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550 posts categorized "Biobiz news"

April 16, 2015

Cardio3 changes name to better fit new focus

The Mayo Clinic-linked firm Cardio3 Biosciences, which is building a manufacturing facility in downtown Rochester, has abruptly decided to change its name to better fit its widening focus in the growing area of cell-based therapies.

Cardiobioscience_jpegThe Belgium-based biotech firm announced Wednesday that it changed its name to Celyad. It started using the new name immediately, though shareholders will not vote on the change until its annual meeting May 5.

This sudden move comes as the company is preparing for an initial public offering on the U.S. stock exchange. Celyad has not released a date for the IPO.

CEO Dr. Christian Homsy was quoted in a company statement saying this new name fits with the firm's new direction following its recent $10 million acquisition of Celdara Medical's oncology division, OnCyte. That signals an expansion beyond its stem-cell-based cardiac regeneration therapy into immuno-oncology. The regenerative stem cell therapy is based on research done by Dr. Andre Terzic and Dr. Atta Behfar, licensed from the Mayo Cli6a00d83451cc8269e201a511d8e824970c-250winic.

“We believe that the name change better aligns our identity with our core activities and overall unified objective of identifying and translating innovative cell-based therapies into therapeutics, not only in cardiology, but now also in oncology and potentially in other areas in the future,” Homsy stated in the announcement of the new name.

Celyad's U.S. communication staff said Wednesday that no one from the company could publicly comment on the name change, other than through the press release. Celyad spokeswoman Kirsten Thomas, of The Ruth Group, explained the silence was due to the U.S Securities Exchange Commission's imposed "quiet period" on promotional publicity during the buildup to the IPO.

Mayo Clinic and Celyad have collaborated since 2007 on the cardiopoiesis technology that the company uses to repair patients' hearts by re-programming their own stem cells to regenerate cardiac tissue. Mayo Clinic owned 2.69 percent of the company as of March 3. Mayo Clinic also is participating in a Celyad clinical trial.
Celyad
If the stem cell therapy makes it to the market, Celyad will pay Mayo Clinic $1 million a year for four years for research as well a 2 percent royalty on sales for 15 years, the press release says.

5503a0ea8a679.image"We are excited that Celyad is branching out beyond cardiology into areas such as oncology," stated Jim Rogers, the chairman of Mayo Clinic Ventures. "Our hope is that they are building a robust capability to deliver breakthrough therapies in the area of regenerative medicine, which is a significant priority for Mayo as well."

The name change comes before new signs have gone up in the city of Rochester's Minnesota Biobusiness Center. The city signed a lease with Celyad earlier this year for it to develop a prototype manufacturing facility in the 14,963 square feet of space on the fifth floor of the downtown building. The five-year lease calls for Celyad to pay a rent of $18 per square foot, or $22,444.50 per month. The city agreed in the lease to pay for $600,000 in equipment and improvements to the space.

The Minnesota Department of Employment and Economic Development also signed a deal with Celyad on Jan. 12 to receive a Minnesota Job Creation Fund award of $357,000. To collect the money, it must invest $1.5 million in Rochester within a year, plus hire 33 employees within two years.

The ultimate goal of the project is for the city, state and Rochester Area Economic Development Inc. to eventually convince Celyad to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester, according to RAEDI officials.

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

It seems as though Celyad is at a turning point. The company has worked on developing its cardiac regenerative therapy since 2007. While it has seen many positive results from trials in Europe and research in the United States, it has no products currently on the market.

The company lost $18.1 million in 2014, up from $15.9 million in losses in 2013. While the cardiopoiesis technology developed by Mayo Clinic appears to be promising, the company seems to be embracing the new CAR T-Cell cancer-fighting approach — essentially, a cancer vaccine — that it purchased from Celdara Medical for $10 million earlier this year.

"Our acquisition of the OnCyte CAR T-Cell portfolio in early 2015 heralds the first major step in our strategy to leverage our unique expertise in cell therapies and drug development to expand beyond the cardiac arena to develop breakthrough treatments to change the outcome of disease," stated Homsy last month.

"We are excited to be expanding our product offering into the prominent area of immuno-oncology and anticipate the initiation of the Phase I trial of our lead immuno-oncology candidate, CAR-NKG2D in the first half of 2015 and look forward to sharing details of our progress as we evaluate its clinical potential," Homsy said. "We intend to leverage our cell therapy know-how and infrastructure to quickly progress those assets into later stage clinical trials in 2016, aiming at more than five trials in liquid and solid tumors in the USA and Europe."

Many companies are vying for a spot in the hot CAR T-Cell area to be the one to develop the breakthrough cancer vaccine. The worldwide market for such vaccines was recently estimated to $8.4 billion in 2020.

