Form 8-K: Life-Sciences Announcements, Exhibits and Deadlines

TL;DR

Item 2.02(a) requires the date of the announcement, a brief identification of it, and the text of the announcement as an exhibit, when a domestic registrant publicly announces material nonpublic information about results of operations or financial condition for a completed quarterly or annual period. [1]

On five life-sciences filings from July and August 2026, Exhibit 99.1 is Agilent’s quarterly earnings release under Item 2.02, Intelligent Bio Solutions’ investor presentation under Item 7.01, NeuroPace’s PMA-supplement notice under Item 7.01, and EyePoint’s LUGANO Phase 3 topline under Item 8.01. OSR Health’s Item 8.01 Nasdaq hearing report lists no Exhibit 99. [2] [3] [4] [5] [6]

Iradimed’s 31 July 2026 EDGAR index lists Item 8.01, and the body is captioned Item 2.02. [7] Boston Scientific’s 26 August 2026 Item 8.01 report says the company has not yet determined whether a cybersecurity incident is reasonably likely to have a material impact. [8] The routing sheet below separates the item, the required information, the attachment, the clock, and the submission tag. Beyond Item 2.02, General Instruction F requires a copy when a published announcement is incorporated by reference to answer an item. [1]

This comparison is informational, not legal advice. It concerns domestic reporting companies; issuer counsel must determine the applicable obligations and deadlines for a particular event.

Exhibit 99.1 on these filings was a quarterly earnings release, an investor presentation, a PMA-supplement notice, and a Phase 3 topline. OSR Health’s Item 8.01 hearing report lists no Exhibit 99. SEC EDGAR Form 8-K reports, read 4 October 2026.

What Exhibit 99.1 was on five 2026 filings

The exhibit number identifies the document, not the legal reason for reporting it. The five reports below illustrate different uses of Exhibit 99.1 and one report without such an exhibit. The examples are historical filings, not recommendations to copy another issuer’s classification.

Agilent, filed 26 August 2026 under Item 2.02 and Item 9.01, says that on that day it issued the press release for the third fiscal quarter ended 31 July 2026 and attached a copy as Exhibit 99.1. The same paragraph says the Item 2.02 information and Exhibit 99.1 are furnished and shall not be deemed “filed” for purposes of Section 18. The announcement date and the filing date are the same day, so the example concerns same-day furnishing. [2]

Intelligent Bio Solutions, filed 28 August 2026 under Item 7.01 and Item 9.01, says that pursuant to Regulation FD it furnishes the presentation it made available to investors that day, and that the Item 7.01 information, including Exhibit 99.1, is furnished and shall not be deemed “filed.” The exhibit index describes a presentation. The saved Exhibit 99.1 file is an image deck, so the description used here is the report body’s. [3]

NeuroPace, filed 28 July 2026 under Item 7.01 and Item 9.01, attaches a press release as Exhibit 99.1 and says that information shall not be deemed filed. The release reports that FDA had notified the company that its PMA supplement, seeking to expand the RNS System indication to patients with antiseizure-medication-resistant idiopathic generalized epilepsy with generalized tonic-clonic seizures, “is not approvable in its current form and that additional clinical evidence supporting the submission has been requested.” The body has no Item 2.02 caption. The subject is that not-approvable notice. [4]

EyePoint, filed 17 August 2026 under Item 8.01 and Item 9.01, says that on that day it issued a press release announcing topline data for LUGANO, a pivotal Phase 3 trial of DURAVYU in wet age-related macular degeneration, attaches the release as Exhibit 99.1, and incorporates it by reference. Exhibit 99.2 is an investor presentation. No Item 2.02 or Item 7.01 caption appears in the body. [5]

OSR Health, filed 28 August 2026 under Item 8.01 only, says that on 27 August 2026 it was notified that the Nasdaq Hearings Panel scheduled its hearing for 29 September 2026 at 10:00 a.m. Eastern Time. The body also says trading was suspended at the open on 26 August 2026 and that the timely hearing request stayed the filing of a Form 25-NSE pending the panel’s decision. The saved document list has no Exhibit 99. A press-release exhibit is conditional under Item 8.01. General Instruction F still applies when the report answers an item by incorporating a published announcement. A hearing notice is a different event from a completed-period result. [6]

Three opened Item 5.02 reports, all filed 28 August 2026, have no Exhibit 99 on the saved document list. Edwards Lifesciences describes a corporate vice president’s planned retirement by mid-year 2027. Outset Medical says its general counsel decided on 27 August 2026 to depart effective 11 September 2026, and attributes the departure to other professional opportunities. Pro-Dex describes discretionary cash bonuses for the chief financial officer and the chief executive officer. [9] [10] [11] The five Exhibit 99.1 filings and these three lists are a reading set. The tag counts later in this article measure something else: how often an item number appears in a submissions field.

