Posts Tagged ‘Initial public offering’

Updated: Investing and Inventing: Is the Tango of Mars and Venus Still on

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 8/18/2014 – Bruce Booth in FORBES


VC-Backed Biotech IPOs: Valuations And Virtuous Cycles


UPDATED on 8/18/2014

7 Unconventional Ways To Fund A Medtech Startup

By Jim Pomager

Gears and dollars

Bringing innovative new medical technology to market today is as challenging, complex, and competitive an endeavor as it’s ever been for entrepreneurs and startups. Making matters worse, venture capital — the fuel that fledgling companies once depended on to drive product development — has dwindled in recent years.

According to an annual report by PricewaterhouseCoopers (PwC) and the National Venture Capital Association (NVCA), venture capitalists (VCs) invested a mere $2.1 billion in medical device and equipment companies in 2013. That may sound like a lot on the surface, but it’s the lowest annual figure for the industry in the last nine years, down 17 percent from $2.5 billion in 2012, and down a whopping 43 percent from the $3.7-billion high-water mark of 2007.

Not only is funding scarce, but VCs have become incredibly risk averse, waiting until much later in the product development cycle to get involved. There was a time not so long ago when new entrants to the medtech sector could obtain funding with little more than a great idea and a solid business plan, or so it seemed. Today, however, investors are withholding their support until a device accumulates significant safety and efficacy evidence, and often until regulatory and reimbursement approval have been secured. This leads to an unfortunate catch-22 — startups need substantial funding to get their technology into clinical trials, but VCs often want to see clinical trial data before committing.

Faced with this conundrum, medtech entrepreneurs have to get creative, and the broader healthcare industry is rallying to help support them. Experts from Cleveland Clinic, UnitedHealthcare, and other organizations discussed this trend during a lively panel session on this topic called How Healthcare Will Support Startups: In Dollars And Beyond, during the recent MedCity Converge conference in Philadelphia. While the panel focused primarily on digital health startups, they did identify 7 nontraditional sources of funding that might fit the bill for your medical technology company.

1. Divergent Corporate Venturing
Seeking capital from established corporations may not sound like a novel idea. In fact, it has become commonplace for large medical device companies to loan small, private companies millions in return for an option to purchase them at a later date. (See Boston Scientific’s $15 million deal with MValve Technologies last month or St. Jude’s acquisition of CardioMEMS in June.) These arrangements have their benefits — medtech corporations offer startups critical market knowledge and tend to be more patient than private VC firms.

However, more interesting strategic partnerships are beginning to form across traditional industry lines. Not only can large corporations outside the medical device space offer medtech startups new investment streams, they can also provide important technological solutions and a fresh perspective on design. “We are typically looking not just for cash, but for other technologies that our startups can embed in theirs to make a better mousetrap,” said Gary Fingerhut, executive director of Cleveland Clinic Innovations.

Fingerhut’s group, whose goal is to translate the ideas of physicians, scientists, and caregivers to the market, manages approximately 450 royalty-bearing licenses a year from a traditional tech transfer perspective, and also has 67 spinoff companies operating underneath it. Among the many cross-industry corporate partnerships it has helped form for its startups in recent years are joint initiatives with Parker Hannifin, IBM, Verizon, and Lubrizol.

“We very much believe that it can bring a lot of resources to the table — not just capital, but resources in other industries that they’ve been in and have not ventured into healthcare,” Fingerhut added. “We bring the domain expertise. They bring their technologies, their experience, their go-to-market capabilities, and their capital. It’s a win-win.”

2. Aggressive Grant Funding
Another twist on a familiar fundraising tactic was identified by Tom Vanderheyden, VP of business development and commercialization for health insurance carrier UnitedHealthcare (UHC). He said that really focused startups can sometimes substitute significant grant funding in lieu of early VC support.

“Something that I’ve seen a few times recently is companies taking the angel rounds of a couple hundred thousand dollars to get started, and then putting a lot of energy into grant funding,” he said. “They go for the non-dilutive $1 million to $3 million. We’ve seen that be very successful, and then you come out of that grant funding phase and you’ve got meaningful enterprise that’s got lots of IP juice behind it.”

Daphne Zohar, founder of PureTech Ventures — a venture creation company that proactively creates new companies to solve unmet healthcare problems (including one developing a noninvasive neuromodulation device for the treatment of neuropsychiatric disorders) — said that her company pursues a great deal of grants for its startups. “We actually have a person full-time on the team who just applies for grants,” she explained. “They have gotten millions in grants, which is terrific, because the funds are non-dilutive and move things forward.”

Cleveland Clinic’s Fingerhut agreed, saying his group has brought in over $150 million of state money through programs like Ohio’s Third Frontier. Many other states offer similar programs to support startups. (For instance, I wrote about Pennsylvania’s Ben Franklin Technology Partners in a previous story.) The federal government is also a good source of grant money, through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs at the National Institutes of Health (NIH) and National Science Foundation (NSF).

3. Accelerators & Incubators
Having founded a medtech startup himself, Joseph Mayer, M.D., extolled the virtues of accelerators and incubators. The CEO of Cureatr, a mobile care coordinator, went through the New York Digital Health Acceleratorwhen his company was starting out.

“For us, it was a good opportunity,” he said. “We had two people when we started, with one customer, and we came out of it with two more customers. At the end of the day, that’s what matters. You have to ask yourself, ‘What would I pay for two customers in terms of salespeople, etc.?’”

Compared to some other sources of funding, the amount of money you can get from an accelerator or incubator is relatively small, typically in the tens or hundreds of thousands. UHC’s Vanderheyden said that Rock Health, a healthcare accelerator that his group supports, characterizes its financial support as “grants and Ramen (the infamous and inexpensive instant noodles) money.” But what these entities lack in funds they more than make up for in value-added services.

“We are very active with accelerators in terms of venturing,” said Vanderheyden. “Some entrepreneurs we have found in this space are focused on the clinical benefit, the physician engagement, etc. They haven’t quite figured out yet the economics of the business. That’s something we feel we can shine some light on.” In addition to business advice, some of the perks provided by these programs can include inexpensive office and lab space, medical expertise and guidance, targeted educational programming, and more.

And some accelerators are now offering funding packages that are “getting closer to real money,” as Vanderheyden put it. You can obtain a total of $300,000 from New York Digital Health, he said. Verizon Foundation gives approximately $800,000, according to Cleveland Clinic’s Fingerhut. And there’s nothing prohibiting startups from going through multiple accelerator programs.

