StimLabs Announces National Availability of Corplex P

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Oct 02, 2024, 07:30 ET

Designed to Manage Hard-to-Heal Wounds, from Chronic to Acute

ROSWELL, Ga., Oct. 2, 2024 /PRNewswire/ -- StimLabs^®, a pioneering regenerative medicine company, announces the nationwide launch of Corplex P™, the first and only medical device derived from human umbilical cord extracellular matrix (ECM). In a significant milestone for wound care, Corplex P was cleared by the US Food and Drug Administration (FDA) in February 2024, putting StimLabs in a class of its own as the first to receive a wound management 510(k) clearance for a human birth tissue product.

Corplex P is a dehydrated human umbilical cord particulate (dHUCP) device designed for the management of hard-to-heal wounds. The primary benefits of the device are in its composition, configuration, and ability to regulate moisture exchange.

Corplex P's connective tissue matrix components include collagens, fibronectin, laminin proteoglycans, and glycosaminoglycans (GAGs). The proprietary processing technique that allows the preservation of these components differentiates Corplex P from many xenograft products whose processing techniques can result in the stripping of valuable GAGs and proteoglycans.¹ Its hydrophilic components, in particular hyaluronic acid, are key to the device's absorptive properties. While the product composition gives Corplex P the ability to provide a moist wound environment, its particulate format enables further moisture management by allowing exudate to drain from the wound. The particulate configuration also provides conformability and wound bed contact, allowing Corplex P to be more readily incorporated into the wound as it heals.

Corplex P addresses a wide range of wound types including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, and draining wounds.

"Chronic and acute wounds present a significant healthcare challenge, affecting millions of individuals each year," said StimLabs Founder and CEO, John Daniel. "With Corplex P, StimLabs aims to address this challenge by providing clinicians and patients with an advanced solution for wound management. Corplex P offers an opportunity for a better quality of life for those in need of care and since its limited release, healthcare practitioners have shown excitement for the impact it's making. We're excited to now make this available nationally."

Key Advantages of Corplex P:

Optimized for complex and irregular wound beds
Provides a complex, porous scaffold
Resorbs naturally into the wound
Facilitates a moist wound environment through the regulation of moisture exchange
Allows a versatile application process and more efficient product usage through the particulate format*

When asked about the innovation and clinical use of Corplex P, Dr. Jamison Feramisco, MD, PhD stated, "StimLabs has done something unique by bringing a human tissue-derived device to the market. Not only is Corplex P rich in biologically important components, but the format allows me to tailor the product to my patients' wounds. I'm treating a non-contiguous venous ulcer and can be more efficient with my product use while maintaining ideal wound coverage. The particulate can be applied at varying densities and hydration levels*, so I can pack it into tunneling wounds or use it on larger shallow wounds, such as those from MASD. Corplex P complements my treatment algorithm for hard-to-heal wounds, and I look forward to how many of my patients can benefit from this technology."

Corplex P is available for use in the hospital setting and will be featured at the Symposium on Advanced Wound Care (SAWC) Fall Conference with a presentation by Dr. Feramisco, a CME-accredited hands-on workshop, an accepted poster presentation, and at the StimLabs booth.

For more information, visit https://stimlabs.com/corplexp.

About StimLabs
StimLabs LLC was founded in 2015 with the mission to advance the state of regenerative medicine. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care through innovation and personalized solutions. StimLabs has a comprehensive product portfolio addressing various clinical needs and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike. Stimlabs.com

Data on file. Corplex P is for adult use and is not indicated for injection. *For detailed product safety and device application information, refer to the Instructions For Use.

1. Cissell D.D., Hu J.C., Griffiths L.G., Athanasiou K.A. Antigen removal for the production of biomechanically functional, xenogeneic tissue grafts. J. Biomech. 2014;47:1987–1996. doi: 10.1016/j.jbiomech.2013.10.041.

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SOURCE StimLabs