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9 posts categorized "Regenerative medicine"

March 26, 2015

Cardio3 reports losing $18 million in 2014

Cardio3 released a financial report today with a lot of interesting tidbits like it's building in the Minnesota BioBusiness Center due to an agreement with Mayo Clinic.

Also it's developing a U.S. headquarters… in Boston.

Here's most of my article on this:

The Belgium-based biotech firm building a manufacturing facility in downtown Rochester reported today that it lost $18.1 million in 2014, up from the $15.9 milCardiobioscience_jpeglion it lost in 2013.

Cardio3 BioSciences, which works closely with Mayo Clinic and is taking over the fifth floor of the Minnesota BioBusiness Center, reported its financials for 2014, plus some highlights of its activities in 2015.

Cardio3 is publicly listed on the European stock markets of NYSE Euronext Brussels and NYSE Euronext Paris, although it is not traded publicly in the United States.

Mayo Clinic owned 2.69 percent of Cardio3, as of March 3. Mayo Clinic first acquired equity in Cardio3 in 2007, when it licensed stem cell research by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. Its cardiopoiesis technology repairs patients' hearts by re-programming their own stem cell to regenerate cardiac tissue.

6a00d83451cc8269e201a511d8e824970c-250wiThe Hong Kong-based Medisun, which is opening an office in Rochester, owned 7.2 percent of Cardio3 on March 3.

In the years since 2007, Mayo Clinic has developed a close working relationship with the Belgian company. Mayo Clinic is participating the U.S. clinical trial of Cardio3.

"We made significant strategic, operational and financial advancements in 2014 as we seek to build C3BS into a global specialty therapeutics company," stated Cardio3 CEO Dr. Christian Homsy in the announcement.

The annual report highlighted "a non-exclusive preferred access agreement" signed with Mayo Clinic in October that cleared the way for Cardio3 to build a facility in the City of Rochester's BioBusiness Center building.

"With this agreement, Cardio3 BioSciences agreed to give preferred consideration for Rochester, Minnesota to the U.S. to build a manufacturing facility for the production of C-Cure, at a facility located adjacent to the campus of the Mayo Clinic, and the Mayo Clinic agreed to periodically review with Cardio3 BioSciences its portfolio of regenerative medicine technologies, including in the areas of cardiology and oncology, with a view towards future potential licensing," according to the Cardio3 report.

Cardio3's prototype manufacturing facility will occupy the 14,963-square-feet of space on the fifth floor of the downtown building. Mayo, which leases the fourth through eighth floors, moved its employees out of the fifth floor earlier this year. Cardio3's five-year lease calls for it to pay a rent of $18 per square foot, or $22,444.50, per month. The city agreed to pay for $600,000 in equipment and improvements to the space.

The Minnesota Department of Employment and Economic Development also agreed to give Cardio3 a Minnesota Job Creation Fund award of $357,000, if the company invests $1.5 million in Rochester within a year and hires 33 employees within two years.

The ultimate goal of this project is for the city and RAEDI to eventually convince Cardio3 to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester, according to officials at RAEDI.

However, Rochester is not the only city wooing the Belgium company. While the Rochester facility is Cardio3's first official U.S. location, the company's report show that it also has plans to build a U.S. headquarters in Boston, Mass.

The company also reported that it's re-stating its 2013 financial reports "to reflect errors" found by PriceWaterhouseCoopers.

"After due consideration with its auditors, we decided that the shareholders convertible loans should have been accounted for as a financial debt instead of equity (previously called 'quasi equity') as originally posted in our 2013 financial statements, because the loans were convertible into a variable number of shares," according to today's statement from the company.

November 14, 2014

Ex-Mayo doc "feared retribution against himself and his family"

It has been an interesting week in the Mayo Clinic vs Dr. Franklin Cockerill legal tussle. So Cockerill's lawyers filed a motion Wednesday to modify the temporary restraining order that blocks Cockerill from working for Quest Diagnostics PLUS a detailed affidavit from Cockerill explaining his side of the case.

