Our Company

BioTissue is the leader in innovative technologies using products derived from human amniotic and umbilical cord tissues. Since its inception in 1997, the Company has pioneered the clinical application of human placental tissues – more than 680,000 patients have been treated with BioTissue products and the Company’s groundbreaking scientific and clinical achievements have been documented in more than 380 peer-reviewed publications.

Promote Regenerative Healing, Backed by Research

Our extensive research allows us to preserve and deliver the most functional allograft for your needs.

36Y

Research & Development

680K

Transplants

380

Clinical Publications

Mission

We empower healthcare professionals to deliver optimal patient healing outcomes, setting the standards that define next-generation care.

Vision

Realize the full potential of regenerative therapy.

Our Core Values:

  • We CARE – Compassionate, Appreciative, Respectful and Empowered – for our donors, patients, providers, and our people.
  • We Build Trust.
  • We Take Ownership.
  • We Deliver Excellence.
  • We are ONE TEAM.

Our Foundation of Healing

The first reported clinical application of Amniotic Membrane (AM) was for skin transplantation in 1910; however, it wasn’t 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 limbal stem cell deficiency model.1 They found that glycerin-preserved human AM promoted corneal recovery in rabbits that would sometimes fail with stem cell transplantation alone. 

It appeared that the AM acted as a substrate to support the regeneration of corneal epithelium, just as good topsoil in the garden supports the growth of newly-planted seeds. This study suggested—for the first time—that inadequate wound healing lies in the lack of a supporting environment, and AM transplantation can serve as a surrogate niche environment to facilitate regenerative wound healing.  

Our Breakthrough Discovery

The therapeutic effect of AM is believed to originate from its innate wound healing, anti-scarring and, most importantly, anti-inflammatory properties. In 2001, when cryopreserved AM received approval for ocular surface reconstruction through 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 pondered the following question: What is in birth tissue that is responsible for these amazing results? One may naturally assume that AM’s complex actions are likely to be based on a symphony of biological molecules, but our cumulative research over the last decade suggests otherwise. Between 2002 and 2013, our research has focused on isolating the key molecules in birth tissue that contributes to its healing properties. We successfully identified and purified HC-HA/PTX3,2 a unique complex naturally present in AM and Umbilical Cord (UC) that orchestrates multiple anti-inflammatory, anti-scarring and anti-angiogenic effects and plays an important role in promoting regenerative wound healing as evidenced in the ocular segment.3-9

Preserving Mother Nature

We have developed a unique processing method (CryoTek®) to preserve HC-HA/PTX3 and growth factors/cytokines from the birth tissue while devitalizing living cells. In contrast, tissues processed via heat dehydration are structurally compromised and contain significantly less of the HC-HA/PTX3 complex.12,13

Our History

TissueTech was founded in 2001 as the parent entity for BioTissue Inc., which develops and markets regenerative therapies for treating the ocular surface. In 1997, BioTissue was the first company to introduce the use of cryopreserved amniotic membrane tissue for clinical application, by utilizing its proprietary CryoTek technology, proven to preserve the innate biological and structural properties of the amniotic membrane tissue.

In 2011, our company expanded from ocular space and its product offerings that, include Prokera®, AmnioGraft® and AmnioGuard® to additional market segments such as orthopedics,14-16 neuropathy,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 coverings. These products are manufactured and distributed in compliance with the regulatory requirements of 361 HCT/Ps that are regulated solely under section 361 of the Public Health Service Act and 21 CFR Part 1271.

Our Future Journey

In 2022, TissueTech has unveiled a corporate rebranding, including a name change and a new logo. BioTissue, Inc. and Amniox Medical, Inc. will now both be known under a single commercial, customer-facing entity, BioTissue, Inc. With three decades of continual advancements in regenerative medicine, BioTissue has been a clear leader in the ocular space. By adopting the BioTissue name across the entire organization, the company will also reflect that innovative heritage and promise in its surgical business, which was previously known as Amniox Medical.

BioTissue is pursuing FDA approval through submission of a Biologics License Applications (BLA) for some 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, solve unmet clinical needs, and lead in technological innovation in seeking to deliver the promise of regenerative healing for our physicians and patients.

