First Patient Enrolled in Revita® Wound Care Study

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We’re excited to announce the commencement of our second level 1 clinical study for Revita!

This level 1 randomized controlled trial will assess the safety and efficacy of Revita as a wound covering for diabetic foot ulcers (DFUs). Diabetes impacts 30 million people across the United States, and as many as 25% of diabetic patients will develop a DFU within their lifetime.1-2 Without proper treatment, DFUs commonly result in amputation, leaving the patient with a 50% chance of survival. 3-4

As the first placental membrane allograft to capture the complete intact membrane in a shelf-stable format, Revita is uniquely capable of addressing DFUs. Since the product was launched, Revita has shown excellent effectiveness as a wound covering for a broad range of wound types including DFUs. This study will build on that experience and demonstrate broader, clinically validated outcomes.

We are thrilled to have this trial underway and are continuing to invest in high quality outcomes data for the complete portfolio of StimLabs products.

More information on this study can be found press release.

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1. American Diabetes Association. Statistics About Diabetes. 2018 Mar.2. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA2005;293:217–228pmid:1564454.3. Alexiadou, Management of Diabetic Foot Ulcers. 2012 Apr 20.4. Armstrong DG, Wrobel J, Robbins JM. Guest editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J 2007;4:286–287pmid:18154621

First Patient Enrolled in Revita® Spine Study

We’re excited to announce our first level 1 clinical study for Revita full thickness placental allograft!

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This clinical trial will assess the safety and efficacy of Revita placement following lumbar microdiscectomy procedures. Common complications following microdiscectomy procedures include scar tissue formation and reherniation, which are known to cause back and leg pain. Patients with extensive scar tissue are 3.2 times more likely to experience recurrent radicular pain than those with less extensive scarring1.

The use of a barrier membrane, such as Revita, is expected to reduce the rate of occurrence for these types of complications and improve functional outcomes following surgery. The first patient has been enrolled in a 182-patient multi-center randomized controlled single-blinded (patient) trial evaluating the use of Revita as a barrier membrane to reduce these types of complications and improve functional outcomes. More information on this study can be found in the press release.

We are thrilled to have this trial underway, and we are continuing to invest in robust clinical validation of both Revita and Ascent through several case series and large randomized controlled trials.

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1. Ross et al,. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. AJNR Am J Neuroradiol, January 1998, 19:183–186