Company That Designed, Funded, Ran, Analyzed, And Wrote Study Thrilled To Report Study Shows Their Product Works

VALENCIA, CA — In a development that has shocked absolutely no one familiar with medical device funding, SetPoint Medical announced this week that a study designed by SetPoint Medical, funded by SetPoint Medical, conducted by SetPoint Medical, analyzed by SetPoint Medical, and written by SetPoint Medical employees who own SetPoint Medical stock has conclusively determined that SetPoint Medical's product is safe and effective.

The study, published in the journal Nature Medicine—which apparently now accepts elaborately formatted press releases as peer-reviewed science—found that implanting electrodes on patients' vagus nerves and zapping them with electricity while they sleep produced results described as "statistically significant" in the same way a coin landing heads 53% of the time is "statistically significant."

"We are thrilled to report that our device works," said Dr. David Chernoff, the study's corresponding author, SetPoint Medical employee, and holder of stock options that will vest if the FDA approves the device he just declared safe and effective. "And I want to be clear: my financial interest in reaching this conclusion did not influence my completely objective analysis of data my company collected about my company's product."

The trial's mathematics tell a compelling story. Of patients who received active treatment, 35.2% showed improvement. Of patients who received sham treatment—the exact same surgery, but with the device set to 0 milliamps—24.2% also improved. The company is seeking FDA approval based on the 11 percentage points they claim credit for, while hoping regulators don't ask why nearly a quarter of patients got better from completely fake surgery.

"The 24% placebo response is actually encouraging," explained a spokesperson, visibly perspiring. "It proves the surgery itself has therapeutic value. The belief that someone installed something in your neck is almost as effective as actually installing something. We're choosing to view this as a feature, not a bug."

The enrolled patients had already failed an average of 2.6 prior medications. Forty-three percent were classified as "difficult-to-treat"—medicine's euphemism for "we've exhausted our options." These patients chose experimental neck surgery over trying drug number four. The paper calls this "strong patient preference for nonpharmacologic treatment options." It might also be called desperation.

Side effects were described as "mild to moderate" and included vocal cord paralysis in 4.5% of patients—treated by injecting filler into the affected cord. Some patients required a year of voice therapy to relearn how to speak. The paper notes these effects "resolved," without specifying that "resolved" sometimes meant "the patient eventually adjusted to their new voice."

In one notable incident, a patient who decided the device wasn't working requested removal. During explantation, the surgeon caused a "pharyngeal perforation"—puncturing the patient's throat. The paper states this was "immediately repaired," which the company insists is the relevant detail, rather than the fact that a hole was accidentally made in someone's pharynx during an elective procedure.

The conflicts of interest section reads like a pharmaceutical industry directory. Twenty-five authors disclosed ties to 63 different companies. Lead author Dr. John Tesser alone lists relationships with seventeen corporations. Multiple authors are SetPoint employees holding "equity/stock options and intellectual property/patents"—meaning they profit directly if the device they evaluated gets approved.

Patient satisfaction was reported at 78%. Critics note that measuring satisfaction among people who've undergone irreversible neck surgery may not be entirely objective. "Of course they're satisfied," observed one analyst. "What are they going to say—'I had neck surgery for nothing'? That's not satisfaction. That's sunk cost fallacy with sutures."

The device requires weekly maintenance via a "wireless charging device worn around the neck." Patients' immune systems now run on firmware. The company has not announced whether the charger will be available in designer colors or if users can expect push notifications about their inflammatory reflex.

As of press time, SetPoint's stock had risen 847%, the FDA was "reviewing" the data, and approximately 24% of patients continued improving from absolutely nothing at all.