When Item 2.02 requires the announcement text

Item 2.02(a) requires the date, a brief identification, and the text of the announcement as an exhibit when its trigger is met. The form states the trigger and the three elements in one sentence:

If a registrant, or any person acting on its behalf, makes any public announcement or release (including any update of an earlier announcement or release) disclosing material non-public information regarding the registrant’s results of operations or financial condition for a completed quarterly or annual fiscal period, the registrant shall disclose the date of the announcement or release, briefly identify the announcement or release and include the text of that announcement or release as an exhibit. [1]

Instruction 1 repeats the trigger. Disclosure of material nonpublic information regarding a completed fiscal year or quarter triggers the item, and release of additional or updated material nonpublic information regarding that completed period triggers it again. Instruction 4 excludes disclosure made in the filed Form 10-Q or Form 10-K from Item 2.02. [1] A figure that appears for the first time inside the filed Form 10-Q or Form 10-K is outside this sentence. A public announcement of that completed period, made beside the periodic report, is inside it. A press release, a trial update, or a regulatory notice meets the sentence only when it discloses that completed-period information. Materiality of a particular figure is the issuer’s judgment.

The oral presentation has four conditions

Item 2.02(b) exempts oral, telephonic, webcast, broadcast, or similar disclosure of that completed-period information from this item’s report requirement if four conditions are met. The presentation is complementary to, and initially occurs within 48 hours after, a related written announcement that has already been furnished on Form 8-K under Item 2.02. The presentation is broadly accessible to the public. The financial and statistical information in the presentation is on the registrant’s website, together with any information required under Regulation G. A widely disseminated press release told the public when and how to access the presentation and where the information would sit on the website. [1]

The Exchange Act Form 8-K CDI page, last updated 24 June 2024, fills the timing around that written release. Question 106.02, answered 11 January 2010, takes an earnings release issued after the close and a call two hours later that contains new Item 2.02 information, and assumes the company cannot furnish the release before the call. The company must still furnish that material as an exhibit and satisfy the other Item 2.02 requirements. “A transcript of the portion of the conference call or slides or a similar presentation including such information will satisfy this requirement.” The answer includes the questions and answers. [12]

Question 106.03, same date, says the website information for the oral exemption must be posted at the time of the presentation. Information disclosed unexpectedly in the question-and-answer portion must be posted promptly after it is disclosed. A webcast meets the website condition. [12] Question 106.04, same date, allows the written release to live on the Form 10-Q: if the company files the earnings release as a Form 10-Q exhibit on Wednesday morning, before a Wednesday afternoon call, and the other Item 2.02(b) conditions are met, the company may rely on the oral exemption without also furnishing that release under Item 2.02. [12]

Question 106.06 says a completed-quarter release that includes expected adjusted earnings, a non-GAAP measure, is subject to Item 2.02, “because it contains material, non-public information regarding its results of operations for a completed fiscal period.” Question 106.07 asks whether a “preliminary” earnings release for a completed quarter, including amounts that may be estimates, must comply with Item 2.02 and its instructions. The answer, dated 24 April 2009, is “Yes.” [12] None of the opened filings was tested against the clock of its earnings call. The 48-hour condition is the form’s condition.

Furnished, and still a reporting duty

General Instruction B.2 names the furnished items. Information furnished under Item 2.02 or Item 7.01 “shall not be deemed to be ‘filed’ for purposes of Section 18 of the Exchange Act,” unless the registrant specifically states that the information is to be considered filed, or incorporates it by reference into a Securities Act or Exchange Act filing. Exhibits relating to Item 2.02 or Item 7.01 follow that treatment unless the registrant specifies, under Item 9.01, which exhibits or portions are intended to be deemed filed. [1]

Question 106.05 asks whether a late Item 2.02 Form 8-K affects Form S-3 eligibility. The answer, dated 11 January 2010, is no, because an Item 2.02 Form 8-K is furnished rather than filed, and Form S-3’s timeliness condition looks to reports required to be filed. The same answer then states the reporting consequence: “While not affecting a company’s Form S-3 eligibility, failure to comply with Item 2.02 of Form 8-K would, of course, be a violation of Section 13(a) of the Exchange Act and the rules thereunder.” [12] That sentence is the staff’s description of the violation.

Agilent and Profusa are the two opened reports captioned Item 2.02 in both the body and the submission tag. Agilent’s exhibit is the release for the quarter ended 31 July 2026, with the furnished legend quoted above. [2] Profusa, filed 20 August 2026, says it issued a press release on certain financial results for the quarter ended 30 June 2026 and furnishes a copy as Exhibit 99.1. The body conditions incorporation into another filing on an express, specific reference. [13] The legends are different sentences. Two earnings bodies attached the quarterly release. Those two exhibits illustrate the text duty within this limited reading set.