4. Partnering With Not-For-Profits
Everyone knows that patient advocacy and other not-for-profit organizations play a major role in financially (and otherwise) backing fundamental research. But what you may not know is that these groups are starting to become much more involved in helping technologies related to their treatment areas of interest reach commercialization.

Zohar described an initiative that PureTech Ventures launched called the Valley of Life, which brings together investors and not-for-profits to achieve common financial and mission-driven goals. The program aims to assist select startups bridge the so-called biomedical “valley of death” between angel and VC funding.

The Valley of Life’s first pilot program is in the juvenile diabetes space and involves the Juvenile Diabetes Research Foundation and the Joslin Diabetes Center (an affiliate of Harvard Medical School). “The idea is basically a $10 million fund that’s funded primarily from patient groups that have been up until now funding basic research, and are now really interested in the translational aspect,” Zohar explained.

5. Customer Investment
The next approach, while admittedly much more straightforward for digital health companies than for pure-play device makers, is still worth noting. Cureatr’s Mayer was the first to point out that customers can be an excellent source of funding for new companies: “You build a strong relationship with a customer, a large health system, the big for-profits in the national market — they’re starting to do more and more, not just biotech but healthcare IT investment.”

In some cases, these current or future customers may be willing to pay an advance on future services. “Another thing I have seen, but I won’t say we’ve done, is what I like to call the prepaid revenue model,” said UHC’s Vanderheyden. “I have seen corporates take some risk and say, ‘I think over the next 12 or 24 months, we plan on spending $600,000 in total for your services, so we’ll give you half of that up front to get the party started. Now you can get some hiring done and expand your infrastructure — whatever you need to do.”

6. Hybrid VC Approaches
Although securing venture capital funding is no picnic these days, there are signs that the situation is improving. According to the latest quarterly report from PwC and NVCA, VC dollars invested in the medical devices and equipment sector rose for the second straight month, reaching $649 million in 73 deals. Narrowing the focus to the capital of the global medical device market, Minnesota saw medical device investing more than double between Q2 2013 and Q2 2014, per a recent report from Life Science Alley.

PureTech’s Zohar shared a potential strategy for working with VC investors — engage a mixture of life science and technology investors, and cater to each group’s specific needs. “I think one thing that’s interesting is the metrics that life science investors use versus the metrics that technology investors use. There really are not many investors that are focused on digital health and can really look at all sides of the spectrum,” she said. “Tech investors tend to look at the customers and whether you have revenue or are likely to have revenue, whereas life science investors will look at the technology IP and the specific application. The kinds of things that we’re doing are really a hybrid, so we have to cultivate a group of investors that have that creativity.”

Regardless of whether you use a traditional approach or a hybrid one, Mayer of Cureatr shared some general advice on engaging the right VC investor. Make sure you pick one that truly understands the healthcare sales cycle, that believes in you and your team, and that you think you will enjoy working with, he suggested.

7. Crowdfunding
The use of crowdfunding was an almost unavoidable topic of discussion. After all, not a week goes by without news of a medtech startup (particularly in the wearable segment) launching a new Kickstarter or Indiegogo campaign. However, I saved it until last because the panel expressed a great deal of concern about the use of crowdfunding, and offered some sound advice as to why.

Vanderheyden shared a cautionary tale, based on an anecdote he heard during a recent investor conference in Minneapolis. “[One of the speakers] said he took over for a company that had crowdfunded. They had 450 non-credited investors, and he said it was a disaster. One of the investors had originally sent in $5,400, and 90 days later he calls the CEO asking for his money back,” Vanderheyden explained. “Think about it as the CEO of an early-stage startup. Now you have dozens and dozens —or conceptually hundreds — of equity stakeholders, non-accredited, that you now have to manage.”

As an inherently public exercise, crowdfunding also exposes startups to potentially negative publicity. Zohar likened it to using an online dating site, where people won’t be willing to engage you until you have built up sufficient credibility and validation on the site. “There’s a bit of a risk in putting yourself out there and saying, ‘Hey, I’m looking for money,’” she said of crowdfunding. “What if you can’t raise the money? What does that say [to potential investors]? Does that say your idea isn’t good?

“During the very early stages, when we actually could use that funding, we would rather find the funding from other sources that exist, and not put ourselves out there as looking like as if we need the money,” she added.

If you are hell-bent on exploring crowdfunding for your startup, the panelists agreed that you should check outAngelList, which is effectively a crowdfunding site for accredited investors. “AngelList is probably the best example of institutionalized crowdfunding,” Mayer said, “where you can get 20 people into a round.”

While finding and obtaining investment for new medtech companies is certainly a challenge in the current economic environment, it is far from impossible, as the examples above attest. I am curious to hear your opinion on these strategies — or other unconventional methods you have either used or learned about. 



UPDATED on 4/15/2014

14th ANNUAL BIOTECH IN EUROPE FORUM For Global Partnering & Investment
30th September – 1st October 2014 • Congress Center Basel

SACHS Associates, London


UPDATED on 4/15/2014

New Trends in Investing and Inventing: Who Benefits from the Booming Success of the Technology Industry


The dealbook.nytimes.com reported in 4/13/2014 the following IPO related and Start up Cases that exemplify the NEW trends

by Sydney Emner with Comments of Scott Kupor, Managing Partner at Andreessen Horowitz.

  • “There’s a broader public policy question here,” Mr. Kupor said. “There is a wealth transfer happening, from public investors to private investors. And the benefits are accruing to the investors that can access the private markets.”
  • Of the 100 largest venture capital rounds on record, 88 were issued within the past five years, according to CrunchBase, which tracks venture funding. Each delivered more than $50 million to the companies.
  • Proliferation of big late-stage investments: The average size of such investments so far this year was $44.1 million, the highest level in the past five years and up 77 percent from last year, according to data from CB Insights.
  • Technology start-ups are staying private longer
  • Venture capital firms are looking to put idle funds to work, and
  • Institutional investors are chasing returns in fast-growing private companies
  • Megarounds, the flood of money is inflating the valuations of early-stage companies. companies are collecting the additional money simply because they can, taking advantage of an ocean of ready cash
  • Over valuations may lead to yet another dot-com bubble 2014 vs 2001
  • For venture capitalists, allowing portfolio companies to take on more funding means their existing stakes can be diluted. But since these big rounds often lead to much higher valuations, many investors don’t mind
  • Partner at Sequoia Capital, conceded that investors were spending less and less time conducting due diligence: playing by slightly different rules than what happened even five years ago
  • In recent years the sheer amount of capital available for investment in Silicon Valley start-ups went up: big venture capital firms have recently raised big rounds, meaning the traditional backers of tech firms are well positioned to write big checks
  • Venture capitalists are increasingly being joined by hedge funds and private equity firms chasing huge returns. Among the top investors in fund-raising rounds that collected over $100 million are
  1. Digital Sky Technologies and
  2. Tiger Global Management, which ranked alongside traditional venture capital firms like
  3. Andreessen Horowitz and
  4. Kleiner Perkins Caufield & Byers, according to CB Insights
  1. T. Rowe Price and
  2. Fidelity Investments.
  3. JPMorgan