So the PB court reporter Kay Fate printed out the documents for me on Thursday and I wrote an article based on the filings last night. The twist here is that Cockerill's legal team withdrew the filings Thursday, after we printed them out.

The upshot is that my article is still running today in the PB. Here's some of it. The full piece is in today's paper:

A former Mayo Clinic doctor and executive said he did not tell Dr. John Noseworthy about his plans to work for a Mayo competitor because he "feared retribution against himself and his family."

CockerillDr. Franklin R. Cockerill III, the former CEO of Mayo Medical Labs, took early retirement at the end of September. However, instead of retiring, he stepped into a new job on Oct. 1 with Quest Diagnostics Inc.

The clinic filed a lawsuit against Cockerill over his decision to not tell Mayo Clinic he had been hired by a competitor; he told co-workers he intended to run his elderly mother's farming business.

The suit claims he misled everyone so he could acquire sensitive competitive information for his new employer. As part of that suit, a temporary restraining order was issued on Oct. 14 that prevented him from working at Quest because he could cause "irreparable harm" to Mayo Clinic.

Members_009-questCockerill filed a motion Wednesday to modify that order to allow him begin his role as Quest's chief lab officer because the person he is to replace will retire at the end of December. However, his lawyers withdrew the filing on Thursday and also withdrew an affidavit that detailed his version of the events surrounding his departure from Mayo after a more than 30-year career there.

However, the withdrawal came after the Post-Bulletin obtained a copy of the affidavit.

"It is now plain that the draconian restrictions that Plaintiffs obtained from this Court and that Dr. Cockerill had no opportunity to oppose are not consistent with Minnesota law and are entirely inappropriate," according to the original filing made by his lawyers from the Minneapolis firm of Lindquist & Vennum.

Cockerill contends Mayo Clinic had approached him with an attractive early retirement offer as his final two-year term as a department head was coming to an end. When asked for a response, Mayo Clinic denied that.

"Claims of an early retirement offer are completely false, and we were prepared to file documentation to prove it," said Mayo spokesman Bryan Anderson this morning.

In his affidavit, Cockerill says he announced his retirement in July, with plans to help his mother, and then he was asked by a Quest recruiter to interview for a position there. He eventually accepted a job with the condition that he work from Rochester, instead of the company's New Jersey headquarters.

Cockerill stressed in his filing he did not make the change to make more money. Mayo Medical Labs is the third largest laboratory company in U.S. and generates "a significant proportion of Mayo's profits." He had made about $580,000 a year at Mayo Clinic. At Quest, he will earn an annual salary of $400,000.

"I left my employment at Mayo reluctantly and only due to the convergence of several factors that arose as I enter the last stages of my professional career," he wrote in the filing. "Finally, in addition to limitation on the role I could still play at Mayo, my interest in the Quest position, and the attractive Mayo early-retirement offer, my decision to change employment was also influenced by my belief that the environment at Mayo had negatively changed over the past five years. Staff satisfaction has declined, burnout has significantly increased, and many people have grown afraid to speak up and voice their opinions."

October 13, 2014

Mayo, Cardio3 sign deal to expand collaboration

Mayo Clinic has deepened its long-time relationship with Cardio3 Biosciences by giving the Belgium firm "preferred access" to new regenerative-medicine discoveries.

Having preferred access means staff from Mayo Clinic Center for Regenerative Medicine meet with Cardio3 on a quarterly basis to discuss technologies and research that are in the "pipeline," according to Michael Pfenning, center administrator. This gives Cardio3 the first chance to ask to license, purchase or otherwise work with the center's regenerative-medicine research.

008661829The access began on Oct. 1 and runs to December 2017. It then could be extended, if both parties agree.

Mayo Clinic and Cardio3 have collaborated for many years on the cardiopoiesis technology the company uses to repair patients' hearts by re-programming their own stem cell to regenerate cardiac tissue. Cardiopoiesis is a process that "re-programs" stem cells taken from a patient's bone marrow from their hip. Those re-programmed cells then are injected back into the patient's heart to repair damaged tissue.

