Kiger's Notebook

Mayo Clinic-linked Cardio-3 rolling along

Cardio3, a Belgium-based biotech firm working on regenerating heart tissue from bone marrow stem cells, is doing something almost unheard of these days in the pharma/medical device industry.It is running ahead of schedule.

It has now signed up 45 patients for a Phase II/III trial of the C-Cure therapy to be conducted in Belgium and Serbia. That puts it about two months ahead of schedule.

Cardio3 licenses Mayo Clinic research and is partially owned by Mayo.

It is currently looking to launch an intitial public offering with hopes of raising $72 million, according to speculation in European press.
Cardio3 will pay grants to Mayo for additional research as part of the deal.

Here is a little from the press release that came out earlier this week.

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in cell-based therapies for the treatment of cardiovascular diseases, announced today that it has completed, two months ahead of schedule, enrolment in the first stage of its pivotal Phase II/III trial of C-Cure, a unique stem cell therapy for heart failure.

Forty-five patients have now enrolled in the study which is being conducted at centres in Belgium and Serbia. The C-Cure trial will ultimately enroll 240 patients making it one of the largest randomized trials in regenerative therapies for heart failure.

  C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA) and at the Cardiovascular Center in Aalst (Aalst, Belgium).

Safety data from this stage of the trial is expected to be available in May 2010. The second stage, which will recruit 195 further patients is expected to start in the third quarter of 2010 and involve further sites in Europe and in the United States. The trial design is a randomized, prospective, multi-center trial, to evaluate the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. The trial will also evaluate socio-economic implications of therapy.

Disclosures

Mayo Clinic has a financial interest in technology related to this research and may stand to gain from the successful outcome of the research. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company.

Mayo Clinic pay rate for 2010

Here's some more detail on the Mayo Clinic pay increase for 2010. Even though the majority of the people who live in the Rochester area already know this, this is interesting info for looking ahead to the city's economic health in 2010:

Most Mayo Clinic employees will see bigger numbers on their March 9 paycheck as the Rochester’s largest employer rolls out its 2010 raises.

Salary ranges will increase by 1.7 percent for “…All Mayo Clinic non-union allied health staff who meet performance standards employees in Rochester, Arizona and Florida.”

Employees’ 2009 salary will be multiplied by the new range maximum by 2.7 percent.

A 2010 salary survey taken in September predicted that the average pay increase by U.S. workers will be 3 percent in 2010.

An internal memo explained the change through an example citing a employee currently in the $10 to $14 an hour range.

That range will increase by 1.7 percent to $10.17 to $15.26 an hour.

If the employee makes $12 an hour, the new rate calculation will be 2.7 percent multiplied by $15.26 totaling a .41 increase.

So a Mayo Clinic staffer making $12 an hour will see their pay increase by 3.4 percent to $12.41 an hour.

Increases become effective Feb. 17 and employees should start to see the extra money March 9.

Health care workers in the Rochester area earned an average weekly wage of more than $1,200 in the second quarter of 2009, according to the Minnesota Department of Employment and Economic Development.

What areas are not included in the general raise hike?

“Mayo Health System, Charter House, Gold Cross or other independent entities and unions,” the clinic announced in the memo.

This raise increase is comparable to the 3 percent raise handed out by  Mayo Clinic last December for 2009.

Mayo Clinic signs deal with Gamma Medica-Ideas

This an interesting deal. Breast cancer detection is really a hot topic these days and Mayo Clinic has worked with Gamma Medica-Ideas since before it had Ideas in its name.

I should have more on this soon, but here's some background on the Mayo Clinic/ Gamma Medica relationship:

In 2005, Mayo Clinic was the first U.S. medical center to have a 3200S/12K model LumaGEM breast imaging camera on its campus. In 2006, Mayo Clinic reported results of a study of the duel-headed gamma camera.

"This new technique, Molecular Breast Imaging, uses a new dual-head gamma camera system and is sensitive enough to detect tumors less than 10 millimeters (about two-fifths of an inch) in diameter in 88 percent of cases where it is used. Early findings from an ongoing comparison of the device with mammography show that it can detect small cancers that were not found with mammography, say the investigators."

Mayo Clinic physicist Michael O'Connor presented those results at the 2006 meeting of the San Antonio Breast Cancer Symposium.

Then in 2007,  Mayo Clinic and Gamma Medica used a $1.8 million National Cancer Institute grant "to  document the advantages of using GM-I’s LumaGEM dual-headed Molecular Breast Imaging  (MBI) technology for the early detection, diagnosis and treatment of breast cancer."

