Merging medical device accelerator and technology transfer office provides opportunity for more expanded product development at MUSC

Operating room inconveniences often spark ideas for solutions and products that spur innovation and serve as a catalyst for advancements in medical technology. The recently unveiled Zucker Institute for Innovation and Commercialization at MUSC serves as an incubator for such ideas and products and allows care team members to explore their ideas and develop solutions to problems plaguing their ORs. 

The Zucker Institute was founded after two formerly separate entities ­— MUSC’s technology transfer office, known as the MUSC Foundation for Research Development (FRD), and its medical device accelerator the Zucker Institute for Applied Neurosciences (ZIAN) — combined to put all intellectual property-backed technology development from MUSC under one centralized umbrella.

Before merging, FRD and ZIAN had collectively supported over 2,000 innovations and over 500 patents, and they plan to continue that trajectory now that they are more intimately connected. With the revamped Institute going live July 1, the team is excited to help MUSC’s innovators develop products that have the potential for beneficial real-world impact. 

Jesse Goodwin, Ph.D., is the chief innovation officer at MUSC. She says the reorganization is a great way to encourage growth and scale of products. “The new institute will continue to support the endeavors of MUSC’s inventive employees and students,” she said. “It’s dedicated to building a robust portfolio of innovations as MUSC’s way of improving the lives of those we serve.” 

The Zucker Institute supports a diverse portfolio of technology ranging from new drugs to medical devices and healthcare information technology, and the following are a few illustrative examples.

Capitalizing on a closing window

At birth, we’re born with a few crucial skills, one of which includes the ability to suck and swallow. Without it, we’re unable to feed – unable to grip a bottle or to breastfeed. Preterm babies, however, are not always able to feed correctly and can struggle to get proper nutrition. 

Some studies show that between 25 and 45% of normally developing babies and up to 80% of preterm babies have difficulties feeding, which led Dorothea Jenkins, M.D., a professor of neonatology in the department of pediatrics at MUSC Health, to partner with colleague Bashar Badran, Ph.D., an assistant professor in the department of psychiatry, after learning about his research. 

“I had been noticing that babies born with brain injuries have a terrible time with some of the early motor skills they have to master, which include sucking, swallowing and breathing,” Jenkins said. “I heard about Bashar’s work on adult stroke patients and approached him even before he had finished defending his thesis to collaborate.”  

Jenkins points to the neuroplasticity of babies’ brains as the basis for her idea. As they grow, they’re constantly forming synapses and reinforcing them. “In my mind, it’s the perfect translation,” she said. “It’s a strong parallel. It’s just that the infant brain isn’t losing a function it already had, which is the case for adult stroke patients, it’s actually developing a skill for the first time.”

There are few options for teaching these motor skills to infants, and it can often result in weeks in the hospital for the family, according to Badran. And in many cases these young infants need a gastrointestinal tube to eat. “All of that time in the hospital also means these newborns miss out on developmental time at home as well as bonding time with the mother through breastfeeding,” he said. 

But by noninvasively stimulating the longest and most complex cranial nerve, the vagus nerve, Badran and Jenkins have developed a potential solution that is showing every sign of success. Vagus nerve stimulation has been used in the past to treat depression and epilepsy, and researchers have also looked into its promise for treating stroke. A medical technology company in Texas has even developed a device called a microtransponder that is implanted in the neck to simultaneously combine muscle movement with electrical stimulation. 

By using electrodes that rest outside the ear almost like small headphones, physicians can send those same electrical impulses to the vagus nerve, which in turn teaches babies to suck, swallow and breathe.

But all of these solutions require some kind of procedure or surgery. With their device, called BabyStrong, Jenkins and Badran have seen results noninvasively. By using electrodes that rest outside the ear almost like small headphones, they can send those same electrical impulses to the vagus nerve, which in turn teaches babies to suck, swallow and breathe.

After an open label trial to test safety and efficacy, BabyStrong became a startup at MUSC with funding from the Zucker Institute. For their first study, Jenkins and Badran took babies at the hospital who were scheduled for gastrointestinal tubes and offered their BabyStrong device first in an effort to avoid the procedure. 

It proved to be a success. “We were able to get more than 50% of the babies to full feeds within about two weeks,” said Jenkins. “And that’s really remarkable in itself. The fact that it was so well tolerated was just another huge factor in the success of the study.” Parents, nurses and occupational therapists also reacted positively. 

