MIDDLETON, Wis.--(BUSINESS WIRE)--Imbed Biosciences announces U.S. Food and Drug Administration 510(k) clearance to market Microlyte® Ag/Lidocaine, the first antimicrobial wound dressing to integrate lidocaine for the management of painful skin wounds. Microlyte® Ag/Lidocaine utilizes Imbed’s patented synthetic matrix to deliver ionic and metallic silver alongside lidocaine, providing both antimicrobial protection and local anesthetic effects.

威斯康星州米德尔顿。-（商业新闻短讯）--Imbed Biosciences宣布美国食品和药物管理局510（k）批准上市Microlyte®Ag/利多卡因，这是第一种将利多卡因用于治疗疼痛性皮肤伤口的抗菌伤口敷料。Microlyte®Ag/利多卡因利用Imbed的专利合成基质与利多卡因一起提供离子和金属银，提供抗菌保护和局部麻醉效果。

The dressing releases 40mg of lidocaine hydrochloride USP per 100cm² of wound surface area, equivalent to a 4% w/w gel. The advanced Microlyte® Ag/Lidocaine wound dressing is indicated for the management of a variety of partial- and full-thickness wounds under the supervision of a healthcare professional, including venous stasis ulcers, pressure sores, ischemic ulcers, partial thickness burns, donor site wounds, surgical wounds, post-surgical incisions, abrasions and lacerations..

敷料每100cm²伤口表面积释放40mg盐酸利多卡因USP，相当于4%w/w凝胶。先进的Microlyte®Ag/利多卡因伤口敷料适用于在医疗保健专业人员的监督下管理各种部分和全层伤口，包括静脉淤滞溃疡、压疮、缺血性溃疡、部分厚度烧伤、供体部位伤口、手术伤口、术后切口、擦伤和撕裂伤。。

In the $22 billion wound care industry targeting both acute and chronic wounds, over 8 million Americans suffer from chronic wounds, with approximately 60% remaining unhealed. These wounds often harbor microbial biofilms, contributing to over $148 billion in annual healthcare costs. Microlyte® Ag/Lidocaine is designed to facilitate wound healing progression in deteriorating wounds by suppressing the growth of microbes in contact with the dressing, maintaining a moist matrix environment conducive to cellular growth, and releasing lidocaine to effect local anesthetic action..

在针对急性和慢性伤口的220亿美元伤口护理行业中，超过800万美国人患有慢性伤口，约60%仍未愈合。这些伤口通常含有微生物生物膜，每年的医疗保健费用超过1480亿美元。。。

“Our patented polymeric matrix architecture incorporates both silver and lidocaine in the dressing enabling the two active ingredients to provide both antimicrobial and anesthetic benefits locally to the patient,” said Dr. Ankit Agarwal, PhD, co-founder and Chief Scientific Officer of the company. “We are the first to demonstrate that stable formulations of silver and lidocaine can be incorporated in a combination device.

该公司联合创始人兼首席科学官Ankit Agarwal博士说：“我们的专利聚合物基质结构在敷料中结合了银和利多卡因，使这两种活性成分能够为患者局部提供抗菌和麻醉益处。”。“我们是第一个证明稳定的银和利多卡因制剂可以结合在组合装置中的人。

Additionally, this achievement demonstrates the ability to use Microlyte® Matrix as an effective drug-delivery platform, creating the potential for numerous pipeline opportunities to improve wound care.”.

此外，这一成就证明了使用Microlyte®Matrix作为有效药物输送平台的能力，为改善伤口护理创造了众多管道机会的潜力。”。

The fully-synthetic antimicrobial wound matrix with lidocaine was shown to provide sustained antimicrobial activity in simulated wound fluid for several days, killing 99.99% of the most commonly identified clinical isolates of gram-positive and gram-negative bacteria, along with prevalent fungal strains..

含有利多卡因的全合成抗菌伤口基质显示出在模拟伤口液中持续数天的抗菌活性，杀死了99.99%最常见的革兰氏阳性和革兰氏阴性细菌临床分离株以及流行的真菌菌株。。

Michael Schurr, MD, Chair of General Surgery at Mission Hospitals in Asheville, NC and co-founder of the company commented, “This will be the first wound dressing in the world with silver and lidocaine together. Along with reducing the incidence of wound infections, this dressing could provide temporary pain relief in some of the most painful wounds, potentially reducing the need for both systemic antibiotics and opioids.

北卡罗来纳州阿什维尔市Mission Hospitals的普通外科主席兼该公司联合创始人迈克尔·舒尔（Michael Schurr）医学博士评论道：“这将是世界上第一种同时使用银和利多卡因的伤口敷料。除了降低伤口感染的发生率外，这种敷料还可以暂时缓解一些最痛苦的伤口的疼痛，从而可能减少对全身抗生素和阿片类药物的需求。

This is a major breakthrough in wound management and is poised to significantly enhance the quality of care for patients living with painful wounds.”.

这是伤口管理方面的重大突破，有望显着提高痛苦伤口患者的护理质量。”。

“Last year, more than 100,000-unit applications of Microlyte® Matrix were used in wounds,” said Dr. Agarwal. “This next-gen version of Microlyte® Matrix, combining silver and lidocaine, strengthens our commitment to advancing wound care standards and reassures clinicians to choose Microlyte® as their preferred synthetic wound matrix in the protocols of wound management.”.

Agarwal博士说：“去年，在伤口中使用了超过10万单位的Microlyte®基质。”。“下一代版本的Microlyte®矩阵结合了银和利多卡因，加强了我们对提高伤口护理标准的承诺，并保证临床医生在伤口管理方案中选择Microlyte®作为他们首选的合成伤口矩阵。”。

The new Microlyte® Ag/Lidocaine matrix will launch at the Symposium for Advanced Wound Care in May 2025.

新型 Microlyte® Ag/Lidocaine 基质将于 2025 年 5 月在高级伤口护理研讨会上推出。

About Imbed Biosciences

关于Imbed Biosciences

Imbed Biosciences is a privately held medical device company developing and commercializing innovative solutions to improve wound care. The company has a portfolio of products on the market and in development to combat local pain and infections in complex wounds using its patented Microlyte® Matrix technology platform.

Imbed Biosciences是一家私营医疗器械公司，开发和商业化创新解决方案，以改善伤口护理。该公司在市场上拥有一系列产品，并正在开发中，以使用其专利的Microlyte®Matrix技术平台对抗复杂伤口的局部疼痛和感染。