Eon Health, Inc.

GERMANTOWN, Md.--( BUSINESS WIRE )--Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the second quarter ended June 30, 2024. Recent Highlights & Accomplishments: Generated revenue of $4.9 million in the second quarter of 2024, representing growth of more than 18% compared to the prior year period FDA review of the 510(k) submission for the next-generation 365-day Eversense® system and operational readiness activities continue to advance for planned fourth quarter 2024 product launch Continued to advance the collaboration with Mercy healthcare system on the first-of-its-kind initiative for a large-scale implementation of Eversense and the launch of our remote patient monitoring service, aimed at improving clinical outcomes and reducing healthcare costs, with initial insertions planned for Q3 2024. Established Eon Care Services, a wholly owned subsidiary of Senseonics, to provide Eversense insertion procedures and training to complement the Nurse Practitioner Group in order to support and expand access to Eversense Began first-in-human testing for the Gemini System, a fully implantable self-powering system designed to include a flash glucose monitor with no on-body component for people with type 2 diabetes “During the second quarter, the Eversense user base in the U.S. expanded and we advanced key strategic initiatives to position the Company to successfully launch the 365-day Eversense system in the fourth quarter, pending anticipated FDA clearance,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We are focused on executing the integration of the Eversense CGM + RPM solution with Mercy, preparing for launch of the 365-day Eversense product, and the progression of exciting offerings in our development pipeline. We envision these initiatives serving as the foundation for significant future growth.” Second Quarter 2024 Results: Total revenue for the second quarter of 2024 was $4.9 million compared to $4.1 million for the second quarter of 2023. U.S. revenue was $3.0 million in the second quarter of 2024 compared to $1.8 million in the prior year period, and revenue outside the U.S. was $1.9 million in the second quarter of 2024 compared to $2.3 million in the prior year period. Second quarter 2024 gross profit of $0.3 million decreased from $0.4 million for the second quarter of 2023. The decrease in gross margin was primarily driven by an increase in fixed manufacturing costs compared to the prior year quarter. Second quarter 2024 sales and marketing and general and administrative expenses increased by $1.5 million year-over-year, to $9.0 million. The increase was primarily driven by expenses to expand commercial initiatives for Eon Care Services and the Mercy collaboration. Second quarter 2024 research and development expenses decreased by $2.0 million year-over-year, to $10.8 million. The decrease was primarily due to the completion of the 365-day sensor pivotal trial. Net loss was $20.3 million, or $0.03 per share, in the second quarter of 2024 compared to net loss of $20.4 million, or $0.04 per share, in the second quarter of 2023. Net income increased by $0.1 million due to the reduction in research and development expenses. Cash, cash equivalents, restricted cash and short-term investments were $84.9 million and outstanding indebtedness was $56.2 million as of June 30, 2024. Full Year 2024 Financial Outlook Senseonics continues to expect full year 2024 global net revenue to be in the range of $22 million to $24 million. The full year 2024 financial outlook assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024 compared to 2023. Inventory dynamics associated with the 365-day product launch are expected to impact third quarter product sales, with sales expected to accelerate in the fourth quarter based on 365-day