Monthly Startups Index - GHDonline · Startups In-Depth: Digital & Health IT ‘Free the data’...

MEDCITY Reports1January 2014

This report sponsored by

Monthly Startups Index

January 2014


Table of Contents

MAIN CONTACT INFORMATIONMedCity MediaP.O. Box 606246Cleveland, OH 44106Phone: (216) 453-2662General inquiries: [email protected]

From the Editor 312

Most Popular Startups This Month 495

Digital & Health IT 4

Startups In-Depth 5

Startup Activity 18

3 Pharma & Biotech 20

Startups In-Depth 21

Startup Activity 28

4 Medical Devices & Diagnostics 29 Startups In-Depth 30

Startup Activity 48

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

MEDCITY Reports3October 2013

From the Editor

Every month in the Startup Index, we publish a list of the startup stories that got the most attention. (Find the list at the end of the report.)

There is usually a common thread among the companies in the list - geography, focus, industry sector. This month the list is all over the place.

1. Rx Savings Solutions

2. Clean Bite

3. Glow app

4. B-Shoe

5. Smart Vision Labs

So we’ve got a tool for managing expensive drugs, a no-water-needed toothbrush, a fertility app, shoes to stop falls and a small, cheap, portable eye exam device.

The initial customer for these companies is an individual with a particular problem, but the benefits of these products stretch into the business of healthcare.

If more people take their meds as directed - if more people can afford to get their meds in the first place! - that has the potential to reduce readmissions and to make more money for the drug companies.

The CDC estimates that falls cost the country’s healthcare system $30 billion in direct medical costs. This doesn’t even take into account how life-shattering a fall can be for an individual - loss of independence, loss of mobility, pain and often death.

In developing countries, untreated vision problems often lead to blindness and there are very few healthcare providers who can do vision exams.

The cost of blindness could go up to $4.3 million per year in sub-Saharan Africa.

There is so much going on. There are so many people working to change every aspect of healthcare.

Yes, there is duplication of effort.

Yes, many of these companies will fail.

But our fee-for-service, expensive and inefficient system won’t survive the current momentum, the new access to data, the focus on reducing unnecessary care and the emphasis on changes that benefit the patient.

The healthcare executives and investors and entrepreneurs currently working to change America’s healthcare system will be remembered as the ones who made “innovation in healthcare” a reality, instead of just a meaningless phrase.

Veronica Combs, Editor in ChiefMedCity Media

Why the January top 5 startup list for January makes me optimistic about innovation in healthcare

http://medcitynews.com/2014/01/personal-shopper-prescription-medications/

http://medcitynews.com/2014/01/sink-problem-edible-toothbrush-aims-make-oral-hygiene-easier-accessible/

http://medcitynews.com/2014/01/pregnant-mhealth-app-upgrades-add-fertility-tracking-tools-undecided/

http://medcitynews.com/2014/01/shoes-seniors-go-high-tech-prevent-falls/

http://medcitynews.com/2014/01/med-tech-startup-takes-1m-prize-verizon-competition/

http://www.cdc.gov/HomeandRecreationalSafety/Falls/fallcost.html

http://www.cdc.gov/HomeandRecreationalSafety/Falls/fallcost.html

http://www.cureblindness.org/world-blindness/

http://www.cureblindness.org/world-blindness/


Digital & Health IT


Startups In-Depth: Digital & Health IT

By: Stephanie BaumJan. 23, 2014

A mobile health startup launched by PayPal co-founder Max Levchin and led by Mike Huang to help women seeking to get pregnant monitor their fertility has updated its app to broad-en its audience.

It has added components to its Glow app to make it relevant to women who may want to have a child in the near future or a few years from now. It also added an app for Android users.

Among the new settings for Glow’s app are profiles for women who fit under the category “considering pregnancy” or “not trying.”

A new interface in the app questions women’s fertility priorities and as-signs them into the relevant group.

Its tools help them track their men-strual cycle and risk of getting preg-nant. It also flags potential problems women may want to check out such as endometriosis and PCOS.

The idea is to give women a better understanding of potential challeng-es to getting pregnant in the future and to help identify potential prob-lems with their reproductive health.

A data analysis component, Glow Genius, relies on information users log each day to track their health.

It formed a partnership with MyFit-nessPal to integrate user data on things like body mass index, nu-

trition and fitness data and analyze that with other user data. It adds to that insights gleaned from medical journals and medical advisers to better assess when a woman has the best chance of getting pregnant.

In response to the fact that IVF treat-ments aren’t covered by insurance in most states, Glow also has an opt-in fund to help users defer infertility treatment costs. Users contribute $50 a month to the fund for 10 months. The contribution pool is equally divided among any partic-ipants who aren’t able to conceive naturally during the 10 months.

The company added a community forum at the end of last year for women to share news about their pregnancy, share insights and ask questions. The company, which is part of HVF Labs, claims that more than 1,000 women have become pregnant using the app.

Some of the other app develop-ers focused on the fertility market include Ovuline, Clue and Fertility Friend.

Another startup with a fertility focus, Sandstone Diagnostics, is looking at the issue from a man’s perspective. It developed a Trak Fertility device to monitor sperm count. Sandstone is in the process of testing the effec-tiveness of the device with plans to submit it to the FDA for 510(k) clearance later this year. It also is looking to add an app to help users monitor their sperm count over time.

Company:Glow

Co-founder:Max Levchin

Website:https://www.glowing.com/

Fertility app to help women get pregnant taps new audience: the undecided



‘Free the data’ meets quantified self in 23andMe co-founder’s startup, Curious


A new company developed by one of the two co-founders of 23andMe wants to help patients not only analyze their data, but influence how it is used. It re-flects the “Free the Data” movement to not only eliminate data silos but also make patients’ own data more accessible

Linda Avey founded Curious (@Wearecurious) to help people interpret per-sonal data in a way that goes beyond the data generated by 23andMe’s platform. It also envisages patients highlighting medical issues of interest to them.

The company’s approach encourages users to put on virtual lab coats and pose health questions based on their environment and diet, for example. Its website includes a scroll of questions from users such as ‘Is diet a factor in cancer?’ and ‘Do blood-glucose or insulin levels correlate with an increased risk of Alzheimer’s disease?’ It is also working to help disease foundations develop data sharing platforms.

In an interview with Bionic.ly, Avey said:

“Curious is a natural extension of ideas I had at 23andMe. But now we’re giving total control of the question-asking to the user. With the madcap emer-gence of sensors, devices and other sources of personal data, my co-found-ers and I see a need to rope it all together in a single place to enable explora-tion and discovery.”

Company:Curious

Founder:Linda Avey

Website:http://wearecurio.us/

Twitter: @Wearecurious



GenePeeks’ ‘digital babies’ technique aims to steer future moms to safer sperm donors

By: Deanna PogorelcJan. 27, 2014

When couples or hopeful mothers turn to a sperm bank to help them con-ceive, they’re presented with a slew of choices about their preferences for a potential donor: brown eyes or blue? What skills are desirable? What is his family medical history?

A Cambridge genetic technology firm is looking to add a new dimension of consideration to that selection process by looking inside of both the woman’s and the potential donors’ DNA for hidden disease risks. It digitally marries the genetic profiles of a woman with potential donors, to predict whether their hypothetical child would be at risk for hundreds of recessive conditions.

Sperm banks now screen donors for infectious disease and to see if they are carriers for a handful of genetic diseases, said GenePeeks CEO Anne Mor-riss. What her company does isn’t carrier testing but something with a more expansive breadth and scope.

To put it simply, GenePeeks gathers raw, sequenced DNA data from a male and female and creates thousands of virtual gametes that represent potential genetic profiles of that couple’s hypothetical child.

Then, an algorithm goes to work, probing NIH clinical databases and us-ing protein modeling to calculate whether variants present in those genetic profiles would likely result in damaged protein production – in other words, whether they would actually be likely to cause disease in that child.

“We’re not looking at carrier status in the hypothetical child,” explained Lee Silver, the Princeton University molecular biology professor who invented the algorithm. “We’re actually simulating the gene expression in each child and looking at whether a hypothetical genome is likely to have a disease.”

Company:GenePeeks

CEO:Anne Morriss

Website:www.genepeeks.com/

Twitter: @GenePeeks

Continued on next page


GenePeeks (Continued)

The result is a personalized catalog delivered to the client that features the pool of donors whose DNA is, for lack of a better phrase, most compatible with hers in terms of low perceived disease risk for the child.

Silver said the first version of the test launching this spring will focus on 500 single-gene dis-eases. These are diseases like cystic fibrosis and spinal muscular atrophy that are extremely well-understood at the genetic level and are caused by mutations on a single gene.

There are limitations to the test, of course. It can’t predict spontaneous mutations and can’t predict chromosomal anomalies, like Down syndrome, that develop during or after fertil-ization.

And there’s the cost factor — Morriss said a personalized catalog of risk-reduced donors will come at a price tag of about $2,000, paid out-of-pocket by the client. “As we grow, we hope to engage payers,” she explained.

GenePeeks, which is backed by two East Coast venture firms, has just secured patents on its algorithm and is working on validating its tech-nology through what Morriss called a “massive virtual clinical trial.” It’s using data from the 1,000 Genomes Project to create a million virtual children and explore the incidence that the algorithm predicts for each disease.

