What changed in this filing

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Item 1. Business

2026-03-05 compared with 2025-03-07 · 66 added, 79 removed, 613 unchanged (19% of the section changed)

We are a commercial-stage medical device company focused on the development and marketing of customizable, incision-free therapeutic systems for the ablation of diseased tissue utilizing our platform technologies.

We are a commercial-stage medical device company focused on the development and marketing of AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue utilizing our platform technologies.

Our lead product, the TULSA-PRO system, combines real-time MRI, robotically-driven transurethral sweeping action/thermal ultrasound and closed-loop temperature feedback control to ablate whole gland or physician defined region of malignant or benign prostate tissue.

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In August 2019, the TULSA-PRO system received FDA clearance as a Class II device in the United States for thermal ablation of prescribed prostate tissue, using TULSA based on the Company’s TACT whole gland ablation pivotal study.

It is also CE Marked in

the EU for ablation of targeted prostate tissue (benign or malignant).

It is also CE Marked in the EU for ablation of targeted prostate tissue (benign or malignant).

The TULSA-PRO system was approved by Health Canada in November 2019.

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We may also consider synergistic strategic acquisitions to expand the applications of our platform technology and expand our commercial footprint.

Our business model in the United States is based primarily upon recurring revenues, charging a one-time fee that includes a supply of one-time-use devices, use of the TULSA-PRO and its ‘Profound Genius Services’, which provides comprehensive clinical training and case support focused on workflow efficiency.

In other, international markets, and more recently in the United States, we continue to deploy a business model that consists of two components - sales of durable goods and one-time-use devices for each patient treated.

Our business model consists of two components - sales of capital equipment and recurring non-capital equipment which includes one-time-use devices for each patient treated and related services.

Our financial strategy to date has been to raise sufficient funds through securities offerings and bank financings to fund specific programs within a focused budget, and, following the August 2019 FDA clearance of our TULSA-PRO system, to drive commercial utilization.

As our commercialization efforts increase and/or further program development costs increase, we may need to raise additional capital.

See Item 4, “Risk Factors” for more information.

See “Risk Factors” for more information.

Our Technology Platform

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Prostate cancer is one of the most common types of cancer affecting men.

The annual incidence of newly diagnosed cases in 2024 is estimated to reach 299,010 in the United States according to the American Cancer Society, representing 29% of all new cancer diagnoses in men.

The annual incidence of newly diagnosed cases in 2026 is estimated to reach 333,830 in the United States according to the American Cancer Society, representing about one third of all new cancer diagnoses in men.

The American Cancer Society further estimates that there are currently 3.3 million men living with prostate cancer in the United States, increasing to 5.8 million men when also including EU.

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All adverse events were mild to moderate with no serious events reported.

A prospective clinical study of TULSA-PRO ® for BPH has been conducted with early outcomes published in 2022.

All measures of urinary function and quality of life improved during the initial twelve-month follow up among the first 10 subjects treated, while no adverse effects were seen on sexual and bowel functions:

average IPSS decreased from 17.5 to 4.0, IPSS QoL decreased from 4.0 to 0.5, and Qmax increased from 12.4 ml/s to 21.8 ml/s, among several other improved urinary measures.

A single serious adverse event had occurred, abscess of the epididymis requiring drainage at two weeks post therapy.

Enrollment of this study has been increased to 30 subjects, with complete study results pending publication.

A prospective Phase II clinical study of TULSA-PRO ® for BPH has been conducted with 1-year outcomes published in 2025.

All measures of urinary function and quality of life improved during the twelve-month follow up among the 30 subjects included and treated.

The median patient age at treatment was 67 years.

During the 12‐month post‐TULSA follow‐up, prostate volume decreased from a median of 52 to 32 mL, and PSA levels decreased from 3.1 to 1.5 μg/L.

The maximum flow rate increased from 11.1 to 18.3 mL/s ( P < 0.001), and the average flow rate increased from 4.2 to 9.1 mL/s ( P < 0.001).

Residual volume decreased from 71 to 40 mL, and voided volume increased from 211 to 301 mL.

The International Prostate Symptom Score (IPSS) decreased from 17 to 4 ( P < 0.001), and IPSS quality of life score improved from 4 to 1 ( P < 0.001).

The 26‐item Expanded Prostate Cancer Index Composite urinary irritative/obstructive scores improved from 66 to 94 ( P < 0.001), and urinary incontinence scores improved from 86 to 100 ( P = 0.008).

Sexual function remained stable or improved.

A total of 13 adverse events (“AEs”) were recorded, including 11 Grade II events (urinary tract infections/retentions) and one Grade IIIb event (epididymitis requiring drainage under general anaesthesia).

