Compassionate Care, Empowered Healing

Compassionate Care, Empowered Healing – Is a leader in innovative technology using products derived from human amniotic membrane tissue. Since its founding in 1997, the Company has pioneered the clinical application of human placental tissue – more than 790,000 patients have been treated with the product and the Company’s outstanding scientific and clinical achievements have been documented in more than 390 peer-reviewed publications.

The first reported clinical application of Amniotic Membrane (AM) was for skin transplantation in 1910; however, it was not until 1995 that our Chief Technology Officer, Scheffer C.G. Tseng, MD, PhD and his colleague J.C. Kim reported the use of AM for ocular surface transplantation in a rabbit model of limbal stem cell deficiency.1 They found that glycerin-preserved human AM promoted corneal recovery in rabbits that sometimes failed with stem cell transplantation alone.

Compassionate Care, Empowered Healing

It appears that AM acts as a substrate to support the regeneration of the corneal epithelium, just as good topsoil in a garden supports the growth of newly planted seeds. This study suggests—for the first time—that inadequate wound healing lies in the lack of a supportive environment, and that AM transplantation may serve as a surrogate specific environment to facilitate regenerative wound healing.

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The therapeutic effect of AM is believed to be due to its natural wound healing, anti-scarring and, most importantly, anti-inflammatory properties. In 2001, when cryopreserved AM received approval for ocular surface reconstruction through a Request for Designation from the Food and Drug Administration (FDA), it was recognized to promote healing through anti-inflammatory, anti-scarring and antiangiogenic effects.

Since that time, we have been thinking about the following question: What in the birth tissue is responsible for this amazing result? One might naturally assume that the complex actions of AM might be based on a symphony of biological molecules, but our cumulative research over the past decade suggests otherwise. Between 2002 and 2013, our research has focused on isolating the key molecules in birth tissue that contribute to its healing properties. We successfully identified and purified HC-HA/PTX3, 2 unique complexes naturally present in AM and Central Cord (UC) that regulate various anti-inflammatory, anti-scarring and anti-angiogenic effects and play an important role in promoting healing regenerative wound. as evidenced in the ocular segment.3-9

We have developed a unique processing method (CryoTek®) to preserve HC-HA/PTX3 and growth factors/cytokines from birth tissue while removing live cells. In contrast, tissue processed through heat dehydration was structurally affected and contained significantly less HC-HA/PTX complex3.12, 13

TissueTech was founded in 2001 as the parent entity for Inc., which develops and markets regenerative therapies to treat the surface of the eye. In 1997, was the first company to introduce the use of preserved amniotic membrane tissue for clinical use, using its proprietary CryoTek technology, proven to preserve the biological properties and natural structure of amniotic membrane tissue.

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In 2011, our company expanded from the ocular space and its product offerings, which include Prokera®, AmnioGraft® and AmnioGuard® into additional market segments such as orthopedics, neuropathy 14-16, 17 wound care, 18-23 spine, 24 urology25, and pain management26, 27 using the same birth tissue products processed using our patented manufacturing technology. Our Neox® and Clarix® allografts are marketed as structural tissue products for homologous use as protective barriers and wound closures. This product is manufactured and distributed in compliance with the 361 HCT/P regulatory requirements regulated solely under section 361 of the Public Health Service Act and 21 CFR Part 1271.

In 2022, TissueTech launched a corporate rebrand , including a name change and a new logo. , Inc. and Amniox Medical, Inc. now both will be known under a single customer-facing commercial entity, , Inc. With three decades of continuous progress in regenerative medicine, has become a clear leader in the ocular space. By adopting the name across the organization, the company will also reflect that legacy and innovative promise in its surgical business, previously known as Amniox Medical.

Is pursuing FDA approval through the submission of a Biologics License Application (BLA) for several of our products as evidenced in a recently published Phase 2 study for complex diabetic foot ulcers.20 Our company will continue to provide sustainable health economic value, solving unmet needs unmet clinical needs, and lead in technological innovation in an effort to deliver the promise of regenerative healing for our physicians and patients.

2017: received the award for Spine Technology Innovation in Biology at the annual meeting of the North American Spine Society

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2020: recognized on MD Tech Review’s annual listing of ten companies as “Top Companies in the Wound Care Market”

Our company was founded on a commitment to patient healing, working alongside surgeons and other healthcare professionals who share a passion for healing and changing patients’ lives. Learn about our pioneering company history and our legacy for a healthier future together.

Kim JC, Tseng SC. Transplantation of preserved human amniotic membrane for surface reconstruction in severely damaged rabbit corneas. Cornea. 1995;14(5):473-484.

He H, Li W, Tseng DY, et al. Biochemical and functional characterization of complexes formed by hyaluronan and inter-alpha-inhibitory heavy chains (HC*HA) purified from human amniotic membrane extracts. J Biol Chem. 2009;284(30):20136-20146.

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Tseng S. HC-HA/PTX3 purified from amniotic membrane as a novel regenerative matrix: insights into the relationship between inflammation and regeneration. Investigative ophthalmology & visual science. 2015.

He H, Zhang S, Tighe S, Son J, Tseng SC. Immobilized Heavy Chain Hyaluronic Acid Polarizes Lipopolysaccharide-activated Macrophages toward an M2 Phenotype. J Biol Chem. 2013;288(36):25792-25803.