Meanwhile, the Cambridge company is work-ing with Manhattan Cryobank and European Sperm Bank USA in Seattle to begin building a network of sperm donors. Once it creates a sizable database of donor DNA data, the com-

pany will be able to begin offering its service to couples and women who are looking for sperm donors. Morriss said she expects that will hap-pen by April of this year.

The company’s mission hits close to home for Morriss, an entrepreneur and founder of the Concire Leadership Institute in Cambridge.

Unbeknownst to her, Morriss was a silent carrier for a condition called MCADD deficiency.

Unfortunately, so was the sperm donor she and her partner chose five years ago when planning for their first child.

Their son, Alex, now lives with the rare and po-tentially fatal genetic disorder that prevents the body from converting certain fats into energy.

“We’re inviting people to go through a screening process that includes both potential mother and potential donor and looks at what happens when they come together,” she explained.

What it doesn’t do, Morriss and Silver clarified, is provide genetic analysis for individuals. Although the process for using GenePeeks’ services starts out like that of 23andMe’s, for example — customers return a DNA collection kit sent in the mail – it doesn’t return any of that traditional analytic information, like whether a woman is a carrier for a particular disease.

“We’re all carriers for diseases, but that doesn’t actually tell us much about reproductive risk,” Silver said. “It’s the combination of the woman and the man together that causes likelihood of a particular disease in a child. That’s one reason I believe this algorithm is so important. “



Google-backed DNAnexus gets $15M to be a hub for all that sequencing data


It’s already working with partners like Stanford University, Baylor College of Medicine and Google, but DNAnexus said today it’s restocked with $15 million from investors to keep pushing adoption of its enterprise platform for DNA sequencing data.

Claremont Creek Ventures, Google Ventures, TPG Biotech and First Round Capital funded the company’s Series C, which CEO Richard Daly said in a statement would help it accelerate commercialization and better support the labs already using its platform.

DNAnexus offers cloud-based solutions that sequencing facilities, diagnos-tic testing labs and research centers use to manage, access and analyze sequencing data and collaborate with other scientists.

It’s working with Amazon and Baylor to provide a cloud-based infrastructure for the Cohorts for Heart and Aging Research in Genomic Epidemiology Con-sortium, an initiative to study how human genetics relates to heart disease and aging. It’s also working with Stanford on the 1000 Genomes Project, which developed a large catalog of human genetic variation.

The Mountain View, Calif., company said it’s “experiencing rapid customer adoption,” but it’s also got plenty of competition from others like Knome and Spiral Genetics.

Google Ventures joined in the company’s investor syndicate with its $15 million Series B in 2011. “The next wave of insights in genetics comes from multi-institutional collaborative efforts producing huge amounts of data,” general partner Krishna Yeshwant said in a statement. “DNAnexus has creat-ed a system where large enterprises, laboratories and individuals can collab-orate more efficiently using modern cloud technologies.”

Company: DNAnexus

CEO:Richard Daly

Website:www.dnanexus.com/

Twitter: @dnanexus



How hospitals, Big Pharma are updating staff training with mobile games


Patients aren’t the only ones who are poised to benefit from gamification in healthcare.

In between rounds at hospitals like Mayo Clinic and Baylor College of Medi-cine, clinicians are answering quiz questions and participating in challenges on their cell phones and tablets. Their hospitals are working with a Harvard spinoff called Qstream to encourage continuous learning and training among their care teams.

“Our co-founder got into this looking at medical education and asking, is this actually working? And he discovered that people are forgetting most of (the material),” said Duncan Lennox, Qstream’s CEO. “That led him down the road of saying, what if we instead looked at it from the point of neuroscience and psychology? Can we build a system more aligned with how that works?”

Qstream’s strategy is simple: Rather than “brain dumping” information on clinicians or medical students, it works with hospitals to deliver a set of sce-nario-based questions to their mobile devices over spaced intervals of time. The questions can be multiple choice, check-all-that-apply, fill-in-the-blank or open-ended, and are usually developed by the client facility.

The idea is for the clinicians and students to spend just 3 to 5 minutes a day learning and refreshing their memories on critical skills by answering the questions.

Company:Qstream

CEO:Duncan Lennox

Website:http://qstream.com/

Twitter: @qstream



Qstream (Continued)

Pediatric faculty at Baylor, for example, developed a set of questions on a range of primary care is-sues that were sent out a few at a time, every other day, to pediatric residents. To encourage partici-pation, Qstream integrated game elements into its platform so users can score points, land on leader boards and see how their colleagues are doing.

The algorithm behind the platform shuffles and changes the content that people see based on how they’re doing. At Baylor, the residents needed to answer each question correctly at least twice before it was removed from their question queue.

The platform is based on an interval reinforce-ment technique developed and studied by Dr. B. Price Kerfoot, an associate professor of surgery at Harvard Medical School. Kerfoot and his Harvard colleagues have run more than a dozen random-ized trials of the technique in various countries and specialties, where it’s demonstrated an ability to improve long-term knowledge retention and change behavior.

Lennox said the area of patient safety has been a big priority for hospital clients recently. “The idea is to make sure that staff, and not just clinical staff, understands policies and regulations and proce-dures – for something as simple as hand hygiene to various other quality metric projects.”

On the back-end, faculty or supervisors can keep tabs on how the participants are doing. Qstream’s

analytics allow them to measure how much scores have improved over baseline, identify problem areas and pick out users who are struggling in a particular area.

Although it was developed with healthcare in mind, Lennox said that as Qstream progressed toward commercialization, the team realized it had some-thing much bigger – it had an effective, efficient and fun way to learn anything. Today the platform is also used as a salesforce education tool by a host of retail, financial services and technology companies.

It’s also got a solid clientele of life science com-panies, including Intuitive Surgical and Boehringer Ingelheim. “Clinicians can get a lot of information online, so it’s harder in today’s world for a drug rep to add value to a physician,” Lennox explained. “They need to be up to date on the latest clinical research, and a lot of that is very difficult material.”

Qstream offers its mobile service via an annu-al subscription charged per-user. According to Lennox, it’s serving customers in 12 languages and sent out some 200 million questions last year. It works in the mobile medical education sector alongside companies like Epocrates and Nearpod.

The Burlington, Mass., company was founded in 2008 and is backed by Frontline Ventures, Launch-pad Venture Group, Delta Partners and Enterprise Ireland.




Google has been fine tuning its search engine to produce better, more targeted search results in what it refers to as a Knowledge Graph.

Facebook has synthesized its users data to illustrate shared interests in social graphs.

One company is applying those big data graph concepts to healthcare.

Healthcare IT startup Lumiata, for-merly known as MEDgle, developed a predictive analytics platform that synthesizes vast amounts of data to produce a “medical graph.”

Its aim is to help diagnose and treat patients more rapidly. Khosla Ven-tures has invested $4 million in the business as part of a Series A round to help commercialize the technology later this year.

The company has sourced data on symptoms, diagnoses, procedures and medications from textbooks, journals and institutions such as the Centers for Disease Control and the National Institutes of Health for its algorithms. Data is also sourced from de-identified patient records.

Applications include helping nurse call centers hyperpersonalize patient triage and providing a reference tool for doctors to speed up diagno-ses and treatment plans. It also has broader population health applications. The predictive ana-

lytics tools are available as applica-tion programming interfaces or APIs.

The investment gives Khosla Ven-tures a seat on Lumiata’s board.

In a statement on its investment, Vi-nod Khosla said: “Lumiata’s medical graph helps providers ensure they’re giving the right care, at the right time, from the right person so they can deliver better value-based health to more patients.”

In a phone interview, Lumiata CEO Ash Damle told MedCity News that 10 to 20 hospitals, health systems and payers are piloting the platform.

Damle said nurses are using the ana-lytics tool before and during a patient visit to guide which lab tests to order or which procedures to recommend.

Since MEDgle’s launch last year, the company has more than doubled in size to 10 full-time staff.

Among recent additions is Wil Yu, a former director with the Office of Na-tional Coordinator, who is heading up the company’s innovation strategy.

The platform also has applications for population health to assess specific patient groups and better understand their cause and treat-ment options.

“We are talking about bringing pre-dictive analytics to all aspects of healthcare,” he said. “We strongly believe there will be continuous movement to value-based care.”

Company:Lumiata

CEO:Ash Damle

Website:http://lumiata.com/

Twitter: @Lumiata

Inspired by Google and Facebook, predictive analytics platform Lumiata raises $4M from Khosla



Rimedio built an elaborate virtual marketplace to fix broken B2B healthcare sales models


Pharmaceutical and medical device sales models are changing, but it’s still getting harder and harder for companies to get face time with physicians.

Richie Bavasso and Dr. Leo Herbette have a solution they think could help put trust back into the relationship among healthcare providers, manufactur-ers and payers.

They co-founded Rimedio, a virtual e-commerce site for healthcare busi-ness-to-business transactions, that’s soft-launching next month. The goal is to bring together providers, payers and manufacturers not only to socialize, but to engage in business transactions, like exchanging content, services or products.

