SOURCE Frost & Sullivan
Innovations in biomaterials, graft design and other technologies have pushed these products to the forefront of the industry, says Frost & Sullivan
LONDON, July 21, 2015 /PRNewswire/ -- Autografts, the gold standard of bone grafts, have several limitations. As a result, new orthobiologics products are being developed for the benefit of patients as well as surgeons. Innovations in biomaterials and graft design have enabled these advanced products that mimic the natural human bone and speed up bone repair and regeneration.
New analysis from Frost & Sullivan, Innovations in Bone Healing, finds that novel ceramic and polymer biomaterial technologies have improved the biocompatibility, osteoconduction and osteoinduction of bone grafts. Meanwhile, other breakthrough technologies like 3D printing, nanotechnology and STEM CELLS have enabled not only healing but remodelling of the bone, thus attracting patients and surgeons seeking improved clinical outcomes.
"Patients are shifting from autografts to other bone graft substitutes in order to avoid the double surgeries the former method entails," noted Technical Insights Research Analyst Debarati Sengupta. "Moreover, procedural volumes are increasing due to the rise in elderly population and their associated bone problems such as osteoporosis and osteoarthritis, fuelling growth in the bone healing market."
Oz, I truly believe we are days away, at most a few months away from a major tipping point for our little hidden gem. Smart people are running and guiding this company, we are nearing the inflection point.
tipping point (noun)
---the point at which a series of small changes or incidents becomes significant enough to cause a larger, more important change.---
Sentiment: Strong Buy
I took the opportunity to add a little near $19.04
There's too much positive momentum building. Earnings will be here in the blink of an eye.
Sentiment: Strong Buy
Here is the trial info from one of the research sites. Note the wound sizes ( 25 cm) and note that it is a Phase IV trial.
South Shore Hospital Approved Research Program
Ver. 4/12 SSH ID: 14-009
PROTOCOL TITLE: A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE®
for the Treatment of Complex Diabetic Foot Wounds with Exposed Tendon and/or Bone,
SPONSOR Osiris Therapeutics, Inc.
PRINCIPAL INVESTIGATOR: Gary Gibbons, MD
OTHER RESEARCH TEAM MEMBERS: Cynthia Hernan
CONTACT INFORMATION: Gary Gibbons 781-624-4950
PURPOSE: Phase IV Multi-center, open-label, single-arm trial to evaluate the safety and effectiveness of weekly applications of GrafixCORE® in patients experiencing a complex diabetic foot wound with exposed tendon and/or bone below the ankle, which has not healed with previous treatment methods.
CONDITION OF TARGET POPULATION: Complex diabetic foot wound with exposed tendon and/or bone,
located below the malleoli
SUBJECT POPULATION: Male and female diabetic patients between ages 18 and 85
PROJECTED ACCRUAL: 4-5 participants at SSH; Up to 40 total participants at up to 10 sites in the United States.
The index wound will be defined as an open wound with exposed tendon and/or bone that can accommodate up to three (3) 5CM X 5 CM pieces of Grafixcore®. The index wound must be classified in the Texas Classification System as a Grade II-III, Stage A or C (without active infection). The longest dimension of the Index Wound cannot exceed 15 CM in any direction at the Baseline visit. Post amputation wounds in diabetic patients will be permitted. Patients must be willing and able to sign the informed consent
Osiris Clinical Trial NCT02260609 scheduled to be completed October 2015. With an estimated enrollment of 40, we should expect to hear about additional cases where amputation was avoid through the use of Grafix.
I have a 2x2cm defect right in the center of my patella. I saw Dr. Jack Farr this Monday and he told me I would be a great candidate for cartiform. He has performed 8 of these procedures and of the 6 he's followed up with they have all had self reported good or excellent outcomes at the 9 month mark. He quoted me a 85% success rate, so I went ahead and had him send the letter to my insurance to try and get it approved ASAP. The good thing about cartiform is it is much more likely to get approved by insurance because it falls under the osteochondral allografting code. Not the same can be said of ACI or Denovo, which are difficult to get insurance approval for. I think cartiform is really a game changer. There hasn't been much research because it is so new, but the one study comparing it to Denovo showed superior tissue morphology (91/100 vs 51/100). Also, histology results in a clinical study of a trochlea showed repair tissue with 85% hyaline cartilage (not just hyaline like, ACTUAL Hyaline cartilage). I have really been trying to get the word out about cartiform on knee guru. There is only one post op diary on here for it. I truly believe it should take the place of ACI and Denovo. They are now obsolete treatments in my opinion
PF's master plan unfolding before our eyes. This is truly exciting news - must mean that BLA pieces are in place, and Osiris wants international locations up and running when BLA comes through.
A novel, cryopreserved, viable osteochondral allograft designed to augment marrow stimulation for articular cartilage repair ((Cartiform)
Nice work by the OSIRIS scientists!
capitalpartner - i see your DOJ dumpster diving was written up and released by shill from SA - too bad it had zero impact. So now you show up and attack DSO? If you pay attention at all, you would know that Osiris auditors adjusted for this with an increased allowance for doubtful accounts. ($1.2M). The P&L and Balance Sheet issues are covered. Try again.
Finance Writer for Hire Tedra DeSue - writes for finance and investment websites. Interested clients can view her work and profile information by visiting ...... FROM ATLANTA