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Transaction will add FDA Breakthrough Device-Designated technology with active U.S. pivotal IDE trial, positioning Galmed to address one of colorectal surgery's most serious unmet needs.
此次交易将引入获美国食品药品监督管理局(FDA)突破性设备认定、且正在开展美国关键性研究者发起试验(IDE)的技术,使Galmed能够应对结直肠外科领域最严峻的未满足临床需求之一。
Colospan's CG-100 Intraluminal Bypass Device, is CE marked under EU's Medical Device Regulation ('MDR') and ready for commercial launch in the EU and Israel. Galmed contemplates an investment of $6 million to launch Colospan's device during H2 2026 in Europe with an initial focus on Germany, Austria and Switzerland..
Colospan 的 CG-100 腔内旁路装置已获得欧盟医疗器械法规(MDR)的 CE 认证,并准备在欧盟和以色列进行商业发布。Galmed 计划投资 600 万美元,于 2026 年下半年在欧洲推出 Colospan 的装置,初期重点面向德国、奥地利和瑞士市场。
Upon closing, Colospan will become a wholly owned subsidiary of Galmed, repositioning it as a GI-focused medtech and biopharmaceutical platform. Transaction approved by both boards; expected to close Q2 2026.
交易完成后,Colospan 将成为 Galmed 的全资子公司,并将其重新定位为专注于胃肠道的医疗科技和生物制药平台。该交易已获双方董事会批准,预计将于 2026 年第二季度完成交割。
RAMAT GAN, Israel
以色列拉马特甘
,
,
June 8, 2026
2026年6月8日
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. ('Galmed') (NASDAQ:
/美通社/ -- Galmed Pharmaceuticals Ltd.(“Galmed”)(纳斯达克股票代码:
GLMD
广义线性混合模型
) today announced that it has entered into a definitive agreement to acquire Colospan Ltd. ('Colospan'), a commercial-stage medical device company that has developed a clinically differentiated solution to one of colorectal surgery's most pressing problems: anastomotic leak complications and the diverting stomas used to manage them..
)今日宣布,已签订最终协议,收购Colospan Ltd.(“Colospan”)。Colospan是一家处于商业化阶段的医疗器械公司,其开发了一种具有临床差异化优势的解决方案,以应对结直肠手术中最紧迫的问题之一:吻合口漏并发症以及用于管理这些并发症的预防性造口。
Upon closing, Colospan will become a wholly owned subsidiary of Galmed. The acquisition is designed to accelerate Galmed's strategy to create a diversified, GI-focused medtech and biopharmaceutical platform, combining Galmed's established public company infrastructure, cash reserves, and GI clinical expertise with Colospan's proprietary device technology and active U.S.
交易完成后,Colospan 将成为 Galmed 的全资子公司。此次收购旨在加速 Galmed 打造多元化、专注于胃肠道的医疗科技和生物制药平台的战略,将 Galmed 成熟的上市公司基础设施、现金储备和胃肠道临床专业知识与 Colospan 的专有设备技术及活跃的美国业务相结合。
pivotal clinical program..
关键性临床项目
Colospan's flagship product, the CG-100 intraluminal bypass device, is a minimally invasive alternative designed to protect the anastomosis, minimize patient burden, and reduce the need for a diverting stoma - a temporary abdominal opening that redirects waste to an external bag while healing occurs.
Colospan的旗舰产品CG-100腔内旁路装置是一种微创替代方案,旨在保护吻合口、减轻患者负担,并降低对转流性造口的需求——转流性造口是指在愈合期间将废物引流至体外袋中的临时腹部开口。
The CG-100 is CE marked under the MDR and is currently under investigational use only (under IDE) in the USA. Colospan is currently conducting a clinical pivotal trial designed to support a future FDA application. By combining resources, Galmed plans to deliver a clinically compelling and economically meaningful tool to reshape the standard of care for colorectal resection patients worldwide..
CG-100已根据欧盟医疗器械法规(MDR)获得CE标志,目前在美国仅限用于研究目的(依据IDE规定)。Colospan公司目前正在开展一项关键性临床试验,旨在为未来向美国食品药品监督管理局(FDA)提交申请提供支持。通过整合资源,Galmed计划推出一款具有显著临床价值和经济意义的工具,以重塑全球结直肠切除手术患者的护理标准。
'CG-100 is a category leader having an FDA Breakthrough Device Designation and a CE (MDR) European regulatory status ready for commercialization. The expected acquisition of Colospan is a defining moment for Galmed and we believe is the type of asset that moves the needle,' said
“CG-100 是同类产品的领导者,已获得美国食品药品监督管理局(FDA)的突破性设备认定,并具备符合欧盟医疗器械法规(MDR)的 CE 认证,已准备好实现商业化。预计对 Colospan 的收购是 Galmed 的一个决定性时刻,我们相信这类资产能够产生显著影响,” said
Allen Baharaff, Co-founder and Chief Executive Officer of Galmed
艾伦·巴哈拉夫,Galmed 联合创始人兼首席执行官
Pharmaceuticals. 'The acquisition of Colospan aligns perfectly with our long-term growth strategy. We are bringing more than 25 years of clinical execution capabilities together with our public company experience and resources to accelerate the CG-100 pivotal study to obtain FDA regulatory approval.
