VIVEX Biologics
Developer, manufacturer, and distributor of human tissue allografts and complementary synthetic biomaterial devices for spine, orthopedic, and wound-care applications. Operates tissue processing, storage, and distribution activities for HCT/P and medical devices in compliance with FDA/state regulations and AATB standards; conducts clinical trials and publishes peer-reviewed and real-world evidence studies to support product safety, effectiveness, and reimbursement.
Industries
Nr. of Employees
large (251-1000)
Patents
Products
Cryopreserved viable bone matrix for spinal fusion
A cryopreserved cellular bone allograft composed of demineralized cortical bone fibers and cancellous components with endogenous cells, supplied for use as a standalone bone graft substitute in lumbar fusion procedures (syringe delivery format described).
Sterilized nucleus pulposus allograft for intradiscal therapy
Sterilized donor-derived nucleus pulposus tissue intended for minimally invasive intradiscal injection to supplement degenerated discs in outpatient procedures.
Amniotic membrane allografts (multi-layer, dual-layer formats)
Multi-layer and dual-layer amniotic tissue allografts processed to retain extracellular matrix components, signaling proteins, and growth factors for wound coverage and soft tissue barrier applications.
Self-assembling synthetic peptide matrix (lyophilized kit)
Fully synthetic, bioabsorbable peptide matrix supplied as a lyophilized powder that self-assembles in situ into a β-sheet nanofiber scaffold to support cell migration and wound healing; described as a 510(k)-cleared medical device.
Moldable bioactive bone graft (strips and putty)
Moldable bioactive bone graft materials available as absorbent strips and putty; composed of carbonate apatite anorganic bone mineral, bioactive glass, and Type I collagen to support bony ingrowth and gradual resorption during remodeling.
VIA Form+
Next generation solution for bone formation packaged in an easy-to-use syringe with minimal preparation time of under 15 minutes.
Cryopreserved viable bone matrix for spinal fusion
A cryopreserved cellular bone allograft composed of demineralized cortical bone fibers and cancellous components with endogenous cells, supplied for use as a standalone bone graft substitute in lumbar fusion procedures (syringe delivery format described).
Sterilized nucleus pulposus allograft for intradiscal therapy
Sterilized donor-derived nucleus pulposus tissue intended for minimally invasive intradiscal injection to supplement degenerated discs in outpatient procedures.
Amniotic membrane allografts (multi-layer, dual-layer formats)
Multi-layer and dual-layer amniotic tissue allografts processed to retain extracellular matrix components, signaling proteins, and growth factors for wound coverage and soft tissue barrier applications.
Self-assembling synthetic peptide matrix (lyophilized kit)
Fully synthetic, bioabsorbable peptide matrix supplied as a lyophilized powder that self-assembles in situ into a β-sheet nanofiber scaffold to support cell migration and wound healing; described as a 510(k)-cleared medical device.
Moldable bioactive bone graft (strips and putty)
Moldable bioactive bone graft materials available as absorbent strips and putty; composed of carbonate apatite anorganic bone mineral, bioactive glass, and Type I collagen to support bony ingrowth and gradual resorption during remodeling.
VIA Form+
Next generation solution for bone formation packaged in an easy-to-use syringe with minimal preparation time of under 15 minutes.
Services
Design and conduct of randomized, double-blind, sham-controlled multicenter clinical studies, site engagement, enrollment management, and outcomes reporting.
Order, billing, and distributor portal services, plus customer service with tissue-banking experience to support hospitals and clinicians.
Design and conduct of randomized, double-blind, sham-controlled multicenter clinical studies, site engagement, enrollment management, and outcomes reporting.
Order, billing, and distributor portal services, plus customer service with tissue-banking experience to support hospitals and clinicians.
Expertise Areas
- Allograft manufacturing and tissue banking
- Regenerative medicine for spine and orthopedics
- Advanced wound care biomaterials
- Clinical trial management and site execution
Key Technologies
- Cryopreserved cellular bone matrices (CBM)
- Demineralized bone matrix scaffolds with endogenous cells
- Amniotic membrane allografts (multi-layer)
- Self-assembling synthetic peptide matrices (bioabsorbable)
News & Updates
Peer-reviewed clinical and radiographic study reporting long-term fusion outcomes using a cryopreserved viable bone allograft in lumbar interbody fusion, reporting 100% radiographic fusion in a small cohort and no device-related complications over follow-up.
Retrospective Medicare claims analysis (2021-2024) with matched cohorts showing reductions in opioid prescriptions, imaging, physical therapy, and injections in patients receiving an intradiscal nucleus pulposus allograft versus conservative care.
Commercial introduction of a lyophilized, self-assembling peptide matrix device indicated for partial and full thickness wounds; device described as 510(k)-cleared and intended to form a β-sheet nanofiber scaffold in situ.
Public updates on enrollment progress and completion for a randomized, double-blind, sham-controlled multicenter ASCEND study evaluating intradiscal allograft therapy with primary endpoint of MCID in VAS at six months.
Announcement of appointment of an experienced clinical leader to lead clinical development programs and trials.
Announcement that CMS assigned a Q-code (Q4282) to a dual-layer amniotic allograft product to facilitate reimbursement under HCPCS starting July 1, 2023.
Peer-reviewed clinical and radiographic study reporting long-term fusion outcomes using a cryopreserved viable bone allograft in lumbar interbody fusion, reporting 100% radiographic fusion in a small cohort and no device-related complications over follow-up.
Retrospective Medicare claims analysis (2021-2024) with matched cohorts showing reductions in opioid prescriptions, imaging, physical therapy, and injections in patients receiving an intradiscal nucleus pulposus allograft versus conservative care.
Commercial introduction of a lyophilized, self-assembling peptide matrix device indicated for partial and full thickness wounds; device described as 510(k)-cleared and intended to form a β-sheet nanofiber scaffold in situ.
Public updates on enrollment progress and completion for a randomized, double-blind, sham-controlled multicenter ASCEND study evaluating intradiscal allograft therapy with primary endpoint of MCID in VAS at six months.
Announcement of appointment of an experienced clinical leader to lead clinical development programs and trials.
Announcement that CMS assigned a Q-code (Q4282) to a dual-layer amniotic allograft product to facilitate reimbursement under HCPCS starting July 1, 2023.