The top 10 medical disruptors of 2019


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The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year.

The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150.

After that, 20 physicians meet and vote the list down to the top 10. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year.

The Cleveland Clinic announced this year’s top 10 list at its Cleveland Clinic Medical Innovation Summit, which took place Oct. 22-24 in Cleveland. From RNA-based therapies to alternative pain therapy to fight the opioid crisis, here are the Cleveland Clinic’s predictions of medical technologies that will prove disruptive in 2019.

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Power morcellation: Questions linger for controversial tech

Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology.

Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, when Dr. Amy Reed, an attending physician at Beth Israel Deaconess Medical Center, underwent a myomectomy using power morcellation at nearby Brigham & Women’s Hospital.

Reed’s fibroids were not benign, but instead a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors. Days after her procedure, Reed’s formerly treatable condition had been upstaged to a deadly cancer.

It turned out that power morcellation, a laparoscopic procedure in which surgeons use the device to mince the tumors, can seed malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. Reed died last year at 44 of complications from her 2013 myomectomy, but not before she and her husband, Dr. Hooman Noorchasm, mounted a successful public health campaign to raise awareness of the risks posed by power morcellation. In 2014 the federal safety watchdog issued a black box warning for power morcellators, prompting Johnson & Johnson to pull its power morcellator from the market.

With the devices gone, a void emerged in the market – women who would have undergone a laparoscopic procedure with a morcellator now faced an open uterine resection. Organizations including the American College of Obstetricians & Gynecologists teamed with the Agency for Healthcare Research & Quality to lobby for the FDA to reconsider its 2014 guidance, arguing that patients need a laparoscopic option for tissue removal.

Meanwhile, some medtech entrepreneurs saw the risks posed by morcellators as an opportunity to create a device that would address the morcellator’s shortcomings. Eximis Surgical, a tiny Colorado-based company, set out to do just that.

Eximis came across Noorchasm’s radar after announcing that it raised $5 million from 33 investors to fund the development of its laparoscopic tissue removal system. He noticed that on their LinkedIn account, Eximis named Reed as the inspiration behind their technology. Noorchasm penned a letter to Eximis executives and published it online, asking them to remove any reference to Reed and, among other things, acknowledge that their technology is simply a resurrected version of a power morcellator.

“What they’re marketing is something that goes directly in opposition to what Amy and myself have been speaking out against,” he told Medical Design & Outsourcing. “It doesn’t matter what words you use, it doesn’t matter if you say morcellate, slice up, dice up, XCor out – if you take a tumor that has malignant potential and you mince it up, you’re exposing that patient to the risk of their cancer being upstaged.”

Get the full story on our sister site Medical Design & Outsourcing.

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The top 10 medical disruptors of 2018


[Image from]

Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor or innovation is that it has to be innovative and could change care in a significant way in the next year.

Approximately 150 to 200 Cleveland Clinic physicians from each of the institutes are interviewed for their suggestions of the top 10 innovations they think will be a disruptor. Venture capitalists and members of the media also get surveyed to consider the top innovation of the next year. From the large list, 300 to 400 suggestions are narrowed down to 150. After that, 20 physicians meet and vote the lists down to the top 10. The results are the Cleveland Clinic’s top 10 medical innovations of 2018.

The top 10 medical innovations of 2018 were announced at this year’s Cleveland Clinic Medical Innovation Summit that took place Oct. 23-25 in Cleveland. From chemotherapy-related hair loss prevention to the closed-loop insulin delivery system, here are the top 10 predicted medical disruptors of 2018.

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U of Miami Health System, Syapse join forces for cancer care

Precision medicine.

The phrase doesn’t fall on unfamiliar ears in the healthcare world. But now it’s getting an extra bit of attention with the launch of a new partnership.

Sylvester Comprehensive Cancer Center, which is part of the University of Miami Health System, and Syapse, a Palo Alto, California-based software company, have teamed up to create a precision medicine initiative specifically focused on cancer care.


Physicians at Sylvester will be able to use Syapse’s platform to give patients more personalized care based on their clinical and molecular information.

“We bring all the data together for the physicians so they can understand what’s going on with the patient,” Jonathan Hirsch, president and founder of Syapse, told MedCity in a phone interview. “We have a decision support framework and a quality improvement framework so we can track the patient’s outcomes.”

With all the buzz surrounding precision medicine, now seemed like a better time than ever to launch the partnership.

Dr. Jonathan Trent, associate director of clinical research at Sylvester and professor of medicine at the University of Miami Miller School of Medicine, expressed a similar sentiment. “Matching a cancer patient with a certain treatment based on the cancer’s molecular profile is among the most promising treatment options in this age of personalized medicine,” he said in a statement.