product sales and the Mercy collaboration. Cash utilization in 2024 is expected to be consistent with 2023 at approximately $70 million. Conference Call and Webcast Information: Company management will host a conference call at 4:30 pm (Eastern Time) today, August 8, 2024, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics' website. Live Teleconference Information : Dial in number: 888-317-6003 Entry Number: 4740206 International dial in: 412-317-6061 Live Webcast Information : Visit http://www.senseonics.com and select the " Investor Relations " section A replay of the call can be accessed on Senseonics' website http://www.senseonics.com under " Investor Relations ." About Senseonics Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® E3 includes a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone. Forward Looking Statements Any statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue projections, assumptions related to U.S. new patient starts and the global installed base under "Full Year 2024 Financial Outlook," statements regarding the integration of the Eversense CGM and the Eversense RPM solution within the Mercy health care system, the adoption or growth of Eversense, and the potential to enhance patient outcomes and reduce healthcare costs, statements regarding Senseonics’ product pipeline, expected regulatory approvals and timing of the potential commercial launch of the 365-day product, statements regarding strengthening the Eversense® brand, and other statements containing the words "believe," “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the execution of the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms with new partners and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and a new RPM solution, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and Senseonics' other filings with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof. Senseonics Holdings, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) June 30, December 31, 2024 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 34,853 $ 75,709 Restricted cash 318 — Short term investments, net 49,774 33,747 Accounts receivable, net 1,277 808 Accounts receivable, net - related parties 3,075 3,724 Inventory, net 7,215 8,776 Prepaid expenses and other current assets 6,502 7,266 Total current assets 103,014 130,030 Deposits and other assets 5,241 7,006 Property and equipment, net 3,306 1,184 Total assets $ 111,561 $ 138,220 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 1,331 $ 4,568 Accrued expenses and other current liabilities 11,916 11,744 Accrued expenses and other current liabilities, related parties 1,226 945 Note payable, current portion, net 18,642 — Total current liabilities 33,115 17,257 Long-term debt and notes payables, net 34,202 41,195 Derivative liabilities — 102 Other liabilities 6,010 6,214 Total liabilities 73,327 64,768 Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares authorized and 12,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023 37,656 37,656 Total temporary equity 37,656 37,656 Commitments and contingencies Stockholders’ equity: Common stock, $0.001 par value per share; 1,400,000,000 shares and 900,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 535,277,362 shares and 530,364,237 shares issued and outstanding as of June 30, 2024 and December 31, 2023 535 530 Additional paid-in capital 908,472 904,535 Accumulated other comprehensive loss (7 ) (11 ) Accumulated deficit (908,422 ) (869,258 ) Total stockholders’ equity 578 35,796 Total liabilities and stockholders’ equity $ 111,561 $ 138,220 Senseonics Holdings, Inc. Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Revenue, net $ 778 $ 437 $ 1,367 $ 750 Revenue, net - related parties 4,087 3,689 8,545 7,513 Total revenue 4,865 4,126 9,912 8,263 Cost of sales 4,567 3,709 9,279 7,433 Gross profit 298 417 633 830 Expenses: Research and development expenses 10,800 12,830 21,238 25,235 Selling, general and administrative expenses 8,991 7,455 17,119 15,173 Operating loss (19,493 ) (19,868 ) (37,724 ) (39,578 ) Other (expense) income, net: Interest income 1,190 1,311 2,574 2,420 Exchange related gain, net — — — 18,776 Interest expense (2,085 ) (2,310 ) (4,133 ) (6,962 ) Gain on change in fair value of derivatives 102 289 102 6,067 Other (expense) income (1 ) 155 17 178 Total other (expense) income, net (794 ) (555 ) (1,440 ) 20,479 Net Loss (20,287 ) (20,423 ) (39,164 ) (19,099 ) Other comprehensive loss Unrealized (loss) gain on marketable securities (5 ) 100 4 558 Other comprehensive (loss) gain (5 ) 100 4 558 Total comprehensive loss $ (20,292 ) $ (20,323 ) $ (39,160 ) $ (18,541 ) Basic net loss per common share $ (0.03 ) $ (0.04 ) $ (0.06 ) $ (0.04 ) Basic weighted-average shares outstanding 616,585,664 567,125,022 615,587,105 532,499,776 Diluted net loss per common share $ (0.03 ) $ (0.04 ) $ (0.06 ) $ (0.04 ) Diluted weighted-average shares outstanding 616,585,664 567,125,022 615,587,105 532,499,776

DENVER, March 6, 2024 /PRNewswire/ -- Based in Upstate New York, Roswell Park Comprehensive Cancer Center is intensifying its efforts to increase lung cancer screenings in the greater Buffalo area by partnering with Denver-based Eon, a leading health-tech company, to leverage its proprietary artificial intelligence patient management software. Continue Reading Roswell Park Comprehensive Cancer Center Expands Lung Cancer Screening Program by Leveraging AI Software to Track and Manage Eligible Patients According to the American Lung Association, 44% of lung cancer cases are not caught until a late stage, when the survival rate is only 8%. In New York State, only 6% of people eligible are being screened for lung cancer, which is a simple low-dose CT exam, and can be crucial to early detection and treatment. In late 2022, Roswell Park launched an initiative to reduce barriers to care and reach more patients by deploying a lung screening program on wheels to provide greater access in both the rural and urban communities they serve. In leveraging Eon Patient Management (EPM) to longitudinally track and manage lung cancer screening patients, Roswell Park will be able to improve outcomes by ensuring more patients return for guideline-driven follow-up care. Lung cancer screening can be laborious and time-consuming and often entails significant manual data entry. Eon's lung cancer screening (LCS) patient management platform uses advanced AI to automate routine administrative tasks, without interrupting radiology workflows. Care teams are then able to focus on patients with significant findings while automating communication and follow-up care for low-risk patients. This not only improves patient care but will significantly broaden their LCS program's bandwidth and increase patient adherence to annual screenings. "Knowing that Eon's lung cancer screening solution will allow us to enroll and screen more eligible patients, and hopefully catch cancer early, gave us the unique opportunity to receive a grant from the state of New York to fund this initiative," said Mary Reid, Chief of Cancer Screening and Survivorship at Roswell Park Comprehensive Cancer Center. "We know there are thousands more patients who should be screened and aren't. As the only National Cancer Institute-designated comprehensive cancer center in Upstate New York, we must ensure we have superior solutions in place to provide patients with the best care." About Eon Eon is a health data science company that utilizes computational linguistics, workflow automation, and tech-enabled virtual navigation services to track incidental findings across a variety of medical disciplines throughout the course of a patient's health journey. Eon exists to ensure the right data reaches the right people at the right time to make patients healthier and health care affordable. About Roswell Park Comprehensive Cancer Center From the world's first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated, and prevented worldwide. Driven to eliminate cancer's grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. Media Contact: Candice Chan 9787930426 374009@email4pr.com SOURCE Eon

