Osiris Therapeutics

https://endpts.com/biotech-scandal-drags-on-as-the-feds-only-score-partial-victory-against-execs-charged-with-cooking-the-books/

Smith & Nephew übernimmt Osiris Therapeutics für 600 Mio. $

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https://www.sharecast.com/news/news-and-announcements/smith-nephew-to-buy-us-biotech-osiris-therapeutics-for-19-a-share--3787465.html

Grafix besser als Dermagraft

http://investor.osiris.com/news-releases/news-release-details/osiris-therapeutics-inc-announces-peer-reviewed-publication

Osiris Therapeutics, Inc. Announces Peer-Reviewed Publication Comparing the Efficacy of Viable Cryopreserved Placental Membranes to Human Fibroblast-Derived Dermal Substitute in the Treatment of Chronic Diabetic Foot Ulcers (DFUs) in a Multicenter Randomi

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COLUMBIA, Md., Aug. 27, 2018 (GLOBE NEWSWIRE) -- Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced today that a new peer-reviewed manuscript entitled “A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute in the treatment of chronic diabetic foot ulcers” has been published in the Wound Repair and Regeneration and is available online https://onlinelibrary.wiley.com/doi/10.1111/wrr.12645

Dermagraft® (1) is a bioengineered human fibroblast-derived dermal substitute product that has been on the U.S. market for more than 15 years (2, 3).  Grafix® is a cryopreserved placental tissue allograft that has been developed using a proprietary cryopreservation method. This method allows the retention of intact matrix, growth factors and cells native to placental tissue.  Prior clinical studies have shown the safety and efficacy of both Grafix and Dermagraft when used in the treatment for chronic DFUs in their respective trials (4, 5). The study’s objective was to compare clinical outcomes and product cost between Grafix and Dermagraft as an adjunct to standard of care (SOC) in the treatment of chronic DFUs in a prospective, multicenter, single-blind study.

The study’s objective was to compare clinical outcomes and product cost between Grafix and Dermagraft as an adjunct to standard of care (SOC) in the treatment of chronic DFUs in a non-inferiority prospective, multicenter, single-blind study. Sixty two patients were evaluable in the per protocol (PP) population: 31 Grafix patients and 31 Dermagraft patients. There were no significant differences between treatment cohorts with an exception of longer wound duration and more plantar wound locations for the Grafix group. The average wound size was 7.12 cm2 in the Grafix group and 5.70 cm2 (p=0.732) in the Dermagraft group. Both patient cohorts had noteworthy comorbidities, such as heart disease (92.1% of Grafix patients and 94.6% of Dermagraft patients) and prior amputations (55.5% of Grafix patients and 54.1% of Dermagraft patients).

Key clinical outcomes include:

• The study met its primary endpoint: Grafix was not inferior to Dermagraft for the proportion of patients achieving complete wound closure (48.4% of Grafix patients and 38.7% of Dermagraft patients, a non-inferiority criterion of the lower limit of 90% confidential interval greater than -15% was met) when the established-for-Dermagraft-treatment- regimen of up to 8 weekly application was used for both skin substitutes.
  
  
• For a subset of patients with typical DFUs (≤ 5 cm2), closure at the end of treatment was achieved in 81.3% (13/16) of Grafix patients, compared to 37.5% (6/16) of Dermagraft patients (p=0.0118).
  
  
• For DFUs of less or equal to 5 cm2, mean per-patient product cost for Grafix patients was $3,846 compared to $7,968 for Dermagraft patients (p < 0.0001).

“With growing number of wound care products and development of new technologies, comparative research in prospective randomized studies has tremendous value,” said Dr. Charles Ananian, DPM, who is the lead study investigator. “Wound-care providers like myself and my colleagues may utilize results of this study when selecting what we believe is the best treatment option for the patient.”

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