Lee SB, Li DQ, Tan DT, Meller DC, Tseng SC. Suppression of TGF-beta signaling in both normal conjunctival fibroblasts and pterygial body fibroblasts by amniotic membrane. Curr Eye Res. 2000;20(4):325-334.

Tseng SC, Li DQ, Ma X. Suppression of transforming growth factor-beta isoforms, type II TGF-beta receptor, and myofibroblast differentiation in cultured human corneal and limbal fibroblasts by amniotic membrane matrix. J Cell Physiol. 1999;179(3):325-335.

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Zhu YT, Li F, Zhang Y, et al. HC-HA/PTX3 Purified From Human Amniotic Membrane Reverts Human Corneal Fibroblasts and Myofibroblasts to Keratocytes by Activating BMP Signaling. Invest Ophthalmol Vis Sci. 2020;61(5):62.

Chen SY, Zhu YT, Zhang Y, Hsu D, Tseng SCG. HC-HA/PTX3 from amniotic membrane reverts senescent limbal-specific cells to Pax6+ neural crest progenitors to support limbal epithelial progenitors. Stem cells. 2020.

Tseng SCG, Chen SY, Mead OG, Tighe S. Specific regulation of limbal epithelial stem cells: HC-HA/PTX3 as a surrogate matrix niche. Exp Eye Res. 2020;199:108181.

John T, Tighe S, Sheha H, et al. Corneal Nerve Regeneration after Self-Preserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017.

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Morkin MI, Hamrah P. Efficacy of self-preserved amniotic membrane for the treatment of neuropathic corneal pain. Ocul Surf. 2018;16(1):132-138.

Tan EK, Cooke M, Mandrycky C, et al. Comparison of the Structure and Biology of Preserved and Fresh Amniotic Membrane Tissue. J Biomate Tissue Eng. 2014;4(5):379-388.

Cooke M, Tan EK, Mandrycky C, He H, O’Connell J, Tseng SC. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorionic tissue. J Wound Care. 2014;23(10):465-476.

Mead OG, Mead LP. Intra-Articular Injection of Amniotic Membrane and Cord Particles for the Management of Moderate to Severe Knee Osteoarthritis. Orthop Res Rev. 2020;12:161.

Healing Time Therapy

Castellanos R. Amniotic Membrane and Cord Particles for Pain Associated with Knee Osteoarthritis: Preliminary Results of a Prospective, Single-Center Pilot Study. ASIPP; 2018; Orlando, FL.

Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulates for osteoarthritis of the knee: A prospective single-center pilot study. Pain Med. 2019.

Buksh AB. Ultrasound-guided injection of amniotic membrane/umbilical cord particles for painful neuropathy of the lower extremities. Cogent Med. 2020;7(1):1724067.

Caputo WJ, Vaquero C, Monterosa A, et al. A retrospective study of preserved umbilical cord as adjunctive therapy to promote healing of chronic and complex leg ulcers with underlying osteomyelitis. Wound Repair Regen. 2016;24(5):885-893.

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Couture M. A Single-Center Retrospective Study of Preserved Central Straps for Wound Healing in Patients With Chronic Wounds of the Foot and Ankle. wound 2016;28(7):217-225.

Marston WA. An open-label trial of preserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. Wound Repair Regen. 2019.

Marston WA, Lantis JC, Wu SC, et al. One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cord-preserved (TTAX01). Wound Repair and Regen. 2020.

Raphael A. A single-center retrospective study of preserved umbilical cord/amniotic membrane tissue for the treatment of diabetic foot ulcers. J Wound Care. 2016;25 Suppl 7:S10-17.

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Bemenderfer TB, Anderson RB, Odum SM, Davis WH. Effect of Umbilical Cord-Preserved Amniotic Membrane Allograft on Overall Wound Healing of Ankle Arthroplasty. J Foot Ankle Jump. 2019;58(1):97-102.

Bennett DS. Cryopreserved amniotic membrane and umbilical cord particles to manage pain caused by facet joint syndrome: A case series. Medicine. 2019;98(10):e14745.

Ahmed M, Esposito M, Lovallo G. Single-center retrospective review of robot-assisted laparoscopic prostatectomy with and without cord-preserved allograft in improving continence recovery. J Robot Surg. 2019. 2020 Apr;14(2):283-289. doi: 10.1007/s11701-019-00972-9. Epub 2019 May 31. PMID: 31152310; PMCID: PMC7125058.

Galli SH, Ferguson CM, Davis WH, et al. Cheilectomy With or Without Cryopreserved Amniotic Membrane–Umbilical Cord Allograft for Hallux Rigidus. Foot Ankle Orthop. 2021;6(1):2473011420967999.

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Warner M, Lasyone L. An Open-Label, Single-Center, Retrospective Study of Preserved Amniotic Membrane and Umbilical Cord Tissue as Adjuncts to Foot and Ankle Surgery. Surg Technol Int. 2014;25:251-255.Dr. Michelle Cárdenas is a naturopathic doctor who offers broad-spectrum care through a comprehensive intake process, individualized treatment, in-depth and customized follow-up visits.

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