App lets child heart patients recover at home—while being monitored at a distance
hirty to 40 years ago, children born with single ventricle heart defects in which the heart only has one of two functioning chambers usually died, according to UVA Health System pediatric cardiologist Dr. Jeff Vergales. In the last 20 years, mortality rates have gone down due to surgical advances, but a large proportion—10 to 15 percent—of patients would leave the hospital and die suddenly at home. Over the last decade, doctors learned that children give warning signs—a steady drop in their oxygen level or an inability to gain weight—and the home-monitoring system was born: Babies and their parents were sent home with equipment such as an oxygen meter and scale, and told to write down everything (a baby’s weight, feeding times, etc.) every day.
With the introduction of the home-monitoring system, the national mortality rate dropped to 4 percent, which was good—but not perfect. The problem, Vergales says, was how the data was being collected, and when he took over the single ventricle heart program at UVA five years ago, he noted flaws in the system: As the main surgical center in the state, the hospital treats patients up to six hours away, and although parents noted their baby’s vital signs and health data in a binder, when they called every couple of days to report the information, doctors were receiving news they should have responded to days earlier.
Two and a half years ago Vergales and close friend and former pediatric ICU nurse Lindsey Koshansky were having drinks on the Downtown Mall and talking about why doctors weren’t receiving patient’s data quicker. Koshansky, who had left UVA to work at Locus Health in 2013, mentioned that the local health care technology company had launched an at-home monitoring program for adults so hospital staff could keep a close eye on patients, and make sure they weren’t readmitted to the hospital. The pair thought why not create a similar program for pediatric patients, and they spent the next eight months building the software platform. But in stark contrast to normal consumer products, they started with the clinician—not with the customer—in mind: The most important thing was how data input by parents would sync directly with a child’s electronic medical records at the hospital.
For the last couple of years, parents of babies with congenital heart disorders have been sent home from the UVA hospital with an iPad loaded with the Building HOPE app. As the parent records a baby’s stats into the app, not only are his electronic records automatically updated, but health care providers can see graphs that chart trends the child’s health. Predictive algorithms also help doctors target children who are becoming at-risk for a certain complication before the situation is dire.
WAVE OF THE FUTURE
The Building Hope app allows HIPAA-compliant video conferences so that a health care provider can see a patient in real time. Cardiologists at UVA might have patients as far as six hours away, and they are able to watch a patient’s breathing, for instance, and determine if he needs to go to the ER.
In the future, Dr. Jeff Vergales predicts the app itself will no longer be necessary when Bluetooth-enabled devices, such as scales, could monitor a patient’s weight and record it directly in his electronic medical records.
Chelle Adewale-Yusuf and her husband, Isah Yusuf, both say the Building Hope app helped ease their minds as they cared for their son, Prince, after his heart surgery.
Chelle Adewale-Yusuf and her husband, Isah Yusuf, found out when they went to their gender-reveal sonogram that their son, Amir “Prince,” had tricuspid atresia, in which the blood can’t flow from the top right chamber of the heart to the bottom. Prince had surgery on June 5, 2017, four days after he was born, to put a shunt in the right side of his heart. Adewale-Yusuf, a labor and delivery nurse at UVA, says she was grateful that the family could use the Building HOPE app during the first five months of Prince’s life because it lessened the stress of caring for a sick baby.
Prince took Lasix (a diuretic) to help reduce fluids, and by tracking his weight daily and interacting with the app, his parents were able to reduce the drug at the correct times. Adewale-Yusuf says it was a relief to note every feeding, bowel movement and comment or question she had in the system, so that when she called her son’s health care providers everything they needed to know was in front of them. The family returned the iPad and the at-home monitoring equipment when Prince had a second surgery November 1 to remove the shunt and use his own tissue to create a pathway in his heart for the blood to flow.
Adewale-Yusuf says she misses the app at her son’s appointments now, when questions such as how often and how much he is eating isn’t available at the touch of a button.