All AEs resolved during follow‐up.

Select outcomes from clinical trial of TULSA-PRO to relieve lower urinary tract symptoms in men with BPH.

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CAPTAIN (A Comparison of TULSA Procedure vs.

Radical Prostatectomy in Participants with Localized Prostate Cancer) is a prospective, multi-centre randomized controlled trial of 201 subjects aimed at comparing the safety and efficacy of the TULSA procedure (performed with the TULSA-PRO system) with radical prostatectomy (“ RP ”) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.

In the CAPTAIN trial, 134 subjects will be randomized to receive one or two TULSA procedures, and 67 subjects will be randomized to receive RP.

Radical Prostatectomy in Participants with Localized Prostate Cancer, NCT05027477) is a prospective, multi-centre randomized controlled trial with target enrollment of 201 subjects (2:1 randomization) aimed at comparing the safety and efficacy of the TULSA procedure (performed with the TULSA-PRO system) with robotic radical prostatectomy (“ RP ”) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.

Enrollment and treatment in the CAPTAIN trial were completed in 2025 with a total of 211 subjects, with 148 subjects randomized to receive one or two TULSA procedures, and 63 subjects randomized to receive RP.

CAPTAIN is the first fully-recruited multicenter RCT of ablation vs.

radical treatment of intermediate-risk prostate cancer.

The trial sites are primarily located in the United States, with the exception of two sites in Canada and one in Europe.

Site activation has been completed for 19 sites to date, and those sites are currently recruiting patients.

RP is currently the gold-standard surgical treatment for intermediate-risk prostate cancer.

RP effectively controls disease but carries risk of significant side effects such as long-term erectile dysfunction and urinary incontinence.

The TULSA procedure may reduce the risk of side effects relative to RP, with high spatial, thermal, and anatomic resolution of the target volume enabling precise ablation of prostate tissue while sparing functionally important structures.

To achieve precise ablation, the procedure combines transurethral, robotically driven therapeutic ultrasound with real-time visualization of temperature and automated control of heating from magnetic resonance thermometry., potentially.

The goal of the CAPTAIN trial is to demonstrate that the efficacy of the TULSA procedure is not inferior to RP, while demonstrating superior quality of life outcomes in patients receiving the TULSA procedure as compared to those patients receiving RP.

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Long-term follow-up will be gathered for up to 10 years after treatment.

CAPTAIN perioperative outcomes were presented at Professional Society Annual Scientific Meetings in 2025, including the American Urological Association (AUA), Radiological Society of North America (RSNA) and the Society of Urological Oncology (SUO).

Baseline patient characteristics were balanced between both arms of the study.

Perioperative outcomes demonstrate that TULSA is statistically and clinically significantly superior to robotic prostatectomy in blood loss, length of stay, post-procedure pain, and recovery to baseline activities and overall health.

RP is currently the gold-standard surgical treatment for intermediate-risk prostate cancer.

RP effectively controls disease but carries risk of significant side effects such as long-term erectile dysfunction and urinary incontinence.

Our Sonalleve system combines real-time MRI and thermometry with focused ultrasound delivered from the outside of the patient to enable precise and incision-free ablation of diseased tissue.

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We initiated our launch of the TULSA-PRO system in the United States in the fourth quarter of 2019 and the first patient was treated in the United States in a clinical service setting in January 2020.

Since then, our business model has evolved to a recurring revenue model that includes durable hardware usage, one-time-use devices and our Genius service, which includes necessary support for a productive start-up of the practice.

In 2024, we introduced in the United States a capital sales model in addition to the purely recurring revenue model that we have been using since 2019.

We generate revenues from capital sales, one-time-use devices and related services, in the EU (principally in Germany), United States and Asia.

Since then, our business model has evolved in the United States to a capital sales model in addition to the purely recurring revenue model that we have been using since 2019.

We generate revenues in the United States, EU and Asia.

For the year ended December 31, 2025, approximately 76%, 5% and 19% of revenues were generated in the United States, EU and Asia, respectively, compared to approximately 78%, 8% and 14%, respectively for the year ended December 31, 2024.

Revenue on a quarter over quarter basis is expected to fluctuate given that we are maintaining a limited European commercial effort and remain primarily focused on the U.S.

On January 10, 2020, we announced the signing of our first-ever US multi-site imaging center agreement for TULSA-PRO with RadNet, Inc., the largest owner and operator of outpatient imaging centers in the United States, pursuant to which we will install TULSA-PRO systems at three RadNet imaging centers in the greater Los Angeles.

Our TULSA-PRO system is primarily marketed to early adopter physicians who specialize in treatment of prostate disease including urologists and radiologists at opinion leading hospitals.

