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Thread: Spinal-injury device For victims of spinal-cord injuries, any significant recovery of

  1. #1

    Spinal-injury device For victims of spinal-cord injuries, any significant recovery of

    January 7, 2008


    Insider Action: Daniel Lee

    Spinal-injury device For victims of spinal-cord injuries, any significant recovery of sensation or movement can make a huge difference.


    A person who regains mobility in a few fingers may be able to use a fork or operate a computer mouse. Increased sensation also may help a person avoid injuries, because he or she can sense pain. In some cases, enough sensation returns to restore sexual function.
    Dr. Scott Shapiro, a professor of neurological surgery at Indiana University, said he has seen those sorts of results from his research of a medical device called the Andara OFS System.
    "The science behind it is well-founded," said Shapiro, who has studied the device in 14 patients. "It's a simple device."
    Shapiro, though, said the business of medicine does not always mesh with the science of medicine: "It may make sense for the patient, but it may not make a lot of money for the company."
    Indeed, the Andara OFS -- for Oscillating Field Stimulator -- is a homegrown Indiana innovation that illustrates the potential rewards -- and risks -- of commercializing cutting-edge medical technology.
    About the size of an old-fashioned cigarette lighter, the Andara OFS must be implanted surgically in a patient's back within 18 days of a spinal-cord injury and kept in place for 15 weeks. The battery-powered device uses six leads attached to the spinal column to create an electrical field around the injury in an effort to stimulate nerves to grow and form new connections.
    The device was invented by Dr. Richard Ben Borgens, a professor of biomedical engineering at Purdue University. In 2005, the university helped create a startup, Andara Life Science, based on the device.

    more:
    http://www.indystar.com/apps/pbcs.dl...326/-1/LOCAL17

  2. #2
    Now Cyberkinetics is depending on the Andara OFS gaining regulatory approval for its own financial viability. The company lost $8.1 million in the first nine months of 2007. Its stock, traded on the Nasdaq Over the Counter Bulletin Board, has lost more than 80 percent of its value in the past 52 weeks.

    "We're going to need more funding to get through the whole year," said Chief Executive Timothy Surgenor. Once on the market, the Andara OFS would carry a price of about $50,000 per unit, he said.

    Cyberkinetics is seeking approval for the Andara OFS under the Food and Drug Administration's Humanitarian Device Exemption, a less burdensome regulatory process designed for medical devices that have no competing products on the market and that serve a patient population of fewer than 4,000 a year.
    This is too bad. Seems like most of the companies that invest in SCI treatments/cures end up losing money.

  3. #3
    Senior Member shak's Avatar
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    do we like this thing ? does it work? will electricity play a role in the combined therapies coming down the pipe?
    if yes to these questions then should'nt we have these cats in a room next Wise, once he tills the soil and plants the seeds with some lithiume for fertilizer we're going need some sun right ?

    maybe zippo might want to merge with the cyber boys?
    Last edited by shak; 01-12-2008 at 01:54 AM.

  4. #4
    Quote Originally Posted by shak
    do we like this thing ? does it work? will electricity play a role in the combined therapies coming down the pipe?
    if yes to these questions then should'nt we have these cats in a room next Wise, once he tills the soil and plants the seeds with some lithiume for fertilizer we're going need some sun right ?

    maybe zippo might want to merge with the cyber boys?
    Shak, this has been discussed extensively. It is a device that places an alternating current across the injury site within the first two weeks after injury. A phase 1 (non-controlled study) was carried out, suggesting that the treatment may restore some function. There is no evidence yet that the treatment will be effective for chronic spinal cord injury. It was originally tested in dogs that had spinal cord injuries from accidents and then in human clinical trial in Indiana, at Purdue University.

    Several studies have reported the axons tend to grow towards the negative pole of electrical fields. The problem with applying this to the spinal cord was that such currents will cause either the ascending (sensory) or descending (motor) axons to grow, and may discourage the other to slow down or stop. However, Richard Borgens and his colleagues showed that alternating currents seemed to encourage both ascending and descending axons to grow in animals. They then took it human clinical trial and implanted the device within 2 weeks after injury. The trial showed that the device was safe and the patients appeared to have more recovery than expected. To my surprise, the FDA approved the device for use on the basis of the data in this one trial. So, the company Andara was formed to market the device.

    Quote Originally Posted by Antiquity
    This is too bad. Seems like most of the companies that invest in SCI treatments/cures end up losing money.
    According to this article, Andara has already spent some $8.1 million last year but is now running out of money. This is unfortunate and surprising. This is quite a lot of money to spend without doing any additional clinical trials. The money was probably spent on overcoming regulatory issues and getting FDA approval. They did accomplish what I consider a miracle of getting this device approved by the FDA based on several dog trials and one phase 1 human clinical trial. Part of the money must have been spent on estabishing a GMP (good manufacturing practice) protocol for the device, getting prototypes of the device built, and getting the appropriate safety studies done. The clinical trials, by the way, were funded by the spinal cord injury research monies from the state of Indiana.

    It is very expensive to develop therapies and get regulatory approval for the therapies. I know this first hand because I am now essentially running a company that is dedicated to getting treatments tested i clinical trial: the ChinaSCINet. We have been extraordinarily careful in keeping a low "burn rate" (the rate at which money is spent to support a company) and doing things as cheaply as possible, using volunteer labor as much as possible, and conserving our funds for the clinical trials and getting regulatory approval. I am a little surprised that they spent $8.1 million already. In any case, they need to raise more money. This is a problem with all startups.

    Wise.

  5. #5
    Quote Originally Posted by antiquity
    This is too bad. Seems like most of the companies that invest in SCI treatments/cures end up losing money.
    Supply and Demand. With the 50 grand price tag it's gonna be very tough. There is as many in the Vet world as in human application that would use this..but not at that price tag. They MIGHT sell one or two a year. That's a definate might. And people do LOVE their animals. Human and animal insurance companies are not gonna jump in and just cover this either.

    The outcomes are NOT spectacular either. Mediocre at best. BUT passed approval due to NOT being controversial.
    Life isn't about getting thru the storm but learning to dance in the rain.

  6. #6
    Senior Member shak's Avatar
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    Dr. Wise thanks. i sure dig it when you answer back so quickly, it really makes this site feel super interactive and quite fun.
    It also feels like your not super keen on the Dr. Fankenstein's theory of graphing spare parts together injecting secret sauce and hittin' it with a lightning bolt . but is there any other forms of electric stimulation that has caught your attention. things that you think we should be checking out . i'm talkin right at or near the spinal cord . stuff like scenar or laser puncture.

  7. #7
    Shak, Dr. Young has been very supportive of Dr. Borgens work. If you search under Borgens or Cyberkinetics, you'll find his responses to Borgens' trial results. There's nothing Frankensteinian about this appoach. Here's a start: http://sci.rutgers.edu/forum/showthr...ghlight=guinea

    The applicability of lasers and laserpuncture has also been extensively discussed here. You can start your search using the names Anders and Bohbot.
    Last edited by antiquity; 01-12-2008 at 07:47 PM.

  8. #8
    Senior Member shak's Avatar
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    thanks for the bohbot lead very cool stuff . I also mentioned scenar technology out of russia has anyone had any experience with this therapy and it's potential with sci.

    oh and hey antiquity frankenstine is the man I'm lookin for . remember the monster walks and is kinda cute to , in that mass of dead tissue come to life sorta way.

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