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858 posts categorized "Mayo Clinic"

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 05, 2015

Three local biotech start-ups win funding

A regional economic development fund is giving three local medical technology start-ups a financial boost.

Southern Minnesota Initiative Foundation recently announced it's giving funding to three local companies: Ambient Clinical Analytics, a Mayo Clinic spin-off software firm in Rochester; Xcede Technologies Inc., a Rochester company that makes surgical sealants; and Sonex Health, a Byron-based company that markets a carpal tunnel surgery device device called Stealth Microknife.

G_southern-minnesota-initiative-foundation-1395-1410186849.1865SMIF, which typically doesn't release the amounts of its economic development investments, is tapping its new $3 million Southern Minnesota Equity Fund for the capital for these three companies. The fund was created to to invest up to $600,000 per year for five years. The maximum investment is $100,000, according to SMIF.

The fund provides capital and expertise to early-stage and start-up companies. SMIF partners with organizations and individual investors to leverage capital and expertise to grow these companies to provide economic opportunities for Southern Minnesota.

"We're pleased to invest in these high-tech businesses through our newly-created equity fund program. Our Foundation remains committed to providing resources to grow local businesses," stated SMIF President/CEO Tim Penny in the announcement of the investments.

Ambient Clinic: Ambient Clinical is based in the newly opened expansion of the Mayo Clinic Biobusiness Accelerator in the Minnesota Biobusiness Center. It's CEO is Al Berning, who previously led Pemstar, Hardcore Computing and other Rochester companies. Drew Flaada, a former Rochester IBM executive, serves as chief technology officer.

Ambient raised $1.18 million in funding in early 2014.

Xcede Technologies Inc.: Xcede, subsidiary of Watertown, Mass.-based Dynasil Corp. of America, designs, develops and manufactures innovative hemostatic (bleeding prevention) and sealant products for surgical application.

Xcede is based at 1815 14th St. NW. Ambient's Berning was listed as an executive director in 2014.

Dynasil acquired Mayo Clinic technology initially invented by Dr. Daniel Ericson in 2011.

Sonex Health: Sonex Health is the creator of the Stealth MicroKnife. The Stealth MicroKnife is a medical device that allows clinicians to perform carpal tunnel release surgery under ultrasound guidance in the office

Sonex is listed as being based in Byron as well as having a presence in Mayo Clinic Mayo Clinic Biobusiness Accelerator. 

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."

February 23, 2015

Delta to end Rochester-Detroit flights in April

Despite their popularity, nonstop flights to Detroit will soon end for passengers using the Rochester International Airport, after only a few months.

5403bad42fa22.imageAfter about six months, Delta Air Lines has notified the airport that it will be pulling the plug on the daily nonstop flights to Detroit on April 9, according the new Airport Director John Reed.

Reed says he received notification from Delta on Feb. 17, his second day on the job. Delta launched the Detroit and Atlanta flights in September with great fanfare with many saying it was needed for the anticipated increase in air travel expected due to Mayo Clinic's Destination Medical Center initiative.

While the City of Rochester owns the airport, Mayo Clinic is contracted to manage it via its Rochester Airport Co.

Delta confirmed Monday that the flights will end with a short statement that said it "has made the decision to indefinitely suspend Rochester service to Detroit to ensure we’re matching capacity with demand."

This is not the first time Delta has ended flights from Rochester to Detroit. It killed a similar flight back in 2011.

While the Detroit will come to an end, Delta did stress that its daily flights to Atlanta and Minneapolis will continue. In fact, Delta intends add another Minneapolis flight as the Detroit one ends, according to Reed.

"Essentially, our seat capacity will remain the same," he said.

Numbers from the airport shows that the new flights did bump up its Rochester passenger numbers in 2014 by 20 percent over 2013. Rochester Airport Co. President Steve McNeill, who works for Mayo Clinic, recently reported that Delta had 120,474 passengers here in 2014. From September through December, the months of service to all three of its hubs, the count was 41,854, an 18 percent or 6,500 increase over the similar period in 2013.