Hirsch also pointed to a number of trends that are impacting the growth of precision medicine. For one, today’s science and medicine and advanced enough to target treatment more specifically.

Additionally, although the physicians are recognizing the effectiveness of precision medicine technology, they don’t always have the correct training to use it.

Patients are also taking note of precision medicine. “Patients are becoming increasingly aware, especially in cancer, of the different options that are out there,” Hirsch said. “They’re becoming very educated and are going to shop for care.”

A final cause of the momentum stems from a value-based care perspective. “A lot of health systems are looking to gain control over the most complex specialty areas,” Hirsch said. “They’re getting more sophisticated about care that necessitates a precision medicine approach.”

Moving forward, Hirsch said the partnership success will be based on cost containment, patients living longer with a higher quality of life and ensuring all patients are receiving the same level of care regardless of their location.

In early 2016, Syapse raised $25 million in Series C funding. It has partnerships with other organizations such as Intermountain Healthcare and Cancer Treatment Centers of America.

Photo: mathisworks via Getty Images

Researchers created a menstrual cycle on a chip, paving the way for innovative cancer research

Researchers from Northwestern produced EVATAR, a modular system designed to replicate hormone signaling in the human menstrual cycle. Photo: Northwestern University Feinberg School of Medicine

Researchers have been looking for better ways to study human biology. Cells in a dish don’t capture the body’s complexity and generally don’t live that long. Recent advances in 3D organoids often fall short on their own. But now, researchers at Northwestern University Feinberg School of Medicine have developed a modular system that incorporates all the necessary organ types to replicate hormone signaling in the human menstrual cycle.

Called EVATAR (a combo of avatar and Eve), the system’s various modules contribute 3D models of human fallopian tube, uterus, cervix, liver and mouse ovary tissue. Microfluidics transfer a universal medium that acts like blood and carries hormonal and other signals between tissues. This communal approach produces a better model.

“They were sharing all this media and releasing factors that were propagating each other,” said Julie Kim, research professor and co-author on the team’s Nature Communications paper in a phone interview. “They survived better and responded to hormones better – more so than if they were alone in a static environment. These different cultures together in this microfluidic platform are able to survive for a whole menstrual cycle, 28 days, which is a long time for cells to grow in culture.”


The effort pulled in experts on each tissue type – Kim’s lab focused on the uterus. Draper laboratory helped engineer the various connected boxes. Because we don’t take out healthy human ovaries, researchers used mouse ovaries, but even that was a win.

“The mouse estrus cycle is only four days long,” said Kim. “But by putting it in a dish and stimulating with hormones, like FSH and LH, we got 14 days of estrogen and 14 days of progesterone.”

The research led to a lot of firsts, such as new 3D models for uterus and cervix, but it’s the applications that are generating the team’s excitement. EVATAR could enhance their ability to study many conditions, such as fibroids, endometriosis and endometrial cancer.

“If we could study tumors long-term in a microfluidic system, then we could see how tumors respond to progestin and see if we can use these types of platforms as mini clinical trials for compounds that can affect these diseases,” said Kim.

The project was spawned by NIH efforts to create a “body-on-a-chip.” The agency solicited proposals for a variety of tissues – cardiovascular, kidney, bowel – though, according to Kim, reproductive tissue was notably absent. The Northwestern team took that as a source of motivation.

Teresa Woodruff (director of the Women’s Health Research Institute and senior author on the paper) said we need a reproductive tract,” said Kim.

Their work is part of a major push to find better models to study human biology, test drugs for safety and efficacy and ultimately personalize care. Companies like Hµrel, Ascendence Bio and Tissuse have developed organs on chips. Others, like Organovo and BioBots, are creating or enabling 3D tissue printing.

Still, there’s lots more to do. The Northwestern group will be working on a male counterpart to EVATAR and there are other tissues that could improve their female model.

“We have only a couple of cell types in the endometrium,” says Kim. “There are more types that play an important role. If we put in blood vessels, immune cells and other cell types, we could see the tissue differentiate and eventually bleed.”

Will cancer research atrophy under Trump administration?

Chatter at an early morning session on the third day of the  43rd annual meeting in Washington, D.C., was largely focused on the state of healthcare — and the survival, or repeal, of the Affordable Care Act — under the new President Trump administration.

A conversation about the state of healthcare at the Association of Community Cancer Centers’ annual meeting mostly focused on speculation over the Affordable Care Act’s future under the Trump administration. But the discussion shifted to the standing of the Cancer Moonshot Task Force, put in place during the final year of President Obama’s tenure.