“Appreciation that normally would have happened in the public market is happening in the private market,” said Mr. Kupor of Andreessen Horowitz. “This is why we see T. Rowe, Fidelity and JPMorgan investing. They’re saying, ‘There’s not a lot of growth for us in the public market.’ ”

  • In many cases, such firms are given access to promising start-ups with the understanding that they would remain investors even after an I.P.O.
  • Some hedge funds are even transforming themselves into so-called growth capital firms that invest in older start-ups. Coatue Management, for example, is planning on raising a $500 million fund devoted to the kinds of investments that the firm has made in companies like Snapchat.com and the last-minute hotel booking site HotelTonight.comDropbox.com  is another case in point
  • Instead of raising just enough money for the next 18 months or two years, companies are now raising all the money they could feasibly need as a private company in one fell swoop.“Today, companies can raise money well ahead of any actual need.” Mr. Fogelsong said.
  • Companies receiving the influxes of capital, having so much money in the bank allows them to control their own destiny, rather than be at the mercy of acquirers or the markets. “If someone wants to buy them, they can turn it down and wait for a higher price,” said Peter C. Wendell, managing director of Sierra Ventures. “If the I.P.O. is looking shaky, they can say, ‘Look at my balance sheet,’ and wait.”
  • The average age of companies going public today is 10 years, in contrast to the average of just six years in 2000, according to Jay R. Ritter, a professor at the University of Florida.
  • On average, between a quarter and just under a third of the late-stage money is being used to buy shares from employees and early investors ahead of an I.P.O.
  • “Rounds that would have otherwise gotten done in the public markets are getting done in the private markets,” said Scott Kupor, partner and chief operating officer of Andreessen Horowitz, a venture capital firm that is among the most active participants in big late-stage rounds.

Case Study #1: Quora.com

Quora, a question-and-answer website, didn’t need to raise money. It had barely touched $60 million in venture capital that it accepted just two years ago. Yet the California company, which has no revenue and just 70 employees, recently announced that it had raised an additional $80 million. The new round valued the company at a reported $900 million, more than double the previous valuation of $400 million. That means that while some early investors may have seen their ownership diluted by the new round, the value of their holdings nonetheless soared.  “When it goes off at a high price, the V.C. gets to change the price of the other stock on his books,” said Mr. Wendell of Sierra Ventures. The result is that much of a company’s gain in value is happening before it even goes public.

Case Study #2: Nextdoor.com

Silicon Valley expression: Eat when the food is passed,” said Nirav Tolia, chief executive of Nextdoor, which last year accepted $60 million in additional venture funding despite having plenty of money in the bank. . “It’s always good to bet on the furthest-out point.” per Mr. Tolia

Case Study #3: Airbnb.com

Airbnb, the home-sharing site, neared a deal to raise as much as a staggering $500 million from investors like TPG Growth, T. Rowe Price and Dragoneer Investment Group, according to people briefed on the matter. TPG Growth alone had been prepared to provide up to $150 million in the round, one of these people said

Case Study #4: Uber.com and Lyft.com

And two weeks ago, Lyft raised $250 million from the likes of the Alibaba Group of China and Daniel S. Loeb’s investment firm, Third Point — despite being widely regarded as significantly behind the leader in the car service industry, Uber.com

Longer incubation periods mean many companies do need more capital for operating expenses. For example, companies that focus on on-demand services, like the car ride companies Uber and Lyft, require capital as they build out their dispatch networks in new cities and offer new products.

Case Study #5: Fab.com

Fab.com, an e-commerce start-up that raised $150 million last summer at the tender age of two years. An overambitious expansion plan and falling sales led to a wave of employee exits and a painful retrenchment.

Case Study #6: Box.com

Box, the cloud storage company, has filed to go public at a time when, filings show, it needs to raise more capital. But its rival, Dropbox, recently raised $250 million and may put off its I.P.O., especially as appetite for technology stocks is faltering.

Case Study #7: HomeAway.com

In 2008, HomeAway, the real estate website, was planning to go public. But as the financial crisis began, HomeAway executives decided to postpone the I.P.O. Instead, in November of that year, HomeAway raised $250 million in additional venture capital and resolved not to think about going public for at least two years.  The company finally went public in 2011.




UPDATED 3/1/2014

The 2nd ANNUAL Sachs Cancer Bio Partnering & Investment Forum Promoting Public & Private Sector Collaboration & Investment in Drug Development, 19th March 2014 • New York Academy of Sciences • USA



UPDATED on 1/10/2014

Biotech Showcase™ 2014

January 13-15, 2014 San Francisco, CA Parc 55 Wyndham, SF, Union Square

Program Overview


Investing and Inventing: Is the Tango of Mars and Venus Still on

Curator: Aviva Lev-Ari, PhD, RN


Investing and inventing has become way too dogmatic:

  • Investors say, “We don’t fund ideas, we fund traction.”
  • Entrepreneurs say, “You never make a business plan. You only make an MVP.”
  • Investors say, “We like companies that are going to get acquired for $100M, not try to go for an IPO.”
  • Entrepreneurs say, “I’ll just aim for an acqui-hire or a small M&A deal, it’s much lower risk.”
  • Investors say, “We make a lot of small investments, instead of one or two that are potential home runs.