Koshansky, the client account director at Locus, says the app has gone through several versions since its creation, and that new features are continually being added for both clients and physicians.
“It’s a no-brainer that children especially do well in the comfort of their own home with their parents, receiving that nurture and support, which lowers risk of infections,” she says.
Since launching two years ago, the app has been used to monitor about 60 to 70 single ventricle patients at UVA, and five children’s hospitals around the country have started using the app as well, with about five other contracts in the works.
Vergales says the great thing about the software is that it’s patient agnostic, meaning it was designed to measure any variable needed. It’s also being used for pediatric hematology/oncology and organ transplant patients at UVA, and in the next couple of weeks, the program will roll out with NICU patients.
“We pride ourselves so much as pediatricians in really feeling like we can become a part of the patient’s family, and there’s no bigger honor for me than to be entrusted with the care of their child, with the health and wellbeing of their child,” says Vergales. “For me to find a way to engage the parent in the health of the child and to feel like we are truly doing this as a team is without a doubt one of the reasons I get up and go to work in the morning.”
Artificial pancreas technology allows children with Type 1 diabetes to live ‘normal’ lives
As Joshua Davis scales a rock climbing wall or leaps off a large boulder with his mouth wide open in a huge grin, the 8-year-old looks like any other summer camper his age. But this is no ordinary camp–it’s a clinical trial for children ages 5 to 8 who have Type 1 diabetes to assess the effectiveness of artificial pancreas technology.
Joshua’s mother, Shannon, says her son didn’t show any diabetes’ warning signs—until it was almost too late. When he was 11 months old, Joshua had been sick on and off for a couple of months but nobody could figure out what was wrong. He had started losing weight, but he had begun walking two months prior. He was wetting his diaper frequently, but they thought he just needed a bigger size. He was hungry and thirsty all the time, but he was a growing baby. Shannon says every symptom seemed like a normal sign of growing up. But the night before Shannon was scheduled to leave town for the weekend, Joshua did something he’d never done before: He fell out of his crib.
After the fall, Joshua didn’t show any signs of concussion, so doctors said he didn’t need to come in, but his dad, Brian, monitored him overnight. The next morning, Joshua threw up, and Brian rushed him to the emergency room in Norfolk. At first, Joshua, who was lethargic and so dehydrated blood couldn’t be drawn, was diagnosed with the flu, but Brian kept insisting something else was wrong. Another doctor came in to see Joshua, and immediately noticed a fruity smell on his breath, a sign of diabetic ketoacidosis, and a vascular team was brought in to draw blood. When Joshua’s blood sugar level was tested it was 1,230–a normal range is 80 to 120. Joshua’s system was shutting down, and if he had gone home he likely would not have survived another three hours. Joshua spent several days in the pediatric ICU getting his levels back to normal, and his parents received strict instructions on how to monitor his glucose levels and deliver insulin. Doctors told Shannon even the smallest miscalculation of an insulin dosage can be lethal.
10 percent of the U.S. population (30 million people) has diabetes. Of those, 10 percent have Type 1 (about 3.5 million people).
Today, Joshua wears an Omnipod insulin pump, and he has to have his blood sugar tested every three hours to see if it’s too high (his body needs insulin) or too low (he needs to eat carbohydrates). On school days when he has P.E., it’s almost a given that Joshua won’t be able to go to recess because his insulin levels will be too low. Hypoglycemia can cause seizures or even death.
Even with his diagnosis, Shannon says her son is an active kid who plays basketball and soccer, and is in Cub Scouts and on the honor roll. But the fear remains that his blood sugar might go too high or too low at any time and cause potentially life-threatening health problems. The good news: Shannon says they found a “life-changing” device. The bad news: It’s not on the market yet.
Through Joshua’s pediatrician, the Davis family was connected with the UVA Center for Diabetes Technology’s clinical trial in May 2016 to test its artificial pancreas in young children.
