Minnetronix, a medical device engineering and contract manufacturing company in St. Paul, has worked for more than 20 years to make life easier for other med-tech companies in the state and across the globe.
Minnetronix components and expertise have long helped power other companies' medical devices, from glucose sensors for diabetic patients to plaque-removal systems for clogged arteries.
Now, the 300-person private company is unveiling plans to tackle a new challenge, launching its first proprietary medical device that it is prepared to take all the way to the hospital with its own brand name emblazoned on the outside.
That name is changing, too. Minnetronix is rebranding itself as Minnetronix Medical. And its new devices for neurointerventional critical-care procedures are planned to form the basis for a new Minnetronix Neuro line of finished devices.
"We have been a medical device company for years. That's the way the company has always thought of itself. So the brand name might be new, but the brand isn't," Minnetronix Medical CEO Rich Nazarian said during a recent tour of the company's 125,000-square-foot engineering and manufacturing space just off Snelling Avenue on Energy Park Drive.
"We didn't come out of contract manufacturing, we came out of the medical device world," he continued. "And we got to a point where we thought, with our scale and our capabilities, we could start to address some of those [unmet clinical needs] directly."
Minnesota is home to other companies that work under contract with OEMs (original equipment manufacturers) in med-tech, including Eden Prairie's SurModics, which like Minnetronix Medical decided in recent years that there would be a benefit in spearheading novel whole products.
SurModics has made strategic acquisitions to bolster its design and manufacturing capabilities, and last February announced a deal worth up to $92 million with Abbott Laboratories to test and eventually distribute SurModics' first device, a drug-coated balloon for artery disease in the leg. Abbott also optioned future drug-coated balloon devices that are still under development.
Minnetronix Medical appears to be charting a similar but different course for its neuro critical-care products. For one, it is doing the clinical trials in-house. In 2016, the company raised $20 million in private equity, which was its first outside fundraising since the company's founding.
The first product is known as Neurapheresis Therapy. It's intended to address the high death and disability rates in patients who have had a subarachnoid hemorrhagic stroke, which is a type of stroke often caused by a burst aneurysm.
Unlike an ischemic stroke, where a blood vessel in the brain becomes blocked, a hemorrhagic stroke happens when a weakened vessel in the brain bursts. Both conditions deprive the brain of oxygen, but a hemorrhagic stroke can cause blood to seep out and contaminate vital cerebrospinal fluid if there is bleeding in the subarachnoid space between the brain and its covering tissue.
The National Stroke Association said hemorrhagic strokes account for just 15 percent of all strokes, but they make up 40 percent of stroke-related deaths. The brain relies on a steady flow of clean cerebrospinal fluid, but blood trapped in a cavity in the brain can block the normal flow of fluid and break down into toxins, damaging brain cells and causing physical and mental problems, the Brain Aneurysm Foundation says.
Minnetronix' Neurapheresis system is designed to be a minimally invasive therapy that draws contaminated cerebrospinal fluid out of the body, sends it through a complex filtration system, and then pumps it back into the body clean.
A positive early feasibility study of the system led to a larger trial. The full study results are still confidential — they are set to be revealed at the Congress of Neurological Surgeons annual meeting next month — but company officials note that the FDA has seen the results and given the go-ahead for an extended study that could eventually lead to full U.S. approval for the device.
University of Minnesota neurosurgeon Andrew W. Grande, one of the Neurapheresis study investigators, said the device could help some patients avoid the lifelong need for a different implanted device called a shunt.
"This partnership has been really meaningful, at least for me and our department," Grande said. "You've got university and industry here together developing a device that has a really relevant clinical purpose. I haven't been through a lot of device development, but my observation with this is that it's been a pretty smooth process."
It's no coincidence that the device, which is being developed in part using funding from the National Institutes of Health, has no competitor on the market. Minnetronix Medical continues to do engineering and production work for startups and large medical device companies, so it's important that the company's proprietary products don't end up competing with products its clients ask it to produce.
But there's a lot of "capital efficiency" in having Minnetronix Medical design the Neurapheresis device, