Vidacare to release results of validation study on its OnControl Bone Marrow System

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 4^th 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.