Other required information and the incorporation-by-reference condition

General Instruction B.4 separates the duty to describe an agreement from the duty to attach it. The instruction requires agreement copies as Form 8-K exhibits only when the applicable item specifically calls for their filing or furnishing. Applicable Item 601 exhibit requirements remain in force for registration statements and periodic reports. An Item 1.01 description, a contract exhibit, a transaction announcement, and an acquired-business financial statement are different documents with different purposes. [1]

General Instruction F adds an important qualification. If, within the report's filing period, the registrant makes available to stockholders or otherwise publishes a press release or other document containing information that answers some or all of the form, it may incorporate that information by reference in answer or partial answer to an item, provided copies are filed as an exhibit to the report. A company can choose to make a public announcement, but choosing to use that announcement as the report's answer carries this attachment condition. It is therefore unsafe to label every non-earnings announcement exhibit optional. [1]

Keep three questions separate. Does an event trigger a mandatory item? What information or documents does that item require? Is the report relying on a published announcement to supply its answer? The last question can matter even without an express press-release requirement in the item itself. Furnished-versus-filed treatment must also be checked against General Instruction B.2 and the report's specific incorporation language; the analysis depends on more than the word “attached”. [1]

A material agreement: the description is the item

Item 1.01 requires the date, the parties, any material relationship, and a brief description of the material terms when the registrant enters into a material definitive agreement not made in the ordinary course, or a material amendment. Item 1.01(b) defines that agreement as one that provides obligations material to and enforceable against the registrant, or rights material to the registrant and enforceable by the registrant, whether or not subject to conditions. Instruction 1 treats an agreement as outside the ordinary course, even if it ordinarily accompanies the business, when it involves the subject matter in Item 601(b)(10)(ii)(A) through (D). [1] This comparison uses the companies’ reported classifications without independently deciding contractual materiality.

CDI Question 102.05, dated 22 March 2022, is asked for the business-combination facts in Question 102.04. The question is whether the registrant should file the material definitive agreement as an exhibit to the Item 1.01 Form 8-K. The answer encourages filing it as a best practice and quotes Release No. 33-8400 (16 March 2004) to explain that the exhibit was encouraged rather than mandatory under that Item 1.01 requirement. It adds that confidential treatment generally can no longer be the reason to omit it, and that a registrant unable to prepare the EDGAR copy within four business days should explain that in the report. [12] This is the staff’s guidance for that business-combination scenario, not a substitute for checking the applicable item and any other exhibit requirements.

Lantheus split the documents across two days. The 3 August 2026 report furnishes the merger press release and investor presentation as Exhibits 99.1 and 99.2 under Item 7.01, says that information shall not be deemed filed, and says the Form 8-K disclosure required for the merger agreement will be a separate Form 8-K. Item 8.01 on that report says the company has paused its CEO search. [14] The 4 August 2026 report captions Item 1.01 and Item 5.02 separately. Item 1.01 files the merger agreement as Exhibit 2.1. Item 5.02 describes a $6.0 million transaction bonus pool, states that a form of the bonus agreement is filed as Exhibit 10.1, and describes amended severance letters dated 1 August 2026. The document list includes Exhibits 2.1, 10.1, and 10.2. The prior day’s press release is absent from this report’s exhibit list. [15] The merger agreement, compensation documents, and prior-day public announcement perform different functions. The agreement and compensation disclosures remained separate from the earlier announcement. Item 5.02 remains its own caption for the bonus pool, Exhibit 10.1, and the severance letters. The separate Item 5.02 caption preserves that distinction.

Baxter, filed 18 August 2026, puts a contract and two releases on one report. Item 1.01 files Amendment No. 2 to an amended and restated five-year credit agreement dated 11 June 2025 as Exhibit 10.1. Item 8.01 attaches the early-tender release and the pricing release, both dated 18 August 2026, as Exhibits 99.1 and 99.2. [16] The contract, public announcement and Item 1.01 description each serve their own function. The attachment list must be read alongside the body and its incorporation language.

A closing: Item 2.01 facts, and the release under Item 7.01

Item 2.01 requires the date, a description of the assets, the counterparty, the consideration, and the item’s other specified facts when a significant acquisition or disposition closes outside the ordinary course. Instruction 4 includes, among its significance tests, equity in net book value or the amount paid or received exceeding 10 percent of consolidated total assets, and a business that is significant under Regulation S-X. [1] Acquisition significance requires an issuer-specific calculation beyond this comparison. Instruction 5 points to Item 9.01 for acquired-business financial statements, pro forma information, and the plans of acquisition. Item 9.01(a)(3) allows those financial statements by amendment up to 71 calendar days after the initial report is due. CDI 129.01, answered 2 April 2008, says that extension is for acquisitions and is unavailable for dispositions. [1] [12]

Teleflex, filed 3 August 2026, puts the closing in Item 2.01 and the announcement in Item 7.01. On that day the company completed the sale of its OEM business to Lotus US Bidco Inc. under the 9 December 2025 equity purchase agreement, for $1,500,000,000 in cash, subject to adjustment. The press release is furnished as Exhibit 99.1. The exhibit index lists the agreement as Exhibit 2.1, “incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on December 9, 2025,” and lists the 3 August press release as Exhibit 99.1. [17] The August document list contains the press-release exhibit and relies on the earlier EX-2.1 filing. The index points readers to the previously filed agreement instead of presenting a new copy. The report says the Item 9.01 pro forma information will be filed by amendment not later than four business days after the closing. CDI 129.01’s 71-day extension is the acquisition extension. Neither timing sentence is scored.

