What unites the diverse group selected to participate in the inaugural ZeroTo510 medical device accelerator?
In a word, entrepreneurship.
That’s the common thread that binds the founders of the six startups selected for the ZeroTo510 program in Memphis.
Some are experienced health care professionals; some are just starting their careers. Some are full-fledged professors at prestigious universities; some are graduate students and research assistants. Some are Memphians; others live and work elsewhere.
“It’s inspirational how the spirit of entrepreneurship brings them together,” said Allan Daisley, director of innovation and entrepreneurship for Memphis Bioworks Foundation, the organization that houses and administers ZeroTo510.
Created as the first medical device accelerator program in the country, ZeroTo510 aims to create more jobs, boost the local economy and make Memphis a place for entrepreneurs. To participate in ZeroTo510, the startups have to be based here.
“Programs like ZeroTo510 help Memphis recruit, retain and support the kind of people that all communities are competing for — focused, risk-tolerant, and goal-oriented entrepreneurs,” said Kevin Boggs, assistant vice president of technology transfer at the University of Memphis FedEx Institute of Technology.
There are a lot of medical device incubators around the country, but ZeroTo510 is a 12-week program designed to provide startups with the right mentors and training they need to get their medical devices through the U.S. Food and Drug Administration’s 510(k) clearance process.
“The difference is the time period,” Daisley said. “Incubators last for years.”
Under the FDA’s 510(k) program, the new device must be substantially equivalent to one that’s already on the market, but hopefully better.
“You must prove it is as effective and safe as the pre-existing one,” Daisley said. “You could say it’s building a better mousetrap, just in faster time and with less money.”
In collaboration with Seed Hatchery and the Greater Memphis Accelerator Consortium, ZeroTo510 is funded by Innova and MB Venture Partners, bioscience and life science investor firms, giving each company $50,000 in seed capital.
“We’ve noticed a lot of capital for more mature companies from all over the country,” said Gary Stevenson, co-founder of MB Venture Partners. “This is the boldest initiative to provide capital and mentorship for the early stages and concepts of entrepreneurship — the startups have to get their start somewhere. We’re taking an active role.”
The entrepreneurs spend their days at Bioworks attending workshops and forums. The students, engineers and scientists are being taught how to start a business.
At the end of the program, they’ll pitch their products to potential investors, and three finalists will be chosen to receive an additional $100,000 each from Innova and MB Venture Partners.
All program participants will have the opportunity to attend the 10th annual Musculoskeletal New Ventures Conference Oct. 16-17 at The FedEx Institute of Technology at the University of Memphis, with the three finalists presenting their companies.
Stevenson said Memphis already has a rich heritage in the medical device industry, with major firms like Medtronic, Wright Medical and Smith & Nephew.
ZeroTo510 has the potential to add even more jobs in this growing sector.
“To encourage and foster development at the early stage could lead to the future Medtronics,” Stevenson said. “There is a deep and talented pool of engineers in this city; providing them with capital may provide the spark.”
Here’s a look at the six companies hoping to make the cut and qualify for additional funding:
Nanophthalmics is creating novel microscopic tools for ocular surgery. Founders are Edward Chaum and John Simpson.
Ophthalmologists use familiar surgical tools like forceps and scissors, but scaled down for eyes.
But, by using etched glass materials, Nanophthalmics has developed an alternative way to manipulate tissue — one that may offer eye surgeons greater flexibility when handling delicate ocular tissues and treating eye diseases, said Edward Chaum, co-founder, president and chief medical officer.
Ben Tempel is CEO and Dr. Edward Chaum is a co-founder of Nanophthalmics, which is creating microscopic tools for ocular surgery.
“The technology allows us to engage tissue in a novel way, both therapeutically and surgically, that we cannot do today with the tools that we have,” Chaum said.
The etched-glass-technology will be used to treat patients with corneal disease and retinal diseases to remove scar tissue from the eyes.
The material has microscopic spikes, just 80 microns long or 80 one-thousandths of a millimeter, Chaum said.
“It works like a bed of nails — like Velcro,” Chaum said. “With forceps you must pinch, but small tissue cannot be pinched. This engages tissue in a truly novel way.”
Chaum is the Plough Foundation Professor of Retinal Diseases and director of Retina Service at the University of Tennessee Health Science Center Hamilton Eye Institute.
Nanophthalmics is a collaboration between Chaum and Dr. John Simpson, a member of the Engineering Science and Technology Division at Oak Ridge Laboratory.
“We’re taking engineering concepts to clinical medicine,” Chaum said.
Currently awaiting approval from the UTHSC Institutional Review Board, Nanophthalmics has applied for its first clinical trial in patients who have corneal disease.
