Monthly Startups Index...It’s messy – in many ways. Healthcare data comes from multiple sources:...

MEDCITY ReportsMay 2014

This report sponsored by

Monthly Startups Index

May 2014

MEDCITY Reports2May 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 525

Digital & Health IT 4

Startups In-Depth 5

Startup Activity 16

3 Pharma & Biotech 19

Startups In-Depth 20

4 Medical Devices & Diagnostics 38 Startups In-Depth 39

Startup Activity 51

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


From the Editor

Apps are out, platforms are in. Investors and entrepreneurs have figured out that not only does it sound better to call your product a platform, but you can charge more, too.

At the start of June, two new healthcare “platforms” are taking shape. At its annual developer conference, Apple gave us a few more clues about its HealthKit:

The new app, called simply “Health,” will collect a number of body metrics including blood pressure, heart rate, and stats on diet and exercise. The app will share all its information with a new cloud platform called “HealthKit.” The platform is designed to act as a global repository for all the user’s health information.

The second bit of healthcare platform news comes from the California HealthCare Foundation. It is running a new contest to help doctors understand a patient’s life beyond the office visit. The nonprofit wants new tools to help doctors understand a patient’s family life, job situation and finances.

Both of these platforms have promise, but to really change healthcare, any platform will have to consider these three realities of healthcare.

1. It’s messy – in many ways. Healthcare data comes from multiple sources: lab results, prescription refills (or lack thereof), doctor visits, specialist visits, personal trackers, CT scans, even gym visits. Consolidating all this information is not easy, but it’s the only way to give a complete picture of a person’s health. Also, there is a lot more emotion in the healthcare equation. This factor affects decisions and communications, so optimizing for logic and efficiency does not guarantee an ideal outcome.

2. There is no one-size-fits-all patient persona. There may not even be a dozen or two dozen. Even if you group people into age ranges, there are many other variables that can put them into their own special groups. Family situation, income (or lack thereof) and education level all affect healthcare choices.

3. The personal touch is unavoidable. There is such a strong push to let technology do everything – algorithms will determine treatment plans, biometrics will set insurance premiums and avatars will give online counseling. But with healthcare, there has to be some element of personal, face-to-face communication. Not for every visit and not every health question, but the option has to be there.

Technology can do a lot to fix healthcare but it is no silver bullet. Any platform that is going to succeed will have to be built around that reality.

Veronica Combs, Editor in Chief, MedCity Media

http://medcitynews.com/2014/06/apple-worked-mayo-clinic-epic-build-heathkit-platform/


Digital & Health IT


Startups In-Depth: Digital & Health IT

Company:ParaWare LLC

Founder & PresidentAaron Burke

Website:http://www.parawarellc.com/

Twitter:@Runmino1

Running shoe sensor could allow payers to create “pay as you exercise” policies

Stephanie BaumMay 9, 2014

One of the biggest problems with running shoes — any shoes, really — is that most people tend not to replace them until they become painful to wear. Digital health company ParaWare LLC has developed an insert called mino that measures the force of the impact wearers make in their stride. The company is one of a group of 350 healthcare startup semi-finalists in the Mass Challenge competition.

Aaron Burke, the president and co-founder, previously worked as a medical device engineer with Accellant and trained as an engineer at Northeastern University. The device represented the culmination of his work there.

Here’s how it works. A new pair of shoes would receive the insert. When it is first used, all the white lights on the device appear. But gradually as the shoes get more use, the lights gradually shut off until finally a red light switches on, showing the shoe is worn out.

Burke said, “I am measuring the destruction of the cushioning [of the shoe]. I think people are poor measurers of their shoe lifespan. They usually replace their shoes when their feet start to hurt. That’s like replacing your brakes after you’ve had an accident.”

Although the company sells the device directly to consumers and to sports stores, it wants to work with insurers to use the shoe insert to demonstrate adherence to care plans that include exercise, such as walking or jogging. Burke likens it to what car insurers have done with telematics, using wireless devices to transmit data in real time back to an organization. Auto insurance companies use the data to develop more accurate pricing, including pay-as-you-drive and pay-how-you-drive policies. The data also improves risk management and allows better claims assessments.

Burke believes the technology could be applied to medical shoe wear as well, such as shoes for diabetics, to make it easier to assess adherence. It could also lower healthcare costs from ankle and foot injuries caused when shoes wear out.



Company:Treato

Executive ChairmanGideon Mantel

Website:http://treato.com/

Twitter:@Treato_com

As health gets social, Treato crawls the corners of the web to discover what patients are saying

Deanna PogorelcMay 5, 2014

“Patients are no longer tied to their physicians, and they’re certainly not tied to a specific prescription drug,” says Ezra Ernst, a former executive of UnitedHealth Group and Medscape. “With healthcare now, it’s just like with hotels – I’ll listen to my travel agent but I have to go to TripAdvisor to see what everyone else is saying, too.”

That consumer empowerment has given rise to the company that Ernst is now chief commercial officer of, Treato.

Treato is making a business out of finding, organizing and analyzing online patient conversations and turning them into insights for other patients, as well as for the industry players who make products for them.

Today, more than 80 percent of Internet users look for health information online. But they’re not just searching; they’re sharing their experiences, in the form of social media posts, message board discussions and blog posts.

The technology that the Israel-based company has been developing for the past four years starts by crawling some 3,000 forums, blogs and websites every day, looking for disease and treatment stories shared by patients.

“In many ways you find them in small corners of the Internet where they’re having incredibly vibrant discussions,” Ernst said.

Continued on next page



Treato (Continued)

He said Treato pulls in more than 1 million pieces of content from those sites every day and then uses natural language processing to break them down and determine which ones are “the good stuff” — patients talking first-hand about their experiences. Ernst said it uses medical ontologies and patient language dictionaries to parse through each paragraph of a post and categorize it on several levels. For example, it looks for words and sentence structures that indicate whether the patient was recently diagnosed or previously diagnosed, and whether she’s talking about a treatment in a positive or negative light.

That’s a lot harder than it sounds. “Someone may say something like, ‘I love Zoloft, but it made me crazy so I had to stop taking it,’” Ernst explained. “That’s not positive sentiment, even though it may initially seem that way.”

That’s why it took so long to refine the analytics technology, he said. Treato was founded in 2008 but only began serious commercialization efforts last year when it raised a $14.5 million venture round.

The company offers a free portal that patients can use to see what people are saying about specific diseases and treatments. Ernst said that 25 million users logged on last year.

I typed Prilosec, a proton pump inhibitor for treatment of GERD, into Treato’s search. That pulled up a description of the drug, a rating of how it compared to the nearest competitors based on what people were saying on the Internet, and what the top concerns were in conversations that mentioned Prilosec. I could also see a list of the specific posts that Treato’s engines had pulled that data from, sorted into positive and negative sentiment categories.

How Treato makes its money, though, is by selling more specific and customized insights to pharmaceutical companies. There are two paradigms here: viewing data by condition and by brand.

A pharma company working on building a pipeline in neurological conditions, for example, could use the condition dashboard to learn what concerns people talking about Alzheimer’s disease have, and what drugs they’re mentioning most. The platform would also let companies determine where certain groups of patients are having these discussions. For example, those who are recently diagnosed with a disease might aggregate in different online communities than those diagnosed a long time ago. That could help a pharma company target its marketing efforts.

In the brand paradigm, a company can explore why people say they like or dislike certain drugs, why they switch drugs, and whether they’re talking about the drug in a positive or negative light.

Ernst said right now most of Treato’s clients are broadly involved with pharmaceutical companies, from market researchers to brand managers to patient safety groups. He wouldn’t say how much a subscription costs, but says companies find it “comparable with their current market research initiatives.”

Next up for the company is adding a feature that identifies lifestyle topics mentioned in conversations about specific conditions. It’s also adding Twitter into its list of sources, which it had previously left out because of the high rate of irrelevant posts.

The company has also just opened a U.S. headquarters in Princeton, New Jersey.



Company:Observe Design

Co-founder and CEOAanan Khurma

Website:http://observedesign.in/

A wearable for healthcare workers prompts, tracks & automatically dispenses hand sanitizer


Cinco de Mayo to some, World Hand Hygiene Day to others.

The World Health Organization, CDC and other partners today are drawing attention to the importance of handwashing in preventing the spread of infection with an education and awareness campaign. Fittingly timed, a startup called Observe Design is launching a new wearable hand sanitizer dispenser it thinks could improve hand hygiene compliance by making it simpler for healthcare workers to follow existing guidelines.

Three alumni of Stanford-India Biodesign formed the company and spent several months observing healthcare professionals to identify challenges they face in following hand hygiene guidelines. With funding from Johnson & Johnson and the Czech ICT Alliance, the founders designed a small dispenser that works with disposable cartridges filled with enough sanitizer to last for a healthcare worker’s shift.

