MEDCITY Reports1December 2013

This report sponsored by

Monthly Startups Index

December 2013

MEDCITY Reports2October 2013

Table of Contents

MAIN CONTACT INFORMATIONMedCity MediaP.O. Box 606246Cleveland, OH 44106Phone: (216) 453-2662General inquiries: info@medcitynews.com

From the Editor 312

Most Popular Startups This Month 405

Digital & Health IT 4

Startups In-Depth 5

Startup Activity 17

3 Pharma & Biotech 19

Startups In-Depth 20

Startup Activity 24

4 Medical Devices & Diagnostics 25 Startups In-Depth 26

Startup Activity 39

Readers on digital devices can click on the headings below to get directly to the page.

@MedCityNews

MEDCITY Reports3December 2013

From the Editor

Healthcare is not all about the patients. Yet. We are getting there, slowly but surely. The combined forces of “but we’ve always done it that way” and “but we make a lot of money from that” are putting up a good fight. But reimbursement changes, consumer-driven healthcare and determined entrepreneurs are almost strong enough to start winning more battles and eventually the war.

Ten startups in this month’s report give us a look at the power of the patient. This trend will only get stronger in 2014 as people have to make sure their Obamacare premiums get paid, track their exercise minutes to level up in corporate wellness programs and make more decisions about efficacy and cost.

These startups reflect the future of patient-centric healthcare whether that means faster diagnosis, customized engagement programs or simply a more convenient system overall.

Take a look at these companies that will be able to say at the end of 2014, “We figured it out first.”

• DioGenix - faster diagnosis of MS

• Health: ELT - patient engagement for Medicaid patients

• Gema Touch - sensor system to boost medication adherence

• iHealth blood pressure cuff - smaller device to make measurements more frequent

• MyDirectives - making end-of-life conversations easier

• Prevail - an online system for better access to mental healthcare for veterans

• Qardio - smart device design for better heart rate measurement

• Joytingle - making shots less painful and scary for kids

• Turntable Health - a new approach to primary care

• WaveCheck - a reality check for the efficacy of cancer treatment

As patients are more and more able to make informed and deliberate healthcare choices, they will vote with their feet. They will give their business and their money to doctors, hospitals, clinics, nurse practitioners and physical therapists that truly make life easier. That means more convenient, more affordable, more effective, and easier to understand.

Veronica CombsEditorMedCity News

Veronica Combs, Editor in ChiefMedCity Media

@vmcombs

10 startups on the last report of 2013 offer early look at 2014 trends

MEDCITY Reports4December 2013

Digital & Health IT

MEDCITY Reports5December 2013

Startups In-Depth: Digital & Health IT

YouTube’s rapping doctor and Zappos’ CEO bring a new model of primary care to Las Vegas

By: Deanna PogorelcDec. 17, 2013

As plans began coming together for Zappos.com CEO Tony Hsieh’s $350 million economic revitalization project in downtown Las Vegas, it was obvi-ous that healthcare needed to be one of the pieces. The state has one of the highest uninsured populations, and the healthcare market was hit hard by the recession.

To lead the charge on revitalizing healthcare in the city, Hsieh recruited an unlikely hero: YouTube’s rapping doctor, ZDoggMD.

On the other side of the computer screen, ZDogg is Stanford-trained internal medicine physician Zubin Damania, and he’s now founder and CEO of Turn-table Health, a primary care clinic opening today in Vegas.

Similar to OneMedical, it’s a membership-based, tech-savvy clinic with the goal of keeping people healthy, instead of just treating them when they’re sick.

In exchange for $80 per month ($60 for kids), Turntable promises members unlimited access to primary care in the form of same-day appointments and the ability to communicate with their health team by phone, email or video chat.

Continued on next page

Company:Turntable Health

CEO, Founder:Zubin Damania

Website:www.turntablehealth.com

Twitter:@TurntableHealth

MEDCITY Reports6December 2013

When MedCity News first wrote about Figure 1 back in August, Landy chalked up the initial popularity of the app to just doctors being doctors. “In medicine there tends to be a culture of sharing interesting findings with

each other,” he said. “After you spend 10 to 12 years training, learning and sharing new findings becomes second-nature to the way you practice.”

Startups In-Depth: Digital & Health IT

Turntable Health (Continued)

The clinic is staffed by physicians, health coaches and a nurse who work together with each patient. It also offers members access to cooking, exer-cise and disease management classes.

Because patients pay monthly, the clinic’s fi-nancial incentive is to keep people healthy and

coming back, not to make referrals and order procedures, Damania explained to The Atlantic.

Day-to-day operations are being run by Iora Health, an innovative primary-care company that runs a handful of other practices on the East Coast.

MEDCITY Reports7December 2013

Startups In-Depth: Digital & Health IT

Sticky sensors help patients and doctors manage at-home cancer treatment plans

By: Veronica CombsDec. 11, 2013

Are you taking your meds or are they rattling around in your purse?

This is the question that GEMA Touch wants to answer with a new medica-tion tracking system.

Joanna Rogerson and Jon Guida have created the Gema Kit, that features stickers embedded with sensors that link to a patient reporting website. These small circles go on pills, pill bottles or blister packs.

The sensor is proximity-based, so when a person’s cell phone is waved at the sticker, it brings up the reporting portal. In addition to recording when a pill was taken, a user can report symptoms, side effects and mood.

The touch-to-activate patches include proprietary technology but also meet NFC Forum Type 2 Tag standards. They can be read by any NFC-enabled mobile device including cell phones, tablets or readers.

Rogerson said she decided to start with cancer patients because of a trend in cancer treatment shifting from the doctor’s office to the patient’s home. One oncologist told Rogerson that oral chemo medications were going to increase from 10 percent of the practice’s business to almost 40 percent in a year’s time.

Unsurprisingly, medication adherence and patient support plans are not

Continued on next page

Company:GEMA Touch

Creators:Joanna Rogerson and Jon Guida

Website:www.gematouch.com

MEDCITY Reports8December 2013

When MedCity News first wrote about Figure 1 back in August, Landy chalked up the initial popularity of the app to just doctors being doctors. “In medicine there tends to be a culture of sharing interesting findings with

each other,” he said. “After you spend 10 to 12 years training, learning and sharing new findings becomes second-nature to the way you practice.”