TULSA-PRO services are available at either independent imaging centers or at hospital-based imaging centers.

TULSA-PRO services are available at either independent imaging centers or at hospitals.

Historically treatment of conditions such as localized prostate disease and uterine fibroids have included surgical intervention.

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We expect to generate recurring revenues from the use of the system, one-time-use devices, clinical support and service maintenance.

We also collaborate with our strategic partners Philips and Siemens for lead generation and distribution of durable equipment.

On December 2, 2024, Profound Medical and Siemens Healthineers announced a definitive co-sales and co-marketing agreement of its TULSA-PRO and Free.Max MRI, to offer a complete solution for MRI-guided prostate therapy.

We also collaborate with our strategic partners Philips, GE and Siemens for lead generation and distribution of capital equipment.

On December 2, 2024, Profound Medical and Siemens Healthineers announced a definitive co-sales and co-marketing agreement of its TULSA-PRO and Free.

Max MRI, to offer a complete solution for MRI-guided prostate therapy.

On December 21, 2020, we entered into a co-development agreement with GE Healthcare (the “ GE Agreement ”) whereby we and GE Healthcare agreed to a non-exclusive, worldwide license that will enable us to interface our TULSA-PRO system with certain GE Healthcare MRI scanners.

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(4) radiation therapies including, external beam radiation therapy, brachytherapy and high dose radiation;

(5) cryoablation;

and (6) trans-rectal high intensity focused ultrasound (“ HIFU ”).

and (5) focal ablation techniques including cryoablation, trans-rectal high intensity focused ultrasound (“ HIFU ”), irreversible electroporation (IRE) and water steam ablation.

In addition, certain adjunct or less common procedures are used or are under development to address prostate disease, such as androgen deprivation therapy and proton beam therapy.

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We believe that the flexibility of the TULSA-PRO system may allow the Company to demonstrate its use as a tool for ablating benign and malignant diseased prostate tissue with greater speed and precision than current options while minimizing potential side effects.

We believe that the TULSA-PRO system may overcome certain limitations of other devices and methodologies for removing or addressing diseased prostate tissue including HIFU, such as complications associated with trans-rectal delivery and limitations relating to prostate size.

We believe that a transurethral (inside out) ablation approach with millimeter accuracy has advantages over HIFU in ablating the whole gland safely.

We believe that a transurethral (inside out) ablation approach with millimeter accuracy has advantages over HIFU, IRE and water steam in ablating the whole gland safely.

Watchful Waiting;

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Most class I devices and some class II devices are exempt from premarket review requirements.

Class I devices are subject to “general controls,” which include establishment registration and device listing, requirements of the Quality System Regulation (“QSR”), labeling requirements, medical device reporting, and reporting of corrections and removals.

Class I devices are subject to “general controls,” which include establishment registration and device listing, quality management system requirements, labeling requirements, medical device reporting, and reporting of corrections and removals.

Most class II devices and some class I devices require FDA clearance of a 510(k) premarket notification prior to marketing;

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To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate device” that is already on the market.

A predicate device is a legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976 (a “preamendments device”) and for which a PMA is not required, (ii) a device that has been reclassified from class III to class II or I, or (iii) a device that was found substantially equivalent

through the 510(k) process.

Following receipt of a premarket notification for a device, the FDA determines whether the submission is sufficiently complete to permit a substantive review.

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If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review and determine whether the proposed device can be approved for commercialization, although in practice, PMA reviews often take significantly longer, and it can take up to several years for the FDA to issue a final decision.

Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with the QSR.

Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance with quality management system requirements.

If the FDA’s evaluation of the PMA application and inspection of the manufacturing facility is favorable, the FDA may issue an approval order authorizing commercial marketing of the device, or an “approvable letter,” which usually contains a number of conditions that must be met in order to secure final approval of the PMA.

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Device manufacturers must register their establishments annually, list the devices they manufacture and pay an annual registration fee.

Device manufacturers are also subject to the QSR, which includes both design control requirements and good manufacturing practice requirements (such as requirements for purchasing controls, document controls, production and process controls, labeling and packaging controls, control of nonconforming product, complaint handling, corrective and preventative actions, storage, handling, distribution, and servicing).

Devices must be labeled in accordance with the FDA’s device labeling regulations, including Unique Device Identification requirements.

Device manufacturers are also subject to the quality management system rules described in the Quality System Regulation (“QSR”), which includes both design control requirements and other current good manufacturing practice (“cGMP”) requirements (such as requirements for purchasing controls, document controls, production and process controls, labeling and packaging controls, control of nonconforming product, complaint handling, corrective and preventative actions, storage, handling, distribution, and servicing).

