Imricor's SEC Registration Statement Targets FDA Approval in 2026. Reaching That Date Would Now Take a Review Faster Than Any of the 141 Cardiovascular Approvals on Record.

The claim#

The document is a registration statement — the Form 10 by which Imricor Medical Systems, Inc., a Delaware company whose CDIs trade on the ASX, registered its shares with the US Securities and Exchange Commission this year. The target sentence first appears in the original Form 10, filed on 18 March 2026 — seven weeks before the May placement was announced. The amendment of 24 April 2026 expanded the paragraph around it with the module chronology, and the amendment of 15 May 2026 repeats that expanded paragraph word for word:

“We are pursuing approval of our Vision-MR Ablation Catheter 2.0 (for treating Type I atrial flutter) and RF-5000 ablation generator system through the PMA pathway. We are utilizing a modular PMA submission strategy for these products, with the first module submitted in June 2024 and the second module submitted in March 2025. We expect to submit the third module in Q2 2026 and plan to submit the fourth module following completion of enrollment in the VISABL-AFL clinical trial and when the resulting clinical data have been cleaned and analyzed. Following submission of the fourth module, we expect the FDA to review the complete PMA application under its standard PMA review procedures, and we are targeting receipt of FDA approval for these devices in 2026.”

And, separately, in the same filings:

“We anticipate completing enrollment in the VISABL-AFL trial in the second quarter of 2026, with data analysis and FDA submission targeted for the middle of 2026. Regulatory approval timeline is contingent on trial outcomes and FDA feedback.”

The dates are these. A A$60m placement — 32,432,433 CDIs at A$1.85 — settled on 7 May 2026. The amendment carrying the paragraph forward was filed on 15 May, and the registration became effective by lapse of time on 17 May (US time) — the ordinary sixty-day operation of the Exchange Act for a Form 10 filed on 18 March, involving no SEC review or approval of its contents. The sequence is recorded here because it dates the target’s last appearance, not because it implies anything about why the paragraph was carried forward: the paragraph predates the placement, and the placement did not rely on the registration statement — the company’s 10-Q records that the CDIs were “sold to non-U.S. persons in Australia” under the Regulation S exemption. The presentation for the raise listed, among six uses-of-funds objectives, “Gain FDA clearance for the EP platform in the U.S. in CY2026”; its word is “clearance”, the 510(k) term that fits the platform’s mapping and diagnostic devices, and the slide does not restate the PMA approval target. The 15 May amendment is the last SEC narrative filing in which the target appears — a Form S-8 filed on 25 June incorporates earlier filings by reference and does not restate it — and its text reached the ASX when the amendment was lodged there on 18 May.

The market context: at A$1.99 — the last ASX close before publication, 17 August 2026 — the 358,572,497 shares of Class A common stock on issue (the Form 10-Q cover count of 7 August, which includes all shares underlying CDIs) are worth A$714m. Revenue for the six months to 30 June 2026 was US$24,643 — twenty-four thousand dollars, not million — all of it European, against a net loss of US$25.1m. The company’s own filing states the pair plainly: it “incurred a net loss of $25,139 thousand on revenues of $25 thousand.” In seven full years since its August 2019 ASX listing, revenue has never reached US$1m in any year, and FY2025, at US$292,309, was the lowest of them. This paper is not about solvency — cash and short-term investments were US$67.5m at 30 June, roughly 2.5 years of runway at the current burn — and it is not about the merits of the device, the trial, or the clinical data. It is about a date.

The constraint#

The constraint is the public record of the regulator itself, in four parts, none of which the company controls.

First, the final module is unfiled — on the company’s own words. An RF cardiac ablation catheter for type I atrial flutter is a Class III device (product code OAD); it requires a Premarket Approval, not a 510(k) clearance. FDA’s PMA database — queried through its own openFDA service at the 3 August 2026 refresh — holds zero records for Imricor, while a control query for an established cardiovascular applicant returns 557. The zero is not itself evidence in either direction: the database is a register of decided applications, and a PMA under review is confidential under 21 CFR 814.9, so a filed-and-pending application would also show nothing. What establishes that the fourth and final module is unfiled is the company’s own statement of 10 August: the final module “will be submitted following completion of the VISABL-AFL clinical trial which is in the later stages of enrolment.” The three Imricor entries that do exist on the FDA record are 510(k) clearances for a diagnostic (recording) catheter and the NorthStar mapping computer, granted January and June 2026; the company’s August materials describe four 1H-2026 clearances including pediatric label expansions, and the register’s three entries at the 3 August refresh may simply lag them. None of the cleared devices ablates.