With just two daily treatments per day for two weeks, the team was able to teach critical motor skills to preterm babies and cut down on half of the intended surgeries in their participants. They’ve seen both neuroplastic changes in the brain and improvements in feeding volume. 

In addition to positive results, the research team was also able to determine which babies did not respond to the treatment. More than half of the infants who didn’t find BabyStrong helpful were infants of diabetic mothers, especially mothers with poor glucose control during pregnancy. Jenkins found that the oxidative stress that accompanies gestational diabetes can lead to neuroinflammation. By combining a safe antioxidant to mitigate that stress with the BabyStrong treatment, Jenkins has seen even more success. Combining pharmacology treatments with vagus nerve stimulation could lead to even more enhanced motor learning, and Jenkins will continue to investigate that line of research going forward, but she is very encouraged by the response to the BabyStrong device.

“Not only are there financial implications to the family and the hospital,” Jenkins said of the potential new treatment protocol. “But there’s also an improvement in quality of life and the development of the bond between the mother and baby. And we get to avoid another surgery for these babies.”

“You can easily see why everyone is so excited about this,” she said.

A clear plane

To Stephen Kalhorn, M.D., a neurosurgeon at MUSC Health, the proverb “necessity is the mother of invention” applies to his product VayuClear, but so do frustration, increased risk and wasted time. 

In his time in the operating room, Kalhorn became intimately familiar with the tools needed to suck blood, tissue and other surgical byproducts out of the surgical field – one of which is a suction tube with a plastic or metal tip on the end. 

Using a pressurized saline system and a patented clearing mechanism, the VayuClear device can clear the suction tube in 1 to 3 seconds without breaking the contained loop of body fluids. Credit: VayuClear, Inc.

 

Suction is needed to give surgeons a clear view while operating, but when the current tool clogs upwards of 4 to 5 times per hour, frustration, increased risk and wasted time can build. To unclog the tube, surgery must stop, and members of the surgical team then either replace the tube or flush water through the clogged portion – both of which break the contained loop of body fluids and increase the risk of staff exposure to those fluids. Unclogging the tube can take upwards of 3 minutes to fix. When he multiplied those 5 instances per hour by the many hours needed for brain and spine surgery, Kalhorn was compelled to find a solution.

Between tinkering with his own ideas and receiving funding and patent assistance from the Zucker Institute and Medical Access Partners, Kalhorn brought VayuClear to life. 

Kalhorn says that good tools help with burnout too. “I think if you have easier tools and more efficient ways to take care of patients, everyone on the health care team is happier,” he said. “The team can be more efficient and the procedure more enjoyable as well as safe. It might sound like a small thing, but people are excited about it.” 

David Maness, the CEO of VayuClear, Inc., and founder of Medical Access Partners, helped bring the device to market after Kalhorn’s initial iterations and prototypes. He says the name VayuClear symbolizes smooth movement through the suction tube and comes from Vayu, the Hindu deity of breath and lord of winds. 

Using a pressurized saline system and a patented clearing mechanism, the VayuClear device can clear the suction tube in 1 to 3 seconds without breaking the contained loop of body fluids. 

“It improves patient safety as well as staff safety,” Maness said. “And you really can’t have enough of that.”

With the help of MUSC Zucker Institute’s engineers and business development specialists, Kalhorn was able to build a business plan and raise private capital in the early stages of the product, after which he partnered with Medical Access to bring it to the market. While VayuClear is not available commercially yet, Maness predicts it will officially hit the market by early 2023.

Seeking the perfect seal

The only double-balloon colorectal catheter currently commercially available also comes from a physician with a difficult case. Cephus Simmons, Ph.D., RRA, was a professor in radiology at MUSC when he created the Cephus Catheter in 2013 and is now the founder and CEO of SealCath.

Performing a procedure on a pediatric patient with a bowel obstruction first inspired Simmons to improve on the existing technology. To maintain an adequate amount of force against an obstruction during a colorectal procedure, radiologists need a continuous seal. With the one-balloon catheter the team was using, Simmons said it was easy to break the seal, and every time a seal broke, the team essentially had to start the procedure over. What should have been a 20-minute procedure took 40 minutes, and Simmons knew the solution involved chasing the proper seal. 

