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7 posts categorized "Medical devices"

May 31, 2016

A look at Mayo Clinic's NIH funding

It was announced last week that the National Institutes of Health awarded Mayo Clinic $142 million, spread out over five years, to a new federal Precision Medicine Initiative Cohort Program biobank.

NIH_Master_Logo_Vertical_2ColorThat made me think of a couple things. First, I remembered writing about the formation of Mayo Clinic Bioservices in 2014. It looks like that program is probably the core of this new project.

Next I wondered how $28.4 million a year or $142 million over five years measures up against Mayo Clinic's typical annual funding grants from NIH. Mayo Clinic has lots of money coming in from government contracts and grants from a variety of sources ranging from NIH to the Dept. of Defense.

Looking at just the NIH funding, this new grant is significant, but not not huge, in comparison to recent years.

Before this latest grant, NIH has already given Mayo Clinic $85.8 million in funding through 176 awards for 2016. The $28.4 million for this year will ramp it up to $114.2 million for 2016, which puts Mayo possibly on track for a record year. Here's the breakdown of Mayo's NIH grants in recent years.

• 2015 - 395 awards - $207.6 million

• 2014 - 401 awards - $201.2 million

• 2013 - 376 awards - $192.2 million

• 2012 - 380 awards - $205.2 million

• 2011 - 362 awards - $193.9 million






2016 - 176 awards - $85,878,422

 

May 20, 2016

Mayo Clinic Ventures looks to Israel for collaborations

Looking to help boost a variety of medical start-up businesses, Mayo Clinic Ventures is targeting collaborations and investments in Israel with a new program.

The goal of the Mayo Clinic Israeli Startup Initiative is to work with companies either through sponsored research grants or co-development.  

Flags"Co-development can include licensing of Mayo Clinic know-how or an investment," explained Timmeko Love, of Mayo Clinic Ventures. "It's about matching the right opportunities with Mayo Clinic know-how for collaboration. It's all about finding the right strategic fit."

Candidates for the Israeli Startup Initiative can include very early stage companies to ones that are much further along in development. They can work in any area of health care. 

"We're not limiting our options," Love said.

The project announced this week actually is a new phase of an existing Mayo Clinic initiative.

It has been active in Israel for about a year, partnering with the philanthropic Merage Institute. The California-based Merage Institute awards up to $150,000 in annual research grants for Israeli companies working with Mayo Clinic. The most recent recipient was EyeYon Medical, which makes a noninvasive medical device to treat corneal edema.

Mayo Clinic Ventures recently took on the Israel initiative and that has put co-development on the table. That new approach is being launched next week in Tel Aviv at IATI-Biomed, Israel’s largest life sciences and technology conference. Mayo teams will meet start-ups to study their technology, and then consider making investments or collaborations.

This is first time Mayo Clinic Ventures has focused on one whole country for business opportunities, despite its long history of international projects. Many might not be aware of it, but Israel is a logical candidate for a such a relationship.

"It's a natural next step for us," Love said.

Israel is considered to be the worldwide leader in innovation in medical devices, biopharma, software and other types of health-care businesses. The U.S imported $600 million of Israeli medical devices in 2011. In 2015, Israel housed 725 medical-devices businesses with an overall total of 1,380 life-sciences companies.

While California's Silicon Valley is known as the hottest spot in the world for business start-ups, Israel is recognized as a close second. A 2009 book, "Start-up Nation," documents how Israel, with a population of 7.1 million, generates more tech businesses than many much larger countries.

"It's kind of a national sport in Israel," said Guy David, a professor of health-care management at University of Pennsylvania’s Wharton School. He was born and raised in Israel and tracks its medical businesses closely.

David said Israel's required military service coupled with an environment that encourages questioning and taking risks is a big factor.

"Israel is hugely innovative. The innovative spirit starts at a very young age," he said.

While launching technology companies is a big focus in the country, the entrepreneurs all know the market for their products or services is elsewhere.

"There is no market in Israel. Israel is tiny," said David. "If they invent something, they know it has to be a global product."

Does that mean businesses partnering with Mayo Clinic could open offices or build facilities in Rochester?

"That certainly could be a possibility. We do look at an economic development when considering companies," said Love. "But it has to make sense for that company. There would need to be a business reason for it."

 

December 16, 2015

New Stewartville firm to collaborate with Mayo Clinic

A new medical device company launched by well-known local experts is joining forces with the top health care name in the region - Mayo Clinic.

