it all about the scaffold !!

This is a report on a stem cell based wound treatment using a extracellular matrix/scaffold. It was well received by the market with Osiris shares rising over $12.00 on the day. Currently capped at $740m+

http://www.nasdaq.com/symbol/osir

http://www.businessweek.com/ap/2013-08-13/osiris-shares-rocket-company-details-grafix-study

"Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a
flexible, conforming membrane that provides a high quality source of living MSCs and growth factors directly to
the site of the wound. Grafix is produced by BioSmartTM Intelligent Tissue Processing of human placental
membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the
neonatal MSCs, and the biologically active growth factors"

As you can see the matrix is not synthetic and production costs are likely to be higher than Polynovo scaffolds.

This is the full release from Osiris

http://www.osiris.com/ (click on press release)

“These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10
years,” said Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery, University of Texas
Southwestern Medical Center. “Compared to other similarly designed studies, this trial demonstrates, by far,
the largest relative improvement in complete wound closure. This is great news for our patients with diabetic
foot ulcers that are at such high risk of losing their legs.”
Grafix is a human cellular repair matrix that provides a high-quality source of living mesenchymal stem cells
(MSCs). It is a flexible, conforming membrane that is applied directly to acute and chronic wounds.
“We know now that an unfortunate consequence of diabetes is the pathological change that occurs with the
number and functionality of certain stem cell populations necessary for optimal wound repair,” said Michelle
LeRoux Williams, Ph.D., Chief Scientific Officer. “With Grafix, we are able to help correct this problem by
providing patients with a rich source of healthy, non-controversial stem cells contained within a biologic matrix
for easy delivery in the out-patient setting.”
Osiris partnered with CPC Clinical Research, an Academic Clinical Research Organization (CRO), who was
responsible for all clinical monitoring, data management, and biostatistics services.
“One key aspect of an academically led CRO is our credible scientific oversight and quality control during the
execution of the trial,” said William R. Hiatt, M.D., President of CPC and Professor of Medicine, Division of
Cardiology, Department of Medicine, University of Colorado School of Medicine. “This is one of the most
rigorous wound care trials conducted, enhanced by our proprietary wound core lab technology which is able to
independently assess wound closure in a blinded manner.”
About the Trial (Protocol 302)
Protocol 302 is a single-blind, randomized, controlled multi-centered trial is evaluating the efficacy and safety of
weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients were
enrolled at 19 leading wound care centers across the United States. Patients between 18 and 80 years of age
with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the
foot were randomized to Grafix or control dressings at a 1:1 ratio. Ulcers had to be present for at least 4 weeks
prior to randomization and be between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the
ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly
for up to 12 weeks. The primary endpoint measures complete wound closure by 12 weeks as determined by the
investigator and confirmed by an independent, blinded Wound Core Lab. Secondary endpoints include
complete wound closure rates for those patients that complete all scheduled treatments, time to wound
closure, number of applications, proportion of patients achieving at least a 50% reduction in wound size by day
28 and number of re-occurrences. Patients randomized to the control group who did not heal within 12 weeks
entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.
About Grafix
Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a
flexible, conforming membrane that provides a high quality source of living MSCs and growth factors directly to
the site of the wound. Grafix is produced by BioSmartTM Intelligent Tissue Processing of human placental
membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the
neonatal MSCs, and the biologically active growth factors.
7015 Albe r t E ins te in Dr i ve ? Columbia, Ma ry land 21046 ? Ph 443.5 45.1800 ? F ax 4 43.545.1701 ? www.Os i r i s . com

The results for the "Novosorb" Human Clinical Trial showed significant wound reduction over the trial period compared with "Granufoam" and one wonders whether wound closure ultimately occurred with "Novosorb". I wonder also if this report added $300m to the market cap of Osiris why the results from our dressing trial and the completion of the BTM trial have CZD still at a market cap of $35mAU.

There is probably no reason Osiris or other companies in this area couldn`t get better results using a synthetic scaffold (more partnering opportunities)and indeed when Dr Greenwood starts the burns trial with CCS the advantages of efficacy and cost will become more apparent because of the large areas that need treating are cost prohibitive with other scaffolds.