We are a commercial-stage medical technology company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease (“COPD”).
−Removed: Our solution, which is comprised of the Zephyr Endobronchial Valve (“Zephyr Valve”), the Chartis Pulmonary Assessment System (“Chartis System”) and the LungTraX Platform (which is called the StratX Platform in international markets), is designed to treat severe emphysema patients who, despite medical management, are still profoundly symptomatic and either do not want or are ineligible for surgical approaches.
+Added: Our solution, which is comprised of the Zephyr Endobronchial Valve (“Zephyr Valve”), the Chartis Pulmonary Assessment System (“Chartis System”) and the LungTraX Platform, is designed to treat severe emphysema patients who, despite medical management, are still profoundly symptomatic and either do not want or are ineligible for surgical approaches.
Patients with severe emphysema generally experience a worse quality of life than patients with lung cancer, and we believe there is both an urgent clinical need and a strong market opportunity for a solution that is safe, effective and minimally invasive.
19 unchanged sentences
We currently generate most of our revenue from the sales of Zephyr Valves and delivery catheters.
−Removed: We also generate a smaller amount of our revenue from our Chartis System, which is comprised of sales of the balloon catheters, usage fees and sales of the Chartis console.
−Removed: The LungTraX Platform, while used to identify patients eligible for treatment with Zephyr Valves, has not independently generated any revenue for us.
+Added: We also generate a smaller amount of our revenue from our Chartis System, which is comprised of sales of the balloon catheters, usage fees and sales of the Chartis console, and from our LungTraX Platform, which is used to identify patients potentially eligible for treatment with Zephyr Valves.
Our Market Opportunity
81 unchanged sentences
The StratX Lung Report is then made available to physicians in the LungTraX Platform.
−Removed: The software of each of these third-party service providers has received either 510(k) approval or successfully underwent a conformity assessment procedure with a Notified Body and was subsequently CE Marked in accordance with applicable legislation governing medical devices.
+Added: The third-party software used in this service has received either 510(k) clearance or successfully underwent a conformity assessment procedure with a Notified Body and was subsequently CE Marked in accordance with applicable legislation governing medical devices.
We provide exclusive access to physicians to their LungTraX accounts and cases and monitor this CT scan upload and analysis process to ensure quality control.
35 unchanged sentences
The most common side effect of Zephyr Valve placement is a pneumothorax, which is the collapse of a lung due to an air leak in the lung and is believed to be a direct result of rapid shifts in the lobar volumes in the chest as the target lobe deflates and the neighboring lobe expands.
−Removed: In clinical trials, in the incidence rate of pneumothorax in patients treated with the Zephyr
+Added: In clinical trials, the incidence rate of pneumothorax in patients treated with the Zephyr
Valve is between 18% and 34%.
39 unchanged sentences
Reimbursement from commercial payors is typically based on a similar methodology but rates vary depending on the procedure performed, the hospital, the commercial payor, contract terms and other factors.
−Removed: The ICD-10 PCS procedure codes that best describe our procedure map to the MS-DRG classifications for Major Chest Procedures, depending on co-morbidities and complications.
−Removed: MS‐DRG classifications calibrate payment for groups of services based on the severity of a patient’s illness and clinical cohesiveness of care.
−Removed: One single MS‐DRG payment is intended to cover all hospital costs associated with treating a patient during his or her hospital stay, while physician charges associated with performing medical procedures are reimbursed to physicians through a different payment system based on the codes they submit.
+Added: The ICD-10 PCS procedure codes that best describe our procedure map to the MS-DRG classifications for Major Chest Procedures, while management of co-morbidities and complications during the hospital stay impacts specific MS-DRG placement within the MS-DRG grouping.
+Added: MS‐DRG classifications calibrate payment for groups of services based on the severity of a patient’s illness, costs and clinical cohesiveness of care.
+Added: One single MS‐DRG payment covers all hospital costs associated with treating a patient during his or her hospital stay.
