BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center.

巴尔的摩-（商业线）-ReGelTec公司宣布，美国食品和药物管理局已批准该公司关键性研究的IDE，以支持其HYDRAFIL®系统的上市前批准。HYDRAFIL系统包含可注射聚合物，其通过针经皮植入以在门诊手术中心在局部麻醉下进行的程序中增强天然椎间盘。

The HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D) Study, is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing..

用于椎间盘腰椎间盘的水凝胶增强（HYDRAFIL-D）研究是一项多中心，单盲，随机，对照试验，用于评估HYDRAFIL系统治疗退行性椎间盘疾病引起的慢性腰痛的安全性和有效性。HYDRAFIL-D研究将在北美多达15个中心招募约225名患者，预计将在公司完成下一轮融资后于2024年初开始。。

“I have been advising ReGelTec on their injectable hydrogel for chronic low back pain for more than four years and was able to treat a number of patients with the device during the initial studies performed outside the United States. The early results are excellenti and I can’t wait to begin the HYDRAFIL-D Study here in Oklahoma City,” said Dr.

“我一直建议ReGelTec使用可注射水凝胶治疗慢性腰痛超过四年，并且在美国以外进行的初步研究期间能够用该装置治疗许多患者。早期结果非常好，我迫不及待地在俄克拉荷马城开始HYDRAFIL-D研究，”博士说。

Douglas Beall, Chief of Interventional Spine Services, Comprehensive Specialty Care, Edmond, Oklahoma, who is an advisor to ReGelTec and one of two national principal investigators for the trial. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. in Walnut Creek, CA and the other national principal investigator said, “the HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery.

Douglas Beall是俄克拉荷马州埃德蒙综合专科护理介入脊柱服务主任，他是ReGelTec的顾问，也是该试验的两名国家主要研究人员之一。加利福尼亚州核桃溪市Boomerang Healthcare，Inc。临床研究主任Kasra Amirdelfan博士和另一位国家首席研究员说：“HYDRAFIL系统专为一部分慢性腰痛人群设计，这些人群不是很好的候选人用于传统的脊柱手术。

When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients, and we are excited to demonstrate the value of the technology in this randomized, controlled trial.”.

当保守治疗失败时，这些患者的治疗选择有限。HYDRAFIL似乎是这些患者的一个很好的选择，我们很高兴在这个随机对照试验中证明该技术的价值。

“Obtaining IDE Approval for the HYDRAFIL-D Study from the FDA is a major milestone for ReGelTec,” said Bill Niland, the company’s co-founder and CEO who has successfully founded and exited multiple healthcare companies including Harpoon Medical, Inc., Vapotherm (NYSE:VAPO), and National Sleep Technologies.

该公司的联合创始人兼首席执行官比尔·尼兰（Bill Niland）说：“获得FDA的HYDRAFIL-D研究的IDE批准是ReGelTec的一个重要里程碑。”该公司成功创立并退出了多家医疗保健公司，包括Harpoon Medical，Inc.，Vapotherm（纽约州：VAPO）和National Sleep Technologies。

The company has treated more than 70 patients with 1-year follow-up on the first sixty patients showing a 69% reduction in pain scores and an 81% improvement in Oswestry Disability Index, a measurement of how low back pain is impacting a person’s daily living.ii Mr. Niland said that “once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval, and now we are fundraising to secure the capital needed to fund the study and attain FDA approval.”.

该公司对前60名患者进行了为期1年的随访，治疗了70多名患者，疼痛评分降低了69%，Oswestry残疾指数提高了81%，这是衡量腰痛如何影响一个人的日常生活。尼兰说：“一旦我们能够与FDA分享前60名患者的1年随访数据，该团队就能够与该机构合作获得IDE批准，现在我们正在筹集资金以确保资助研究并获得FDA批准所需的资金“。

ABOUT REGELTEC, INC:

关于REGELLEC，INC：

ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL®, a percutaneous treatment for chronic low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful exits.

ReGelTec，Inc。是一家临床阶段医疗器械公司，将HYDRAFIL®商业化，HYDRAFIL®是一种经皮治疗退行性椎间盘疾病引起的慢性腰痛的药物。该公司成立时，拥有丰富聚合物科学经验的化学工程师团队与多个成功退出的医疗器械专业人员跨职能团队合作。

The HYDRAFIL System contains a hydrogel that can be injected into a degenerated disc via a needle. Once approved, HYDRAFIL will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. The HYDRAFIL System is an investigational device, limited by United States law to investigational use..

HYDRAFIL系统包含一个水凝胶，可以通过针注入退化的椎间盘中。一旦获得批准，HYDRAFIL将为退行性椎间盘疾病引起的慢性背痛患者提供超越传统保守治疗的微创治疗选择。HYDRAFIL系统是一种研究设备，受美国法律限制用于研究用途。。

i https://www.jvir.org/article/S1051-0443(23)00694-2/pdf

和https://www.jvir.org/article/S1051-0443（23）00694-2.pdf

ii Internal data on file

ii文件中的内部数据