IBJNews

Medical device startup FlowCo enlists Guidant alums

Back to TopCommentsE-mailPrintBookmark and Share

The upstart developer of a device to help doctors choose the right-sized stent to prop open clog-prone arteries has brought aboard former Guidant Corp. executives.

FlowCo factboxTheir regulatory and marketing expertise could help FlowCo Inc. bring its artery-measurement product to market as soon as 2011.

Indianapolis-based FlowCo earlier this year named as its CEO Bill McConnell, who’d been chief information officer at Guidant, the coronary products company spun off from Eli Lilly and Co. in the 1990s and acquired by Boston Scientific in 2006.

McConnell had recently retired as a senior vice president at Boston Scientific’s cardiac rhythm management unit in Minnesota.

Just a few months earlier, FlowCo device inventor Ghassan Kassab, a biomedical engineer and IUPUI professor, lassoed no less than former Guidant CEO Ron Dollens to serve as chairman of the budding firm.
 

Dollens Dollens

Dollens replaced Eli Lilly’s former chief science officer, Gus Watanabe, who died last summer. Watanabe was also chairman of the local life sciences initiative BioCrossroads.

“When Gus died, I worried more about FlowCo. He was so instrumental,” said David Johnson, president and CEO of BioCrossroads.

“Here you have this little company with these really heavy hitters. It remains one of the most cool, promising companies,” Johnson said of FlowCo, on whose board he serves.

And it’s ambitious.

FlowCo intends for its technology to challenge what is now the No. 1 tool in the market for complicated stent placement—intravascular ultrasound, or IVUS, technology.

Typically, surgeons use X-ray images to judge artery characteristics and select the appropriate stent size and placement. Stents are metal tubes with slots and have been used for years to keep open arteries clogged by plaque.

In some cases, however, it’s hard to image the artery. To minimize the risk of complications from poor stent implantation, many insurers, including Cigna, will pay for IVUS when, for example, “the angiographic image does not explain the individual’s degree of symptoms.”

FlowCo’s device uses not ultrasound but electrical impedance to gauge artery characteristics.

It’s said to be more precise, less cumbersome to use, and less expensive than IVUS. It will also be able to measure flow reserve in a diseased artery, a measurement today that requires the use of a different device.

But competing with IVUS in what could be a $1 billion annual artery measurement market won’t happen unless FlowCo can first thread Kassab’s “LumenRECON” device through the tortuous bureaucracy of the U.S. Food and Drug Administration.

Last month, FlowCo completed a human pilot study and is in the process of preparing a filing with the FDA, McConnell said.

To avoid years of regulatory exercises, McConnell and Dollens are trying to get the device classified by FDA as “substantially equivalent” to products using the IVUS and flow-reserve technology.

“There may be some additional clinical work that’s required,” McConnell said, before it can be classified as equivalent.

FlowCo could have its device on the market for use in peripheral arteries next year, with a coronary version perhaps in 2012, McConnell said.

He cautions that’s only a best guess, based on his experience with heart stents, defibrillators and other products.

The company’s lifeblood—funding—has been flowing smoothly so far. FlowCo in 2007 landed $250,000 from BioCrossroads’ Indiana Seed Fund. That year, it also pulled in $2 million from the state’s 21st Century Research and Technology Fund.

And last November, FlowCo raised $1.2 million from outside investors, according to Securities and Exchange Commission records.

“The company has attracted a tremendous amount of highly sophisticated angel investment and other funding,” Johnson said.

Better mousetrap?

That such a product opportunity exists in a maturing stent market may be surprising to those outside the operating room—particularly now that stents are coated with drugs to further reduce the likelihood the passage where the stent is placed will narrow again—known as restenosis—or develop dangerous blood clots.

The restenosis rate averages 4 percent to 8 percent, depending on which study one reads. Put in too big a stent and vessels can be damaged. Too small a stent can cause turbulence between the tube and cell wall—inducing blood clots.

Either way, the complications can be expensive. A few years ago, in an interview with CathLabDigest, Kassab estimated that an 8-percent restenosis rate could translate into 56,000 patients per year, with retreatment costs of more than $15,000 per patient—or more than $800 million a year.

Kassab used his electrical engineering expertise to design a better mousetrap, mindful of the key weaknesses of IVUS. That technology requires some interpretation by doctors of the ultrasound image, making it more subjective.

It also is a two-step process, with its sensors housed on a separate catheter from that used for the angioplasty balloon system that presses the stent into the artery wall. The wires used with IVUS can also be difficult to maneuver through certain kinds of arteries. Measuring flow reserve requires yet another, specific-purpose guide wire.

In contrast, Kassab’s device can use standard catheters or guidewires with which surgeons already are accustomed. Lumen-RECON has four tiny wires, or electrodes, running through the center of the guidewire, popping out at the tip.

Two of the wires send an electrical current and the other two measure the voltage difference, to take key measurements of the artery.

The conductivity of electrical current differs depending on the material through which it passes. That holds potential for getting a better idea of the composition of plaque in a patient’s arteries.