+Added: Physician charges associated with performing medical procedures are reimbursed to physicians through a different payment system based on the codes they submit.
Payment for Zephyr Valve is expected to, on average, be sufficient to cover costs of the procedure.
8 unchanged sentences
A majority of our patients are Medicare-eligible beneficiaries.
−Removed: Without a national coverage determination (“NCD”) or a local coverage determination (“LCD”), Medicare claims are processed by Medicare Administrative Contractors
−Removed: (“MACs”), which assess coverage under Medicare’s reasonable and necessary standard.
+Added: Without a national coverage determination (“NCD”) or a local coverage determination (“LCD”), Medicare claims are processed by Medicare Administrative Contractors (“MACs”), which assess coverage under Medicare’s reasonable and necessary standard.
We estimate that roughly 75% of the potential Zephyr Valve patient population are Medicare beneficiaries, 5% Medicaid and 20% of the potential Zephyr Valve patient population is under third-party commercial payor policies or other government programs.
19 unchanged sentences
We shared the clinical data from the full 101-patient cohort in the AeriSeal CONVERT Trial at the 2024 European Respiratory Society Congress in Vienna.
−Removed: The CONVERT Trial data demonstrates that the AeriSeal System is safe and effective in occluding small airways and/or collateral air channels, allowing patients with collateral ventilation to undergo, and benefit from, treatment with Zephyr Valves with 77.6% of patients converted from CV+ to CV-.
+Added: The CONVERT Trial data demonstrates that the AeriSeal System is safe and effective in occluding small airways and/or collateral air channels, allowing patients with collateral ventilation to undergo, and
+Added: benefit from, treatment with Zephyr Valves with 77.6% of patients converted from CV+ to CV-.
If successfully developed and approved, the AeriSeal System could further expand the addressable market of our solution.
28 unchanged sentences
(“Spiration”) (later acquired by Olympus Medical Systems Corp.).
−Removed: Since both companies were developing products in the same field, they entered into this agreement to minimize the risk of intellectual property disputes in the future and their associated cost.
+Added: Since both companies were developing products in the same field, they entered into this agreement
+Added: to minimize the risk of intellectual property disputes in the future and their associated cost.
When we acquired Emphasys in 2009, we became the successor-in-interest to Emphasys’ rights under the Spiration Cross-License.
−Removed: Under the agreement, each company non-exclusively licensed the other party to make, have made (solely for such
−Removed: other party), sell, offer for sale, import and export specific products under their respective patent portfolio at that time that covers such products or a method of use thereof.
+Added: Under the agreement, each company non-exclusively licensed the other party to make, have made (solely for such other party), sell, offer for sale, import and export specific products under their respective patent portfolio at that time that covers such products or a method of use thereof.
The license granted to us by Spiration is limited to devices where the outer perimeter of the device seals with the airway wall and the device allows fluid flow only through one or more openings in the device radially inward of such outer perimeter.
20 unchanged sentences
We perform the final assembly, inspection, testing, packaging and product release testing for the Zephyr Valve, the EDC and Chartis System at our headquarters in Redwood City.
−Removed: These products are sterilized using ethylene oxide at a qualified sterilization supplier in Los Angeles, California.
−Removed: In the United States, we generally ship products from our third-party logistics provider in Memphis, Tennessee and our facilities in Redwood City to our direct sales territory managers, who deliver these products to our hospital customers.
+Added: These products are sterilized using ethylene oxide or E-beam at qualified sterilization suppliers in California.
+Added: In the United States, we generally ship products from our third-party logistics provider in Memphis, Tennessee or our facilities in Redwood City to our direct sales territory managers, who deliver these products to our hospital customers.
Once they are trained and proficient in the procedure, we may also sell our products directly to our hospital customers.
2 unchanged sentences
The FDA monitors compliance with the Quality Management Systems Regulations (“QMSR”) through periodic inspections of our facilities, which may include inspection of our suppliers’ facilities as well.