Cardio3 BioSciences has licensed Mayo Clinic's research in this area, since 2007. That research was led by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. Dr. Terzic, who along with Mayo Clinic has a financial interest in Cardio3, also is the director of Mayo Clinic's Center for Regenerative Medicine.

Mayo Clinic is helping Cardio3 with its new phase III clinical trial of its regenerative therapy. The trial is approved to recruit up to 240 patients and it is expected to begin in January. Rochester Area Economic Development Inc., the City of Rochester and Mayo Clinic are establishing a 2,000-square-foot facility in the Minnesota Biobusiness Center to freeze and prepare patient samples for shipping to Belgium.

"We have a great relationship with them from a commercialization perspective," said Timothy Argo, a technology licensing manager of Mayo Clinic Ventures. "From our perspective, this is all about finding ways to get things from our labs to patients faster."

Cardio3 sees the new relationship as a win-win.

“Mayo will continue to invent new concepts, while Cardio3 will offer its development expertise to those technologies, as well as guidance in the early development phases to the Mayo research teams," stated Cardio3 CEO Dr. Christian Homsy in the announcement of the deal. "This agreement is in line with our business development strategy defined earlier this year, and enables our company to rapidly and significantly enlarge its product portfolio with high quality research programs across multiple therapeutic areas.”

November 26, 2013

Mayo Clinic-linked Cardio3 part of Europe group awarded $6M research grant

C3bs_logoCardio3 BioSciences, the biotechnology firm based on Mayo Clinic research, is part of a European research consortium that recently snagged a four-year research grant for $4.5 million euros or $6 million U.S. dollars to develop "a bioresorbable polymeric valve tube for the treatment of patient suffering congenital heart defects." 

Cardio3 licensed Mayo Clinic's research back in 2007. That research is led by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. The therapy uses stem cells from a patient's  bone marrow. Through a proprietary process called Cardiopoiesis, Cardio3 re-programs those cells to become heart cells. The cells are then injected back into the patient's heart to repair damaged tissue.
Here's some from the announcement of this latest project:

Cardio3 BioSciences…  is part of a consortium which has been awarded a highly competitive European Union Seventh Framework Programme for Research and Innovation (FP7) research grant from the European Union to support the development of a bioresorbable polymeric valve tube for the treatment of patient suffering congenital heart defects.

The project, titled "Tissue engineering of the right heart outflow tract by biofunctionalized bioresorbable polymeric valved tube", or "TEH-TUBE", is a four year project and will start on 1st January 2014.

Dorv4C3BS is part of a first-in-class, pan-European consortium composed of seven companies and universities, led by the "Assistance Publique Hopitaux de Paris (APHP)" and the team of Professor David Kalfa and Philippe Menasché.


C3BS is the exploitation manager of the consortium and as such is in charge of exploiting the outcome of the research project. Within the consortium, Cardio3 is also in charge of the production of the mesenchymal stem cells and the definition and the implementation of the regulatory strategy.


"We are delighted to be part of a project which represents a potential paradigm shift in the treatment of congenital cardiac diseases," said Dr. Christian Homsy, CEO of Cardio3 BioSciences. "We are also honored to be chosen by our partners to exploit the outcome of this program. It demonstrates the confidence and the recognition of our peers in the expertise we have built over the past years. FP7 grants are awarded on the basis of a highly competitive, two-stage, peer-review process, therefore this award serves as recognition of our cell production, regulatory and clinical expertise."

This wraps up a big year for Cardio3 BioSciences. It released an IPO in July on NYSE Euronext stock exchanges in Brussels and Paris that raised $29.6 million, or 23 million Euros.

October 01, 2013

Cardio3 cleared to test patients in Spain

Cardio3 BioSciences, the biotechnology firm based on Mayo Clinic research, has received approval to test its regenerative heart therapy on patients in Spain.