Healthcare workers would wear Hansure over any attire and activate it with a simple single hand action, the company says. A premium version of the device uses proximity-sensing technology to monitor how frequently workers sanitize their hands with the device, and prompt them to do so after being in contact with another person.

The New Delhi-based startup employed user-centered design with the hope of making it more convenient for healthcare workers – as well as travelers, food handlers and other kinds of high-risk workers – to fight the spread of infections. In the U.S., hospital-acquired infections affect more than 720,000 patients a year.

Several other companies are doing this, too. Among them are SwipeSense, which developed a dispenser that clips onto a coat pocket, and Pure-Go, which makes a wrist-worn dispenser. Hansure attaches to the belt with a magnet, or can be used as a bench-top or a wall/surface-mounted dispenser when it’s not being worn, said Observe Design CEO Aanan Khurma.

The company said in a statement that its device would be available “very soon.”

The most basic device has a price point of $25 with $3 cartridges. The advanced version will be $60.



Company:emocha

CCGHE Director and Professor of MedicineRobert C. Bollinger

Website:http://main.ccghe.net/content/emocha

Twitter:@emochaHealth

A remote patient management tool using video, texts, email could help TB patients


What started as a Johns Hopkins Hospital program to train healthcare workers to treat HIV in Uganda has evolved into a multimedia platform for adherence, clinical trials and chronic diseases rolled into a healthcare startup, emocha. In a presentation at DreamIt Health Baltimore’s demo day, CEO Sebastian Seiguer talked about the company’s origins at Johns Hopkins University Hospital and its relevance for both developing and industrialized countries.

Tuberculosis is one area where the connected care platform has an interesting application. In 1995, the World Health Organization required that TB patients be observed taking their medication by a medical professional — referred to as directly observed therapy. About 10,000 people were diagnosed with TB in the U.S. in 2012. To save the time of people visiting a healthcare facility every day, it developed a telemedicine component for the app. It gives a countdown so users know when to take their medication and films that action. Then they can transmit it to their physicians.

Emocha is working with the South African government to roll out its mobile health platform to healthcare workers at patient clinics around the country to combat drug resistant tuberculosis.

It is also working with the National Institutes of Health on pilots that focus on adherence once patients are discharged. In addition to TB, other conditions supported by its app include smoking cessation, weight management and diabetes.



Company:Flatiron Health

Flatiron Health Co-founderNat Tuner

Altos Solutions PresidentCarla Balch

Website:http://www.flatiron.com/

Twitter:@flatironhealth

Cancer data analytics team Flatiron Health acquires specialized EMR business Altos, raises $130M


Oncology analytics company Flatiron Health is part of a healthcare industry trend to de-silo and aggregate cancer data to help physicians and patients make more informed decisions about treatment. It has completed a $130 million series B round led by Google Ventures — its largest medical software investment to date, according to The Wall Street Journal.

Other participants in the Series B included First Round Capital and LabCorp.

Some of the funds from the Series B were used to amp up its business with the acquisition of oncology software business Altos Solutions. The company has an oncology electronic medical record system OncoEMR, used by 1,300 oncology clinicians, which also includes a patient portal called SeeYourChart. The plan is to integrate OncoEMR and OncologyCloud, the statement said.

In a phone interview with MedCity News, Flatiron Health co-founder Nat Tuner and Altos Solutions president Carla Balch said although the companies will have separate products they will be connected so it will be easier to move back and forth between their tools. They will also collaborate. When asked about the challenges of negotiating the balance between the insights about promising cancer treatments their tools can provide with what patients’ insurance will cover, Turner and Balch




Flatiron Health (Continued)

distinguished their decision-making tools from the oncology software businesses that work with insurance companies.

“Our respective tools are based on helping doctors and patients manage patients’ care,” Turner said. “They are providing an infrastructure. We are very different than some of the other companies in this space trying to force doctors down a particular path.”

Flatiron Health developed a platform called OncologyCloud that helps cancer centers and physicians to pool together clinical, practice management and billing data. Its first application for providers is a web-based program that’s designed to integrate a cancer center’s disparate data systems and give real-time business and clinical intelligence with benchmarking. The plan is to enable providers to use de-identified data from other cancer centers on the platform. It’s also developing a tool for life science

companies to use OncologyCloud to accelerate research by matching patients to available clinical trials and automating data collection, according to a company statement.

Flatiron was founded by Turner and Zachary Weinberg. Prior to Flatiron, they co-founded advertising technology company Invite Media until Google acquired it in 2010.

Ultimately, Flatiron plans to expand its data analytics platform beyond cancer to other diseases, according to the statement.

A wide variety of groups have sought to crunch big data in cancer treatment to deliver more effective treatment guidance, such as IBM’s Watson collaborations, eviti and its collaboration with Aetna, and Via. The American Society of Clinical Oncology is developing a clinical decision support tool called CancerLinQ.



Company:Wellthie

Founder and CEOSally Poblete

Website:https://www.wellthie.com/

Twitter:@Wellthie

A health insurance navigator for consumers, Wellthie wants to boost insurance literacy


The enrollment deadline for Obamacare may have come and gone, but for anyone who loses a job, has a reduction in salary, gets married or divorced, these life changing events generate a need for a change in insurance. Healthcare industry veteran Sally Poblete who founded Wellthie, wants to help consumers and employees navigate the complexities of getting health insurance or changing plans.

The StartUp Health company’s first product Affordable Care Advisor is all about explaining terminology and eliminating the mysteries of using health insurance. It went live in the fall last year.

“I think the inspiration for me to leave [WellPoint after eight years] is that consumers in general are utterly confused about which health insurance to buy. They don’t know how to find a doctor. They don’t understand deductibles, the difference between in network and out of network and they don’t know how to access their medical benefits.”

The company licenses its product marketing software to insurance companies which is designed to highlight insurers’ plans and help them better understand the costs by giving estimates on users’ premium costs.

It also wants to roll out a platform for business owners to help them make decisions about employee coverage, such as whether to offer an employer plan or individual plans that employers help fund.

There are no shortage of startups that have seen the rollout of Obamacare as a great opportunity for insurance education and planning tools to supplement what state health insurance exchanges have offered. Bloom Health and Change Healthcare have focused their attention on employer plans. Stride Health, although restricted to California, is a consumer-focused website which offers estimates.



Company:Aver Informatics

Founder and CEOKurt Brenkus

Website:http://www.averinformatics.com/

Twitter:@averinformatics

GE, Drive Capital lead $8.5M round for bundled payment analytics specialist Aver Informatics


Healthcare data analytics company Aver Informatics thinks the next generation of healthcare reimbursement lies in bundled payments, and now Drive Capital and GE Ventures have backed up that hypothesis too.

The investors led an $8.5 million Series A that will allow the startup to expand its engineering and sales teams and accelerate growth, execs said.

Aver’s corner of the high-demand data analytics space involves helping payers and providers look at a patient population’s bills and “transform and modernize” them into payment bundles that create standardized protocols for different episodes of care.

“There’s a perverse incentive that the more services you do, the more money you make,” said Kurt Brenkus, founder and CEO. “We’re trying to realign all of these incentives around episodes that match reality of what doctors and patients are doing to radically simplify the way in which healthcare operates.”

The software helps create the financial engineering of what a bundle should look like, Brenkus said. In the case of a knee replacement, the entire episode of care might cost $20,000 for one patient and $80,000 for another. The goal is to identify if the order in which certain tests and imaging procedures are done correlates with lower costs and better outcomes, for example, or if patients with certain comorbidities would benefit from different protocols.

Payers account for the largest slice of Aver’s 15 customers, Brenkus said, including the newest additions, integrated health system UPMC and managed care company Molina Healthcare. “Ultimately we think this will go downstream, and benefit plan designs will change and simplify the process,” he added.

Green Bay, Wisconsin-based Aver was founded by Brenkus, a former operations director at United Health Group, and developer Matt Frohliger, in 2010. Since then they’ve raised about $2.5 million in angel capital and were selected for StartUp Health and GE’s three-year entrepreneurship program.

Despite the company’s ability to secure several customers early on, Brenkus said that transforming the fee-for-service paradigm – Aver’s ultimate goal – is a one-day-at-a-time process. “We’re transforming 1 trillion in spend,” he said, “and you can’t do that overnight.”



Company:Apixio

CEO and ChairmanShawn Dastmalchi

Website:http://www.apixio.com/

Twitter:@Apixio_Inc

Using data, NLP & machine learning to explore patient risk wins Apixio $13.5M in new capital

Mark SullivanMay 27, 2014

Medicare rolls are swelling and the Affordable Care Act is bringing more people under the umbrella of insurance coverage. As a result, medical groups and health plans have an ever more pressing need to predict the costs of care.

San Mateo, Calif.-based Apixio wants to fill that need by crunching a lot of existing clinical data, providing healthcare organizations with the intel they need to accurately estimate patient risk. That enables providers to more accurately (and profitably) bill for their services.

Apixio says it uses natural language processing and machine learning to make sense of a mountain of unstructured data.

Bain Capital Ventures and a group of Silicon Valley angel investors are getting behind the concept by infusing Apixio with $13.5 million in new capital. The new capital brings Apixio’s investment total up to $22.6 million.

“The proceeds will be used to ramp up our sales and operations in support of the strong growth we are experiencing in our risk adjustment business,” said Shawn Dastmalchi, CEO and co-founder of Apixio, in a statement. “We also intend to further develop our Big Data technology and to build on our vision to provide analytic solutions that power value-based care.”

Apixio was founded in 2009 and raised $500,000 from undisclosed investors that year.



Company:Medical Information Records, LLC

CEOTerrence Ray

Website:http://medicalinformationrecords.com/

Dell healthcare pitch winner applies big data to anesthesia information management system


Creating an anesthesia information management system is one of the challenges associated with converting paper records to electronic formats. They need to have an intuitive interface that easily fits in with anesthesiologists’ workflow, but also need to be easily integrated into an electronic medical record. Healthcare IT company Medical Information Records LLC tackled those challenges with its Anesthesia OS and has been rewarded as the winner of Dell’s Healthcare Pitch competition.

The system was developed by a couple of anesthesiologists — co-founders Dr Christopher Ray and Dr. George Armendariz.

In a presentation to Dell and Intel Capital, Ray, the CTO, said the company spent a lot of time on the interface. Although it had sought to collaborate with healthcare software vendors, Ray said the problem was that vendors weren’t responsive to anesthesiologists’ workflows and tended to put processes over people. Ray pointed out the more intuitive and simple the user interface is, the more likely anesthesiologists will be to document more information.

Among the company’s priorities in developing Anesthesia OS were data integration, suggestive therapy and predictive outcomes, building situational awareness and providing targeted clinical decision support. It also needed to be cost-effective and empower providers. The point of these systems is to aggregate information in one place from the lab, billing, imaging, communication, pharmacy and scheduling. By collecting the data automatically, it helps anesthesiologists create an accurate record. It can also be used to generate big data insights to improve outcomes.

Among the winner’s prize package is a Dell Venue Pro Set, the opportunity to pitch joining Dell as a business partner and to work with Dell on a proof-of-concept test to evaluate its healthcare solution.


Startup Activity: Digital & Health IT

Indiana HIT startup Diagnotes to pitch at Silicon Valley World Cup Tech Challenge

Based in Indiana, Diagnotes is a virtual solution to doctor-patient communication when the doctors are out.

http://bit.ly/T9v8hq

Your digital footprint can say a lot about your health. Clariture leverages that for healthcare advertising

Healthcare providers are looking for ways to connect with potential patients on the web, on mobile devices, and through social channels.

http://bit.ly/U8GBP8

Sherpaa Health has raised $3.92M to expand primary care services for employer plans

Health IT companies that can provide tools to help employers lower healthcare costs have attracted a growing amount of venture investment, not to mention at least one high-profile IPO.

http://bit.ly/S1Du9D

Physician appointment scheduling startup HealthPost snapped up in $25M deal

The Advisory Board Company snagged physician referral and appointment scheduling startup, HealthPost, for around $25 million, executives disclosed in a conference call.

http://bit.ly/1gx4JPT

Improving quality of life for people with tremors, rewarding caregivers, ear care win AARP live pitch

Lift Labs Design, a healthcare engineering company that uses stabilization technology as part of the foundation for a cutlery for people with essential tremor, is one of three companies that walked away with awards from the American Association of Retired Persons’ Innovation@50 Live Pitch event this week.

http://bit.ly/1iOwap0

Newest Rock Health class focusing on telemedicine, blood thinners, and metabolic score

The digital healthcare incubator Rock Health today announced its sixth class of digital health startups, which in-cludes app makers, analytics companies and even an insurance plan suggestion site.

http://bit.ly/U8GW4h

6 digital health companies reimagine their healthcare apps with help from Watson

An innovation throwdown by IBM asked companies to devise mobile applications tapping Watson’s cognitive com-puting technology.

http://bit.ly/1hzidL7

BioTime commits $5M to spinoff working with Mount Sinai on big data-powered mhealth products

In a decidedly vague announcement Tuesday, regenerative medicine company BioTime’s subsidiary LifeMap Scienc-es said it’s spun off a mobile health company.

http://bit.ly/1mMNLQZ



Forget the wrist; OMsignal, launching today, weaves biometric sensors into shirts

Smart wearables are here, and they’re huge. But most of them just hang on your wrist and count your steps.

http://bit.ly/1oReh0n

Entrepreneurs from China, Brazil, India compete with U.S. startups for best idea to fix healthcare

The incubator 1776 is hosting a Challenge Cup for healthcare. Of the 16 startups selected for the Challenge Festival, five are from outside the U.S.

http://bit.ly/1ovO1Il

Qstream uses competitive gaming to beat clinical inertia in hospitals, sharpen pharma sales staff

A competitive game could help physicians and nurses bring patients’ blood pressure levels down faster, according to a study published in Circulation.

http://bit.ly/1m7zn3Y

3 healthcare startups win $100K to grow businesses in Maryland

Brain injury detection, improving access to care in developing countries and adding more context to electronic health records. Those healthcare challenges occupy three healthcare startups, each of which has received $100,000 to develop their businesses in Maryland.

http://bit.ly/1kEw8j9

Modernized, personalized care plans draw investors into Filament Labs’ $1M seed round

Filament Labs, one of a handful of digital health startups leveraging smartphones to connect patients and their doc-tors during the last mile of care, will be able to build onto its flagship product thanks to a $1 million seed round.

http://bit.ly/1ksW71K

QPID Health Series B rakes in $12.3 million for surgery risk assessment platform

A pre-operative risk assessment tool developed at Massachusetts General has raised more than $12 million in a Series B round to expand its business, according to a company statement.

http://bit.ly/1ijrf2C

Smart TV maker VIZIO joins interactive fitness coaching platform PEAR’s $5M round

PEAR Sports has taken a $5 million second round of funding to fuel the marketing of its interactive fitness trainer app and white label platform.

http://bit.ly/1oRgo43

Dermatologist’s virtual visit startup secures $2.9M to expand into more states this year

A Pennsylvania dermatologist has rounded up some new capital to grow his mobile telehealth startup.

http://bit.ly/S1Irzn



SolveBio scores $2M to clean up & index genomic data for developers

Now that the $1,000 genome has arrived, the healthcare industry has wasted no time putting the mass amount of genomic data being generated to work.

http://bit.ly/1m7AIrw

Can an app mimic the effect of medication? New crowdfunding campaign seeks answers

It’s pretty much the worst news a biotech company can get when they’re told that a placebo was more effective than their drug.

http://bit.ly/1l2rSPh

Cleveland Clinic partners with HealthSpot to expand the reach of its doctors

Telemedicine company HealthSpot and Cleveland Clinic are launching a joint venture intending to use telehealth technologies to reach more patients.

http://bit.ly/1oghCmO

Wellframe’s personalized care plan tool gets validation from Merck

Wellframe, a health IT company that’s developed a cloud-based platform to personalize care plans for people with chronic conditions, won an innovation challenge set down by Merck and Heritage Provider Network. It bested Sense Health, the other finalist, to win $100,000.

http://bit.ly/1lhV5TJ

Innovative health insurer Oscar will ramp up business with $80M fundraise

Startup health insurer Oscar chose Tumblr as its social media venue of choice to announce that it raised $80 million in a Series A round.

http://bit.ly/SpT7s6

Mobile health app that uses incentives to improve pill taking raises $5.25M

Mango Health, a mobile health company that works with health plans and self-insured companies to help reinforce healthy behavior among members, has raised $5.25 million, according to a company statement.

http://bit.ly/1rGAgJk

California payer one of 9 healthcare companies on Red Herring Top 100 list

SeeChange Health has won a Red Herring Top 100 North America Award. The award recognizes private companies from North America for innovation and new technology in their respective industries.

http://bit.ly/1pCaDY9


Pharma & Biotech


Company:Scripps Research Institute

Professor of chemistryFloyd Romesberg

Website:http://www.scripps.edu/romesberg/

Twitter:@scrippsresearch

Scripps spinoff pushes synthetic biology a step forward by engineering 2 new DNA bases

NewsCredMay 9, 2014

NEW YORK (Reuters) - Scientists have taken the first steps toward writing the blueprint of life in an alphabet unknown to nature, they reported online in the journal Nature.