The FDA issued a new final rule called the

Quality Management System Regulation (“QMSR”) to harmonize the FDA’s medical device cGMP regulations with the International Organization for Standardization standard for device quality management systems (ISO 13485:2016).

The effective date for the QMSR final rule is February 2, 2026.

Until then, manufacturers are required to comply with the QSR.

Devices must also be labeled in accordance with the FDA’s device labeling regulations, including Unique Device Identification requirements.

The FDA also regulates the promotion of medical devices, including a requirement that all device promotion be truthful and non-misleading and a prohibition against the promotion of devices for “off-label” uses, i.e., uncleared or unapproved uses.

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FDA enforcement typically takes the form of inspectional observations at the close of inspection, a warning letter (a public letter alleging violations of regulatory significance), or an untitled letter (a typically non-public letter alleging violations of lesser significance).

However, the FDA has authority to take additional enforcement actions, including:

However, the FDA has authority to take, or recommend that the U.S.

Department of Justice take, additional enforcement actions, including:

civil monetary penalties, criminal fines and prosecution, injunctions, product seizure, withdrawal of marketing authorizations, mandatory recall, and import detentions.

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If the device presents a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical studies.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a patient.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining

human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a patient.

An IDE application must be supported by appropriate non-clinical data, such as animal and laboratory test results, showing that the device has a safety profile appropriate for human testing and that the trial protocol is scientifically sound.

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The FDA may grant a waiver for some or all of the requirements for a diversity action plan.

It is unknown at this time how the diversity action plan may affect device pivotal clinical trial planning and timing, but if FDA objects to a sponsor’s diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.

If FDA objects to a sponsor’s diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.

Federal Trade Commission Regulatory Oversight

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The Notified Body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the Essential Requirements.

This certificate, which is

valid for up to five years, entitles the manufacturer to affix the CE Mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

This certificate, which is valid for up to five years, entitles the manufacturer to affix the CE Mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

Therefore, when the MDD certificates become void, medical devices need to fully comply with the New EU MDR.

The MDR changed several aspects of the regulatory framework for medical device marketing in Europe in order to increase regulatory oversight of all medical devices marketed in the EU (which, in turn, increased the costs, time and requirements to place innovative or high-risk medical devices on the European market).

The MDR among other things:

The New EU MDR changed several aspects of the regulatory framework for medical device marketing in Europe in order to increase regulatory oversight of all medical devices marketed in the EU (which, in turn, increased the costs, time and requirements to place innovative or high-risk medical devices on the European market).

The New EU MDR among other things:

● strengthens the rules on placing devices on the market and reinforces surveillance once they are available;

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● strengthens the rules for the assessment of certain high-risk devices, which may have to undergo an additional check by experts before they are placed on the market.

An overarching requirement under the MDR is that any device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.

An overarching requirement under the New EU MDR is that any device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.

In addition, the device must meet the performance specifications intended by the manufacturer and be designed, manufactured and packaged in a suitable manner.

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While not mandatory, compliance with harmonized standards is a way for manufacturers to demonstrate that products comply with relevant EU legislation.

To demonstrate compliance with the General Safety and Performance Requirements (“GSPRs”) set forth in the MDR, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification, similar to the conformity assessment procedure under the MDD.

To demonstrate compliance with the General Safety and Performance Requirements (“GSPRs”) set forth in the New EU MDR, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification, similar to the conformity assessment procedure under the MDD.

Conformity assessment procedures require an assessment of the technical documentation, including the device description, the design stages, the manufacturing process, available clinical evidence, literature data for the product, and post-market experience in respect of similar products already marketed.

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Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

In order to demonstrate safety and effectiveness for their medical devices, manufacturers must, save limited exceptions, conduct clinical investigations in accordance with the requirements of Annex VII and Annex XV to the MDR.

Clinical investigations for medical devices usually require the approval of an ethics committees and approval by the national regulatory authorities.

Clinical investigations for medical devices usually require the approval of an ethics committee and approval by the national regulatory authorities.

Both regulators and ethics committees also require the submission of periodic safety reports during a study and may request a copy of the final study report.

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For CE marked devices, certain modifications to the device or quality system depending on the conformity assessment procedure used must be submitted to and approved by the Notified Body before placing the modified device on the market.

Economic operators, include device manufacturers, must register their establishments and devices in the EUDAMED database starting in January 2026.

Under new device registration rules, economic operators, including device manufacturers, must register their new devices in the EUDAMED database starting May 28, 2026, and legacy devices placed on the market before May 28, 2026 must be registered in EUDAMED by November 28, 2026.

