Innova provides sterile, ready-to-use amniotic membrane allografts that serve as protective coverings and barriers over the wound bed or surgical site. Each allograft is recovered from consenting donors and processed under current Good Tissue Practices.
Reducing Costs · Driving Value · Increasing Quality of Care
Sterile & ready-to-use · Aseptically processed, terminally gamma sterilized · Regulated as an HCT/P under 21 CFR Part 1271
Innova's placental membrane allografts serve as a protective covering and barrier across a range of surgical and wound care settings.
Supplied terminally sterilized and dehydrated, ready to place directly into the wound bed or surgical site.
Stored at ambient temperature (15-25°C / 59-77°F). No refrigeration or freezing required.
Aseptically processed and terminally gamma irradiated to a sterility assurance level of 10⁻⁶.
Human tissue allografts under Section 361 of the PHS Act and 21 CFR Part 1271.
Each Innova allograft is derived from donated human placental tissue and is intended for homologous use, to serve as a covering or barrier in surgical and wound care applications.
Dual-Layer Dehydrated Human Amnion Membrane
Dua Nova™ AA is a dual-layer dehydrated human amnion allograft designed to serve as a protective covering over the wound bed or surgical site. Composed exclusively of two amnion layers, it offers flexible coverage with no sidedness for placement, and is supplied sterile and ready to use.
| Size | Sq. cm | SKU / REF | GTIN-14 |
|---|---|---|---|
| 1 × 1 cm | 1 | INV-BBAA-001 | 00850078361004 |
| 2 × 2 cm | 4 | INV-BBAA-004 | 00850078361011 |
| 2 × 3 cm | 6 | INV-BBAA-006 | 00850078361028 |
| 2 × 4 cm | 8 | INV-BBAA-008 | 00850078361035 |
| 4 × 4 cm | 16 | INV-BBAA-016 | 00850078361042 |
| 4 × 6 cm | 24 | INV-BBAA-024 | 00850078361059 |
| 4 × 8 cm | 32 | INV-BBAA-032 | 00850078361066 |
For single-patient, single use only. Do not re-sterilize or reuse. Full descriptor: Dual-Layer Amniotic Allograft Membrane.
Triple-Layer Dehydrated Human Amnion / Chorion / Amnion Membrane
Tri Nova™ is a triple-layer amnion-chorion-amnion human tissue allograft derived from the amniotic membrane. It serves as a barrier and provides a protective covering over the wound bed or surgical site, and is minimally manipulated, preserving the properties of the membrane in its natural state.
| Size | Wound coverage |
|---|---|
| 1 × 1 cm | 1 cm² |
| 2 × 2 cm | 4 cm² |
| 2 × 3 cm | 6 cm² |
| 4 × 4 cm | 16 cm² |
| 4 × 6 cm | 24 cm² |
| 4 × 8 cm | 32 cm² |
| 6 × 8 cm | 48 cm² |
| 10 × 10 cm | 100 cm² |
For single-patient, single use only. Do not re-sterilize or reuse. Innova product codes pending final assignment.
Single-Layer Amnion Membrane for the Ophthalmic Surface
A single-layer human amnion allograft that serves as a barrier and protective covering for the ocular surface. Part of Innova's expanding placental allograft portfolio and available to qualified customers on request.
The placental membrane naturally functions as a protective barrier surrounding the developing fetus. Innova's allografts preserve that native structure so the tissue can perform the same basic function in the recipient: serving as a covering and barrier over a wound or surgical site.
Illustrative structure of the placental membrane. Layer composition varies by product configuration.
Innova allografts are handled, stored and distributed in accordance with FDA requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Regulated solely under Section 361 of the PHS Act and 21 CFR Part 1271, with no premarket approval required when the criteria for a 361 HCT/P are met.
Donors are screened and tested for relevant communicable disease agents, with eligibility determined under 21 CFR Part 1271 Subpart C.
Aseptically processed under current Good Tissue Practices by FDA-registered tissue establishments and terminally gamma sterilized to SAL 10⁻⁶.
Each unit carries a unique serial number and lot, enabling traceability from donor recovery through distribution.
Innova Regenerative Health is registered with the FDA as a human tissue establishment for HCT/P distribution.
Every allograft is intended for single-patient, single use and must not be re-sterilized or reused.
Innova Regenerative Health, LLC is a Louisiana-based distributor of human placental membrane allografts. We partner with FDA-registered tissue establishments to bring dependable, high-quality coverings to the operating room and wound care clinic, guided by a simple mission.
Reducing costs. Driving value. Increasing quality of care.
For product details, pricing, or distribution inquiries, reach out to our team. Innova products are made available to licensed healthcare professionals and qualified distribution partners.