“The original vision was a professional, regulatory-compliant social network where hospitals, payers, government and manufacturers could collaborate,” said Bavasso, a former hospital administrator and pharmaceutical marketing consultant. “But you can’t do business on that kind of site. Why can’t I, on LinkedIn, reach out to someone and say, can I show you my product? And if they’re interested, they can buy it right there.”

What’s interesting about Rimedio’s approach is that it puts healthcare provid-ers – the customers – in control of their relationships with manufacturers.

“Industry has always controlled the conversation” by sending representa-tives on sales calls to physician offices, Bavasso said. Rimedio changes the approach from vendors pushing their information to stakeholders, to those stakeholders pulling in the information, services and products that are most relevant to them.

When the platform launches, healthcare providers will be able to set up Ri-medio profiles and use the platform as a single access point to interact with

Company:Rimedio

Co-founders:Richie Bavasso and Dr. Leo Herbette

Website:www.rimedio.com/



Rimedio (Continued)

multiple companies, Bavasso said. They can use it to send inquiries to manufacturers, receive inqui-ries from companies that they want to hear from, and work with sales representatives they know and trust.

On the platform, those sales representatives are called agents. Rimedio requires all agents to pass a background check, have a demonstrated medi-cal background and complete 13 hours of compli-ance and best practices training.

Agents create profiles that convey their skills, experience and existing healthcare provider rela-tionships (providers can also publicly indicate their “favorite agents” on their own profiles).

Manufacturers can use the platform to post oppor-tunities for these independent agents and hire the ones with optimal experience and relationships for that specific opportunity’s set of target customers.

If a medical device company, for example, wants to recruit a focus group around a new product it’s developing for cardiologists, it would create a posting for an agent who’s well-connected within that specialty.

Companies should also like the platform, Bavasso said, because it allows them to share resources. The platform features a web conferencing tool, reporting and analytics, a payroll tool and an iPad app.

Providers, agents and manufacturers will be able to sign up for free. Rimedio will only get paid when

a transaction is successfully completed and vali-dated by the provider, Bavasso said.

The software has been built and tested; now the big question is how to attract a critical mass. “Building a software platform was a piece of cake compared to building a community,” Bavasso said.

In addition to Bavasso and Herbette, a former professor of medicine and pharma consultant, the Hartford, Conn., company’s board of directors includes medical, pharmaceutical, legal, social net-working and marketing leaders including Dr. How-ard Luks and digital media entrepreneur Mitchell Davis.

The launch strategy is to get a group of agents on board first, then move to pharmaceutical and medical device companies, who he hopes will be intrigued by the opportunity to hire agents for specific projects based on their experience and relationship.

Then, the doctors could be persuaded to join, he reasoned.

But that’s all a bit of a question mark at this point. Will Rimedio be able to find the reps who have the access they claim to have? Will doctors come?

Rimedio will soft launch with four manufacturers and a set of agents on February 1. Bavasso said he’s hopeful that if manufacturers continue to come on board from there, the platform would be open for physicians to join by June 1.



Shoes for seniors go high-tech to prevent falls


Sensors and apps designed for seniors and their caretakers may be able to detect when falls occur, but Dr. Yonatan Manor wanted to take that a step further.

He assembled a team of doctors and engineers to prototype a smart shoe that they think might be able to prevent falls when they’re about to occur.

The so-called B-Shoe is a walking shoe that incorporates pressure sensors, a microprocessor, an algorithm, a motion device and a rechargeable battery. When the sensor and algorithm detect imbalance, they prompt the motion device to perform a backward step to help the wearer regain balance. It operates only when imbalance is detected and is designed for use by seniors or by people who are injured, physically challenged, sick or in post-surgery recovery.

According to the CDC, falls are the leading cause of both fatal and nonfatal injuries among older adults.

B-Shoe Technologies, based at the hiCenter Business Incubator in Haifa, Israel, is in the prototype and testing phase of development. It’s about a third of the way to its $30,000 goal for its Indiegogo campaign that runs through February 10.

“We are currently seeking investment that will allow us to complete the regu-lation process, miniaturize the entire mechanism and start mass production,” the company writes on its website. “We estimate about two years for this to happen.”

Company:B-Shoe Technologies

Creator:Dr. Yonatan Manor

Website:www.b-shoe.com/



Stop the duplicate medical images! SaaS firm crowdfunds ‘people-focused’ image sharing


There’s too much time and distance involved in sharing medical images to-day, says the team of physicians and computer scientists at MyMedImage.

Instead of patients carrying CDs or printouts of ultrasounds, MRIs, PET scans, mammograms and other diagnostic images from doctor to doctor, MyMedImage wants to enable them to manage, share and store their own images — and to do it for free.

That’s a lofty goal. To help it get there, the physician-led California startup is campaigning to raise $200,000 through Indiegogo.

CEO Dr. Christopher Hancock said MyMedImage circumvents the interop-erability of hospital systems’ EMR and picture archiving and communica-tions systems. It’s a DICOM-compliant, cloud-based service designed to let patients and providers upload, archive, transmit, download and transmit images.

The lack of sharing of diagnostic images between healthcare systems hinders communication between patients and doctors, and sometimes even delays care decisions because images have to be re-taken, or transported physically via CD. That’s a problem that’s addressed in the upcoming stage 2 of mean-ingful use.

MyMedImage is positioning itself as a people-focused solution to a medi-cal-business-created problem.

Company:MyMedImage

CEO:Dr. Christopher Hancock

Website:http://mymedimage.com/

Twitter:@MyMedimage


MyMedImage (Continued)

“A lot of systems charge millions of dollars for pic-ture archiving and communications systems – do they truly want them to be interoperable?” Han-cock said. “We’re designed to participate through HL7 and other interoperability standards. We’re taking standardized DICOM data and stripping all of the vendor-specific data to make it available to any kind of software.”

The vision is that a patient could obtain a CD of their image, upload it to MyMedImage and push a button to export to whatever imaging facility or hospital system they wish. Then, the appropriate providers could access patients’ images on a computer or mobile device, potentially preventing duplicate medical images. By serving as a tele-

medicine tool, the company thinks it could also enable specialized care to underserved areas of the world.

Hancock said the system would be free to patients and paid for by an imaging facility, a payer, a phy-sicians practice or a hospital, for example.

The team bootstrapped development of the software and now needs to hire additional staff to handle the 24/7 tech support to scale, Hancock said. The Indiegogo campaign, which has brought in a little over $10,000, goes through the end of the month.

Cool idea, but I wonder if it will encounter some of the same challenges of PHR adoption?


Startup Activity: Digital & Health IT

7 healthcare big data projects get Knight Foundation funding to push for public health – Jan. 1, 2014

An online portal connecting researchers with people willing to share their health data, a community health dashboard and a text-based counseling program for teens were the big winners of The Knight Foundation’s $2.2 million health data challenge.

http://bit.ly/1fA07IP

As Zephyr Health brings data analytics to life sciences, it picks up $15M – Jan. 8, 2014

Some big data analytics companies strive to stand out with real-time mobile applications, captivating visualizations or extra-simple search functions. And then there are startups targeting specific industries, like Zephyr Health, which takes in different kinds of data and displays findings in vertical-specific applications.

http://bit.ly/1firLfg

Audax Health confirms UnitedHealth and Audax merger documents – Jan. 23, 2014

An Audax Health spokeswoman confirmed that UnitedHealth and Audax were granted approval by the FTC for early termination, an important step in significant merger and acquisition deals.

http://bit.ly/1eVWBIb

Buoyed by mobile health trends, TigerText raises $21M in Series B round – Jan. 27, 2014

One significant area of health IT growth has been in companies that have responded to the dual need for improving communication between medical staff to reduce errors and duplicated tests and the security challenges the growing Bring Your Own Device trend poses. TigerText is a big player in that space. It’s raised $21 million to further expand its network of hospitals and health systems.

http://bit.ly/1iPC0e4

Can better care plans increase adherence between patient office visits? Merck’s picks will see - Jan. 27, 2014

One of the frustrating aspects of getting patients to follow a care plan is the inability to have a clear window to pa-tient activity between office visits. If care providers had more information about their patients between those visits, they might get a better understanding of why so many fail to complete cardiovascular rehabilitation programs, a widely reimbursed 12-week program implemented when patients have had a heart attack. The program suffers with a 25 percent adherence rate.

http://bit.ly/1f8UC3d

Dermatology app zeroes in on children’s skin problems – Jan. 21, 2014

Dermatology app developer iDoc24 has expanded the focus of its teledermatology platform to include children’s skin problems with its iOS mobile health app that responds to parents’ concerns over rashes or an unusual skin problem with their children and infants.

http://bit.ly/1dt2utQ

http://bit.ly/1fA07IP

http://bit.ly/1firLfg

http://bit.ly/1eVWBIb

http://bit.ly/1iPC0e4

http://bit.ly/1f8UC3d

http://bit.ly/1dt2utQ


Startup creates mobile app aimed at completely eliminating trips to the pharmacy – Jan. 8, 2014