Minnesota Medical Technologies, recently started by Jim and Philip Conway, announced this week that it will collaborate with Mayo Clinic in the development of new fecal incontinence products. As part of the deal, Mayo Clinic will have some ownership of Minnesota Medical Technologies.

5627967a5e7bd.imageThe Conways have experience working with Mayo Clinic at their former company, Rochester Medical, which made catheters and urinary incontinence products.

"We are pretty expert in fabricating and designing devices, but we can't pretend to experts in the medical field. That's why working with Mayo Clinic makes sense," said Jim Conway. "It's very likely when we get our first patents, a Mayo Clinic name will also be on it."

The Conway brothers, along with partners Lonnie Boe and Sarah Grinde, are building a 6,500-square-foot pilot manufacturing facility in Stewartville's Schumann Business Park. Jim Conway says the goal is to start using the building sometime in April with early prototype production starting soon after.

"We're shooting to get FDA approval by the end of 2016," he said.

Minnesota Medical is already working on the early groundwork to develop a dual U.S.-European market for these new products. Like when they entered the catheter field in 1989, the Conways see a lot of opportunity to develop better products in area where there is a lot of need.

Fecal incontinence affects an estimated 1 percent to 2 percent of the general population and 40 percent to 50 percent people living in long term care facilities. U.S. sales of fecal incontinence products is predicted to hit $1.9 billion by 2018. Minnesota Medical is targeting 10 percent of U.S. and international sales, a goal they hit with Rochester Medical and urinary incontinence.

Rochester Medical grew into a major international manufacturer with hundreds of local employees and more than $60 million in annual sales. In 2013, the Conways sold it to rival C.R. Baird for $262 million. They signed a five-year, non-compete agreement not to make urinary incontinence products.

September 01, 2015

Celyad, Medisun collaborating on new China deal

Two international firms with deep Mayo Clinic and Rochester ties are joining forces for a new $22.4 million collaboration. 

Belgium-based Celyad, formerly called Cardio3, announced Monday it's entering into a new venture and distribution deal with its partner, Medisun International Limited, for its C-Cure cardiac treatment. C-Cure is based on stem-cell technology called cardiopoiesis licensed from Mayo Clinic.

CelyadBoth Celyad and the Hong Kong-based Medisun continue to collaborate with Mayo Clinic and both are in the process of creating facilities in Rochester.

This new 15-year agreement between Celyad and Medisun guarantees Celyad will "conduct all clinical development and undertake any regulatory steps necessary for market approval in China, Hong-Kong, Taiwan and Macau (collectively 'Greater China')," according to a news release about the venture.

Medisun will fund that push with a minimum of 20 million Euros, or $22.4 million. In addition to the funding cash, Celyad will collect royalties and profit sharing. The royalty rates, based on the total revenues from C-Cure, are expected to range from 10 percent to 30 percent. Profit-sharing amounts will be based on total revenues after royalties are taken out. The profit sharing is expected to range from 20 to 25 percent.

"We are pleased to have this new license agreement in place with our local partner Medisun, which give us full control over clinical developments in these territories, fully funded by our local partner. Pending receipt of necessary approvals, we look forward to giving access to this technology to patients in Greater China," stated Celyad CEO Christian Homsy in the release.

6a00d83451cc8269e201b8d0c98293970c-120wiCelyad is paying rent on the entire fifth floor, or 14,963 square feet, 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 downtown building. Construction has been underway for months, but is not yet completed. 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.

Local officials hope to convince Celyad to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester, according to officials at Rochester Area Economic Development Inc.  Celyad also has plans to build a U.S. headquarters in Boston.

The company recently reported a $17.04 million loss for the first half of 2015. It lost $18.1 million for the whole year in 2014, up from $15.9 million in losses in 2013. Dr. Homsy told Reuters last week the company has enough cash to make it through the end of 2017.

The company did an initial public stock offering in 2014, which yielded about $500,000 worth of shares for Mayo Clinic.

Medisun also is collaborating with Mayo Clinic on a project to bring more patients from China to Rochester for treatment. While Medisun began building a $1 million office in the H3 Plaza building in downtown Rochester earlier this year, it recently put an end to that project.

Mayo Clinic, however, has confirmed it still is working with Medisun. Mayo Clinic spokeswoman Duska Anastasijevic said she didn't believe "the scope and nature of the relationship has been impacted or altered, just the planned location of their offices has changed." 

