Protégé Biomedical is a medical device company with a unique and patented line of hemostatic products, including ClotIt. Up until September, the company’s products could only be used on animals. With a recent 510(k) clearance from the Food and Drug Administration (FDA) for its Ionic Hemostatic Mineral (IHM) Bandage, humans also will be able to use Protégé Biomedical’s products.
The duo will be part of a panel at the Opus College of Business Executive Conference on the Future of Health Care at the St. Thomas Minneapolis campus on Nov. 2. On the panel, “Start-ups Disrupting Health Care,” the Wuolletts will share their insights on entrepreneurship and industry disruption.
A major part of Protégé Biomedical disrupting its industry relates to the recent FDA clearance.
“We have a product that stops bleeding, and it will be disruptive because we’re faster than anything out there and we might change the standard of care as it pertains to hemostasis,” Susan said. “But our first indication is more over the counter, topical, so it’s a product that you’d see in convenience and drug stores for minor cuts and scrapes.”
With potential breakthrough success at their doorstep, it’s interesting to note that the Wuolletts never aspired to be entrepreneurs.
“We wanted to enter the [Fowler Business Concept Challenge] competition and we wanted to win the scholarship money,” Susan said. “The morning of the competition, I told Michael, ‘Don’t worry, whatever happens with this, even if we win, I promise we won’t actually do this as a business. We won’t quit our jobs.’”
Their entry in the 2010 competition, a styptic fibrin bandage, won first place in the graduate division.
Inspired by the military’s use of fibrin, a combination of thrombin and fibrinogen, to stop bleeding, the Wuolletts thought of using that technology on a finger bandage – until they learned that fibrin costs $1,000 per square inch. They then thought of styptic pencils as a way to make it cheaper and ended up writing a paper for their styptic fibrin bandage Fowler Business Concept Challenge entry.
Even after winning the Fowler Business Concept Challenge, the Wuolletts weren’t planning on doing anything more with their idea.
Susan and Michael are children of entrepreneurs – her dad was a psychologist who owned a practice, and his mom owned a couple of salons.
The Fowler Business Concept Challenge judges encouraged them to give their technology a shot.
They named their business Protégé Biomedical, Susan said, because “We’ve always considered ourselves protégés of a group of mentors and advisers.”
One of their mentors is Ron Fowler, the namesake of the Fowler Business Concept Challenge. They stay in regular contact with him and gave him the first product once manufacturing was completed.
On the horizon
Protégé Biomedical already has many noteworthy highlights. The life of a K-9 was saved because ClotIt was used on a gunshot wound. A Basset Hound’s tumor stopped bleeding. Their product took off in the equestrian market. They were on a TV commercial as part of the St. Thomas awareness campaign.
Up next: launching their product for human use and raising $5 million to fuel future growth. “We’re at an inflection point,” Susan said.
“I feel like we’re officially starting chapter two,” said Michael.
Protégé Biomedical timeline
- Oct. 22, 2010 – Won first place in graduate division of the Fowler Business Concept Challenge for styptic fibrin bandage
- June 30, 2011 – Protégé Biomedical incorporated
- September 2011 – First provisional patent filed
- November 2011 – First investment from William C. Norris Institute, for $25,000
- April 23, 2012 – First animal trial
- Sept. 4, 2012 – First exhibit and presentation at Animal Science Conference and Venture Forum
- June 2013 – Mike Wuollett leaves 3M to join Protégé Biomedical full time
- September 2013 – ClotIt launches, full patents filed in 36 countries
- January 2014 – First angel round, for $500,000
- June 2014 – First full-time employee hired
- April 2015 – Susan Wuollett leaves Wells Fargo to join Protégé Biomedical full time
- July 2015 – First 510(k) submitted
- November 2015 – Hired vice president of sales, Ron Shay
- August 2016 – First patent issued
- September 2018 – Receives 510(k) clearance from FDA for Ionic Hemostatic Mineral (IHM) Bandage