Dr. Kavita Patel of the D.C.-based think tank The Brookings Institution and Dan Todd of Todd Strategy, both former Capitol Hill staffers, said any push for increasing the funding for cancer research will most likely come from agency heads, at the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.

“There’s a commitment on Capitol Hill,” Todd said. “But the moonshot folks all went to work with former Vice President Biden. If there’s nobody [in the White House], it’s going to atrophy.”

The task force, helmed by former Vice President Joe Biden whose son, Beau, died of brain cancer in 2015, left D.C. the same day as the rest of the White House staff when President Obama left on Jan. 20. Today, it lives on as the nonprofit Biden Cancer Initiative, and the former vice president said the nonprofit’s work will focus on bringing down the cost of cancer treatments, enabling wider access to clinical trials, and supporting community oncology efforts.

Even before Obama and Biden left the White House, national cancer research received a boost. In December, the 21st Century Cures bill was passed into law. Through the law — the Capitol Hill commitment to which Todd referred — Congress appropriated $1.8 billion in new funding for cancer research.

Whether President Trump’s White House will take up the mantle of moonshot cancer research is an uncertainty. Although former members of the Cancer Moonshot Task Force had spoken with the incoming administration about the research — which includes a conversation between Biden and his successor, Vice President Mike Pence, about continuing the work — the new White House’s proposed budget removes $6 billion in funding from the National Institutes of Health.

“Trump’s [administration] agreed to help continue some of those efforts,” Patel said. “Doing that but releasing a budget where you’re cutting the NIH by billions of dollars does not make sense to me.”

Photo: azerberber, Getty Images

5 healthcare trends impacting cancer care

Lindsay Conway, a managing director of The Advisory Board Company. Photo: Andrew Zaleski

Five big trends will shape the business of cancer care in 2017, according to Lindsay Conway, a managing director of The Advisory Board Company in Washington, D.C. As part of the company’s Research and Insights division, she conducts research for The Advisory Board Company’s Oncology Roundtable on topics such as the effects of healthcare reform on cancer patients and cancer-care providers.

At the annual meeting of the Association of Community Cancer Centers this week, Conway talked about trends impacting cancer care, some of which I’ve highlighted.

Reimbursement and reform are at a turning point.


The healthcare industry is “continuing to grapple with how to deal with cost,” Conway said, something that will “remain true regardless of what happens in Congress.” As healthcare repeal, reform, and replace continues to be debated by D.C.’s lawmakers, the question then becomes: What happens in the interim that will drive high-quality cancer care at a lower cost? Conway said private payers can do their own reform. She added that private payers are increasingly aggressive about pushing cancer patients to lower-priced care. Instead of paying for infusion therapy at the hospital, for instance, private insurera may suggest having it done at an outpatient facility. Still, Conway’s message was cautionary. “Private payers have been on the forefront of designing value-driven ways to pay for cancer care, but we’re not going to arrive at a satisfying payment solution any time soon.”

Enhanced care navigation will be necessary as cancer patient comorbidities increase.

Cancer care programs need to worry about the services cancer patients are using across the healthcare system as they’re going through cancer treatment. As Conway said, roughly 22 percent of Medicaid patients are also dealing with ailments like diabetes, COPD, and heart disease. Citing an example from the University of Alabama at Birmingham (UAB) Health System, Conway said that enhanced navigation services are the answer to an increasingly comorbid population of cancer patients. Over the last decade at UAB, a new approach has taken shape, where care navigators work exclusively with high-risk patients and focus time on activities that might generate cost-savings. (Checking to make sure a patient is taking their medication, for instance.) The results Conway shared were huge. Of the patients in the UAB Health System who received navigation, there was a 58 percent decrease in hospitalizations. That equates to $4,000 in savings per patient to Medicare, or a total of $54 million in savings to Medicare across all patients over a two-year period.

The rise of telehealth in cancer care 

Virtual care, through smartphone app or over the Internet, can reduce costs and increase access. Virtual consultations, Conway said, will increase 60 percent by 2020. They’re gaining traction now for two main reasons: value-based payment, and the ability to quickly and easily do things like monitor patients at home remotely. Conway cited the University of Michigan’s Breast Cancer Ally app as one of the revolutionary models of virtual care currently in use today. Oncologists introduce the app to patients once they receive their diagnosis, and then the patient and oncologist collaborate to enter pertinent information into the app. From there, the app takes over, providing information, for example, about treatment options or instructions on recommended exercises to perform after surgery. As Conway said, the app serves the dual purposes of virtual care: improving patient education and a patient’s ability to make complex decisions about their breast cancer treatment in consultation with their oncology team.