Imagine being able to submit your prescription right from your doctor’s office in 10 to 15 seconds and having the medicine delivered to your office or home within a couple of hours. No extra drive and agonizing wait at the pharma-cy -- or worse, the chance that you procrastinate and never get that prescription filled.

http://bit.ly/1bagNnf

Startup Activity: Digital & Health IT

Startup OnBeep making a wearable device that will ‘directly change the lives of everyone on the planet’ – Jan. 3, 2014

A Form D filing reveals that the mobile health startup Lark Technologies has raised $3.1 million from six investors and could continue raising another $450,000. The device tracks sleep time and patterns and can be purchased alongside additional sleep coaching services.

http://bit.ly/1mPr5OX

VCs bet $100M that Health Catalyst can take on Oracle and IBM in big data healthcare – Jan. 28, 2014

Health Catalyst is betting that every hospital will need a data warehouse to organize and visualize its data.

http://bit.ly/1n1iZ5R

WellDoc attracts funding from Merck’s investment arm as part of $20M strategic financing – Jan. 10, 2014

In the run-up to WellDoc’s commercial launch of its mobile health prescription app for Type 2 diabetes, it has fo-cused exclusively on angel investors for fundraising. In a shift from that strategy, it has attracted investment from two institutional investors in a $20 million strategic financing deal, according to a company statement.

http://bit.ly/1dDsu6v

Online research study tools, MD performance measures among new Blueprint Health ac-celerator members – Jan. 19, 2014

Medical staff performance tools, health literacy and an online platform to develop and carry out research studies are among Blueprint Health’s fifth class of health IT startups.

http://bit.ly/1jNXHvo

xG Health Solutions CEO: We are not looking for every customer – Jan. 15, 2014

Geisinger Health System’s spinout company, xG Health Solutions, may be looking for provider customers for its healthcare analytics tools and consulting business to help them convert from fee-based to outcomes-based care, but it’s pretty selective.

http://bit.ly/LsPSNt

http://bit.ly/1bagNnf

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Pharma & Biotech


Startups In-Depth: Pharma & Biotech

Avelas’ luminous mapping technology to guide breast cancer surgery attracts $6.85M


The development of ways to illuminate cancerous tissue to guide surgeons is a life science innovation that’s attracted a growing amount of interest. Avelas Biosciences has raised $6.85 million as part of a Series B round to advance its fluorescent peptide Cancer Illuminator through the proof-of-concept stage, according to a company statement.

This is how the treatment, based on technology developed by Nobel Prize winner and Avelas co-founder Roger Tsien, works: The fluorescent peptide illuminates the presence of cancerous tissue. When it is used with a fluores-cence imaging camera system during surgery, a color-coded image showing cancerous tissue is superimposed onto the surgical view and maps the can-cer location for the surgeon.

Although breast cancer is the lead indication, the technology could be ap-plied to other types of cancer. Avalon Ventures led the round and new inves-tors Torrey Pines Investment, WuXi AppTec and an unnamed investor also took part.

One advantage of Avelas’ platform is that it can help surgeons evaluate tumor samples in real-time. According to the company, the fluorescent peptide pro-vides enough information to make a decision during the first surgery. Current practice requires doctors to wait for the results of pathology reports before they perform a second operation that can drive up healthcare costs and add to patient risk.

Avelas was founded by Avalon Ventures on technology from Tsien. He won a Nobel Prize in chemistry in 2008 for his discovery of the green fluorescent protein, as Xconomy points out. Among some of the companies that are developing their own approach to illuminating tumors for cancer surgery are Blaze Bioscience and Presage Biosciences.

Company:Avelas Biosciences

Founder/CEO:Roger Tsien

Website:http://www.avelasbio.com/



Biopharma company raises $21.5M to treat inflammatory skin disorders


A biopharma management company has created a new business that will use liver X receptor agonists to take on dermatological disorders. NeXeption has raised $21.5 million in a Series A financing round to form Alexar Therapeutics, according to a company statement.

New Science Ventures and Third Point Ventures led the financing round and will each get a board seat. Palo Alto Investors also participated in the round. They will fund the initial development of Alexar’s lead compound, A-110, a topical LXR agonist to treat inflammatory cutaneous disorders.

Alexar is developing a portfolio of Liver X receptor (LXR) agonists. LXR ago-nists are members of the nuclear receptor superfamily that directly interacts with and regulates genetic pathways. They also have and exhibit potent anti-inflammatory activity. LXR agonists have generated interest as a source of life science innovation with the potential to treat conditions such as athero-sclerosis and Alzheimer’s disease.

Dr. Neal Walker is a dermatologist and serial entrepreneur who will serve as vice chairman of the new business. He is also the CEO of dermatology treatment developer Aclaris Therapeutics. “There is a growing need among patients and physicians for innovative therapeutics that treat inflammatory skin disorders…. This portfolio of products has a well-established mecha-nism of action applicable to a number of indications in dermatology as well as demonstrated potential in other therapeutic areas,” he said.

Dave Pfeiffer will lead the company as CEO. Prior to Alexar, he worked for surgical device and aesthetics company Ellman International as chief com-mercial officer and executive vice president. He also has 25 years of expe-rience as a senior executive at both large and small life science companies. Steve Tullman, managing partner of NeXeption, will serve as chairman of Alexar’s board of directors.

Although the company declined to detail specific conditions it would target, cutaneous disorders affect skin, hair, nails and related muscles and glands and could include dermatitis.

Company:Alexar Therapeutics

CEO:Dave Pfeiffer

Website:www.alexartx.com/



Biopharma using fungal carbohydrate for innovative cancer immunotherapy raises $3.6M


Biopharma startup ImmuneXcite is developing an immunotherapy to treat cancer that depends on an innovative catalyst — a fungal carbohydrate.

The life science innovation relies on neutrophils, white blood cells that repre-sent the body’s first defense against fungal and bacteria infections. By chem-ically linking this carbohydrate to cancer-targeting monoclonal antibodies, neutrophils are drawn to the site of tumors and initiate destruction, according to a company statement.

The scientific founder of Lexington, Mass.-based ImmuneXcite discovered the fungal carbohydrate. In a Series B round, the company secured $3.58 million in second-round financing from new and existing private investors. In 2011, it raised $2.42 million in its first round of financing and also received a $1 million accelerator loan from the Massachusetts Life Science Center.

The funding will help the company advance its technology toward an investi-gational new drug filing.

Among the company’s backers are Massachusetts Technology Transfer Center, Deshpande Center for Technological Innovation at the Massachusetts Institute of Technology, the Department of Defense, Massachusetts Life Sci-ence Center, National Cancer Institute and private investors.

Company:ImmuneXcite

Co-founders:Yaniv Bejerano (CEO) and Ifat Rubin-Bejerano (CSO)

Twitter:@immunexcite

Website:http://immunexcite.com/



Shark model for drug delivery drives collaboration for biopharma startup and Lundbeck


Two years after securing strategic investment from Danish pharmaceutical company Lundbeck, a biopharma startup is collaborating with the company on a drug delivery platform for pain relief and central nervous system disor-ders. Ossianix’s single domain antibody platform takes its inspiration from a shark model.

The first project will advance its antibody platform to treat pain, which is modeled on the shark variable new antigen receptor structure. Among the desirable qualities of the shark model are the antibodies’ unique mechanism of binding to proteins with a high affinity and their ability to interact with two or three proteins at the same time.

The second project uses Ossianix’s blood brain barrier targeting technology for the development of bispecific biopharmaceuticals to treat CNS disorders. The company’s platform is designed to improve bioavailability compared with current antibodies, according to a company statement.

Ossianix CEO Frank Walsh told MedCity News that it expected to advance its pain treatment through the proof-of-concept stage this year. Lundbeck is funding the research plan with development and regulatory milestones, the statement said.

Sharks have been a growing source of life science innovation. Last year, can-cer research charity Association for International Cancer Research awarded a grant to researchers to investigate the use of an antibody found in shark’s blood to combat breast cancer. Sharklet is developing a synthetic surface to mimic the bacterial-resistant properties of shark skin for medical devices and hospitals.

Company: Ossianix

CEO:Frank Walsh

Website:www.ossianix.com/



He is one of 12 patients that have re-ceived a gene therapy developed by Children’s Hospital of Philadelphia’s Center for Cellular and Molecular Therapeutics to reverse the effects of inherited retinal degeneration from mutations associated with the RPE65 gene.

Spark Therapeutics is a CHOP spinout that’s advancing the gene therapy and other treatments through Phase 3 clinical trial and FDA sub-mission.

The treatment is designed to address an unmet need for patients with inherited Leber’s congenital amau-rosis and retinitis pigmentosa.

In an interview with MedCity News at the JP Morgan Healthcare Con-ference, CEO Jeff Marrazzo likened the effects of retinal dystrophy to film that degrades in a camera that produces a blurry or distorted image.

Spark Therapeutics has enrolled 24 patients in a Phase 3 trial, including 16 in the treatment arm and eight in the control group. The open-la-bel, randomized controlled trial will assess the safety and effectiveness of its therapy approach as a possi-ble treatment for blindness caused by mutations of the RPE65 gene.

Participants receive a subretinal injection and are monitored for any improvements to orientation, mobility and navigational ability, as well as performance on tests of visual and retinal function, according to the company’s website.

