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554 posts categorized "Biobiz news"

July 28, 2015

Mayo Clinic-linked NeoChord on 'Hot Devices We Can't Get in US' list

NeoChord, a medical device firm I first wrote about in 2007, made a top 10 list this week on the Medical Device and Diagnostic Industry news site.

They posted a "10 Hot Devices We can't Get in the US" list on their Device Talk blog with this set-up text block:

Patients in the United States enjoy some of the best medical care in the world, but many observers worry that the country's regulatory environment is pushing medical innovation to other shores. Whether you believe FDA oversight is too stringent, too lax, or strikes the right balance, there are numerous medical devices that have achieved CE Marking, but aren't yet FDA approved.

NeoChord's DS1000 made the list. It earned a CE Marking in December 2012 but does not have FDA approval.

 

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

NeoChord-DS1000Beside licensing its technology, Mayo Clinic has also previously invested in NeoChord. 

The 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. 

July 23, 2015

Quiet period to end for Celyad (former Cardio3) on July 29

Here's an interesting update from a site called Marketbeat.com about the former Cardio3, now trading in U.S. as Celyad. This Belgium firm has deep ties to Mayo Clinic and will soon occupy an entire floor of the Minnesota Biobusiness Center in downtown Rochester.

 Celyad SA’s  quiet period is set to expire on Wednesday, July 29th. Celyad SA had issued 1,460,000 shares in its initial public offering on June 19th, Market Beat reports.

CelyadThe total size of the offering was $100,097,600 based on an initial share price of $68.56. During Celyad SA’s quiet period, insiders and underwriters involved in the IPO are restricted from issuing any research reports or earnings estimates for the company because of SEC regulations. Following the expiration of the company’s quiet period, it’s expected that the brokerages that served as underwriters on the stock will initiate research coverage on the company.

 

CYAD has been the subject of a number of recent recent research reports. Analysts at Piper Jaffray initiated coverage on shares of Celyad SA in a research note on Tuesday, July 14th. They set an “overweight” rating and a $95.00 price target on the stock. Separately, analysts at Maxim Group reiterated a “buy” rating on shares of Celyad SA in a research note on Sunday, June 21st.

Celyad SA remained flat at $60.44 during during mid-day trading trading on Wednesday. 126 shares of the company’s stock traded hands. Celyad SA has a one year low of $47.52 and a one year high of $67.94. The stock’s 50-day moving average is $54.65 and its 200-day moving average is $54.65.

 

July 14, 2015

Piper Jaffrey gives Celyad (former Cardio3) stock positive rating

Here's an interesting item that floated into my email box this a.m. about the former Cardio3, now trading in U.S. as Celyad. This Belgium firm has deep ties to Mayo Clinic and will soon occupy an entire floor of the Minnesota Biobusiness Center in downtown Rochester.

By the way, a rating of "overweight" is a good thing. It means the stock is a better value that other stocks in the same sector.

Here's the item as posted by Piper Jaffray:

Piper Jaffray initiates coverage on Celyad SA with a Overweight rating and a price target of $95.00.

Analyst Edward Tenthoff commented, "Celyad is a leading cell therapy company. CelyadCelyad is conducting the Phase III CHART-1 trial of autologous cell therapy C-CURE in heart failure patients with data likely next summer. The company will initiate the CHART-2 trial this year with data in 2017. Celyad recently in-licensed novel CAR-T technology for cancer currently in a Phase I AML and multiple myeloma study. Celyad is listed on the EuroNext exchange in Brussels and Paris, and just completed a U.S. IPO issuing 1.46 million shares at US$68.56 raising gross proceed of US$101 million. CYAD shares have sold off since the IPO providing an attractive entry point at US$54.71, in our view. We are initiating coverage with an Overweight rating and US$95 price target."

Shares of Celyad SA closed at $54.71 yesterday.

 

 

June 15, 2015

Former Cardio3 launching $99 million IPO in US and worldwide

Celyad, formerly Cardio3 Biosciences, announced the terms for its $99 million stock offering this morning.

The Belgium-based Celyad, which is building a manufacturing facility in downtown Rochester and has close ties with Mayo Clinic, hopes to raise $99 million by offering 1.4 million shares at $70.98 per share.

CelyadWhile Celyad has traded on the European stock markets of NYSE Euronext Brussels and NYSE Euronext Paris for some time, this stock offering would introduce the regenerative medicine firm directly to the U.S. market. It has applied to make the U.S. offering on the Nasdaq stock market under the symbol CYAD.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. It cannot sell or accept offers to buy until the SEC OKs the registration.