Patients are acting more and more like consumers.

Patients have increasing expectations for service, convenience, and coordination of their care,” Conway said. Learning about providers and treatment options is getting easier thanks to the wealth of information available online. Even for patients who don’t have Internet access, a friend or family member usually steps in to direct and help out with online research. Perhaps most surprising: Online reviews cancer patients read on websites like Zocdoc and Angie’s List are more persuasive than experiences shared by friends or family members. Conway said 69 percent of cancer patients in a recent survey said they’d be inclined to switch care providers if they read a negative review online.

Navigating precision medicine

A variety of key innovations are revolutionizing how oncologists are treating cancer. How much of a dent those innovations, like hormone therapy and next-generation sequencing, are making all depends on how widespread they are. (The former is almost standard practice, whereas next-gen sequencing — capturing genomic information about a cancer — is still being perfected.) But as precision medicine becomes more prevalent, cancer care organizations will need to navigate three challenges, Conway said: how to make sense of new developments in precision medicine; how to prioritize investments in new medical equipment and facilities; and how to operationalize their approaches by making sure key care providers receive ongoing and up-to-date education. “We are all betting big on the promise of precision medicine,” she said.

How to make ultrasound zap tumors in a moving organ

focused ultrasound liver tumors cancer

[Image courtesy of Fraunhofer Institute for Medical Image Computing]

Researchers led by the Fraunhofer Institute for Medical Image Computing think they’ve overcome the challenges standing in the way of using ultrasound to kill cancer tumors in organs that move with breathing.

Until now, health practitioners have mostly limited ultrasound to treating prostate cancer, bone metastases and uterine myoma, according to the Fraunhofer Institute (Bremen, Germany). Organs that move when a patient breathes are trickier, with doctors telling patients to hold their breath or putting the patients under anesthesia.

The Trans-Fusimo project – a Fraunhofer-coordinated effort including 11 research institutions in 7 countries – developed a new ultrasound therapy concept. The patient lies in an MRI producing an image of the liver’s position every 10th of a second while an ultrasound transducer with more than 1,000 small transmitters sits on the stomach. The MRI scanner controls the process, ensuring that the transducer only cooks the tumor cells and not healthy tissue.

Get the full story on our sister site, Medical Design & Outsourcing.

BMS signs new $200M licensing deal for CytomX probodies

Bristol-Myers Squibb (BMS) is back for seconds, dropping $200 million for up to eight more “probody” drug candidates from CytomX Therapeutics.

Announced Monday, the deal also outlines a potential boost of “up to $448 million in future development, regulatory and sales milestone payments for each collaboration target.” In a perfect (probably unrealistic world) that would amount to $3.6 billion.

It builds on a similar agreement announced in 2014, which saw BMS license up to four candidates for an initial $50 million and $1.2 billion in possible royalties.

As the millions add up, would it have more efficient for BMS to acquire the 2008 startup? Based in South San Francisco, California, CytomX had a market capitalization of around $550 million on Monday.

Debanjan Ray, SVP of corporate development and strategy, declined to comment on any past or future M&A proposals in a phone interview. He did, however, highlight the immense scope of the probody platform.

“I think we can create very differentiated molecules with our technology and I think BMS believes that as well,” Ray said. “They’re basically expanding their access to the platform, while CytomX is maintaining our late-stage pipeline, as well as different investigational targets in the preclinical stage.”

Debanjan Ray

Debanjan Ray, SVP at CytomX

The platform focuses on “masked” monoclonal antibodies, which offer a second layer of specificity.

The trick is that the probodies are activated by the tumor microenvironment. Until that activation takes place, the drugs are inert; they can travel innocuously through the bloodstream without affecting healthy tissue.

When they arrive at the site of the tumor, the probodies interact with certain proteases that are dysregulated in that tumor microenvironment. Through that interaction, the ‘mask’ is removed and the underlying antibody is revealed to bind, block or augment target receptors. 

The design gets to the heart of one of oncology’s greatest challenges; finding protein targets that are highly expressed on cancer cells and absent from healthy tissue.

“Our view is that there are lots of great antibody targets out there that aren’t druggable with traditional antibodies because there isn’t sufficient differential expression between healthy tissue and tumor tissue,” Ray said.

The obvious targets are solid tumors that have a well-established tumor microenvironment. The BMS deal, however, also involved two “non-cancer” probody candidates, which have not been publicly named.

It could be autoimmune. Conditions such as rheumatoid arthritis require targeted monoclonal antibody therapies. If the probodies could be programmed to turn on at the site of inflammation in joints, it could reduce the off-target effects.

