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In reference to your point on the US and FDA, you get the...

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ajbhu

85 Posts.

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03/08/14

05:39

Post #: 13760434
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Originally posted by hvalfisken ↑

Thank you abjhu for your response. I do have the journal article to which you refer (abstract appended for others) in which 35.6% of patients with VG plus standard treatment had wound close at 12 weeks. I am well familiar with the chronic wound market and the costs DFUs impose on the health systems.
But I am unable to find any economic studies for VG and of most importance, nor any controlled studies. I have raised this point before. We all believe that VG will be a good product and solution but until there are of controlled studies evidencing performance in a direct comparison against an accepted control (eg pressure alone) I do not believe it will be adopted by clinicians or obtainment of reimbursement. A small single arm non-controlled study as have been presented is not equivalent to a P2 FDA study and a full controlled study would be required by the FDA for US clearance. I do not understand why the company has not conducted such controlled trials as it may be that even a small sample of perhaps 50 (25 in each arm of trial) would indicate efficacy. But it may a strategy that VG get allowed CE marking and obtain sufficient sales in the EU that a large partner will pay for FDA studies.

Int Wound J. 2014 Apr;11(2):129-37. doi: 10.1111/iwj.12115. Epub 2013 Jul 9.
Effectiveness of an acellular synthetic matrix in the treatment of hard-to-heal leg ulcers.
Harding K1, Aldons P, Edwards H, Stacey M, Finlayson K, Gibb M, Jenkins L, Shooter G, Lonkhuyzen DV, Lynam E, Heinrichs EL, Upton Z.
Author information
Abstract
Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population. Despite improvements in wound care, some wounds will not heal and they present a significant challenge for patients and health care providers. A multi-centre cohort study was conducted to evaluate the effectiveness and safety of a synthetic, extracellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal venous or mixed leg ulcers. Primary effectiveness criteria were (i) reduction in wound size evaluated by percentage change in wound area and (ii) healing assessed by number of patients healed by end of the 12 week study. Pain reduction was assessed as a secondary effectiveness criteria using VAS. A total of 45 patients completed the study and no difference was observed between cohorts for treatment frequency. Healing was achieved in 35·6% and wound size decreased in 93·3% of patients. Median wound area percentage reduction was 70·8%. Over 50% of patients reported pain on first visit and 87·0% of these reported no pain at the end of the study. Median time to first reporting of no pain was 14 days after treatment initiation. The authors consider the extracellular synthetic matrix protein an effective and safe adjunct to standard care in the treatment of hard-to-heal leg ulcers.
© 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.
KEYWORDS:
Biomimetic scaffold; ECM protein; ECM replacement; Hard-to-heal wounds; Vitronectin

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In reference to your point on the US and FDA, you get the information's directly from the US Government website.
http://clinicaltrials.gov/ct2/show/NCT01982318

As you can see there is already a filing number for VitroGro© ECM (NCT01982318) and it has already a Phase 2 classification.
The expanded clinical trials with 250 patients, will be based on a comparative treatment used as placebo (Dulbecco's Phosphate Buffered Saline) and VitroGro© ECM.

Anyhow, all informations are available from the US Government website above.

TIS Price at posting: 29.5¢ Sentiment: Buy Disclosure: Held
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