"We're certainly happy with the new, expanded service," said McNeill earlier this month, "and I'm sure Delta is, too." Flight payloads, or occupancy levels, were slightly above expectations, with flights to Atlanta averaging at about the mid-80s percent, and to Detroit slightly lower, he added.

Reed says data shows that the Detroit flights ran about 75 percent filled, most of the time.

"It wasn't that the community wasn't supporting us, because they were," he said.

Mayor Ardell Brede hadn't been notified yet about the change on Monday. He said, if true, it would a loss for Rochester.

"I liked that flight," he said. Brede added that it was full when he recently used it.

Reed and Brede both said that they had heard that a shortage of pilots was one reason that Delta ended the flight.

Another possible factor could be a $950,000 "risk mitigation fund set up to guarantee Delta a profit on the new flights during the first year. The rub is that the fund, made up of federal grants, a city match and private donations, doesn't cover the Detroit flight. It only guarantees a profit for Delta's Atlanta fight.

A Delta media representative didn't know about the fund or if it could have played a part in this change.

The ending of the Detroit flights does cast a pall on the airport's future requirement of airlines, to add flights, like ones to Denver.

In May, a national air service consultant said in a Rochester Area Chamber-sponsored forum that, "Adding Atlanta and Detroit is a game changer."

He followed that by saying that many other airlines will be watching how those flights fare.

"This is an important test case to prove that you can fill the larger airplanes. If they (Delta) have to pull it, it would be a big red flag," Joseph Pickering told the crowd of local business leaders.

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.
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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.

January 15, 2015

Roch. start-up licenses virus to pharmaceutical giant

An international pharmaceutical giant has signed a deal to license a cancer-killing virus from Rochester drug company.

MedImmune, which is owned by London-based AstraZeneca, is licensing a genetically engineered strain of the vesicular stomatitis virus from Omnis Pharmaceuticals. Omnis is a Rochester start-up founded by Dr. Stephen J. Russell, Dr. Kah-Whye Peng, Shruthi Naik and Mark Federspiel, who all work at Mayo Clinic in Rochester. A fifth founder, Glen Barber, is based at the University of Miami.

The companies now will collaborate to combine the Omnis virus with a check point inhibitor created by MedImmune. The goal is to eventually create a treatment for types of cancer affecting the liver, but potentially could be developed to treat a broad array of cancers.

"For us, it's a very big and very important step forward," Omnis CEO Russell said. "Essentially, we have AstraZeneca/MedIummune saying, 'We love this lead product of yours. We want to pick it up, cover the development costs and run with you to bring it to market.' That's a huge accelerator for this development program."

He explained that oncolytic viruses, similar to the one MedImmune is licensing from Omnis, have been found to be effective in destroying cancer cells. Many companies, in the U.S. and internationally, are working on their own treatment based on viruses.

"That's why they're excited about this virus. They can inject it directly into a tumor and kill tumor cells. That wakes up immune system, which adds to the attack," Russell said. "Then if you get the check point inhibitor antibody, the hope is that will lead to major tumor destruction."

This collaboration could mean a lot to Rochester. The US cancer vaccine market was estimated in 2012 to be worth about $14 billion. With about 1.5 million Americans being diagnosed with cancer every year, that market could possibly grow to reach $20 billion by 2020.

While the companies declined to release any financial details of the deal, it's clear the upfront payment portion of the agreement has given Omnis a boost to pursue its own goals, parallel to MedImmune project.

"Our obsession, if you like, is to develop viruses that could be given as systemic intravenous anti-cancer therapy," Russell said.

This virtual start-up, which was founded in late 2013, is "based" on the first floor the Minnesota BioBusiness Center in downtown Rochester in the facilities of Imanis Life Sciences.

