Health Canada Medical Device License makes VitaSmart® available to transplant centers across CanadaU.S. FDA grants Breakthrough Device Designation for the use of the VitaSmart® System for investigational hypothermic oxygenated perfusion of donor intestines

DULUTH, Ga., Nov. 3, 2026 /CNW/ — Bridge to Life™ Ltd., a global innovator in organ preservation solutions and perfusion technologies, today announced two regulatory milestones that expand the company’s addressable market and build momentum for its VitaSmart® platform. Health Canada has issued a Medical Device License for the VitaSmart® Hypothermic Oxygenated Perfusion (HOPE) System for hypothermic oxygenated perfusion of donor livers, making the system available to transplant centers across Canada, while the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the system’s investigational use in hypothermic oxygenated perfusion of donor intestines.

More than 4,000 Canadians and over 100,000 Americans are currently on waiting lists to receive life-saving organ transplants, and the shortage of transplantable organs remains one of the greatest constraints in transplant care. VitaSmart® is designed to help transplant teams address this gap by mitigating ischemic injury and supporting confident use of more donor livers. In the U.S. Bridge to HOPE randomized controlled trial, conducted across 15 transplant centers with 219 recipients, VitaSmart® HOPE improved early allograft function in liver transplantation. These milestones strengthen Bridge to Life’s position as it converts pipeline innovation into commercial opportunities with scalable adoption.

“Securing our Canadian market authorization alongside FDA Breakthrough Device Designation continues to accelerate momentum in our global commercial trajectory,” said Don Webber, President and Chief Executive Officer of Bridge to Life™. “Our vision has always focused on removing friction points within the transplant care ecosystem. VitaSmart® is engineered to be portable, operationally versatile, and seamless to embed into standard clinical workflows. By giving surgical teams better preservation options, we aim to help them use more of the organs available to them, improve outcomes for recipients, and save more lives.”

Opportunity to save more lives with Canadian authorization

With Health Canada authorization secured, the company is set to introduce VitaSmart® to liver transplant surgeons and care teams across Canada. This achievement underscores a commitment to working alongside North American healthcare professionals to deliver technologies tailored to modern transplantation needs, advancing organ preservation standards and improving outcomes for transplant recipients. As part of this Canadian market launch, Bridge to Life™ leaders attended the Canadian Society of Transplantation (CST) Annual Scientific Meeting in Montreal, QC, in October.

FDA Breakthrough Device Designation in the U.S.

Following the FDA’s January 2026 De Novo clearance of the VitaSmart® System for hypothermic oxygenated perfusion of donor livers after static cold storage, within defined DBD and DCD donor criteria, the FDA has now granted Breakthrough Device Designation for the system’s investigational use in the hypothermic oxygenated perfusion of donor intestines. The Breakthrough Devices Program is intended to provide more timely FDA interaction and prioritized review for devices that may offer more effective treatment of life-threatening or irreversibly debilitating conditions. Breakthrough Device Designation does not constitute FDA clearance or approval, and the intestinal application remains investigational.

The designation is a meaningful milestone for the platform in intestinal transplantation, a field with significant unmet need given the intestine’s sensitivity to ischemic injury. It also builds upon Bridge to Life’s broader strategy to establish VitaSmart® as a versatile, multi-organ platform. Beyond North America, VitaSmart® is already used for both liver and kidney preservation in Europe. It is also available in Saudi Arabia, India, and in all countries accepting the CE mark.

Bridge to Life™ is also supporting active investigator studies evaluating the system’s efficacy in pancreas preservation. VitaSmart® was recently highlighted in Sydney during the 31st International Congress of The Transplantation Society, which featured presentations on successful pediatric multivisceral transplant cases involving all abdominal organs.

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is a global innovator in organ preservation and perfusion technology. Driven by a commitment to science-based innovation, the company empowers transplant teams with advanced tools that help expand the donor pool, streamline clinical workflows, and improve patient outcomes worldwide. VitaSmart® joins a preservation franchise anchored by Belzer UW®, one of the most widely used preservation solutions in abdominal organ transplantation. Together, the portfolio gives Bridge to Life™ a differentiated position spanning both established preservation and next-generation machine perfusion.

Product Development Statement

Pipeline programs described in this release, including applications for intestinal perfusion, are investigational, and are not cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. Nothing herein should be construed as a claim of safety or effectiveness for any use that has not received clearance or approval.

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SOURCE Bridge to Life, Ltd.