A departure: fact and date, and a letter only in the disagreement case

Item 5.02(b) requires the fact and the date when a covered officer or a director departs outside the disagreement case. The covered officers include the principal executive, financial, accounting, and operating officers, persons performing similar functions, and named executive officers. Item 5.02(a)(2) requires the director’s written correspondence as an exhibit only in a disagreement resignation or a removal for cause. Any response letter received under Item 5.02(a)(3) must be filed by amendment within two business days after receipt. If the company will announce an Item 5.02(c) appointment other than by Form 8-K, the report may wait until the day of that announcement. [1]

Outset’s report gives the fact and the date, attributes the departure to other professional opportunities, and lists no Exhibit 99 and no Exhibit 17. [10] Edwards lists no Exhibit 99. Whether the officer was covered by Item 5.02 requires more than the corporate-vice-president title. [9] Pro-Dex describes the bonuses under Item 5.02 and lists no Exhibit 99. [11] The departure item requires the fact and the date. A press release is outside that sentence.

An unregistered sale: the Item 701 facts, above a threshold

Item 3.02(a) requires the information in Item 701(a) and Item 701(c) through (e) when the registrant sells equity securities in an unregistered transaction. “Furnish” in that sentence means include those facts. Instruction B.2’s furnished-not-filed list names Item 2.02 and Item 7.01. For the filing-date trigger, Item 3.02 waits until the registrant enters an agreement enforceable against it, whether or not subject to conditions, under which the securities are to be sold. The ordinary four-business-day period then applies. Without such an agreement, disclosure is due within four business days after closing or settlement. The exemption applies when aggregate equity securities sold since the more recent of the last Item 3.02 report or last periodic report are less than 1 percent of the outstanding shares of that class, or less than 5 percent for a smaller reporting company. The outstanding-shares denominator excludes outstanding securities convertible into or exchangeable for the class. Sales of convertible securities and shares issued on conversion still require their own reporting analysis. [1] Neither percentage was computed here.

VolitionRx, filed 24 August 2026 and tagged Item 3.02 only, describes share issuances under previously reported senior secured convertible notes issued to Lind Global Asset Management XII LLC in original principal amounts of $7,500,000 and $2,400,000. On 11 August 2026 the company issued 220,264 shares to satisfy a $150,000 conversion obligation, and on 20 August 2026 it issued 553,097 shares to satisfy a $250,000 conversion obligation. The document list has no Exhibit 99. [18] Biomerica, filed 26 August 2026 and tagged Items 1.01, 3.02, and 9.01, incorporates the Item 1.01 disclosure into Item 3.02 and says the shares are offered under Section 4(a)(2) and/or Rule 506. The exhibit index lists a securities purchase agreement and a registration rights agreement, each dated 20 August 2026, as Exhibits 10.1 and 10.2, and lists no Exhibit 99. [19] Autonomix, filed 26 August 2026 and tagged Items 1.01, 3.02, 8.01, and 9.01, says under Item 3.02 that it issued the New Warrants under Section 4(a)(2) and incorporates the Item 1.01 description. Item 8.01 says that on 24 August 2026 the company issued a press release announcing the Item 1.01 transactions, attaches that release as Exhibit 99.1, and incorporates it by reference. The exhibit index also lists a form of inducement letter as Exhibit 10.1. [20] On that third report the release is attached and incorporated under Item 8.01. Item 3.02 calls for the specified Item 701 information; the release’s use elsewhere in the same report must be assessed separately.

Where other news goes, and which clock runs

EyePoint’s topline and Intelligent Bio’s presentation are both Exhibit 99.1, on Item 8.01 and Item 7.01. The choice to use those items must be separated from any underlying Regulation FD duty. Neither contains Item 2.02’s express announcement-text requirement, but General Instruction F can still require an exhibit when the report incorporates the announcement as its answer. Items 7.01 and 8.01 receive different treatment under Instruction B.2.

Item 7.01 says: unless the information is filed under Item 8.01, disclose under this item only information that the registrant elects to disclose through Form 8-K pursuant to Regulation FD. [1] Item 8.01 says the registrant may, at its option, disclose any events, beyond those otherwise called for by the form, that the registrant deems of importance to security holders. The same item says the registrant may, at its option, file under Item 8.01 the nonpublic information required to be disclosed by Regulation FD. [1] Instruction B.2 limits its specified furnished treatment to Items 2.02 and 7.01. Instruction B.6 says a report under Item 7.01 or Item 8.01 will not be deemed an admission as to the materiality of information in the report that is required to be disclosed solely by Regulation FD. [1]

Mandatory-event, Regulation FD and voluntary-disclosure timing

Instruction B.1 sets the ordinary period. Unless the form specifies otherwise, a report is to be filed or furnished within four business days after the event. If the event occurs on a Saturday, Sunday, or holiday when the Commission is closed, the four-business-day period begins on, and includes, the next business day. The same instruction then names a different clock for Regulation FD: a report furnished under Item 7.01, or a report the registrant elects to file under Item 8.01 solely to satisfy Regulation FD, must meet Rule 100(a) of Regulation FD, including that rule’s deadline. A purely voluntary Item 8.01 report outside Regulation FD has no four-business-day deadline in Instruction B.1. [1]