She added that Mayo staff working with Medisun said the company will be using one of its Rochester homes as "a guest house" and headquarters for the project. Medisun CEO Danny Wong personally owns two houses in Rochester. He bought a house at 2515 Crest Lane SW for $1.4 million as well as one at 615 10th Ave. SW for $1.31 million. It is not known which property will serve as the guest house.

August 10, 2015

TapImmune using Mayo Clinic tech for possible cancer vaccine

 

Assistant Manager Editor Mike Klein spotlighted a press announcement from a Seattle-based biotech company called TapImmune Inc. working with Mayo Clinic this morning.

I remember in 2010, when TapImmune first licensed Mayo Clinic technology and began collaborating with Mayo's world-renowned vaccine exTapimmunelogopert, Dr. Gregory Poland.

At that point, they were working with a Small Pox construct to create the vaccine for cancer as well as other infectious threats like, Ebola.

In May of this year, reports came out about Mayo Clinic's Dr. Edith Perez saying how this vaccine changed her view towards preventative medicine. She is working with TapImmune oon applying the vaccine to fight breast cancer.

TapImmune had only $142,000 in and $3.3 million in losses at that point in May.

This appears to be a promising company with deep ties to Mayo Clinic. It seems like a good candidate to based in Rochester rather than someplace like Seattle.

Here's some of what Klein filed on this for today's paper:

Seattle-based TapImmune Inc. has exercised its option agreement with Mayo Clinic to use its technology in a possible vaccine for certain types of cancer, it announced.

TapImmune signed a worldwide exclusive license agreement to commercialize a "proprietary folate receptor alpha vaccine technology for all cancer indications."

This technology, developed in the laboratory of Keith Knutson at Mayo, has successfully completed Phase I clinical trials in ovarian and triple-negative breast cancer. The trial demonstrated the experimental therapy was "safe, well-tolerated, provided a robust immune response," according to the news release. Next, TapImmune plans a Phase II clinical trial in the second half of the year.

TapImmune CEO Dr. Glynn Wilson said the company's future clinical programs will be "aimed at developing this leading vaccine candidate as a stand-alone therapy or in combination with other immunotherapies."

Mayo Clinic has a financial interest in the technology.

August 05, 2015

Boston Scientific buys major stake in local firm, Preventice

Preventice Solutions, a maker of wearable cardiac monitors with deep Rochester roots, is getting a major boost from a medical giant.

Boston Scientific Corp. announced Tuesday it now is "a significant shareholder" in Preventice as well as its "exclusive worldwide sales and marketing representative."

Preventice, which has a large development center in northwest Rochester, makes the wearable BodyGuardian Remote Monitoring System, developed from research licensed from Mayo.

144536The new deal clears the way for Preventice to reach the remote monitoring market estimated to total $19 billion to $21 billion by 2016. Experts anticipate almost five million patients will be using some type of wireless monitoring by then.

"As our health-care environment continues to evolve, health-care practitioners, administrators and payors are looking for solutions that identify relevant clinical insights from large volumes of patient data and integrate those insights to improve clinical decision-making," said Boston Science Executive Vice President Joe Fitzgerald in Tuesday's announcement.

Fitzgerald described Preventice as having "an infrastructure optimized to monitor hundreds of thousands of patients each year."

The privately owned firm has grown quickly since being launched in 2007 with only its founders on staff. Preventice evolved from Boost Information Services. It was founded by Jon Otterstatter, Greg Wobig, Dan Spors and Scott Burrichter.

Preventice started as a developer of medical information smartphone apps, in collaboration with Mayo Clinic and Merck. Then it shifted gears to begin developing wearable cardiac monitors. The U.S. Food and Drug Administration approved its wireless BodyGuardian monitor to be prescribed to track nonlethal arrhythmia, or irregular heartbeats, in 2012.

In 2013, Preventice began shipping out its BodyGuardian systems to feed what CEO Otterstatter described then as the health-care industry's growing "fever" for remote medical monitoring. That year, it expanded to about 100 employees, with about half in Preventice's Rochester offices. Based in Minneapolis, Preventice also has an office in Fargo, N.D.

Preventice Solutions merged with Houston, Texas-based eCardio Diagnostics in 2014, under the holding company of Preventice Inc.

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.