REGENERATING THE GIFT OF HEALING Advanced Tissue Processing

Our Work

The gift of human tissue is given with the hope that another life will be enhanced because of the donation. At Alaris, we value these altruistic gifts and constantly strive for new innovations that advance our tissue processing and manufacturing to capture the most regenerative properties in the products we create. We take to heart the trust that donor families, surgeons, and eventually patients put in us and keep that responsibility as a focal point in everything we do.

Donation

All Donor tissue is obtained through a first-person consent program with FDA registered recovery agencies. Donors undergo a series of pre-production serological and microbiological testing, coupled with an extensive eligibility and suitability determination by a medical director prior to release for implant. In addition, in-process tests are conducted that are congruent with FDA Regulations 21 CFR 1270 and 1271.

Advanced Tissue Processing

Through our proprietary tissue processing, we focus on capturing the most healing properties possible, utilizing one of three accepted methods. EBeam Sterilization, Gamma Sterilization, and Aseptic Sterile-Fill are technologies we currently use in creating our products.

eBeam Sterilization Technology (e10-6)

Alaris utilizes eBeam technology, a validated process and a sterilization technique for bone tissue. The low dose radiation preserves proteins within the bone and structural tissue. This mitigates the risk of micro-fracture within structural allograft tissue intended for compression and load bearing applications.

Gamma Sterilization Technology (r10-6)

Alaris utilizes low dose gamma radiation technology as a sterilization technique for paste, putty, and allograft patch products. This low dose radiation protects the proteins and collagen within the tissue grafts. This type of sterilization also allows for the crosslinking of proteins within the allograft patch.

Aseptic
Sterile-Fill

Alaris utilizes a validated aseptic process for production of Allograft Fluid. This proprietary process has no terminal sterilization step, however includes several in-process controls that involve environmental testing and monitoring, adherence to USP <71> for sterility testing, as well as UPS <85> for LAL/Endotoxin testing. This process provides a safe tissue graft for wound covering.

bone-grafts

Bone

Bone grafts are processed with proprietary processes to chemically clean the tissue. Our validated processes achieve the sterility assurance levels needed to become sterile. These chemical cocktails allow for viral inactivation, but are also specifically designed to preserve and not to denature the bone morphogenic proteins needed for remodeling of bone tissue. In some specific grafts, we demineralize the grafts so bio-incorporation can occur on a more broad and rapid scale.

Reconstructive allograft bone selections:
(Multiple sizes available)

  • Allograft Cancellous Crushed
  • Allograft Demineralized Cube
  • Allograft Demineralized Strip
  • Allograft Demineralized Paste
  • Allograft Demineralized Putty
  • Iliac Crest Wedge

Soft Tissue Grafts

The soft tissue grafts are processed to preserve the connective structure with the graft. Each measure of time, temperature, and titration of chemical washes and detergents is combined in a way to mitigate the risk of disease transmission. The validated processes to sterilize the tissue utilize only a low-dose sterilization.

The sports-medicine grafts can be utilized in several different ways including ACL, MCL, and PCL repair. In addition, a complete line of pre-sized bone-tendon-bone (BTB) grafts, as well as pre-sized Achilles grafts are available.

Reconstructive soft tissue allograft selections: (Multiple sizes available)

  • Achilles Tendons (can pre-size to 10mm)
  • Gracilis Tendons
  • Patella Tendons (can pre-size to 10mm)
  • Peroneus Longus Tendons
  • Semitendinosus Tendons
  • Tibialis Tendons
Tissue Grafts
Patch

Protein-Preserved Allograft Patch

Durable Soft Tissue Covering
The protein-preserved allograft patch is a layer of cuboidal epithelial cells attached to the collagen matrix that makes up the basement membrane and stromal fibroblast layer.

Natural Biological Scaffold
It is an Extracellular Matrix (ECM) isolated from placental origin, an elegant model for cellular signaling and tissue formation.

Versatile Surgical Applications
The protein-preserved allograft patch is a versatile product with a variety of potential clinical applications when a biological covering or cell scaffold is needed. The use of membrane has demonstrated potential applications in the following areas:

  • Adhesion Barrier
  • Chronic Wound Allograft
  • Reduce Scar Tissue Formation
  • Nerve Bundle and Peripheral Wrap
  • Periodontal Guided Tissue Regeneration
  • Dermal Burns

Injectable Liquid Allograft

The injectable liquid allograft is an alternative in injury and wound management. It is a non-structural decellularized fluid allograft intended for homologous use such as providing a cushion around a tissue. It contains high levels of growth factors and anti-inflammatory Cytokines.

Potential Clinical Applications
As a unique alternative to invasive surgical procedures it has a variety of potential applications that may include:

  • Tendonitis
  • Reduction of scarring
  • Chronic wound covering
  • Soft tissue or bone trauma
  • Localized inflammation

The injectable liquid allograft is processed using an extensively tested proprietary amniotic fluid purification technology, which allows for rapid retrieval of fluid without compromising protein integrity.

Liquid

About Us

Dedicated to Advancing Human Healing

Alaris is a biologic technologies company that is focused on advancing human healing. Though a young company, Alaris boasts one of the most experienced and respected teams in the industry. Alaris utilizes proprietary processes to maximize the healing properties of its products all while meeting or exceeding the highest safety and quality standards.

Alaris, which was founded in 2013 as Amniolife, is a portfolio company of Fountainhead Investment Partners. The company offers a selection of human-derived products, including (sports medicine) soft tissue grafts, bone and gestational-based biologics, and serves as a contract manufacturer of biologic products for distributors.

 

Licensing & Regulation
FDA Federal Establishment Number- 3010898668

Distributors

Alaris products are available to doctors and hospitals through a selected list of distributors currently focused in the United States. Contact us for the distributor in your area.

Alaris is highly selective in determining our distributor network partnerships. We look for distributors with recognized high quality service delivery. If you are interested in learning more about joining the Alaris distribution network, please contact us.

News & Events

April 27, 2017