Second, the clock has not started, and modular review does not shorten it. The judges of this thesis inside the desk raised the obvious objection: the 180-day statutory review period is a ceiling, not a floor, and the modular pathway exists to compress the end of the process. FDA’s own guidance, reissued January 2025, answers it. Modules are pre-reviewed at a 90-day objective each; on receipt of the final module the application converts to an original PMA; a filing decision follows within 45 days; and — verbatim — “the filing date is the date that the application became complete, typically the receipt date of the final module. The 180-day ‘PMA clock’ under 21 CFR 814.40 also begins on that date.” Modular review front-loads preparation. It does not shorten the review that follows the final module. The company’s own registration statement expects the same thing: “standard PMA review procedures.” No Breakthrough Device designation, priority review or any other expedited pathway appears anywhere in the company’s filings — searched across all four SEC documents — and FDA publishes no register of such designations that could be checked directly, a limitation noted in the methodology.

Third, the base rate. How long does the review after the final module actually take? The desk did not take a summary statistic on faith: it pulled all 27,699 PMA decision records from FDA’s database for 2015 through 13 August 2026, extracted the 413 original PMAs (records with no supplement number, de-duplicated), and computed the distribution of calendar days from date_received to decision_date. For the 141 approved originals reviewed by FDA’s Cardiovascular advisory panel — Imricor’s panel — the fastest review on record took 128 days, the tenth percentile 177, and the median 304. The check that date_received means what this analysis needs it to mean — the date the completed application was received, which for a modular PMA is the final module — is the shape of the distribution itself: 25 of the 141 cardiovascular approvals fall inside the narrow band of 171–189 days, just under the 180-day statutory clock, while only 5 sit below 170 — a pile-up hard to explain unless the recorded date is the one that starts the clock. A second, weaker triangulation is stated with its limits in the methodology box: FDA’s published average total time to decision for the FY2023 cohort (original PMAs and panel-track supplements together) is 302 calendar days, against this dataset’s median of 327 and mean of 468 for approved originals across 2015–26 — different cohorts and different statistics, consistent in order of magnitude and no better than that. FDA’s negotiated MDUFA V goal is a decision within 180 FDA days for 90% of applications, and a shared total-time-to-decision goal of 290 calendar days for FY2023 — a goal FDA’s report to Congress says it missed, at 302.

Fourth, the trial. The final module cannot be filed until VISABL-AFL — the 91-patient pivotal trial of the ablation catheter — completes enrolment and its data are, in the company’s words, “cleaned and analyzed.” ClinicalTrials.gov registers the trial as RECRUITING, with a primary completion date of 31 December 2026 and an enrolment field that has read “91, ESTIMATED” — never an actual count — since 30 June 2023. The record was last updated on 13 April 2026, 127 days before this paper. The company’s own statement is more current and points the same direction: on 10 August 2026 its quarterly report said the trial “is in the later stages of enrolment”, and its Form 10-Q, filed 7 August, said “We are continuing enrollment.” Whatever the trial’s true position, on the company’s own words enrolment was not complete eight days before this paper was published — six weeks after the end of the quarter in which the registration statement anticipated completing it.

The gap#

Count the days. From 18 August there are 135 days left in 2026.

Suppose, first, the impossible-favourable case: the final module is already at FDA today. A 2026 approval would then need a review in 135 days or fewer. One of the 141 cardiovascular approvals on record — 0.7% — was that fast, and the MDUFA decision goal itself is 180 FDA days. The counterfactual is false, but it is worth stating because everything real is worse.

Now the company-favourable scenario the desk actually prices. Take the 10 August statement — “later stages of enrolment” — at its most generous and assume the last patient is ablated on 31 August, three weeks from that statement. The trial’s primary endpoints run to 7 days post-procedure; give the acute data a 7-day window and assume FDA accepts a final module built on the primary endpoints alone, with the 90-day chronic endpoints to follow — an assumption in the company’s favour that FDA may not share. Allow 21 days for database lock, event adjudication, statistical analysis and module assembly — faster than the company’s own April guidance implied. The fourth module is then filed on 28 September 2026, and 94 days of the year remain.