Company Recognition

2014: recognized as one of the  5000 Fastest Growing Incorporated Private Companies in the United States

2014: The Greater Miami Chamber of Commerce named its business unit BioTissue Minority-Owned Business of the Year.

2015: recipient of the prestigious Tibbetts Award from the U.S. Small Business Administration (SBA)

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

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

One Company. One Purpose. One Vision.

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

By clicking the button below, I agree to receive marketing communications from BioTissue. I am aware that I can unsubscribe at any time.
This field is for validation purposes and should be left unchanged.
References
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 characterization and function of complexes formed by hyaluronan and the heavy chains of inter-alpha-inhibitor (HC*HA) purified from extracts of human amniotic membrane. J Biol Chem. 2009;284(30):20136-20146.
Tseng S. HC-HA/PTX3 purified from amniotic membrane as novel regenerative matrix: insight into 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 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, TGF-beta receptor type II, and myofibroblast differentiation in cultured human corneal and limbal fibroblasts by amniotic membrane matrix. J Cell Physiol. 1999;179(3):325-335.
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. Investig 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 niche cells to Pax6+ neural crest progenitors to support limbal epithelial progenitors. Stem Cells. 2020.
Tseng SCG, Chen SY, Mead OG, Tighe S. Niche regulation of limbal epithelial stem cells: HC-HA/PTX3 as surrogate matrix niche. Exp Eye Res. 2020;199:108181.
John T, Tighe S, Sheha H, et al. Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017.
Morkin MI, Hamrah P. Efficacy of self-retained cryopreserved amniotic membrane for treatment of neuropathic corneal pain. Ocul Surf. 2018;16(1):132-138.
Tan EK, Cooke M, Mandrycky C, et al. Structural and Biological Comparison of Cryopreserved and Fresh Amniotic Membrane Tissues. J Biomater 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/chorion tissue. J Wound Care. 2014;23(10):465-476.
Mead OG, Mead LP. Intra-Articular Injection of Amniotic Membrane and Umbilical Cord Particulate for the Management of Moderate to Severe Knee Osteoarthritis. Orthop Res Rev. 2020;12:161.
Castellanos R. Amniotic Membrane and Umbilical Cord Particulate for Pain Associated with Knee Osteoarthritis: Preliminary Results of a Single-Center, Prospective, Pilot Study. ASIPP; 2018; Orlando, FL.
Castellanos R, Tighe S. Injectable amniotic membrane/umbilical cord particulate for knee osteoarthritis: A prospective, single-center pilot study. Pain Med. 2019.
Buksh AB. Ultrasound-guided injections of amniotic membrane/umbilical cord particulate for painful neuropathy of the lower extremity. Cogent Med. 2020;7(1):1724067.
Caputo WJ, Vaquero C, Monterosa A, et al. A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis. Wound Repair Regen. 2016;24(5):885-893.
Couture M. A Single-center, Retrospective Study of Cryopreserved Umbilical Cord for Wound Healing in Patients Suffering From Chronic Wounds of the Foot and Ankle. Wounds. 2016;28(7):217-225.
Marston WA. An open-label trial of cryopreserved 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 cryopreserved umbilical cord (TTAX01). Wound Repair and Regen. 2020.
Raphael A. A single-centre, retrospective study of cryopreserved umbilical cord/amniotic membrane tissue for the treatment of diabetic foot ulcers. J Wound Care. 2016;25 Suppl 7:S10-17.
Bemenderfer TB, Anderson RB, Odum SM, Davis WH. Effects of Cryopreserved Amniotic Membrane-Umbilical Cord Allograft on Total Ankle Arthroplasty Wound Healing. J Foot Ankle Surg. 2019;58(1):97-102.
Bennett DS. Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome: A case series. Medicine. 2019;98(10):e14745.
Ahmed M, Esposito M, Lovallo G. A single-center, retrospective review of robot-assisted laparoscopic prostatectomy with and without cryopreserved umbilical cord 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.
Warner M, Lasyone L. An Open-label, Single-center, Retrospective Study of Cryopreserved Amniotic Membrane and Umbilical Cord Tissue as an Adjunct for Foot and Ankle Surgery. Surg Technol Int. 2014;25:251-255.