The Outer Biosciences skin AI platform feeds on something no large language model can scrape from the internet: living human tissue, kept functional outside the body for up to a month, generating biological data that simply did not exist before. The company emerged from near-total public silence this week, and the details it is sharing are worth pausing on.
Michael Polansky, the startup’s chief executive, is better known in tabloid pages as the partner of Lady Gaga than in biotech circles. That is about to change. Polansky co-founded Outer Biosciences alongside chief scientist Kyung-Jin Jang, chief technology officer Chris Hinojosa, and chief business officer Stanley King. BioPharma Dive reports the company was formed in 2020, not 2022 as stated in some early descriptions, with Polansky telling the publication that it took ‘a long time in startup years’ because so many components of its skin-preserving process had to be custom-built from scratch.
Keeping Skin Alive: The Foundation of the Outer Biosciences Skin AI
The core problem Outer Biosciences set out to solve is that biology has no ethical equivalent of a software test environment. Animal models and simplified cell cultures behave differently from real human organs. Lab-grown organoids are better, but still imperfect proxies. So the company sources skin that would otherwise be discarded after surgery, principally plastic surgery, through vetted non-profit and commercial biobanks operating under institutional review board oversight and documented donor consent. The two primary suppliers are the National Disease Research Interchange and the Cooperative Human Tissue Network, both of which receive federal funding from the NIH and the National Cancer Institute.
Tissue arrives within hours of surgery while it is still living. A proprietary support system then feeds nutrients to the sample and removes metabolic waste, extending viability well beyond the industry norm of a few days. Outer Biosciences keeps tissue alive for up to 30 days, and Polansky says it retains its ‘day-zero architecture and preserves its day-zero epidermal, stromal and immune-associated molecular programs.’ In practical terms, month-old tissue still closely resembles tissue on the day it was collected, though not indistinguishably so.
That extra time opens biological windows that short-lived samples cannot. Researchers can induce UVB damage, then track the stress, inflammatory, and recovery responses that follow over the subsequent weeks. Collagen remodelling, pigmentation change, and barrier repair, all processes that take weeks to unfold, become observable for the first time under controlled experimental conditions.
750 Million Compounds a Year, Six Active Leads
The company’s platform, named Yuna, has generated more than 10 terabytes of data across more than 300 donors and some 10,000 compound-sample pairings, with each pairing producing more than 30,000 data points, according to BioPharma Dive. The same outlet reports that Yuna can computationally screen roughly 750 million compounds annually.
The workflow is a closed feedback loop. An AI model predicts which untested chemicals are likely to improve a specific skin function. Those chemicals are run through the living-tissue system. The results, whether the prediction proved correct or not, feed back into the model, sharpening the next round of predictions. Early on, the company used a brute-force approach: mining scientific literature and partnering with the National Cancer Institute on natural compounds from extreme environments. That phase produced a couple of leads over roughly 18 months. With AI embedded in the process, the company now generates a new candidate approximately every six weeks. Six leads are currently active in its pipeline, and Polansky says several dozen additional hits have been logged. Four of the six active leads appear likely to reach commercialisation.
The target market is narrow but uncluttered. The FDA maintains rules covering 13 categories of over-the-counter skin drugs, and across all of them only about 120 to 130 active ingredients are approved. Add cosmetic ingredients backed by substantive research and the number climbs to roughly 200. Outer Biosciences is discovering cosmetic ingredients rather than regulated drugs, so there is no FDA approval to pursue. The commercialisation route runs through two steps: first, securing a standardised industry name for the ingredient, then safety testing under guidelines set by the OECD, whose 40-plus member countries agree to accept each other’s properly conducted studies.
Rather than build a consumer brand, the company plans to licence or sell finished ingredients to beauty or pharmaceutical companies, which will formulate them into products and bring them to market under their own labels. Revenue is already flowing from collaborative research partnerships, including a pharmaceutical partner studying why certain cancer drugs cause severe skin rashes.
Funding, Team, and a Competitive Field
To date, Outer Biosciences has raised roughly $23 million. Early backers include Wing Ventures, Initialized, and Polansky’s own investment firm, Hawktail. FinSMEs reports the syndicate also includes Sozo Ventures, Lightspeed Venture Partners, Third Kind Venture Capital, Liquid 2 Ventures, and SV Angel. The company employs 19 people, with all but Polansky based just outside Cambridge, Massachusetts.
Polansky came to life sciences through cancer immunotherapy. He spent more than a decade managing the business, investment, and philanthropic interests of Sean Parker, including helping establish the Parker Institute for Cancer Immunotherapy. The Parker Institute for Cancer Immunotherapy lists his role as Executive Director of the Parker Foundation. The institute itself was created through a $250 million grant from The Parker Foundation and now encompasses collaborations with Memorial Sloan Kettering Cancer Center, Stanford Medicine, UCLA, UCSF, the University of Pennsylvania, and MD Anderson Cancer Center, among more than 40 industry and non-profit partners, according to the institute’s own announcements.
The competitive landscape is filling in. Philadelphia-based Vivodyne, which builds lab-grown human organ tissue rather than working with natural tissue, announced a $38 million seed round led by Khosla Ventures, followed by a $40 million Series A also led by Khosla, bringing its total funding to close to $80 million. Other competitors are pursuing organ-on-a-chip and microphysiological systems for preclinical testing.
Polansky’s position, for now, rests on a simple asymmetry: unlike AI companies training on internet-scraped text, there is no biology internet to scrape. The data Outer Biosciences generates does not exist anywhere else. All of its AI work runs on-premise rather than in the cloud, because, as Polansky puts it, ‘we don’t want the data in the cloud.’ The next step on the roadmap is building a product-development team with experience turning discovered compounds into manufactured, safety-tested ingredients. The pace of discovery is already set. The question is whether the commercial infrastructure can keep up.
