CV — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• enrolled. We currently expect to submit the 510(k) application for the Second-Generation Product in the fourth quarter of 2026, subject to any further requests from the FDA.

• Since we continue to invest in AI to improve our existing products, we completed a clinical study to demonstrate the benefits of our incorporation of AI technology into CapsoCam Plus, our existing product for the small bowel. We submitted the related 510(k) application to the FDA in December 2025. I…

• introducing complementary products such as our (a) capsule delivery device with full commercialization expected in the fourth quarter of 2026, and (b) patency capsule (for verifying whether a capsule endoscope can pass through the bowel without retention prior to an exam) with the FDA 510(k) applica…

• service revenue). We recognize revenue for our product and reading service performance obligations at a point in time, that being when the performance obligations are satisfied and control is transferred to the customer (generally upon shipment for products, or conveyance of final deliverable for se…

• Our revenue for the three months ended June 30, 2026 and 2025 was $3.6 million and $3.3 million, respectively, representing a period-over-period growth of $0.3 million or approximately 10% (7% in the U.S. and 20% internationally). The primary driver for the revenue growth was a 13% increase in the n…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Quarterly Report, over 600 patients have been enrolled in the second arm pivotal study. We currently expects to submit the 510(k) application for the Second-Generation Product in the third quarter of 2026.

• Since we continue to invest in AI to improve our existing products, we completed a clinical study to demonstrate the benefits of our incorporation of AI technology into CapsoCam Plus, our existing product for the small bowel. We submitted the related 510(k) application to the FDA in December 2025. W…

• CapsoCam Plus, allowing patients to ingest our capsules in the comfort of their own homes with remote provider supervision; and (vi) following related FDA 510(k) clearance (expected by the middle of 2026), commercializing our updated CapsoCam Plus which incorporates our AI assisted pathology detecti…

• less than one fiscal quarter, representing the estimate of the typical period of time in which customers derive utility from the cloud-based service.

• Our revenue was flat when comparing the three months ended March 31, 2026 and 2025. The reason was a period-over-period decrease of 3% in the number of CapsoCam Plus capsules sold for the three months ended March 31, 2026 and 2025 offset by a period-over-period increase of approximately 1% in the av…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act and the material weaknesses previously identified and further discussed bel…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act

• and the material weaknesses previously identified and further discussed below, our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were not effective at the reasonable level of assurance as of March 31, 2026, the end of the p…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• •Incorporating our AI assisted pathology detection technology into our CapsoCam Plus capsule. We conducted related clinical studies to demonstrate the benefits of our AI technology as incorporated into CapsoCam Plus and submitted the related 510(k) application to the FDA in December 2025. In respons…

• The second generation of our CapsoCam Colon solution incorporates our AI assisted pathology detection technology. The second-generation product will incorporate improvements—such as a new lens and illumination optics with an increased field of view and improved image quality—designed to increase the…

• Our GI-tract capsule endoscopy solution comprises our CapsoCam capsules and the associated software (CapsoCloud and CapsoView), including their related components. We may encounter technical, operational, or regulatory challenges or limitations in developing, testing, validating, or implementing imp…

• Furthermore, the results of the utilization of our GI-tract capsule endoscopy solution (including CapsoCam Colon) may not be accepted or replicated by the scientific or medical community, or may be challenged or disputed by our competitors or other third parties. Physicians and third-party payors ma…

• If other companies or institutions develop or market methods that do not require fasting or bowel cleansing or require less stringent preparation, our products may become less attractive to patients. For example, non-invasive stool-based DNA tests generally require no specific dietary restrictions o…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• •Incorporating our AI assisted pathology detection technology into our CapsoCam Plus capsule. We conducted related clinical studies to demonstrate the benefits of our AI technology as incorporated into CapsoCam Plus and submitted the related 510(k) application to the FDA in December 2025. We also ma…

• The second generation of our CapsoCam Colon solution incorporates our AI assisted pathology detection technology. The second-generation product will incorporate improvements—such as a new lens and illumination optics with an increased field of view and improved image quality—designed to increase the…

• in terms of polyp-detection sensitivity and specificity) and benefits of using our CapsoCam Colon solution to visualize the colon and detect and measure polyps. We plan to focus our regulatory efforts on first obtaining U.S. FDA clearance followed by obtaining EU clearance. We plan to use the clinic…

• Our GI-tract capsule endoscopy solution comprises our CapsoCam capsules and the associated software (CapsoCloud and CapsoView), including their related components. We may encounter technical, operational, or

• regulatory challenges or limitations in developing, testing, validating, or implementing improvements to our GI-tract capsule endoscopy solution, which could delay or prevent us from achieving our desired outcomes. Moreover, related components (including the lens module, image sensor, processor and …