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, a startup that helps companies test new therapies on human organs, has raised $14.5 million in seed funding, the company told 附近上门 News exclusively.

New Haven, Connecticut-based Revalia launched operations in March 2023 as a spinout from . The company claims to be a pioneer of what it has dubbed 鈥溾�榟uman data trials,鈥� or as executives describe it, a new category of pre-clinical research that aims to give drug developers early and 鈥減redictive鈥� insights from real, functional human organs.

The organs used in the trials have been revived and sustained using proprietary and come from donors whose organs aren鈥檛 viable for transplant.

Revalia is seeing 鈥渟ignificant demand鈥� for its human data trial platform and, in its most recent year of operations, achieved multimillion-dollar top-line revenue, according to co-founder and CEO . It recently signed two of the world鈥檚 top 10 pharmaceutical companies as customers, he said.

Tietjen believes that Revalia鈥檚 early growth is at least in part due to what he describes as the field of biomedical innovation 鈥渕oving rapidly to human-centered development driven by recent changes at and that that simply don鈥檛 translate to human biology.鈥�

鈥淗istorically, this type of preclinical or translational research was done either in large animal models or petri-dish models using human cells,鈥� he told 附近上门 News. 鈥淥ur new approach to integrated human data provides better patient relevance than these traditional approaches and allows us to dramatically reduce the timeline, cost and risk profile of developing a new therapy.鈥�

A biophysicist and former assistant professor at Yale, Tietjen ran an academic lab focused on perfusion science. He left his tenure-track position in 2023 to work on the human, data-driven trials that serve as the premise of Revalia.

鈥淭he old model of drug development is broken 鈥� decade-long timelines, 90% failure rates, and billion-dollar costs are no longer sustainable,鈥� he said.

Business model

In its first year of operation, Revalia worked to validate demand for its human data trials and identify 鈥渢he optimal product and payment models,鈥� according to , the company鈥檚 co-founder and chief product officer.

One advantage of these types of human data trials, DiRito claims, is that researchers no longer have to 鈥済uess from animal models or in vitro chips.鈥� (The FDA in April announced to phase out animal trials for monoclonal antibodies and other drugs, she pointed out.)

鈥淲e make it possible to study human disease directly in living organs, revealing insights into human biology that were previously impossible,鈥� DiRito noted. 鈥淭hese living organs act as the Rosetta Stone of human data because they allow us to align patient history, anatomy, physiology, cellular and molecular profiles into a single complete picture.鈥�

Through its human data, the startup then aims to transform the information gleaned into 鈥渄ecision grade evidence on safety, dosing and efficacy鈥� without putting patients at risk.

鈥淛ust as importantly, human data trials create a new path for organ donation when a donor鈥檚 organs cannot be used for clinical transplant,鈥� added DiRito, a Forbes 30 Under 30 transplant scientist who鈥檚 perfused human organs and is now scaling that expertise through product at Revalia.

Funding and backers

and co-led Revalia鈥檚 seed raise, which also included participation from , former vice chair of the and a member of the board of directors at , as well as other existing backers.

Early investor and neuroscientist believed in the company鈥檚 mission so much that he joined the company to help scale it.

The startup also previously raised $5 million in pre-seed funding in the form of SAFE notes from a mix of institutional investors, angels, friends and family.

Revalia makes money in several ways.

Customers can start with an initial starter trial package. For those ready to go beyond the trial package, Revalia offers a recurring subscription model.

For now, Revalia is focused on running its human data trials in kidney disease and oncology. Looking ahead, the company plans to expand to include new diseases and applications, such as medical device testing.

鈥淲e are especially excited to expand human data trials as a companion to existing clinical trials, providing integrated data that better supports adaptive trial designs,鈥� DiRito said.

It is now launching the beta version of its platform.

, managing partner at America鈥檚 Frontier Fund, said his firm invested in Revalia because it believes that 鈥渄rug development needs a revolution.鈥�

鈥淎nd it starts with finally understanding human biology,鈥� he told 附近上门 News via email. 鈥淭he ability to generate high-fidelity, human-specific data at scale is one of the most important advancements in biomedicine today,鈥� Wilcove added in a written statement. 鈥淩evalia鈥檚 platform has the potential to not only transform clinical trials, but to strengthen national health resilience.鈥�

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