At the end of one year, subjects ran-domized to the non-intervention con-trol group will cross over to receive vector injection. The Phase 3 trial means they can also treat patients as young as age 3, compared with earlier studies which have an age minimum of 8. Marrazzo said Spark expects to have final data from the clinical trial available in the first half of 2015.

“We are in the midst of a remarkable chapter in medicine right now,” he said.

If successful, the company could have the first FDA-approved gene therapy and could contribute to Philadelphia’s profile as a life science center.

Separately, the company has a dis-ruptive Hemophilia B gene therapy treatment and is currently enroll-ing patients in a Phase 1/2 study. Although the dosing schedule has not yet been defined, a patient in the current study has been able to go six months so far without receiving any infusions of traditional therapy.

The treatment delivers a disarmed adeno-associated virus carrying a healthy gene to the liver, where factor IX is normally produced. Marrazzo sees the treatment as having the potential to have a huge impact in reducing the doses of clotting fac-tor that hemophiliacs need to take to avoid excessive bleeding. There are about 20,000 people with the condition in the U.S., according to the Centers for Disease Control.

Company: Spark Therapeutics

CEO:Jeff Marrazzo

Website:http://www.sparktx.com/

Twitter:@spark_tx

Spark’s gene therapy to reverse blindness hopes to be first commercialized therapy of its kind


A video that shows a 13-year-old child kicking a soccer ball would be a fairly typical scene were it not for the fact that for much of his life he was profoundly blind.



With $20M and 15 preclinical candidates, Moderna launches spinoff for mRNA-based cancer drugs


With a $110 million financing round and big-time deals with AstraZeneca and Alexion Pharmaceuticals in the bag, biotech company Moderna Therapeutics‘ next big move is to spin its pipeline of cancer drug candidates into a new, separate venture.

Moderna said today it’s committing $20 million to the new company, Onkaido Therapeutics. Leveraging Moderna’s mRNA Therapeutics platform, Onkaido will develop potential new cancer treatments aimed at targets not addressed through current approaches, the company said. Initially, it will focus on 15 preclinical drug candidates from Moderna.

“Moderna Therapeutics focuses on developing and commercializing the world’s best mRNA technology platform. This goal is independent of de-veloping best-in-class treatments,” said Dr. Stephen Hoge, Moderna’s SVP of corporate development and the founding CEO of Onkaido Therapeutics. “Onkaido was launched to enable a team to focus solely on the development of mRNA oncology drugs.”

Moderna’s approach employs messenger RNA, which acts as a blueprint for protein production in cell cytoplasm, to enable the body to make its own healing proteins. Last year, AstraZeneca paid $240 million up front for access to 40 drug candidates based on the technology, and Alexion Pharmaceuticals just announced a $25 million investment and $100 million drug development deal with Moderna.

Although mRNA-based therapies are a new modality of treatment, there are a few other companies working in this space. Germany-based Ethris, for ex-ample, is developing modified mRNAs as drugs, and CureVac is developing mRNA vaccines (including a flu vaccine partnership with Janssen).

Cambridge-based Moderna was founded in late 2010 by Flagship Ven-tureLabs.

Company:Onkaido Therapeutics

Founding CEO:Stephen Hoge

Website:http://onkaido.com/



How healthy is your DNA? This biotech is crowdfunding a way to let you know


DNA is damaged and broken every day, sometimes naturally and sometimes as a result of exposure to ultraviolet and other kinds of radiation and chemical toxins.

But sometimes, it can’t be repaired. DNA damage and poor repair capabilities have been linked to some cancers, immunological diseases and premature aging.

A startup called Exogen Biotechnology is recruiting a group of citizen scien-tists – and $50,000 – to help it bring technology that monitors DNA health out of the lab and into the hands of consumers.

Exogen, founded by a biophysicist and a computational biology fellow at Lawrence Berkeley National Laboratory, says the ability to measure DNA damage has been around for more than a decade but is time-consuming and prone to error when done manually. So the company has developed a high-throughput technology that automates the process of measuring dou-ble-strand breaks in blood samples. Its technology looks at 53BP1, a binding protein thought to participate in a cell’s response to DNA damage.

The duo has turned to Indiegogo to collect the data they need to explore how DNA damage correlates to specific diseases and environmental and lifestyle factors. Donors to the campaign receive a kit that contains tools used to col-lect and ship a small blood sample for analysis. In return, they get an analysis of their DNA health.

Exogen will compile the data from the blood sample, plus a survey the donor fills out about him or herself, with data from other participants. That will allow them to identify patterns, for example, or map the data to explore geographi-cal areas where there may be high levels of environmental toxins.

The company is halfway to its goal of raising $50,000.

Company:Exogen Biotechnology

Co-founders:Sylvain Costes and Jonathan Tang

Website:http://exogenbio.com


Amazon CEO adds second healthcare investment with cancer immunotherapy funding – Jan. 14, 2014

Amazon founder Jeff Bezos has taken an interest in cancer immunotherapies. The investment in life science innova-tion marks a shift in his personal investment focus from the technology startups that he has favored.

http://bit.ly/1daOe98

Startup Activity: Pharma & Biotech

Biopharma management team ISO growth-stage companies to advise and direct – Jan. 16, 2014

The co-founders of 6-month-old consulting company NovoBioPharma want to carve a niche for themselves in the area of helping manage and advise growth-stage life science industry companies — an area they view as under-served.

http://bit.ly/1nqUguK

Biotech engineer: Nanopatch vaccines could replace the camel fridge – Jan. 16, 2014

In his TEDGlobal talk in Edinburgh, Scotland last summer, Mark Kendell listed four ways that a new delivery method could change the game for vaccines. His nanopatch uses microneedles instead of a syringe to deliver the treatment. Solving the “fear of needles” problem is a big deal but breaking the “cold chain” is a bigger one.

http://bit.ly/LezKOS

British biotech startup turns to crowdfunding to help eliminate malaria – Jan. 10, 2014

A British biotech startup is developing a handheld diagnostic device that it claims can help eradicate malaria. The Newcastle-based company, QuantuMDx, is the brainchild of molecular biologist Jonathan O’Halloran. O’Halloran said he got the idea over a decade ago when he invented a new DNA sequencing device in his garage.

http://bit.ly/1k1FpEq

Molecular diagnostics biotech startup QuanDx raises $950K – Jan. 17, 2014

Biotech startup QuanDx has received $950,000 in funding from undisclosed investors.

http://bit.ly/1bvLljd

Online research study tools, MD performance measures among new Blueprint Health ac-celerator members – Jan. 19, 2014

Medical staff performance tools, health literacy and an online platform to develop and carry out research studies are among Blueprint Health’s fifth class of health IT startups.


This resourceful pharmacist built a software startup to help people shop for prescription meds – Jan. 21, 2014

Pharmacist Michael Rea got his startup idea from one particular customer whose mother was paying so much for her prescriptions that she was considering selling her house or stopping some of her medications. Her fixed income just didn’t support paying for both.

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Medical Devices

& Diagnostics


Startups In-Depth: Medical Devices & Diagnostics

A new blood test could help doctors pinpoint the cause of a stroke


Clinical trials are underway for what could be a first-of-its-kind blood test that would help doctors determine what caused a patient to have a stroke.

Developed by Cincinnati-based Ischemia Care, the test isolates RNA from whole blood and examines immune responses, with the goal of differentiating where an ischemic stroke originated in a patient’s body.

Stroke is normally diagnosed through physical examinations and diagnostic imaging. But in about one-third of cases, doctors aren’t able to identify a cause. Being able to determine whether the stroke originated in the heart or in the blood vessels could have a huge impact on how patients are treated and on preventing recurrent strokes, said CEO Jeff June. About a quarter of the 800,000 Americans who have a stroke each year will go on to have another one, which carries a higher risk of death and disability.

The idea behind Ischemia Care’s test, ISCDX, is that a physician would order it for patients who present with stoke symptoms.

They would draw a vial of blood, send it to the company’s CLIA-certified lab and expect results within four to five days. That’s a critical time frame because most patients who have a stroke are hospitalized for five to 12 days, June said, so if physicians know what caused the stroke within that time frame, they can get a patient started with the proper treatment regimen before leaving the hospital. The ultimate goal of the company is to develop a point of care test that can stratify patients within hours of an event.

“We have a much better understanding of the market and the uptake,” June said, recalling the last time he talked to MedCity News about the compa-ny nearly two years ago. “Before, we looked at ischemic stroke and could discern between originating in the heart and blood vessels. Now we also look at patients who come in the door with suspected stroke, a transient ischemic attack or some perceived neurological deficit.”

Another important feature the company has added to its test is the ability to differentiate between ischemic strokes that originate in the heart and are caused by atrial fibrillation and those that originate in the heart but aren’t caused by AF.


Company:Ischemia Care

CEO:Jeff June

Website:www.iscdx.com/

Twitter: @IschemiaCare


“This is often missed in early clinical assessment of pa-tients because many times when patients are evaluated for stroke, they’re not in A-fib,” June said.

While other blood tests might provide hints that a pa-tient has had a stroke, June said this is the first tech-nology he’s aware of that identifies immune response based upon the cause of stroke.

