An Allograft that Sets the Pace for Regeneration

PRODUCT INFORMATION

As a leader in oral regeneration, Geistlich understands that in certain clinical situations, rapid turnover of bone is important. With our comprehensive allograft portfolio, vallos® provides you the optimal allograft scaffold to meet a variety of regenerative needs.


About vallos®:

  • Single source supplier ensures consistent product quality1
  • A full portfolio offering that includes, granules, fibers, demineralized, mineralized and blended allografts
  • Stringent donor selection and proprietary aseptic processing that protects the native integrity of the graft
  • Comprised of 100% bone
  • No synthetic carriers added

UNIQUE PROPERTIES

The optimal allograft scaffold


vallos® allografts are natural bone graft substitutes, which due to the preservation of inherent biological properties, provides the optimal characteristics and scientific properties required for bone formation.1 With our comprehensive allograft portfolio, you can be assured of the versatility required to meet your regenerative needs.

Osteoconductive: The porous interconnected scaffold provides an ideal surface for osteoblasts to attach and proliferate. The large trabecular surface area in cancellous bone encourages revascularization and incorporation into the graft.2

Osteoinductive: Anatomical levels of growth factors present in demineralized bone are essential to healthy bone formation.3 Aseptic processing retains the endogenous growth factors present in the bone. Growth factors present in MTF demineralized bone are characterized as BMPs, FGFs, and angiogenic growth factors1 and are known to be beneficial to bone formation.3

Cell-friendly structure: The natural porous structures of vallos® allografts encourage cellular attachment and infiltration into the scaffold.1

A Trusted Partner

Geistlich is excited to introduce our partner MTF Biologics®, a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. Standards for safety and quality are set by a Medical Board of Trustees to ensure the same processes for donor recovery and processing – delivering you a consistent graft.

Every vallos allograft is backed by the MTF Difference™:

Stringent Donor Selection:

  • Largest recovery network1
  • Less than 2% of all donated tissue is accepted1

Rigorous Testing:

MTF is the only tissue bank to use The Vanguard Method™ that exceeds industry standards

  • Qualitative and quantitative assessment of bioburden testing1
  • Surface and internal evaluation with enhanced accuracy compared to the recovery swab method

100% Aseptic Processing:

  • Avoids harsh chemicals
  • Preserves inherent biologic and biomechanical properties
  • Each DBM lot tested for OI potential, including BMP-2

No terminal sterilization which has been shown to reduce OI potential in DBM by 50%1

Unmatched Tissue Integrity:

  • The MTF process maintains the most natural tissue
  • Exceptional biocompatibility with the recipient host tissue
  • Delivers safe and consistent allograft tissue

Full Product Range

vallos® mineralized cortical & cancellous 

  • Various sizes of cortical, cancellous, and corticol-cancellous blends available
  • Osteoconductive scaffold1 which encourages bone formation and allows remodeling with the patient’s own bone
  • 80% cortical and 20% cancellous bone ratio by weight which most closely represents the skeletal mass ratio in the human body4
  • Cortico-cancellous bone is known to provide a natural scaffold for cell attachment and infiltration.2

vallos®f demineralized fibers

  • Rapid rehydration with saline, blood and bone aspirate, ready for use in < 2 minutes
  • Contains 100% demineralized bone while retaining a putty-like consistency that is packable and conforms to the shape of the defect
  • Large surface area of the fibers creates an environment for easy cell attachment and infiltration1
  • Fibers are consistently osteoinductive when compared to competing allografts

vallos® demineralized cortical

  • 100% demineralized cortical bone
  • Processed to preserve native structural & biologic properties1
  • Consistently osteoinductive1

vallos® demineralized cortico-cancellous

  • 80% cortical bone, 20% cancellous bone ratio by weight which most closely represents the skeletal mass ratio in the human body4
  • Osteoconductive porous scaffold to allow ingrowth of host vasculature, osteoblasts, and mesenchymal stem cells2
  • Pre-blended with no need to mix various graft materials

Handling vallos® granules

Handling vallos® fibers

vallos®

An Allograft that Sets the Pace for Regeneration

To keep pace with treatment innovation, vallos® is the first in a line of products coming to our Geistlich Select family.


Extensive research and collaboration have created a partnership to bring you select allograft materials designed for clinical versatility and success. vallos® and vallos®f offer clinicians more options to enhance their ability to manage a variety of clinical indications.

“vallos® is extremely easy to handle and manipulate. Its ability to be molded and retain its shape certainly increases bone graft stability.”

– Dr. Lea Hachem | San Antonio, Texas, USA

Frequently Asked Questions

How do tissue banks differ?