Zero of the 141 approved cardiovascular original PMAs since 2015 were decided in 94 days. Across every panel, not just cardiovascular, two of the 349 approved originals came inside 94 days — an opioid-risk genetic test at 85 days and a pathology assay at 92, both in-vitro diagnostics, neither an implantable cardiac device — so the cardiovascular restriction removes nothing that would help the company. The fastest cardiovascular review — Medtronic’s Harmony valve, 2021 — took 128 days. To approve by 31 December, FDA would have to beat the fastest cardiovascular review of the last eleven years by 27%, on a first-of-kind MRI-guided ablation platform, under the standard procedures the company itself expects. One loophole cannot be closed from the register, and is stated plainly: FDA publishes no list of Breakthrough Device designations, and openFDA’s expedited-review flag is a legacy field that does not record them — Harmony itself was a Breakthrough-designated device by its sponsor’s own announcement, though the register flags it otherwise. That cuts against the company’s date, not for it: the 128-day record was set by a device carrying an expedited designation that Imricor has never disclosed for its application. The two nearest analogues by product code point the same way: the only approved original PMA since 2015 under Imricor’s exact product code, OAD — Boston Scientific’s Blazer open-irrigated ablation catheter, decided February 2016 — took 387 days, and the only one under the adjacent ablation-catheter code LPB — Stereotaxis’ MAGiC ablation catheter, a first-of-kind robotic catheter from a small-cap sponsor, decided January 2026 — took 633.

Run the same arithmetic backwards and the conclusion sharpens. For a 31 December approval at the record 128-day review, the module must be filed by 25 August — which, allowing the same 28 days from last ablation to filing, means the last patient needed to be ablated by 28 July 2026, twenty-one days before this paper. At the tenth-percentile review, by 9 June. At the median, by 2 February. Even a zero-day data lock — last ablation today, module filed the moment the 7-day endpoint closes on 25 August — leaves 128 days: exactly the fastest review on record, with no day to spare. A 2026 approval now requires both that enrolment is already effectively over, against the company’s own “continuing enrollment” eleven days ago, and that FDA matches or beats its fastest cardiovascular review since at least 2015.

And the base case is not close. Take the registry’s own estimate — primary completion 31 December 2026 — at one month’s discount, so the last ablation falls on 30 November. Add the 90-day chronic follow-up the registered endpoints actually run to, and 60 days to lock, analyse and file. The module is filed on 29 April 2027; module 4 does not reach FDA inside 2026 at all. At the median cardiovascular review the approval lands on 27 February 2028 — 423 days past the registered target. At the tenth-percentile review, 23 October 2027. The desk asserts no impossibility — the statute’s 180 days is a ceiling, FDA can be faster, and two reviews in eleven years were faster than 140 days. The claim is a bound: the target standing in the registration statement is outside every observed precedent, on the company’s own most favourable public facts.

One number would collapse the pessimistic end of this range: the enrolled count. It does not exist in public. Not in the registry, which has carried “91, ESTIMATED” unchanged for three years; not in any of the four narrative SEC filings; not in one of the 32 ASX-lodged quarterlies, presentations and reports the desk reviewed back to 2022; not in the Dutch or Swiss national registers, which carry the trial’s protocol but no accrual; not in any journal or conference abstract — Europe PMC returns zero hits for the trial name. Two years and two months into a 91-patient trial whose protocol triggers an interim analysis at 76 patients, no cumulative enrolment figure has ever been published by anyone. No rule requires a sponsor to publish rolling accrual, and the desk does not suggest otherwise. It refuses to estimate the count, and says plainly: the timing case above rests on the review-time record, which is sufficient, and not on an enrolment rate, which cannot be computed.

Corroboration#

Everything below is secondary. None of it is the thesis; each is a dated fact consistent with it.

The finish line has receded at the speed of the calendar. The trial’s registered primary-completion date has carried four values — the original registration and three re-registrations: 15 December 2023, then 31 December 2024, then 31 July 2025, then 31 December 2026 — 1,112 days of slippage across 1,013 days of elapsed calendar between the first and latest registration. The registered date is currently the fourth answer to the same question, and for three years it has moved away at almost exactly the speed time passes.

