Reprise Biomedical, Inc., an innovative medical device company focused on developing and commercializing biologic solutions using its proprietary perfusion decellularization technology, has commenced U.S. sales of its Miro3D wound matrix through its direct U.S. sales force and independent sales agent network. Reprise received FDA 510(k) clearance for Miro3D on August 18, 2022, and initial clinical evaluations have already been successfully completed.
Miro3D is a three-dimensional (2cm thick) biological matrix designed to be cut and shaped to fill deep or tunneling wound beds. Manufactured from decellularized porcine liver, Miro3D is a highly porous matrix which allows rapid cellular infiltration and integration in situ. Miro3D is the first U.S. commercially available wound matrix that is designed to fill a wound with its three-dimensional scaffold, rather than cover the wound with a traditional two-dimensional wound dressing.
Dr. Moses Shieh of Lee Memorial Hospital and Surgical Healing Arts in Fort Myers, FL commented on his first clinical uses of Miro3D: “Miro3D has the potential to be a substantial advance in my wound care practice. My first cases included a stage IV sacral pressure ulcer which had been present for greater than 13 months and a post panniculectomy surgical dehiscence wound which had a 4cm medial undermining region, with both patients now progressing nicely toward full healing. Miro3D has volume and depth like no other product available in our health system. With these early clinical results, I am encouraged that Miro3D has the potential to drastically reduce length of stay in the hospital for patients with these complex wounds.”
Dr. Brian Parkes of Scotland Memorial Hospital in Laurinburg, NC commented on his first clinical use of Miro3D: “I was eagerly awaiting FDA clearance of Miro3D since it provides a three-dimensional approach that was previously unavailable. My first Miro3D surgery was a necrotizing fasciitis patient who had a previously placed two-dimensional matrix but was experiencing delayed healing. Miro3D was easy to handle, robust to suture in place, and at follow-up, the results were remarkable. The wound responded with great granulation within just five days, and was ready for skin grafting, something that I would never have expected in this type of patient.”
Carrie Powers, CEO of Reprise Biomedical, added the following: “We are excited to advance the treatment of deep and tunneling wounds, a U.S. market opportunity we estimate at over $1.4 billion annually, with our launch of the transformative Miro3D wound matrix. Because the most difficult to treat wounds are three-dimensional, advanced wound care surgeons have been asking for a product that can fill the wound, rather than just cover it. Our launch of Miro3D is Reprise’s first step in offering a range of three-dimension matrices with unique delivery systems designed to treat deep wounds and improve patient lives by quickening their recovery."
Miro3D is available in four sizes (2x2cm, 3x3cm, 5x5cm and 5x10cm), with all sizes having a thickness of 2cm. Miro3D is also available in a Fibers configuration, consisting of a tray of loose fibrillar strands designed for packing small crevices and tunnels in wound beds. Photographs of Miro3D and before and after photographs of initial clinical uses are available on Reprise’s website at reprisebio.com/Miro3D.
Miro3D wound matrix is intended for the management of wounds including: partial and full thickness wounds; pressure ulcers; venous ulcers; chronic vascular ulcers; diabetic ulcers; tunneled, undermined wounds; trauma wounds (abrasions, lacerations, second-degree burns, and skin tears); draining wounds; and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
About Reprise Biomedical
Reprise Biomedical’s mission is to deliver solutions to the unmet clinical needs of physicians in biological medical device markets. To learn more about Reprise Biomedical and its medical devices, visit reprisebio.com.
Reprise Biomedical, Inc.
Carrie L Powers
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