All tissue banks are required to register with the U.S. Food and Drug Administration (FDA) and are inspected regularly for compliance to federal regulations. The American Association of Tissue Banks (AATB) is a voluntary organization that provides additional recommendations on standards that effect allograft safety and efficacy. Beyond the FDA and the AATB recommendations, each tissue bank has its own methods for donor screening, processing and sterilization which play a role in the effectiveness of the grafts to the patient.

It is important to ask questions regarding a tissue bank’s donor screening criteria, processing methods, testing, and studies to ensure the allografts used meet the clinical need for safety and efficacy.

It is important to note*:

  • MTF Biologics is accredited by the AATB and the Standards and International Standards Organization (ISO). 
  • MTF Biologics’ donor safety criteria are among the most stringent of any tissue bank.
  • MTF Biologics meets and exceeds industry, state, and federal standards and regulations.
  • MTF Biologics does not accept donors that have been rejected by another tissue processor.

*https://www.mtfbiologics.org/resources/news-press/fact-sheet

How is osteoinductivity (OI) assessed? What impact is processing and sterilization methods on the presence of growth factors in bone?

Several methods exist to evaluate the osteoinductive potential of allografts, both in vivo and in vitro. The gold standard for assessing osteoinductivity for allografts was developed by Marshall Urist known as the “Urist model.” This testing method involves a graft material that is being implanted in the thigh muscle of a small animal (mouse or rat)1. Since then, several in vitro methods (assays) have been developed to assess growth factors in these materials2. The ideal in vitro study is one that is correlated to the gold standard Urist model to ensure the proper level of growth factors to achieve bone growth are present.

Osteoinductivity of allografts can be impacted by both processing and sterilization methods. Several growth factors are found naturally in bone and are bound by calcium. Growth factors become exposed when the bone is treated with solvents, typically acid, to remove the mineral during processing. Tissue banks may use different protocols to remove the mineral to create demineralized bone. This preparation can affect the concentration and potency of the available growth factor within the final product3. In addition, terminal sterilization methods, such as gamma irradiation have been well documented to reduce the osteoinductive potential of demineralized bone up to 50%4. It is important that the osteoinductive potential is assessed post processing and sterilization to ensure that the demineralized bone testing is representative of the final product.

vallos®f’s three-dimensional architecture provides an ideal osteoconductive environment, resulting in easy cell attachment and continued binding throughout the remodeling process.5

Both animal and bench-top studies demonstrate vallos® broad spectrum of osteoinductive growth factors inclusive of BMP-2, BMP-7, PDGF-BB, FGF-1, IGF-1, TGF-B, and VEGF.5

  1. Urist MR. Bone: Formation by autoinduction. Science, New Series, 1965; 150 (3698), 893-899.
  2. Tal H, et al.: Clin Oral Implants Res 2008; 19(3): 295-302. 
  3. Becker J, et al.: Clin Oral Implants Res 2009; 20(7): 742-49
  4. Gertzman AA, Sunwoo M, Raushi D, Dunn M. The Effect of Cold Gamma Radiation Sterilization on the Properties of Demineralised Bone Matrix. In: Kennedy JF, Philips GO, Williams PA, editors. Sterilization of tissues using ionising radiations: CRC Press; 2005. p 151-156.
  5. Data on File [MTF Biologics]

What is the standard hydration time for demineralized and mineralized allografts?

Typically, the decision of rehydration time is based on the clinician’s preference. Demineralized grafts will readily wick hydration solution in a short period of time.

Each tissue bank will provide recommended rehydration times on their package inserts provided with the allografts and each bank may vary with their instructions for use. 

What are the advantages of demineralized bone versus mineralized bone? Where would you use a demineralized allograft versus a mineralized allograft in clinical procedures?

The demineralized bone has increased osteoinductivity potential compared to mineralized bone due to the exposure of growth factors in the matrix. Mineralized allograft remains longer, providing a matrix for new bone formation to occur. The main therapeutic area indication for demineralized allograft is guided tissue regeneration1.

  1. Gruskin, E. et al. Demineralized bone matrix in bone repair: History and use. Advanced Drug Delivery Reviews 64 (2012) 1063-1077.

Are allografts visible on radiographs?

Mineralized allografts are visible on radiographs due to the mineral content in the materials. Demineralized bone, however, is not visible on radiographs, until the bone is reincorporated as a part of the healing process and becomes mineralized.

What is the resorption profile of a demineralized versus a mineralized allograft?

Demineralized bone will have a faster absorption profile compared to that of mineralized grafts. Mineralized bone grafts will integrate between 6-12 months depending on particle size, whereas demineralized bone grafts will integrate within 18-20 weeks1.

Traditionally a blend of mineralized and demineralized grafts is used to balance the healing process and incorporation times.

