Who will be the next Medtronic? What will be Minnesota's next breakthrough industry? James Walsh will provide the latest information and commentary on the people, companies and trends driving innovation in Minnesota. From visionary entrepreneurs to game changing technologies, this blog offers a window into the future of Minnesota's economy.
St. Teresa Medical, a medical-device startup from Maple Grove, competes tonight in the final round of "Get in the Ring: The American Startup Clash." Folks can watch the stream at 7 p.m. Central Time and cast votes for their favorite startup at www.Kauffman.org/GITR.
The company is commercializing a new technology called FASTCLOT that stops bleeding more quickly and has less potential for adverse side effects than current products, according to company officials.
FASTCLOT combines a fiber dressing “delivery system” with two human-derived clot-forming proteins. When applied, the dressing rapidly dissolves and speeds the formation of a clot over a bleeding injury. It is also quickly absorbed. Other such products are either applied as a patch or with a syringe, making them less user-friendly for the surgeon, St. Teresa said. The product can be used in surgical, trauma, dental, veterinary, military and consumer applications.
The company has conducted 12 pre-clinical studies. Two FASTCLOT products are being used on dogs and horses with “excellent results,” officials said. The company anticipates European regulatory approval for human use in mid-2014 and in the United States in early 2016.
St. Teresa Medical was founded 2010. The company is one of eight organizations from seven states facing off in the final round tonight. The Ewing Marion Kauffman Foundation is hosting the first-ever U.S. competition and will live stream the competition for the title of America’s most promising entrepreneur.
A cash prize of $10,000 will be awarded to the top U.S. finisher; $5,000 will go to the runner-up. Online viewers will be able to vote for the "audience favorite" via a special URL to be announced during the event.
In addition to the cash prize, the startup named U.S. champion will travel the next day to the Nov. 22 Get in the Ring global finals in Rotterdam, the Netherlands. That entrepreneur will face seven other international finalists, selected from 30 participating nations, for a chance to secure angel investment from a potential pool of €1,000,000, or approximately $1.3 million.
The U.S. finalists were selected from 283 applicants from around the country. They are:
Drazil Foods, Edina, Minn.
EyeVerify, Kansas City, Kan.
MANA Nutrition, Matthews, N.C.
POPVOX, Redwood City, Calif.
St. Teresa Medical, Inc., Maple Grove.
Travefy, Lincoln, Neb.
weeSpring, New York
Get in the Ring was founded in 2009 by the Erasmus Centre for Entrepreneurship in the Netherlands to bring the world's most promising entrepreneurs together with those who can help them succeed and to inspire others to start their entrepreneurial journeys. The international finals are held each November during Global Entrepreneurship Week.
Medtronic announced on Thursday that a German court has ordered the discontinuation of a prior court ruling that prohibited the Fridley-based company from marketing or selling its CoreValve transcatheter aortic valve replacement system in Germany.
Medtronic had been prohibited from selling CoreValve in Germany since August 26, after a lower German court ruled that Medtronic infringed on a patent by Edwards Lifesciences. Edwards also makes a transcatheter aortic valve.
But, on Thursday, a higher German court ruled that, because of a preliminary opinion by the European Patent Office that Edwards’ patent claims are not valid, it could not assume that the Edwards patent is valid. Essentially, the higher court decided to discontinue enforcing the earlier patent infringement ruling.
“Medtronic is very pleased with this decision as it will ensure that patients in Germany who need aortic valve replacement will have access to this life-saving therapy,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “As a result of the ruling, Medtronic will resume distribution of the CoreValve System in Germany.”
Medtronic said it will post a required bond as soon as possible and resume sales in Germany.
CoreValve is not yet commercially available in the United States. Medtronic officials expect CoreValve to win U.S. regulatory approval sometime in 2014. Edwards’ Sapien transcatheter aortic valve is currently the only such valve approved for use in the U.S., and only for patients considered extreme risk for open heart surgery.