Nanophthalmics is Chaum’s third startup company. His first two are Hubble Telemedical, which developed technology to provide a 90-second diagnosis of retinal diseases over the Internet using retina cameras, and Infusense, a biosensor company that is working on an automated delivery system of anesthesia to wounded soldiers in the field.
His goal is to do the research and secure grant funding, then “try to spin them out into the commercial space.”
Nanophthalmics has a prototype and is looking for the right partner to fabricate the product, Chaum said.
Randall Surgical is developing an eco-friendly recipe for making disposable foam positioners used in the operating room. Michael R. Randall is the founder.
Surgeons use foam positioners to support patients’ bodies during surgery. The positioners come in a variety of wedges, rolls and rings. There are also head rests and limb cradling positioners.
“Foam positioning products protect patients from getting nerve damage, stiffness and discomfort during surgery,” said Michael R. Randall, president and chief executive officer.
The Centers for Disease Control and Prevention reports approximately 48 million inpatient surgeries are performed in the U.S. each year. Up to seven foam positioners can be used during one inpatient procedure, Randall said.
The problem: Foam positioners aren’t reused and they aren’t biodegradable.
“Petroleum deposits are found in pre-existing products — not environmentally ideal,” Randall said. And when they’re burned as medical waste, they release harmful chemicals.
“It’s like burning plastic,” Randall said.
His alternative: Make the positioners from a soy-based alternative to petroleum. It’s a “secret sauce,” he quips.
Randall recently received his master of business administration degree from Clemson University in a program titled SEED, or Sustainable Entrepreneurship and Economical Development.
“I was working for a health care distributor, I saw the products out there and I thought I could make a difference in that space,” Randall said.
Along with improving the manufacture and disposal of the product, Randall also wants to create a product that is customizable to surgeons’ and patients’ needs.
Restore Medical Solutions
Restore Medical Solutions has developed a steel tray with modular components to help reduce the risk of infection and speed up surgical instrument sorting after surgery. Founders are Ryan Ramkhelawan and Shawn Flynn.
After surgical instruments are used, they’re placed in a metal basket, transported to decontamination where they are washed by machine, then sorted and assembled by hand for sterilization.
At the typical large hospital, this process can take more than an hour-and-a-half and is performed more than 100 times a day.
On average, most major hospitals do roughly 30 to 40 surgeries a day, using two to three surgical cases, each consisting of 60 to 100 surgical instruments.
Ryan Ramkhelawan and Shawn Flynn, two health-care professionals from Atlanta, launched Restore Medical Solutions to develop a process to reduce the number of touch points in the operating room and eliminate the sorting process altogether.
Their invention, Modular Sterilization Tray, allows the surgical staff to presort the instruments as they finish using them in the operating room.
The steel tray is made up of modular sections and locking components for the surgical team to fill with categorized surgical instruments. The lid consists of a locking mechanism, Ramkhelawan said, for ring-type instruments, such as scissors.
“It’s engineered to lower the common touch points, decreasing a risk of infection,” Ramkhelawan said.
The instruments remain in the trays from the operating room to the washer, preparing them for sterilization.
“It helps the surgery departments save time and money while reducing the risk of infection,” Ramkhelawan said.
The method utilizing the Modular Sterilization Tray takes 37 minutes, Ramkhelawan said.
The time saved adds five cases to the surgical schedule each day and creates more than $14 million in additional revenue, he said.
“The biggest asset is the higher efficiency of surgery for hospitals,” Ramkhelawan said.
Restore Medical Solutions plans to stay in Memphis because “it’s a better fit,” Ramkhelawan said.
“In the Memphis medical community everyone knows everyone — it’s easy to get connected,” he said.
HandMinder is creating a rehabilitation device to increase sensory and motor skills in stroke patients. Founders are Yu Liu, Randall J. Nelson and John Denton.
More than 7 million people in the United States today are stroke survivors, and the cost of caring for them is measured in the billions of dollars. The average medical bill for the first 90 days after a stroke is $15,000, according to The University Hospital in Newark, N.J., with 16 percent going toward rehabilitation.
The co-founders of HandMinder, Yu Liu, Randall J. Nelson and John Denton, say they can help shave the cost of rehab with their new invention, which helps stroke patients regain some motor control.
Worn like a glove, the self-contained, battery-operated HandMinder device sends a series of tasks to the hand through vibration patterns along the fingers. Activated by the push of a button, the device can be set to send set-patterns or random sequences.
“The nonpredictable paradigms are an important component of rehabilitation,” Nelson said.
Similar devices exist on the market, but none that combine all the elements of HandMinder’s, Liu added.
“This is a product that patients can use by themselves,” Liu said. “Others are expensive and not convenient — they must pay to go to the doctor’s office to use it. This is affordable and convenient.”
The device is supported by UTHSC through the use of labs, licensing agreements and general encouragement, Liu said. As assistant professor, Liu has reduced his university hours to devote time to developing the product.
