December 3-6, 2025.
VitaSmart™ is CE-Marked and available in several markets outside of the United States. VitaSmart™ is pending FDA clearance in the United States.
