Kiger's Notebook

Big money biotech guru to speak @ RAEDI meeting

This is interesting (to me, anyway).

G. Steven Burrill, one of the top biotechnology evangelists in the U.S. and a backer of the Elk Run bio park by Pine Island, is headlining the annual meeting of the Rochester Area Economic Development entity.

The event is Feb. 12, 2010 at the Rochester International Event Center. Here's some from an editorial by Burrill that I read in the Nov. 1 issue of the Genetic Engineering & Biotechnology News:

There are 328 biotechs that are publicly traded on major U.S. markets (down 7.8% year-to-date), and at the end of September the group of public biotech companies had an aggregate market cap of $352 billion (up 10.4% for the quarter).

In addition, there are 51 companies that have market caps greater than $1 billion (up 4% year-to-date); 36 companies that have market caps between $500 and $999 million (up 38% year-to-date); and 136 public biotech companies (41%) that have a market cap below $100 million.

While the data is encouraging, we don’t yet believe biotech is fully back on track, as many companies are still struggling to find the necessary funding to maintain their operations.

Almost half of U.S. public biotechs have market caps below $100 million and we are seeing companies still consistently turning off their lights for the last time.

It is important to remind ourselves that the biotech industry is undergoing a major transition, a process that will likely continue for at least another two quarters.

This is because we do not yet know how President Obama’s proposal for healthcare reform will fully impact the biotechnology industry, and the status of biosimiliars legislation (follow-on biologics) is also still unresolved.

There are fears that these issues will drive the prices of innovative drugs lower and eat away at biotech company profits. Despite the market uncertainties, we will likely see the industry build on the momentum it has gained over the past several months.

Mayo Clinic works on new monitoring device

Mayo Clinic is testing a remote health monitor device, or “guardian angel,” it developed with a Swiss company that could snag a piece of a multimillion-dollar market.

STMicroelectronics, which has engineers in Rochester working with doctors, is collaborating with Mayo on a device that monitors a patient’s heart rate, blood pressure, activity levels and breathing. The goal is to create a device that goes home with patients and tracks their conditions.

One clinical study of the device has already been conducted here, and a second study targeting hospitalized heart patients began Thursday, said Kathy Anderson, a Mayo Clinic spokeswoman. The goal is to enroll 10 patients, Anderson said.

Mayo Clinic and ST do not have a financial relationship connected to the project.

“This is what we consider a co-development or collaboration agreement,” Anderson says. “There is no technology license. We hope to take this technology to patients, and ST has been the one to help us create the prototype device.”

-------------

“If there is joint intellectual property between Mayo and ST, there will be a co-patent or license,” says Anderson.

Having even half of such a device could prove profitable. Estimates of the telemedicine or health monitoring market by industry experts range between $3.6 billion to $11 billion.

Berg Insight estimated in a recent report that home monitoring could be an option for 300 million people in Europe and the U.S. The report also estimated that the market could grow by 10 percent a year.

Seven patents issued for Roch., Minn. inventors today

Random fact - When the weekly announcement of the awarding of patents was made today by the U.S. Patent and Trademark Office, seven of the patents were issued to inventors in Rochester, Minn.

That's out of the 44 U.S. patents that came out today.

Six of those seven went to people that work for IBM Rochester. The seventh was issued to someone that works for Pharmexa Inc.

---------------

Here's the list of patents:

1. Allocating entitled processor cycles for preempted virtual processors

2  Maintain owning application information of data for a data storage system
3  Deferring refreshes during calibrations in memory systems
4  Efficient memory usage in systems including volatile and high-density memories
5  Selectively removing entities from a user interface displaying network entities
6  Alarm system for hearing impaired individuals having hearing assistive implanted devices
7  Inducing cellular immune responses to hepatitis B virus using peptide compositions

NeoChord's first human patient

Remember NeoChord?

That's the Minneapolis biotech company founded in 2007 that is working on bringing to market a Mayo Clinic-created non-invasive method for fixing a leaky heart valve AKA mitral-valve regurgitation.

Mayo Clinic does have an investment in an equity position in NeoChord. 

Well, it has installed its heart fix in a human patient in Europe now.

That sounds like a solid step toward getting a product to market, assuming the test goes well.

Here's some from a press release on the study:

NeoChord, Inc., a venture-backed, Minneapolis-based medical technology company, announced today that it has enrolled the first patient in its European clinical trial.

The trial is being conducted in Germany, Denmark, Czech Republic and Norway.