It’s being evaluated in a 600-patient clinical trial already underway at Cleveland Clinic and The Medical Universi-ty of South Carolina, with plans to bring three other sites onto the study, he said. He’s hoping to have results by the third quarter of this year.

Ischemia Care is focusing its early efforts toward clinical

adoption on the nearly 800 U.S. hospitals designated as Primary Stroke Centers.

Although it’s taking the CLIA-lab approach initially, June said the long-term strategy involves a blood test that could be done at the point of care.

Ischemia Care, founded in 2009, has designed the study and the test with help from partners including Medtronic and Affymetrix. It’s been financed both by grants and by investors — most recently a $750,000 round in Decem-ber. Previously, the company raised a $1.1 million round led by Cincinnati’s Queen City Angels.

June said the company is actively looking for a corpo-rate partner or for venture investors.


Ischemia Care (Continued)



GE, NFL fund 5 emerging companies attempting a better test for concussion


The device that Cortical Metrics is developing looks like a computer mouse but is designed to some day change the way doctors detect and diagnose concussion.

The University of North Carolina spinoff is one of five companies (plus 11 university and medical school-based research groups) just awarded $300,000 in funding from GE and the National Football League.

A panel of judges chose the 16 projects as finalists for phase one of GE and the NFL’s $20 million Head Health Challenge, an initiative the duo hopes will speed diagnosis and improve treatment for traumatic brain injury.

Cortical Metrics says its device vibrates a person’s fingertips, activating ad-jacent places in the brain that typically communicate with each other. When plugged into a computer, the device works with a web-based program to determine how well those places in the brain are communicating, as a way to measure the severity of a brain injury.

Banyan Biomarkers and BrainScope Company are also focusing on point-of-care diagnostic devices. Banyan is working with a University of Florida foot-ball team physician on a biomarker blood test that would identify traumatic brain injury within 30 minutes. It secured $6 million from private investors this summer.


Company:Cortical Metrics

Website:www.corticalmetrics.com/


Meanwhile, BrainScope is first targeting the military market with a mobile device it’s developing that would use EEG technology to help medics identify and stage traumatic brain injury. The company will work with Pur-due Neurotrauma Group to conduct a study in college athletes.

Another company called Quanterix is exploring the use of its singular molecule array technology to develop and validate blood biomarkers that would help physicians make more accurate TBI diagnoses and better predict long-term prognosis.

It’s worked with the Swedish Hockey League on a pilot study.

The last company, ImmunArray Inc.‘s research is explor-ing how the body’s immune response is connected to the progression of brain injury, with the ultimate goal of developing a simple blood test to diagnose TBI quickly and with certainty.

As many as five projects could win an additional $500,000 next year.

The second phase of the Head Health Challenge, now underway, also includes Under Armour as a partner and is looking for innovative materials that could protect the brain from injury, as well as new tools for tracking head impacts.


Cortical Metrics (Continued)



InvisionHeart is building a small, smart 12-lead EKG device to get scans in the cloud

By: Veronica CombsJan. 16, 2014

A Nashville medical device company is working on a new approach to EKGs that is easier, more convenient and more portable than current 12-lead sys-tems.

InvisionHeart is developing both the hardware component that takes the EKG and the software that turns the scan into a digital file.

“We will take patient data and then upload it to the cloud to give the doctor access to make quick decisions,” said InvisionHeart CEO Joshua Nickols.

EKGs are an example of another healthcare communication process that desperately needs updating. The current solution involves – you guessed it – paper and faxing.

“EKGs as they exist in the hospital are 20- or 30-year-old devices that print paper, and they’ve gone overlooked as a problem over time,” he said. “We are updating a critical diagnostic tool that is still wedded to an old way of data transmission.”

The file would be available to all providers in an institution.

“If the doctor has a nurse practitioner supporting her work, she could double her workload,” Nichols said. “This system also could work in nursing homes or minute clinics.”


Company:InvisionHeart

CEO:Joshua Nickols

Website:http://signup.invisionheart.com/


InvisionHeart has also updated the form factor of the device. The prototype is the size of a deck of cards.

“By having a very small form factor, the device could be brought to the patient much more easily,” he said. “Also with the back-end piece, a doctor could look at the EKG at home.”

The system would also allow an archive of patient EKGs. Nickols said that there is potential for Medicare fraud if EKG reports are unsigned. His solution would take care of that problem as well.

Nickols came to Nashville 15 years ago to get a doctor-ate degree in molecular neuroscience from Vanderbilt University. He also has an MBA and was the CTO for a

molecular diagnostic company.

InvisionHeart has been around for about a year, and went through the Jumpstart Foundry program in Nash-ville. InvisionHeart has raised some angel capital so far and is looking to raise a Series A round of $750,000 to $1 million.

Nickols estimates that he needs a year to get to market with the new system. He said the prototype has demon-strated proof of concept and now he is working with a manufacturer to commercialize the device.

“We need a robust software architecture to capture the data and make it available from the point of acquisition to a doctor’s smartphone or tablet,” he said.


InvisionHeart (Continued)



Kinsa says FDA has cleared Smart Thermometer as makers work on big data tool


For mobile health to become more mainstream, companies will have to provide tools that add value, save time and get the blessing of the U.S. Food and Drug Administration.

Today, Kinsa said the FDA gave 510(k) clearance to its Smart Thermometer, according to an emailed statement. It’s used with a smartphone to generate readings.

The FDA device approval fits into a broader movement in the future of mobile technology in healthcare to increase the capacity of smartphones to help people track their health and make informed decisions based on the results.

The thermometer connects to the headphone jack of smartphones and other mobile devices.

The display shows reading progress and alerts parents if the thermometer slips out of place.

It also shows images to distract children as it measures their temperature.

Users can create individual profiles and track their fever, symptoms and illness history.

In a statement, the company said it is conducting a private beta test of the device this month and expects to start delivering the Smart Thermometer in


Company:Kinsa

Founder/CEO:Inder Singh

Website:www.kinsahealth.com/

Twitter:@KinsaHealth


March or April. One of its backers is IA Ventures, but it has also raised money with crowdfunding campaigns on Indiegogo and AngelList.

It also won in the consumer category of the DC to VC competition.

Inder Singh, founder and CEO of Kinsa, is a former ex-ecutive vice president for Clinton Health Access Initia-tive, a public health organization that claimed success reducing drug prices for AIDS, malaria and TB medi-cines in more than 70 developing countries

The ultimate goal is to use the data collected by the thermometers in real time to map out hotspots for illnesses and where they are spreading.

It is currently developing software that will provide alerts when there is an illness outbreak in the user’s area or at their child’s school.

In the statement Singh said:

“… by piggy-backing off of the most widespread med-ical behavior in the world –- a parent taking a child’s temperature at the first sign of illness, even before scheduling a doctor’s appointment –- we can simultane-ously create a highly accurate, first-of-its-kind system to track the spread of illness, revolutionizing health across the globe.”

Part of its work on the software includes working with the Centers for Disease Control, the World Health Orga-nization and state and local health departments.

Of course, it depends on enough people buying and using its product to generate meaningful insights. Other companies have used social media to map flu outbreaks and other illnesses across the U.S. and other countries such as Sickweather, Fount.in, and Mappy Health.


Kinsa (Continued)



Med tech startup takes $1M prize from Verizon for eye exam device


Two medical device companies won first and fifth prize Wednesday in the Verizon Powerful Answers contest.

The co-founders of Smart Vision Labs Yaopeng Zhou and Marc Albanese won the first prize of $1 million in the healthcare category of the contest. They met in graduate school when they were building a tabletop version of an eye exam device.

Their new product is a smartphone-sized version. The Smart Aberrometer uses a phone’s flashlight and camera, combined with an add-on microlens array, to analyze refractive errors.

This will make it faster, easier and cheaper for people to get their vision eval-uated. The ultimate goal is to get a device in every home in the developing world.

Zhao said that his inspiration for the company came from the fact that 500 million people in developing countries lose their vision because they don’t have eye glasses.

“Some nonprofit groups actually travel with a backpack of glasses, so the healthcare worker could take the measurement and then get a pair of glasses right away,” he said. Zhao said that he plans to launch the product in Rwan-da because the country has a population of 10.5 million but only 14 vision


Company: Smart Vision Labs

Co-Founders:Yaopeng Zhou and Marc Alba-nese

Website:http://smartvisionlabs.com/

Twitter: @SmartVisionLabs


specialists to treat vision problems. He plans to use the money to hire more engineers.

There are other startups working on diagnostic devic-es for smartphones, but I do not know of a company addressing warfarin use. Factor 14, which won the fifth-place prize in the healthcare category in the Verizon contest, is designing a new sensor to make it easier to collect a blood sample at home.

The device would then transmit the data to the cloud. An algorithm would analyze the data and alert a doctor depending on the results. The San Francisco team of engineers – Ryan Bloom, Suresh Gurunathan and Raman Talwar – won $285,000 in the competition. They are using proprietary technology developed at the University of Michigan.

The other three winners were:

Seratis - $850,000, a comprehensive communication system to make it easier for doctors and other providers to understand each patient’s caregiver network.