The company’s own promised dates trace the same curve. On the ASX record: “All 91 patients in the VISABL-AFL trial are expected to be treated by year-end CY24, opening the door for FDA approval of Imricor’s platform of capital and consumable devices in CY25” (quarterly report, 30 April 2024); “we are on track with our goal of completing enrolment in 2024” (CEO commentary, 31 July 2024); “Expected FDA approval: Mid 2025” (investor presentation, August 2024); “preparing for the commercial launch following US FDA approval expected in the second half of 2025” (quarterly report, 23 January 2025). After February 2025 the “Expected FDA approval” line disappears from every ASX-native presentation and quarterly — the last dated approval target given to the ASX in an ASX-native document was “2H 2025”. In July 2025 the company said it in its own words: “We have faced some delays on the PMA schedule with the FDA. However, module 2 is currently under review by the agency, and the regulatory and quality teams continue to progress module 3 which will be submitted early in Q4.” Module 3 was submitted in June 2026, roughly two quarters after that commitment. The sister trial shows the same arc over a longer span: VISABL-VT was expected to begin enrolment in Q3 2023 and actually commenced in April 2025.

The 2026 target lived a narrower life than the earlier ones. It reached the ASX only as the text of the US filings that carry it — the 154-page “Form 10 Registration with the U.S. SEC” lodged 19 March, the 160-page “Amendment to Form 10” lodged 27 April, and the 197-page “Amendment to Form 10” lodged 18 May, each the required ASX release of an SEC document. No ASX-native quarterly or presentation ever stated it. The quarterly report lodged on 28 April, the day after the first amendment, gave no date. The 4 May placement announcement gave no date; its forward statements were “Fund the commercial rollout in 2027 and beyond” and “Commence VT trial in the U.S. in 2027”. The placement presentation carried the objective “Gain FDA clearance for the EP platform in the U.S. in CY2026” — “clearance”, the 510(k) term, without restating the PMA approval target. The nearest an ASX-native document came is the February 2026 results presentation, whose value-driver slide for “2025/26” listed “FDA Approval for US commercial release of platform technology” without a date of its own.

In August 2026 the target is absent from the company’s forward story — and the registration statement is not the kind of document that updates. The company lodged four documents with ASX in August: the Form 10-Q of 7 August, and the quarterly report, results presentation and a commercial-momentum announcement of 10 August. None restates the target. The 10-Q contains zero occurrences of “PMA”, “premarket approval”, “module” or “targeting” — against eight, three, five and five in the 15 May amendment — though a Form 10-Q is an update, not a full business description, so the absence of the paragraph is expected and is not a retraction; the desk does not treat it as one. Its only forward statement on the trial is “We are continuing enrollment.” The quarterly commits to “completing VISABL-AFL enrolment and submitting the final PMA module” — submission, not approval — and describes “14 of 15 total FDA submissions (510(k) and PMA) … complete or under review”. The company’s phrasing is accurate on its own terms; the desk sets out what the tally counts so a reader can weigh it: the four modules of the single PMA application count as four of the fifteen submissions, alongside eleven 510(k) items, and the one item not yet complete or under review is the fourth module — the document whose receipt starts the statutory review clock. The presentation repeats the tally and lists “Final PMA submission / approvals” as an undated bullet on its value-drivers slide for “2H 2026 and beyond”, following the section heading “2H 2026 & into 2027”. The commercial-momentum announcement does not mention the trial or the application at all. The load-bearing fact is narrower than a retraction claim, and no retraction is claimed: no document since 15 May restates the 2026 target, none amends it, and a Form 10 is not brought current after effectiveness — its description stands until a later filing replaces it, which is the mechanism, not a duty neglected.

What the market is being told, and what it is paying. The CY2026 “revenue inflection point” in the company’s August materials is attributed to NorthStar capital sales after two named US hospital customers, a Philips scanner-compatibility declaration, and a vendor-financing facility — not to ablation approval. Neither customer announcement discloses a contract value, which is ordinary for individual hospital orders; it means the inflection cannot be sized from the record, and the desk does not attempt to. The revenue base beneath the claim is the seven-year record above. The company’s stated explanation for FY2025’s decline is that European sites enrolling trial patients consume catheters that are not recognised as product revenue; the desk records that explanation as given and has no basis to dispute it — it means part of the revenue base is suppressed by the trial itself and will be released as the trial completes. Reported short interest was 0.15% of issue at the 11 August ASIC report — roughly tripled off a March low, and still effectively nil. The desk found no published version of the review-clock arithmetic anywhere it could search; HotCopper’s forums and Reddit could not be read by the desk’s tools, and the freshness claim is scoped accordingly.