WHO披露，自1975年以来，全球肥胖率几乎增加了两倍。2023版《世界肥胖地图》预测，到2035年，全球将有超过40亿人属于肥胖或超重，占全球人口的51%。由于生活习惯、饮食结构、社会心理等因素的影响，肥胖正在成为一个不得不引起重视的社会问题。由此而产生的减脂塑形手段也日益丰富。从单纯的节食、运动，演变到后来的减脂手术，可谓层出不穷。但是通过节食和运动无法消除的顽固脂肪区域总是令人苦恼。有没有新的疗法可以解决这一难题？答案是肯定的。除了节食、运动、抽脂手术以外，一种新型减脂方法正在打入这一市场。非接触式、非侵入性、无需手术、无痛安全地减脂如何实现？Dominion Aesthetic Technologies给出答案。Dominion Aesthetic Technologies成立于2016年（以下简称“Dominion”），是一家激光平台美容设备公司，公司总部位于美国德克萨斯州休斯顿，研发实验室位于佛罗里达州。其核心技术为无接触式机器人激光塑形技术。该技术脱胎于行业领先的激光和冷却技术，植根于多年的科学研究和临床试验。以此为基础，Dominion 研发出非接触式智能减脂机器人EON。目前，EON已获得 FDA 批准，可用于减少大腿、腹部和背部的脂肪。EON治疗：对于节食、运动、抽脂手术的革新传统的减脂塑形方法以节食和运动为主。有氧运动依靠长时间、中低强度的运动来燃烧脂肪。虽然安全、健康，可以提高心肺功能，但需要较长时间才能看到效果，对于局部塑形效果有限，且实际效果因人而异。节食通过减少食物摄入来减少脂肪。虽然简单易行，但可能导致营养不良，影响新陈代谢，且容易反弹。过度节食还可能引起饮食失调症，如厌食症或暴食症等。除此之外，还有一种方法便是抽脂手术——通过手术方式直接去除多余脂肪。这种疗法虽效果立竿见影，但存在一定的手术风险，恢复期长，且可能导致皮肤不平整、感染、出血等问题。作为对以上三种减脂方式的革新，EON治疗能够去除人们通过节食和运动无法消除的顽固脂肪，并且能够使患者免受手术侵扰。Thomas Fiala博士曾经领导了一项为期12周的研究，研究对象使用EON的110厘米治疗模式对每个侧腹部进行治疗（侧腹部是指患者肋骨和髋骨之间的脂肪分布）。该研究共有11名受试者，年龄在24到63岁之间，体重指数在22.3到34.2之间。结果显示，单次分段治疗后，受试者的平均脂肪减少了6.1毫米。该研究还证实了1064纳米无接触激光设备EON用于消除皮下脂肪的安全性，患者满意度达到100%，没有治疗无反应者。非接触式激光能量输送和皮肤冷却，60分钟完成治疗EON的治疗方法简单快捷，治疗过程无创无痛，且能够在1小时内完成。首先，EON的智能机械臂会扫描患者，利用智能传感器技术绘制他们的脂肪形态分布图，并为患者定制个性化的治疗方案，提供非接触式的激光能量输送和皮肤冷却。该设备的治疗头由一个关节机器人臂驱动，能够均匀地输送激光能量。治疗头使用1064nm波长的激光，将热能传递到皮肤下方的脂肪细胞，加热脂肪组织至51℃，从而诱导脂肪细胞凋亡，这些皮下脂肪细胞死亡后，身体会随着时间的推移通过淋巴系统自然排除它们，最佳效果在12周后可见。EON设备  图源Dominion官网该过程不需要任何麻醉、切口、导管、盐水溶液或药物。并且，EON设备拥有QUICKCOOL技术，包括空气冷却系统和温度监控，能够确保患者皮肤表面的温度不超过39.5℃，以保持患者舒适，避免皮肤灼伤。在该技术的赋能下，操作者只需要按下一个按钮，EON设备便会在10秒内停止激光能量输送，同时机器人手臂会向患者皮肤表面喷射冷风。EON专有的射流冲击冷却技术可实现业界最佳的温差(Delta=11.5℃)。在Dominion进行的一项冷却效果验证研究中，使用EON的激光/冷却头在活体猪模型上进行实验。在不同深度埋入热电偶，测量并记录脂肪组织的温度，同时使用校准的传感器连续测量并记录皮肤温度。结果显示，EON在将皮下脂肪组织激光加热至49℃的过程中，能将活体组织的皮肤表面温度保持在或低于40℃，从而降低皮肤表面以及皮下脂肪组织层以外的附带热组织损伤的风险。并且，EON可以立即移动到相邻的位置进行治疗，这使得EON的治疗范围比其他固定接触系统更大，且能够提供连续、灵活的治疗。EON用智能机器人来完成治疗过程，避免了操作员进行耗时、费力、复杂的手术操作，取而代之的是高效快捷的治疗方式和一致的治疗效果。由于是机器人控制，EON可以在整个治疗区域提供一致的激光能量，确保治疗效果的均匀性。直观的操作设计以及智能传感器技术能够实时监测皮肤的接近度和温度，同时实现动态的功率调节，以达到最有效的治疗效果。值得注意的是，非接触式治疗还意味着不需要凝胶或涂抹器，无需后期护理，治疗和恢复期间不需要任何药物，可以最大限度地减少患者的恢复时间或副作用。由于无需物理接触，该疗法减少了因接触导致的感染风险。同时，与其他需要使用一次性治疗器械的设备不同，EON不需要额外的消耗品，降低了长期使用的成本。EON在为患者提供减脂治疗 图源Dominion官网此外，Dominion还对EON进行了热穿透性研究，以评估该装置的功率-温度关系和冷却系统效率。结果显示，在本研究过程中，研究人员能够安全地将每个治疗区域施加的最大激光能量增加60%（相比于初始研究中使用的基线功率），同时保持皮肤表面温度和深层组织温度在理想和安全的范围内。通过优化激光和冷却参数，EON能在不造成热损伤的基础上增加对患者施加的激光能量，实现更加安全有效的治疗。虽然EON的治疗效果因人而异，但研究表明，经过一次60 分钟的治疗，患者的脂肪平均减少了21.6%（下腹部减少 25.3%）。一些患者的减脂幅度甚至多达40%。并且，EON能够实现更快的治疗速度，60分钟内完成整个腹部的治疗，40分钟内完成两侧胁部的治疗。B轮融资2370万美元，已获得FDA批准2020年8月31日，Dominion宣布与Cogmedix Inc.建立战略合作关系。Cogmedix Inc是世界级医疗器械商业化公司Coghlin Companies, Inc.的全资子公司，已通过FDA注册和ISO 13485 认证，将为Dominion提供一站式的医疗器械制造服务，并具体服务负责EON的设备生产。2021年1月28日，Dominion宣布成功完成 B 轮融资，融资总额达2370万美元。2022年4月5日，Dominion宣布EON被选为第12届NewBeauty奖的“2022年最佳身体塑形激光器”。NewBeauty 编辑测试和审查了近万种美容产品、治疗方法。为了满足当年的标准，获奖者必须解决美容领域的最大痛点之一，并成为所在赛道最为出色的企业。在测试产品时，NewBeauty纳入了产品治疗效果前后对比图片、产品标签、技术、成分等。选定的产品还经过了30位权威的整形外科医生和皮肤科医生组成的的专业评审团的评审。在一系列严格考核中，EON设备脱颖而出。“无接触、快速、容易接受，EON减脂治疗是一种创新性高、安全有效的身材塑造方案”，NewBeauty杂志的特稿编辑Tatiana Bido说。2022年4月28日，Dominion宣布，EON已获得FDA的批准，可用于侧腹的非侵入性激光溶脂治疗。这是EON自2021年2 月推出以来第二次获得FDA批准。此前，EON已获得FDA批准用于全腹治疗，并在超过18个州被整形外科医生、皮肤科医生和医疗水疗中心用于永久性减脂。2023年3月21日，EON第三次获得FDA批准，能够用于背部和大腿的减脂治疗。未来，Dominion将继续扩大EON的制造能力和市场推广，开发更多的创新美容技术，以满足美容医生和消费者的需求。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台