Until now, biologists who synthesize DNA in the lab have used the same molecules - called bases - that are found in nature. But Floyd Romesberg of the Scripps Research Institute in La Jolla, California, and colleagues not only created two new bases, but also inserted them into a single-cell organism and found that the invented bases replicate like natural DNA, though more slowly.

The scientists reported that they got the organisms, the common bacteria E. coli, to replicate about 24 times over the course of 15 hours.

The accomplishment “redefines this fundamental feature of life,” wrote biologists Ross Thyer and Jared Ellefson of the University of Texas, Austin, in a commentary in Nature on Wednesday.

The booming field of synthetic biology holds promises for creating new antibiotics and other drugs. It has also raised concerns scientists are in some way “playing God” by creating living things that could escape from labs into the outside world where they have no natural predators and nothing to check their spread.


Startups In-Depth: Pharma & Biotech


Scripps Research Institute (Continued)

In the current experiment, the scientists took pains to make that impossible, according to their paper. The new bases are not found in the natural environment, Romesberg and his colleagues said, so even if organisms with manmade DNA were to escape from the lab they could not survive, let alone infect other organisms.

In nature, DNA’s bases, designated A, T, C, and G, pair up. A pairs with T and C with G, forming what looks like steps in a winding staircase - the double helix that is the DNA molecule. Bases determine what amino acids a particular strand of DNA codes for, and therefore what proteins (long strings of amino acids) are produced.

So far, the synthetic bases, which Romesberg’s team call X and Y, do not code for any amino acids, the scientists reported. But in principle they--or other manmade bases--could. Much as adding a 27th and

28th letter to the English alphabet would allow more words to be created, so adding X and Y to the natural DNA bases would allow new amino acids and proteins to be created. Unknown at this early stage is whether the new proteins would be gibberish or meaningful.

Believing that they will be useful, Romesberg co-founded a biotechnology company named Synthorx, which was officially launched on Wednesday. Based in San Diego, California, it will focus on using synthetic biology “to improve the discovery and development of new medicines, diagnostics and vaccines,” the company said in a statement.

Synthorx has the exclusive rights to the synthetic DNA advance.

Copyright (2014) Thomson Reuters.



Company:Gelesis

ChairmanJohn LaMattina

Website:http://www.gelesis.com/

An obesity treatment that looks like a pill but acts like a device takes in $12M from investors


A young Boston company thinks it has what could be a safe, effective and noninvasive way to help overweight and obese people drop those dangerous extra pounds.

Investors including PureTech Ventures and a group of prominent senior leaders from the pharmaceutical, biotech and finance sectors have just entrusted Gelesis with $12 million to continue developing its smart pill for obesity.

The oral capsule is a super-absorbent hydrogel made of two unnamed food ingredients. It’s swallowed 20 minutes before a meal with a glass of water and dissolves to release Gelesis100 particles in the stomach.

Those particles absorb and hold water in an elaborate 3D network so that they swell and create a larger volume in the stomach when food is eaten. Gelesis thinks this will make people feel more full with less food.

The particles shrink with a drop in pH levels, which occurs when stomach acid is secreted during digestion. They reswell in the small intestine, slowing gastric emptying and the passage of sugars and fatty acids into the bloodstream. Once they reach the large intestine, the particles degrade, release the water and are excreted from the body.




Gelesis (Continued)

A safety and tolerability study a few years back offered an early glimpse at how people would respond to a dose of Gelesis100, but the company will need much more rigorous testing to win FDA clearance (the capsule is considered a medical device because it acts mechanistically in the stomach and intestine).

It’s working on that now. Chief Business Officer Robert Armstrong said Gelesis has some fresh data in its hands from a larger trial which had weight loss as its endpoint. That data will be presented at the Endocrine Society meeting in Chicago next month, Armstrong said.

Obesity is the world’s largest health problem, so fittingly there are a number of competitors developing new ways to induce weight loss. The closest to Gelesis might be Allurion Technologies, another Boston company that’s working on a hydrogel technology that swells in the stomach. While weight loss surgeries have become more common in recent years, they’re typically not an option for people who are mildly obese or just overweight. Thus, a number of less-invasive options

like implants, balloons and medicines are also under development.

Armstrong said he thinks Gelesis’ device has the potential to achieve the efficacy/safety balance that’s lacking with the existing interventions for obesity.

“This is a non-systemically-absorbed device, so we avoid many of the safety issues that might come through other means of administration,” he said. “We believe we’ve created an optimal device that has multiple mechanisms that can address satiety and hunger.”

Armstrong is the former VP of global external R&D at Eli Lilly & Co. and recently joined the Boston-based device company, which was founded in 2008 by PureTech Ventures and Israel R&D company ExoTech Bio Solutions.

Including the new funding, the company has raised $42 million from investors.



Company:Sanaria

Chief executive and scientific officerStephen L. Hoffman

Website:http://www.sanaria.com/

Twitter:@sanaria_inc

A mosquito-dissecting robot could help bring the coveted malaria vaccine closer to reality


Biotech company Sanaria has spent the last decade working on a malaria vaccine that in early tests has shown tremendous potential to protect people from the deadly infection transmitted by mosquitoes.

Now, to scale up, it’s turning to the crowd to fund a robot that would speed up part of the production process by 20 to 30 times.

The vaccine, called PfSPZ, is made from malaria parasites at the immature, or sporozoite, stage of their life cycle. Sanaria extracts, purifies and weakens the sporozoites to make them into a vaccine, which triggers the immune system to recognize them without actually causing disease, Sanaria says.

The tricky part is, they’re produced inside mosquitoes and concentrate inside mosquitoes’ salivary glands so they can be released during a bite. In order to make the vaccine, the company has to extract those salivary glands, a delicate process that it now does by hand.

But SporoBot, the robot it’s been working on with Harvard University’s Biorobotics Lab, would do that much more quickly and cheaply.

Sanaria says it’s figured out how to make all of the individual components of the robot work and now needs to make them work together. It’s hoping to raise $250,000 through Indiegogo by June 5 to build a small-scale prototype of the robot.

Much of the research behind the vaccine so far has been funded by awards from the NIH, the DOD and the Bill & Melinda Gates Foundation, but Sanaria says the sequester has made it harder and more time-consuming to secure those grants. “We at Sanaria feel a strong sense of urgency, and after years of progress, our goal of elimination is in sight,” the biotech says on its crowdfunding page. “We could wait until public funding and economic conditions improve, but waiting comes at the cost of thousands of lives.”

Indeed. There’s currently no preventive vaccine for malaria, which in 2012 killed an estimated 627,000 people globally, according to the World Health Organization, the majority of them in developing countries.

Sanaria’s vaccine is currently being tested for effectiveness in clinical trials across the world.



Company:Sinapis Pharma

CEODonald Picker

Website:http://www.sinapispharma.com/#/HomePage.xaml

A small dose of medical meth might go a long way in limiting post-TBI brain damage


A mistake made by a PhD student in a University of Montana lab nearly a decade ago is now on the brink of mid-stage clinical trials as a potential treatment for traumatic brain injury.

And, most surprising of all, the treatment consists of a small dose of methamphetamine.

It all started when a research assistant in David Poulsen‘s neuroscience research lab was doing an experiment that involved using high doses of methamphetamine to create brain damage in small animal models. But somewhere along the line, he misread one of the concentrations of meth that he was preparing and accidentally gave a dramatically diluted dose to one group of rats.

When the team later processed the brain specimens, they found that one group of rats was mysteriously neuroprotected. It was the group that had mistakenly received a small dose.

Poulsen’s team took that discovery and ran with it, spending the next several years applying for grants and studying how it was possible that a drug so dangerous to the brain in high doses could be so beneficial in low doses.



http://www.sinapispharma.com/#/HomePage.xaml

http://www.sinapispharma.com/#/HomePage.xaml


Sinapis Pharma (Continued)

Actually, medical meth has been in use for quite some time. It was used in the 1930s to treat asthma and narcolepsy, and during World War II to keep pilots awake. Today, a low dose is used in the ADHD drug Desonyx.

Dr. James Fonger, a heart surgeon who’s CEO of the venture that’s commercializing the lab’s work, said it has to do with dopamine. “At high doses, there are a couple of well-known receptors in the brain which get hit by the drug and cause damage. Underneath that, there’s dopamine receptors that are completely overwhelmed at high doses and have no effect,” he explained. “But if you only mildly stimulate the dopamine receptors, they are very neuroprotective.”

With method of use patents from University of Montana, Buffalo-based Sinapis Pharma is commercializing low-dose IV methamphetamine as a new way to treat traumatic brain injuries, potentially up to 12 hours after they occur.

TBI is an appealing market for the neuroprotective treatment because there’s currently no therapeutic treatment out there. “It’s a little bit like what we used to do with people who had a heart attack or conventional stroke, which was put them to bed and hope they get better,” Fonger said.

