Category Archives: Biologics

MIT NanoTech Team produces a SuperGlue for Implants

An Massachusetts Institute of Technology (MIT) research team that may have found a way to make bone implants less likely to fail using a high-tech adhesive that more securely bonds implants to bone by promoting cell growth between natural and artificial body parts.

In a study published in the June 26 online edition of Science Translational Medicine, the MIT team and its collaborators from several other institutions reported that the implant adhesive — a multilayered coating of ceramic and nanolayers of polymers infused with proteins — worked so well on lab rats that they will soon be ready to test it in humans.

The nanolayers, or super-thin sheets of material, hold therapies such as growth factors

Professor Paula Hammond specializes in materials design and molecule delivery at very small scales

that attract and encourage the formation of bone cells, causing them to firmly attach to the titanium implant. The coated implants required significantly more force to pull free than uncoated ones; indeed, the researchers said the resulting bond is so strong that under stress, the bone would fracture first before the interface with the implant.

The implant coating works like a tiny, elegant machine. The top coating consists of repeating layers, each impossibly thin, that contain the bone growth factor BMP-2. The layers gradually break apart over a period of weeks, releasing BMP-2 into the body. The factor then stimulates stem cells in bone marrow to transform themselves into new bone cells.

The bottom part of the coating is made of a ceramic that mimics bone, thereby attracting bone cells to its surface. This side of the coating is attached to the implant, and recently formed bone cells tend to affix to this ceramic and grow outward, adhering like “superglue” to attach the implant to the bone.

Read more at the Boston Globe

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Topic: Biologics, Bone Grafting, Research Tagged , |

Infuse Bone Graft Linked to Life-threatening Complications in Dozens of Patients

The Wall Street Journal is reporting that Medtronic`s `Infuse Bone Graft` has been linked to life-threatening complications in dozens of patients. The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries, according to reports filed with the FDA.

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Topic: Biologics

NV101 – Local Anesthetic Reversal Agent

Novalar has developed NV101, a novel compound that is the only local anesthetic reversal agent that accelerates the return to normal sensation and function following restorative and periodontal maintenance procedures. Novalar has contracted with the leading North American supplier of dental anesthesia cartridges to manufacture NV-101. NV-101 treated patients reported the return of sensation and function in less than half the time it normally took after receiving local dental anesthesia. NV-101 induced a 54.8 percent and a 62.3 percent decrease in time to normal for those with anesthesia administered in the mandible and maxilla respectively.

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Topic: Biologics

GEM 21S – Recombinant human platelet derived growth factor (rhPDGF-BB)

Osteohealth`s GEM 21S is a wound healing and bone regeneration technology termed growth-factor enhanced matrix (GEM). It has recently become available for clinical use. This graft material consists of a concentrated solution of pure recombinant human platelet-derived growth factor (rhPDGF-BB), the synthetic form of the body’s key natural wound healing stimulator PDGF-BB, and an osteoconductive (bone scaffold) matrix. This is the first available purified, recombinant (synthetic) growth factor product and is the result of over a decade of extensive research. Clinical and animal study results with this graft material demonstrate that it is capable of simultaneously promoting wound healing, regeneration of bone and acceleration of gingival attachment gain in challenging periodontal and periimplant defects.

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Topic: Biologics

FDA sends `Warning Letter` to Straumann`s Biora

In the course of a routine inspection of Biora AB, Straumann`s oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company`s products. Biora has received a “warning letter“ from the FDA, which indicated that its “dental bone grafting materials“ are on import detention in the U.S., until the inspectional observations are resolved. No other countries apart from the U.S. are affected. The products concerned are: Straumann BoneCeramic, Emdogain, and PrefGel.

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Topic: Biologics

FDA Approval: Recombinant human bone morphogenetic protein-2 (rhBMP-2)

Medtronic recently announced that the FDA Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSE® Bone Graft for certain oral and maxillofacial bone grafting procedures. INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and tibial fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body’s own biology to induce normal physiologic bone formation.

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Topic: Biologics