Imanis is a related company that was founded by Russell, Peng and Dennis E. Young. It launched in the Mayo Clinic Business Accelerator on the second floor of the building and soon leased 1,736-square-feet of space for its offices and a "wet lab." Imanis makes genetic tracking agents for use in medical research. It also does medical imaging and conduct experiments for clients.

Russell said while Omnis has a lot of potential to break new ground scientifically, Imanis is the more likely candidate to grow into a economic driver and job creator in Rochester.

"That company (Imanis) will probably grow to occupy a fairly large footprint. This company (Omnis) is less likely to arrive at that point," he said.

In 2015, Peng said, "We hope to build it faster to up to 30 to 50 people as we do more manufacturing. We hope to be able to keep it in downtown Rochester. This is our home."

The group also has a third virtual start-up company called Magnis Therapeutics, which is working on a cancer treatment based on the measles virus.

Having three companies with names that end in "-nis" seemed like a good idea at first, said Russell with chuckle. But now, he admits it might be a bit confusing.

January 07, 2015

Cardio3 buys cancer-fighting firm for $10 million

Cardio3 BioSciences, which works closely with both Mayo Clinic and the City of Rochester, has paid $10 million for the oncology division of a New Hampshire firm.

The Belgium-based Cardio3 agreed to pay Celdara Medical $6 million in cash and $4 million in new shares for the division called OnCyte. Celdara could receive up to $50 million, if its lead product in-development CM-CS1 hLogo_cardio_3its specific development and regulatory milestones.

The same type of payments for milestones could also reach $21 million per product for others in the pipeline. If CM-CS1 reaches market and net sales top $1 billion, Celdara will receive up to $80 million in payments from Cardio3.
OncyteCM_png
This is Cardio3's second acquisition in recent months. In November, it purchased a virtual company called CorQuest Medical Inc. Corquest is developing a sheath to provide a minimally invasive way to insert therapeutic devices. The CorQuest technology platform is complementary with Cardio3’s C-Cathez and C-Cure systems. Financial terms were not released.

The OnCyte expands Cardio3's reach beyond regenerating cardiac tissue by entering into the rapidly growing immuno-oncology cancer treatment area using chimeric antigen receptor (CAR) T cells. OnCyte's CM-CS1 uses (CAR) technology to destroy cancer tumors. The Federal Drug Administration has cleared CM-CS1 to begin a clinical trial using patients with acute myeloid leukemia /advanced myelodysplastic syndrome and multiple myeloma. Juno Therapeutics, Amgen and Kite Pharma and others are developing products based on this concept.

In an interview with Bloomberg News, Cardio3 CEO Dr. Christian Homsy described acquiring OnCyte as “Our first foray into an area that is of very high interest… It opens a new reach, a new broad area of growth for the company that is of very high value to us and our shareholders.”

Those shareholders include Mayo Clinic, which held 3 percent ownership of Cardio3, as of Aug. 4. 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. The cardiopoiesis technology uses to repair patients' hearts by re-programming their own stem cell to regenerate cardiac tissue.

When announcing the acquisition, Homsy said that four of Cardio3's top shareholders supported the move. A Belgium family-owned holding company called Tolefi SA is the lead shareholder with 32.23 percent of the shares. The Hong Kong-based Medisun, which is building an office in Rochester, owns 8.08 percent.

In the years since 2007, Mayo Clinic has developed a close working relationship with the Belgian company. Mayo Clinic is leading the U.S. clinical trial of Cardio3 and is using a lab in the Minnesota Biobusiness Center in downtown Rochester.

A possible deal is in the works for Cardio3 to occupy the entire fifth floor of the city-owned Minnesota Biobusiness Center. Gary Smith of the Rochester Economic Development Inc. said the company has not signed a lease yet and some financial details still need to be worked out.

If Cardio3 does decide to occupy the fifth floor, Mayo Clinic will need to move its staff that currently fills the space.