“We are very pleased with the early results of this first procedure,” said Per Wierup and Sten Lyager Nielsen, the cardiac surgeons who performed the surgery. “The patient is an otherwise healthy, very active 47-year-old male who preferred to not have a sternotomy or cardiopulmonary bypass to fix his severe mitral regurgitation. The NeoChord approach has successfully treated his mitral regurgitation and potentially offers him a quick return to his military career and favorite hobby, scuba diving.”

Intra-operative transesophageal echocardiography (TEE) confirmed that the patient’s severe, eccentric mitral regurgitation was reduced to zero or trace mitral regurgitation. 

Giovanni Speziali, MD, the cardiac surgeon who is the primary inventor of the NeoChord device also attended the procedure.  “These results, although early, are equivalent to what we obtain in traditional open heart surgery for correction of mitral regurgitation,” said Dr. Speziali.

More on Kardia's new offering

Here's more on Kardia's new product/service.Extra info tidbits:

• Roch. developer Gus Chafoulias is major financial backer and he has an office in Kardia's management suite in the Minnesota BioBusiness Center.

• Kardia posted a $9 million loss in 2008 as the firm spent about $600,000 a month during the year

• Kardia logged 150 new customers in 2008 and took more than $2 million in orders.

--------

Kardia Health Systems launched a new online platform this week for managing and archiving cardiology medical reports.

ConnectedCare is a software service that allows doctors to study and archive all medical images, like echocardiograms, for heart patients.

“As cardiologists do their work today, they have a vast amount of information they can use when treating a patient and much of it is image-based,” said Doug Marinaro, chief operating officer of Kardia Health Systems. “ConnectedCare helps them with the acquisition, archiving and management of those images, so they can be accessed from anywhere and at anytime.”

Kardia, which was founded in Rochester in 2006, recently moved into offices in the third floor in the Minnesota BioBusiness Center in downtown. It also has offices in Minneapolis and Denver.

This pay-per-use service complements Kardia’s earlier online offerings of imaging system specific programs for echocardiography, vascular echocardiography and nuclear cardiography.

The echocardiography system is the foundation that Kardia started with and built upon. Kardia licensed that original software from Mayo Clinic, which created it.

Those first online services are tailored more towards larger, research-based medical centers, like Mayo Clinic. Marinaro said ConnectedCare is anticipated to open new doors for Kardia.

“This market has been developed and penetrated at the level of large hospitals. The medium and small practices are an unpenetrated market. We think it is wide open for us,” he said.

This system knocks down the two main barriers that has kept smaller medical organizations from adopting such services — complexity of the technology and price, he said.

Kardia’s online interface addresses the technology and using the pay-per-use model is expected to keep costs down, according to the company.

“ConnectedCare will transform health care by streamlining the way physicians manage, view and report cardiovascular information,” said Marinaro.

Kardia Health Systems launches new service

Rochester-based Kardia Health Systems, the imaging software firm based in the Minnesota BioBusiness Center, announced this afternoon that it is launching a new service.

Here's a little bit from the press release. I'll check for more details to see what this means for Rochester.

Kardia Health Systems, today announced the immediate availability of ConnectedCare, the first complete, online, fee-per-study cardiovascular information system. ConnectedCare combines Structured Reporting and picture archiving and communication systems in an online solution.  

ConnectedCare is a comprehensive image management system for cardiology, including remote archiving, viewing, analysis and intelligent structured reporting, in one solution. ConnectedCare includes Kardia’s new ConnectedArchive, a unique remote archiving system that lets physicians edit and complete reports remotely, while eliminating the administrative task of implementing and maintaining a local archive. T
 
“ConnectedCare will transform health care, by streamlining the way physicians manage, view and report cardiovascular information,” said Doug Marinaro, chief operating officer of Kardia Health Systems. “Increasing productivity ultimately leads to improved patient care.”
 ------
ConnectedCare is priced on a fee-per-study basis….

Roch. council OKs downtown sports grill lease

 City and county reporter Jeffrey Pieters covered last night's Rochester City Council meeting and he reported on the approval of a new lease with Rochester businessman

Tom Murphy for a proposed sports grill in the Minnesota BioBusiness Center downtown. Remember, this is a deal I wrote about last week.

For the real estate geeks out there (You know who you are), here's a page from the lease agreement.

To read this, just click on it and it will open as a full-size image in a new window.

Anti-obesity device maker+ big hurdle + $4.9M = ?

Here's a couple tidbits that seem to signal action @ EnteroMedics, a St. Paul, Minn. company that Mayo Clinic back in 2005 to work together to develop an external, Pacemaker-like weight control device.

“Spectacularly successful” is how EnteroMedics CEO Mark Knudson described the relationship with Mayo Clinic back in 2006. 