−Removed: Our European Union Notified Body and Great Britain approved body, British Standards Institute (“BSI”), monitors compliance with the European Union Medical Devices Directive (Council Directive 93/42/EEC) (“MDD”), the Medical Device Regulation (Regulation (EU) 2017/745) (“MDR”), and the UK Medical Devices Regulations 2002 requirements through both annual scheduled audits and periodic unannounced audits of our manufacturing facilities as well as our contract third-party suppliers’ facilities.
+Added: Our European Union Notified Body and Great Britain approved body, British Standards Institute (“BSI”), monitors compliance with the European Union Medical Devices Directive (Council Directive 93/42/EEC) (“MDD”), the Medical Device Regulation (Regulation (EU) 2017/745) (“MDR”), and the UK Medical Devices Regulations 2002 requirements
+Added: through both annual scheduled audits and periodic unannounced audits of our manufacturing facilities as well as our contract third-party suppliers’ facilities.
Our quality management system in our Redwood City manufacturing facility is currently ISO 13485:2016 certified and licensed by the California Department of Public Health (“CDPH”) Food and Drug Branch.
22 unchanged sentences
The IDE application must be approved in advance by the FDA for a specified number of subjects.
−Removed: Generally, clinical trials for a
−Removed: significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate IRBs at the clinical trial sites.
+Added: Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate IRBs at the clinical trial sites.
There can be no assurance that submission of an IDE application will result in the ability to commence clinical trials, and although the FDA’s approval of an IDE application allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and effectiveness, even if the trial meets its intended success criteria.
21 unchanged sentences
New PMA applications or PMA supplements are required for modification to the manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, ingredients, materials or design of a device that has been approved through the PMA process.
−Removed: PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
+Added: PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement
+Added: is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
In approving a PMA application, as a condition of approval, the FDA may also require some form of post-approval study (“PAS”) or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and effectiveness data for the device.
4 unchanged sentences
These include:
−Removed: • the FDA’s QSR, which requires manufacturers, including their suppliers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
+Added: • the FDA’s QMSR, which requires manufacturers, including their suppliers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
• labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses;
9 unchanged sentences
To demonstrate compliance with the GSPRs provided in the MDR and obtain the right to affix the CE mark, medical devices manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
−Removed: Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.
+Added: Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is
+Added: an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.
Depending on the relevant conformity assessment procedure, the Notified Body audits and examines the technical documentation and the quality system for the manufacture, design and final inspection of the medical devices.
−Removed: The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment
−Removed: procedure conducted in relation to the medical device and its manufacturer and their conformity with the GSPRs.
+Added: The Notified Body issues a CE 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 GSPRs.
This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.
14 unchanged sentences
The AeriSeal System is expected to be classified as Class III on the basis of the MDR.
−Removed: We are currently placing our medical devices on the market in accordance with the MDR, as well as the stringent requirements of the transitional provisions of the MDR, which, among other conditions, requires continuous compliance with the requirements of the MDD, as applicable to our products, and the guidance of the European Commission’s Medical Devices Coordination Group.
−Removed: For those devices we are placing on the market in accordance
−Removed: with the transitional provisions of the MDR (the Zephyr System, the AeriSeal System and the Chartis Console (for which we have received a CE certificate under the MDR and are transitioning to the MDR)), we intend to complete conformity assessment procedures in accordance with the MDR prior to the expiration of our existing CE Certificate(s) of Conformity issued by our Notified Body BSI on the basis of the MDD, in accordance with the transitional provisions of the MDR.
+Added: currently placing our medical devices on the market in accordance with the MDR, as well as the stringent requirements of the transitional provisions of the MDR, which, among other conditions, requires continuous compliance with the requirements of the MDD, as applicable to our products, and the guidance of the European Commission’s Medical Devices Coordination Group.
+Added: For those devices we are placing on the market in accordance with the transitional provisions of the MDR (the Zephyr System, the AeriSeal System and the Chartis Console (for which we have received a CE certificate under the MDR and are transitioning to the MDR)), we intend to complete conformity assessment procedures in accordance with the MDR prior to the expiration of our existing CE Certificate(s) of Conformity issued by our Notified Body BSI on the basis of the MDD, in accordance with the transitional provisions of the MDR.