The device uses smart phone technology that is connected to an insulin pump and glucose monitor. The diabetes assistant software connects the pump with the monitor, which is a small probe under the skin that reads a body’s glucose level every five minutes. The software on the phone tells the pump exactly how much insulin to give Joshua based on the glucose level, thus the name artificial pancreas. The software was initially developed at UVA’s Center for Diabetes Technology about a decade ago, and it has undergone clinical trials with adults and children since. (Brian Davis, who was diagnosed with Type 1 diabetes at age 26, has participated in two of them, and says being able to trust the technology has allowed him to “live life the way I want to.”)
During Joshua’s trial, the children spent three days at the Wintergreen camp, participating in physical activities while wearing the artificial pancreas. They were then monitored using their regular systems for another three days at home. Shannon says she and Joshua both cried when they had to give the artificial pancreas back—there were no interruptions to Joshua’s day, and the family could sleep through the night without needing to test his blood sugar. Even better, Joshua’s blood glucose levels were steady—no peaks and valleys—with only one slightly low reading of 70 the entire weekend.
“They say Type 1 is a science, because it falls under the sciences, but it’s really an art form because every beat of their heart is a different stroke,” Shannon says. “When you think about a painting or a piece of music, it’s constantly changing. You can do the same things today that you do tomorrow and it’s a completely different day.”
Dr. Daniel Chernavvsky, a UVA Diabetes Center for Technology researcher and chief medical officer at TypeZero, a digital health and medicine company formed by doctors at the center to help make the technology commercially available, says the clinical trials for younger patients are important because steady blood glucose levels throughout their lives help them avoid long-term complications such as heart disease. He stresses this is not a cure—although he says he has colleagues at UVA working on that—but it’s a way to make patients’ lives easier.
“The idea is first of all to avoid severe complications, mainly hypoglycemia in young children, and I hope we will save lives,” he says. “This system allows parents to have a good night’s sleep and kids to have a safe and good night’s sleep—that, for me, is a big achievement…to give people their life back.”
The UVA Center for Diabetes Technology’s smartphone-based automated insulin delivery system, the DiAs (Diabetes Assistant), has been used by 425 subjects in clinical trials for a cumulative operation time of more than 18 years.
Tandem Pump, an insulin pump company, just ran the first pilot trial and is doing clinical trials with the artificial pancreas technology licensed from TypeZero in order to collect documentation to get the artificial pancreas FDA approved and on the market.
Breaking out: UVA researchers zero in on ebola “cure”
Ebola. The flu. The common cold. None of them have cures, or even adequate prevention drugs because they evolve and splay into thousands—possibly millions—of varying strains each year. “One therapeutic that fights one strain, or variation, of the virus will not fight the other variations,” says Dr. Judith White, a UVA researcher.
White and Dr. Lukas Tamm have dedicated their academic and professional lives to researching designs for preventative drugs. Both lead separate labs at UVA Health System.
Tamm was fascinated by molecular structures and the shapes of viruses when he was a student. That fascination developed into a critical need to observe and study these varying shapes, and how their structures could be the key to determining how they react to certain drugs.
“My very first project was working on studying the structure of flu and understanding it more,” says Tamm. Many researchers jump ahead, eager to be a hero and deliver a cure-all vaccine, he says. “It’s important to start at a basic level. We need to look at changes in the structure and how it moves before we can treat it.”
White’s research is focused on practical solutions or prophylactics for fighting neglected tropical diseases and viral infections in remote areas of the world. She is frustrated with labs and clinics that focus on creating “fancy therapeutics” that contain antibodies that will only fight one specific strain.
Since the 2014 Ebola outbreak, 11,315 people from six countries have died from the disease.
Beyond the improbability of being able to keep up and create specific vaccines or pills to combat each strain, White says it’s “incredibly expensive and time-consuming to develop a new ‘designer drug,’” so they repurpose existing drugs. At the moment, her data suggest people could take two or three already available drugs that would work synergistically to prevent viruses like Ebola.