Startups In-Depth: Digital & Health IT

keeping up with this change.

“Doctors are losing the monitoring capability and increasing treatment costs,” Rogerson said. “Ba-sically the nurse calls the patient at set intervals to check in, it’s very labor intensive.”

The kit goes to the patient and he or she affixes the stickers to the medication. The GEMA Touch system also includes a reporting and tracking sys-tem for oncologists.

Rogerson said the system includes alerts for individual patients to let a doctor know if a patient is feeling worse. The platform also can aggregate data for patients in the same treatment program.

Rogerson said that once GEMA Touch has estab-lished oncology customers, the plan is to expand to other highly managed diseases.

“The hardware doesn’t change, we can link it to any passive surface, like fabric or plastics,” she said. “The user experience will be different, to reflect different motivations and drivers.”

Before joining the Healthbox class, Rogerson and Guida got a $50,000 grant from NC Idea to devel-op the technology. Healthbox was the company’s first equity investor.

Rogerson said that she has one confirmed pilot that will launch in early 2014. She is looking for in-troductions to more oncology clinics. She said she expects to do a Series A round in late 2014.

There was an audience voting contest at the end of the demo day and GEMA Touch won. Rogerson and Guida took home an extra $20,000 to Raleigh.

Rogerson is the president and CEO of GEMA Touch and a molecular biologist. She previously worked as an innovation and commercialization adviser at RTI International and the NC Biotechnol-ogy Center.

She has an MBA with a concentration in technol-ogy, entrepreneurship and commercialization, an MS in biotechnology and a BS in biology. Guida is the vice president of business development and specializes in consumer behavior and psychology.

GEMA Touch (Continued)

MEDCITY Reports9December 2013

Startups In-Depth: Digital & Health IT

Navy veteran’s eHarmony for mental health offers self-guided therapy for veterans

By: Stephanie BaumDec. 18, 2013

A Navy pilot who served in the Iraq war has developed a counseling plat-form designed to overcome a big challenge in getting veterans therapy by providing anonymous enrollment. It’s part of a self-directed program the Department of Veterans Affairs is offering called Vets Prevail through health IT startup Prevail Health Solutions’ website.

The CEO of Prevail Health Solutions, Richard Gengler, flew F/A 18 Hornets in Iraq for the U.S. Navy. Vets Prevail guides users, who enroll anonymously, through interactive questions to develop an initial assessment. It tailors a multistep program to their needs.

It combines calls with military peers who have been through similar expe-riences with reading assignments. By completing directed tasks, users get points that can be used to buy items such as gift cards for purchases.

The scale of behavioral health needs among military veterans returning from Iraq and Afghanistan is significant. A Rand Institute study from 2009 estimat-ed that 300,000 veterans are coping with some form of psychological prob-lem such as depression or PTSD. Coupled with that is an aversion to seeking help, with the assumption that it will be bad for their military career.

Continued on next page

Company:Prevail Health Solutions

CEO:Richard Gengler

Website:www.prevailhs.com

MEDCITY Reports10December 2013

When MedCity News first wrote about Figure 1 back in August, Landy chalked up the initial popularity of the app to just doctors being doctors. “In medicine there tends to be a culture of sharing interesting findings with

each other,” he said. “After you spend 10 to 12 years training, learning and sharing new findings becomes second-nature to the way you practice.”

Startups In-Depth: Digital & Health IT

Prevail Health Solutions (Continued)

In an interview with MedCity News, Gengler said he got the idea for the company when he was study-ing for an MBA at University of Chicago. He got the idea for the platform after he encountered a primary care physician who told him about how many of the patients he was seeing have underlying behavioral health issues. When he would try to refer them to psychologists, most wouldn’t go. He impressed on Gengler the need for online avenues to help them.

That was the seed for what became Vets Prevail. He secured funding and collaboration help from the Na-tional Science Foundation. He also attracted funding from Bristol-Myers Squibb Foundation, Goldman Sachs Gives and the Robin Hood Foundation to test the program. Collectively, Gengler raised more than $3 million to develop his program.

“A lot of behavioral health programs like this are dry.” said Gengler. ” We wanted to create a specifi-cally tailored and dynamic program. It creates initial assessments and tailors them, like an eHarmony for mental health.” By including targets users have to meet it helps keep them engaged.

Two pilot programs showed equivalent reductions in symptoms for people with PTSD and users with high levels of depression and those symptoms signifi-cantly declined as part of the four-week program, Gengler said. The second pilot earlier this year was a control trial. Of the 200 vets who used the program, 160 made it through each step of the program. He said their outcomes rivaled those of an in-person visit and were much less costly.

The program also partners with Give an Hour – a nonprofit founded in September 2005 by psychol-ogist Dr. Barbara Van Dahlen. The 5,000 therapists who are members give one hour a week of free counseling to vets.

Gengler sees its potential to help not just veterans but active-duty soldiers and civilians as well. He has developed similar apps for active duty military per-sonnel (Warriors Prevail) ,college-aged students (Stu-dents Prevail), employees (iPrevail) with behavioral health problems such as depression and women with postpartum depression (Women Prevail).

All of these applications are ready to be deployed, but Gengler is first looking for collaborative partners for pilots. He takes the view that having an online option that combines anonymity and accessibility will provide help for people in these groups who might otherwise not get any.

“We are a push program not a pull,” said Gengler. “We are interested in getting reluctant care seek-ers to make early first steps and hopefully, they will make positive decisions and hopefully we will nudge them along.” One goal of the online program is to give users a comfort level with the therapy that will spur them to seek in-person therapy, guided by the program.

Depending on how reimbursement evolves with telemedicine, Gengler sees the potential to add a video interaction component to the program if users are interested.

I’m skeptical as to how effective the platform will be as a substitute for in-person care. But it could do a lot for helping ease personal resistance to seeking mental health treatment. It could also help them build the confidence to get more help.