In September, 2009, Gamma Media landed $24 million in venture funding to primarily help continue "…Aggressively marketing our FDA cleared LumaGEM product for molecular breast imaging.

And that brings us to today when Mayo Clinic and Gamma deepened their relationship by signing "…An exclusive license and commercialization agreement with Mayo Clinic to further develop and commercialize a suite of technologies invented by a team of Mayo physicians and scientists, headed by Michael O'Connor, PhD."

Here's a little more from the press release:

The Company aims to utilize the licensed technology in conjunction with its Lumagem molecular breast imaging system to improve the diagnosis of cancers in women with dense breasts. An estimated 30% of women have dense breast tissue, which can impede diagnosis of abnormalities. Existing mammography and other screening techniques are at times either insufficient or very expensive diagnostic tools. Molecular breast imaging promises to be a cost-effective solution for these women.

Dr. Bradley Patt, CEO of GMI, said, "We are extremely pleased that Dr. O'Connor and his team at Mayo have chosen GMI to bring their important technology to market. This is very timely given the release of the US Preventative Task Force report on mammography. The underlying reason for the controversy in mammography is the fact that mammography has underserved groups of women such as the 40-50 year old age group, where higher breast density has rendered mammography much less effective. GMI's LumaGEM system, now enhanced with Mayo's technologies, will be a highly effective solution for such cases. The Mayo technologies, which have been under development and evaluation for the last 7 years, enable this procedure to be performed at a radiation dose comparable to a mammogram."

The suite of technologies invented by Mayo Clinic enhance the existing capabilities of GMI's LumaGEM dual headed imaging system through special image processing software algorithms and collimator and detector optimization techniques. The license also includes methods and devices developed at Mayo for combining next generation x-ray tomosynthesis techniques with molecular imaging of the breast. In initial clinical studies, the Mayo algorithms licensed to GMI yield better images at lower dose.

Funding from internal sources at Mayo, GMI, and the National Cancer Institute has been instrumental in moving the technology forward. Under an IRB approved screening study the technology is already showing promising results with just one-third of the standard dose of Tc-99m Sestamibi typically utilized in the procedure.

Mayo Clinic linked biotech plans estimated $74M IPO

A Beligum biotech company that licenses Mayo Clinic research and is partially owned by Mayo - Cardio3 BioSciences - is looking to launch an intitial public offering with hopes of raising $72 million, according to speculation in European press.
Cardio3 BioSciences is licensing Mayo Clinic research about "differentiating" stem cells, or turning generic stem cells from bone marrow into cardiac cells. Mayo Clinic Health Solutions' office of Intellectual Properties - which is taking five floors of the new Minnesota Bioscience Center – also owns a portion of the company. 

Cardio3 will pay grants to Mayo for additional research as part of the deal.
Here's some from Reuters on this topic:

Proceeds will fund development of the
group’s lead therapy C-Cure, which has been through phase I of clinical
trials, de Tijd claimed.

Reports made no mention of wh
ere
Cardio3 would list and did not give a timeframe for the IPO, though the
group is expected to be a publicly traded company by the autumn of 2010.

It was established in 2007.
Cardio3 is still 26.0 per cent owned by its founders, while management control 5.0 per cent of the company. 

Other investors include the Mayo Clinic with a 30.0 percent stake, Tolefi (9.0 percent) and Technowal (4.0 percent).

Fantasy/historical novelist gives Mayo Clinic $2M

This is a little old since this came out earlier this week, but I couldn't resist pointing this out.

As a lover of classic pulp-style fantasy fiction, I consider John Jakes the creator of one of the best swords and sorcery characters behind Conan and the duo of Fafhad and the Grey Mouser.

While best known for U.S. south historical fiction like "North and South," "The Rebels" and "California Gold," Jakes wrote several books  about a character called Brak the Barbarian.

The Brak stories as well many sci-fi, fantasy and noir thriller-style books came early in his career before hitting his groove with historical fiction. His popularity attests to how well he can reach readers with a story.

Jakes is considered one of the best historical fiction authors, but I think he should also be known for his very fun and cool earlier works like When "The Idols Walked," "The Fortunes of Brak," "Tonight We Steal the Stars," "Six Gun Planet," "Monte Christo 99" and "Mention My Name in Atlantis."

