Four Genes Identified that Influence Levels of ‘Bad’ Cholesterol; May Be New Targets for Treatments to Reduce Heart Disease Risk
SAN ANTONIO, May 15, 2013 - Scientists at the Texas Biomedical Research Institute have identified four ...
By Scott Bailey, San Antonio Business Journal The University of Texas Health Science Center at San Antonio ...
By W. Scott Bailey, San Antonio Business Journal
Vidacare Corp. has been given the green light to begin marketing a new product that could save a significant number of lives in war zones.
That approval, granted recently by the Food and Drug Administration, will give the San Antonio-based company an opportunity to expand its revenue opportunities as the medical device industry prepares to take a hit from a new tax that will be levied with the roll-out of the Affordable Care Act.
The Tactically Advanced Lifesaving Intraosseous Needle, or TALON, is a variation of Vidacare's core product, the EZ-IO, a drill-driven needle system used by an assortment of medical professionals to access the vascular system via the bone in order to deliver vital fluids and drugs.
Unlike the EZ-IO, the TALON is a manually-operated device that is lighter in weight and more compact, features which are critical for medics in a combat arena.
"The military wanted an alternative (device) for the battlefield," says Vidacare President and CEO Mark Mellin. "That's what this is. There is no other product out there like this."
Medical device manufacturers are required by the FDA to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or to reintroduce a device that will be significantly changed or modified.
Vidacare has received the necessary FDA clearance for the TALON and plans to introduce the device commercially next month.
Military hospital personnel have used the EZ-IO. But Vidacare wanted to create a device that was more mobile and could be used to save more lives in combat.
"This is an important device for the military," says Vidacare founder and chief medical officer Dr. Larry Miller.
"Historically, the military has used the sternum (for intraosseous, or via-the-bone, access)," Miller explains. "The problem is that if you go through the other side of the sternum you will kill the patient."
The TALON allows vascular access through seven points, including the knee, ankle and shoulder areas. It can be inserted in less than 30 seconds.
"This system is designed specifically to address the needs and concerns of military personnel treating patients under strenuous conditions," Mellin says. "The efficacy and safety of the system will save lives when seconds count."
Vidacare has received additional good news.
It has been approved to conduct a study to prove that its EZ-IO can be left in patients for as long as 48 hours. Presently, such devices must be removed after 24 hours.
"We've been working on that for two and a half years," says Miller about efforts to gain approval for the study.
With the good news comes some consternation.
One of the elements of the Affordable Care Act is a 2.3 percent tax that will be levied beginning next year on medical-device makers. Critics say it will be based on companies' total revenues, meaning some will have to pay it whether or not they earn a profit in a given year.
The Medical Device Manufacturers Association warns that the results of this tax will be devastating to innovation, patient care and job creation.
"If the true goal of health care reform is to reduce costs and to improve patient care, then Congress and the President need to repeal the device tax so America's medical technology innovators can continue to develop cutting-edge products," says Mark Leahey, president and CEO of the Medical Device Manufacturers Association.
"We've had to overcome a lot of challenges," says Mellin about Vidacare and its efforts to introduce new technologies to the health care industry.
Despite those challenges and the uncertainties surrounding the roll out of federal health reform, Vidacare officials believe the San Antonio company has overcome a number of hurdles and is poised for more growth opportunities.
Vidacare, which was established in 2001, has been on a steady upward trajectory on the revenue front, even during the recession, growing from about $20 million in revenue in 2008 to $32 million in 2010 to some $43 million last year, according to company officials and reports.
San Antonio leaders have taken note of Vidacare's climb.
Last week, BioMed SA named Miller the recipient of its 2012 Julio Palmaz Award, which recognizes individuals for their innovation in health care and the biosciences.
Says Miller, "I never could have done this alone. My secret to success has been to surround myself with people who are smarter than I am and who are highly motivated. You have to be generous and persistent, and you have to always look to do the right thing for the right reason. If you do that, you will be rewarded."
The hard work and persistence has opened new doors for Vidacare.
For example, the FDA recently cleared the path for bone biopsies of vertebral body and bone lesions. Vidacare plans to take full advantage of that opportunity with a new extension of its own OnControl Bone Access System. Its technology will allow clinicians to access hard bones and perform biopsies of bone lesions.