At the heart of everything we do is a commitment to quality, safety, and scientific integrity. We understand that providers rely on us to deliver products they can trust, which is why every solution we offer is developed to high standards. Our mission is to ensure reliable access to high-quality, tissue-based products for wound care.
*Ponya Therapeutics is an FDA-registered and inspected HCT/P manufacturer that follows all relevant sections of the Code of Federal Regulations, including 21 CFR 1271, and adheres to Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP).
Amono® is a minimally processed, dual-layer, sterile, dehydrated amniotic ocular membrane patch intended for use as an ocular covering or protective barrier. Amono® is derived from human birth tissue obtained from screened donors who meet established donor eligibility criteria. The processing and manufacturing of Amono® are performed in accordance with applicable FDA regulations and AATB standards, and the product is manufactured in a GMP-compliant facility within an ISO Class 5 cleanroom environment. Amono® is designed to be an easy-to-use product for ocular surface protection in post-surgical applications.
Tunza® is a human tissue allograft composed of dehydrated amniotic membrane, sourced from prescreened, donated placental tissue. The tissue is minimally manipulated using aseptic techniques designed to gently process the amniotic membrane into dual-layer dehydrated patch products. It is intended for use as a protective barrier or covering for a variety of acute and chronic wounds.
