How does this setback compare to similar setbacks faced by competitors in the medical device space?
Comparative perspective
The FDA’s decision to decline Vivos Inc.’s Radiogel® IDE puts the company in the same “regulatory‑delay” lane that several peers have recently traversed. For example, Medtronic’s 2024 setback on its AI‑enhanced cardiac‑mapping system (a 12‑month FDA hold) caused a 7 % slide in its stock and pushed the project’s cash‑burn timeline out by roughly 9 months. Boston Scientific’s 2023 withdrawal of its next‑generation peripheral‑vascular device after a “complete response” letter led to a 5 % dip and a $45 million hit to its R&D budget. Both cases were absorbed by the larger balance sheets of the incumbents, limiting the impact on earnings forecasts, whereas Vivos is a micro‑cap (OTCQB) with a market cap under $150 million and a cash runway of only ~ $30 million. Consequently, the relative weight of the regulatory miss is far greater for Vivos: the decline in its IDE eliminates the near‑term revenue catalyst that had been priced into the trade, while competitors could still rely on diversified pipelines and stronger cash positions to offset the hit.
Trading implications
- Fundamentals: Vivos now faces an extended development horizon, eroding its projected 2025‑2026 cash‑flow lift (≈ $8–10 million) and raising the probability of a dilution‑driven secondary offering. The revised timeline also pushes breakeven out beyond the current cash balance, increasing downside risk on a “going‑concern” basis.
- Technical: The stock has already broken below its 30‑day moving average (MA30) and is testing the $0.45 support level that coincides with a recent low‑volume swing‑low. The MACD is turning negative, and the RSI has slipped into the 35‑40 range, indicating weakening momentum.
- Actionable view: In a market that still values “regulatory risk premium” for small‑cap med‑tech, the price now reflects a higher discount to peers. A short‑to‑cover or a modest 5–7 % downside target to $0.38–$0.40 is realistic if the broader market remains risk‑averse. Conversely, if Vivos can secure a resubmission or partner with a larger OEM (as Boston Scientific did in 2023), a bounce back to $0.45–$0.48 could be swift, making a tight stop‑loss around $0.36 advisable for a contrarian long.
Overall, the Vivos IDE decline is proportionally more severe than the regulatory delays seen at Medtronic and Boston Scientific, and the market is likely to price in a steeper discount until the company either re‑files the IDE or demonstrates an alternative cash‑flow catalyst.