This curation was conceived following the review on the following Sources:

Source # 1 


By Laura Entis, November 20, 2013

Posted by Healthios Xchange Administrator Wed at 10:23 AM – 301 views – Filed in Healthios Selections



Source #2




Source #3

Special Issue: Silicon Valley: Global model or unique anomaly by Social Science Information/SSI – A Sage Publicationsinternational  journal

Reporter: Aviva Lev-Ari, PhD, RN

Source #4

Innovators can exit with an idea: How to Monetizing Patents and ideas: yazamIP.com launches Idea Lab

Reporter: Aviva Lev-Ari, PhD, RN


Source #5


Source #6

University-Industry Partnerships; NIH/DOD Funded Industry – Academic Collaborations

According to Source #1: Investing and inventing: Is the Tango of Mars and Venus Still on

Where Startup Funding Really Comes From (Infographic)

According to Source #2: Investing and inventing: Is the Tango of Mars and Venus Still on

Ten Theories explain the REALITY



THEORY 4: “minimally viable product” The MVP OBSESSION



Second 7 in the Original Article, thus,

  • 2nd 7 = Theory 8
  • Theory 8 = Theory 9
  • Theory 9 = Theory 10




According to Source #3: The SILICON VALLEY Tango of Investing and inventing is Still on

Henry Etzkowitz

Silicon Valley at risk? Sustainability of a global innovation icon: An introduction

to the Special Issue

Social Science Information December 2013 52: 515-538,


Doug Henton and Kim Held

The dynamics of Silicon Valley: Creative destruction and the evolution of the

innovation habitat

Social Science Information December 2013 52: 539-557,


James C Williams

From white gold to silicon chips: Hydraulic technology, electric power and

Silicon Valley

Social Science Information December 2013 52: 558-574,


Annika Steiber and Sverker Alänge

The formation and growth of Google: A firm-level triple helix perspective

Social Science Information December 2013 52: 575-604,


Henry Etzkowitz

StartX and the ‘Paradox of Success’: Filling the gap in Stanford’s

entrepreneurial culture

Social Science Information December 2013 52: 605-627,


Steven Casper

New-technology clusters and public policy: Three perspectives

Social Science Information December 2013 52: 628-652,


Helen Lawton Smith, John Glasson, Saverio Romeo, Rupert Waters, and Andrew


Entrepreneurial regions: Evidence from Oxfordshire and Cambridgeshire

Social Science Information December 2013 52: 653-673,



According to Source #4: Investing and inventing: Is the Tango of Mars and Venus Still on

 The IDEA as Entry and as Exit Point

1. yazamIP.com launches Idea Lab, enabling innovators to exit without necessarily establishing a startup.

If you: (A) have a track record of innovation and have a solution for a significant technical problem, and (B) are interested in either of the options below, both have no cost to you: (i) a $1,000,000 “exit” from your idea without necessarily leaving your “day-job”; (ii) having proven innovation, patent and business experts work with you to establish a robust patent portfolio based on your idea. And you maintain the option to spin off the strong portfolio into a startup for you to build the market.

Then yazamIP.com’s Idea Lab is for you. See http://www.yazamip.com/valuations

2. Tel Aviv University’s Ramot raises $17m from Tata & SanDisk.http://yazamip.com/node/84

3. Elvis Presley IP sells. http://yazamip.com/node/82

4. Innovation and patents are helping to increase gun sales.http://yazamip.com/node/85

Want to get a valuation on your patent? See http://yazamip.com/valuations

Do not forget to contact yazamIP.com to inquire about our most generous “referral a patent” fee arrangement.

NEWS AND DEVELOPMENTS1. yazamIP.com launches patent valuation service. http://www.yazamip.com/valuations2. yazamIP.com client initiates patent infringement action against Sony.http://www.yazamip.com/node/743. Twitter has only 9 patents pre-IPO, a fact that has investors worried.http://www.yazamip.com/node/734. Marijuana-related patents? Now that is a market to corner!http://www.yazamip.com/node/77
  1. If the companies are in distress and have US patents then we can sell them for the inventor
  2. If the patents are being infringed upon, we can see how we can help the inventor get compensated
  3. If the inventors have great ideas that they have not turned into companies yet, we would consider investing in them to convert the ideas into patent portfolios

According to Source #5: Connecting INVENTORS to BUSINESS BUILDERS and INVESTORS — Investing and inventing: Is the Tango of Mars and Venus Still on

National Venture Capital Association <http://www.nvca.org/>
DEN =http://www.den.dartmouth.edu/     http://www.den.dartmouth.edu/about/overview.html
Small Business Investment Companies (SBIC) <http://www.sba.gov/content/venture-capital-startups-high-growth-technology-companies>   programs by state
Directory of Angel-investor networks <http://www.inc.com/articles/2001/09/23461.html>
Tech Coast Venture Network <http://tcvn.org/>
Start-up Report posting service <http://www.startupreport.com/>
Hub Angels Investment Group, LLC <http://www.hubangels.com/>
Links to Angel networks in Midwest <http://www.northstareconomics.com/angel_investing.htm>
The San Diego Venture Group <http://www.sdvg.org/>
Angels in Arizona <http://www.arizonaangels.com/index.htm>
The Aurora Angels <http://www.auroraangels.com/>
Atlanta, Georgia, Angel network <http://angelatlanta.com/>
Valley Angel Investment Fund
<http://gust.com/angel-group/valley-angel-investment-fund> Ohio Angel network <http://www.c-cap.net/about.html>
Great Valley Pennsylvania Angel network <http://www.greatvalleyalliance.com/programs/paan.htm>
Vancouver, British Columbia Angel network <http://www.vef.org/>
Information and links to venture capital sources in China <http://www.chinasite.com/Business/VentureCapital.html>
Los Angeles Regional Technology Alliance <http://www.larta.org/>

According to Source #6:University-Industry Partnerships; NIH/DOD Funded Industry – Academic Collaborations – Investing and inventing: Is the Tango of Mars and Venus Still on

Presentation and Panel Discussion
University-Industry Partnerships; NIH/DOD Funded Industry – Academic Collaborations

The 9th Annual Non-Dilutive Funding Summit is proud to host Dr. Anthony Boccanfuso, Executive Director, The National Academies’ University-Industry Demonstration Partnership (UIDP) who will discuss in his presentation industry-academic collaborations and how the life science industry can leverage such ties to secure non-diltuive capital to fund their R&D activities.