Seattle Genetics, an antibody-drug conjugate (ADC) company, is applying its technology to systemic lupus erythematosus. That’s notable because of the overlaps between ADCs and the probody drugs.

In fact, CytomX is developing several probody-drug conjugates or PDCs. These would have the same guiding mechanism but carry a more potent payload to be dropped on the cancer cells.

There are a lot of avenues to explore. Thus, it’s probably a good thing that the company, which floated on the NASDAQ in 2015, remains independent.

CytomX shares jumped 33 percent following Monday’s announcement.

Photo: triloks, Getty Images

At the intersection of cancer treatment and technology, it’s more evolution than revolution

For the first time at SXSW, a series of panel discussions in the health track zoomed in on cancer — Connect to End Cancer. The themes that dominated tended to be the role of technology such as telemedicine and data from connected devices, the role of 5G technology and technology’s shortcomings. But concerns over what Trump’s FDA nominee will do with the FDA cast a long shadow over parts of the discussion.

Here were some of the more interesting conversation points across a couple of the panel discussions I attended.

 Telemedicine, telehealth and the impact of 5G


Most people don’t think of cancer treatment and telemedicine intersecting but as Rebecca Kaul, Houston-based MD Anderson Chief Innovation Officer noted, cancer center patients tend to have a varied geographical base. “We think telemedicine is highly important — two-thirds of our patients come from outside of Texas.”

John Donovan, AT&T Chief Strategy Officer and group president for AT&T Technology and Operations, noted that 5G had the potential to improve the quality of virtual interactions between patients and physicians.

5G will improve the quality of technology execution from telemedicine from near real time to real time, he noted. Donovan pointed out that healthcare is one of several industries hindered by slow technology. This advancement could help not only healthcare but other industries as well such as fintech.

Coping with technology shortcomings

Another interesting part was when the discussion tackled some of the shortcomings of technology, particularly when our expectations can’t be matched by the reality on the ground. Greg Simon, director of the Biden Cancer Initiative at the Biden Foundation, defended platforms like IBM Watson by noting that even the Hubble space telescope when initially launched had blurry vision. It took a team of scientists to correct that.  The computer platform is not a panacea because one of the challenges of new technology is that it takes time before it rises to its potential.

“It’s not that surprising that Watson isn’t perfect,” Simon noted. “It is still a student. It reads everything but it doesn’t know everything.”

Aman Bhandari, Merck executive director of data, sciences and partnerships, observed that there is dissonance between what we have the ability to do and what is actually happening in the healthcare delivery system.

“So much great innovation is happening, yet our current health delivery system isn’t working to make those innovations available to everyone,” Bhandari said.

Even immunotherapy, which is a hot area of investment for venture capital and is regarded as a promising new technology, has its own set of shortcomings. The problem with immunotherapy is that it can attack healthy tissue as well as unhealthy tissue.

Big data and interoperability often rise to the surface as obstacles in healthcare and these sessions were no exception. In a lightning round for a panel moderated by Halle Tecco, who founded Rock Health and now teaches a class at Columbia Business School, she asked panelists what’s the biggest challenge they currently face. Bhandari noted data liquidity and Tecco’s husband Jeff Hammerbacher, the cofounder of Cloudera, called attention to the “Tower of Babel” around data.

Every regulation at the FDA has been written in blood

With speculation that President Donald Trump’s nomination to head up the U.S. Food and Drug Administration will champion deregulation, several of the panelists in one session feared what the consequences might be. Simon and Bhandari touched on the evolution of the FDA.

“Every regulation at the FDA has been written in blood,” said Simon solemnly. “You will not hear from the cancer community that the FDA is slow and burdensome.”

Bhandari added, “Every major regulation has happened because of a public health concern.”

Simon expressed the hope that the administration would steer clear of cancer initiatives that have already been launched.

Another panelist expressed the hope that providing better education support to patients about particular clinical trials would help with poor recruitment efforts.

Simon was also frustrated by the way data from clinical trials is not released until one year after the clinical study was finished and hoped that would change.

Advice for startups

Tecco also asked her panel to offer some advice for startups. At some point in the conversation, Bhandari expressed some frustration with startups that make AI and machine learning claims without providing a more nuanced approach to how they are using these tools or even noting the slight differences between the two. Machine learning is one aspect of AI, which is a much broader term.

Simon advised entrepreneurs to “immerse yourself in patients” and focus on their interests and priorities rather than investors, adding:

“Don’t think about investors or the markets — if you immerse yourself in patients, you will figure something out.”

Photo: xrisca30, Getty Images,