Two further items on the record. First, executive option grants made in May 2025 include performance conditions tied to “the first U.S. customer site product order following FDA approval and the first sale of product in the U.S. following FDA approval”. The 10-Q’s share-payment note explains that no expense had been recognised because achievement “was not considered probable as of June 30, 2026”, gives the accounting basis — “Under current U.S. GAAP, milestones related to the receipt of regulatory approvals are generally not considered probable until the regulatory approval is obtained” — and adds: “Subsequent to June 30, 2026, the Company’s assessment of the probability of achieving these conditions increased based on information obtained after period end, indicating that achievement of these conditions may no longer be dependent upon additional regulatory approvals.” The obvious reading, and the one the company’s own August record supports, is that the milestones are now expected to be met on clearances already granted rather than on the PMA: NorthStar was cleared under 510(k) in January and June 2026, and the company announced its first two US hospital customers on 27 July and 10 August, after the balance date. Read that way, the note says nothing about the ablation application. Performance vesting tied to regulatory and commercial milestones is standard practice in the sector, and the desk draws no inference from any of this about the company’s disclosure choices. Second, the company’s ASX reporting regime changed in May 2026. Its Form 10 became effective on 17 May (US time), making Imricor a US public reporting company; on 27 May it announced that ASX had granted a waiver from the quarterly Appendix 4C cash-reporting rules, on ASX’s stated basis that requiring two sets of periodic reports “would impose unnecessary duplication where market disclosure would not be improved”, and on the condition that information usually required by the ASX report and “not otherwise covered by the corresponding SEC filing, will be included with the filing”. The waiver was ASX’s decision, is ordinary for a dual-regime issuer, and nothing about it is improper. Its practical effect is that the Appendix 4C’s “receipts from customers” line — US$1.23m cumulatively across the final eight quarters it was published, against US$37.6m of operating outflow — has no direct line-item equivalent in a Form 10-Q, so readers who tracked it will need to derive it from the SEC cash-flow statements instead.

What would explain this instead#

The registry is stale and enrolment is nearly done. The strongest version of the innocent case. The ClinicalTrials.gov record is 127 days old; two US sites registered as not-yet-recruiting may be enrolling now; the company added its sixth and seventh sites in January and February 2026 precisely to finish, and “later stages of enrolment” may mean a handful of patients remain. A third-party transcript of the company’s 10 August earnings call — which the desk could not verify against a company-published recording and does not quote — reports management describing scheduled dates for the remaining cases and an expectation of finishing enrolment in August. All of this may be true, and the paper’s arithmetic already grants it: the company-favourable scenario assumes the last ablation within three weeks of the August statement — exactly what that account implies — and the shortest data-to-filing path the protocol could conceivably allow, and the year still comes up 34 days short of the fastest review on record. Staleness shortens the miss; on the observed record it cannot close it. What would settle it: an enrolment-completion announcement with a date, or the registry flipping to an actual count.

“Targeting” is a forward-looking word, and the company has already re-based expectations in public. Also substantially true, and the paper’s frame accepts it. The registration statement carries customary forward-looking qualifications, and the same paragraph concedes the timeline “is contingent on trial outcomes and FDA feedback.” A target that slips is the ordinary condition of device development, and slipping is not misconduct — this paper alleges none, against the company or any officer. The desk’s finding survives the concession in a specific form: the earlier targets — CY25, mid-2025, 2H 2025 — were each replaced by a successor in the company’s next communications. The 2026 target has not been. It was last carried forward, unchanged from March, on 15 May 2026; the four August documents neither restate nor amend it; and a Form 10 is not brought current after effectiveness, so its description stands until a later filing replaces it. A reader of the SEC record today is told 2026; a reader of the August presentation is given the undated heading “2H 2026 & into 2027” — a range that includes 2026 but does not commit to it, and the desk reads the change as a widening rather than a contradiction. What the record does not contain is any document since 15 May that restates the 2026 date or replaces it with a specific successor — which is what each earlier target received.