April 10, 2015

FDA gives green light to Rochester medical software start-up

A Rochester medical software start-up with financial ties to Mayo Clinic says getting approval from the U.S. Food and Drug Administration is a major milestone for the company.

"It's tough to get. It's a big deal for us. Historically been rare in the software industry to have these type of devices to fall into that class," said Al Berning, CEO of Ambient Clinical Analytics.

Berning is known in Rochester as a former IBMer, a co-founder of Pemstar and former CEO of Hardcore Computers/LiquidCool Solutions.

Ambient, which was founded in 2013, makes analytical software that helps physicians make decisions about patient treatment in emergency room and intensive care situations. The FDA gave 510(k) clearance for Ambient's AWARE software platform as a Class 2 device this week.

The FDA has three classes with highest level being Class 3, which is typically used for implantable devices like pacemakers and heart valves. Dental floss is categorized as a Class 1 device. An example of a device with a Class 2 ranking is a condom.

Ambient, which licenses the core of the AWARE software from Mayo Clinic, describes it as "a clinical decision support tool."

Berning explained that means it uses algorithms to shift through massive amounts patient data, prescription reports and more to select the most important information for the clinical staff to consider during real-time treatment of patients.

"It takes a lot of administrative and IT drudgery off of the physician to allow them to focus on medical care," he said.

Ambient has 10 employees and it's based in the Mayo Clinic Biobusiness Accelerator in the Minnesota Biobusiness Center. Berning says the firm plans to add more employees within the next several months.

"We could need to double or triple our staff," he said.

Berning plans to announce the commercial availability of AWARE at the top health care software industry conference next week in Chicago.

"That's where we'll let everyone know that we are open for business," he said.

April 04, 2015

Rutgers hires away Mayo Medical School dean

Remember Dr. Frank Cockerill, the former CEO of the for-profit (and wildly profitable) Get_photo Mayo Medical Labs? Mayo Clinic accused the well-respected and long-time Mayo exec of taking trade secrets and misrepresenting his departure from Mayo as a retirement.

He took a job at Quest Diagnostics, a competitor of the successful Mayo Medical Labs. Mayo Clinic sued and eventually Cockerill resigned from his new position at Quest.

Cockerill's wife, Sherine Gabriel, is the dean of the Mayo Medical School. Now she's in the news by being hired away by Rutgers.

Rutgers seems particularly gleeful about being able to "steal people from the Mayo Clinic."

Here's a staff and wire story on this:

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The dean of the Mayo Medical School in Rochester has been hired as the new dean of Rutgers University's Robert Wood Johnson Medical School.

Gabriel orig C hi resSherine Gabriel, 57, will take over as head of the New Brunswick, N.J.,-based medical school in August, Rutgers officials announced, according to NJ Advance Media.

"Rutgers can now steal people from the Mayo Clinic," Brian Strom, chancellor of Rutgers Biomedical and Health Sciences, said when he announced the appointment to the university's board of governors Thursday.

Gabriel has worked at the Mayo Clinic for nearly 30 years, serving as a professor of medicine and epidemiology and as a federally-funded researcher of rheumatic diseases.

She will be paid $560,000 a year at Rutgers, a university spokesman said. That will make her one of the highest-paid administrators at the state university, according to the NJ Advance Media article.

Medical school deans are traditionally one of the highest-paid academic positions at universities and their salaries have been rising, the NJ Advance Media article says.

This year, the median salary for medical school deans is $492,213 nationwide and $525,966 at research universities, according to a survey by the College and University Professional Association for Human Resources, a national group that tracks salaries.

Rutgers acquired two medical schools — Robert Wood Johnson Medical School and New Jersey Medical School in Newark — when it took over most of the former schools of the University of Medicine and Dentistry of New Jersey in 2013.

Gabriel was selected as dean of Robert Wood Johnson Medical School after a national search.

"Our search committee recognized the combination of assets that Sherine Gabriel brings," Strom said. "She has exceptional strengths in medical school education administration and instruction. In addition, she is a noted researcher with a strong background in research administration and has played significant roles in the success of Mayo Clinic's business development activities."

Gabriel has been dean of the Mayo Medical School since 2012.

As a researcher, she has focused on the risks of connective tissue diseases among women with breast implants, as well as studies on rheumatic diseases and the economic impact of rheumatoid arthritis.

April 02, 2015

Cardio3 announces plans for IPO in the U.S.

Cardio3 Biosciences, the Belgium-based biotech firm building a manufacturing facility in downtown Rochester, has announced plans to issue stock in the U.S. Logo cardio 3

Cardio3 BioSciences, which works closely with Mayo Clinic and has its U.S. headquarters in Boston, Mass., confidentially filed  "a draft registration statement" with the U.S. Securities and Exchange Commission this  week about its intention.

