FROM LAB TO GLOBAL MARKET

Volume 2

From Lab To Global Market

Drexel University’s IBreastExam finds market in developing nations to position itself properly in the market

By Michelle Andrews

 

A decade ago, a scientific researcher at Drexel University had an idea: Give clinicians a hand-held tool they could use during a medical exam to quickly and effectively screen women for breast cancer. The device she envisioned would supplement the doctor’s manual breast exam, allowing patients to avoid awkward, often painful mammograms and, importantly, the radiation that goes with them.

 

With financial support from a university-foundation partnership, Wan Y. Shih, a biomedical engineering professor, developed a highly sensitive intelligent sensor called a piezoelectric finger. While breast tissue is generally fatty and soft, a tumor is harder, like a speed bump. Moving over the skin’s surface, Shih’s sensor would detect minute differences in tissue stiffness and softness, called elasticity, that could indicate abnormalities in the breast.

 

But then Shih and her colleagues hit a speed bump of their own. Researching the potential market for the device, they learned that clinicians in the United States weren’t interested in a tool to stand in for mammography, which they considered the gold standard for detecting breast cancer.

 

“That was a teachable moment,” says Robert McGrath, senior associate vice provost and executive director of technology commercialization at Drexel Ventures. “We funded it before we realized what these market challenges would be.”

 

It took more than a year for the team to figure out where the new device could find a robust market. Working with a Philadelphia entrepreneur who licensed Shih’s technology, they decided to market the device in developing countries overseas, where mammography was often less accessible and breast cancer was too often detected at later stages.

 

Mihir Shah, the CEO of UE LifeSciences, which licensed the sensor technology from Drexel, was well placed for the shift in market focus. A Drexel graduate whose company was developing a related medical product, Shah was born in India and has deep ties to the development community and health care system there.

 

The iBreastExam, as the device came to be called, was finally positioned properly. But there were many challenges yet to be addressed.

 

 

Translating laboratory discoveries into commercial products

 

Every university is working to take the cutting-edge discoveries and innovations developed by researchers in its labs and find a broader market for them. While some schools emphasize pure scientific inquiry, at Drexel the focus is on real-world problem-solving, says Keith Orris, senior vice president for corporate relations and economic development.

 

“It’s the DNA of Drexel,” he says. “We are very much a culture that looks for problems and the means of solving them as quickly and efficiently as possible. Through Drexel Ventures, we connect the university’s innovations and innovators to market opportunities that solve society’s greatest problems using our commercialization expertise and early-stage funding programs.”

 

Still, it can be tough to transition from lab bench to viable real-world product. While the federal government provides research and development grants through the National Institutes of Health and other agencies, researchers often need gap funding to get their technology from concept to concrete product.

 

That’s where the Drexel-Coulter Translational Research Partnership Program comes in. Through this program, promising biomedical innovations like Wan Y. Shih’s sensor technology are identified and funded to get them on a fast track toward commercialization.

 

The program has awarded more than $8 million to support the development of more than 50 Drexel projects that improve human health, ranging from diagnostics to drugs to devices, and works closely with Drexel Ventures to successfully commercialize these technologies.

 

In 2011, the Drexel program was endowed with $10 million each from Drexel and the Wallace H. Coulter Foundation to support the translational health care grant program.

 

 

Swimming with sharks

 

To be awarded funding through Drexel-Coulter, promising ideas must survive a rigorous winnowing process.

 

McGrath said that, across the university, there are 110 to 125 discoveries reported every year, about half of them in the life sciences. In any given year, nothing will come of most of them, he says, “because they’re either too early or too risky.”

 

Researchers who want to apply for Coulter funding submit white papers that describe their inventions. An oversight committee reviews them with a number of criteria in mind. It is looking for ideas that address real medical needs, no matter how small, and that have intellectual property behind them that will allow licensing or the creation of a startup. Ideas must have advanced past the proof-of-concept phase, with some evidence that they’re feasible and will perform as promised.

 

The evaluators are a tough crowd. Of the 20 to 30 researchers who submit white papers to the Coulter oversight committee every year, 10 to 12 make it to the next stage.

 

This cadre of researcher-inventors receives training to prepare for “Shark Tank”-like oral presentations in which they pitch their ideas to a panel of investors, entrepreneurs, and medical experts, among others. They must answer hard-nosed questions about their potential market size and competition, regulatory hurdles, and manufacturing challenges to gauge whether their innovations could succeed outside the ivory tower and earn investors a decent return. Those whose ideas pass muster receive grants and help developing them.

 

“No matter how loud we yelled about the virtues of this device, a doctor would say, ‘I want to see it on film.’”

The right stuff

 

Wan Y. Shih’s invention had what the Coulter committee was looking for. Through 2009, it awarded Shih’s piezoelectric finger project total grant funding of roughly $200,000 so she could further develop the technology with her husband and research partner, Wei-Heng Shih, a professor in Drexel’s Materials Science and Engineering Department.