医药领域。“收购Colospan与我们的长期增长战略高度契合。我们将二十余年的临床执行能力与上市公司经验及资源相结合,以加速推进CG-100的关键性研究,从而获得美国食品药品监督管理局(FDA)的监管批准。”
We believe our shared vision will allow us to scale Colospan's technologies faster, and substantially accelerate our path to success.' .
我们相信,共同的愿景将使我们能够更快地扩展Colospan的技术,并大幅加速我们通往成功的道路。
Boaz Assaf,
博阿兹·阿萨夫,
Founder and Chief Executive Officer of Colospan
Colospan 创始人兼首席执行官
commented: 'Colorectal cancer is the third most commonly diagnosed cancer in both men and women with ~ 1.9M diagnosed cases worldwide annually. Colorectal resection is the most common medical treatment for colorectal cancer and is performed on majority of patients worldwide to remove the tumor. Anastomotic leaks, a failure of the surgical connection, occur in up to 21% of procedures contributing to increased morbidity, mortality, longer hospital stays, and higher healthcare costs.
评论:结直肠癌是男性和女性中第三大常见确诊癌症,全球每年约有190万例新发病例。结直肠切除术是结直肠癌最常见的医学治疗方法,全球大多数患者接受该手术以切除肿瘤。吻合口漏(即手术连接失败)的发生率高达21%,导致发病率和死亡率上升、住院时间延长以及医疗成本增加。
To prevent clinical leaks, surgeons routinely create a diverting stoma: a temporary abdominal opening that redirects waste to an external bag while the anastomosis heals. While clinically standard, living with a stoma significantly impairs quality of life and creates substantial clinical and economic burden for healthcare systems.
为预防临床漏,外科医生常规创建转流性造口:一种临时性的腹部开口,在吻合口愈合期间将废物引流至体外收集袋。尽管这在临床上属于标准操作,但携带造口会显著降低患者的生活质量,并给医疗保健系统带来沉重的临床和经济负担。
Colospan was founded specifically to answer the clinical and economic burden associated with this problem, creating a stoma-free future for patients.' .
Colospan 的成立旨在专门应对与这一问题相关的临床和经济负担,为患者创造一个无需造口的未来。
Under the terms of the definitive agreement, Colospan shareholders and SAFE holders will receive $2.5 million in cash and $2.0 million in Galmed ordinary shares at closing, subject to customary adjustments and escrow. The transaction has been unanimously approved by the boards of directors of both companies.
根据最终协议的条款,在交割时,Colospan 的股东和 SAFE 持有人将获得 250 万美元现金以及价值 200 万美元的 Galmed 普通股,须受惯例调整及托管安排的约束。该交易已获得两家公司董事会的一致批准。
The transaction is subject to customary closing conditions and is expected to close in Q2 2026..
该交易须满足惯例交割条件,预计将于2026年第二季度完成。
Roth Capital Partners, LLC served as financial advisor to Galmed. Meitar Law Offices serves as legal counsel to Galmed, and Matry Meiri Wacht & Co. serves as legal counsel to Colospan.
罗斯资本合伙公司(Roth Capital Partners, LLC)担任加尔梅德(Galmed)的财务顾问。梅塔尔律师事务所(Meitar Law Offices)担任加尔梅德的法律顾问,而马特里·梅里·瓦赫特律师事务所(Matry Meiri Wacht & Co.)则担任科洛斯潘(Colospan)的法律顾问。
ABOUT GALMED PHARMACEUTICALS LTD.
关于加尔德医药有限公司
Galmed Pharmaceuticals Ltd. (NASDAQ:
Galmed制药有限公司(纳斯达克:
GLMD
广义线性混合模型
) is an Israel-based biopharmaceutical company headquartered in Ramat Gan, with a growing focus on gastrointestinal and oncological innovation. Galmed's flagship asset, Aramchol, is a first-in-class synthetic fatty acid-bile acid conjugate molecule under evaluation across liver disease and oncological indications, including GI cancers.
