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糖尿病治疗器械开发商Endogenex宣布获得8800万美元C轮融资,以完成ReCET™系统在2型糖尿病患者中的关键试验

Endogenex™ Announces $88 Million Series C Financing to Complete Pivotal Trial of the ReCET™ System in Patients with Type 2 Diabetes

CISION 等信源发布 2024-06-25 08:22

可切换为仅中文


Oversubscribed financing led by strategic investor, with participation from new and existing investors

战略投资者主导的超额认购融资,新投资者和现有投资者参与

MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million. The new capital will be used to complete the pivotal ReCET Clinical Study, which has been granted an Investigational Device Exemption (IDE) by the U.S.

明尼阿波利斯,2024年6月25日/PRNewswire/--Endogenex,一家致力于改善2型糖尿病患者预后的临床阶段医疗器械公司,宣布已关闭了一笔超额认购的C系列融资,总额为8800万美元。新资金将用于完成关键的ReCET临床研究,该研究已被美国授予研究设备豁免(IDE)。

Food and Drug Administration (FDA). A group of new investors, including Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, joined an undisclosed strategic lead investor and existing investors Intuitive Ventures, Longitude Capital, Mayo Clinic, and Santé Ventures in the Series C funding..

美国食品和药物管理局(FDA)

'We are excited to take this significant step forward in our mission to transform diabetes care,' said Stacey Pugh, CEO of Endogenex. 'This funding will enable us to complete our pivotal clinical study, bringing us closer to offering a groundbreaking solution for type 2 diabetes patients. The therapeutic landscape in diabetes continues to evolve, especially around the earlier use of SGLT2i and GLP-1RA.

Endogenex首席执行官斯泰西·普格(StaceyPugh)说,我们很高兴在转变糖尿病护理的使命中迈出这一重要的一步这笔资金将使我们能够完成关键的临床研究,使我们更接近为2型糖尿病患者提供开创性的解决方案。糖尿病的治疗前景继续发展,特别是在早期使用SGLT2i和GLP-1RA的情况下。

However, there remains a considerable unmet need to address the underlying pathophysiology and progression of the disease.'.

然而,解决疾病的潜在病理生理学和进展仍然存在相当大的未满足需求。”

'We are very proud of the company's progress, and this successful funding round is a testament to Endogenex's innovative technology,' said Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital. 'This milestone underscores our investors' confidence in the company's vision and the impact it can make in treating the epidemic of type 2 diabetes around the world.'.

Endogenex董事会主席兼经度资本董事总经理朱丽叶·塔梅努姆斯·巴克(JulietTammenomsBakker)说,我们为公司的进步感到骄傲,这一轮成功的融资证明了Endogenex的创新技术这一里程碑突显了我们的投资者对该公司愿景的信心,以及它在治疗全球2型糖尿病流行方面可能产生的影响。”

About the ReCET Clinical StudyThe ReCET Clinical Study is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the ReCET System. The pivotal study received IDE approval in November 2023. The study will enroll up to 350 patients at clinical sites in the United States and Australia..

关于ReCET临床研究ReCET临床研究是一项多中心,前瞻性,随机,双盲,假对照研究,评估ReCET系统的安全性和有效性。该关键研究于2023年11月获得IDE批准。该研究将在美国和澳大利亚的临床地点招募多达350名患者。

About the ReCET™ ProcedureReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes.

关于ReCET™程序ReCET是一种针对十二指肠细胞病理的新型内镜门诊手术。

The ReCET System aims to initiate the body's natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels..

ReCET系统旨在通过向粘膜和粘膜下十二指肠组织施加高度可控的非热脉冲电场来启动身体的自然再生过程。这种方法可能有助于恢复十二指肠正常的细胞信号传导,改善代谢功能,包括更好地控制血糖水平。

The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications.

ReCET系统已在可行性临床研究中进行了评估,例如REGENT-1 US,REGENT-1 Australia和荷兰的Excellent。这些研究评估了成人2型糖尿病患者的治疗安全性和有效性,尽管使用胰岛素和非胰岛素药物,但其血糖水平控制不足。

Preliminary outcomes from these studies have been presented at medical conferences globally..

这些研究的初步结果已在全球医学会议上发表。

The ReCET System has received an FDA Breakthrough Device Designation for treating type 2 diabetes in adults inadequately controlled by glucose-lowering medications.

ReCET系统已获得FDA突破性设备指定,用于治疗降糖药物控制不足的成年人的2型糖尿病。

About Endogenex™Endogenex, founded in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). The company's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function.

关于Endogenex™Endogenex,与梅奥诊所合作成立,旨在彻底改变2型糖尿病(T2D)患者的治疗选择。该公司的创新重点是通过利用其自然再生能力来改善代谢功能,从而重置身体的代谢信号系统。

Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in T2D therapy, helping patients regain control of their blood glucose levels and slow disease progression..

通过ReCET系统的开发和精确、可控、非热脉冲电场的新应用,Endogenex正在T2D治疗中开创一个新时代,帮助患者重新控制血糖水平并减缓疾病进展。