Fonger sees the TBI treatment paradigm shifting in the same way that it did in cardiac care in the 1970s and 1980s. Now, he said, cardiologists have a whole library of things they can do after someone has a heart attack to both fix structural heart problems and prevent future heart attacks.

Although some work has been done toward finding a treatment, the field has struggled to translate promising research into approved therapies. A short window for intervention and the feat of getting drugs across the

blood-brain barrier have proved challenging. And that short window of intervention has also made it hard to carry out the protocols of clinical trials.

But the FDA has made some recent changes to the design of clinical trials that Fonger is encouraged by. And he’s convinced Sinapis’ approach is different than others tried in the past because its neuroprotective effect has multiple pathways and a long therapeutic window. “Other drugs, to have their effect, have to be given within three to four hours after injury,” Fonger said.

Not to mention it’s cheap to make, stable on the shelf and easy to manage, he added.

Now it’s time to show that it works. With phase 1 safety studies complete, Sinapis is in the middle of raising a $6 million Series B that will fund an upcoming trial in 30 patients with brain injuries, which will establish dosing for the subsequent Phase 2b efficacy study. That one will include 400 patients and is slated to begin in 2015, Fonger said. It will cost a lot of money, too, but he’s hopeful about “significant” interest he’s seen at the professional sports level and by the NIH and Department of Defense.

“We’re hopeful that a large part, if not all of the funding for the 400-patient trial, might actually be non-dilutive because of the unique position of a brain injury drug,” he said, pointing out that athletes and soldiers are common victims of concussions.

If treatment succeeds in Phase 2b, it would advance to Phase 3. But by then, it would ideally have backing from a Big Pharma partner.

“It’s a big swing for the fences,” Fonger said, “but people have got to step up and do these things.”



Company:Lysosomal Therapeutics, Inc.

Founder, President and CEOKees Been

Website:http://www.lysosomaltx.com/

Ex-Genzyme CEO’s new company looks to rare diseases for insight into treating Parkinson’s


Scientists suspect there’s a connection between many common neurodegenerative diseases and malfunctioning lysosomes, or processing centers in human cells that break down proteins and eliminate debris. Now a new company called Lysosomal Therapeutics is tapping into the relationship between the two to discover and develop new treatments for rare diseases and common neurodegenerative diseases, starting with Parkinson’s disease.

Lysosomal Therapeutics debuted today with $4.8 million in seed funding from an impressive group of healthcare venture capitalists led by Atlas Venture. Three pharma corporate investment funds – Lilly Ventures, Sanofi-Genzyme BioVentures and Roche Venture Fund – also got in on the round, as did Hatteras Venture Partners and Partners Innovation Fund.

What the new company is proposing to do is use its molecular platform to discover and develop a new class of small molecules that cross the blood-brain barrier, normalize lysosomal function and improve the ability of neurons to survive.

Its lead program is focused on a link between Parkinson’s disease and the most common lysosomal storage disease called Gaucher’s disease.

“This inventive approach to treating Parkinson’s disease was really facilitated by the success of current treatment strategies, such as enzyme




Lysosomal Therapeutics, Inc. (Continued)

replacement therapy, that have enabled the Gaucher disease patient population to live longer,” President and CEO Kees Been said in a statement. “However, an unfortunate consequence of this longevity is the finding that Gaucher patients experience a 20-fold increased risk of developing Parkinson’s disease.”

When there are genetic mutations in lysosomal enzymes, proteins build up in cells and cause cellular damage. In the case of Gaucher’s, the buildup is caused by a mutation in the glucocerebrosidase (GCase) gene.

Interestingly, as Dr. Dimitri Krainc and Joseph Mazzuli at Massachusetts General Hospital discovered, the toxic deposits that are characteristic of Gaucher’s are also found in Parkinson’s disease. They damage neurons and eventually cause neurons to die, which leads to a loss in cognitive, sensory and motor function.

The idea, then, is that increasing GCase activity in these patients could not only slow disease progression but potentially reduce their risk of Parkinson’s disease.

Krainc and Mazzuli, both now working in the neurology department at Northwestern University, are co-founders in Lysosomal Therapeutics along with four former leaders at Genzyme: Bob Carpenter, Peter Wirth, Ted Sybertz and former CEO Henri Termeer.

President and CEO Been is a former SVP at Biogen Idec’s oncology business and has led EnVivo Pharmaceuticals and Bionaut Pharmaceuticals. In a statement, he said the new funding will allow the company to move through the lead-generation process and prepare for preclinical development.

Lysosomal Therapeutics is based in Cambridge.



Company:Requis Pharmaceuticals

CEO and PresidentLars J.S. Knutsen

Website:http://www.requispharma.com/

Biotech company wants to be first with OTC sleep aid that’s also a snoring remedy


A biotech company developing an over-the-counter sleep aid came across an intriguing discovery — it also helps snoring. Requis Pharmaceuticals hopes to be the first company to develop a drug to prevent snoring that also functions as a sleep aid.

Requis is developing a series of de-risked pharmaceuticals and nutraceuticals based in part on tryptophan.

Requisom, its lead product, is a mixture of doxylamine, GRAS nutraceuticals melatonin and tryptophan, the source of serotonin and a universal feel-good neurotransmitter, according to the company. In an interview with MedCity News, CEO Lars Knutsen said that some friends were testing the drug as a sleep aid and the wife was surprised to find it helped keep her husband from snoring.

Requis is preparing to submit an investigational new drug application for Requisom to the U.S. Food and Drug Administration.

There is currently no drug available to prevent snoring so a sleep aid that can do that has the potential to get a decent slice of the market. Another potential advantage to a drug that prevents snoring is that adherence would be higher since bed partners suffer from a lack of sleep.

The over-the-counter sector of the pharmaceutical industry tends to yield good margins but with relatively low capital requirements, according to Knutsen, especially if cost of goods can be controlled. Add to that the reduced risk factor of using an FDA-approved drug and Knutsen projects that the company will be profitable three years after initial capital is raised, if the drug is approved, compared with the typical eight to 10 year time frame for biotech startups.




Requis Pharmaceuticals (Continued)

The company wants to tap the estimated $750 million OTC sleep-aid market and sees the potential for the market to expand much more with an anti-snoring drug.

The Sleep Foundation estimates that about 90 million Americans snore, but the reasons vary. For some it is caused by obstructive sleep apnea, obesity, alcohol consumption or allergies. Others snore due to anatomical reasons such as enlarged tonsils or adenoids, nasal polyps, or a deviated nasal septum.The current treatments tend to be in the form of devices

such as mouth guards, breathing strips and earplugs for the unfortunate bed partners.

In addition to Requisom, Requis is also developing a treatment for jet-lagged travelers.

Knutsen, who co-founded West Chester, Pennsylvania-based Requis with his wife Judi, has worked for Cephalon, GlaxoSmithKline, Novo Nordisk, Vernalis and Ionix Pharma, which was acquired by Vernalis. He has also held senior roles in four biotech startups.



Company:Viking Therapeutics

President and CEOBrian Lian

Website:http://www.vikingtherapeutics.com/

In California biotech deal, startup Viking Therapeutics snags 5 programs, $2.5M


A San Diego biotech startup focused on treating metabolic and endocrine disorders has picked up a portfolio of drug candidates and a $2.5 million investment from Ligand Pharmaceuticals (NASDAQ:LGND).

Viking Therapeutics said it’s licensed five programs from Ligand, including a Phase 2 program aimed at type 2 diabetes and another at wasting syndrome in cancer.

“Each of the licensed programs has what we believe to be first-in-class or best-in-class characteristics and a differentiated therapeutic profile,” said Brian Lian, president and CEO, in a statement.

Its lead candidate is an oral inhibitor of the enzyme FBPase, which plays an important role in how the body synthesizes glucose. According to Viking, the small-molecule drug has demonstrated safety and tolerability in early clinical trials and is headed for a Phase 2b trial in patients with poorly controlled type 2 diabetes.

Shortly behind is a potential cancer cachexia treatment. The oral, non-steroid drug has a tissue-selective mechanism that’s designed to deliver the therapeutic benefits of testosterone with improved safety and tolerability, according to Viking, which is planning a Phase 2 proof-of-concept clinical trial.

Three preclinical programs were also included in the deal: two targeting lipid disorders and another oral candidate for anemia.

Under the terms of the deal, Viking is responsible for all development activities related to the drugs. The 2-year-old company will also get a $2.5 million investment from Ligand to cover operating expenses.



Company:Omniox

CEO and Co-FounderStephen Cary

Website:http://www.omniox.com/

New brain cancer treatment targets tumor hypoxia to make radiation therapy work better

Sandra LoboMay 29, 2014

Omniox, Inc. is a biopharmaceutical company with a new protein-based platform (H-NOX) that has been engineered to make radiation therapy more effective for certain brain tumors.