Rule 100(a), read from 17 CFR 243.100, applies when the issuer, or a person acting on its behalf, discloses material nonpublic information to a person described in the rule, including brokers, dealers, investment advisers, investment companies, and holders who are reasonably likely to trade. Public disclosure of that information is due simultaneously if the selective disclosure is intentional, and promptly if it is non-intentional. [21] “Promptly,” in 17 CFR 243.101(d), means as soon as reasonably practicable, and in no event after the later of 24 hours or the commencement of the next day’s trading on the New York Stock Exchange, after a senior official learns of the non-intentional disclosure and knows, or is reckless in not knowing, that the information disclosed is both material and nonpublic. Public disclosure under paragraph (e)(1) is furnishing or filing a Form 8-K. Paragraph (e)(2) is another method, or combination of methods, reasonably designed to provide broad, non-exclusionary distribution. [22] Rule 100(a) requires the covered selective-disclosure circumstances; broad distribution of a release alone is insufficient. Assess the covered recipient, intent, senior official’s knowledge and public-disclosure method together. Exchange advance-notice requirements need a separate current-rule check.

Question 101.01, answered 2 April 2008, gives one further path for most items. A triggering event that occurs within four business days before the registrant files a periodic report may be disclosed in that periodic report, under Item 5 of Part II of Form 10-Q or Item 9B of Form 10-K, except events that must be reported under Item 4.01 or Item 4.02. Those two items stay on Form 8-K. [12] Item 1.05 has its own start date. Its four business days run from the materiality determination. [1]

One study update, written in two items

Fractyl Health, filed 15 July 2026, puts one clinical update in both places. Item 7.01 says the company issued a press release on one-year results from the REMAIN-1 midpoint cohort, furnishes the release as Exhibit 99.1, and furnishes a conference-call presentation as Exhibit 99.2. The item says the Item 7.01 information, including those exhibits, shall not be deemed filed and shall not be deemed incorporated by reference into the company’s Securities Act or Exchange Act filings. Item 8.01 states the same day’s findings in the body. The report describes the clinical findings in Item 8.01 while separately furnishing the release and presentation under Item 7.01. [23] The report’s relevant captions are Items 7.01, 8.01 and 9.01.

EyePoint’s LUGANO topline appears under Item 8.01, alongside the Item 9.01 exhibit list, and the company attaches and incorporates the release. [5] A trial result can still contain completed-period financial information that triggers Item 2.02. The examples here concern the clinical-news portions. The choice between Item 7.01 and Item 8.01 changes furnished-versus-filed treatment under Instruction B.2 and changes which clock Instruction B.1 names. It leaves the scientific result where the company wrote it.

Cybersecurity: what the company disclosed, and what the rule requires

Boston Scientific’s 26 August 2026 report says the company has not yet determined whether the incident is reasonably likely to have a material impact. The report is captioned Item 8.01. The body says that on 25 August 2026 the company identified a cybersecurity incident affecting certain information technology systems and causing a global disruption to operations, that the investigation is ongoing, and that the operational and financial impacts remain unknown. The company’s statement about its assessment was: “Accordingly, the Company has not yet determined whether the incident is reasonably likely to have a material impact on the Company.” The body’s operative caption is Item 8.01. The saved document list has no Exhibit 99. [8]

Item 1.05(a) applies when the registrant experiences a cybersecurity incident that the registrant determines to be material. The required disclosure is a description of the material aspects of the nature, scope, and timing of the incident, and the material impact or reasonably likely material impact on the registrant, including its financial condition and results of operations. Item 1.05(b) requires that information in an Interactive Data File. The required disclosure concerns the incident and its impacts. Instruction 1 to Item 1.05 says the materiality determination must be made without unreasonable delay after discovery. Instruction B.1 says the report is due within four business days after the registrant determines that it has experienced a material cybersecurity incident. [1]

On 21 May 2024, Erik Gerding, then Director of the Division of Corporation Finance, addressed the item a company uses before that determination: “If a company chooses to disclose a cybersecurity incident for which it has not yet made a materiality determination, or a cybersecurity incident that the company determined was not material, the Division of Corporation Finance encourages the company to disclose that cybersecurity incident under a different item of Form 8-K (for example, Item 8.01).” If the company later determines that the incident is material, “it should file an Item 1.05 Form 8-K within four business days of such subsequent materiality determination.” Footnote 4 says a company that used Item 8.01 before a determination “is still subsequently required, under Item 1.05 of Form 8-K, to determine, without unreasonable delay, whether the incident was material.” [24]

The historical report describes an ongoing assessment. Establishing when a legally sufficient materiality determination was or should have been made requires evidence beyond that statement. The staff statement explains why a company may use Item 8.01 while an assessment remains unresolved, while preserving the obligation to make any required Item 1.05 report. The example is limited to what this historical report said; compliance, later developments and incident frequency remain outside its evidentiary scope. The form also contains narrowly specified disclosure-delay provisions; those must be evaluated separately rather than assumed to apply to an ordinary investigation. [1]

Item tags in one life-sciences extract

Iradimed’s 31 July 2026 submission is why these tag counts stay in the background: the item field and the body caption on that filing are different words. The counts show how often the tags appear in one extract. The routing sheet, not the count, is what assigns an item to a draft.