 

At about the same time, the project received $100,000 from the University City Science Center’s translational grant program that aims to accelerate the commercialization of life-enhancing scientific breakthroughs.

 

Shih’s prototype “finger” was a hand-held probe with a line of exquisitely sensitive sensors that measured forces and displacements at the breast tissue’s surface.

These were converted into electrical impulses that could identify tumors and other

solid masses in the breast, even very small ones. The data were transferred to a laptop and processed into a form clinicians could use.

 

No matter how skilled the clinician performing a breast exam, “Human fingers have limitations,” Shih says.

 

“Piezo” comes from the word “press” in Greek, and piezoelectricity is thus energy that is derived from pressure, Shih says.

 

A breast cancer survivor herself, Shih keenly understood that early detection

can save lives. Shih knew that breast density can increase breast cancer risk and make it more difficult to read mammograms. Dense breasts are more common in Asian and younger women. Mammography identifies 85 to 90 percent of breast cancers, but in women with dense breasts the figure is closer to 65 percent, according to Shih.

 

Shih’s device not only would enhance the detection of tumors in dense breasts but would do so without radiation. And unlike mammography, ultrasound, and breast MRIs that require specially trained staff to operate bulky machines, the device

Shih had in mind would be hand-held, easily portable, and require little training

to operate.

 

But as Shih and her team began to flesh out a business model for the probe,

they learned that they’d misjudged their market. Physicians in the United States weren’t interested in an inexpensive alternative to the mammogram.

 

“No matter how loud we yelled about the virtues of this device, a doctor would say, ‘I want to see it on film,’” McGrath remembers.

 

The technology was sound, but where was it going to sell?

 

 

Thinking globally

 

When you encounter a brick wall, sometimes you should just walk away. Instead of trying to convince skeptical doctors in the United States that they needed a device they didn’t want, the inventors trained their sights on the developing world, where they hoped to show clinicians that the device was exactly what they needed.

 

It wasn’t much of a stretch. In many parts of the developing world, mammography is scarce even in the wealthiest sections of bustling cities. Even if it’s available, for many poor women it’s an expense they can’t afford.

 

In addition, there was the biological reality that Asian women often have denser breasts than Western women, making mammograms less effective for this group and potentially leading to a lag in cancer detection even if they can afford an expensive scan.

 

This is why Mihir Shah, who had tested other medical devices in India, proved a valuable resource because of his deep familiarity with the country. Shah, a computer engineer by training, has a passion for translating academic ideas into real-world products. Wan Y. Shih’s technology was spot on, he says, but the prototype was clunky and slow.

 

Because that early device had only a single line of sensors, doing a full breast exam took 20 to 30 minutes, after which someone had to manually input the data to read it.

 

The device also wasn’t scalable. “It was a lab prototype; it wasn’t meant to be a manufacturable device,” Shah says. “Only one person knew how to make it.”

 

He and his UE LifeSciences partner, Matthew Campisi, had their work cut out for them. Before Shah could put all the pieces in place to build the device — demonstrating its effectiveness through clinical studies, making the device commercially reproducible, and obtaining regular approvals for clearance by the Food and Drug Administration — he had a bigger hurdle to overcome: money.

 

Shah had a product but no funding to develop it commercially. Then fortune smiled. Following a head’s-up from McGrath at Drexel Ventures, Shah applied for a grant from the Pennsylvania Department of Health’s Commonwealth Universal Research Enhancement Program (CURE). As luck would have it, that year the program was seeking to fund proposals for innovative technologies in cancer detection.

 

Shah wrote his first grant proposal ever and submitted it 30 minutes before the noon deadline. He must have done a decent job. He was awarded $878,422.

 

“That non-diluted fund saved us from the valley of death,” Shah says, referring to the funding gap that startups often face when they have a product in development but aren’t yet bringing in revenue from it. “I had no way to develop this product without it. We were able to put together a phenomenal team of clinicians and tech people.”

 

Shah also won a $50,000 grant from the University City Science Center that allowed them to do necessary testing so they could apply to the FDA for clearance in 2014.

 

To be cleared by the FDA, medical devices like the iBreastExam go through the agency’s 510(k) process to demonstrate that the device is at least as safe and effective as another device that’s already on the market.

 

Even though the device would be marketed overseas, Shah knew it was critical to get clearance by the FDA. Its strict regulatory requirements would smooth the way in other countries when they applied for approval to sell the device there.

 

 

 

Passage to India

 

Meanwhile, Mihir Shah went to India to move ahead with developing and testing the product. By locating those activities there, he could do the necessary work at far lower cost. Plus, he’d already made connections with hospitals and clinicians in India for an earlier breast cancer detection device, so he had a ready-made network to tap into.