Following the presentation, Dr. Boccanfuso will lead a panel discussion featuring top industry executives who will detail how non-dilutive funding substantially assisted in maintaining a sustainable business while promoting their R&D efforts.
1:00 – 2:30
Presentation – University-Industry Partnerships
Presenter and Panel Moderator:
Anthony Boccanfuso
Executive Director, The National Academies’ University-Industry Demonstration Partnership (UIDP)

Panel Discussion
University-Industry Partnerships; NIH/DOD Funded Industry/Academic Collaborations
Dr. Eric Patzer
Founder and President, Aridis Pharmceuticals
Dr. Scott Thatcher
CEO & Founder, Orphagen
Dr. Timothy A Antaya
CEO, Antaya Science and Technology
James Knighton
CEO, AvidBiotics
Full Meeting Agenda
07:30 – 08:30
Pre-Conference Workshop – 1X1 RO1 for Companies
Ayal Ronen
Vice President, FreeMind Group
08:30 – 09:00 Breakfast and Networking  
09:00 – 10:15

Welcome Presentation 

– Non-Dilutive Funding Forecast 2014


Ram May-Ron
Managing Partner, FreeMind Group
10:30 – 11:30
Keynote – National Heart, Lung, and Blood Institute (NHLBI; NIH) Presentation: “Navigating the Transition from Discovery to Market” 
Dr. Jodi Black
Deputy Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, NIH
11:30 – 12:00 NIH Round Table Discussion – Meet with NHLBI OfficialsDr.JodiBlackDeputy Director, Division of Extramural Research Activities, National, Heart, Lung, and Blood Institute,NIHLarryMahanDirector, Office of Translational Alliances & Coordination at National Heart, Lung, and Blood Institute, NIH
12:00 – 1:00 Break  
1:00 – 2:30
Presentation – University-Industry Partnerships
Presenter and Panel Moderator:
Anthony Boccanfuso
Executive Director, University-Industry Demonstration Partnership (UIDP)

Panel Discussion
University-Industry Partnerships; NIH/DOD Funded Industry/Academic Collaborations
Dr. Eric Patzer
Founder and President, Aridis Pharmceuticals
Dr. Scott Thatcher
CEO & Founder, Orphagen
Dr. Timothy A Antaya
CEO, Antaya Science and Technology
James Knighton
CEO, AvidBiotics
2:30 – 3:00 Coffee Break  
3:00 – 3:30

Meet the Expert – Round Table Discussions

Neurological Disorders Funding Opportunities

Guy Har-Chen
Chief Analyst, FreeMind Group

3:30 – 4:00

Meet the Expert – Round Table Discussions

Infectious Diseases and Biodefense Funding Opportunities
Guy Har-Chen
Chief Analyst, FreeMind Group
4:00 – 4:30 Closing Remarks  


This email was sent to avivalev-ari@alum.berkeley.edu by carla@freemindconsultants.com |

FreeMind Group | 423 Brookline Avenue #124 | Boston | MA | 02215 

617-648-0340 ext 249


by Aviva Lev-Ari, PhD, RN

  • Investing and inventing is a Market Place as well as a Profession. Market places are typified by information imperfection and Professions are typified by very steep Specialization and Competition
  • I am in full agreement with the comment made by

Stephen J. Williams, Ph.D.

Stephen J. Williams, Ph.D, Cancer Pharmacologist, Expert, Author, Writer and Senior Editor @ http;//pharmaceuticalintelligence.com
“Quite interesting that average family and friends investment is $23,000. I wonderhowtheywereabletoseperateoutcrowdfunding, angel investors, from family and friends. I also wonder whattherateofincreasewithcrowdfunding is? However equally surprising is that VC does not make that much of initial startup funding. I think banks level of funding have steadily decreased since the consolidation of the 90’s.”

  • I followed the advice of Dr. Dror Nir and I perfectly agree with his observation on the relevance of the Ten Theories by  JERZY GANGI, SERIAL ENTREPRENEUR

Dror Nir
Dror Nir, Managing partner at RadBee, Expert, Author, Writer, Editor and Top Contributor to LinkedIn Group: Leaders in Pharmaceutical Business Intelligence

“I think you should read this, there are interesting insights which I very much agree with.”

  • Innovators can exit with an idea: How to Monetizing Patents and ideas: yazamIP.com launches Idea Lab. yazamIP.com launches Idea Lab, enabling innovators to exit without necessarily establishing a startup. This is a desruptive technology with great potential designed to solve problems emerging from the Ten theories of the dogmatic nature of the interplay between Investors and Entrepreneurs who are either the Inventors or the Team members of Start ups.
  • I agree with JERZY GANGI, SERIAL ENTREPRENEUR that Investing and inventing has become way too dogmatic:
    • Investors say, “We don’t fund ideas, we fund traction.”
    • Entrepreneurs say, “You never make a business plan. You only make an MVP.”
    • Investors say, “We like companies that are going to get acquired for $100M, not try to go for an IPO.”
    • Entrepreneurs say, “I’ll just aim for an acqui-hire or a small M&A deal, it’s much lower risk.”
    • Investors say, “We make a lot of small investments, instead of one or two that are potential home runs.
  • Source #1 – is a MUST information to be mastered by both Investors and Entrepreneurs
  • The ten theories are very insightful, they mirror my own views on  Investing and inventing as is manifested in the US and in other Developed countries.
  • Angel Investment is there to stay and is the MOST sensitive source of funding affected by volatility in economic markets conditions. Source #5 was add as an endorsed suggestion made by Dr. Justin D Pearlman, MD, PhD, FACC an Expert, Author, Writer, Editor @ http://pharmaceuticalintelligence.com, a Patent holder and an Inventor at Leaders of Pharmaceutical Business Intelligence
  • Silicon Valley is where I lived, 1978 – 1990 (Palo Alto), pursued Graduate studies (UC, Berkeley, Stanford GSB) and worked as an Executive in the Largest Think Tank in the US, SRI International, and at Amdahl Corporation, Sunnyvale, CA]. The SIlicon Valley is not an anomaly but a Singular point in the Entrepreneurship Ecosystem.
  • Silicon Valley is being followed by another Singular point driven by and derived from a different ethos and impatus, namelythe ecosystem in the “Start ups Nation” Israel.
  • Israel is different than the Silicon Valley in CA, or any other Start ups hub in the US.
  • I am in full agreement, based on my own experience as an Israeli resident in Israel, 1958 – 1978, with the differences and the unique reasons for the Israeli success, as presented  in

Start-up Nation: The Story of Israel’s Economic Miracle by Dan Senor (Author), Saul Singer (Author)

Other related articles published on this Open Access Online Scientific Journal include the following:


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Reporter: Aviva Lev-Ari, PhD, RN