The EDGAR Filer Manual’s automated conformance guide says: “The various Form 8-K submissions require reporting of one or more specific events by specifying the Item Number for each reportable event.” Table 1 of that guide lists the item numbers. The cited passage establishes the submission-field requirement, rather than a substantive comparison with the prose caption. [25]

The counts were independently recomputed from a saved SEC submissions-metadata extract assembled for a 1,273-company research frame, with filing dates from 1 January 2022 through 29 August 2026. The public origin of that metadata is the SEC’s EDGAR submissions API. [26] The saved event rows cover 366 distinct companies across all included forms; the 1,273 figure is the target frame, not the number of companies contributing Form 8-K reports. Inside that extract there are 14,416 Form 8-K filings. Form 8-K/A amendments are outside that denominator. On those 14,416 filings, the items field contains Item 2.02 on 4,152, Item 7.01 on 3,490, Item 8.01 on 3,041, Item 1.01 on 2,311, and Item 5.02 on 2,742. A filing can carry more than one item, so the overlapping figures cannot be added to obtain a total number of filings. From 1 July 2026 through 29 August 2026 the same extract has 478 Form 8-K filings, and 128 of them are tagged only 2.02 and 9.01. Item 9.01 is the financial-statements-and-exhibits item, so that pair is the earnings tag plus the exhibit list.

These are submission tags in this 1,273-company extract. They measure item metadata within this extract only; population totals, press-release volumes and classification accuracy would require different research. A research flag that marks some rows as likely public communications was computed and left out of the figures above. The flag is a triage code. Form 6-K is a different form, the one foreign private issuers use, and it has no Form 8-K item list. A blank items cell on a Form 6-K is the form. This article’s question is the domestic item.

When the submission tag and the body caption diverge

On Iradimed’s 31 July 2026 submission, the EDGAR index says Item 8.01 only, and the body is captioned Item 2.02 and Item 9.01. Both labels are present. The claim is the pair, on one accession.

The body says that on 31 July 2026 IRADIMED Corporation issued a press release announcing financial results for the quarter ended 30 June 2026, that a copy is furnished as Exhibit 99.1, and that the information in Item 2.02, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 and shall not be deemed incorporated by reference except as expressly set forth by specific reference. The exhibit index describes the exhibit as the press release dated 31 July 2026. Its operative body headings are Item 2.02 and Item 9.01. [7]

The same submission’s EDGAR index lists “Item 8.01: Other Events” and lists Exhibit 99.1. Item 2.02 is absent from that index field. The submissions items field used for the extract is Item 8.01. Accession number 0001628280-26-051240. [7] [25] [26]

Iradimed’s body uses the furnished-not-filed legend. Inferring an intentional choice to file earnings information from the metadata alone would conflict with the body’s furnished legend. The legal effects on Section 18 status, Form S-3 eligibility and timeliness require a separate issuer-specific analysis. The conformance guide requires the item number. The body caption is the heading the company included. On this filing they differ, and the exhibit is the quarterly earnings release either way. This is a single-accession observation. A second apparent index-versus-body difference, on an Avanos report, was a 500-character scan of the index block. The full Avanos index lists the later items the scan had cut off, including Item 7.01. The full index resolved that apparent discrepancy.

A phrase in the exhibit can name a different event

United Health Products, filed 10 July 2026, was opened because a full-text search for FDA approval language returned it. The report is captioned Item 8.01 and Item 9.01. Item 8.01 says that on 7 July 2026 the company issued a press release announcing an agreement with NAMSA to serve as regulatory sponsor of a clinical study of CelluSTAT hemostatic gauze in connection with a PMA application, and that the release is Exhibit 99.1. [27] The exhibit’s FDA sentence is about study oversight: consistent with the company’s proposal “to have a non-affiliated party oversee a new clinical study, which the FDA approved in March of this year,” NAMSA would seek an investigational device exemption. [28] The subject of the report is the study-sponsor arrangement. The company used the phrase “FDA approved” for the oversight proposal, not for marketing approval of CelluSTAT. This article verifies what the company said, not an independently obtained FDA approval decision.

That is one counterexample. Full-text search served as discovery; approval-announcement counts would require separately validating the search results. No report opened for this comparison had a newly granted FDA approval, or a new 510(k) clearance, as its subject. That limits this reading set; EDGAR may contain relevant announcements outside it.

How to route one draft

Start with the event and required information, not the number 99.1. The following is a bounded desk aid for the items discussed here, not a complete inventory of Form 8-K triggers. Other events, including delisting notices, debt obligations and impairments, require assessment under their own items.

The table summarizes the form and the staff interpretations already discussed. Materiality, acquisition significance, transaction thresholds and Regulation FD knowledge facts remain issuer-specific determinations. [1] [12] [21] [22]

A release-to-filing handoff the team can actually review

A communications team can prepare a useful handoff without claiming to make securities-law decisions. Keep a short event record alongside the release: what happened, when it happened, who confirmed it, what is already public, and which source supports each factual sentence. For a trial update, the scientific record and approved result wording matter. For a completed-quarter result, finance should identify the period and the authorized figures. For an agreement or a departure, use the executed document or confirmed notice rather than the wording of an earlier news draft.