NEWTOWN SQUARE, Pa., Nov. 3, 2026 /PRNewswire/ — Delphinus Engineering (“Delphinus”), a leading provider of maintenance, modernization and industrial services for the U.S. Navy and maritime defense community, today announced its combination with Professional Analysis, LLC (“PAI”). Based in Alexandria, Virginia, PAI provides logistics, materials management and program support services to the U.S. Navy, U.S. Marine Corps and other Department of War customers. Delphinus is a portfolio company of Bluestone Investment Partners.

Founded in 2003, PAI has grown to more than 200 employees supporting customers across the United States and overseas. The company manages military logistics and sustainment activities for the Department of War, ensuring warfighters have access to critical resources. This includes providing spares planning and configuration management for new ship construction and delivering program support to commands including Naval Sea Systems Command (NAVSEA), Naval Facilities Engineering Systems Command (NAVFAC), Naval Supply Systems Command (NAVSUP), Military Sealift Command (MSC), Marine Corps Logistics Command (MARCORLOGCOM), and the Air Force Special Warfare Distribution Center (AFSWDC).

“For over twenty years, PAI has earned the trust of our customers by consistently delivering on our commitments,” said Stephen Mellis, Chief Executive Officer of PAI. “Delphinus demonstrates that same spirit and focus, which makes this a natural fit for our people and our customers. Together, we are bigger than the sum of our individual parts, as our team gains deeper technical resources and opportunities to grow with the fleet, while also giving our customers a single partner that can support them from the waterfront through the supply chain.”

“PAI is a strong strategic and cultural fit for Delphinus. Both companies have built their reputations by delivering for their customers and taking care of their people,” said Roby Lentz, Chief Executive Officer of Delphinus. “The combination expands our ability to support the Navy and Marine Corps across engineering, maintenance, modernization, and logistics. It is an important step toward our ambition of building the nation’s premier naval sustainment organization. We are proud to welcome the PAI team to Delphinus.”

“Bluestone partnered with Delphinus in July 2026 to build a leading naval maintenance, modernization and sustainment platform through investment in its workforce, technical capabilities and strategic acquisitions,” said Kevin Doherty, Principal at Bluestone Investment Partners. “PAI advances that strategy by connecting maintenance and modernization with the logistics and supply chain capabilities essential to fleet readiness. We are excited to support Roby and his team as they continue to grow the company.”

WISTLR served as exclusive financial advisor to PAI.

About Delphinus

Founded in 1994, Delphinus Engineering is a trusted, high-impact partner executing the U.S. Navy’s most complex ship upgrades and engineering challenges, ensuring operational agility and fleet readiness in an evolving defense landscape. Please visit www.delphinus.com for more information.

About PAI

Founded in 2003 and headquartered in Alexandria, Virginia, Professional Analysis, LLC provides logistics, materials management, and program support services to the U.S. Navy, U.S. Marine Corps and other federal customers worldwide. Please visit www.pai-inc.com for more information.

About Bluestone

Bluestone is a private equity firm investing exclusively in lower middle-market companies in the defense and government sector. Bluestone’s principals have a long and successful track record of owning, operating, and investing in businesses supporting critical national security missions. Please visit www.bluestoneinv.com for more information.

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SOURCE Bluestone Investment Partners

Latest RECMA Diagnostics Report sees OM agency OMD scoring its 12th consecutive #1 ranking, with PHD and Initiative ranked in the top five

NEW YORK, Nov. 3, 2026 /PRNewswire/ — In the latest edition of the Network Diagnostics report from RECMA (Research Company Evaluating the Media Agency Industry), Omnicom Media, an Omnicom (NYSE: OMC) Connected Capability, has again been named the best performing global media group, topping both the global ranking as well as the regional rankings across North America, EMEA, APAC and LATAM.  This marks the second consecutive report in which Omnicom Media has topped the Network Diagnostics report’s global and regional rankings.

As RECMA notes in its report, Omnicom Media “is emerging as the new industry powerhouse.”  The leader in Activity Volume/Billings with approximately 30% industry share, Omnicom Media also leads this Diagnostic Report with just under 35% of quali-share.

Widely considered the most comprehensive report for analyzing media agency performance, the bi-annual RECMA Diagnostics report is based on the evaluation of approximately 700 agencies in 45 markets. Utilizing 19 KPIs to evaluate vitality and structure, the report offers an assessment index that goes beyond typical quantitative metrics such as new business wins or billings volume alone to also consider criteria such as client portfolio and relationship stability; digital, data & content resources; and homogeneity across geographies. Participating agencies are ranked both numerically by “quali-points” and by the following profiles: Dominant, High Profile, Very Good Profile, Good Profile, and Average Profile.