Earlier this year, Veterans Affairs began piloting a program to deploy iPads loaded up with mobile health apps. It is part of the Family Caregiver pilot program that provides iPads to 1,000 caregivers of seriously injured veterans of the Iraq and Afghanistan wars.

MEDCITY Reports11December 2013

Startups In-Depth: Digital & Health IT

MyDirectives wants to change how people think of ad-vance care planning (or just make them think about it, period)

By: Deanna PogorelcDec. 18, 2013

The end of life isn’t a topic people generally like talking about, but according to Jeff Zucker, it’s a topic better discussed at the kitchen table than on the operating table.

Zucker is CEO of a company that’s trying to empower consumers to make sure they get what they want, and deserve, in their end-of-life care. Last year, his company, ADVault, launched MyDirectives.com, a site where anyone can go to create a digital advance care plan that’s stored in the cloud, so they can edit or access it at any time, from anywhere.

The idea is that, if someone is in an accident or struck by a terminal illness or injury that leaves them unable to communicate, their wishes for how they’d like to be cared for have been documented and can be accessed by the care team.

But the idea isn’t just to digitize existing advance care plans. It’s to change the way people think about them altogether.

Before creating MyDirectives, Zucker and co-founder Scott Brown talked to doctors, lawyers, consumers and technology experts and found that a pleth-ora of hurdles stood in the way of great end-of-life care planning. One hurdle is that people don’t realize they should have advance directives until they’re

Continued on next page

Company:MyDirectives

CEO:Jeff Zucker

Website:www.mydirectives.com

Twitter:@MyDirectives

MEDCITY Reports12December 2013

Startups In-Depth: Digital & Health IT

MyDirectives (Continued)

in an emergency situation and either unable, or not in the right mindset, to communicate their preferences. Or, if people do think about creating a directive, they don’t think anyone would ever be able to find it if something happened — because there’s a good chance no one would.

“Even if you do have one and the care provider could find it, what happens if the family walks in and doesn’t agree with them?” Zucker questioned. “We needed to make something that was actionable for doctors.”

They did that by creating a system that’s HIPAA compli-ant, meaningful-use certified and aims to address many of the gray areas in end-of-life care.

Users set up an account and fill out the directive, which consists of multiple-choice and free-text questions. (It took me about 10 minutes.)

Along the way, users can click on discussion guides if they’re not sure how they feel about a particular ques-tion (for example, in which scenarios would you want CPR administered?). Zucker said there’s also an algo-rithm built in that alerts users if they’ve responded to a question in a way that conflicts with a previous answer they’ve given. Two questions that ask about a person’s joys and fears allow for video or audio files to be at-tached.

It’s all free to consumers and hospitals. In the U.S., health plans foot the bill to offer the service as a tool for their beneficiaries.

Those are all great features for creating a more clear and thorough directive, but Zucker said the real innovation

isn’t in the technology — it’s in the process. “It wasn’t about making a technology solution to a problem; it was about figuring out the hopes and challenges of consum-ers, and the obstacles in changing consumer behavior and creating a system that doesn’t beat them into (mak-ing an end-of-life care plan).”

Zucker wants to see advance care planning become something like becoming an organ donor or buying life insurance — something most people make decisions about in advance.

How will MyDirectives make that happen? “We’re work-ing on this, but there’s no one-size-fits-all solution,” he explained, pointing to a few different places he imag-ines a person could be prompted to create an advance directive. “It could be when you’re signing up for health insurance, or when your health plan is re-enrolling you, or when you become a patient at a hospital for a stan-dard procedure.”

That would only solve some of the problem, though. If more people made care plans, how would doctors know about them when the situation presented itself? For now, MyDirectives prompts people who complete their plan to print a wallet card. Down the road, though, Zucker said integrating the technology with hospitals’ electronic medical records systems will become a priority.

“That’s a later phase of our growth; right now we just want to build on the database,” he said.

“We want to continue to drive toward normalizing this topic. We think everyone over the age of 18 should have a great quality plan that’s stored in the cloud available, and we should have a system that truly respects the

MEDCITY Reports13December 2013

Startups In-Depth: Digital & Health IT

Health IT firm raising $2.5M for digital tools to help MCOs manage, engage Medicaid patients

By: Deanna PogorelcDec. 19, 2013

In the world of commercial insurance, patient engagement might mean of-fering incentive or reward programs for healthy behaviors, or providing tools that help consumers choose the lowest cost and best quality care providers. In Medicaid, it’s a little bit different.

“In Medicaid, it means ‘see if you can find me,’” explained L. Cade Havard, chairman and CEO of health technology company Health: ELT (which stands for engagement, logistics and technology).

Many of the highest-cost Medicaid beneficiaries are disabled or have multiple chronic conditions. But because low-income populations are more likely to lack stable housing, transportation and means of communication, it can be hard to keep them engaged in their health and healthcare. As a result, they often receive fragmented or uncoordinated care.

Health: ELT wanted to leverage technology to improve how Medicaid func-tions for both plans and the growing number of Medicaid members. The Dal-las-based company is developing a suite of mobile and digital media services for managed care organizations, managed care service providers and certain states that manage their own Medicaid benefits.

Havard couldn’t get into specifics about the services it plans to provide, but

Continued on next page

Company:Health: ELT

CEO, Chairman:L. Cade Havard

Website:www.healthelt.com

MEDCITY Reports14December 2013

the company’s website lists clinical support and reporting tools, case management tools, automa-tion for specialty reporting and refining workflow processes, and provider database management among its potential offerings.

He said the team comes from an extensive back-ground in health IT and the commercial and man-aged care sectors.

The company is raising a $2.5 million round in preparation to launch a handful of pilot projects next year, Havard said. So far, it’s been financed by $5 million put up from the owners, he added.

Several other companies make software for man-aged care organizations, but Health: ELT claims to be the only one working in Medicaid engagement and logistics technology.