White’s research is done independently, and she uses a surrogate laboratory system, which means the live Ebola virus is not housed at UVA. They use pseudo viruses that mimic the effects, and allow them to safely observe reactions to drugs without the risk of exposure to Ebola.
“During the outbreak of Ebola in 2014 [in West Africa], a lot of unethical decisions were made by other organizations,” says Tamm. “People were in a hurry. You can’t test fast on animals, much less humans,” he says.
The work of both researchers depends greatly on grants they receive and their partnership with the National Institute of Allergy and Infectious Diseases in Frederick, Maryland. (Tamm’s lab just secured a new four-to-five-year grant from the NIAID.) “They are integral to our research, and help conduct clinical trials that we cannot perform here,” White says. In the next few years, they hope to proceed with animal trials, and then human trials. They believe a preventative drug for Ebola could be introduced within the next decade.
“This solution isn’t lightyears away, but we do have to be patient,” Tamm says.
UVA Health System
What’s the latest: Earlier this month, UVA Health System held a topping-off ceremony for its expansion of the University of Virginia Medical Center, which will increase UVA’s emergency department from 43 beds to approximately 80 beds. A six-story tower is being constructed on top of the expanded emergency department on West Main Street; three floors will accommodate the conversion of semi-private rooms to private rooms, and the top three floors are earmarked as future space. A helipad will grace the top of the tower.
Completion date: New section of emergency department to open in summer/fall 2019; total project complete in 2021
Cost: $394 million
Fiscal year 2017
29,046 inpatients admitted
62,759 visits to the Emergency Department
883,251 visits to outpatient clinics
850 doctors on the clinical staff
23 U.S. patents issued
5 new startups
No. 1 hospital in Virginia according to U.S. News rankings
2017-18 Best Doctors in America list
195 UVA physicians
2017-18 Best Children’s Hospitals list
No. 30 Neonatology
No. 34 Diabetes and Endocrinology
No. 41 (tie) Orthopedics
No. 44 Cardiology and heart surgery
2017-2018 Best Hospitals (adults) list
No. 30 Cancer
No. 32 Ear, nose and throat
No. 35 Urology
No. 44 Diabetes and endocrinology
No. 50 Cardiology and heart surgery
High-performing departments (top 10 percent among their specialty nationally)
Gastroenterology and GI surgery
Neurology and neurosurgery
Sentara Martha Jefferson Hospital
What’s the latest: On January 2, the hospital held a ribbon-cutting for its new Sentara Sports Medicine Center located at its Outpatient Care Center at Pantops. The sports medicine physicians at the center have worked with athletes from novice to Olympians, and will provide a variety of techniques in treating injuries, including an advanced technique called platelet-rich plasma therapy, in which a patient’s blood is taken and doctors isolate and concentrate their platelets and inject them back into the injured area to aid in treatment.
52,523 emergency rooms visits
475 medical staff members
1,687 total employees
13 primary care practices
8 specialty care clinics (covering 26+ specialties)
Top five areas of care
1. General hospital medicine
2. Obstetrics and women’s health
Rare tumors lead to the creation of a community healing network
iffany Black stood behind the starting line at the Running for Answers 5K, huddled with 40 friends and family members all dressed in matching white shirts with black sleeves and penguin hats. Normally, only Black and her mom attended the annual September race in Philadelphia that raises money for the Desmoid Tumor Research Foundation. But 2014 was different: Black’s brother, Spencer (who loved penguins), had died that year at the age of 30 of complications from familial adenomatous polyposis, a rare disease.
It wasn’t until her brother passed away, though, that Black truly understood that the incurable disease (she, her brother and father were all diagnosed with the hereditary form that causes tumors and polyps to grow in the intestines) could have life-threatening effects for her as well. That year, bolstered by a strong support system, Black began to network with more people who were also survivors of desmoid tumors, including Sera Snyder, founder of the 5K, which has raised $2.5 million since 2010.
