Final Validation Testing for Vidacare's OnControlTM Bone Marrow System Shows Positive Results

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Thu Oct 22, 2009 11:44am EDT

Clinicians and Patients Benefit from System to Commercially Launch in November
SAN ANTONIO--(Business Wire)--
Vidacare Corporation has completed an analysis and is releasing the results of a
validation study on its OnControl Bone Marrow System, the first effort in
decades to improve the safety, control, and comfort of bone marrow aspiration
and biopsy procedures. The validation study measured successful sample
acquisition rates, quality of sample, ease of use, and overall user
satisfaction. Vidacare is launching a full-scale commercial launch in the 4th
quarter of 2009. 

Thirty-one clinicians from thirteen sites in the U.S. participated in this
evaluation, and all were first-time users. Testing sites include the Cancer
Research and Technology Center of the University of Texas/San Antonio (San
Antonio, Texas), M.D. Anderson Cancer Center (Houston, Texas), Wilshire Oncology
(Glendora, CA) and Kaiser Permanente Riverside (Riverside, CA) among others. Of
the 84 patient procedures completed during the validation testing, results
show:

* Mean user satisfaction score of 4.4 (on a scale of 0-5, with 5 indicating high
satisfaction) 
* Needle insertion success rate of 94% 
* Biopsy core acquisition success rate of 90% 
* Mean length of core sample of 1.32 cm 
* Median time to core extraction of 81 seconds 
* Zero complications

With nearly 700,000 bone marrow diagnostic procedures done in the U.S. annually,
these procedures can be difficult due to the pain involved for the patient and
the strenuous nature of getting the bone marrow for the clinician. Traditional
bone marrow procedures use a manual device hand-inserted by the clinician and
can take from 2 minutes to more than 30 minutes, with a mean of 7 minutes, to
collect a core biopsy. The procedure can be arduous for the clinician and very
painful for the patient. Frequently, a second or third attempt is required to
collect a core of sufficient length. 

The quality of the captured samples is also an issue; in an article published in
the Journal of Clinical Pathology (FW Bishop, K McNally, M Harris. Audit of bone
marrow trephine biopsy. J Clin Path 1992: 45: 1105-1108), investigators reported
that 58% of the time, the samples collected were "inadequate". This can pose
serious challenges to clinicians who analyze the samples and to those whose
clinical judgment and treatment decisions rest on this analysis. 

The OnControl Bone Marrow System addresses these issues and offers patients and
clinicians a safe, fast, reliable and more comfortable alternative to the
traditional manual procedure, and consists of a patented power driver and needle
set based on Vidacare`s innovative intraosseous technology platform. 

"The OnControl Bone Marrow System will increase the efficiency of bone marrow
biopsies and aspirations while also reducing patient discomfort. The validation
testing proves this system is successful in capturing core samples of acceptable
length as well as substantially decreasing the time to capture samples," said
Phil Faris, President and CEO of Vidacare. 

"Just lying on the table waiting for the next move is a major anxiety. With your
[OnControl] device, it was over quickly, and afterward, I noticed I was not as
sore as the ones before," noted a patient on whom the system was used. "The bone
marrow aspiration is the WORST part of my treatment - it is worse than being
hooked up to an IV for 5 hours. Your system is definitely better." 

Full commercial release of the OnControl Bone Marrow System is slated for
November 2009. There is also a special Luminary Program created by Vidacare to
recognize clinical early adopters of the OnControl Bone Marrow System. 

Established in 2001, Vidacare is the leading developer, manufacturer and
marketer of advanced intraosseous technology which offers the potential to
establish new standards of clinical excellence in the safe, rapid performance of
medical procedures using the intraosseous space. The Wall Street Journal named
Vidacare`s EZ-IO Vascular Access System its sole Technology Innovation of the
Year Gold Award Recipient in October, 2008. Vidacare products are marketed in
over 50 countries worldwide. www.vidacare.com

Vidacare Corporation
Lisa Owens, 210-601-6647
lisaowens@regval.com

Copyright Business Wire 2009

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