Polaroid Therapeutics Receives CE Mark for POLTX_Fiber™
Polaroid Therapeutics (PTx) recently announced an impressive milestone: POLTX_Fiber™, a groundbreaking antimicrobial gel-forming wound dressing, has received the CE mark as a Class IIb medical device. This certification enables the product to be marketed in the European Union, paving the way for the introduction of innovative wound care solutions based on advancing technologies.
What is POLTX_Fiber™?
POLTX_Fiber™ utilizes Antimicrobial Polymer Technology (APT™), which was exclusively developed by PTx. This product stands out as the first of its kind to integrate this technology, aiming to enhance wound care by preventing bacterial colonization without contributing to antimicrobial resistance. The dressing is made from sodium carboxymethyl cellulose (CMC) fibers and strengthening cellulose fibers. When it comes into contact with wound exudate, POLTX_Fiber™ transforms into a gel that maintains a moist healing environment, promoting autolytic debridement and protecting the wound's margins as well as surrounding skin.
Clinical Applications
Under the supervision of healthcare professionals, POLTX_Fiber™ can be applied to a variety of wound types, including:
- - Wounds with moderate to heavy exudate.
- - Acute and chronic wounds.
- - Leg ulcers, pressure ulcers (stage II to IV), and diabetic ulcers.
- - Surgical wounds, including post-operative sites and donor areas.
- - Traumatic wounds such as abrasions and lacerations.
- - Oncological wounds with exudate.
- - Superficial or cavity wounds.
A Leap Toward Better Patient Care
Ran Frenkel, co-founder and CEO of PTx, stated, "Receiving the CE mark for POLTX_Fiber™ is a significant step in our ambition to provide better patient care solutions through human-centered, technologically advanced methods. We believe this device represents a new standard in wound care and protection."
The certification allows PTx to expand the use of POLTX_Fiber™, working closely with healthcare professionals, wound treatment centers, and distribution partners to showcase its benefits and generate clinical experience. PTx is committed to developing a broader portfolio based on APT™, envisioning additional medical devices to enhance various wound care applications.
The Future of Wound Care
As the healthcare landscape evolves, effective wound management technologies become increasingly essential. POLTX_Fiber™ embodies the intersection of innovation and clinical necessity, addressing modern challenges in wound care.
By harnessing antimicrobial properties directly in the dressing, POLTX_Fiber™ minimizes the risk of side effects commonly associated with systemic antimicrobial agents. The proprietary chemistry offers sustained antimicrobial activity, ensuring effective protection while aligning with long-term goals in combating antimicrobial resistance.
Polaroid Therapeutics, founded in 2022, operates with a commitment to responsible innovation and regulatory compliance. The company aims to create human-centered medical solutions, integrating scientific advancements into practical healthcare applications. Through the development of APT™, PTx showcases its dedication to addressing the pressing needs of patient care with intelligent, adaptive technology.
In conclusion, with the declaration of POLTX_Fiber™ as a CE-approved medical device, Polaroid Therapeutics marks a pivotal moment in both its corporate journey and the future of wound care, setting a new industry standard shaped by continuous innovation.