An associate vice chancellor for research, Nelson is still teaching full-time, working on the product after hours and on his own time.
Denton, Nelson’s research assistant, is a co-founder and secretary for HandMinder.
UroGuide as a permanent solution to stress urinary incontinence in women. Founders are Runbin Dong, Vidhan Agrawal, Shida Li and Frank Yao.
More than 14 million adult women in the U.S. currently suffer from stress urinary incontinence, with many cases going unreported, according to a report by research firm Frost and Sullivan. Weakened pelvic floor muscles, often a consequence of pregnancy or obesity, compromise support for the bladder and urethra. When that happens, a little abdominal pressure — a simple cough, sneeze or laugh — can be enough to cause urine to leak.
A surgical response to this condition has often relied on the use of transvaginal surgical mesh to support the bladder and urethra. But the safety of the mesh has been challenged — so much so, that one of the major manufacturers, Johnson & Johnson, recently announced plans to stop producing the mesh.
Urova Medical was founded by Runbin Dong, Vidhan Agrawal, Shida Li and Frank Yao on the basis to develop a safer alternative.
The team’s device, the UroGuide, is designed to be implanted in a simple outpatient procedure.
“Our technology is defined and optimized to provide a safer and more convenient solution to treat patients with stress urinary incontinence,” said Dong, co-founder and chief executive officer of Urova. “This device will provide sufficient support for the urethra while minimizing the risks of complications.”
Dong, originally from China, is a 2012 graduate of Duke University with a bachelor’s degree in biomedical engineering, which he describes as a “jack of all trades,” combining the problem-solving skills of an engineer with medicine and biology to improve the healthcare field.
Recent graduates Yao, Urova’s chief technology officer, and Li, chief financial officer, began working on the project while at Johns Hopkins University as biomedical engineering majors.
“If you’re one of the patients who has few options, you’d want this to come about as soon as possible,” he said. “It is embarrassing and expensive. Women do not want to wear adult diapers to work; self-confidence is a huge thing.”
Agrawal, chief operating officer of the startup, is a recent Duke biomedical engineer graduate. Michael Chen, Kelsey Humphries, Adam Xiao, Amanda Ojeda and Logan Howard, all Johns Hopkins students, were involved in the design of UroGuide.
“We feel like we could do something in the market, but we can’t do it alone,” Dong said. “We need a significant investment — we’ll need millions, and being so young we’ll need the human capital of experience.”
BioNanovations is developing a bacterium detection method that uses “bio-nano” particles to reduce the time it takes to determine the type of bacterial infection present in a sample. Founders are Charleson S. Bell and Andre’ T. Stevenson.
There are more than 1.7 million cases of bacterial infection acquired in hospitals each year, costing the health care industry $5.7 billion annually, according to BioNanovations.
Outside the hospital, there are more than 2.9 million cases of flesh-eating bacterial infections that could cause the loss of a limb in a matter of 24 hours.
BioNanovations founders Charleson Bell and Andre’ Stevenson have developed TestQuick, a technology that uses “bio-nano” particles to reduce the time needed to determine the type of bacterial infection present in a sample.
But the process of identifying a bacterial infection can take four to five days.
“They take samples, ship them off and give you a broad band of antibiotics, taking days to pinpoint the infection,” said Charleson S. Bell, a doctoral candidate in biomedical engineering at Vanderbilt.
To speed up the process, Bell co-founded BioNanovations, a company that has developed TestQuick, a method to cut the time to detect flesh-eating bacterial infection to 30 minutes.
“We’re cutting down the time and money,” said Bell, who serves as the company’s chief executive officer. “The goal is to save life and limb. The sooner we can detect the bacteria, the better we can prevent the amputation of limbs.”
TestQuick, is a portable, handheld reader that allows medical staff to insert a body fluid, such as blood or mucus, into a lab cassette that uses bionanotechnology to identify the bacterium.
If the harmful bacterium is present in the sample, the bionanotechnology will react to it, allowing medical staff to diagnose and monitor the infection in real time, Bell said.
“We don’t use bacterium cells to detect the bacteria itself,” Bell said. “That’s the beauty of our technology; we don’t have to come into contact with the bacteria.”
The portability of the device allows doctor’s offices, clinics and emergency medical technicians to detect bacterial infections before patients arrive at a hospital.
Bell is putting his degree on hold to develop BioNanovations. If successful, he expects the company to remain based in Memphis.
“What better community than this?” Bell asked. “The ecosystem and timing are perfect. In running this business there’s more than experiments, it’s about making connections and building relationships.”
Andre’ T. Stevenson, chief technology officer, graduated from Vanderbilt in May with a bachelor’s degree in biomedical engineering. He has spent 21/2 years as a researcher while at Vanderbilt.