Additionally, manufacturers and authorized representatives must now appoint a person responsible for regulatory compliance.

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However, as a result of Brexit, the New EU MDR will not be implemented in the United Kingdom (except in Northern Ireland), and previous legislation that mirrored the New EU MDR in UK law has been revoked.

The regulatory regime for medical devices in the United Kingdom will continue to be based on the requirements derived from previous EU legislation, and the United Kingdom may choose to retain regulatory flexibility or align with the MDR going forward.

CE-Markings will continue to be recognized in the United Kingdom, and certificates issued by EU recognized Notified Bodies will be valid in the United Kingdom, until the earlier of June 30, 2028 or the expiration of the certificate for devices compliant with the MDD or until June 30, 2030 for devices compliant with the New EU MDR.

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Under the Windsor Framework, which became effective on January 1, 2025, the New EU MDR and CE-mark requirements will continue to apply to medical devices marketed in Northern Ireland.

It remains to be seen how UK rules will

impact regulatory requirements for our product candidates and our product in the United Kingdom.

It remains to be seen how UK rules will impact regulatory requirements for our product candidates and our product in the United Kingdom.

We continue to evaluate the potential impacts on our business of the TCA, and any amendments, or other agreements affecting trade between the UK and EU.

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On July 11, 2024, it was announced that U.S.

Centers for Medicare and Medicaid Services (“ CMS ”) has issued its proposed rules establishing, for the first time, a Category 1 CPT code for the TULSA procedure, effective January 1, 2025.

On November 1, 2024, CMS announced its final rule, including final payment rates for the new TULSA codes effective in 2025.

According to the final rule, TULSA will have three Category 1 CPT codes to cover how therapy is delivered depending on if there are one or two physicians involved in the procedure:

Centers for Medicare and Medicaid Services (“ CMS ”) has issued its proposed rules establishing, for the first time, a Category 1 CPT code for the TULSA procedure, which became effective January 1, 2025.

TULSA has three Category 1 CPT codes to cover how therapy is delivered depending on if there are one or two physicians involved in the procedure:

51721 TULSA Device Management and 55881 TULSA Treatment, when two physicians are involved in the procedure, and 55882 TULSA Complete Procedure, when performed by a single physician.

TULSA will have a 0-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is performed.

TULSA has a 0-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is performed.

Physicians will thereby bill for any pre or post patient visit separately using existing codes.

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For ASCs, the facility payment for CPT 55882 will be $10,874 (Medicare National Average).

This represents increases of approximately 41% and 49% for hospitals and ASCs, respectively, over TULSA payments previously set in the Proposed Rule announced in July 2024 and is also higher than the Final Rule for mainstream treatment modalities for prostate cancer, such as robotic radical proctectomy (Laparoscopy Level 2), as well as for benign prostatic hyperplasia (BPH) treatments, such as Aquablation (Urology Level 6).

These payment rates are higher than the Final Rule for mainstream treatment modalities for prostate cancer, such as robotic radical proctectomy (Laparoscopy Level 2), as well as for benign prostatic hyperplasia (BPH) treatments, such as Aquablation (Urology Level 6).

The Final Rule for the Physician Fee Schedule has set the total Facility (HOPD or ASC) Relative Value Units (“RVU”) at 5.75 for CPT 51721 TULSA Device Management and 12.86 RVU for CPT 55881 TULSA Treatment, when 2 physicians are involved in the TULSA procedure.

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As noted above, the TULSA procedure will have a 0-day Global Period, meaning that all post-operative visits are billed separately.

This is distinct from all other comparable prostate treatments which are 90-day Global Period and therefore include bundled payments

for all post-operative visits performed in the first 90 days.

This is distinct from all other comparable prostate treatments which are 90-day Global Period and therefore include bundled payments for all post-operative visits performed in the first 90 days.

The typical range of post-operative office visits would be approximately 9-11 total RVUs in the first 90-days.

The below tables summarize the proposed rule Codes, RVUs and Facility Dollar Amounts.

Facility Fee Schedule:

TULSA Complete Procedure

Amounts are exact, not in thousands.

Physician Fee Schedule:

Physician Total RVU

Physician Total RVU with

typical 90-day Follow-Up

Typical 90-Day

TULSA Device Management

15.84 - 18.08

25.62 - 27.86

TULSA Treatment

51721 & 55881 Total

Procedure Total

30.40 - 32.66

288.67 - 290.91

(Two Physician)

TULSA Complete Procedure (One Physician)

27.28 - 29.52

281.58 - 283.82

The below tables summarize the rule Codes, RVUs and Facility Dollar Amounts.

Employees and Human Capital Resources

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business