Next, have the issuer’s disclosure team record its item assessment. More than one item can apply to the same development. A financing can involve an agreement, an unregistered issuance, and an additional public announcement; a transaction can involve signing, compensation arrangements, and a later closing on different dates. Each event retains its own trigger even if one press release discusses several. The relevant record should show which dates drive which obligations and who has approved that assessment.

Keep a separate attachment inventory. Name the document, its proposed exhibit number, whether it is newly attached or incorporated from a prior filing, and the body paragraph that relies on it. For an earnings release, confirm that the attached file is the announced version and not a superseded draft. For a deck, check that the exhibit list calls it a presentation rather than a press release. If a published release supplies the answer by reference, flag General Instruction F for the filing team. If a contract is described, check its required terms against the release and report body.

Before submission, compare four surfaces: the event record, the numbered body headings, the submission’s selected item numbers, and the exhibit index. The Iradimed example shows why checking only one surface is insufficient. This comparison is a production control, not a claim that an EDGAR acceptance message validates legal classification. A discrepancy should return to the filing team for resolution, rather than being silently “fixed” by a marketing editor.

Finally, retain the approved publication and filing versions, their timestamps, the actual public URLs and the acceptance record. A release distribution receipt answers whether a distribution job ran. An accepted submission answers whether EDGAR accepted that submission. Neither alone proves that the item choice, announcement wording, deadline or furnished/filed treatment was correct. If a correction becomes necessary, the issuer and counsel should determine the filing and public-communications response together. These handoff practices are editorial recommendations, not additional SEC-prescribed forms or a promise of compliance.

What the issuer still decides

This comparison explains how to assess a domestic Form 8-K announcement and when its text may be a required exhibit. Company names identify filings that were read. They are public registrants. Issuer counsel must assess agreement materiality, transaction significance and any Regulation FD trigger using the company’s facts. The comparison offers no enforcement prediction.

The opened reading set lacks a report whose subject was a newly granted FDA approval or a new 510(k) clearance. United Health Products illustrates the ambiguity of searching for “FDA approved” without reading the surrounding statement. For an actual approval or clearance announcement that triggers no mandatory item, a company may assess Item 7.01 or Item 8.01 and any underlying Regulation FD obligation. Item 2.02 is added when the same draft also announces material nonpublic results for a completed period.

The opened set is 32 Form 8-K submissions with filing dates from 1 July 2026 through 29 August 2026, all inside the 1,273-company extract. The set was chosen by item and then supplemented to locate filings to read. Selection was purposive, so the set cannot support a population misclassification rate. The cited case descriptions were checked against the saved filing bodies and document lists during editorial review. The broader hand-labeled set and its automated phrase checks remain exploratory research aids.

The public announcement still has a life outside the item line. A medical-device company that has already written the release can look at what distributed releases produced in Medical device press release distribution benchmarks, 2026, at how “cleared” and “approved” are used in public claims in FDA cleared vs approved: a 2026 claim-accuracy audit, and at whether buyers can find the company after clearance in After a 510(k): a commercial-readiness audit. Those pieces examine the public communication after the issuer has assessed its disclosure obligations.

VayoMed’s work sits on that public side of the draft. The Done-for-You subscription includes a monthly press release, distributed through PR Newswire, Yahoo Finance, Morningstar, and more than 50 syndicated channels, and a program of source-grounded articles published to the company’s site. Its scope is production and distribution; editorial coverage, traffic outcomes and securities-law compliance remain separate matters. Form 8-K preparation and filing are outside the service described here. Many life-sciences companies never have this duty because they are private. For a domestic reporting company, the item, the exhibit, and the clock remain the issuer’s disclosure decisions. The sheet is the way to make those decisions visible before the submission is accepted.

Sources

1. U.S. Securities and Exchange Commission, Form 8-K, SEC 873 (02-25), OMB 3235-0060, approval expires 30 November 2027. Source. Accessed 4 October 2026. General Instructions B.1, B.2, B.4, B.6, and F. Items 1.01, 1.05, 2.01, 2.02, 3.02, 5.02, 7.01, 8.01, and 9.01.

2. Agilent Technologies, Inc., Form 8-K filed 26 August 2026, accession 0001090872-26-000062, Items 2.02 and 9.01, Exhibit 99.1. Source. Accessed 4 October 2026.

3. Intelligent Bio Solutions Inc., Form 8-K filed 28 August 2026, accession 0001493152-26-040656, Items 7.01 and 9.01, Exhibit 99.1. Source. Accessed 4 October 2026.

4. NeuroPace, Inc., Form 8-K filed 28 July 2026, accession 0001193125-26-321083, Items 7.01 and 9.01, Exhibit 99.1. Source. Accessed 4 October 2026.