Spain is the sixth country to clear the way for European Phase III trial of Cardo3's C-Cure. The United Kingdom, Belgium, Israel, Serbia and Hungary have all given the Belgium-based Cardio3 approval to conduct the tests of its treatment of congestive heart failure.

The company reports that 11 medical centers have already begun recruiting patients in those countries. The first patients were treated in June 2013.

"The authorization by the Spanish authorities is another important step in our development plan. We believe our unique therapy offers the potential to revolutionize treatment for heart failure, a common and severe illness," stated Cardio3 BioSciences CEO Dr. Christian Homsy in the announcement.

C3bs_logoThese tests are important in clearing the way for the revolutionary treatment to make its way to the public. The therapy uses stem cells from a patient's  bone marrow. Through a proprietary process called Cardiopoiesis, Cardio3 re-programs those cells to become heart cells. The cells are then injected back into the patient's heart to repair damaged tissue.

The potential for patients, the company as well as Mayo Clinic is huge.

It's estimated that about 23 million people worldwide are afflicted with congestive heart failure and 2 million new cases are diagnosed each year worldwide. It is a disorder on the increase in the U.S., in particular. Analysts have estimated a successful treatment for congestive heart failure could bring in about $1 billion a year for whatever company that brings it to market.

Home_productsCardio3 licensed Mayo Clinic's research in 2007. That research is led by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. The company lists Mayo Clinic as controlling 25 percent of the company's capitalization.

While no royalties have accrued yet, Cardio3 says Mayo Clinic has rights to receive future royalties, which will be shared with Drs. Terzic and Behfar.

To help fund this ambitious study, Cardio3 BioSciences released an IPO in July simultaneously on NYSE Euronext stock exchanges in Brussels and Paris that raised $29.6 million, or 23 million Euros.

Prior to the IPO, Cardio3 had raised a total of $66 million in financing since it first formed and began working in this treatment.

March 01, 2013

Mayo Clinic Biz Accelerator already speeding along

Here's some from my 2nd Mayo Clinic Business Accelerator story of the week. I'll have more in seperate post soon.
The just-opened Mayo Clinic Business Accelerator is already bursting at the seams with companies, including some local start-ups that are ready to aim high.

051509biobusinesscenteratnight"We want to be the Amgen (the largest biotechnology company in the world) of Rochester," says Dr. John Burnett Jr., who with Dr. Horng Chen founded Zumbro Discovery just a few weeks ago.

The pair develop peptides to help treat medical conditions and two of their previous creations were licensed by out-of-state companies.

"We really had the desire to set something up here," says Chen. And as the inventors, they believe they will be able to better direct the course of the product as well as do it faster.

Their first patented peptide is designed to treat a condition known as Resistant Hypertension. It is generally defined as high blood pressure that standard treatments can't lower. About 10 to 20 percent of people diagnosed with hypertension are believed to be resistant.
It can lead to heart failure, myocardial infarction, stroke as well as kidney failure.

The Federal Drug Administration has already given the doctors the greenlight to begin testing on patients with Resistant Hypertension and they hope to do that by the end of the year.

"Being in the Accelerator is great for a young, virtual company like us. It gives a chance to interact with venture capitalists and network with other businesses," says Burnett. "And it is just a short walk from our lab."

The Accelerator offices in the Minnesota BioBusiness Center were packed this morning as crowds of Mayo Clinic administrators, city officials and community leaders packed into the just-completed space to christian is open for business.

It's "business" is to speed up local business development and ultimately create new jobs.

“The Accelerator is an example of the strength of a strong partnership between Mayo Clinic and the community to make it easier and more affordable for companies to start and locate in Rochester,” says Mayo Clinic CEO Dr. John Noseworthy.

A collaboration between Mayo Clinic, the City of Rochester and Rochester Area Economic Development Inc., the Accelerator is starting out with a full boat of tenants that include biotech businesses, medical device makers, software start-ups, venture capitalists and health care consultants.