The UK left the EU in January of 2020 and the transitional period ended on December 31, 2020.
4 unchanged sentences
Medical devices which meet all requirements of the EU MDR may be placed on the market until June 30, 2030.
+Added: However, the government has indicated that it intends to launch a consultation (that was penciled in for late 2025 but has not yet commenced) on proposals to indefinitely recognize CE marked medical devices.
Manufacturers of medical devices located outside the UK, including manufacturers of CE marked medical devices, need to appoint a UK Responsible Person before the devices may be placed on the UK market.
−Removed: The UK government plans on introducing new legislation governing medical devices which they have indicated is to be delivered though secondary legislation.
−Removed: The first piece of legislation was laid in 2024 and updates post-market surveillance requirements.
−Removed: Additional instruments are currently scheduled to follow in 2025 and 2026 to introduce new pre-market requirements including international reliance, and further enhancements to the regulations.
+Added: The UK government has introduced, with the first regulations strengthening post-market surveillance requirements having come into force June 16, 2025.
+Added: Further updated regulations are scheduled to follow in the course of 2026.
Our devices were regulated under MDD prior to Brexit and are subject to the UK Medical Devices Regulations 2002.
Pulmonx has registered all products in accordance with the UK Medical Devices Regulations 2002 , we received a UK Declaration of Conformity from our Great Britain Approved Body BSI and we place our products on the Great British market under a UKCA Mark.
−Removed: In addition, the advertising and promotion of medical devices in the EU is subject to the national laws of the individual EU Member States that implemented the MDD, the AIMD and that apply the MDR, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.
+Added: In addition, the advertising and promotion of medical devices in the EU is subject to EU laws and the national laws of the individual EU Member States that implemented the MDD, the AIMD and that apply the MDR, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.
EU Member States’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.
5 unchanged sentences
Business Associates have a corresponding obligation to maintain appropriate Business Associate Agreements under HIPAA.
−Removed: In certain circumstances, we may be considered a Business Associate and be responsible for implementing reasonable administrative, physical and technical safeguards as required by HIPAA, including, among other things, maintaining Business Associate Agreements with our customers and our subcontractors that have access to protected health information on our behalf.
−Removed: In addition, companies that would not otherwise be subject to HIPAA may become
−Removed: contractually obligated to follow HIPAA requirements through agreements with Covered Entities and Business Associates, and some of our customers may require us to agree to these provisions.
+Added: In certain circumstances, we may be considered a Business Associate and be responsible for implementing reasonable
+Added: administrative, physical and technical safeguards as required by HIPAA, including, among other things, maintaining Business Associate Agreements with our customers and our subcontractors that have access to protected health information on our behalf.
+Added: In addition, companies that would not otherwise be subject to HIPAA may become contractually obligated to follow HIPAA requirements through agreements with Covered Entities and Business Associates, and some of our customers may require us to agree to these provisions.
Privacy and Information Security Laws
3 unchanged sentences
In addition, states within the United States and other jurisdictions where we do business have enacted or are considering enacting similar data privacy laws.
+Added: Numerous U.S.
+Added: states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
The CCPA and GDPR are examples of the increasingly stringent and evolving regulatory frameworks related to personal data processing and that increase our compliance obligations and exposure for any non-compliance.
−Removed: For example, the CCPA imposes obligations on covered businesses to provide specific disclosures related to a business’s collecting, using and disclosing personal data and to respond to certain requests from California residents related to their personal data.
+Added: For example, the CCPA applies to personal data of consumers, business representatives, and employees who are California residents, and requires covered businesses to provide specific disclosures related to a business’s collecting, using and disclosing personal data and to respond to certain requests from California residents related to their personal data.
Also, the CCPA provides for civil penalties and a private right of action for data breaches that may include an award of statutory damages.