)是一家总部位于以色列拉马特甘的生物制药公司,日益专注于胃肠道和肿瘤学领域的创新。Galmed 的核心资产 Aramchol 是一种首创新类的合成脂肪酸-胆汁酸结合分子,目前正在针对肝病及肿瘤适应症(包括胃肠道癌症)进行评估。
For more information, visit .
更多信息,请访问。
www.galmedpharma.com
www.galmedpharma.com
.
。
ABOUT COLOSPAN LTD.
关于 COLOSPAN 有限公司
Colospan Ltd. is a commercial-stage medical device company headquartered in Kfar Saba, Israel. Its flagship product, CG-100, is an intraluminal bypass device designed to protect colorectal anastomoses and reduce the need for diverting stomas, offering a less invasive alternative to standard
Colospan Ltd. 是一家处于商业化阶段的医疗器械公司,总部位于以色列的凯法尔萨巴。其旗舰产品 CG-100 是一种腔内旁路装置,旨在保护结直肠吻合口并减少预防性造口的需求,为传统标准疗法提供了一种创伤更小的替代方案
surgical practice. CG-100 was granted FDA Breakthrough Device Designation, is CE marked under the EU Medical Device Regulation, and is approved for investigational use in the United States under an FDA approved IDE. The device is not approved for commercial use in the US. For more information, visit .
外科实践。CG-100 已获得美国食品药品监督管理局(FDA)的突破性器械认定,根据欧盟医疗器械法规获得 CE 标志,并在 FDA 批准的 investigational device exemption(IDE)下获准在美国用于研究性用途。该设备尚未获准在美国进行商业使用。欲了解更多信息,请访问 。
www.colospan.com
www.colospan.com
.
。
FORWARD-LOOKING STATEMENTS
前瞻性陈述
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to anticipated or expected events, activities, trends, or results as of the date they are made, including statements regarding the expected benefits of the acquisition and transaction timing.
本新闻稿包含1995年《私人证券诉讼改革法案》所定义的“前瞻性陈述”。这些陈述涉及截至作出之日所预期或预计的事件、活动、趋势或结果,包括关于收购预期收益及交易时间的陈述。
Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or implied..
前瞻性陈述涉及固有的风险和不确定性,可能导致实际结果与明示或暗示的结果存在重大差异。
Factors that could cause differences include, but are not limited to the possibility that the transaction does not close, including due to failure of closing conditions; Galmed's inability to recognize the anticipated benefits of the acquisition of Colospan; expectations with respect to future performance and growth of Colospan; Galmed and Colospan's ability to execute their business plans and strategy and to receive regulatory approvals; potential litigation involving the parties; changes in domestic and foreign business, market, financial, political and legal conditions; market adoption and pricing barriers; intellectual property enforcement or infringement claims; manufacturing and supply chain constraints; intense industry competition; the ability to maintain listing on the Nasdaq Capital Market; geopolitical events, including the security situation in Israel; regulatory changes; access to additional financing; and other risks and uncertainties indicated from time to time in filings with the SEC by Galmed Additional risks relating to Colospan's product and its strategy are detailed in a report on Form 6-K filed by Galmed with the SEC on June 8, 2026 and risks associated with Galmed are detailed in Galmed's Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 under the heading 'Risk Factors.' Galmed undertakes no obligation to publicly update or revise any forward-looking statements to reflect new information, change in expectations, subsequent events, or otherwise, except as required by law. .
可能导致差异的因素包括但不限于:交易未能完成的可能性(包括因交割条件未获满足而导致);Galmed 无法实现收购 Colospan 的预期效益;对 Colospan 未来业绩和增长的预期;Galmed 和 Colospan 执行其业务计划与战略以及获得监管批准的能力;涉及各方的潜在诉讼;国内外商业、市场、金融、政治和法律环境的变化;市场接受度及定价障碍;知识产权执行或侵权索赔;制造和供应链限制;激烈的行业竞争;维持纳斯达克资本市场上市地位的能力;地缘政治事件(包括以色列的安全局势);监管变化;获取额外融资的渠道;以及 Galmed 在向美国证券交易委员会(SEC)提交的文件中不时指出的其他风险和不确定性。与 Colospan 产品及其战略相关的其他风险详见 Galmed 于 2026 年 6 月 8 日向 SEC 提交的 6-K 表格报告;与 Galmed 相关的风险详见 Galmed 于 2026 年 3 月 31 日向 SEC 提交的截至 2025 年 12 月 31 日年度的 20-F 表格年度报告中“风险因素”标题下的内容。除法律要求外,Galmed 不承担公开更新或修订任何前瞻性陈述以反映新信息、预期变化、后续事件或其他情况的义务。
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SOURCE Galmed Pharmaceuticals Ltd.
来源:Galmed Pharmaceuticals Ltd.
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