The eight-year-old regenerative medicine company  is already publicly listed on the European stock markets of NYSE Euronext Brussels and NYSE Euronext Paris. However, issuing an IPO in the U.S. would significantly boost its finances and garner the firm a lot more attention.

Such a move could benefit Mayo Clinic, which 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.

This week's  statement stressed that the possibility of a Cardio3 IPO is still in the very early stages.

"The timing, number of shares and price of the proposed offering have not yet been determined," according to the firm.

This filing follows last week's financial report that showed it lost $18.1 million in 2014, up from the $15.9 million it lost in 2013.

That annual report also 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 Minnesota 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.

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.
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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.

March 06, 2015

10 years of blogging Rochester

On March 4, 2005, I wrote my first blog post. Kiger's Notebook blogo 2x

It was my sixth year at the Post-Bulletin. I created the "Heard on the Street" column about three years before the blog began. 

More  than 6,200 posts, stacks of columns, mountains of tweets and many gray hairs later, I'm still here writing about business and things vaguely related to businesPhoto on 2015-03-03 at 18.11s in southeastern Minnesota.

It'syou, the readers, who make this career such a fulfilling and entertaining one. Thank you everyone for your feedback, criticism and support over these past 10 years. 

10 years of blogging Rochester

On March 4, 2005, I wrote my first blog post.Kiger's Notebook blogo 2x

It was my siPhoto on 2015-03-03 at 18.11xth year at the Post-Bulletin. I created the "Heard on the Street" column about three years before the blog began. 

More than 6,200 posts, stacks of columns, mountains of tweets and many gray hairs later, I'm still here writing about business and things vaguely related to business in southeastern Minnesota.

It's you, the readers, who make this career such a fulfilling and entertaining one. Thank you everyone for your feedback, criticism and support over these past 10 years.  

March 02, 2015

Mayo Clinic-linked NeoChord looking to drum up $1.5 million

NeoChord, a medical device firm I first wrote about in 2007, filed with the SEC in February to raise $1.5 million in funding. So far it has pulled in $457,000 or so of that.

I need to give a nod to the intrepid Katharine Grayson of the Minneapolis/St. Paul Business Journal for first pointing this out. I'm always impressed by how closely she tracks Form D filings for financing.Portfolio-neochord-260x138

The Eden Prairie-based NeoChord surfaced locally in 2007, when it licensed technology designed by Mayo Clinic cardiac surgeons Dr. Richard Daly and Dr. Giovanni Speziali. Speziali was named as the company's chief medical officer in 2013. 

Beside licensing its technology, Mayo Clinic has also previously invested in NeoChord. I'm checking to to see if that is still the case.

Neochord deviceThe NeoChord DS1000 device is used to treat a heart condition called mitral regurgitation. Mitral regurgitation means the valve or leaflet that controls the flow of blood from the left atrium to the left ventricle is not working properly.

Treatment typically consists of “cracking the chest,” stopping the heart and doing surgery. NeoChord's approach is much less invasive and can be done on a beating heart.

A tool is inserted between the ribs and into the heart. Then it is used to attach a chord to the faulty valve leaflet, which is tethered to the heart.

The market for less invasive techniques for mitral valve repair has been estimated at more than $2 billion. There are 50,000 surgeries done in the U.S. each year. An estimated 2 million patients are treated due to the risks of surgery.

Since it formed in 2007, NeoChord's lifeblood has been venture capital funding. By 2008, it had raised $3 million. It raised another $5.1 million in 2011 to finance the European clinical trial. In March 2013, it raised $3 million through the sale of its series B-2 preferred stock.

 

February 25, 2015

City to lease former Mayo Clinic space to Cardio3

This has been in the works for quite a while. It looks like it's now a done deal, at least on the city, RAEDI and DEED side.

We'll see what happens next. After following this for more than a decade, it will be interesting to see how it plays out. I'm particularly fascinated with how the China piece of this, including Medisun and Danny Wong, turns out.

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After amending its original lease, Belgium-based Cardio3 BioSciences is now finally cleared to take over the entire fifth floor C3BS_may_spotlightof Rochester's Minnesota BioBusiness Center.

In December, the Rochester City Council originally approved a five-year agreement with Cardio3 for the 14,963-square-feet of space to use as a prototype manufacturing facility. However, the company then asked for "an early termination provision" in the lease.

The deal is being driven by the city, Rochester Area Economic Development Inc., Mayo Clinic and the Minnesota Department of Employment and Economic Development to make Rochester more attractive to Cardio3, so that the company will build a major manufacturing plant here.

This is the second phase of deal funded by $1.2 million from the city of Rochester's economic development sales tax fund. The first phase was developing little more than 5,000 square feet of unused space on the third floor of the BioBusiness Center to build a special manufacturing lab for Cardio3.