−Removed: In addition, the California Privacy Rights Act of 2020 (“CPRA”), which became effective January 1, 2023, expands the CCPA by, among other things, giving California residents the ability to limit use of certain sensitive personal data, along with establishing restrictions on personal data retention and a new California Privacy Protection Agency to implement and enforce the new law.
US federal and state consumer protection laws may require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.
8 unchanged sentences
Our business is subject to compliance with these laws.
−Removed: If our operations are found to be in violation of any of the federal, state and foreign laws described below or any other current or future fraud and abuse or other healthcare laws and regulations that apply to us, we may be subject to significant penalties, including significant criminal, civil, and administrative penalties, damages, fines, imprisonment for individuals, additional oversight and reporting obligations, exclusion from participation in government programs, such as Medicare and
−Removed: Medicaid, imprisonment, contractual damages, reputation harm and disgorgement and we could be required to curtail or cease our operations.
+Added: If our operations are found to be in violation of any of the federal, state and foreign laws described below or any other current or future fraud and
+Added: abuse or other healthcare laws and regulations that apply to us, we may be subject to significant penalties, including significant criminal, civil, and administrative penalties, damages, fines, imprisonment for individuals, additional oversight and reporting obligations, exclusion from participation in government programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputation harm and disgorgement and we could be required to curtail or cease our operations.
Anti-Kickback Statutes
20 unchanged sentences
Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government.
−Removed: The federal government has used the FCA to assert liability on the basis of kickbacks, or in instances in which manufacturers have provided billing or coding advice to providers that the government considered to be inaccurate.
+Added: The federal government has used the FCA to assert liability on the basis of kickbacks, or in
+Added: instances in which manufacturers have provided billing or coding advice to providers that the government considered to be inaccurate.
In these cases, the manufacturer faces liability for “causing” a false claim.
−Removed: In addition, the federal government has prosecuted companies under the FCA in connection with off-label promotion of
+Added: In addition, the federal government has prosecuted companies under the FCA in connection with off-label promotion of products.
Our activities, including those relating to the reporting of discount and rebate information and other information affecting federal, state and third-party reimbursement of our products (such as our patient reimbursement support programs) and the sale and marketing of our products, may be subject to scrutiny under these laws.
+Added: The federal physician self-referral prohibition, commonly known as the Stark Law, prohibits, among other things, physicians who have a financial relationship, including an investment, ownership or compensation relationship with an entity, from referring Medicare and Medicaid patients to that entity for designated health services, which include clinical laboratory services, unless an exception applies.
+Added: Similarly, entities may not bill Medicare, Medicaid or any other party for services furnished pursuant to a prohibited referral.
Civil Monetary Penalties
14 unchanged sentences
Bribery of foreign public officials also falls within the scope of the Bribery Act.
−Removed: An individual found in violation of the Bribery Act, faces
−Removed: imprisonment of up to ten years.
+Added: An individual found in violation of the Bribery Act, faces imprisonment of up to ten years.
In addition, the individual can be subject to an unlimited fine, as can commercial organizations for failure to prevent bribery.
16 unchanged sentences
The implementation of the Affordable Care Act in the United States, for example, has changed healthcare financing and delivery by both governmental and private insurers substantially, and affected medical device manufacturers significantly.
−Removed: There have been executive, judicial and congressional challenges, and a number of health reform measures that have impacted certain aspects of the Affordable Care Act.
−Removed: For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025.
−Removed: The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.
−Removed: It is possible that the Affordable Care Act will be subject to judicial or congressional challenges in the future, including congressional legislation to modify or replace the Affordable Care Act or elements of the Affordable Care Act.
−Removed: It is unclear how such challenges and such healthcare reform measures will impact the Affordable Care Act and our business.
+Added: There have been executive, judicial and congressional challenges, and a number of health reform
+Added: measures that have impacted certain aspects of the Affordable Care Act.
+Added: For example, on July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”), was signed into law, which narrowed access to Affordable Care Act marketplace exchange enrollment and declined to extend the Affordable Care Act enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.