Black was first diagnosed with the condition at age 16, and at 22 she had to have her colon removed (fortunately, doctors were able to perform the procedure without an ostomy). But nine months after that surgery, a desmoid tumor—soft tissue tumors that are considered non-cancerous because they don’t spread to other parts of the body—formed at the incision area. At that time (1995), Black says her doctor could only find two medical articles written about these tumors—and one was in French. He put her on estrogen blockers and anti-inflammatories and hoped for the best. When Black eventually underwent surgery to have a large tumor removed from her abdomen, three more formed in its place (an effect of the hereditary condition).
900 people a year in the U.S. are diagnosed with desmoid tumors. The tumors are slightly more prevalent in women than men, with a ratio of 2:1. The age range of patients is 15 to 60, with an average of 30 to 40.
Today, she’s decided to live with the tumors, which are not getting bigger, although one has partially blocked one of her kidneys. The 47-year-old says the tumors make her look pregnant, and she went through a long period when the emotional stress of living with an incurable disease responsible for several health problems caused her to be caught in a depressive cycle. She wasn’t eating properly or taking care of herself—and that’s when she found Healing U.
In April of last year, Snyder, a Charlottesville resident, held Healing U’s first retreat for 12 women who are all survivors of desmoid tumors. The women came to Madison’s Sevenoaks Retreat Center from New York, New Jersey and Seattle (Black had just a one-hour drive from Warrenton, but says she would have driven 500 miles), to attend the weekend of healing that included sharing their stories with one another and seminars with a nutritionist and functional medicine doctor, as well as restorative yoga and meditation sessions. Both Black and Snyder say the best part of the weekend was the camaraderie among the women, and that sharing went beyond medical tribulations to how their relationships with their families and partners had been affected by the disease. Each woman was paired with a buddy, and Black says she keeps in close contact with several of the women she met that weekend. Today, Black exercises regularly, eats well and says she’s going to remain “positive and happy and as stress free as I can be” while hoping for a cure.
“I just believe we heal in community,” Snyder says. “I believe that when we come together we give someone else the opportunity to say me too. I’ve experienced that too, we heal in a new way that we can’t heal individually.”
The nexus of Healing U formed after Snyder’s own harrowing battle 10 years ago with a desmoid tumor, which she refers to as a cancer (the aggressive fibromatosis is treated in the same way a cancerous fibrosarcoma would be, with treatment options including chemotherapy, radiation and surgery). Snyder’s doctor in Philadelphia had only seen two other patients with this type of tumor, and Snyder, then 26, says she knew in her gut (her pun for her medical journey) he was leading her to make a rushed surgical decision. After the tumor was removed, she continued to have chronic pain and had to give up running, her favorite activity. Snyder spent the next four years struggling with depression and pain and working through the isolating emotional aspect of dealing with a rare disease. Although her oncologist told her she was in remission, she knew she had more healing to do, so she assembled her own team: a therapist, nutritionist and functional medicine doctor (someone who treats the root causes of problems and not just symptoms), among others. As Snyder became healthier (she changed her diet and way of thinking), she says she also found confidence in making medical decisions for herself. Four years after her first surgery in 2009, a Dallas specialist performed a complete abdominal reconstruction, and he told her that her instincts that something was wrong were correct. This time, Snyder says her healing process was much smoother, because she had a strong team helping her—and she was in a better mental state.
Since her surgeries, Snyder has switched careers from finance to health care consulting for integrative health and functional medicine physicians, whom she helps to navigate the health care system and bring this type of care to patients who need it. Snyder’s Healing U, which includes an online support system for women with desmoid tumors and cancer around the world, and the annual April retreat, is an offshoot of her consulting work—she says there’s a lack of support in the health care system for cancer survivors after they’re in remission, and she hopes to help facilitate more resources for local women.
