FDA clears first particulate placental extracellular matrix medical device for wound management

Convatec product is only medical device of its kind

MEMPHIS, Tenn., Feb. 23, 2023 /PRNewswire/ -- Convatec today announced it has received clearance from the U.S. Food and Drug Administration for its InnovaMatrix^® PD particulate placental extracellular matrix medical device for wound management.

The medical device joins Convatec's existing InnovaMatrix^® AC product as the first and only next-generation placental-derived medical devices designed for management of complex surgical wounds, chronic stalled wounds and burns. It gives physicians a placental-derived particulate product that can replace the human particulate placenta products no longer on the market. The product is commercially available.

 "Convatec is always proud to bring healing innovations to patients with hard-to-heal wounds," said David Shepherd, President and Chief Operating Officer of Advanced Wound Care at Convatec. "We're pleased to offer physicians this new particulate product that is the first of its kind. It gives physicians a new, important tool for healing hard-to-heal wounds, continuing our efforts to expand the InnovaMatrix^® platform as part of our 'forever caring' promise."

InnovaMatrix^® PD is indicated for the management of wounds, including full- and partial-thickness wounds, surgical wounds and traumatic wounds. It is a xenograft that has been controlled for genetic variability and environmental and lifestyle factors, such as diet and activity levels. The device can be used to treat traumatic lacerations, dehisced incisional wounds, pressure and venous ulcers, post-Mohs surgery wounds, partial thickness burns, post-surgical incisions and diabetic foot ulcers.

InnovaMatrix^® PD requires no preparation, no tissue tracking and no special storage. It offers the inherent benefits of the placenta plus the quality control, reliability and safety profile of a medical device.

"This new, first-of-its-kind medical device was cleared by the FDA through the 510(k) pathway, meaning it passed very rigorous review," said Divakar Ramakrishnan, Chief Technology Officer at Convatec. "It's just one example of Convatec's commitment to bringing patients innovative products of the highest quality. Physicians tell us they are excited to have a particulate placental-derived product that can support the healing process for patients with complicated wounds."

InnovaMatrix^® products are manufactured with Convatec's proprietary TriCleansetm Placental Extracellular Matrix Process, which thoroughly decellularizes the ECM, disinfects the tissue and deactivates viruses while maintaining its structural proteins that help with healing. This creates a clean, efficient matrix for host cells to bridge across and remodel the defect.

Medical devices are products that are reviewed by the FDA and meet specific criteria via the 510(k) or Premarket Approval pathway. FDA-cleared devices undergo rigorous review.

Convatec Advanced Tissue Technologies, formerly Triad Life Sciences, focuses on regenerative medicine and developing biologically derived innovative products to address unmet clinical needs in surgical wounds, chronic wounds and burns. Regenerative medicine and biologically derived therapies are frequently used to treat hard-to-heal wounds, which affect about 8.2 million Medicare patients each year in the U.S., according to Advances in Wound Care's May 2021 publication 'Human wound and its burden: Updated 2020 Compendium of Estimates.' Founded in 2017, Triad Life Sciences, based in Memphis, Tennessee, was acquired in 2022 by Convatec Group Plc.

For more information about InnovaMatrix^® products, visit www.triadls.com and follow on LinkedIn @ConvatecWound, on Twitter @ConvatecWoundUS and on Facebook @ConvatecInc.

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE:CTEC) and in 2021 revenues were over $2 billion. To learn more about Convatec, please visit?http://www.convatecgroup.com. 

SOURCE Convactec