Fluidigm Corporation (NASDAQ: FLDM) develops, manufactures and markets microfluidic systems for growth markets in the life science and agricultural biotechnology, or Ag-Bio, industries. Fluidigm’s proprietary microfluidic systems consist of instruments and consumables, including chips, assays and other reagents. These systems are designed to significantly simplify experimental workflow, increase throughput and reduce costs, while providing the excellent data quality demanded by customers. Fluidigm actively markets four microfluidic systems, including nine different commercial chips, to leading academic institutions, diagnostic laboratories, and pharmaceutical, biotechnology and Ag-Bio companies. Fluidigm products are marketed for research purposes only (not for diagnostic use).
Fluidigm Announces Exercise of Underwriters’ Over-Allotment Option and Closing of $60 million Public Offering of Common Stock

SOUTH SAN FRANCISCO, CALIFORNIA – August 21, 2012 – Fluidigm Corporation (NASDAQ: FLDM), a supplier of microfluidic systems for growth markets in the life science and agricultural biotechnology industries, today announced that it has closed the previously announced underwritten public offering of 4,209,000 shares of its common stock at a price to the public of $14.25 per share for gross proceeds of approximately $60 million. The shares include 549,000 shares of common stock sold pursuant to the over-allotment option granted by Fluidigm to the underwriters, which option was exercised in full. The net proceeds from the sale of the shares, after deducting the underwriters’ discounts and commissions and other estimated offering expenses payable by Fluidigm, will be approximately $56.1 million.
Fluidigm currently plans to use the net proceeds from this offering for research and development, commercialization of its products, working capital and other general corporate purposes.
Piper Jaffray & Co. and Cowen and Company, LLC acted as the joint book-running managers for the offering.  Leerink Swann LLC, Oppenheimer & Co. Inc. and Cantor Fitzgerald & Co. acted as the co-managers for the offering.

A shelf registration statement (File No. 333-180550) relating to these securities was filed on April 4, 2012, as amended on May 7, 2012, and declared effective by the Securities and Exchange Commission on May 10, 2012.  A final prospectus supplement and accompanying prospectus describing the terms of the offering was filed with the SEC on August 16, 2012.  Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402 or by telephone at 800-747-3924 or by email at prospectus@pjc.com, or from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: 631-274-2806, Fax: 631-254-7140). An electronic copy of the prospectus supplement and accompanying prospectus relating to the offering is available on the website of the Securities and Exchange Commission at http://www.sec.gov/.
This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Fluidigm, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

In order to provide Fluidigm’s investors with an understanding of our current intentions and future prospects, this release may contain statements that are forward-looking.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include our expectations regarding the offering and the use of proceeds from such offering.
Forward-looking statements involve risks and uncertainties related to our business and the general economic environment, many beyond our control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements, including market risk and the risks we identify in reports filed with the SEC.
Although we believe that the forward-looking statements contained herein are reasonable, we can give no assurance that our expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of our risks and uncertainties, you are encouraged to review the official corporate documents filed with the SEC. Fluidigm does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.


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Obstructive Coronary Artery Disease diagnosed by RNA levels of 23 genes – CardioDx, a Pioneer in the Field of Cardiovascular Genomic Diagnostics

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 11/15/2013

CardioDx, Inc. Nixes IPO, Cites Unfavorable Market Conditions

11/15/2013 10:31:01 AM


CardioDx postpones its initial public offering, citing ‘unfavorable market conditions.’ California molecular diagnostics company CardioDx spiked its initial public offering, citing “unfavorable market conditions,” according to news reports. The 5.8-million-share offering by Palo Alto-based CardioDx was slated to raise $92 million at a share price of $14-$16 apiece. The IPO, originally scheduled for yesterday, would have seen CardioDx shares trade under the “CDX” symbol.



CardioDx had planned to use some of the funds to expand its commercial efforts, including its sales and marketing workforce; to fund operations as the company pursues more insurance coverage and reimbursement; to “conduct additional clinical and marketing activities” for the company’s Corus CAD blood-based gene expression test; to fund R&D activity; and for “general corporate purposes.” CardioDx will later specify just the how much it plans to put toward each of those activities.

Investors in the company include V-Sciences Investments, Longitude Venture Partners, Artiman Ventures, Kleiner Perkins Caufield & Byers, JP Morgan and Mohr Davidow Ventures.



CardioDX pulls IPO, citing poor market conditions

CardioDX, led by David Levison, was one of three medical technology companies to postpone their IPOs on Thursday due to poor market conditions.

Senior Technology Reporter-Silicon Valley Business Journal
CardioDX postponed an IPO on Thursday after deciding that the market is unfavorable at this time.


The Palo Alto company led by CEO David Levison was one of three planned medical tech companies that postponed going public on Thursday. San Diego-basedCelladon and Monrovia-based Xencor also decided to hold off due to poor market conditions.

Redwood City pharmaceutical developer Relypsa, meanwhile, went ahead with a drastically reduced IPO that raised about half of what it had been projected for it.

CardioDX, which sells diagnostic tests for cardiovascular disease, reported total revenue in in 2012 of $2.5 million and a net loss of $25.6 million. The company expects to continue to show losses for the next several years and has an accumulated deficit through June totaling $165.9 million. As of June 30, it had $46.8 million in cash, equivalents and investments.

The company’s biggest existing stakeholder is V-Sciences Investments, a wholly owned subsidiary of Temasek Life Sciences Private Ltd., which holds 19.9 percent of outstanding shares.

Other big stakeholders are Longitude Venture Partners, with a 17.9 percent stake; Artiman Ventures, 13.9 percent; Kleiner Perkins Caufield & Byers, 9.5 percent; JP Morgan, 6.4 percent; and Mohr Davidow Ventures, 5.8 percent.



Cardiovascular MDx Firm CardioDx Files to Go Public

UPDATED on 10/14/2013

October 14, 2013

NEW YORK (GenomeWeb News) – Cardiovascular molecular diagnostics firm CardioDx has filed with the US Securities and Exchange Commission to go public with an intended offering of up to $86.3 million of common stock.

The Palo Alto, Calif.-based firm has not priced its offering yet or said how many shares it plans on offering. Bank of America Merrill Lynch and Jefferies are listed as joint book-running managers on the offering, while Piper Jaffray and William Blair are co-managers.

The company plans on listing on the Nasdaq Global Market under ticker symbol “CDX.”

In its Form S-1, CardioDx said that its tests provide healthcare professionals with “critical, actionable information to improve patient care and management,” with an initial focus on coronary artery diseases (CAD), arrhythmia, and heart failure.