The Dominant profile is awarded in a market where an agency significantly outperforms its competitors across multiple Diagnostic criteria.  In the current report, Omnicom Media agency brands were dominant in 19 markets – more than any other media group – encompassing all four regions.  

“These results are a powerful validation that our Growth by Design strategy – built on the simple premise of bringing together our singular advantages in scale, data, identity, commerce, and talent to create a competitive advantage for our clients – is working,” says Omnicom Media CEO Florian Adamski.  “Leading RECMA’s global and all four regional rankings for the second consecutive time since the integration of Omnicom and IPG’s media groups, and with three agencies among the global top five, demonstrates the strength of our connected capabilities and our ability to consistent translate them into outsize growth for the world’s leading brands.”  

The RECMA ranking lands amidst a winning streak for Omnicom Media, which in October alone won the media business for The Coca-Cola Company in North America; grocery retailer Lidl across Europe; the global assignment for Lavazza coffee; The British Council; and the L’Oréal business in the DACH region. Adding this 30-day sprint to a 2026 global and regional win record that already included Adidas, Aviva, CVS, Delta, Dyson, IBM, Novo Nordisk, Uber, and Xiaomi brings Omnicom Media’s YTD total to approximately US$10 billion in billings won or retained through competitive pitches, more than any other holding company.

Omnicom Media Agencies Dominant the Top Five

Three Omnicom Media agencies – OMD, PHD and Initiative – were among the top five best performing global media agencies, with OMD topping the ranking for the 12th consecutive report.

OMD also stood out as the most balanced agency in terms of performance across the 45 countries studied, ranked as Dominant or High Profile in 29 markets (65% of those evaluated); and was ranked #1 globally for both Digiday Data & Content Experts and its Client Portfolio Profile, which shows very good relationship stability across a roster that includes both major international accounts and a strong local client base.

Hearts United – OM’s newly launched agency that brought together Hearts & Science and Mediahub – and PHD were both among the agencies that showed the greatest increase in quali-share scores since the last report as well as over a three-year window, with Hearts United topping this ranking and PHD close behind at #3. 

Noting the positive impact that Omnicom’s acquisition of IPG has had on the OM agency portfolio, RECMA notes, “all of the group’s agencies are benefiting from the advantages in this evaluation, particularly the integration of data and digital specialist units.”

Says Adamski, “RECMA’s findings underscore the value of what we are building together. The integration of our data and digital specialists, combined with the depth of talent and expertise across our agency portfolio, is creating capabilities that are greater than the sum of their parts. We have the scale to shape the marketplace, the intelligence to make better decisions and the talent to turn those advantages into results. That positions Omnicom Media not simply to lead today’s industry, but to help define what the next generation of media looks like.”

 “Ultimately, the value of our combined capabilities is measured by what they make possible for our clients,” says Adamski.  By connecting data, identity, commerce, technology, and talent across our business, we can give clients a more complete view of their opportunities, make better investment decisions and turn those decisions into stronger business outcomes. The advantage is not simply the scale of what we bring together, but how we put it to work to help our clients grow, compete, and stay ahead in an increasingly complex marketplace.”

CONTACT:  isabelle.gauvry@omc.com

ABOUT OMNICOM MEDIA

Omnicom Media, an Omnicom (NYSE: OMC) Connected Capability, is the world’s largest global media management network. Powered by the Omni Intelligence Platform, Omnicom Media agencies leverage $75.6 billion in billings, 47,000 specialists across 70+ markets, and the industry’s most powerful portfolio identity, commerce, and intelligence assets to design dynamic Growth Ecosystems that enable the world’s most ambitious businesses to grow faster and smarter. The Omnicom Media portfolio includes global media agency brands OMD, PHD, Initiative, Hearts United, and UM; core Omnicom Integrated Media offerings Acxiom, the world’s premier identity solution, and the Flywheel end-to-end commerce solution; and specialty services across the cloud consulting, creator, financial, healthcare, and sports & entertainment categories.  For more information visit omnicommedia.com

About RECMA

RECMA was founded in June 1991 in Paris and is the only global research company that evaluates and rates media agencies qualitatively and quantitatively. RECMA is the leading research company producing a wide range of rankings and reports dedicated to the media industry professionals. RECMA collects and analyzes data from more than 1000 media agencies in 70 countries. For more information visit recma.com.

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