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Aroa Biosurgery Launches New Product, Myriad Morcells™ - Offering Highly Conformable Tissue Regeneration in Wound Beds - Following Recent FDA Clearance
HIGHLIGHTS
Soft tissue regeneration company Aroa Biosurgery Limited has this week launched a new product named Myriad Morcells™, a morcellized (powder) format of Myriad Matrix™ that easily conforms to optimize contact with irregular wound beds.
It received U.S. FDA 510(k) clearance received for the product on 6 April 2021.
The morcellized format increases AROA ECM™ surface area to maximize delivery of important ECM proteins.
This clearance further builds on applications for the Myriad™ portfolio, following recent studies showing positive clinical outcomes for Myriad Matrix™’s use in surgical treatment of hidradenitis suppurativa, complex wounds and exposed vital structures.
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Soft tissue regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘Aroa’ or the ‘Company’) has gained further validation for Myriad™, a device for soft tissue reconstruction, with two studies published in successive months in a leading peer reviewed scientific journal, Journal of Wound Care, official journal of the European Wound Management Association (EWMA) and World Union of Wound Healing Societies (WUWHS).
A study published in the November 2020 edition of Journal of Wound Care showed 100% healing when Myriad™ was used in eight surgical reconstructions to address inflammatory skin condition Hidradenitis Suppurativa (HS). No major complications were reported out to three months, or longer.
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HIGHLIGHTS
Further validation for Aroa s Myriad™ from two clinical studies and peer-reviewed publications in Journal of Wound Care.
One study shows high success rates, from use of Myriad™ in tissue reconstruction after surgical treatment of Hidradenitis Suppurativa, an inflammatory skin condition affecting around 1% of the adult population.
A second study showed 100% success rates from use of Myriad™ when patients underwent surgical reconstruction of exposed vital structures such as bone and tendon, demonstrating the utility of Myriad™ for both implant procedures and dermal reconstruction and across a wide range of surgical procedures.
The national regulatory authority of India, the Central Drugs Standard Control Organisation (CDSCO), has approved Myriad™, Endoform® Natural and Endoform® Antimicrobial. India has significant market potential with a large volume of acute and chronic wounds and distribution expected to commence in second half of the 2021 calendar