  1. Wood and Mealey, Histologic comparison of healing after tooth extraction with ridge preservation using mineralized versus demineralized freeze-dried bone allograft, J Periodontol, March 2012.

What is MTF Biologics’ Vanguard® Method?

Not all tissue banks are the same, so it’s important to understand how your tissue bank screens and processes tissue.

MTF Biologics’ vast donor recovery network of organ procurement organizations allows MTF Biologics to have strict donor selection criteria, resulting in the acceptance of less than 2 percent of donor referrals.

MTF Biologics is the only tissue bank in the industry to use the VanGuard Method®, a qualitative and quantitative data assessment tool designed to evaluate the incoming bioburden levels of donor tissue. 

MTF Biologics’ VanGuard Method™ is used to screen tissue by taking representative samples and testing them. This highly accurate quantitative and qualitative method allows MTF Biologics to direct the tissue down minimally processed aseptic pathways. By employing this state-of-the-art test method, MTF Biologics is able to avoid harsh processing and sterilization techniques.

One hundred percent of MTF Biologics allografts undergo aseptic processing. In summary, MTF Biologics has developed and validated processing techniques that preserve the biological integrity of the tissue by carefully controlling the exposure of the tissue to harsh processing chemicals. MTF Biologics also utilizes stringent aseptic processing which eliminates the need for terminal sterilization. This MTF Biologics differentiating method has resulted in over 10 million allografts distributed with no transmittable diseases.1

  1. Data on File [MTF Biologics]

What is ratio of vallos®’ coritco-cancellous particles, and why was that ratio that selected?

The ratio of vallos® cortico-cancellous particles is 80% cortical to 20% cancellous by weight.  The ratio most closely represents the mass in the human body.  Cortical bone represents 80% of the skeletal mass in humans and therefore supports most of the mechanical function, while cancellous bone is only 20% of the skeletal mass but is metabolically four times more active per unit volume than cortical bone.1

vallos® is offered in a wide variety of demineralized and mineralized forms, as well as in provided in either exclusively cortical or cancellous configurations that can be mixed to the desired ratio of choice.  

  1. Metabolic Bone Disease and Clinically Related Disorders (Third Edition), 1998, Pages 237-273, 274e-280e

Are cancellous and cortical bone both osteoconductive?

Yes, both mineralized and demineralized cancellous and cortical bone can provide osteoconduction.  Osteoconduction by definition means that bone grows on a surface.  An osteoconductive surface is on that permits bone growth on its surface or down into pores, channels or pipes.1

Given that cortical and cancellous bone can serve as a scaffold for ingrowth of new bone, they both can be considered osteoconductive.2

  1. Eur Spine J (2001) 10: S96–S101 DOI 10.1007/ s005860100282
  2. Principles of Bony Reconstruction, Steffen Baumeister MD, Günter K. Germann MD, PhD, in The Mutilated Hand, 2005

If MTF Biologics’ aseptic processing does not require terminal sterilization, why are most of Geistlich other offerings terminally sterilized?

While xenografts are regulated as medical devices, most allograft tissue is classified as a Human Cell & Tissue/Product (HCT/P) by the FDA and not as a medical device.

Terminal sterilization for medical devices which include Geistlich’s xenografts are subject to

FDA and other regulatory bodies requirement that the sterilization process be validated, and these validations typically require a bioburden and sterility testing.  Sterility testing and bioburden testing are also performed on devices as part of routine quality control.1

  1. Center for Devices and Radiological Health. (n.d.). Sterilization for medical devices. U.S. Food and Drug Administration. Retrieved February 20, 2023, from https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

What is the FDA regulatory status for vallos®?

vallos® is regulated as a human cell/tissue product (H/CTP) under 21 CFR Part 1271 and Section 361 of the Public Health Services Act. FDA registration listing can be found on the company website at  https://www.mtfbiologics.org/licenses-certifications or can be provided upon request.

Is vallos® sterile?

vallos® is tested for sterility per USP <71> and undergoes a chemical disinfection step. The resulting allograft is tested to confirm no evidence of microbial growth.  Note that for MTF allografts, and to comply with the standard, 10% of each lot packaged in its final form will be pulled for destructive sterility testing.  MTF Biologics does not subject the allograft to additional terminal sterilization procedures.

  1. Data on file, MTF Biologics
  2. Roberts TT and Rosenbaum AI. Bone grafts, bone substitutes and orthobiologics; The bridge between basic science and clinical advancements in fracture healing. 2012. Organogenesis 8 (114-124)
  3. Gruskin E, et al. Demineralized bone matrix in bone repair; History and use. Advanced Drug Delivery Reviews, 2012; 64, pp. 1063-1077.
  4. Metabolic Bone Disease and Clinically Related Disorders (Third Edition), 1998, Pages 237-273, 274e-280e