Startups In-Depth: Digital & Health IT

Health: ELT (Continued)

MEDCITY Reports15December 2013

Online medical education tool aspires to improve pa-tient interactions in challenging situations

By: Stephanie BaumDec. 4, 2013

How do you talk to a family who has just lost a loved one in an accident and persuade them to donate organs? What about telling a patient she has can-cer? Those are just a couple of the challenging interactions used in a platform developed at Drexel University College of Medicine: WebPatientEncounter.com.

It has developed an online medical education program to help healthcare professionals hone those skills in simulated interactions with patients and their families.

Although the goal is to improve performance by physicians and other health-care professionals, it is also designed to help hospitals boost patient satis-faction scores, which impact Medicare reimbursement. This is one trend in healthcare that startups are increasingly addressing.

Dr. Christof Daetwyler of Drexel University College of Medicine will use the $100,000 he received from the University City Science Center QED Proof of Concept award to fund a pilot program with a well-known hospital next year and build a company around the technology.

In an interview with MedCity News, Daetwyler said one of Drexel’s collabora-tion partners is the Gift of Life donor program in Philadelphia, which licensed the technology.

Company:WebPatientEncounter.com

Website:http://webpatientencounter.com/

Startups In-Depth: Digital & Health IT

MEDCITY Reports16December 2013

Online medical education tool aspires to improve patient interactions in challeng-ing situations

By: Stephanie BaumDec. 4, 2013

A prototype of the technology was developed in 2002 at the Technology in Medical Education group at Drexel.

It was used as a video conferencing tool to help med-ical students prep for the Objective Structured Clinical Examinations through simulated patient interactions.

Since then, technology advancements have made it easier to bring the platform online. User interactions with simulated patients are recorded online. Users get structured feedback on performance.

They can also access videos that offer examples of best practice. In addition to organ donation and breaking bad news, it also includes modules on how to broach other difficult situations such as smoking cessation.

A separate joint venture between the College of Medi-cine and the American Academy on Communication in Healthcare, Doc.Com, produced 41 modules to improve communication skills.

The company’s approach also helps address the physician shortage, which is projected to worsen as Obamacare extends healthcare access to millions of people.

Several other health IT companies are taking differ-ent approaches to medical training using simulators. Shadow Health and Kognito Interactive have focused on developing patient simulator tools to improve patient and physician communication.

SimplySim developed a way to train physicians to prop-erly use a stethoscope and CaseNetwork developed a training tool to reduce readmissions.

The idea is to provide more meaningful interactions to improve adherence and to help healthcare professionals better understand their patients’ needs.

Startups In-Depth: Medical Devices & Diagnostics

WebPatientEncounter.com (Continued)

MEDCITY Reports17December 2013

Startup Activity: Digital & Health IT

Leap Motion’s gesture tech senses movement through bonesDec. 5, 2013

Founders Fund and SOSventures have joined to launch Leap Axlr8r –– a startup accelerator for companies building on Leap Motion, the gesture-based technology that’s dictating the future of 3D human computer interaction.

http://bit.ly/18B5yZf

Health tech startup Practice Fusion picks up $15M from Qualcomm

Dec. 9, 2013

Practice Fusion, a health care technology startup, has closed another $15 million in funding, the company an-nounced recently.

http://bit.ly/18B5yZf

New startup HealthLoop brings in $10M for better patient engagement in healthcareDec. 9, 2013

Health IT is a booming sector, but physicians are already becoming inundated and overwhelmed by the influx of new tools.

http://bit.ly/1fpwpGK

Telehealth startup RingMD receives funding to boost access to healthcare in AsiaDec. 22, 2013

The Singapore government has invested $500,000 in funding in a new healthcare startup called Ring.MD.

http://bit.ly/1hzpwUE

Health IT startup gets seeded to streamline regulatory compliance for clinical researcheDec. 9, 2013

The process of conducting a clinical trial generates mounds of paperwork, some of which is kept in a binder as a reference for members of the research team and regulatory authorities that might audit the trial sponsor. But the reg-ulatory documentation in that binder isn’t always complete or reliable.

http://bit.ly/18TS8m0

Canadian investors inject $2M in seed funding into medical photo sharing app Figure 1Dec. 10, 2013

Six months post-launch, medical photo sharing app Figure 1 has attracted tens of thousands of users and now $2 million in venture and angel funds to expand to new platforms.

http://bit.ly/1jI4i8W

MEDCITY Reports18December 2013

Startup Activity: Digital & Health IT

Telehealth startup Doctor on Demand raises $3M in seed fundingDec. 12, 2013

A healthcare startup that is using mobile phones and iPads to provide video access to physicians has raised $3 million in seed funding.

http://bit.ly/IYYYQN

Maxwell Health adds Catalyst Health Ventures in $6M financing roundDec. 17, 2013

The business is carving a niche in the private health insurance exchange sector serving employers. It sets up private health insurance exchanges for employers and advises them on their insurance options.

http://bit.ly/IZ3Kxw

MEDCITY Reports19December 2013

Pharma & Biotech

MEDCITY Reports20December 2013

Startups In-Depth: Pharma & Biotech

Radiation, chemo, surgery — hyperthermia? Startup sees heat as a 4th modality of cancer treatment

By: Deanna PogorelcDec. 5, 2013

A San Jose startup is planning the first clinical trial on its mission to add hy-perthermia to the arsenal of cancer treatment options.

Driven to find an alternative for his patients who had run out of treatment options for their cancer, gynecologic oncologist Dr. James Lilja came across a heat-based therapy called hyperthermia.

It’s a technique in which all of the cells and tissues in the body are exposed to temperatures above 107 degrees Farenheit, at which point they can be-come more susceptible to treatments like radiation therapy or chemotherapy. Very high temperatures can even kill cancer cells.

While targeted forms of hyperthermia are FDA-approved in the form of radiof-requency ablation, full-body hyperthermia is still considered experimental. Just as they can kill cancer cells, very high temperatures can also kill healthy cells and tissues, so the technique requires careful control.

And although it’s been studied in clinical trials, strong efficacy data has not yet been achieved.

One study conducted in the early 2000s at the University of Texas, Galveston, found that whole-body hyperthermia significantly extended length-of-survival in a small cohort of late-stage lung cancer patients.

