Fziomed, Inc.('Fziomed' or the 'Company'), a recognized global leader in postsurgical adhesion prevention, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification and marketing authorization for Oxiplex

Fziomed, Inc.（“Fziomed”或“公司”），术后粘连预防领域的全球公认领导者，今天宣布美国食品药品监督管理局 (FDA) 已授予Oxiplex De Novo分类和营销授权。

gel, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is now the first and only FDA authorized intraoperative gel specifically designed for this indication.

减少成人患者腰椎手术后腿部疼痛和神经症状的凝胶。Oxiplex是目前第一个也是唯一一个FDA授权的专为该适应症设计的术中使用凝胶。

'The FDA De Novo process is a rigorous regulatory pathway utilized when there is no substantially equivalent predicate device to reference,' said

“当没有实质等效的对照设备可供参考时，FDA的De Novo流程是一种严格的监管途径，”

Paul Mraz

保罗·姆拉兹

, President and CEO. 'To satisfy FDA's benefit-risk criteria, Fziomed submitted Level 1 clinical evidence from multiple U.S. randomized clinical trials, along with international post-marketing studies, demonstrating Oxiplex's strong safety profile and clinical benefit. With this robust clinical evidence and over 20 years of real-world use outside .

，总裁兼首席执行官。“为了满足FDA的利益-风险标准，Fziomed提交了来自多个美国随机临床试验的1级临床证据，以及国际上市后研究，证明了Oxiplex良好的安全性和临床益处。凭借这一强有力的临床证据和在美国以外超过20年的实际使用经验。

the United States

美国

, we are confident Oxiplex has the potential to become a new standard of care as an adjunctive therapy.'

我们相信Oxiplex有潜力成为辅助治疗的新标准。'

'Oxiplex represents an important new adjunctive treatment for spine surgeons in

“Oxiplex脊柱外科医生来说是一种重要的辅助治疗手段，

the United States

美国

to address a significant unmet clinical need,' said

“为了解决一个重要的未满足的临床需求，”

Jeffrey Fischgrund

杰弗里·菲施格伦德

, MD, Chairman of the Orthopedic Department at William Beaumont University Hospital (

，医学博士，威廉·博蒙特大学医院骨科主任（

Royal Oak, MI

皇家橡树，密歇根州

) and principal investigator of the Oxiplex clinical studies. 'Thanks to the commitment of our clinical sites, study coordinators, and patients, this technology is now available to benefit U.S. patients.'

）以及Oxiplex临床研究的首席研究员。 “由于我们的临床基地、研究协调员和患者的承诺，这项技术现在可供美国患者受益。”

Fziomed's Oxiplex is a safe, easy-to-use, absorbable, clear viscoelastic gel applied to tissues and surrounding anatomy during surgery, immediately prior to closure. In spine surgery, Oxiplex acts as a temporary physical barrier between adjacent tissues and has been shown in multiple peer-reviewed publications to reduce postoperative leg pain and neurological symptoms.

Fziomed的Oxiplex是一种安全、易于使用、可吸收的透明粘弹性凝胶，在手术过程中于关闭前直接应用于组织及其周围解剖结构。在脊柱手术中，Oxiplex充当相邻组织之间的临时物理屏障，并在多篇同行评审的出版物中被证明能够减轻术后腿部疼痛和神经症状。

Oxiplex gel has been available outside .

Oxiplex凝胶已经在国外上市。

the United States

美国

since 2002 and has been used in more than 750,000 spine procedures worldwide for postoperative adhesion prevention.

自2002年以来，已在全世界超过750,000例脊柱手术中使用，用于预防术后粘连。

'This De Novo grant from FDA represents a major milestone for Fziomed,' said Gere diZerega, MD, Medical Director. 'It is the culmination of extensive clinical and regulatory work, and the first step in making our platform of intraoperative gel technologies available to U.S. patients across a range of surgical disciplines – such as spine, tendon, nerve, women's health, and general surgery.'.

“FDA授予的这份De Novo许可对Fziomed而言是一个重要的里程碑，”医学总监Gere diZerega博士说道，“这是大量临床和法规工作的结晶，也是将我们术中凝胶技术平台推向美国患者的第一步，涵盖脊柱、肌腱、神经、女性健康及普通外科等多个手术领域。”

'We are excited to achieve this important milestone and bring Oxiplex to the U.S. market,' added

“我们很高兴能够实现这一重要里程碑，并将Oxiplex推向美国市场，”他补充道。

Ron Haynes

罗恩·海恩斯

, Executive Chairman and co-Founder. 'This achievement highlights the strength of our science and the dedication of our world-class team.'

执行主席兼联合创始人。“这一成就凸显了我们科学的实力和我们世界级团队的奉献精神。”

About Fziomed, Inc.

关于Fziomed公司

Pioneering biomaterials since 1996, Fziomed is a vertically integrated medical device company focused exclusively on preserving surgical excellence in spine, tendon, nerve, abdominal, pelvic, and intrauterine procedures. Fziomed develops, manufactures, and commercializes surgical biomaterials used by clinicians to improve surgical outcomes and is a global leader in postsurgical adhesion prevention..

自1996年以来，Fziomed作为一家垂直整合的医疗器械公司，专注于在脊柱、肌腱、神经、腹部、骨盆和子宫内手术中保持外科卓越。Fziomed开发、制造和销售用于改善手术效果的外科生物材料，是术后粘连预防领域的全球领导者。

Fziomed's synthetic, clear, absorbable gel formulations are based on the Company's proprietary dual-polymer technology platform that provide a temporary, physical separation of tissues during the body's natural healing process – reducing adhesion formation. Fziomed's portfolio of adhesion barrier products are marketed in more than 70 countries under various brand names and have been used clinically since 2002 in nearly 1 million procedures worldwide..

Fziomed的合成、透明、可吸收凝胶制剂基于公司专有的双聚合物技术平台，该平台在人体自然愈合过程中提供临时的组织物理分隔，减少粘连形成。Fziomed的防粘连产品组合以不同品牌名称在全球70多个国家销售，并自2002年以来已在近100万例全球临床手术中使用。