Frenome – $700,000, a system to use molecular analysis in a doctor’s office.

Solar Ear – $500,000, a cheap and portable system to do

hearing tests in developing countries.

About 1,300 entries were submitted. Five finalists each won a monetary prize, with the first-place winner taking home $1 million. Lowell McAdam, the CEO of Verizon, awarded the prizes at CES 2014 in Las Vegas.

“We saw the wave of innovation we hoped for,” he said.

The contest was announced a year ago at CES. McAdam said that the company helped applicants write a busi-ness case for each idea to help both the entrepreneurs and Verizon understand how the ideas would benefit communities around the world.

The top 30 entries went to San Francisco to present to the final round of judges. Fifteen of those groups made it to Las Vegas.

The other two categories were sustainability and educa-tion.

A company making it easier to support solar projects with small donations won $1 million from Verizon.

Tiny Tap won the top prize in education with its plan to build a collection of educational games built by individu-als instead of corporations.


Smart Vision Labs (Continued)



Medtronic-backed Intersect ENT finalizes enrollment for third chronic sinusitus solution

By: Lindsay AlexanderJan. 14, 2014

Intersect ENT, a California-based medical devices company with chronic sinusitus drug-delivery solutions, presented a company overview at the JP Morgan Healthcare Conference in San Francisco.

Chronic sinusitis, which can cause headaches, congestion, facial pain and breathing problems among other issues, affects one of seven adults in the U.S. The company’s tapped this largely unmet clinical need with two implants that deliver localized drugs, and is well on its way to meeting patients with a third option.

But the hot healthcare startup’s true genius lies in moving tech from the heart to the head.

The company has completed enrollment for its RESOLVE study.

This randomized clinical trial will investigate the company’s third product, an in-office solution for patients with chronic sinusitus. In the study, the compa-ny will look at how the drug-eluting implant might work for patients indicated for revision sinus surgery.

According to the company website, “the product releases mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolves. The implant has more radial strength than the PROPEL products in order to dilate the obstructed sinus and releases the steroid over a longer period of time.”

The current standard of care: upping the dosage of steroids (either orally or through irrigation), with all their potential for side effects, or undergoing yet another surgery (or two, or three), President and CEO Lisa Earnhardt said.

“Instead of taking them back to the OR, (the product would be) placed by a

Company:Intersect ENT

President, CEO:Lisa Earnhardt

Website:www.intersectent.com/

Twitter:@PROPELOPENS



Intersect ENT (Continued)

physician with local anesthesia in a matter of min-utes to treat inflammation,” Earnhardt said. Com-mercialization for the product is “a couple years out,” but the company will likely begin its second Phase III trial this year.

In true CEO-speak, Earnhardt calls the new device a “quintessential win-win-win,” and if the device succeeds in its trials and FDA route, she’s right.

In theory, it would cut costs from patient, payer and provider.

The patient gets immediate relief and doesn’t have to take time off work.

The physician can perform the procedure more quickly, freeing him up to see more patients. And the cost of a surgery (or, for those with multiple re-visive surgeries on the horizon, the cost of several operations) is avoided.

There’s a lot of reason to believe in the device if the company’s short history is any indicator.

The team’s won two PMA approvals for its chronic sinusitis Propel and Propel Mini, essentially dis-solving drug-eluting stents that release steroids for patients who undergo chronic sinusitis surgery.

These quickly achieved milestones have been met with strong investments. The company’s investors include such heavyweights as Medtronic (MDT), PTV Sciences, Norwest Venture Partners, U.S. Venture Partners and Kleiner, Perkins, Caufield and Byers. They joined to kick off the startup’s 2013

with a bang: a $30 million Series D bang.

The biggest lesson from the bankable, smart ap-proach of the company’s engineering? Fit near-ex-isting technologies to different anatomies.

The dissolving drug-eluting stent from the heart to the head, from a man’s nasal passages (Propel) to a woman’s (the “Mini”) and so on.

(It’s no coincidence, Earnhardt said, the leadership team has strong ties to drug delivery primarily in drug-eluting stents designed for the cardiovas-cular space. Earnhardt worked for Boston Scien-tific (BSX) as the president of its cardiac surgery division.)

Intersect ENT’s also made a serious U.S. sales push, which Earnhardt said will continue.

The number one priority for the foreseeable future: “ensuring patient access to therapy, in terms of covering the country in representation and educat-ing physicians about the technology,” she said.

The second prong of that goal is working to make certain the procedure is reimbursed, Earnhardt said.

Though the United States is the company empha-sis for now, Earnhardt said Intersect ENT anticipates CE Marks for Propel and Propel Mini this year.



had lost arms to brush their own, he sketched up an alternative tooth-brush that required no water, tooth-brush or toothpaste.

Now called the Clean Bite, Galla-gher’s invention is a dissolvable mouthpiece that’s made of gelatin, the sugar alcohol xylitol and a dentri-fice (another word for an agent that cleans and polishes the teeth) called The Answer.

A user puts it in his mouth, chews it for 60 to 90 seconds – at which point it begins to dissolve – and then either swallows it or throws it away.

The cost of having the device patent-ed was too high for Gallagher at the time, so his design sat on the back burner for upwards of three decades. Finally, he decided the time was right about five years ago and set out to raise money, build a prototype, do usability tests and have the design patented.

Today, he’s got more than a doz-en people helping with the project, including collaborators at Creighton University School of Dentistry and the University of Maryland Dental School.

And, Gallagher said he’s in talks with a few medical distributors to bring the Clean Bite to market.

Each mouthpiece has about 800 bristles that help distribute the dentrifice, which is stored in four reservoirs that rupture when a person bites down on them. If the idea of swallowing the dissolved material sounds a little strange, Gallagher

said not to be alarmed: “It’s a certi-fied food product; there’s nothing in it that’s not found in other food-relat-ed products.”

Plus, it’s not meant to replace a toothbrush and toothpaste. Rather, it’s intended to be an alternative way to clean the teeth, gums and tongue when brushing isn’t an option.

Although it has potential applications for the military, disaster relief and managed care facilities, to name a few, Gallagher said the primary mar-ket will be U.S. children who receive free or reduced-cost meals at school and are more likely to have untreated cavities.

Eventually, he sees them being sold on the shelves of drug stores or other places one might buy a pack of gum.

He also sees them being sold out-side of the U.S., in markets where oral health isn’t as strong.

Because the mouthpieces are edible, he sees potential for them to be a way to deliver vitamins or other pharmaceutical products to those populations as well.

But first, he said he wants to prove that Clean Bite can keep teeth clean by running an efficacy study, which he said will require additional funding for the company, Dent-ChewBrush LLC.

“We don’t want to be looked at as a feel-good product,” he said. “We an-ticipate to hit 75-80 percent efficacy in what you would traditionally realize from toothbrush and toothpaste.”

Company: Clean Bite

Creator: John Gallagher

Website: www.dent-chew.com/

By:Deanna PogorelcJan. 16, 2014

Most of us probably take the abili-ty to brush our teeth every day for granted. It’s a task that’s not quite so easy for people with a medical condition that affects motor control, or for people who are paralyzed or have had an arm amputated, or for people without access to supplies and running water.

John Gallagher observed that some 40 years ago while serving as an Army medic during the Vietnam War.

Finding that it wasn’t easy for him as a traveler to find a sink and supplies to brush his teeth, much less for the patients he was working with who

No sink? No problem. Edible ‘toothbrush’ aims to make oral hygiene easier, more accessible




A California medical device company hoping to bring a less invasive alterna-tive to bariatric surgery to market says it’s raised $5.5 million from investors to test the device in humans.

Onciomed is developing an implantable device designed to restrict the food intake of someone who’s obese or has type 2 diabetes without permanently removing parts of the stomach.

During a laparoscopic procedure, the stomach is tucked into itself and the Gastric Vest System is placed around it, so that the stomach holds the shape of a channel to the intestine. The idea is that food will pass through the stom-ach quicker and will trigger satiety signals to the brain sooner.

To see whether the promising results seen in animal studies carry over to humans with obesity or T2D, Onciomed has launched clinical trials in Latin America, Asia and Europe and hopes to begin tests in the U.S. later this year. Company officials said the Series A funding will also go toward developing a patient compliance system and supporting company operations.

GVS is designed to be a less invasive, reversible alternative to other forms of bariatric surgery, founder and CEO Dr. Raj Nihalani said when he presented the company at the Medical Innovation Summit in the fall.

Market analysts have predicted that the U.S. market for weight loss and obe-sity management will grow over the next few years, fueled by the expected availability of lower-cost and less risky surgery alternatives like intragastric balloons and gastric stimulation devices.

Onciomed, founded in 2009, is based in Irvine, Calif.

Company:Onciomed

Founder and CEO:Dr. Raj Nihalani

Website:www.onciomed.com

Twitter: @Onciomed

Obesity device maker pulls in $5.5M for trials of stomach ‘vest’ implant



PhoneSoap should be added to all doctor and visitor lounges at every hospital


I saw the T-shirts promoting this device at CES 2014, some-thing along the lines of “Your phone is dirty, come clean,” with pictures of urine-yellow petri dishes full of germs. I was focused on all the germs at the show, so the implications of PhoneSoap for healthcare didn’t hit me until later.

