November 14, 2018
Mitovation Inc. has a prototype device designed to stop cell damage after heart attacks
Device uses infrared light, a safe, noninvasive technology that should have a clear MTpath to FDA approval
Led by Mark Morsﬁeld, who has a background in medical device startups
Venture capitalists have a saying: "We bet on jockeys, not horses."
Investors in Ann Arbor-based Mitovation Inc. have a proven jockey in Mark Morsﬁeld, the chairman, president and CEO, and he says he's riding a good horse.
Mitovation has licensed three patents from Wayne State University and has built a prototype device designed to stop cell damage that occurs because of a lack of blood flow after heart attacks, something called post ischemia brain injury. The device looks like a small bike helmet, and it shoots infrared light through the skull and into the brain.
Most of the damage occurs after a patient is resuscitated and the blood begins flowing again, a process known as reperfusion. The goal is to improve clinical outcomes of hospital patients who suffer heart attacks during their stay, shorten the length of their stay in intensive-care units and reduce long-term disability of those affected by brain injury in the wake of a cardiac arrest.
It is estimated that 400,000 hospital patients in the U.S. a year suffer brain damage after cardiac arrest that occurs after their admission. The resulting cost of care is as much as $6 billion.
Research at WSU has shown that a combination of various wavelengths of infrared light minimizes cell damage in the brain during reperfusion. The ﬁndings were accepted by the journal Scientific Reports and published online on Feb. 22 this year.
In 2016, WSU helped vet the technology and build out a commercialization program through a pair of $25,000 grants from its technology incubator program. Morsﬁeld was then a mentor-in-residence at WSU and thought the technology promising and its co-founders coachable. "What was intriguing to me was their depth of understanding of the mechanism of action. In my history of this, a lot of people say, 'Look what it does.' And when you ask them how it does it, they say 'I don't know.' They know the mechanism of action, and that's a big box to check."
At the end of 2016, the technology got a grant of $100,000 from the Michigan Translational Research and Commercialization (MTRAC) program, part of the Michigan Economic Development Corp.'s entrepreneurship and innovation initiative, to develop a prototype. Early this year, having seen the technology advance and considering it viable for commercialization, the university signed a license option with the company.
Mitovation's helmet device is branded as the MitoLUX. It uses a ﬁber-optic cable to deliver infrared light from the light source to dozens of transmitters inside the helmet. The infrared beams have wavelengths that allows them to easily penetrate the skull.
The technology has been well-funded by a combination of 16 large and small grants totaling almost $8.1 million since 2006. In addition to the MTRAC funding, grants have included $2.8 million from the U.S. Department of Defense; three grants totaling $4.4 million from the National Institutes of Health; $200,000 from Wilson Medical Research Foundation;$143,000 from the American Heart Association; and $125,000 from the Kellogg Foundation.
The company is currently raising a seed investment round of $500,000 to continue prototype development, expand its intellectual property and begin the regulatory process. "We're talking to angel investors and institutional investors who like early stage companies," said Morsﬁeld, who hopes to ﬁnish that round by the end of this year and then soon after start to raise a Series A round of $3 million to $5 million to build out the team and begin human trials. He said trials should be relatively fast and inexpensive because infrared technology is well understood and considered very safe, minimizing the need for safety studies.
Large animal studies are being conducted jointly at WSU and the University of Michigan and should be ﬁnished by the end of the ﬁrst quarter next year, at which point Morsﬁeld said he will meet with representatives of the U.S. Food and Drug Administration to plan human trials, which he hopes will start before the end of next year.
"It's a really simple technology. The beauty is it's noninvasive and easy to administer," said Morsﬁeld. "You don't need special training. There's no black box. You put it on and turn it on."
Hugo Braun, a co-founder and managing partner of Ann Arbor-based North Coast Technology Investors LP, a venture capital ﬁrm, is on Mitovation's board of advisers. He said he likes a lot about Mitovation but particularly its CEO. "I've known Mark Morsﬁeld a long time and have worked with him at other companies. He's a really good CEO when it comes to understanding technology."
In 2013, Morsﬁeld joined one of North Coast's portfolio companies, Delphinus Medical Technologies Inc., a maker of ultrasonic breast-cancer detection devices, as interim CEO when investors were unhappy with the management team. Braun said Morsﬁeld was instrumental both in getting Delphinus back on track and helping recruit a permanent CEO, Mark Forchette, the next year.
In 2014, Morsﬁeld re-joined another of Braun's portfolio companies, Ann Arbor-based CytoPherx Inc., which is developing therapies for inflammation-based diseases, as vice president of ﬁnance and operations. At CytoPherx he helped raise $50 million in funding and complete a strategic acquisition. Mitovation shares space at CytoPherx's headquarters.
Morsﬁeld had been the CFO and COO at CytoPherx from 2007-2013, and from 2003-2007 was president of another of Braun's portfolio companies, Ann Arbor-based Nematron Corp., a maker of components for industrial PCs and monitors.
Braun says Mitovation is too early for North Coast to invest in, yet, but considers it a good possibility if expected milestones are reached.
Braun likes more than just Mitovation's leadership. He said the technology offers a rare combination for a medical-device startup. The market is big and the path to approval by the Federal Drug Administration is fairly straightforward. Not much time or money is needed to make prototype devices for human tests.
"The downside to patients is minimal. You're treating them with infrared light," said Braun. "We're not an investor, yet, but there's no technology risk at all. They're taking well understood technology and trying to do something with it no one has thought of before. It works in small animals. They just need to see if it works in humans, and that's not a very expensive proposition."
"We like Mitovation for multiple reasons," said Joan Dunbar, associate vice president of technology commercialization at WSU. "We've put a considerable amount of resources into the technology and keep getting to go instead of no-go when it comes time to make decisions about it. I'm optimistic about this one."
"Wayne State is right to be excited about it," said Braun.
The company co-founders are Maik Hütteman and Thomas Sanderson. Sanderson has since left WSU and taken a faculty position at UM. They share the title of chief science ofﬁcer at Mitovation.
Hütteman is professor of molecular medicine and genetics and of biochemistry, microbiology and immunology and division director at the school's Center for Molecular Medicine and Genetics.
Sanderson is an associate professor of emergency medicine and molecular and integrative physiology in UM's Center for Integrative Research in Critical Care.