 

Because the primary target population for the device — women in developing countries — was based overseas, that helped drive those decisions as well, McGrath says.

 

Shah learned about the challenges of early detection and treatment of breast cancer in the developing world when his mother-in-law in India was diagnosed with the disease a few months before his marriage. In the United States and other developed countries, five-year survival rates for breast cancer approach 90 percent. In developing countries such as India, where early detection and treatment are less routine, long-term survival rates are lower, sometimes significantly so.

 

In fact, breast cancer is the No. 1 cancer killer among women in developing countries. Whereas breast cancer is often detected in its earliest stages in women who live in developed countries, diagnosis is often made at later stages in women in developing countries. The reasons are many. Women often have less access to routine care and exams in developing countries, and information about breast health may be scarce. A stigma associated with having breast cancer may discourage women from seeking care early. Crucially, women may have little or no access to mammography or other screening tools that could improve early detection.

 

With 16 sensors arrayed in a square on the bottom of the palm-sized, pink-and-white device, it’s reminiscent of the scanners that clerks at some retail stores use to help shoppers check out.

 

Scanning both breasts takes about five minutes and requires minimal training. It can be performed by a community health worker. The device connects via Bluetooth to a tablet that displays a drawing of breasts with a squared grid superimposed on it. Normal breast tissue without any stiffness displays as green on the monitor; quadrants where the device senses stiffness that indicates a solid mass show red. Findings in red would be followed up with a targeted ultrasound to zero in on the type of mass and a biopsy if necessary, Shah says.

 

The results of clinical studies of the iBreastExam are beginning to be published in medical journals. In one study published in the Indian Journal of Gynecologic Oncology, more than 900 women who visited a hospital in Bangalore, India, were each given three screening exams — an iBreastExam, a clinical breast exam by a trained medical provider, and a mammogram or ultrasound. Of 916 participants, 93 had at least one breast lesion. The iBreastExam identified more lesions overall than were found during clinical breast exams but fewer than were seen on mammograms or sonograms. However, the hand-held scanner correctly identified all nine malignant breast lesions.

 

Shah offers several pay-per-use subscription-based models for the iBreastExam. One is like a prepaid phone; clinicians load several scans on the device and can reload as they wish. Or they can buy the device outright and replace the sensor cartridge every 2,000 scans. That model is the most cost effective, with a per-scan cost of $1.

 

Since the iBreastExam’s introduction in India in 2015, the device has been used to screen 75,000 women for breast cancer. But that’s just the start. Shah says that 190 million women in India could benefit from regular breast health checks.

 

The company has raised $4.2 million in private equity funding that has allowed it to expand clinical trials in India and ramp up its distribution networks of public and private health care providers.

 

They’re beginning to expand beyond India. In recent months, they began doing iBreastExam scans in Myanmar and then planned to launch in Mexico.

 

As the device has begun to find its place in the developing world, UE LifeSciences has grown with it. The company employs more than 50 people in five offices worldwide, including its Philadelphia headquarters.

 

“I knew it was a disruptive technology,” Shah says. Still, no one anticipated the literal and figurative journey the device would take. “There is a long arc from development of idea to having a tool to put into the hands of someone.”

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The fight for breast cancer survival in low-income countries

 

When actress Julia Louis-Dreyfus publicly revealed she had breast cancer, she noted that not all women are “so lucky” to have the support and “fantastic insurance” she has. This is true in the United States, where breast cancer is the second-leading cause of cancer death in women. Louis-Dreyfus’ statement is especially true for women in developing countries, where the chances of surviving breast cancer are much lower.

 

According to the American Cancer Society, one in 37 women in the United States loses her battle.

 

This number is higher in developing countries. For instance, more breast cancer cases are diagnosed in high-poverty countries (53 percent), according to World Cancer Research Fund International. Studies show the highest proportions of five-year breast cancer survivors are in North America and Europe, with the lowest incidences in Africa and Asia. Women in developing  countries have a 40 percent breast cancer survival rate. North America sees double that rate.

 

In the United States, extensive resources and technological advances allow scientists to predict the development of tumors

and hinder their progression, thus increasing chances of survival.

 

In developing countries, however, this is not always the case.

In Myanmar, nearly half of breast cancer diagnoses are fatal, which can be attributed to the lack of health care infrastructure. Resources and expertise needed for diagnosing and treating breast cancer are unavailable and result in high breast cancer mortality rates.

 

Ultimately, a woman’s survival is largely determined by socioeconomic status, ethnicity, and location. To see a breast cancer mortality turnaround, low- to lower-middle-income economies must acquire the proper tools and expertise to diagnose and treat this unforgiving disease. iBreastExam is an example of Drexel Ventures’ commitment to commercializing the university’s innovations to solve one of the world’s greatest problems.

 

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