Lilja recruited the study’s lead researcher, Roger Vertrees, and several other physicians to form ThermalCore with the goal of refining the technique and showing that it’s safe and reproducible as a complementary cancer treat-ment.

The company says it’s received a green light from the FDA to begin clinical trials of a device that removes blood from the body, circulates it through a

Continued on next page

Company:ThermalCore

Founder:Dr. James Lilja

Website:http://thermalcore.org

MEDCITY Reports21December 2013

series of pumps, heats it and returns it back into the body.

Here’s how ThermalCore describes the treatment on its website:

“The HEATT technique developed by ThermalCore uses a combination of cardiac bypass, kidney di-alysis and liver detoxification resulting in balanced blood chemistries and homogenous distribution of heat, while allowing precise control of the body temperature.

Heated blood is returned to the patient from the device and then the heart’s output is used to dis-tribute the heat, allowing for rapid ramp-up of the core body temperatures and a higher sustained temperature.

This creates a better tumoricidal effect and is less likely to cause damage to healthy tissues via a predictable, substantial thermal dose.

During animal trials, our HEATT procedure has allowed us to achieve and maintain a core tem-perature of up to 110-degrees Fahrenheit for 2

hours, while balancing blood chemistries in real time and eliminating adverse effects on the heart and lungs.”

The upcoming Phase 1 safety trial will consist of 20 patients, each receiving six rounds of treatment in a 28-day cycle, according to the company’s media rep, Aaron Henderson.

To complete the trial, the San Jose startup is look-ing for $2 million in capital, as disclosed in a recent SEC filing.

Initially the team will focus on treating ovarian can-cer. But long-term, they think the treatment could be beneficial to all kinds of cancer patients.

“We also intend to prove hyperthermia’s utility in treating multiple solid tumors and to build a shared central reference knowledge base for physicians,” Henderson said. “Another important goal is creat-ing a clinical board for hyperthermia, as we believe that once this technique is established as safe and reproducible, whole-body hyperthermia will become the ‘fourth modality’ in the treatment of cancer.”

Startups In-Depth: Pharma & Biotech

ThermalCore (Continued)

MEDCITY Reports22December 2013

Diabetes-focused MicroBiome Therapeutics raises $1.3M to test meds that alter gut bacteria

By: Deanna PogorelcDec. 16, 2013

The microbiome and metabolic diseases like obesity and diabetes might be more closely linked than previously thought.

As that research continues to advance, a company called MicroBiome Thera-peutics is hoping that, by altering certain bacteria in the gut, it will be able to help prediabetics delay or prevent the progression of the condition into Type 2 diabetes.

MicroBiome Therapeutics (formerly NuMe Health) is running two clinical trials of a microbiome modulator designed to enhance insulin sensitivity in patients with prediabetes, and lessen adverse GI effects in those who are taking the antidiabetic drug metformin. To carry the company through those trials, its investors, including BVM Capital, have provided $1.3 million in bridge financ-ing.

MicroBiome Therapeutics completed a $1.5 million Series A last year.

“These additional funds will enable us to complete our ongoing studies and prepare for our next set of clinical trials,” CEO Steve Orndorff said in a pre-pared statement. “We expect to report results from the current studies soon, prior to the launch of a significant Series B financing during 2014.”

The goal with NM504 is to build up specific good bacteria strains and dis-courage the growth of other strains in the GI tract in order to affect appetite, metabolism and energy storage. It does that using prebiotics and other naturally occurring ingredients, MBT says.

Continued on next page

Company:MicroBiome Therapeutics

Founders:John Elstrott and Dale Pfost

Website:www.mbiome.com

Startups In-Depth: Pharma & Biotech

MEDCITY Reports23December 2013

Startups In-Depth: Medical Devices & Diagnostics

MBT (Continued)

An estimated 79 million U.S. adults have prediabe-tes, which increases a person’s risk of developing type 2 diabetes.

Dietary changes, increased physical activity and sometimes metformin are encouraged to prevent the development of type 2 diabetes.

Boulder, Colorado-based MBT was founded by Whole Food Chairman John Elstrott and life science entrepreneur Dale Pfost, now a partner at Advent Ventures.

MEDCITY Reports24December 2013

British medical device startup selling its tissue regeneration product in 25 statesDec. 13 2013

A British medical device company that opened its American subsidiary in San Antonio last year is preparing to com-mercially launch its first product in the United States in the first quarter of 2014.

http://bit.ly/1jYpoA7

Startup Activity: Pharma & Biotech

Biomedical tech firm lands $7.3 million in new venture capitalDec. 10, 2013

An Orlando-based newcomer to the healthcare technology industry has landed another multimillion-dollar infusion of venture capital to boost its expansion and marketing efforts.

http://bit.ly/1bTn9Gy

Flu vaccine developer Visterra gets a Series A boost for clinical trials in 2014Dec. 1, 2013

The annual flu vaccine only prevents against three or four strains of flu-causing viruses that are circulating during any given year.

http://bit.ly/1bXRZlR

MEDCITY Reports25December 2013

Medical Devices

& Diagnostics

MEDCITY Reports26December 2013

Startups In-Depth: Medical Devices & Diagnostics

Researchers crowdfund a device to let doctors, breast cancer patients see if chemo is working

By: Deanna PogorelcDec. 3, 2013

Why wait months to determine whether a tumor is responding to cancer treatment if it’s possible to know sooner?

That’s the question being posed by a pair of inventors in Toronto who are crowdfunding clinical studies of a new device to monitor the effectiveness of chemotherapy on breast tumors.

Called WaveCheck, the noninvasive device combines traditional ultrasound with new software to detect responses to chemotherapy in breast tissue.

Dr. Gregory Czarnota, the chief of radiation oncology at Sunnybrook Health Sciences Centre, and Ryerson University physics professor Michael Kolios invented the device to facilitate better conversation between patients and doctors and help identify the right treatment for each person.

They say it can provide insight about a treatment’s effects as early as four weeks after the start of therapy, although they eventually hope to bring that down to one week. An observational study is underway at Sunnybrook’s Odette Cancer Center in Toronto, and the researchers have published early results from 24 patients.