Last month, Boston Scientific announced European approval of its Lotus transcatheter valve. Last year, St. Jude hit the European market with its Portico valve.
Transcatheter aortic valve replacement allows doctors to insert a new valve into the heart by snaking a catheter up into the patient through an artery in the leg or through an incision in the upper body. It is a much less invasive procedure than open heart surgery and patients can be home from the hospital within a couple of days, instead of weeks after the procedure.
Got this from the folks at the University of Minnesota:
The Design of Medical Devices Conference to be held April 7-10, 2014, has extended the deadline for its call for papers. The conference seeks original, two-page papers that demonstrate new technologies and applications in medical device design. They invite submissions from academic and industry researchers, clinicians and practicioners.
Authors of accepted papers woll be invited to present at a scientific poster session held on Wednesday, April 9, at the DQ Room of TCF Bank Stadium. You must register and participate in the conference poster session to have your paper published.
Here is the publication schedule:
Nov. 19,l 2013 – 2-page technical brief due.
Dec. 30, 2013 – Notification of acceptance and revisions needed.
Jan. 27, 2014 – Permission to Publish form due.
Jan. 27, 2014 – Final 2-page technical briefs due.
For more information on the conference, which will be held at the Commons Hotel and McNamara Alumni Center, go to: www.dmd.umn.edu.
For more information about how to submit papers, go to the Call for Papers site.
This week, technology and business leaders praised a research collaboration between the University of Minnesota and medical technology company Boston Scientific with a 2013 Tekne Award.
Given by the Minnesota High Tech Association, the award celebrates "technological breakthroughs that improve the lives of Minnesotans and people around the world."
Boston Scientific became the university’s first collaborator in the Minnesota Innovative Partnerships (MN-IP) program, which allows companies to pay an upfront fee and receive an exclusive worldwide license to intellectual property resulting from sponsored research.
Jay Schrankler, executive director of the U’s Office for Technology Commercialization, said the award was positive feedback for MN-IP.
“It’s encouraging to see that our efforts to make the U more inviting for business are beginning to show real results,” Schrankler said. “Our partnership with Boston Scientific is resulting in exciting new medical technologies and innovative approaches to some of our society’s greatest healthcare challenges.”
According to the university, Boston Scientific and the U are now working on several projects to improve patients’ health through "cutting-edge medical solutions. Boston Scientific’s industry experience pairs up with the university’s world class talent and facilities, granting both parties access to resources normally out of reach."
For more information about MN-IP, go to: http://www.research.umn.edu/techcomm/industry-sponsor.html#.Un1Qkfmkqmw
Medtronic on Thursday announced U.S. Food and Drug Administration approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic leads.
The software, which has been a standard feature on Medtronic devices since 2008, is now approved to report performance issues on Durata and Riata defibrillator leads made by St. Jude Medical and Endotak defibrillator leads made by Boston Scientific. Those leads must be connected to a Medtronic device.
Medtronic said LIA has shown the ability to detect lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone. Impedance monitoring measures the electrical continuity of a lead four times per day.
For Durata and Riata leads, Medtronic said its software detected circuit issues six times more frequently than impedance monitoring. For Endotak, circuit issues were detected four times more frequently, Medtronic said.
In the U.S., approximately 12,000 Medtronic LIA-enabled defibrillators are connected to non-Medtronic leads, the company said. That includes approximately 5,100 Endotak leads and 6,100 Riata and Durata leads.
Leads are considered the weak link in pacemaker and defibrillator therapy. The thin wires can fracture, disconnect from the heart and short-circuit. St. Jude's Riata lead was removed from the market in late 2010 after it was discovered that the lead's inner wires were coming through its outer insulation. A year later, the FDA recalled the device.
St. Jude Medical has repeatedly said it has seen no similar problems with its Durata leads, pointing to years of data and monitoring of thousands of patients.