5. EyePoint, Inc., Form 8-K filed 17 August 2026, accession 0001193125-26-353308, Items 8.01 and 9.01, Exhibits 99.1 and 99.2. Source. Accessed 4 October 2026.

6. OSR Health, Inc., Form 8-K filed 28 August 2026, accession 0001213900-26-094654, Item 8.01. Source. Accessed 4 October 2026.

7. IRADIMED Corporation, Form 8-K filed 31 July 2026, accession 0001628280-26-051240. Report body captioned Item 2.02 and Item 9.01. EDGAR index item: Item 8.01. Exhibit 99.1. Source. Index: Source. Accessed 4 October 2026.

8. Boston Scientific Corporation, Form 8-K filed 26 August 2026, accession 0000885725-26-000056, Item 8.01. Source. Accessed 4 October 2026.

9. Edwards Lifesciences Corporation, Form 8-K filed 28 August 2026, accession 0001099800-26-000048, Item 5.02. Source. Accessed 4 October 2026.

10. Outset Medical, Inc., Form 8-K filed 28 August 2026, accession 0001193125-26-374323, Item 5.02. Source. Accessed 4 October 2026.

11. Pro-Dex, Inc., Form 8-K filed 28 August 2026, accession 0001079973-26-001196, Items 5.02 and 9.01. Source. Accessed 4 October 2026.

12. U.S. Securities and Exchange Commission, Exchange Act Form 8-K Compliance and Disclosure Interpretations, page last updated 24 June 2024. Source. Accessed 4 October 2026. Questions 101.01, 102.05, 106.02, 106.03, 106.04, 106.05, 106.06, 106.07, and 129.01.

13. Profusa, Inc., Form 8-K filed 20 August 2026, accession 0001213900-26-091905, Items 2.02 and 9.01, Exhibit 99.1. Source. Accessed 4 October 2026.

14. Lantheus Holdings, Inc., Form 8-K filed 3 August 2026, accession 0001193125-26-329622, Items 7.01, 8.01, and 9.01, Exhibits 99.1 and 99.2. Source. Accessed 4 October 2026.

15. Lantheus Holdings, Inc., Form 8-K filed 4 August 2026, accession 0001193125-26-331138, Items 1.01, 5.02, and 9.01, Exhibits 2.1, 10.1, and 10.2. Source. Accessed 4 October 2026.

16. Baxter International Inc., Form 8-K filed 18 August 2026, accession 0001628280-26-057739, Items 1.01, 8.01, and 9.01, Exhibits 10.1, 99.1, and 99.2. Source. Accessed 4 October 2026.

17. Teleflex Incorporated, Form 8-K filed 3 August 2026, accession 0000096943-26-000084, Items 2.01, 7.01, and 9.01. Exhibit index lists Exhibit 2.1 incorporated by reference to the Form 8-K filed 9 December 2025, and Exhibit 99.1 as the 3 August 2026 press release. Source. Accessed 4 October 2026.

18. VolitionRx Limited, Form 8-K filed 24 August 2026, accession 0001477932-26-005251, Item 3.02. Source. Accessed 4 October 2026.

19. Biomerica, Inc., Form 8-K filed 26 August 2026, accession 0001493152-26-040251, Items 1.01, 3.02, and 9.01. Source. Accessed 4 October 2026.

20. Autonomix Medical, Inc., Form 8-K filed 26 August 2026, accession 0001437749-26-029024, Items 1.01, 3.02, 8.01, and 9.01, Exhibit 99.1. Source. Accessed 4 October 2026.

21. 17 CFR 243.100, Regulation FD, Rule 100, paragraph (a). Source. Accessed 4 October 2026.

22. 17 CFR 243.101, Regulation FD definitions, paragraphs (d) and (e), including the senior official’s knowledge condition. Source. Accessed 4 October 2026.

23. Fractyl Health, Inc., Form 8-K filed 15 July 2026, accession 0001193125-26-303948, Items 7.01, 8.01, and 9.01, Exhibits 99.1 and 99.2. Source. Accessed 4 October 2026.

24. Erik Gerding, Director, Division of Corporation Finance, “Disclosure of Cybersecurity Incidents Determined To Be Material and Other Cybersecurity Incidents,” 21 May 2024. Source. Accessed 4 October 2026. Paragraphs on Item 1.05 and Item 8.01, and footnote 4.

25. U.S. Securities and Exchange Commission, EDGAR Filer Manual, automated conformance rules for data fields, section 1, “8-K and 1-U Items,” Table 1. Source. Accessed 4 October 2026.

26. U.S. Securities and Exchange Commission, EDGAR application programming interfaces, submissions metadata. Source. Item-tag counts are a VayoMed analysis of a defined 1,273-company extract with filing dates from 1 January 2022 through 29 August 2026, accessed 4 October 2026. The extract is not the population of SEC life-sciences registrants.

27. United Health Products, Inc., Form 8-K filed 10 July 2026, accession 0001477932-26-004244, Items 8.01 and 9.01. Source. Accessed 4 October 2026.

28. United Health Products, Inc., Exhibit 99.1 to the Form 8-K filed 10 July 2026, press release dated 7 July 2026. Source. Accessed 4 October 2026.