The lead H-NOX product (OMX-4.80) is being developed in partnership with UC San Francisco Division of Neurooncology and is funded by a $7.5 million grant from the National Cancer Institute. OMX-4.80 is being developed as an oxygen delivery carrier for reversing hypoxia in glioblastoma (GB), the most common and aggressive primary brain tumor.

Although widely used in cancer therapy, the effectiveness of radiation is limited by certain factors such as tumor hypoxia.

Hypoxic cancerous tumors are known to be 2-3 times less sensitive to radiation than oxygenated tumors. This discovery has accelerated research in the discovery of agents that can safely deliver oxygen to hypoxic cancer tissue to re-oxygenate and make radiation effective.

Patients diagnosed with large hypoxic tumors often have only several months to live. Hypoxia in GB is to blame for poor treatment responses to




Omniox (Continued)

the standard of care radiotherapy/chemotherapy that rely on oxygen to be effective. Hypoxia also promotes tumor invasion and spreading. Pre-clinical studies in animal models of human GB have demonstrated that a single dose of OMX-4.80 overcomes hypoxia and improves tumor-killing and survival compared to radiotherapy treatment alone. This data has encouraged the addition of new therapeutic options such as OMX-4.80 that address tumor hypoxia to the current standard of care in combating this deadly cancer. In addition to glioblastoma, OMX-4.80 may also benefit other cancers such as head-and-neck, pancreatic, lung, and prostate cancers where hypoxia predicts poor outcomes.

The H-NOX platform has competitive advantage over other proteins that have been developed as therapeutics for oxygen delivery. These include hemoglobin-based oxygen carriers that are highly effective at delivering oxygen to tissue. However, they were found to have a major disadvantage due to their ability to scavenge nitric oxide causing hypoxic vasodilation, hypertension and organ toxicity. Oxygen-binding proteins in the H-NOX platform have a competitive advantage over hemoglobin-based oxygen carriers as they are usually non-reactive to nitric oxide and are non-toxic even at supra-therapeutic doses. In addition, the H-NOX proteins have been engineered to finely tune their size, ability to bind and release their gas payload and other characteristics for optimal therapeutic activity. This

versatility allows the targeting and release of carrier gas such as oxygen directly into the hypoxic tissue instead of premature release in the blood stream post-intravenous delivery. CEO and co-founder Dr. Stephen Cary said that “Hypoxia has long been known to be a major limiting factor in radiotherapy, and many approaches to oxygenate tumors have been tried. We are excited about our tuned oxygen carriers, and the preclinical data are promising, but we know there is still a long way to go in patients before we have a therapy.”

Omniox was spun out of the University of California Berkeley and was formerly housed in QB3 Garage on the Mission Bay campus of the University of California, San Francisco. It was the only company to receive the NCI Small Business Innovation Research (SBIR) 2012 bridge award. The company has raised slightly more than $3 million in angel money and is in the midst of a new round.

The money will be used for proof-of-concept experiments and comparative oncology clinical trials in veterinary patients. The company is poised to file an IND application in the next 12 to 24 months. The H-NOX platform is protected by patents in both the U.S. and Europe. In the future, Omniox intends to develop its H-NOX platform for other hypoxic indications beyond cancer that could include cardiovascular and neurodegenerative diseases.



Company:Spark Therapeutics

CEOJeffrey Marrazzo

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

Twitter:@spark_tx

Spark Therapeutics’ late-stage gene therapy for inherited blindness takes a $73M step forward


A Children’s Hospital of Philadelphia spinout with the potential to be the first to win U.S. FDA approval of a gene therapy is now funded through the rest of development of its lead treatment for inherited blindness.

Spark Therapeutics is in the middle of a Phase 3 clinical trial that will determine whether the gene therapy it’s developed can successfully restore some vision to people with rare degenerative eye diseases caused by mutations in the RPE65 gene. There’s currently no treatment available for these diseases.

To allow Spark to continue that study and prepare for commercialization, the company has just closed an oversubscribed $72.8 million Series B financing. Investors including Sofinnova Ventures, Brookside, Deerfield, Rock Springs Capital, T. Rowe Price, Wellington and CHOP participated.

Developed at CHOP’s Center for Cellular and Molecular Therapeutics, the therapy uses a neutralized virus as a vehicle to deliver a function gene to targeted cells in the eye. Once there, it enables production of a critical protein that’s missing as a result of a mutation and causes vision loss.

In earlier studies, the company reported that some children who were nearly blind as the result of a RPE65 mutation were able to recognize faces and walk without aid after receiving the treatment.

“One major difference between Spark’s approach and others under development is that gene therapy has the potential to be a one-time, curative treatment, rather than a treatment patients would need to take for life,” said CEO Jeffrey Marrazzo in an email.




Spark Therapeutics (Continued)

The current Phase 3 open-label, randomized, controlled study includes 16 patients who are receiving the therapy through a subretinal injection and eight patients in the control arm. They’re being monitored for improvements to orientation, mobility, navigational ability and performance on vision tests.

Marrazzo said data is expected in 2015.

In addition to the lead therapy, funding will also support growth in Spark’s other gene therapy programs in hemophilia B and other rare diseases.

Although the concept of gene therapy has been around for decades, it’s only recently advanced to the point

where regulatory agencies are acknowledging it as safe and effective enough to approve for sale. A number of companies including Amgen, BlueBird Bio and Advantagene are working toward U.S. approval for gene therapy treatments for cancer or rare diseases.

A number of researchers from the Center for Cellular and Molecular Therapeutics are involved with Philadelphia-based Spark, including two scientific co-founders, Dr. Katherine High and J. Fraser Wright, who serve as advisers.



Company:Second Genome

CEOPeter DiLaura

Website:http://www.secondgenome.com/

Twitter:@SecondGenome

Pfizer joins the microbiome movement, enlisting Second Genome for obesity study


Scientific understanding of the microbiome – the ecosystem of bacteria in the gut – has matured to the point where the pharmaceutical industry recognizes it as a critical part of drug discovery, says Peter DiLaura, CEO of Second Genome.

“The microbiome certainly is not the total picture of disease, but there’s now recognition that you can’t ignore it if you’re trying to understand complex chronic diseases,” he said.

Second Genome has just struck its second Big Pharma deal to explore the role of microbes in disease, and to identify potential new drug targets. Last summer, it paired up with Janssen Biotech to study ulcerative colitis. Now it’s working with Pfizer on what DiLaura called the largest microbiome study in humans to date.

In an effort to better understand the relationship between the microbiome, obesity and metabolic disorders, they’ll study about 900 obese individuals selected by a team at Massachusetts General Hospital over 12 months. In addition to looking at their microbiomes, they’ll also look at their genome and other components of the host biology to understand how interactions between the gut microbes of obese and non-obese people differ.




Second Genome (Continued)

A correlation between microbes and metabolic disease has emerged in several recent studies, including studies of microbiome transplants in mice. Now that the correlation has been established, DiLaura said, it’s time to untangle the functional relationships that microbes have with the host, to determine how they could best be modulated to prevent or correct a diseased state.

For Pfizer, that knowledge could lead to better drugs for obesity and diabetes.

“Understanding the complex set of interactions between the gut microbes in obese and non-obese individuals

is critical to our research in metabolic disease, a key area of focus at Pfizer,” said Barbara Sosnowski, vice president of external R&D innovation at Pfizer, in a statement.

The terms of the deal were not disclosed.

San Bruno, California-based Second Genome has raised more than $11 million in funding since its inception in 2009.



Medical Devices

& Diagnostics


Company:Veritas Medical

Chief Administrative & Research OfficerNate Rhodes

Website:http://www.lightlinecatheter.com/

Twitter:@AnesthesiaOS

Could a catheter using a narrow-spectrum light ward off hospital-acquired infections?


A medical device startup co-founded by five University of Utah graduates and students has taken on the challenge of combating the 100,000 deaths from hospital-acquired infections transmitted from catheters each year. They developed a bacteria-killing catheter that uses light to cleanse the catheter. Veritas Medical’s winnings from the International Business Model competition will help lay the groundwork for clinical trials early next year.

Medical device companies have developed different strategies for combating bacteria transmitted by catheters. Some use chemicals and drugs while others use UV light. In an interview with MedCity News, Veritas Medical co-founder and acting CEO Nate Rhodes said the company wanted to use light but also wanted to reduce the risk of melanoma.

Its Light Line Catheter uses high-intensity narrow spectrum light to kill bacteria without any harmful effects to human cells. So far Veritas Medical has filed a utility patent on the technology and will complete laboratory testing later this year before seeking 510(k) clearance for the Class 2 medical device.