+Added: The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.
+Added: Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired Affordable Care Act subsidies.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.
−Removed: For example, the Budget Control Act of 2011, among other things, included reductions to CMS payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect until 2032 unless additional congressional action is taken.
+Added: These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is taken.
+Added: The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies.
+Added: These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.
+Added: Recent actions, for example, include directing agencies to reduce agency workforce and cut programs.
+Added: Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to lower government subsidies to private insurance companies and increase healthcare price transparency, among other things.
+Added: In June 2024, the U.S.
+Added: Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.
We believe that there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payors to reduce costs while expanding individual healthcare benefits.
5 unchanged sentences
The outcome of HTA regarding specific medical device will often influence the pricing and reimbursement status granted to these products by the competent authorities of individual EU Member States.
−Removed: On January 31, 2018, the European Commission adopted a proposal for a regulation on health technologies assessment.
−Removed: The Regulation is intended to boost cooperation among EU Member States in assessing health technologies, including new medical devices, and providing the basis for cooperation at EU level for joint clinical assessments in these areas.
−Removed: In December 2021 the HTA Regulation was adopted and entered into force on January 11, 2022.
−Removed: It began to apply on January 12, 2025.
+Added: On January 12, 2025, Regulation No 2021/2282 on Health Technology Assessment (HTA Regulation), entered into application through a phased implementation.
+Added: Select high-risk medical devices came into scope in 2026.
+Added: The HTA Regulation is intended to boost cooperation among Member States in assessing health technologies, including new medical devices new medical devices.
+Added: The Regulation establishes a framework for EU-level joint clinical assessments and increased cooperation among Member States on clinical aspect of health technology evaluation.
+Added: Individual EEA countries will continue to be responsible for assessing non-clinical (e.g.
+Added: economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.
Human Capital Management
2 unchanged sentences
None of our employees are represented by a labor union or are a party to a collective bargaining agreement.
−Removed: We believe that we have good relations with our employees.
−Removed: We believe that our employees are the foundation of our business and we are committed to the development and retention of our workforce.
+Added: We believe that we have good relations with our employees and that they are the foundation
+Added: of our business.
+Added: We are committed to the development and retention of our workforce through ongoing training and development programs, and career growth opportunities.
Code of Business Conduct and Business Ethics
4 unchanged sentences
At Pulmonx, we are committed to creating and nurturing an inclusive workplace, where everyone feels respected, valued, and included – not only because it’s the right thing to do, but also because we strongly believe that it’s vital to our success and crucial to fully support the communities we serve.
−Removed: We value a variety of perspectives and experiences.
−Removed: We continue to create an inclusive culture where differences drive innovation.
+Added: We value diverse perspectives and experiences and continue to build an inclusive culture where differences drive innovation.
Talent and Compensation Philosophy
1 unchanged sentence
To ensure we can attract, retain and develop high performing teams, we offer competitive, market-based salaries and an annual cash bonus program.
−Removed: Additionally, to further align the interests of our
−Removed: employees with those of our shareholders, employees in most of the countries where we operate have the opportunity to have an ownership interest in our company.
+Added: Additionally, to further align the interests of our employees with those of our shareholders, employees in most of the countries where we operate have the opportunity to have an ownership interest in our company.
We have an equity-based incentive plan that provides for the grant of stock options and awards to eligible employees.
12 unchanged sentences
The health and safety of our employees is a key focus at our Company.
−Removed: We are committed to protecting our employees everywhere we operate and we comply with applicable health and safety laws and regulations.
+Added: We comply with applicable health and safety laws and regulations and maintain workplace safety programs.
+Added: Employees complete annual safety training and we maintain emergency preparedness protocols across our locations.
+Added: We are committed to protecting our employees everywhere we operate and comply with applicable health and safety laws and regulations.
We strictly prohibit any violent or threatening behavior on our premises or during any work-related activities.
8 unchanged sentences
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.