MIAMI--(BUSINESS WIRE)--Privately-held company Guard Medical Inc. today announces FDA 510(k) clearance for additional large sizes (surgical wounds up to 25cm) of its next generation Negative Pressure Wound Therapy (NPWT) dressing NPseal for the treatment of closed surgical incisions. NPseal is an easy-to-use, affordable, and cost-effective NPWT surgical dressing with an integrated pump that establishes and maintains negative pressure with just a few pinches..

迈阿密--（商业新闻短讯）--私人控股公司Guard Medical Inc.今天宣布，FDA 510（k）批准其下一代负压伤口治疗（NPWT）敷料NPseal用于治疗闭合性手术切口的额外大尺寸（手术伤口高达25cm）。NPseal是一种易于使用，价格合理且具有成本效益的NPWT外科敷料，配有集成泵，只需几次挤压即可建立并维持负压。。

“Following the successful clinical results of NPseal with my hip replacement patients, the additional large sizes will expand the use of NPseal to all our patients including knee replacement patients,” stated Asit Shah, MD, PhD, Englewood Orthopedic Associates, Englewood, NJ. “I look forward to dressing my patients’ wounds for success with NPseal.”.

新泽西州恩格伍德Englewood Orthopedic Associates医学博士Asit Shah表示：“随着NPseal在我的髋关节置换患者中取得成功的临床结果，额外的大尺寸将扩大NPseal的使用范围，包括膝关节置换患者。”。“我期待着用NPseal成功包扎患者的伤口。”。

“We’re excited to expand our portfolio with the NPseal 20 and NPseal 25. FDA clearance for the additional large sizes allows NPseal to become the dressing of choice for the treatment of closed surgical incisions in orthopedic, cesarean, and cardiothoracic procedures,” stated Machiel van der Leest, CEO of Guard Medical.

“我们很高兴能用NPseal 20和NPseal 25扩大我们的投资组合。Guard Medical首席执行官Machiel van der Leest表示：“FDA对额外大尺寸的批准使NPseal成为治疗骨科，剖宫产和心胸手术中闭合手术切口的首选敷料。”。

“We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”.

“我们认为NPseal独特地适应了日益增长的门诊趋势，需要更高的患者流动性和自我护理。”。

NPWT has been shown to reduce Surgical Site Complications (SSC) in a large number of peer reviewed articles. Until now, however, conventional disposable NPWT devices have not achieved wide-spread use due to their high cost and complexity. NPseal dressings uniquely broaden NPWT’s application while driving conversion from the Advanced Wound Dressing and Standard Dressing markets..

在大量同行评审的文章中，NPWT已被证明可以减少手术部位并发症（SSC）。然而，到目前为止，传统的一次性NPWT设备由于其高成本和复杂性而尚未得到广泛应用。NPseal敷料独特地拓宽了NPWT的应用范围，同时推动了先进伤口敷料和标准敷料市场的转型。。

Guard Medical Inc. (www.guard-medical.com), a privately-held company, is commercializing easy-to-use, affordable, and cost-effective solutions that enable prophylactic Negative Pressure Wound Therapy (NPWT) wound care of closed surgical incisions. Guard Medical’s simple NPWT technology originated with New York-Presbyterian and Weill Cornell Medicine in response to physicians’ identification of unmet needs related to Surgical Site Infections (SSI).

Guard Medical Inc.（www.Guard-Medical.com）是一家私营公司，正在将易于使用，价格合理且具有成本效益的解决方案商业化，以实现对闭合手术切口的预防性负压伤口治疗（NPWT）伤口护理。Guard Medical的简单NPWT技术起源于纽约长老会和威尔康奈尔医学，以响应医生对与手术部位感染（SSI）相关的未满足需求的识别。

Current investors include Bpifrance and Matignon Investissement et Gestion..

当前投资者包括Bpifrance和Matignon Investissement et Gestion。。

Guard Medical’s vision is to develop NPWT solutions for use on a wide range of surgical wound types and sizes with broad applications for infection prevention, scar mitigation, and enhanced cosmesis.

Guard Medical的愿景是开发NPWT解决方案，用于各种手术伤口类型和大小，广泛应用于预防感染，减轻疤痕和增强美容。