This move could benefit Mayo Clinic, which owned 2.69 percent of Celyad 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 cells to regenerate cardiac tissue.

Earlier this year, the Rochester City Council recently approved a lease for Celyad to take over the entire fifth floor of Rochester's Minnesota BioBusiness Center. Rochester Area Economic Development Inc. and the Minnesota Department of Employment and Economic Development also are involved in the deal.

Celyad is building a prototype manufacturing facility in 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. The five-year lease calls for it 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.

DEED is offering Ceylad a $357,000 Minnesota Job Creation Fund award if it invests $1.5 million in Rochester within a year and hires 33 employees within two years. The average wages of the new jobs will be $21.52 per hour.

May 28, 2015

Mayo hires consultant to map out Discovery Square

To help fire up Discovery Square as "a catalyst" to create jobs in downtown Rochester, Mayo Clinic has contracted a feasibility study, independent of the Destination Medical Center Corp.

Mayo Clinic has hired the DMC development manager, Hammes Co. of Madison, Wis., to analyze the Discovery Square piece of the DMC vision and offer a market plan of how DiscoverySquarethe medical and technology research area might be developed. Mayo is paying Hammes $1.5 million to conduct the study, which is expected to be completed by the end of the year.

One expected tenant is Epic, a Madison-based software system that recently signed a contract to help build an electronic health record system for Mayo Clinic. It's planning on having many employees based in Rochester.

"They've indicated a strong interest in the Discovery Square concept, and we're exploring ways they may participate in that," said Bolton.

Discovery Square is described as "the focal point" for Mayo Clinic's expansion of its science and technology institutes, and it's designed as a place for private companies and others to work with Mayo on research and other projects. It's marked on the DMC map as being central to the Gonda Building and the Mayo Medical School.

"The Square is designed to be playful and artful, similar to the Google Commons in order to, quite simply, attract the best and the brightest, the most creative minds in the world," according to the DMC plan.

Mayo Clinic owns about 35 percent of the property within the proposed Discovery Square area.

The goal of the new study is to map out the area more specifically and identify potential partners and funding streams to make it sustainable.

Jeff Bolton, Mayo's chief administrative officer and the chair of DMC's Economic Development Agency, said Mayo funded the study because it's not part of the DMC EDA's scope.

"The EDA budget is really to provide staffing to support the DMCC board, to work with developers and help market the DMC concept," he said. "Mayo Clinic views this as area where we could serve as an important catalyst to advance the DMC vision. That's why we stepped up and are making this investment."

Mayo Clinic's relationship with Hammes dates back to the very early days of the DMC concept in 2008 before it became public. Mayo Clinic first officially contracted with the company about DMC in 2011. When the EDA signed its own contract with Hammes last year for $2.3 million a year, it had no ongoing Mayo contracts.

Bob Dunn, president of Hammes, explained that this study will be similar to his company's work on the overall DMC plan but will be much more detailed.

This study will include a master plan, a conceptual design, preliminary engineering, financial analysis, financing plan, a market analysis, a review of effective land use and operational aspects for Discovery Square.

"This will be a block-by-block plan," he said. "But we're not starting at ground zero. Mayo, which owns a good portion of the land in Discovery Square, has already thought a lot about this development."

Meanwhile, Mayo is actively working with companies to try to get them to locate there, Bolton said.

"We're out marketing the concept," said Mayo's Bolton. "Obviously, we have an interest in terms of attracting groups to collaborate with us."

The project's success likely will be driven by what partners want to work with Mayo Clinic.

"If I were to forecast, I'd say there will be multiple of owners of facilities in Discovery Square. Many will probably be owned by private developers," predicted Bolton. "There won't be a monolithic owner of the facilities. The free market will play out in this environment."

He added that Mayo Clinic may participate "directly or indirectly" in some of the development.

The multimillion dollar question is when actual development of this new job generator area will begin.

"We'll need a critical mass of corporate engagement in order to have a developer to put that first shovel in the ground," said Bolton.

Dunn said this is a fascinating feature of what is already a unique project.

"DMC and Discovery Square, to me, is one of the most interesting things that I can think of nationally in terms of major economic development," he said. "It's unique because impact Mayo Clinic can bring to something like this in a market that's now beginning to mature and evolve very quickly."

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.