Rhodes said he co-founded the company after winning a medical device competition at the University of Utah two years ago. The Bench to Bedside challenge involved pairing medical students with other students at the college to try to solve some of the challenges facing healthcare. The faculty adviser and chief medical officer for Veritas is Dr. John Langell, who mentored the team in that challenge. He is the director of the university’s


Startups In-Depth: Medical Devices & Diagnostics


Veritas Medical (Continued)

Center for Medical Innovation. He also serves as chief of surgery for the local VA hospital.

Langell said the company is a reflection of the kind of graduates it hopes to see more of. “We started focusing on training future health care innovators through our interdisciplinary innovation programs only a few years ago, and we are already seeing many successful technologies like this ready to transform the market,” according to a statement.

Alongside Rhodes, who received a masters in bioengineering this spring, other co-founders include James Allen, a bioengineering graduate; Mitch Barneck, a bioengineering graduate currently in medical school at Oregon Health and Science University; Martin de La

Presa, a University of Utah medical school student; and Ahrash Poursaid, who received a bachelor’s degree in bioengineering from the university this spring.

The catheter uses a visible 405 nanometer light. It is still debating whether to go with an LED light or a laser light. Either way, it can be turned on and off.

With an eye to clinical trials, University of Utah would probably host them. The state’s health system has a big push to reduce hospital-acquired infections. The cost of the device is aligned with industry costs.

Rhodes said it has had some encouraging conversations with C.R. Bard but “nothing in print yet.”



Company:BREATHE: The Connected Inhaler

DesignerOsman Cueto

Video:http://www.youtube.com/watch?v=dhEdGH_5uy4

Twitter:@occman

An asthma inhaler and app designed from the patient’s point of view


Misplace your inhaler lately? Are you due for a refill? Staying away from spots that exacerbate your asthma? A senior at Drexel University re-imagined an asthma inhaler with a companion app so users can keep a personal record of the quality of their breathing and do a better job of managing their health. Who better to design this product than an asthma patient who has had to live with the condition most of his life?

Osman Cueto developed BREATHE: The Connected Inhaler to help the 40 million people with asthma, according to a statement from the university. The companion app can trigger an alarm that helps users track down their inhalers — no doubt in the last jacket or set of trousers they were wearing. It also lets users map out nearby areas to avoid lest it trigger an attack. If users are about to cross into those areas, it triggers a warning on their smartphones.

Cueto also redesigned an inhaler that’s flatter and easier to store and carry around. It includes a mouthpiece within a sleeve so it doesn’t need a cap, which can often go missing.

The point of the app is to not only help people manage their conditions but to make users more engaged in their healthcare by developing a device from a patient’s point of view.

Asked what factors informed the design of the inhaler and app, Cueto responded in an email:



http://www.youtube.com/watch?v=dhEdGH_5uy4

http://www.youtube.com/watch?v=dhEdGH_5uy4


BREATHE: The Connected Inhaler (Continued)

“…The idea really came after reaching out and talking to other people suffering from asthma. I realized that, although everyone’s case of asthma is different, the issues they had were generally the same. I came to the realization that the unknown is what most people are afraid of. Not knowing how many doses are left, not knowing what exactly triggers an attack, not knowing where their inhaler is when in need, etc. With my design, I wanted to make people as comfortable as possible with their disease. I want the user to feel empowered through education, learning about their disease, going back and seeing when and where they used their inhaler and learning why. As far as we know, asthma is

incurable, so why not at least be in control of how you treat the symptoms?”

Cueto is one of 12 undergraduate students in the first graduating class of product design majors in Drexel’s Antoinette Westphal College of Media Arts & Design. The program takes a multidisciplinary design approach focused on product development and commercialization, according to a statement from the university. The inhaler represents the culmination of his degree and will be part of a senior show highlighting his design along with designs from his 11 classmates.



Company:Rotation Medical

President and CEOMartha Shadan

Website:http://www.rotationmedical.com/

New rotator cuff repair technique uses dissolving scaffold + special staples

Sandra LoboMay 29, 2014

Rotation Medical has developed a new way to treat rotator cuff injuries that addresses both the pain and degenerative nature of this problem. The treatment includes a proprietary, reconstituted collagen scaffold and a disposable instrument system, which includes the arthroscopic scaffold delivery, the tendon staple and the bone staple instruments. The Rotation Medical Rotator Cuff System induces formation of well-integrated and new mature tendon-like tissue in the injured tendon.

Rotator cuff tendon tears are common and can lead to persistent shoulder pain. Many tears do not heal readily, and over time small ones can become larger and more painful. Current therapies involve surgical interventions based on the size and morphology of the tear.

For small tears or in the early stages of this degenerative disease, surgeons use acromioplasty, which treats only pain, not the degenerative nature of the injury.

For larger tears, the surgeon sutures the tendon to the head of the humerus bone, but the mechanically reattached sutures often pull through the injured tendon and cause re-tears 25 to 40 percent of the time. The procedure also requires prolonged rehabilitation.

The Rotation Medical scaffold is designed to be placed over partial-thickness tears or over small to large full-thickness tears to allow for repair. It is not intended for use on rotator cuff tears greater than 5 cm. The




Rotation Medical (Continued)

scaffold is derived from bovine Achilles tendon and has been reconstituted to the fiber level to achieve high purity and porosity. The proprietary scaffold design is unique in the number, size and orientation of pores in the scaffold that allow for desired porosity required for infiltration of new blood vessels and fibroblasts. This facilitates growth and formation of a new tendinous tissue that is unlike scar tissue and provides biological support for the tendon. The low tensile strength of the scaffold reduces strain on the tendon, allowing the natural healing process to occur. The scaffold is available currently in two configurations: flat for mini-open procedures and pre-loaded into a delivery instrument for arthroscopic procedures.

The Rotation Medical instruments and the procedure used in surgery are unique. The instruments enable the scaffold to be delivered arthroscopically to a precise location and held in place while the tendon staples and bone staples are put in place. The instruments are disposable after surgery. Material used for the scaffold is biocompatible and within 6 months the scaffolds and the tendon staples are completely reabsorbed into the body. The bone staples are permanent.

Unlike other augmentation methods, increased tendon strength in the Rotation Medical System does not come from the scaffold but from the induced, remodeled tendinous tissue that augments the existing tendon biologically. As compared to other surgical methods for rotator cuff tendon tears, surgery using the Rotation

Medical System can cut down rehabilitation time by 50 percent.

Rotation Medical was founded in 2009 and is located in St Paul, Minnesota. The company recently announced that it has received 510(k) clearance from the Food and Drug Administration for its implantable collagen scaffold technology. Martha Shadan, appointed president and CEO in July 2013, said the company’s goal is to improve quality of life for people with rotator cuff injuries by treating them earlier and potentially preventing the progression of disease.

On the recent 510(k) FDA clearance she said, “This regulatory clearance enables us to begin to commercialize our bio-inductive scaffold solution, and we expect to launch in the U.S. later this year.”

The company will also be later pursuing a CE Mark approval on its collagen scaffold technology.

Rotation Medical is currently raising a Fund B for $20 million. The company has already raised $25 million in Fund A. The company is looking for new investors in addition to the primary investors who will be investing in the second round of funding or Fund B. The money will be used for commercialization of the product and will support expansion of the product into 2015. The money will also be used to conduct post-market clinical studies in the U.S. to further demonstrate the effectiveness of its collagen scaffold technology.



Company:Sano LLC

CEOPaul Hayre

Website:http://masschallenge.org/start-ups/2014/profile/sano-llc---low-cost-point-of-care-diagnostics

Chronic wound diagnostic as cheap as a home pregnancy test could be on the market by 2015

Lindsey AlexanderMay 6, 2014

Boston-based startup Sano LLC seeks $1 million in seed funding to commercialize its chronic wound diagnostic in 2015. The recent winner of M2D2 aims to bring the diagnostic to market at a price point as low as a home pregnancy test.

While Woundchek has a CE Mark, American physicians are left with a pretty basic tool kit for wound treatment: sniffing for foul odor, looking at the color and how much liquid the wound is producing and considering the amount of granulation in the tissue. Sano LLC CEO Paul Hayre said Sano wants to “bring in a little bit of science to the art of wound care.”

These more subjective measures will likely continue to help physicians determine treatment on a first pass, and a diagnostic would help determine (or reroute) treatment for persistent wounds.

Sano’s bedside diagnostic measures the amount of MMPs, a naturally occurring enzyme in wound healing. Hayre said the body secretes a high concentration of MMPs about three days after a wound is created. They should digest and “clean the slate” so around day five or six the wound can build a matrix over which cells migrate to heal the wound, he said.

But, in more than 30 percent of wounds, this concentration remains high, and the wound can’t heal.



http://masschallenge.org/startups/2014/profile/sano-llc---low-cost-point-of-care-diagnostics




Sano LLC (Continued)

“These enzymes are constantly destroying that process,” he said.