Now, to study the device’s accuracy and sensitivity at three other cancer cen-ters in Canada and the U.S. next year, WaveCheck has raised nearly $50,000 through an Indiegogo campaign.

Continued on next page

Company:WaveCheck

Inventors:Dr. Gregory Czarnota, the chief of radiation oncology at Sunny-brook Health Sciences Centre, and Ryerson University physics professor Michael Kolios

Website:http://wavecheck.ca

Twitter: @WaveCheckYellow

MEDCITY Reports27December 2013

The research behind WaveCheck has so far been fund-ed by granting agencies, foundations and universities in Canada and the United States.

But the researchers are still hoping to raise another

$40,000 through the campaign.

The campaign is part of Indiegogo’s #GivingTuesday promotion and it received an extra dollar for every $20 raised Dec. 3.

Startups In-Depth: Medical Devices & Diagnostics

WaveCheck (Continued)

MEDCITY Reports28December 2013

Startups In-Depth: Medical Devices & Diagnostics

Imaging agent that ‘paints’ tumor cells for more precise removal nets $9M for clinical trials

By: Deanna PogorelcDec. 3, 2013

A toxin produced by scorpions to paralyze their prey is the backbone of a new imaging agent that could enable cancer surgeons to perform more pre-cise cancer surgeries.

In the video, Blaze Bioscience’s scientific founder, Dr. James Olson, de-scribes how the scorpion-derived protein “happens to bind to cancer cells, but not to normal tissues.”

A team from the Fred Hutchinson Cancer Research Center and Seattle Chil-dren’s Hospital Research Institute attached a flourescent dye to the protein to create what they call “tumor paint.”

The agent would be injected into a patient before tumor removal surgery, at-taching to cancerous cells and making them visible under near-infrared light.

In concept, it would allow surgeons to see precisely which tissues are can-cerous, so they can remove as much of the tumor as possible while leaving as much healthy tissue as possible.

Currently, surgeons use MRIs or PET to visualize a tumor before surgery.

Blaze has just picked up $9 million in Series B financing to begin clinical trials of the imaging agent “shortly,” the company said in a release today.

The money came largely from investors who participated in an $8.5 million

Continued on next page

Company:Blaze Bioscience

Founder:Dr. James Olson

Website:http://www.blazebioscience.com

MEDCITY Reports29December 2013

Series A financing that closed early this year.

Blaze is also developing other optimized peptide drug candidates in collaboration with Fred Hutchison Cancer Research Center.

Meanwhile, Olson’s research is also the basis of another Seattle biotech, Presage Biosciences, which is enabling drug companies to test potential treatments in living tumors in a lab, to compare side-by-side how well they kill cancer cells.

Startups In-Depth: Medical Devices & Diagnostics

Blaze Bioscience (Continued)

MEDCITY Reports30December 2013

Startups In-Depth: Medical Devices & Diagnostics

DioGenix picks up $3.2M in search of a clearer, earlier way to diagnose multiple sclerosis

By: Deanna PogorelcDec. 5, 2013

Over the past 20 years, several new treatments for multiple sclerosis have been approved. Unfortunately, though, diagnostics have not progressed alongside them.

A young company called DioGenix thinks it’s found a new way to identify MS patients sooner, enabling them to receive treatment sooner and potentially delay injury to the nervous system.

Its solution is a next-generation sequencing assay that measures changes in human immunity.

To complete a validation study of its assay, the Bethesda, Md., company has just secured $3.2 million from new and existing investors including Nerveda LLC.

Currently the study has enrolled more than 200 subjects at 13 sites, President and CEO Larry Tiffany said, and enrollment should be complete in early 2014. What DioGenix is studying is cerebral spinal fluid and blood samples col-lected from individuals being evaluated for some kind of immune-mediated neurological disorder that may or may not be MS.

The problem is that the underlying cause of MS is not clear, although sci-entists know that it’s characterized by inflammation in the central nervous system triggered by an autoimmune response. It’s a chronic condition that

Continued on next page

Company:DioGenix

President, CEO:Larry Tiffany

Website:http://diogenix.com/

MEDCITY Reports31December 2013

can lead to blurred vision, poor coordination, slurred speech, numbness and paralysis. Because MS shares symptoms and characteristics with other neurological diseases, doctors perform an extensive workup that includes physical examinations, MRI, blood tests and a cerebral spinal fluid analysis, to determine what might be the cause.

The DioGenix diagnostic, called MSPrecise, takes the current cerebral spinal fluid test a step further.

The lab-based test looks for gene mutations in certain spots within the B-cell genome that research has sug-gested is driven specifically by MS.

That could help doctors distinguish MS from other immune-mediated diseases that share similar biological features, and may also help them identify more aggres-sive cases, Tiffany said.

Although treatment of MS has advanced over the last several decades, diagnostics have not, Tiffany said. Treatments that emerged in the 1990s were relatively safe and inexpensive, he explained.

“During this evolution on the therapeutic side, doctors became more comfortable saying, ‘let’s put a patient on therapy if we think they have the disease.’”

But a new wave of drugs has come onto the market over the past few years — drugs that Tiffany said pro-vide great benefits to patients but are more expensive

and carry more concerning safety profiles.

“What we see is a real opportunity to continue to get the right patients on these therapies as early as possible but to make sure we’re not putting patients without the disease on these drugs,” he said.

With the additional funding, DioGenix should be able to complete the study, publish the results, expand its lab and go through the CLIA licensure process. Initially, it won’t need FDA clearance, since the tests will be con-ducted in the lab.

“We’ve run (the trial) with an eye to prepare the data to meet all the regulatory endpoints so that someday we could actually provide this data as part of a regulatory filing,” Tiffany added.

Meanwhile, the company is also collecting blood sam-ples that it will examine to see if the same DNA mutation signature found in patients with MS is also found in blood.

The hope is that the company could create follow-on products that use more accessible fluid samples, like blood or urine.