PhoneSoap is a box that uses UV light to sterilize your phone. Cleverly, the box includes a charger, so your phone can multi-task while out of your clutches. The company says it takes about 5 minutes to kill all the germs, so the separation anxiety is tolerable.

The company raised $63,478 on a goal of $18,000 in its Kick-starter campaign in May 2012. The device is $50 and comes in white or black.

You may have blocked these particular studies from your mind, but researchers have found scary germs on cell phones carried by doctors and visitors in hospitals.

A 2009 study found that 95 percent of the cell phones of doctors and nurses in ORs and intensive care units were con-taminated with bacteria. Staphylococcus aureus was found on about one-quarter of the phones and 52 percent were methi-cillin resistant.

A more recent study showed that phones belonging to visitors and patients were not any cleaner. The Doctor Will See You Now explains:

The new study found that visitor and patient phones were considerably more contaminated than those of hospital em-ployees. Roughly 40% of the non-employee phones tested contained disease-causing bacteria, compared to 20% of the employee phones.

And the phones of patients and visitors were much more likely to contain multi-drug resistant pathogens than the hospital workers’ phones were.

Company: PhoneSoap

CEO:Wesley LaPorte

Website:www.phonesoap.com/



PhoneSoap (Continued)

This 2011 study looked at 200 phones, 133 belonging to patients, their companions and visitors and 67 medical employees’ phones. Swab samples were collected from earphone, keypad and speaker, and these samples were then grown on appropriate culture medium to determine the types of bacteria present on the phones.

The 2011 study was published in the June issue of American Journal of Infection Control. The 2009 study was published in the March 6, 2009 issue of Annals of Clinical Microbiology and Antimicrobials.

It was the 2011 study that inspired the creators of PhoneSoap to build their sanitizer. The company could donate several units to children’s hospitals to help protect patients with the most fragile immune systems.





A medical device company looking to improve the way difficult, debilitating diseases of the brain are treated has secured new funding for product development.

Alcyone LifeSciences just closed a $4 million Series B, according to an SEC filing. Company officials said in a statement that the round would support further development of its platform technology.

Neurological disorders are hard to treat for a few reasons, one being the existence of the blood-brain barrier, which blocks poten-tially damaging toxins from the brain but also keeps out small- and large-molecule drugs.

While some pharmaceutical and medical device compa-nies are working on ways to penetrate the barrier, Alcyone’s devices are based on a way of circum-venting it. They build on a drug delivery modality called convection-enhanced deliv-ery, where a fine needle or cannula is inserted into the brain through a small hole in

the skull, so that therapeu-tics can be pumped directly into brain tissue.

According to the company’s website, the devices can be smaller than standard nee-dles and designed to avoid challenges with traditional CED infusion therapy, like backflow and plugging. They could also have the ability to deliver multiple thera-peutic fluids in programmed sequences.

Target applications for the devices include delivery of drugs for brain cancers, hydrocephalus (often called “water on the brain”) and Huntington’s and Parkinson’s diseases.

Last spring, Alcyone announced a collabo-ration with DNAtrix to investigate potential use of Alcyone’s microcathe-ter system for delivering DNAtrix’s anti-cancer agents directly to brain tumors. Meanwhile, the company is also develop-ing technology to manage cerebrospinal fluid shunt occlusions.

PJ Anand, who was also a founding executive of Arsenal Medical, founded

Company:Alcyone LifeSciences

Co-founders:PJ Arnand (CEO) and Dr. Adam Fleisher (CMO)

Website:www.alcyonels.com/

Potential to improve delivery of drugs directly into the brain nets Boston-area device firm $4M

the Concord, Mass.-based company in 2010 with neurologist Dr. Adam Fleisher and Cornell biomedical engineering profes-sor William Olbricht.

Prior to the Series B, Alcyone received a $750,000 loan from the Massachu-setts Life Science Center and a $1.8 million Series A in 2012.

Harbor Light Capital Partners and Ed-gar D. Jannotta Jr., a former principal and co-manager of the healthcare group at private equity firm GTCR Golder Rauner, are investors.



ZipLine Medical wants to close up surgical wounds without stitches or staples


To prevent the scarring and discomfort of stitches and staples, a medical device company has created what it thinks is a quicker, simpler and more desirable way to close small surgical wounds.

ZipLine Medical‘s product uses two sticky strips and a series of ratcheted plastic ties that connect them. The strips are placed on either side of a surgi-cal incision after the procedure is completed. Then the straps are tightened to close the incision, and a protective bandage is placed over the top.

Whereas stitching and stapling puts stress on points where the skin is punc-tured, this design distributes stress more evenly and provides uniform closure across the incision, the company says. It doesn’t puncture the skin and could be applied by someone other than a skilled surgeon.

ZipLine Medical began marketing its line of Zip devices this summer and just closed on a $4.3 million Series C from RA Capital Management LLC, XSeed Capital and Claremont Creek Ventures.

The Zip, which is being sold in 8 cm and 15 cm lengths, is designed to with-stand normal activities (like moving, showering, etc.) and can be worn for up to two weeks, according to the company. Then, instead of returning to the doctor to have stitches or staples removed, the patient can peel it off of their skin. Xconomy reported that the 8 cm version costs $60.

Last month, ZipLine Medical presented preliminary data from a prospective clinical study that compared the device to traditional stitches in skin can-cer excisions. According to the company, the data suggests that the device reduced the time it took to close a wound by 57 percent and led to similar cosmetic outcomes as stitches.

ZipLine Medical launched the class 1 exempt medical device in June with an initial focus on plastic surgery, cardiology and orthopedic markets. It will use the new round of funding to expand sales and marketing.

The Campbell, Calif., company was founded in 2009 by serial entrepreneur Dr. Amir Belson, who also co-founded Neoguide Systems. That company made a minimally invasive colonoscopy scope and sold its assets and IP to Intuitive Surgical in 2009.

Company:ZipLine Medical

Founder:Dr. Amir Belson

Website:www.ziplinemedical.com/

Twitter: @Zipline_Medical


French startup Gecko Biomedical creating surgical glue strong enough to seal a beating heart – Jan. 8, 2014

A new surgical adhesive is strong enough, and elastic enough, to seal a beating heart. Many infants born with heart defects have to undergo repeated surgeries as they grow. Replacing the sutures and staples used in surgery today with fast-acting, biodegradable glues could help make these cardiac procedures faster and safer.

http://bit.ly/1d0nE6L

Startup Activity: Medical Devices & Diagnostics

Hemanext banks on removing oxygen to extend the shelf life of donated blood – Jan. 17, 2014

Technology developed nearly two decades ago with the goal of allowing U.S. Navy submarines to remain submerged for longer periods of time might be making some waves here on land within the next few years.

http://bit.ly/1jTvDGS

Mhealth company’s disruptive diagnostics platform on track for launch in H2 2014 – Jan. 20, 2014

When will the U.S. market be ready for disruptive mobile health diagnostics tools? That’s a question at the front of the mind of mBio Diagnostics CEO Christopher Myatt.

http://bit.ly/1cMwelh

In Merck patient adherence throw down, 5 teams reimagine care plans for diabetes, heart disease patients – Jan. 20, 201

One of the biggest challenges to improving care for patients with diabetes and heart disease is figuring out the best tools for those patients. The problem is, there’s no such thing as a typical patient. Things like co-morbidities, support system, age and financial standing all have an impact on their disease and set them apart from each other.

http://bit.ly/1dNJufz

http://bit.ly/1d0nE6L

http://bit.ly/1jTvDGS

http://bit.ly/1cMwelh

http://bit.ly/1dNJufz


Most Popular Startups This Month

2) Clean Bite

Most of us probably take the ability to brush our teeth every day for granted. It’s a task that’s not quite so easy for people with a medical condition that affects motor control, or for people who are paralyzed or have had an arm am-putated, or for people without access to supplies and running water.

John Gallagher observed that some 40 years ago while serving as an Army medic during the Vietnam War. Finding that it wasn’t easy for him as a traveler to find a sink and supplies to brush his teeth, much less for the patients he was working with who had lost arms to brush their own, he sketched up an alternative toothbrush that required no water, toothbrush or toothpaste.

Read more: http://bit.ly/1kE5GN0

1) Rx Savings Solutions

Pharmacist Michael Rea got his startup idea from one particular customer whose mother was paying so much for her prescriptions that she was considering selling her house or stopping some of her medications. Her fixed income just didn’t support paying for both.

It was an aha moment for Rea – at the time a pharmacy manager at a Kansas City Walgreens.

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

3) Glow app The idea is to give women a better understanding of potential ... Read more: http://bit.ly/1n8Lwqc

4) B-Shoe It’s is a walking shoe that incorporates pressure sensorsead ... Read more: http://bit.ly/1nOkNlW

5) Smart Vision Labs The new product is a smartphone-sized version ... Read more: http://bit.ly/1lq9DW2

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

http://bit.ly/1kE5GN0


http://bit.ly/1n8Lwqc

http://bit.ly/1nOkNlW

http://bit.ly/1lq9DW2

MedCityNews.com


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