Mayo Clinic and Cardio3 have collaborated for years on the cardiopoiesis technology the company uses to repair patients' hearts by re-programming their own stem cells to regenerate cardiac tissue. Mayo Clinic owned 2.96 percent of the company as of Jan. 21. It's also managing a clinical trial for Cardio3.
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On Wednesday, city council members voted to add an early termination provision to the deal that allows Cardio3 to end the five-year lease after just two years in the space. That provision kicks in only if Cardio3 decides to "construct or lease a larger production facility in Rochester" or the clinical trial on its regenerative heart treatment is not successful.

To leave early, Cardio3 will need to notify the city six months ahead of time. Under the modified lease, the earliest that the regenerative medicine firm could pull out is April 30, 2017. Cardio3 would need to pay the city $269,334 if it did leave earlier than five years. That amount equals about one year of base rent.

If Cardio3 does leave before its lease is up, all of the city-funded fixed equipment and improvements will become the city of Rochester's property. The city agreed in the lease to pay for $600,000 in equipment and improvements to the space.

The final version of the lease calls for Cardio3 to pay a rent of $18 per square foot or $22,444.50 a month.

Mayo Clinic, which leases the fourth through eighth floors of the BioBusiness Center, moved its employees out of the fifth floor earlier this year. At one point, Mayo Clinic Global Products' corporate accounts had offices on the fifth floor.

In earlier discussions about this project, RAEDI estimated that Cardio3 will need 30 to 50 employees to staff the proposed prototype manufacturing facility on the fifth floor.

The ultimate goal of this project is to convince Cardio3 to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester. That's what Cardio3 anticipates it will need if the Federal Drug Administration gives it a green light to take its stem cell treatment to market.

RAEDI President Gary Smith calls it "the big enchilada."

January 27, 2015

Mayo looks to attract more patients from China

To take advantage of the rapidly growing medical tourism market, Mayo Clinic has deepened its relationship with a Hong Kong firm to bring more Chinese patients to Rochester.

Medisun Holdings Ltd. announced Monday it has signed a collaLogoborative deal to "Ensure efficient referral of patients" to Mayo Clinic. The agreement also calls for Mayo Clinic "to provide health care consulting services to aid Medisun’s work" in Hong Kong and mainland China.

This will allow Mayo Clinic to enlarge its patient pipeline from China. It has added a Web page in Mandarin Chinese and has hired interpreters, the article notes. The Wall Street Journal recently reported increasing numbers of Chinese residents are going overseas "in search of treatment that is either unavailable or ineffective in China."
800px-Gonda_building,_closer_up
Mikel Prieto, medical director of Mayo Clinic's international office, told the Wall Street Journal that "China, probably of all countries, is the one where we see the greatest growth right now."

Melissa Goodwin, Mayo Clinic's manager of global referrals, told China's Caixin Media this summer the number of Chinese people going to Mayo has climbed to 200 in 2013. That's up from just 30 in 2008 and 100 in 2012. She estimated that number would reach 400 by the end of 2014. 

H3-treesDetails of the new Medisun/Mayo Clinic arrangement still are being hammered out, according to Dr. Jason Zhang, of Medisun.

Zhang did confirm that a $1 million office being built in Titan Development and Investments's new H3 Plaza complex on South Broadway will house Medisun's Rochester operations. It's being built under the name Alphaomega Healthcare, though Zhang said he expects it to eventually change to Medisun.

He explained the office will be used to support Chinese patients traveling to Rochester for treatment.

"The medical service will be provided by Mayo, and everything else will be provided by Medisun," Zhang said.

The Medisun office is expected to open in March or April in the west corner of H3 Plaza at 300 S. Broadway, he said. The office will occupy parts of the second and third floors of the seven-story complex, which is being developed by Titan's Andy and Gus Chafoulias.

“Consulting with Mayo Clinic, and leveraging Medisun’s top-quality medical institutions in Hong Kong … Medisun’s experienced medical team will facilitate access to Mayo Clinic’s world-class model of care in order to provide patients in China and Asia with superior medical services,” Medisun's Chairman Danny Wong said in Monday's announcement.
20150126_03A
Wong visited Rochester this summer in connection to his company's investment in Cardio3 Biosciences. Cardio3, a Belgium company with deep business and scientific ties with Mayo Clinic, is negotiating a lease deal with the City of Rochester for the fifth floor of the Minnesota Biobusiness Center.

While in Rochester, Wong had his photo taken at the clinic with local leaders, including Gus Chafoulias and Mayo's Lisa Clarke, who leads the Destination Medical Center initiative.

Wong recently showed his interest in Rochester by buying two large estates here. On Oct. 31, he bought an estate at 2515 Crest Lane SW for $1.4 million. Wong followed that up by buying a Pill Hill house at 615 10 Ave. SW for $1.31 million.