Physician entrepreneurs bring products to market

Inform 99.7 percent of women as to whether they have pre-cancer in the breast? Genuinely block the pain sensation when a child receives a shot?

These would be great leaps forward in the eyes of each of these patient groups—and these physicians have combined their medical skills with an entrepreneurial spirit to make great strides in these areas.

MASCT System and ForeCTYE Breast Health Test: Confirming pre-cancer

The end game for steven quay, M.D.’s, latest of six biotech companies was to build on the work of Dr. George Papanicolaou of Pap Smear fame who tested breast secretions. Whereas Papanicolaou could only successfully retrieve test samples from 18 percent of his patients, Quay was eager to test a full 100 percent of samples for pre-cancer.

“I took a leap of faith. What I started to realize was that the size of the specimen I needed to see pre-cancer cells under the microscope was actually a smaller amount of liquid than the human eye can see,” Quay says.

Quay developed and now markets the Atossa Genetics MASCT System and the ForeCYTE Breast Health Test (atossagenetics.com) to effectively collect and test the infinitesimal samples.

“I developed a special filter that can pull tiny samples out of the nipple by capillary action. I can actually detect as little as seven Pico liters,” Quay says. From those, Quay’s lab can confirm the presence of atypical hyperplasia of the cells where the risk of cancer is significantly higher than with normal cells.

Kathryn Wood, M.D., FACOG, an OB/GYN and medical director of her practice Dermalase, incorporates the Atossa Genetics MASCT medical device and the ForeCYTE Breast Health Test into her practice routinely. “It really helps me get a better risk assessment on each individual patient,” Wood says.

Prior to the arrival of the MASCT device and accompanying test, Wood used a HALO machine, which is much less comfortable for the patient than the MASCT device.

The MASCT device, a screening tool, is quick and effective with a test result turn time of about two weeks, according to Wood. The pathologist’s results combine the ForeCYTE Breast Health Test results with the patient’s family and personal history and use the Gail Model to derive an individual risk assessment for the patient for risk of cancer in a lifetime or the next 10 years, Wood explains. 

“Then they compare that patient’s to the population’s risk at that age. I can say to a patient for example that, ‘Your risk is 20 percent for developing breast cancer in a lifetime while the population’s risk is 8.5 percent, so your risk is much higher.’ From there, we may do more screening, even MRIs, and use other means to find cancer early,” Wood says. 

The reception from Wood’s patients to the MASCT device and test is decidedly positive. 

“It helps prompt the breast health discussion when my patients come in for their annual visit,” says Wood. She performs the procedure and her patients read about the device and test. “If the test comes back reassuring, I reassure them. If it comes back abnormal, I bring them back in and we talk about it. We talk about risk factors and how to minimize the risk of developing breast cancer.” 

Wood appreciates the current device and test and would like to see some advancements when possible such as incorporating more detailed risk models and a better presentation of the pricing model for the pathology results.

“There are more detailed risk models in addition to the Gail Model that could be utilized. The Gail Model doesn’t ask anything about breast density, which is a risk factor. There are more detailed software programs that input more risk factors when they are computing a risk assessment, as well,” Wood says. 

Though the fee for the procedure is small, the pathology and other fees are a little bit unexpected by comparison, says Wood. “We do try to offer patients encouragement to go ahead and get the test,” she says. “I think they [Atossa Genetics] are trying to create a better way to address the fees.”

Buzzy: Blocking the pain of shots

Amy Baxter, M.D., CEOof MMJLabs, LLC, had been a pain researcher for five years when she took her son to get his shots. “I was all ready for it. I had all you could use for decreasing pain, and then the nurse came in and said, ‘That stuff doesn’t work. You’re going to sit there or this is really going to hurt.’ I started to cry,” Baxter says.

After that shot, Baxter’s son would become nauseous every time he had to go to the doctor. 

From there, Baxter experimented with ideas and methods in Gate Control searching for an answer to block injection pain. 

“One night when I was coming back from the night shift, my hands were vibrating on my steering wheel and I realized that they were numb. I thought, ‘If I can overwhelm the transmission of pain via the spinal cord with the transmission of cold and vibration, it will crowd out the pain sensation,’” Baxter says. 

Baxter started with a personal massager and an ice pack. “I actually tried it on my kid’s hands with a Turbo Flex 4000 personal massager and a frozen bag of peas the first time there was a proof of concept,” she says. 

It worked.

The end result was Buzzy, a vibration device with an ice pack enclosed for canceling pain during injections. 

Pip Spandorfer, M.D., a pediatrician at North Atlanta Pediatrics, sees lots of children who need their immunizations. “We use Buzzy as a distraction from the pain,” he says. 

He recalls one particular patient: “When her Mom brought her in for her checkup and she had to get her vaccines, we told her about Buzzy.

She used it and said it was honestly a godsend—the fact that [her daughter] was able to get the vaccines without screaming, without the whole traumatic experience that she has had almost every other time she’s had interactions with doctors.” 

Buzzy not only vibrates but also uses a small gel pack that the doctor stores in a freezer until it is needed. When the cold gel pack is inserted in Buzzy, it enables a two-pronged pain sensation blocker. “It vibrates cold on the arm or leg, wherever you are doing the vaccinations,” says Spandorfer. 

“Now we put the vibrating cold Buzzy device on their body and then also use the distraction cards that come with the device. There is a picture and you say, ‘Find the kitty cat. Find the flag.’ So they are looking for things in the picture as the needle is injected.”