In March, our Fund III Investment Committee spent a morning with Randy Hubbell, CEO of Solaris Endovascular. He walked us through a covered stent that releases a drug at the exact spot where covered stents fail. By the end of the meeting, the question on the table wasn't whether the technology was interesting. It was whether we could underwrite the risks fast enough to participate.
We could. Here's the thinking.
The problem
Patients on hemodialysis depend on a surgically created access point, usually a fistula or graft in the arm, that gets punctured several times a week and carries far more blood flow than the vessel was built for. That flow injures the vessel wall. Scar tissue narrows it. The access fails, and the patient goes back for another procedure. Balloon angioplasty, the standard fix, keeps vessels open only about half the time at six months. Covered stents raised that to roughly 75%. Better, but the failures didn't disappear. They moved. Across every major covered stent on the market, restenosis now clusters at the stent edges, where the covering ends and bare metal meets the vessel. Roughly one case in four still fails, almost always right there.
The company's answer
Solaris DE takes the company's covered stent platform, already approved in 45 countries with more than 15,000 units sold internationally, and adds the drug sirolimus, released precisely at the exposed edges. Not coated everywhere, which is how coronary drug-eluting stents work. At the edges, where the failures happen. The PTFE covering protects the treated lesion; the drug defends the two spots the covering can't reach.
The major endovascular players sell covered stents or drug-eluting stents, not both in one device. The company estimates a competitor starting today would need years and upwards of $75 million to catch up, with a patent pending on exactly this approach.
The team
Randy Hubbell is on his sixth company, with operating history at IBM, Boston Scientific, and Johnson & Johnson. At J&J he helped launch Cypher, the first drug-eluting coronary stent, which reached $1 billion in revenue in eight months. He later led commercialization at Cardiva Medical and took Carmel Therapeutics public in 2023. Alongside him: Dr. Marco Costa, a globally recognized interventional cardiologist, as Chief Scientific & Medical Officer.
The team that commercialized the original drug-eluting stent is now applying the same playbook to a device class it already understands.
What the committee weighed
Four things carried the decision. A failure mode you can point at, and a device engineered against that specific mode rather than a general claim of "better." A commercial platform that already sells in 45 countries, so the drug-eluting variant rides on proven hardware. A leadership team with direct, repeated experience taking exactly this kind of device from clinic to market to exit. And a company structured for capital efficiency from day one, with a regulatory strategy built to de-risk in stages rather than all at once. The FDA Breakthrough Device application was already in motion when we met.
We also talked honestly about what could go wrong. Class III devices live or die on regulatory timelines. Six-month patency has to hold at twelve. Strategics move on their own clocks. None of that is avoidable. What we underwrote was a team that has crossed this terrain before, working on a problem specific enough to solve.
And because it's part of every Beyond Capital decision: our criteria include high-integrity, values-driven leadership. That doesn't get verified on a checklist. It shows up in how founders talk about their patients, their people, and their obligations when no term sheet is on the table. The committee came away convinced.
What's happened since
Two months after our meeting, the FDA granted Solaris DE Breakthrough Device Designation. And in September, the full six-month DEScover results arrived: 92.7% patency, a 26-point advantage over balloon angioplasty in the randomized arm. The bet is doing what bets rarely do: resolving early, in the right direction.
Read the DEScover results from CIRSE 2026 →
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About Solaris Endovascular: a U.S.-based, growth-stage medical technology company developing next-generation endovascular covered stents for dialysis access dysfunction and peripheral artery disease.
Solaris DE is an investigational device and is not approved for commercial sale in the United States. Company, clinical, and competitive figures are as presented by Solaris Endovascular. This insight is provided for information purposes only and is not an offer to sell or a solicitation to buy securities, nor investment advice. Past performance is not indicative of future results.