The company also sees potential for its test to be used as a monitoring tool for pharmaceutical companies developing and testing MS drugs. DioGenix’s technolo-gy was licensed from University of Texas Southwestern Medical Center and initially developed as a subsidiary of

Startups In-Depth: Medical Devices & Diagnostics

DioGenix (Continued)

MEDCITY Reports32December 2013

Startups In-Depth: Medical Devices & Diagnostics

Ray the toy rabbit helps kids overcome the fear of getting blood drawn

By: Deanna PogorelcDec. 10, 2013

Taking a child to the doctor doesn’t have to be a traumatic experience, even if there’s a needle involved.

So says a Singapore startup called Joytingle, whose designer founders want-ed to calm the fear of needles in kids. They concluded that it’s often a fear of the unknown, rather than the pain, that makes kids squirm and cry. So they went the way of startups like iDerma and Sproutel and developed a doll called Rabbit Ray. He comes in two forms — one is a plush hand puppet designed for use at home, and the other is a silicone and plastic doll that can be wiped down and used in a hospital setting.

With the doll comes a set of kid-friendly tools that resemble a syringe and plastic tube used during a blood draw, so little ones can play doctor on Rab-bit Ray. He also comes with an interactive e-book and an X-ray transparency showing major body organs that kids can attach to his belly.

The idea is that children play with the doll and the e-book to understand how and why a blood draw is performed, with the hope of soothing some of their fear leading up to the procedure. It’s been tested with kids and healthcare professionals, and now Joytingle has turned to Indiegogo to raise the $15,000 it needs to start production of the dolls.

Previously, Rabbit Ray was a finalist in the 2011 James Dyson Awards, an annual international student design competition.

Company:Joytingle

Website:http://joytingle.com

MEDCITY Reports33December 2013

Startups In-Depth: Medical Devices & Diagnostics

Qardio plans 2014 launch of a mobile blood pressure monitor, à la Withings, iHealth

By: Deanna PogorelcDec. 12, 2013

Another Silicon Valley startup by the name of Qardio is planning its jump into the remote health monitoring pool early next year with a mobile blood pres-sure cuff and a cardiac monitoring chest strap.

Qardio thinks that many people who should be taking daily blood pressure readings aren’t because it’s inconvenient to carry around a clunky device, and it wants to change that.

It says its offering is different from other products on the market, in its design and user experience.

“Our innovation is in the design,” explained the company’s spokeswoman. “It’s wireless, uses Bluetooth, is portable and small – it fits in your pocket, your purse or in the back of your jeans.”

QardioArm is a cuff that’s put on the upper arm and reads a person’s systolic and diastolic blood pressure and heart rate. Perhaps best suited for someone who has hypertension or is at high risk for a cardiac event, the cuff wirelessly transmits the readings to an iOS device.

A corresponding app aggregates and stores those readings, so users can track their data over time and let their doctors have access if necessary.

The app has a few other features, like reminders and a patent-pending func-

Continued on next page

Company:Qardio

Co-Founders:Marco Peluso and Rosario Iannella

Website:http://www.getqardio.com/38/

Twitter:@getqardio

MEDCITY Reports34December 2013

Startups In-Depth: Medical Devices & Diagnostics

Qardio (Continued)

tion that displays calming images when a person is taking a reading, to prevent their blood pressure from rising due to the anxiety of knowing they’re taking a measurement.

The similar Withings and iHealth systems got a lot of hype a few years ago at CES, but Dr. Iltifat Husain brought up a few good points to consider in a review of them.

For example, only 30 percent of iPhone users are above age 45, and even fewer are above age 55. Even if an Android version is made, is that enough potential users for these companies be able to find market traction?

Qardio will soon find out, as it’s recently closed a $1 million fundraising round and is in the process of sending out its manufacturing model. The com-

pany, which will sell directly to consumers, should be ready to bring the device to market in the U.S. in early 2014.

The company is also awaiting a green light from the FDA.

The startup’s founders, Marco Peluso and Rosario Iannella, started the company after Peluso’s dad had a small stroke a few years ago.

Doctors were initially unable to determine what caused the stroke, making it hard to know what could possibly prevent another one. That was also the impetus for developing the company’s other forthcoming product, QardioCore – a chest strap that monitors EKG, heart rate, physical activity and skin temperature without wires, buttons or any kind of skin preparation.

MEDCITY Reports35December 2013

Startups In-Depth: Medical Devices & Diagnostics

Smart design meets affordability in an $80 prosthetic knee for amputees in poor countries

By: Deanna PogorelcDec. 21, 2013

Prosthetic limbs have come a long way in look and functionality (there are even bionic legs!).

But, unfortunately, there’s no way some of the people who could benefit most from them could ever afford that kind of advanced technology.

A nonprofit incubator called D-Rev is focused entirely on designing products for people living on less than $4 a day, and one of its projects is a sleek and functional $80 leg prosthetic for above-knee amputees.

In some developing countries, the best option for amputees is a bamboo staff to walk with, D-Rev CEO Krista Donaldson said in a recent TED talk, so this kind of product could be the difference between working and having a social life or not.

Around the 4:30 mark of the talk, she shows video of a man walking with a cheap, single-axis knee prosthesis currently on the market, and then a man walking with the ReMotion Knee. The difference is pretty amazing.

More than 5,000 amputees have been fitted for the knee, and Donaldson said nearly 80 percent of them are still wearing it six months later.

Donaldson pointed out a few keys to designing a product that will be able to reach the users who need it, no matter how low their income:

Continued on next page

Company:D-Rev

CEO:Krista Donaldson

Website:http://d-rev.org

Twitter:@d_rev_org

MEDCITY Reports36December 2013

Startups In-Depth: Medical Devices & Diagnostics

D-Rev (Continued)

It needs to perform as well as or better than prod-ucts on the market, in both technical performance and human performance.

Most medical devices are designed for Western-ers, Donaldson explained, but D-Rev’s customers do different things like squat, kneel in prayer and sit cross-legged more often.

Designers must not be user-centered but user-ob-sessed, considering the experience of everyone who’s going to touch the product. It needs to be market-driven instead of relying on being donated or heavily subsidized. In order to create impact, it should create actual value to the end user while also being affordable.