Its flagship product is the Corus CAD, a gene expression-based test for assessing non-diabetic patients who display symptoms suggestive of obstructive CAD. The test was launched in 2009 and through June 30, CardioDx delivered results for more than 40,000 tests, it said.

Corus CAD received Medicare Part B coverage in August 2012, making it a covered benefit for about 48 million Medicare beneficiaries, the company added.

In 2012, CardioDx posted $2.5 million in revenues with a net loss of $25.6 million. Through the first six months of 2013, the firm had revenues $2.9 million and a net loss of $18.4 million.

It had $46.8 million in cash, cash equivalents, and investments as of June 30, it said.

In August 2012, CardioDx raised $58 million in private financing. Before that, it raised $60 million in a financing round. In 2010, GE Healthcare invested $5 million in the company as part of a Series D financing round.

David Levison heads the firm as President and CEO. Other members of the management team include CFO Andrew Guggenhime; Chief Scientific Officer Steven Rosenberg; Chief Medical Officer Mark Monane; and Chief Commercial Officer Deborah Kilpatrick.

CardioDx is the latest in a recent string of omics-related companies who have gone public or have filed to go public in the US. Cancer GeneticsNanoString Technologies, and Foundation Medicine launched their IPOs earlier this year. Meanwhile, VeracyteBiocept, and Evogene have filed to float.

UPDATED on 2/25/2013

CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

February 24, 2013
CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

Tue Feb 19, 2013 8:30am EST

– Study Highlights the Validity of Corus CAD as a First-Line Test to Help Clinicians Exclude Obstructive CAD as a Cause of the Patient’s Symptoms – PALO ALTO, Calif.,  Feb. 19, 2013

/PRNewswire/ — CardioDx, Inc., a pioneer in the field of  cardiovascular genomic diagnostics, today announced the publication of the COMPASS (Coronary  Obstruction Detection by  Molecular
Personalized Gene Expression) study in  Circulation: Cardiovascular Genetics,  a journal of the American Heart Association. 

Results of the prospective, multi-center U.S. study showed that  Corus®  CAD, a blood-based  gene expression test, demonstrated high accuracy with both a high negative predictive value (96 percent) and high sensitivity (89 percent) for assessing  obstructive coronary artery disease  (CAD) in a population of patients referred for stress testing with myocardial perfusion imaging (MPI).  The study’s authors conclude that using Corus CAD earlier in the diagnostic algorithm could reduce the number of invasive cardiac tests by more accurately evaluating the presence of obstructive coronary artery disease compared to the traditional algorithm of stress myocardial perfusion imaging (MPI) in these patients.

COMPASS enrolled stable patients with symptoms suggestive of CAD who had been referred for MPI at 19 U.S. sites.  A blood sample was obtained in all 431 patients prior to MPI and Corus CAD gene expression testing was performed with study investigators blinded to Corus CAD test results. Following MPI, patients underwent either invasive coronary angiography or coronary CT angiography, gold-standard anatomical tests for the diagnosis of coronary artery disease. 

The study was designed to provide additional independent validation of the Corus CAD test in a real-world intended use patient population of patients presenting for MPI, a common noninvasive test for CAD, and builds on the results of the previous PREDICT validation study. Corus CAD requires only a simple blood draw for testing, making it safe, convenient, and easy to administer. The study evaluated results in stable non-diabetic patients with typical or atypical symptoms suggestive of CAD and found that Corus CAD surpassed the accuracy of MPI, a test that was administered more 10 million times in the U.S. in 2010.[1]

“The evaluation of stable patients with chest pain and other symptoms suggestive of CAD is a common challenge for clinicians, accounting for as many as 10,000 outpatient visits each day,” said the publication’s lead author,  Gregory S. Thomas, M.D., M.P.H., Medical Director of the MemorialCare Heart & Vascular Institute at Long Beach Memorial Medical Center and Clinical Professor of Medicine and Director of Nuclear Cardiology Education at the  University of California-Irvine  School of Medicine. “In the U.S., MPI testing is often performed in these patients and is followed by referral to invasive coronary angiography. Based on the results of this study of the Corus CAD gene expression test, we now have a reliable diagnostic approach for evaluating patients with symptoms of obstructive CAD.  With its high sensitivity and negative predictive value, Corus CAD may help clinicians accurately and efficiently exclude the diagnosis of obstructive CAD early in the diagnostic pathway, so they can assess for other causes of their patients’ symptoms.”

The pre-specified primary endpoint of the COMPASS study was the receiver-operator characteristics (ROC) analysis to evaluate the ability of Corus CAD to identify coronary arterial blockages of 50 percent or greater by quantitative coronary angiography.  Corus CAD outperformed MPI in overall diagnostic accuracy for assessing obstructive CAD, with an area under the curve (AUC) of 0.79 for the Corus CAD test compared to MPI site and core-lab read AUCs of 0.59 and 0.63 respectively (p<0.001).  In addition, Corus CAD performed better than MPI in sensitivity (89 percent vs. 27 percent, p<0.001) and negative predictive value (96 percent vs. 88 percent, p<0.001) parameters, thus demonstrating excellent performance for excluding obstructive CAD as the cause of a patient’s symptoms.  The COMPASS results corroborated earlier findings from the PREDICT multicenter U.S. validation study[2] demonstrating that the Corus CAD score is proportional to coronary artery stenosis severity.

“Corus CAD can help solve an enormous unmet need in healthcare by providing clinicians with a safe, convenient and reliable tool to help evaluate common patient symptoms and triage them more appropriately for subsequent therapy or additional testing,” said  David Levison, President and CEO of CardioDx.  “In addition to its higher diagnostic accuracy, Corus CAD holds potential to reduce a major healthcare expense category – unnecessary noninvasive imaging and/or invasive coronary angiography procedures and their associated risks and side effects. We have worked closely with leading clinicians to build a solid clinical and economic foundation for Corus CAD, leading to its growing acceptance in the medical and payer communities as evidenced by the more than 35,000 tests performed to date and Medicare’s decision to cover the test.”



CardioDx is promoting yet another post-marketing study whose data may help the company’s gene expression test for obstructive coronary artery disease reach more patients, better compete with the standard of care and also build vital market share.

Executives at the California-based 2012 Fierce 15 company say they wanted more data on Corus CAD‘s real-world use, building on its previous PREDICT validation trial as a result. The test has been on sale commercially since 2009 and won crucial Medicare reimbursement last fall. Chief Scientific Officer Steven Rosenberg told FierceMedicalDevices via email that the results from the latest study pointed in a number of positive directions.