Funded by $100,000 from Mayo Clinic and $100,000 from local sales tax money, the 2,500-square-foot cluster of offices is located on the second floor of the city-owned Minnesota BioBusiness Center. RAEDI is handling the management and leasing of the space.

“We hope to provide a nurturing space for new company formation in Rochester,” says Jim Rogers of Mayo Clinic Ventures.

February 27, 2013

A window on Mayo Clinic's business accelerator plans

It is getting close to the big reveal of the Mayo Clinic Business Accelerator in the City of Rochester's Minnesota BioBusiness Center.

02272013mayoaccelerator1The plan, as I understand it, is to announce the new tenants - possibly eight - in the 2,500-square-foot center at RAEDI's annual meeting on Thursday. Remember this new twist on a business incubator is designed to house early biotech start-ups as well as venture capitalists. The tenant names have been kept hidden from anyone outside of Mayo Clinic and the usual insider crowd of public figures.

And yet this morning, a couple of venture capitalist firms' names are as clear as glass as being part of this private/public project.

Sanderling Ventures and Versant Ventures are up on the window, along with Mayo Clinic Ventures, the City of Rochester and RAEDI.

The California-based firm has a lot of experience working with Mayo Clinic and Mayo-related companies, like Torax and Naviscan.

02272013mayoaccelerator2I don't know as much as about Versant Ventures, but it is also based in California. However, it also has an office in Minneapolis.

Here's some background on the accelerator:

Mayo Clinic is giving $100,000 to turn the unused space, which is owned by the city, into offices. RAEDI will handle the management and leasing of the space.

HGA, which was the architect firm for the building, handled designs for this space. Lots of glass walls, I hear. Rents are expected to range from $13 to $15 per square foot.

February 22, 2013

Highlights of Mayo Clinic's 2012 financials

Here are a few random, fun facts from Mayo Clinic's 2012 financials:


800px-Gonda_building,_closer_up• Spent on charity care: $83.4 million, up from $61.8 million in 2011.

• Spent to support Medicaid: $321.7 million, up from $260.4 million in 2011.

• Revenue from retail pharmacy sales: $149 million, up from $134 million in 2011.

• Revenue from technology commercialization, health information and medical products: $34.1 million, down from $40.4 million in 2011.

• Revenue from cafeteria sales: $28.8 million, down from $30.3 million in 2011.

• Cash and cash equivalents: $59.6 million, down from $141.3 million in 2011

• Earned incentive from federal government for introducing electronic medical records: $44.7 million

February 06, 2012

Hormel Institute, U of M makes stem cell breakthrough

Here's a little from an interesting press release from Austin's Hormel Institute.

This looks like a good fit for regenerative medicine push underway in Rochester and Mayo Clinic at the Minnesota BioBusiness Center.

This research seems to fit with Cardio3's work, though this is embryonic stem cells and Cardio3 works with stem cells from a patients' bone marrow.

A University of Minnesota-led research team has proposed a mechanism for the control of whether embryonic stem cells continue to proliferate and stay stem cells, or differentiate into adult cells like brain, liver or skin.

Hormel_2The work has implications in two areas. In cancer treatment, it is desirable to inhibit cell proliferation. But to grow adult stem cells for transplantation to victims of injury or disease, it would be desirable to sustain proliferation until a sufficient number of cells have been produced to make a usable organ or tissue.

The study gives researchers a handle on how those two competing processes might be controlled. It was performed at the university's Hormel Institute in Austin, Minn., using mouse stem cells. The researchers, led by Hormel Institute Executive Director Zigang Dong and Associate Director Ann M. Bode, have published a report in the journal Nature: Structure and Molecular Biology.

"This is breakthrough research and provides the molecular basis for development of regenerative medicine," said Dong. "This research will aid in the development of the next generation of drugs that make repairs and regeneration within the body possible following damage by such factors as cancer, aging, heart disease, diabetes, or paralysis caused by traumatic injury."