Here's some from a Dow Jones story by Jon Kamp:

EnteroMedics Inc. on Friday became the latest company to stumble in the medical-devices field of neuromodulation, where treating various disorders with electric pulses to the nervous system remains a promising but sometimes hard-to-achieve goal.

The small company, which has been working on a device called "Maestro" that blocks signals on a major nerve to treat obesity, said initial analysis showed a key U.S. trial for the device failed to meet its main goals. Shares closed Friday down 78.2% as a result to 98 cents a share, and down to 97 cents in recent late trading. The results are a blow for company that has been burning through tens of millions of dollars to develop this system and bring it to market.

EnteroMedics followed up with a late announcement Friday that it has reached a deal with an institutional investor to sell 6.2 million shares for 80 cents a piece to raise $4.9 million. The news didn't stop the tumbling share price, however. As of June 30, cash on hand was nearly $35 million and debt was $20 million. The company burns between $6.5 million and $7 million per quarter.
----------
An interim study in January showed positive results for the Maestro system, but the much larger Empower study didn't bolster those findings.

According to the company's announcement, the sale of the 6.2 million of shares should wrap up by Wednesday.

Another local link of EnteroMedics is that former Pemstar exec Greg Lea is the chief financial officer for what was a very rapidly rising company. That position might not be as fun today as it was during the very optimistic days as a few months ago.

Downtown Roch. sports grill is a go

A Rochester businessman is investing about $1.5 million in a new sports bar and grill in the Minnesota BioBusiness Center downtown.

Tom Murphy, owner of McMurphy’s and Aquarius, signed a lease Tuesday for 7,600 square feet on the street level of the eight-story building at 221 First Ave. S.W.

“I’ve been watching how the energy has been escalating downtown and we wanted to be part of it,” Murphy said Wednesday.

His plan is to create a sport grill with an emphasis on good food, sports viewing and a fun atmosphere.

“From 11 a.m. to 8 p.m., I see it as more of a restaurant. Then from 8 to close, it will be a high energy, fun place to go to,” he says.

Murphy hasn’t chosen a name yet for the bar, which he hopes to open May 1.

The bar will have its own entrance from the street and an elevator from the parking ramp above it. It also has a large sidewalk area that Murphy hopes to use as a sidewalk cafe, particularly during the Thursdays on First weekly events.

The restaurant, which will seat around 150, is expected to add 30 to 40 jobs downtown and move into a space that has sat empty since the building was completed earlier this year.

This is the first business to sign up for the street-level space set aside for restaurants and stores. The rest of the building is designated for biobusiness and technology firms.

Besides Murphy, the building has three signed tenants. Mayo Clinic’s Office of Intellectual Property, which in charge of bringing work created by Mayo researchers to the consumer market, has already moved into three floors. Another half of a floor is occupied by Kardia Health Systems, a medical software company built around technology originally created by Mayo. That space also includes a Rochester social networking firm called SocialBrowse.

In addition, the city staff is in negotiations with Martell Biosciences, a Wisconsin medical testing firm.

“I think it is the start of something big. All of these things are starting to fall into place,” says Rochester City Council President Dennis Hanson.

The city council Monday will vote on approving the contract with Murphy.

Murphy, who has owned businesses in the city since he was 23, has owned and managed McMurphy’s, previously known as Dooley’s, in southeast Rochester, since 1980. 

“We’re still rolling out here. McMurphy’s and Aquarius are not going any place.”

Stress incontinence = $?

Rochester Medical Corp. is looking to start 2010 by launching a major play for the female stress incontinence market in both the U.S. and the U.K.

“The market potential for this is bigger than any of our other products,” said Anthony Conway, CEO of the Stewartville catheter maker, after announcing that its FemSoft Insert has been approved by in the United Kingdon as a prescription product.

It is a soft silicone insert with a fluid-filled bulb at the end to conform inside the patient to block leakage.

This follows U.S. Medicare’s preliminary reimbursement approval for the FemSoft Insert earlier this year.

If all goes as expected, both the U.S. and the U.K. will begin reimbursing for the product in January 2010.

“The market potential for this is bigger than any of our other products,” says Conway.

It is estimated that more than 12 million women are diagnosed with stress incontinence in the U.S. This condition can cause urinary leakage occurs during certain physical activities such as exercise, coughing, laughing, or sneezing.

Conway believes FemSoft could used by about five percent of that group, which tallies to about an estimated $1 billion piece of the market.

While being OKed for Medicare reimbursement spotlights FemSoft, it has been used for years by women paying the full cost for the product. The Federal Drug Administration approved it after a five year, eight clinical site study.