Even though double-balloon catheters for other procedures were already on the market, there wasn’t anything available that was designed for the colon. Simmons was able to patent his idea and grow it from there to the medical device company he runs today. 

Cephus Simmons, Ph.D, RRA, holds his colorectal double balloon catheter.

He also points to the challenges of proper diagnosis without the entire picture. “Using the single-balloon catheter gave us suboptimal results,” Simmons said. “We do a lot of procedures in radiology to evaluate a patient’s rectum and colon, but we never really had the right tool before.”

Having a balloon on the outside of the rectum as well as the inside keeps pressure inside the colon and holds the internal balloon in place. That seal also helps patients after colorectal surgery when surgeons check the colon for leaks. In a CT enema for instance, an optimal seal provides the appropriate stretching of the colon to help evaluate for any injury, leaks or other abnormalities. In patients who have had rectal surgery, one balloon can be used to see the anal canal from the outside, which allows radiologist to use contrast and inspect the site of surgery.  Without this safety check using the catheter, patients carry a risk of leakage, and by the time they come back to see their physician, they have often developed an abscess from the damage. 

Aside from supporting radiologists, Simmons says the catheter is designed to support pediatric surgeons, gastroenterologists, internists and family practitioners. While the first application of the product is already in hospitals, the second application will be made of silicone and will be available in late 2022. 

Zeroing in

While osteosarcoma is classified as a rare disease – meaning it affects fewer than 200,000 people in the U.S. under the 1983 Orphan Disease Act – it is still the most common cause of bone cancer in children and adolescents. 

The underlying causes of the tumors that coincide with osteosarcoma are often unknown, so when researchers at MUSC discovered a new target to inhibit tumor growth they were excited about the treatment possibilities. 

Nancy Klauber-Demore, M.D., FACS, a surgical oncologist and the BMW Endowed Chair in Cancer Research at MUSC Health, discovered that a particular protein known as secreted frizzled-related protein plays a role in cancer growth. She then spent the next decade developing medication to target the protein IVT-8086, and she cofounded biotech company InnovaTherapeutics which is located locally in Mt. Pleasant, SC. 

The protein was initially discovered in breast cancer, but Klauber-Demore quickly realized it was important in other tumors as well, including osteosarcoma. 

“This protein’s role in cancer had not previously been known,” said Klauber-Demore. “And what’s so unique about it is its mechanism – it doesn’t just affect one cell pathway, which means the drug can act by inhibiting tumor growth, improving efficacy of immunotherapy and inhibiting blood vessel growth to the tumor.”

By targeting the secreted frizzled-related protein with a monoclonal antibody, treatment can impact the tumor’s immune cells. As lab-created proteins capable of targeting specific areas of the body, monoclonal antibodies are often used in cancer treatment either alone or as carriers for drugs or toxins to deliver them to a cancer cell. The IVT-8086 has shown an additive effect to immunotherapy in pre-clinical osteosarcoma models. 

Immunotherapy stimulates the immune system to fight cancer, and while this new drug is effective on its own, it’s even more effective when combined with immunotherapy. Sometimes monoclonal antibodies cause side effects such as fever, chills, nausea or vomiting, but preclinical trials show this particular monoclonal antibody to be safe and effective with few side effects. 

Klauber-Demore says the drug is very specific for tumor cells in the tumor microenvironment. It’s not intended for normal tissue, which helps with potential side effects. And by helping patients with osteosarcoma, she is offering a potential treatment for a disease that has had no new therapies developed for the past 20 years. Furthermore, with the rare pediatric disease and orphan designation for IVT-8086 from the FDA, InnovaTherapeutics will receive accelerated review by the FDA for approval once they reach the clinical trial phase.

Continuing the innovation

The successful creation of biotech companies like InnovaTherapeutics and medical devices like the Cephus Catheter, BabyStrong and VayuClear points to the importance of the Zucker Institute for fulfilling MUSC’s vision of continuous progress and innovation. 

By funding and assisting in the development of new technology, the Zucker Institute is helping MUSC researchers reach more and more patients with life-changing solutions. They’re able to see something wrong in the operating room and come up with a solution with the potential to affect other surgeons or physicians across the country and even the globe.

The Zucker Institute has brought over $10 million in royalties back to MUSC in addition to helping members of the MUSC Health care team see their ideas come to life. And that will only become easier with the latest merge and consolidation.

Progressnotes Summer 2022