SENS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• We continue to expand commercialization of the Eversense brand and are focused on driving awareness of our CGM system among people with diabetes and their healthcare providers. Effective January 1, 2026, U.S. commercialization activities were returned to us. In March 2026, we executed separate Europ…

• In February 2022, we received approval from the FDA for Eversense E3. The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology doubles the sensor life to six months with MARD of 8.5%. Ascensia began commercializing Eversense E3 in the United States d…

• The ENHANCE clinical study was initiated as a pivotal study with the purpose of gathering additional clinical data to support an integrated continuous glucose monitoring (“iCGM”) submission for Eversense E3 using the SBA technology. In March 2022, we extended the ongoing ENHANCE clinical study to ev…

• On September 3, 2025, the Company and Ascensia signed the MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company a…

• network, we expect established CPT codes associated with Eversense insertions to enable a self-sustaining economic model for this initiative in the future.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• We continue to expand commercialization of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. Effective January 1, 2026, U.S.

• commercialization activities were returned to the Company and in Europe, Ascensia continues to sell and market the Eversense product to support the orderly transition of the business to Senseonics anticipated in the second quarter of 2026. In both the United States and our overseas markets we will c…

• On September 3, 2025, the Company and Ascensia signed the MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company a…

• other things, the Company agreed to acquire Ascensia’s right, title and interest in and to certain assets related to the marketing, selling and distribution of Eversense in the United States (such assets, the “U.S. Purchased Assets”).

• In February 2022, we received approval from the FDA for Eversense E3. The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology doubles the sensor life to six months with MARD of 8.5%. Ascensia began commercializing Eversense E3 in the United States d…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was resolved on June 24, 2026 an…

• The case was filed by a non-practicing entity alleging patent infringement of three patents. The validity of all three of these patents was challenged in Inter Partes Review proceedings at the U.S. Patent and Trademark Office by another party, TikTok Inc., (the “TikTok IPR”) and on September 30, 202…

• Venture (and the referenced ownership attributes thereof), the parties were authorized to file an additional brief addressing whether the evidence Cellspin Soft, Inc. submitted is sufficient to put TikTok Inc.’s real party in interest identification into dispute, and what effect, if any, the announc…

• Prior to the hearing on Senseonics’ invalidity challenge to the three patents in the Senseonics IPR proceedings, on June 24, 2026, the parties entered into a Settlement and Field Limited Covenant Not to Sue, pursuant to which the Senseonics IPR proceedings were terminated and the Cellspin complaint …

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing en…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• The consummation of the European Asset Purchases is subject to conditions that may not be satisfied, and delays or failures in completing the European Closings could adversely affect our business, financial condition and results of operations.

• On March 12, 2026, we entered into the Local Purchase Agreements with Ascensia, pursuant to which we agreed to acquire certain commercial assets and assume certain related liabilities in Italy, Germany, Spain and Sweden. The closing of each of the European Asset Purchases is subject to the satisfact…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• During the fiscal quarter ended June 30, 2026, none of our officers or directors, as defined in Rule 16a-1(f), adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• During the fiscal quarter ended March 31, 2026, none of our directors and officers (as defined in Rule 16a-1(f) under the Securities and Exchange Act of 1934, as amended) adopted, modified or terminated the contracts, instructions or written plans for the purchase or sale of the Company’s securities…