The clinician would swab the wound, then insert the swab into the company’s device and proprietary cherry-pink liquid and shake it up. The device offers a color metric read-out. The higher the concentration of MMPs, the darker the color.

Allowing doctors to offer more accurate treatment would cut some cost from care. But making a diagnostic intended to be used throughout the treatment process — perhaps several times per patient, Hayre said the company wants to shoot for a point-of-care price on par with a home pregnancy test. That way, there’s no reason clinicians wouldn’t use the test multiple times to monitor the wound’s progress and adjust treatment, he said.

“We need to make money, of course. But at the same time, if a diagnostic is priced too high it won’t find its way into a cycle of care today,” Hayre said.

The company has a prototype in hand and will work on human trials during the next three to five months. The company was built with the exit strategy in mind — creating a diagnostic after interviewing wound care strategics’ M&A teams, Hayre said. He said the startup is in talks with at least four such strategics about licensing or partnership.

Though Hayre said all the company’s eggs are currently in the wound-care basket, the MMP technology could provide a platform for the company to reach into cancer and other disease diagnostics, and even equine medicine.

If all goes according to plan, the company would take the 510(k) de novo pathway, aiming for commercialization of this product by Q2 or Q3 in 2015.



Company:Gauss Surgical

CEOMilton B. McColl

Website:http://www.gausssurgical.com/

Twitter:@gausssurgical

FDA approves Gauss Surgical’s app that turns iPads into real-time surgical blood loss monitors


A system that uses an iPad camera and cloud analytics to help anesthesiologists monitor how much blood a patient is losing during surgery has gotten the FDA’s OK for use in the operating room.

Mobile health startup Gauss Surgical said today it plans to begin rolling out its Triton Fluid Management System to hospitals next month.

The Triton app uses an iPad camera to scan surgical gauze covered in blood, and sends those images to the cloud where its algorithms go to work. In real-time, the app provides the OR staff with an estimate of how much blood has been collected in the sponges. That can be helpful to the team when deciding if, or when, to start a blood transfusion.

Traditionally, surgeons keep track of a patient’s blood loss by weighing sponges, or just guessing based on what they see. It’s not very accurate, and as a result, studies have suggested that blood transfusions are overused during some surgeries. Any time blood is transfused, the receiving patient is exposed to risk of infection or other complications.

“Over or under estimation of blood loss may lead to wrong clinical decision,” said Dr. Aryeh Shander, chief of the Department of Anesthesiology at Englewood Hospital and Medical Center in New Jersey, in a statement. “This new technology avails us the ability to more accurately account for blood loss with the potential to not only improve patient outcomes but also conserve healthcare resources.”




Gauss Surgical (Continued)

Gauss validated its technology with two clinical studies in which it demonstrated superior performance compared to visual and weighing methods, said Chief Operating Officer Eric Lindquist in an email.

The Los Altos, California-based company initially submitted a 510(k) request to the FDA in the summer of 2012, but after about six months of processing it was determined that it was not substantially equivalent to a predicate device, Lindquist said. So instead the company went through the de novo classification process, which took about 15 months, he said.

Gauss was founded in 2011 by Siddarth Satish, a graduate of Stanford’s biodesign program and Milton McColl, a former pro-football player-turned VC-turned medical device entrepreneur. They were early participants in the StartX accelerator and followed that up with a $6.2 million Series A round from LifeForce Ventures, Promus Ventures and Taube Investment Partners.



Company:Cocoon Biotech

CEOAilis Tweed-Kent

Boston startup with silk osteoarthritis treatment seeks up to $750K in seed round

Lindsey AlexanderMay 21, 2014

Silk is one of the hottest materials and shows much promise for medicine, particularly in targeted drug delivery. Cocoon Biotech, a Boston-based startup, wants to build on that promise with a silk injectable to be used for joint treatment. The company is raising a seed round up to $750,000, including $500,000 in equity.

The funding will take the company through animal studies and product optimization for the osteoarthritis product, CEO Ailis Tweed-Kent said.

Cocoon has licensed co-founder David Kaplan‘s silk ideas for joint and veterinary medicine, plus ophthalmology. Kaplan is the chair of biomedical engineering at Tufts University. (Check out Kaplan’s “partner-in-crime” — crime meaning research — Fiorenzo Omenetto’s TEDTalk on silk’s potential.)

The company’s technology “reverse engineers the cocoon.” Kaplan learned how — to oversimplify — to take the solution the silkworm makes in its glands, then go back to where the silkworm starts, which could lead to hydrogels, microparticles, films and sponges. Tweed-Kent was in clinics, seeing patients with osteoarthritis and yearning for more innovation in the space. When she connected with Kaplan, she said “serendipity” took its course, founding Cocoon in July 2013. The company was recently a finalist in the M2D2 competition.




Cocoon Biotech (Continued)

Almost 30 million Americans have osteoarthritis. Right now, osteoarthritis requires constant or repetitive treatment — from NSAIDs to physical therapy, which only subdue pain rather than cure the disease, or surgery, which doesn’t allow for preservation of anatomy and limits activity, such as total knee replacement.

Tweed-Kent said a real solution must meet the two major obstacles of the disease:

1. The mechanical component — that wear and tear over time that leads to inflammation and cascades to eliminate cartilage

2. The product should be able to be delivered locally to “take advantage of biochemical pathways”

Cocoon is pursuing several products that Tweed-Kent said could meet these needs. The material is most exciting maybe because of its potential to be combined with drugs to target different biochemical pathways, she said.

Though several such products are in preclinical development, the first product Cocoon will push forward is a lubricant that “reduces that friction and inflammation and in many ways can halt the progression of disease,” Tweed-Kent said.

The lubricant requires a PMA route, and Tweed-Kent said she expects the product will be commercialized by 2020.



Startup Activity: Medical Devices & Diagnostics

Medivizor expands healthcare literacy platform, adds collaboration partner

In a bid to boost health literacy and to improve the interactions between physicians and patients, Medivizor has massively expanded its healthcare content platform for patients in the past year and has added some interesting collaborations.

http://bit.ly/1iSRclA

E-cigarette-inspired inhaler releases measured doses of nicotine to help people quit smok-ing

When Noah Minskoff’s mother died of lung cancer in 2007, e-cigarettes were just entering the U.S. market. Minskoff, who had just started medical school in Utah, wondered whether the devices might have saved his mother’s life by helping her quit smoking.

http://bit.ly/1q6tMmm


Most Popular Startups This MonthA list of the five startups that got the most attention from readers on MedCityNews.com.

Covidien makes wearables acquisition with Zephyr Technology deal

Covidien, the medical device manufacturer, has acquired Zephyr Technology Corp. for an undisclosed amount. Rhonda Luniak, a vice president of communications at Covidien, confirmed the deal, originally reported by Mobi-HealthNews.

http://bit.ly/RjGVsF

An obesity treatment that looks like a pill but acts like a device takes in $12M from investors

A young Boston company thinks it has what could be a safe, effective and noninvasive way to help overweight and obese people drop those dangerous extra pounds.

http://bit.ly/1k88C2g

Customized mobile health platform acts like a “Swiss Army knife of apps” for hospi-tal communication

There is a sense of urgency in responding to calls and text alerts on mobile devices that make them both especially useful for contacting others faster and attention diverting. It has spurred mobile health startups and growth-stage companies from Seratis and Cureatr to Voalte to help medical staff ditch their pagers to make communication faster and more efficient. Mobile health company Practice Unite has developed several different applications within one app platform.

http://bit.ly/1nXZ4aC

Physician appointment scheduling startup HealthPost snapped up in $25M deal

The Advisory Board Company snagged physician referral and appointment scheduling startup, HealthPost, for around $25 million, executives disclosed in a conference call. It’s an interesting move because it overlooks higher profile scheduling platforms such as Vitals and ZocDoc. The Advisory Board Company’s motivations have a lot to do with the versatility of the cloud-based platform for both consumers and providers and helping healthcare systems retain and grow their patient base. It also complements the company’s previous acquisitions, such as CareTeam Connect.

http://bit.ly/1gx4JPT

An asthma inhaler and app designed from the patient’s point of view

Misplace your inhaler lately? Are you due for a refill? Staying away from spots that exacerbate your asthma? A senior at Drexel University re-imagined an asthma inhaler with a companion app so users can keep a personal record of the quality of their breathing and do a better job of managing their health. Who better to design this product than an asthma patient who has had to live with the condition most of his life?

http://bit.ly/1nPU8qx

stonearchcreative.com

EXPERTS INHEALTH MEDICALMARKETING

Monthly Startups Index...It’s messy – in many ways. Healthcare data comes from multiple sources:...

Documents

Transcript of Monthly Startups Index...It’s messy – in many ways. Healthcare data comes from multiple sources:...