LUNG — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-04

• overall manufacturing costs. However, other factors will continue to impact our gross margins such as geographic mix, pricing and customer discounts, incentives, support services and potential seasonality.

• overall market conditions. We expect cost of goods sold to increase in absolute dollars to the extent more of our products are sold.

• Revenue decreased by $1.1 million, or 4.6%, to $22.8 million for the three months ended June 30, 2026, compared to $23.9 million for the three months ended June 30, 2025. The sale of products in the United States decreased by $0.5 million to $14.2 million for the three months ended June 30, 2026, co…

• Research and development expenses decreased by $0.3 million, or 5.1%, to $5.0 million for the three months ended June 30, 2026, compared to $5.3 million for the three months ended June 30, 2025. The decrease in research and development expense was primarily due to a decrease of $0.2 million in payro…

• Selling, general and administrative expenses decreased by $4.9 million, or 18.5%, to $21.8 million for the three months ended June 30, 2026, compared to $26.7 million for the three months ended June 30, 2025. The decrease in selling, general and administrative expenses was primarily due to a decreas…

Text removed vs the prior filing · source: 10-Q · 2026-05-04

• Revenue decreased by $2.0 million, or 8.7%, to $20.6 million for the three months ended March 31, 2026, compared to $22.5 million for the three months ended March 31, 2025. The sale of products in the United States decreased by $0.9 million to $13.3 million for the three months ended March 31, 2026,…

• 77.9% for the three months ended March 31, 2026, compared to 72.5% for the three months ended March 31, 2025. The increase in gross margin was primarily due to geographic mix during the three months ended March 31, 2026.

• Research and development expenses increased by $0.1 million, or 3.0%, to $4.9 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025. The increase in research and development expense was primarily due to an increase of $0.2 million in pa…

• Selling, general and administrative expenses decreased by $2.0 million, or 7.8%, to $24.1 million for the three months ended March 31, 2026, compared to $26.1 million for the three months ended March 31, 2025. The decrease in selling, general and administrative expenses was primarily due to a decrea…

• Interest expense increased by $0.2 million to $1.0 million for the three months ended March 31, 2026 compared to $0.8 million for the three months ended March 31, 2025, primarily due to higher interest rates under our Perceptive Loan compared to our CIBC Loan which was fully repaid in March 2026. In…

Text added vs the prior filing · source: 10-Q · 2026-08-04

• The Centers for Medicare & Medicaid Services (“CMS”) have established guidelines for the coverage and reimbursement of certain products and procedures by Medicare. In general, in order to be reimbursed by Medicare, a

• healthcare procedure furnished to a Medicare beneficiary must be reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body part. The methodology for determining coverage status and the amount of Medicare reimbursement varies ba…

• While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. The reliability and continuous availability of our LungTraX Platform is critical to our success. However, software such as ours, or that of thi…

• Moreover, a disruption in access to the system that controls the LungTraX Platform would prevent physicians using our solution from receiving the StratX Lung Report indicating whether their patients are good candidates for the Zephyr Valve. In the event we experience significant disruptions, we may …

• on complex information technology to manage our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance our existing systems. Failure to maintain or protect our information systems and data integrity effectively could negatively…

Text removed vs the prior filing · source: 10-Q · 2026-05-04

• The Centers for Medicare & Medicaid Services (“CMS”) have established guidelines for the coverage and reimbursement of certain products and procedures by Medicare. In general, in order to be reimbursed by Medicare, a healthcare procedure furnished to a Medicare beneficiary must be reasonable and nec…

• may receive regulatory approval may not be available or adequate in either the United States or international markets, which will negatively affect our business, financial condition and results of operations.

• incur increased costs or otherwise experience impairment to our customer relationships. We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all.

• have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.

• While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. The reliability and continuous availability of our LungTraX Platform

Text added vs the prior filing · source: 10-Q · 2026-08-04

• The following discussion includes trading arrangements adopted or terminated by our directors and officers during the three months ended June 30, 2026.

• On June 11, 2026, Glendon French, our President, Chief Executive Officer, and Director, adopted a new Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act for the sale of up to 360,000 shares of our common stock. The trading …

Text removed vs the prior filing · source: 10-Q · 2026-05-04

• During the three months ended March 31, 2026, none of our directors or officers adopted or terminated (i) any contract, instruction or written plan for the purchase or sale of securities of the Company intended to satisfy the affirmative defense conditions of Rule 10b5–1(c) (a “Rule 10b5-1 trading a…