“It demonstrates performance at least as good as that seen in the PREDICT study, but in the population the Corus CAD is indicated for,” Rosenberg said, “It shows significantly higher performance for obstructive CAD than MPI, which is the most common non-invasive imaging test used in this regard.”

A 431-patient clinical study of the blood diagnostic rated the test with a 96% negative predictive value and 89% high sensitivity, in assessing the condition in patients who were referred for stress testing with myocardial perfusion imaging (MPI). (Last November, CardioDx heralded similar results from another study using Corus CAD on 98 geriatric patients.) Details are published in the journal Circulation: Cardiovascular Genetics.

The blood test, conducted at 19 U.S. sites through multiple academic institutions, determined that using Corus CAD earlier in the diagnostic process better assessed the presence of coronary artery disease versus MPI. This might encourage doctors to cut back on invasive, more expensive cardiac tests by ruling out obstructive CAD sooner. In other words, determining a patient doesn’t have obstructive CAD eliminates the need for diagnostic procedures such as coronary angiography or coronary CT angiography, the company explains.

Post-marketing studies are increasingly important in today’s health care market, with the need to demonstrate the utility of a device or diagnostic in as most detailed a way possible. And it’s not just boosting the standard of care; the Affordable Care Act means value matters, too, more than ever before. Success with this mission can help broaden market share and also increase the chance of private as well as government insurance coverage. Additionally, new post-marketing trials can also set the stage for expanded indications down the line.



A Blood Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Non-Diabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study

  1. Gregory S. Thomas1*,
  2. Szilard Voros2,
  3. John A. McPherson3,
  4. Alexandra J. Lansky4,
  5. Mary E. Winn5,
  6. Timothy M. Bateman6,
  7. Michael R. Elashoff7,
  8. Hsiao D. Lieu7,
  9. Andrea M. Johnson7,
  10. Susan E. Daniels7,
  11. Joseph A. Ladapo8,
  12. Charles E. Phelps9,
  13. Pamela S. Douglas10 and
  14. Steven Rosenberg7

+Author Affiliations

  1. 1Long Beach Memorial Medical Center, Long Beach & University of California, Irvine, CA

  2. 2Stony Brook University Medical Center, Stony Brook, NY

  3. 3Vanderbilt University, Nashville, TN

  4. 4Yale University School of Medicine, New Haven, CN

  5. 5Scripps Translational Science Institute, La Jolla, CA

  6. 6University of Missouri, Kansas City, MO

  7. 7CardioDx, Inc., Palo Alto, CA

  8. 8New York University School of Medicine, New York, NY

  9. 9University of Rochester, Rochester, NY

  10. 10Duke Clinical Research Institute, Duke University, Durham, NC
  1. * MemorialCare Heart and Vascular Institute, Long Beach Memorial Medical Center, 2801 Atlantic Avenue, Long Beach, CA 90806 gthomas@mimg.com


Background—Obstructive coronary artery disease (CAD) diagnosis in symptomatic patients often involves non-invasive testing before invasive coronary angiography (ICA). A blood-based gene expression score (GES) was previously validated in non-diabetic patients referred for ICA but not in symptomatic patients referred for myocardial perfusion imaging (MPI).

Methods and Results—This prospective multi-center study obtained peripheral blood samples for GES before MPI in 537 consecutive patients. Patients with abnormal MPI usually underwent ICA; all others had research coronary CT-angiography (CTA), with core laboratories defining coronary anatomy. A total of 431 patients completed GES, coronary imaging (ICA or CTA), and MPI. Mean age was 56±10 (48% women). The pre-specified primary endpoint was GES receiver-operator characteristics (ROC) analysis to discriminate ≥50% stenosis (15% prevalence by core laboratory analysis). ROC curve area (AUC) for GES was 0.79 (95% CI 0.73-0.84, p<.001), with sensitivity, specificity, and negative predictive value (NPV) of 89%, 52%, and 96%, respectively, at a pre-specified threshold of ≤15 with 46% of patients below this score. The GES outperformed clinical factors by ROC and reclassification analysis and also showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of patients showed that 27/28 patients with adverse cardiovascular events or revascularization had GES >15. Site and core-lab MPI had AUCs of 0.59 and 0.63, respectively, significantly less than GES.

ConclusionsA GES has high sensitivity and NPV for obstructive CAD. In this population clinically referred for MPI, the GES outperformed clinical factors and MPI.

Clinical Trial Registration Information—www.clinicaltrials.gov; Identifier: NCT01117506.

  • Received June 6, 2012.
  • Revision received January 15, 2013.
  • Accepted February 5, 2013.



CardioDx heart disease test wins Medicare coverage

San Francisco Business Times by Ron Leuty, Reporter

Date: Wednesday, August 8, 2012, 4:00am PDT

CardioDx's test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.
Photo supplied by CardioDx

CardioDx’s test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.

Reporter- San Francisco Business Times

A key national Medicare contractor will cover the cost of a coronary artery disease test developed by CardioDx Inc.

The move is important for Palo Alto-based CardioDx because private insurers tend to follow the federal government’s Medicare health insurance program. The company has had to seek reimbursement on a case-by-case basis with those private insurers since its Corus CAD gene expression test hit the market in June 2009.

The decision disclosed Tuesday by Palmetto GBA, a national contractor that administers Medicare benefits in Columbia, S.C., means that Medicare will cover the test for as many as 40 million enrollees. Coverage is retroactive to Jan. 1.

Corus CAD is a shoebox-size kit that uses a simple blood draw to measure the RNA levels of 23 genes. Using an algorithm, it then creates a score that determines the likelihood that a patient has obstructive coronary artery disease.

“By providing Medicare beneficiaries access to Corus CAD, this coverage decision enables patients to avoid unnecessary procedures and risks associated with cardiac imaging and elective invasive angiography, while helping payers address an area of significant healthcare spending,” CardioDx President and CEO David Levison said in a press release.

The decision represents the latest Medicare-coverage win for Bay Area diagnostic test makers. Palmetto earlier this year opted to cover the Afirma gene expression test from South San Francisco’s Veracyte Inc. to diagnosis thyroid nodules, and last summer Palmetto said it would cover Redwood City-based Genomic Health Inc.’s (NASDAQ: GHDX)colon cancer recurrence test.

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