Halo

Saving Lifetimes, One Surgery at a Time

Research: Birth Defects

Dr. Phil Frykman at Cedars-Sinai Medical Center invented a device that has saved dozens of newborns from a cruel birth defect. Help advance his research project so it can save thousands more.


For years, Dr. Philip Frykman has helped save the lives of babies born with serious birth defects. As Associate Director of Pediatric Surgery at Cedars-Sinai Medical Center in Los Angeles, Frykman specializes in anorectal malformation (ARM), a rare but devastating condition in which a child is born with a malformed rectum blocking its pelvis and sphincter complex. When a baby can’t do what babies do best – dirty diapers – corrective surgery must happen fast and with the utmost precision. The baby’s survival is at stake. “If the infant is not treated within, at the latest, four days, they'll end up getting septic and die,” Frykman says.

A Life-Altering Birth Defect

For decades, corrective surgery for ARM has been expensive, intricate and dependent on a very specific piece of technology – an expensive muscle stimulator that allows surgeons to identify the location and size of each muscle in an infant’s tiny GI tract. Without the device, surgeons risk permanently damaging the infant’s intestine and muscles for fecal continence in their attempt to repair it. The alternative is less risky and invasive, but requires the child to wear a colostomy bag. Life with a colostomy bag isn’t easy for anyone, especially a little kid.

Surgical mission to Zhengzhou, China Oct 26-Nov 5, 2017. Photo courtesy of Mending Kids.

An Innovative Solution

Frykman and anesthesiologist Dr. Keith Kimble wondered if they could create an equally effective stimulator that all hospitals could afford. They traded in their white coats and scrubs for books on product design, created a prototype, and put it to work. Not only was their device far cheaper than the current stimulator, it worked better. These little patients went on to live happy, normal lives without debilitating side effects or stigma.

Surgical mission to Zhengzhou, China Oct 26-Nov 5, 2017. Photo courtesy of Mending Kids.

With support from Mending Kids, Frykman and his team began traveling regularly to China and Africa, performing these operations for free, and receiving new requests for the device from other parts of the world, including right here in the U.S.

How You Can Help

Then last year, the stimulator Frykman was hoping to replace suddenly ceased production, leaving surgeons in the U.S. in a similar predicament. Since Frykman’s stimulator has not received regulatory approval, surgeons in the U.S. can't use it either. With a small amount of funding, however, Frykman can complete the necessary tests and have the stimulator in hospitals across the United States in as little as two years. The device just needs to make it out of the valley of death. That’s why he’s partnered with Halo. Donate now so ARM babies born in the United States can live normal lives.

Milestone Timeline

Dr. Frykman reached Milestone 1 with external funding and volunteer support. Now he needs your help to fund Milestone 2.

    • Funding: Success
    • Goal: $40,000
    1
    Milestone 1
    Proof of Concept
    • Project Duration: 24 months
    • Goal: Developed working prototype that has been successfully used in surgeries on dozens of babies in 40+ countries
    • Project: Success
    • Funding: In Progress
    • Goal: $150,000
    2
    Milestone 2
    Design
    • Project Duration: 6 months
    • Goal: Enlist medical device company to modify design to meet rigorous quality and safety standards
    • Project: In Progress
    • Funding: Not Started
    • Goal: $150,000
    3
    Milestone 3
    FDA Approval
    • Project Duration: 10 months
    • Goal: Implement safety and quality control system; File and receive FDA approval
    • Project: Not Started
  1. Goal Achieved!
    Device is available to pediatric surgeons in the United States

Ask Dr. Frykman

Tell us more about the problem...

For the past six years, Dr. Keith Kimble and I have been traveling to China to perform surgeries on babies born with anorectal malformations (ARM). It’s a serious birth defect in which the child’s gastrointestinal tract is improperly developed and blocked in the lower rectal region. Surgery requires the use of a muscle stimulator to avoid permanent damage or even death, but many hospitals can’t afford stimulators. What’s more, the only muscle stimulator on the market ceased production in 2014. As of today, there is no approved muscle stimulator for ARM surgeries in the U.S. or anywhere else in the world.

What is the goal?

The ultimate goal is regulatory approval in the U.S., which has the strictest standards, so surgeons here and the rest of the world can start using the device.

How long will it take?

We estimate the entire process to take about two years. We have divided the work into phases and will keep donors apprised as each benchmark is achieved. With their successful completion, our stimulator could be available in hospitals within two years.

What are the risks?

At the outset, we commissioned a third party analysis detailing the requirements to bring our device to market. In addition, Phase I is designed to surface any changes to these requirements prior to significant expenditures being made. However, as with any new medical device, there can be unforeseen circumstances that influence time and budget estimates.

Is my donation tax deductible?

Yes. Your donation goes directly to GPSTEP, a nonprofit I created to fund this project. Our tax ID is 61-1632833.

What was your discovery?

Dr. Kimble and I realized that we could have a far bigger impact if we developed a stimulator that all hospitals could afford and then trained local surgeons on how to use it. Through trial and error, we discovered that a modified version of a nerve stimulator costing $200 was just as effective as a muscle stimulator. We started a nonprofit and assembled a multi-disciplinary team to help bring an approved version to market. The result was the Frykman-Kimble Stimulator, which was first evaluated in clinical use in Cape Town, South Africa in 2014.

What sort of validation have you received?

Since our first patient in Cape Town, South Africa, ARM surgeries have been successfully completed in more than 40 countries using the Frykman-Kimble Stimulator. It has given hundreds of babies the opportunity to live normal, fulfilling lives.

How will the money be used?

Any new clinical device must pass a series of tests to ensure it’s safe and effective for use on patients. Your donation will directly fund these studies.

How It Works

Donate Directly
Donate Directly Your tax-deductible donation funds a defined research project required to advance discovery
Track Your Progress
Track Your Progress Receive regular updates on progress once the research project is funded
See Your Impact
See your impact Earn tokens of appreciation when you donate yourself or simply share the campaign

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