MEDCITY Reports37December 2013

Startups In-Depth: Medical Devices & Diagnostics

Vibration and neurostimulation ease the ouch of needle sticks in this startup’s med devices

By: Deanna PogorelcDec. 30, 2013

For the healthcare industry, the pain caused by a needle prick is more than just a momentary annoyance. Needle pain and fear is thought to have a more serious effect on compliance with immunizations, injectible drugs and blood draws.

“If pain decreases, compliance goes up, and if compliance goes up, out-comes get better and costs go down,” explained Tim O’Malley, CEO of Innova Medical Design.

Rather than trying to replace needles in medicine with painless microneedles or light sensing technology, Innova Medical Design is adding onto them with a combination of neurostimulation and vibration, with the goal of blocking pain signals at the sight of an injection, blood draw or IV.

The company’s pain relief devices are based on the gate control theory of pain, which projects that pain messages encounter “nerve gates” in the spi-nal cord that control whether they will reach the brain. Sensory nerve fibers triggered by other kinds of stimulation, like rubbing your elbow after you bump it, are thought to essentially reach the nerve gates faster and override or block the pain signals.

Innova has developed a technique that combines vibration with a few kinds of transcutaneous electrical nerve stimulation (TENS) to “occupy” nerve end-ings and reduce or block pain. Its first two products apply the technique to

Continued on next page

Company:Innova Medical Design

CEO:Tim O’Malley

Website:www.innovamedicaldesign.com

MEDCITY Reports38December 2013

Startups In-Depth: Medical Devices & Diagnostics

Innova Medical Design (Continued)

pediatrics and diabetes.

At the top of the company’s pipeline is an adhesive patch that’s placed on a child’s arm when he’s about to get a shot or have an IV inserted.

Embedded in the patch are two dual-layer elec-trodes. When a reusable stimulation device is placed on top of the electrodes, it transmits the TENS and vibration signals that create a comfort-able sensation on the arm during needle insertion.

O’Malley said the pediatrics market seemed to be the lowest-hanging fruit for this technology, as fear of needles tends to be obviously troublesome in children. But the company would also like to move into additional consumer pain models once it gets an initial device on the market.

To get that initial product on the market, O’Malley said he’s looking to raise about $2.5 million to $3 million to complete a final design of the patch and obtain 510(k) FDA clearance.

Additional funding beyond that would allow Innova to simultaneously commercialize a lancet it’s been developing with the same TENS/vibration mech-anism, to block daily pain for diabetics when they check their blood sugar and inject insulin.

In a pilot test with 24 people, two-thirds of the subjects experienced an average reduction of pain of over 60 percent when using the device, O’Mal-ley said. It would only cost two or three dollars more to make than a standard lancet, he added.

Because both the lancet and TENS technology have been around for decades, O’Malley sees a well-defined and relatively quick regulatory path for the devices. “We’d like to produce a new prod-uct every nine months for three years after initial launch,” he explained.

Minneapolis-based Innova formed in early 2009 out of a relationship between O’Malley, a medical device executive with a background in diabetes and neurology products, and Dr. Mel Vallero, an emergency medicine physician at Kaiser Perma-nente.

“What was attractive about this particular idea for needle pain is that Dr. Vallero, being an ER doctor, had a very pragmatic sense of doing something rather basic,” O’Malley said. “There is more em-phasis now on the more pragmatic things that we do every day, where if we could improve those, the significance to compliance and cost could be as significant as those big medical breakthroughs.”

MEDCITY Reports39December 2013

Software to interpret EEG for neurological disorders gets proof-of-concept fundingDec. 3, 2013

A medical education teaching tool and software to speed up the diagnosis of electroencephalograms were a couple of the research projects picked for funding in the University City Science Center’s QED Proof of Concept program.

http://bit.ly/1hhu2qK

Startup Activity: Medical Devices & Diagnostics

Medical device maker nets $4.7M to tackle peripheral artery disease complicationsDec. 23, 2013

Medical device company Intact Vascular, which is developing tools to help the 8 million people with peripheral artery disease, has raised fresh capital.

http://bit.ly/1e664fK

SynCardia raises another big round to build a new version of artificial heartDec. 18, 2013

An artificial heart maker in Tucson, Ariz., has raised $14 million to go small with its temporary Total Artificial Heart.

http://bit.ly/1dWM0MO

MEDCITY Reports40December 2013

Most Popular Startups This Month

2) ThermalCore

The San Jose startup is planning the first clinical trial on its mission to add hyperthermia to the arsenal of cancer treatment options.

Driven to find an alternative for his patients who had run out of treatment options for their cancer, gynecologic oncol-ogist Dr. James Lilja came across a heat-based therapy called hyperthermia.

Read more: http://bit.ly/1kSqQBS

1) InnoVital Systems

A new licensing agreement with Maryland tech company InnoVital Systems marks an important milestone for the Cleveland Clinic’s commercialization arm as the first such deal to come out of its seven-member Healthcare Innova-tion Alliance.

InnoVital Systems, which develops sensors, robotics and electronics for the defense industry, licensed patent rights from Cleveland Clinic Innovations and Maryland health system MedStar Health for a device that would help patients with severe lung and neuromuscular diseases breathe.

Read more: http://bit.ly/1eYM2bU

3) iHealth A smart cuff may be able to save your life by alerting you when you’re at a high risk of a heart attack or stroke ... Read more: http://bit.ly/1g3cApw

4) Tissue Regenix Wound Care Inc A British medical device company that opened its American subsidi-ary in San Antonio last year is preparing to commercially launch its first product in the United States ... Read more: http://bit.ly/1jYpoA7

5) Doctor on Demand This healthcare startup that is using mobile phones and iPads to provide video access to physicians has raised $3 million in seed funding ...Read more: http://bit.ly/IYYYQN

A list of the five startups that got the most attention from readers on MedCityNews.com.

MEDCITY Reports41December 2013

stonearchcreative.com

EXPERTS INHEALTH MEDICALMARKETING