“Ultimately, my dream is to create a clinic where we can be focused on cancer survivorship and have that community where we can also talk about chronic disease, not just cancer,” Snyder says. “Half the battle is knowing you’re not alone.”
Local lens: Meet four health companies making headlines for groundbreaking work
Hunting for the ‘holy grail’
Kevin Eisenfrats graduated from University of Virginia in 2015 with the goal to be the first person to create a reliable, reversible and “easy” male contraceptive. You’ve seen the headlines: Labs and clinics around the world claim to have a vaccine or pill in the works. The fact is, there are only two or three for-profit organizations working on the technology—it’s a slow process, and most pharmaceutical companies are looking for groundbreaking advancements in cancer or genetics research. Eisenfrats’ company, Contraline, has raised about $3 million to date, and is leading the way in developing biotechnology centered on a hydrogel-based male contraceptive, which Eisenfrats calls the “holy grail” in health care.
Hydrogel is nontoxic and nonhormonal, and would be injected directly into a man’s vas deferens tubes, where it would block the sperm from traveling through. The procedure would be quick and nearly pain-free. Because a vasectomy is often permanent, more than 75 percent of couples rely on female contraceptives. And unlike with a vasectomy, which cuts the tubes, the hydrogel can be reversed. Like an IUD implant, Eisenfrats says they hope to offer different expiration options.
With the help of his mentor, Dr. John Herr, Eisenfrats made connections, found investors and collaborated with a handful of other professors at UVA. The company also recruited top-notch scientists and executives from all over the world to live and work here, and partner with them.
Kevin Eisenfrats was named a 30 under 30 in health care in 2018 by Forbes magazine
This year, Contraline hopes to start testing on small animals in clinical trials, and then conduct human trials in 2019, with the hope of the product being on the market by 2022.
Eisenfrats is tight-lipped on distribution plans, but prides himself on how hands-on his team is and how local the lab is. “[Most] biotech companies are outsourcing their R&D, whereas we do at least 95 percent of everything in-house,” says Eisenfrats.
1855—The invention of rubber condoms
1897—First vasectomy performed in humans
1960—The birth control pill approved by the FDA
1968—The first IUD approved by the FDA
1993—The female condom approved by the FDA
1999—Plan B approved by the FDA
*Information courtesy Contraline
Focused Ultrasound Foundation makes waves
“A focused ultrasound is the most powerful sound you will never hear, but it’s the sound that could someday save your life,” says Dr. Neal Kassell, founder of Focused Ultrasound Foundation. Focused ultrasound is an early stage, non-invasive therapeutic technology that could serve as an alternative or supplement to traditional surgery for cancer treatment (based in radiation and chemotherapy), and “improve the lives of millions of people who suffer from serious medical disorders around the world,” he says.
The technology has received FDA approval to treat essential tremor patients (such as Parkinson’s disease), and could be used to treat myriad other diseases, from hypertension and Alzheimer’s disease to neuropathic pain to fibrosis. The device uses multiple beams of light to focus on the center of the disease or damaged tissue, treating the heart of problem.
But the dream-like-sounding technology has met many blockades. Kassell describes the current market as a glacial process: “The evolution of taking an idea and seeing widespread adoption as a standard of care takes decades.” He sees each day without utilizing this therapy as a day wasted; leading to “unnecessary death and disability for countless people.”
Founded in 2006, the Focused Ultrasound Foundation has connected more than 550 providers with the technology via educational programs, initiatives, interactions and speaking opportunities.
The Focused Ultrasound Foundation is now holding clinical trials to help treat animal patients. The first program takes place early this year at the Virginia-Maryland College of Veterinary Medicine at Virginia Tech in Blacksburg and will use the ultrasound technology to treat soft-tissue tumors, such as sarcomas, in dogs.
