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MiMedx Group, Inc. (Nasdaq: MDXG) ("MIMEDX" or the "Company") today announced the commercial launch of AMNIOFIX Thyroid Shields, a product line extension of the Company's AMNIOFIX dehydrated human amnionchorion membrane (DHACM) allografts.
AMNIOFIX Thyroid Shields are allografts designed and intended for use in endocrine surgery. Following a thyroidectomy, the sheets—provided in preconfigured sizes—are applied to the exposed Recurrent Laryngeal Nerve (RLN) and parathyroid glands to provide a protective barrier and thereby support the healing cascade. The product is designed to prevent the need for intraoperative modification, saving valuable time in the operating room. AMNIOFIX Thyroid Shields are manufactured by MIMEDX using the PURION® process, are easy to apply, and are shelf-stable for up to five years.
"Injuries to the recurrent laryngeal nerve are a great concern during thyroid and parathyroid operations, particularly as damage to the vocal cord nerve can result in severe impairment to voice production and increased risk of aspiration," stated John Harper, Ph.D., MIMEDX Chief Scientific Officer and SVP, R&D and Medical Affairs. "This product line extension offers our proven AMNIOFIX placental allograft, in a configuration designed to address this complication and supported by clinical data. We are excited for the full commercial release of this product line as we continue cultivate more surgical use cases for our portfolio."
A retrospective, single center study compared thyroidectomy patients with and without AMNIOFIX applied to >3 cm fully dissected RLNs (n=670 and n=1,420 matched patients) as a protective barrier to support the healing cascade. The study observed a 76% reduction in the incidence of RLN damage at 24 hours postop in the AMNIOFIX group (3.4% rate) compared to the incidence of RLN damage at 24 hours postop in the non-AMNIOFIX group (14.4% rate, p<0.01). All operations were performed by the same surgeons using nerve monitoring endotracheal tubes. An open source link to the publication is available here.
About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade and a half of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX provides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company's vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.
Contact:
Matt Notarianni
Investor Relations
470-304-7291
mnotarianni@mimedx.com