The electrodes also take measurements as the balloon is inflated and give the surgeon real-time, digital data as to how much to expand the stent.

“It’s a more complicated process to interpret what you see from the IVUS image,” McConnell said.

Price-point potential

Perhaps the biggest selling point could be on price.

McConnell declined to elaborate, but said the FlowCo device could run roughly half that of the combined cost of IVUS and flow-reserve devices. In the United States alone, there are about 1 million coronary artery interventions annually, plus about 400,000 procedures on peripheral arteries.

Kassab hailed from the University of California, San Diego. He trained under Y.C. Fung, known as the father of biomechanics. Kassab inherited Fung’s program in California. IUPUI later recruited him and 14 of his staff. Among local firms involved in the design of the FlowCo product are Catheter Research Inc. and engineering/prototyping firm Priio.•

ADVERTISEMENT

  • Know Your Facts
    Ron Dollens and Bill McConnell are of great character. Dishonest is a strong word. Know the story before throwing stones.
  • Potential "FLOWCOrruption"
    Based on the headlining article in the Company News section, I don't know if I would be putting the welfare of my upstart company into the hands of dishonest former Guidant executives. This would seem to lead itself to difficultly in establishing corporate and public trust for your products.

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. Uh, sorry Johnnie, but you are incorrect. Despite the assertions by yourself and various defenders and captains, sports attendance is NOT off significantly at most sporting events in the US. Variances in attendance has been in the range of single digits, both + & - for years now. MLB has had most of its best overall attendance nubers in the last decade, and that trend has been consistent for most major sporting events. The number one issue cited by most fans when asked about attendance is the overall cost of attending. The presence of HD and big screen televisions in home doesn't even register, as a factor for not attending an event. VALUE in the product is the key, and apparently is something lacking in the current ICS. What other explanation is there when with what is routinely touted as the "best" racing on the planet, fans are staying away in DROVES. A "close" title battle into the last event at Fontana, with the "cars and stars" of the ICS, and who showed up? MAYBE 8K. Sorry, but HD TV isn't to blame for that kind of fan apathy.

  2. Do you need finance to establish your business ? Are you interested in getting a loan at 3% from our private company? If so please Email: suntrust_oil@blumail.org

  3. If she was worth the $ the public outcry over direct tv dropping them would have kept them on their dishes as we have seen with other companies. I too quit watching channel 13 after she showed up since I left channel 8 because of her all show rather than production results. When Randy on 8 corrected her she had a big head and incorrectly challenged his correction for pronunciation of a city. Other antics while she matures was too much for me with her very inaccurate forecasts. All the forecasters were predicting rain until Thursday except Chris. They predicted sunny on Thursday but instead of rain until Thursday upon which the sun would finally make it out in full glory Chris was right on the money just as I too predicted looking at the radar on weather.gov. One thing I love about Angela is the fear you can see in her every time it thunders in the winter. It far exceeds the entertainment value of her body language (high heel noise drags, depression, etc) when her forecasts are so incorrect. Her hair stands on end, you have to see it!!!

  4. Good Day, Apply For A Loan I am Mr Fernadez Antonio, a private Loan lender and a cooperate financial for real estate and any kinds of business financing. I also offer Loans to individuals, Firms and cooperate bodies at 3% interest rate We offer any kind of loans. email us via fernadezloaninvest@outlook.com LOAN APPLICATION FORM First name:......................... Middle name:......................... Last name:........................................ Date of birth (yyyy-mm-dd):....................... Gender:........................................... Marital status:................................... Total Amount Needed............................... Loan Duration.................................... Address:.......................................... City:............................................. State/province:................................... Zip/postal code:.................................. Country:.......................................... Phone:............................................ Fax:.............................................. Mobile/cellular:.................................. Monthly Income.................................... Occupation:....................................... Best Regard, Mr Fernadez Antonio.

  5. i will love to share my testimony to you all the people in world i got married to my husband about 2 year ago we start having problems at home like we stop sleeping on the same bed,fighting about little things he always comes home late at night,drinking too much and sleeping with other women out side i have never love any man in my life except him. he is the father of my child and i don't want to loose him because we have worked so hard together to become what we are and have today .few month ago he now decided to live me and the kid,being a single mother can be hard sometimes and so i have nobody to turn to and i was heart broken.i called my mom and explain every thing to her,my mother told me about DR.okoro how he helped her solve the problem between her and my dad i was surprise about it because they have been without each other for three and a half years and it was like a miracle how they came back to each other. i was directed to DR. okoro on his email:okorospell@gmail.com and explain everything to him,so he promise me not to worry that he will cast a spell and make things come back to how we where so much in love again and that it was another female spirit that was controlling my husband he told me that my problem will be solved within two days if i believe i said OK So he cast a spell for me and after two days my love came back asking me to forgive him i Am so happy now. so that why i decided to share my experience with every body that have such problem contact Dr okoro the great spell caster on his email addresses spellcasterforlove@outlook.com

ADVERTISEMENT