The company has major national and international clients (from China, Britain, Germany, Cypress and Israel, to name a few), backing it, and its clients help “do the busy work” by assisting manufacturers in getting reimbursements for filing and contracts, and continually working to get the clients’ technology FDA approval for treating diseases.
One of the biggest validations the foundation has received, Kassell says, is being featured at the largest consumer electronics conference in the world, the 2018 Consumer Electronics Show in Las Vegas.
“As UVA’s co-chairman of surgery for years, I made outstanding connections with what is now a spectacular team of 25 of superstars MDs and Ph.D.s,” Kassell says. “Charlottesville is a very good place for a position like the one we’re in. We are happy to be here, and will stay here.”
Forging a healthy relationship with food
AgroSpheres CEO Reese Blackwell says the biotechnology company aims to “develop novel nanotechnologies [to set] a clean standard for crop protection.” But what the heck does that mean?
Consumers have been paying closer attention to nutrition labels, with many opting to skip products containing genetically modified organisms. Farms and companies around the world have both relied on and experimented with GMOs (altering a plant’s DNA for added benefits) since the 1970s, with blowback first being recognized widely in the 2000s. Although there is no documentation of GMOs causing health problems in humans, farmers have noticed pesticide resistance, and negative effects on their land and in runoff after extended use.
AgroSpheres, made up entirely of UVA graduates, was recently named Student Startup of the Year by the Charlottesville Business Innovation Council.
This is where AgroSpheres comes in. The company has recently seen “a breakthrough in genetic engineering [that has] created a solution to deliver crop protectants in a safe and scalable manner,” says Blackwell. Using their bioparticles, farmers won’t have to “worry about runoff, premature degradation or volatilization.”
Currently, AgroSpheres is working to fully develop an encapsulated pesticide product. They are in the early stages, but close to having a biocontrol product. “We are testing and continuing to focus on the increase of product efficacy,” says Blackwell. Their intent is to decrease the reliance on synthetic chemicals.
As they started researching and developing their technology, AgroSpheres “forged relationships with many of the local farms. Those relationships have helped us greatly,” says Blackwell. They were especially critical in the earlier field trials.
“We are greatly tied to the region through our education and farming relationships,” says Blackwell.
Homegrown drug improves cancer treatments
Diffusion Pharmaceuticals is a locally founded publicly traded lab tech company that is developing drugs that improve cancer treatments and susceptibility of the treatments. During his time at UVA, John Gainer, Ph.D., invented the novel concept of introducing drugs to enhance cancer treatments that work in tandem with a physician’s plan for his patients.
The company’s leading drug is Trans Sodium Crocetinate, which, as CEO David Kalergis explains, would help patients fight their diseases better, with a better chance at survival. TSC encourages an increase in the amount of oxygen delivered to the tumor or affected areas in the body.
“Doctors often see their cancer patients have a deficiency in oxygen, or the needed plasma in their blood, which results in hypoxia,” says Kalergis. Hypoxia can cause the death of tissue due to deprivation of oxygen and nutrients for an extended period of time, which exasperates the cancer symptoms and makes it more difficult for patients to fight the disease. Cancer patients with hypoxia are three times more resistant to their chemotherapy or radiation treatments, Kalergis says.
The drug is non-invasive, and helps patients with inoperable cancers, particularly those with glioblastoma—the brain cancer Senator John McCain has.
In animal clinical trials, researchers compared the injected subjects to those that continued treatments sans TSC.
“Those that received the vaccine, had 40 percent—a four-fold increase—chance at survival,” Kalergis says.
Diffusion will begin trials on human cancer patients this year, and will wait up to three and a half years for the completion of all patients’ treatment plans and document their life post-cancer, before determining if the drug is ready for FDA approval.
TSC wouldn’t be reserved just for cancer patients, though. “It could save someone’s life after they have a stroke or heart attack,” Kalergis says. “We foresee this drug being a standard in ambulances down the road. You have a stroke, you call 911, and a paramedic administers the shot on the way to the hospital.”