 Enough of his biblography, here is the press release about very kind donation Jakes and his wife made to Mayo Clinic in Jacksonville.
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JACKSONVILLE, Fla. — Family sagas that delight millions are John Jakes's claim to fame, but he and his wife, Rachel, have added a new chapter to that legacy, making a $2 million estate gift to Mayo Clinic in Florida. 

Residents of Sarasota, Fla., the Jakes are long-time patients of Mayo Clinic in Florida, and their gift is in honor of their physician team and an expression of gratitude for their care, which Mr. Jakes credits with saving his life.

"Mayo Clinic has become a vital part of our lives since we first visited in 1990," says Mr. Jakes. The Jakes' estate commitment will help future patients receive the same kind of care that inspired the couple's generosity.

Their gift will create a posthumous fund that supports all areas of Mayo Clinic in Florida's mission in patient care, medical education and research. 

He is the creator of the legendary eight-volume Kent Family Chronicles; the Main and Hazard families of The North and South Trilogy; and the Crowns of Chicago, German-Americans whose stories interweave the history of the 20th century in "Homeland" and its sequel, "American Dreams." His 2002 novel, "Charleston," returned him to the turbulent years of the Revolution and the Civil War. "The Gods of Newport" (2004), dealing with the "queen of resorts" in the age of robber barons, became his 18th consecutive "New York Times" bestseller.

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.”

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“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.

Mayo Clinic's retiring CEO to partner w/ Smoldt

Here's an interesting tidbit from health reporter Jeff Hansel on what Mayo Clinic's top leader will do after he retire.
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When Mayo Clinic’s departing national president and CEO Dr. Denis Cortese retires Nov. 20, he’ll leave Rochester — but he’ll rekindle an old partnership.

Mayo spokesman Karl Oestreich said Cortese will work in concert with former Mayo national chief administrative officer Bob Smoldt.

Together, they’ll lead the new Healthcare Delivery and Policy Program at Arizona State University.

The program “will focus on health care delivery changes that result in higher value health care, as well as the role of public policy in delivery system reform,” Oestreich said.

He noted that Cortese will stay involved in health-care reform and continue to support the mission of the Mayo Clinic Health Policy Center’s efforts.

Smoldt led the center in 2007 while he transitioned out of his role as Mayo chief administrative officer. But he and Cortese will reprise their roles, this time at Arizona State.

Roch. Chamber bash 2009 - awards and pics

Here's a little bit from my story about about tonight's Rochester Area Chamber of Commerce Celebration and a few pics.

A crowd of 634 area business leaders heard a message of optimism tempered with the knowledge of the difficulties that lay ahead Thursday.

“ We must dream big and the time is now,” John Wade told the crowd gathered for the annual Rochester Area Chamber of Commerce celebration at the International Event Center.

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He concluded his time at the podium by saying, “ We are indeed the front door of free enterprise and we are indeed open for business in Rochester.”

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A special President’s Award, only the second ever presented in the Chamber’s 150 year history, was given to  A.M. ‘”Sandy” Keith for his long service to the community culminating in his role as executive director of the Rochester Downtown Alliance.

Keith, known for his gruff, but playful demeanor, stalked up to the podium and barked “Absolutely no standards” into the microphone as he accepted the award.

With a grin, Wade said he along with the staff at the chamber and the RDA will miss that gravely voice.

Other awards presented included:

• Business of the Year: John Hardy’s Bar-B-Q. The award was accepted by owner John Brockman.

• Jan Warfield Volunteer of the Year Award: This went to two Chamber volunteers this year. Kristine Ihrke of Best Western Soldiers Field and Eric Jenney of IBM.

• Lamp of Knowledge: Kathy Meyerle of Mayo Clinic.

• Ambassador of the year: Vinny Barry of Value Place hotel.

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.

Mavo on the move

An accidental blaze in January ruined plans to expand its Rochester office, but Mavo Systems now has a new and much larger place to call home in Med City.

Mavo Systems, an environmental and mechanical systems contractor, closed on the purchase Friday of a 9,000-square-foot building at 3030 Prow Lane N.E., near Valleyhigh Drive Northwest.

Dana Krakowski, Mavo’s director of sales, says the firm based in White Bear Lake, Minn., has about 50 on staff in Rochester. It has been working out of the ex-Mill’s Fleet Farm store on U.S. 63 South since the fire at 6844 10th Ave. S.W.

Why have such a large presence in Rochester?

“We do a lot of work for Mayo Clinic and IBM and Rochester Public Schools,” she says.

The firm does environmental work like removing asbestos, lead and toxic flooring. It also does mechanical installation, flooring treatments like polishing concrete as well as other services.