FDA could simply be faster than its record. The statute’s 180 days is a ceiling; the agency approved two cardiovascular originals inside 140 days in eleven years; module pre-review means the reviewers will know this file intimately by the time module 4 arrives; and an interactive review could run concurrently with late follow-up. The same unverified transcript of the 10 August call reports management describing efforts to have FDA schedule its review promptly on submission — the strongest available version of this counter, and module pre-review makes it plausible. Possible, and the paper prices it: the claim is a percentile, not a proof, and the scenario arithmetic already grants the shortest observed review. But the direction of every checkable fact runs the other way — the company expects “standard PMA review procedures” in its own words; no expedited designation is disclosed, and the fastest cardiovascular review on record was set by a device that did carry one; the nearest product-code analogues took 387 and 633 days; this is a first-of-kind MRI-guided ablation platform, not a follow-on device in a crowded code; and FDA missed its own 290-day total-time goal in the most recent published cohort, at 302 days.

The market is not paying for the 2026 date anyway. The price record supports much of this: the Form 10 filings that carry the target moved the stock −2.15% and −0.5%; the August releases produced a +4.2% move that faded within two sessions; the run from under A$1 began in November 2024, well before the SEC registration existed; and the company’s own August story leads with NorthStar. If the 2026 approval target is priced at zero, its unreachability changes nothing — that is the limit of this paper, and it is stated here rather than papered over. What remains is narrower but real: the one CY2026 FDA date the May raise put in front of investors was the “clearance” bullet, which on its narrowest reading the 510(k) record has already partly delivered; the company’s own platform tally counts the unfiled, trial-gated module as one of fifteen submissions rather than as the item that starts a 304-day median clock; and the most recent full business description on the company’s SEC record — the document a new reader of EDGAR reaches first — carries a date the calendar can no longer accommodate on any observed precedent. Whether or not the date is in the price, it is in the record.

Kill criteria#

Written before the conclusion, and specific.

1. An Imricor PMA record appears in FDA’s database with an approval decision dated on or before 31 December 2026. The thesis is dead — FDA will have beaten its eleven-year cardiovascular record on a first-of-kind device, and this paper will have been wrong about the single thing it claims. A correction will run at the top of the page.
2. The final module is filed on or before 25 August 2026. The “faster than any of the 141 on record” formulation dies (128 days would remain), and the thesis decays to “faster than 98.6% of the record” — publishable only with a prominent correction and re-framing. Because a pending PMA is confidential, a filing is observable only through the company’s own disclosure; the desk watches its announcements for exactly that.
3. Any disclosure of a Breakthrough Device designation, priority review, or other expedited pathway for the ablation application. The base-rate leg must be rebuilt on the expedited population, and the paper’s central percentile claim is withdrawn pending that rebuild.
4. A dated, sourced enrolled-patient count showing enrolment effectively complete before June 2026. The trial-timing corroboration (though not the review-clock arithmetic) substantially weakens, and the receding-finish-line framing must be re-examined against the count.
5. The company reaffirms the 2026 target after this paper’s date, with a stated basis. The “left standing, unrepeated” framing dies; the paper would then be about a live claim, which is a different and stronger thesis requiring re-verification before any republication.
6. The registry updates to show a completion date or status that makes the company-favourable scenario conservative — for example, actual completion recorded before 31 August. Scenario arithmetic must be re-run and the paper corrected to the new floor.

Right of reply#

The company was not contacted before publication. Every claim above is drawn from the company’s own SEC filings, its own ASX announcements and presentations, its own website, and the public registers of the US Food and Drug Administration, ClinicalTrials.gov, the Dutch and Swiss trial authorities, and ASIC, each linked in the source list with access dates. Where the company has addressed a point, its position is quoted in its own words and engaged with rather than dismissed — including its August 2026 re-framing of the forward timeline as “2H 2026 & into 2027”, its attribution of the coming revenue inflection to the NorthStar launch, the Philips declaration and vendor financing, its statement that the trial is “in the later stages of enrolment”, and its explanation that trial enrolment suppresses European product revenue. Nothing in this paper alleges any breach of law, of the ASX Listing Rules, of the US securities laws, or of any regulator’s requirements, by the company, by any of its officers or directors, or by any counterparty named; nothing in it alleges that any forward-looking statement was made otherwise than in good faith; and nothing in it speaks to the safety, efficacy or clinical merit of the company’s devices, which the desk has no basis to assess. The finding is arithmetic: a dated target stands in the company’s most recent full business description on the SEC record, and the regulator’s own published record of how long its reviews take leaves that date outside every observed precedent. Non-contact before publication is this desk’s stated policy, recorded on the methodology page; should the company respond, its response will be published here in full. If the company completes enrolment, files its final module and receives approval in 2026, this paper will have been wrong, and will say so at the top of the page.

Methodology#