#USA #FDA Clearance #StimLabs #Roswell #Theracor

StimLabs Obtains FDA Clearance for Theracor™

In a groundbreaking achievement for the wound care sector, StimLabs has proudly announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Theracor™, marking it as the first-ever medical device sheet produced from human umbilical cord. This significant milestone not only emphasizes the commitment of StimLabs to innovation in regenerative medicine but also positions the company at the forefront of advancements in wound management.

Theracor, which builds upon the success of Corplex P®, another human umbilical cord-derived product previously cleared by the FDA, aims to fulfill the diverse needs of patients with various wound types. According to StimLabs' Founder and CEO, John Daniel, the last decade has seen the company dedicated to pioneering technologies that enhance healthcare outcomes, and obtaining 510(k) clearance for Theracor is a testament to their ongoing leadership in this arena. Daniel stated, "With the introduction of Theracor, we are not only expanding our product line but also enriching the clinical choices available to healthcare professionals and patients who rely on human tissue solutions for managing both acute and chronic wounds."

Theracor showcases a unique design that employs the extracellular matrix (ECM) derived from human umbilical cords, offering a protective cover that helps maintain a moist environment essential for effective wound healing. It is specifically indicated for a wide range of wound types, including partial and full-thickness wounds, venous ulcers, diabetic ulcers, pressure ulcers, surgical wounds, and trauma wounds such as abrasions and burns. With Theracor, healthcare providers can access a ready-to-use sheet format that caters to patients with ongoing treatment needs—enhancing the effectiveness of their care strategies.

Notably, Theracor is designed to complement Corplex P, which is available nationally. This strategic expansion of StimLabs' product offerings not only gives care professionals more choices in addressing the unique challenges that patients face but also reinforces the company’s commitment to meeting missing clinical needs while adhering to the highest quality standards. Daniel enthusiastically described the clearance of Theracor as empowering for clinicians: "Our mission is rooted in innovation, and with the successful 510(k) clearance of Theracor, we further our dedication to developing products that make a meaningful impact on patient outcomes."

Clinicians can look forward to using Theracor in their practices very soon. As a part of its commitment to equipping healthcare providers with the best tools available for wound care, StimLabs continues to advocate for advancements in regenerative medicine. For more information about Theracor and StimLabs' ongoing initiatives, interested parties can visit StimLabs' official site.

About StimLabs

StimLabs is recognized as a leader in regenerative medicine, focusing specifically on wound care and surgical applications. Its expert team strives to provide the highest level of care to patients, while being committed to creating solutions for areas with significant unmet needs. The company has developed a comprehensive range of products tailored for various clinical applications and possesses a robust catalog of intellectual property. As a reputable partner for healthcare providers, StimLabs prioritizes delivering premium products that enhance patient care.

For Media Inquiries:
Contact us
Phone: 470-616-0958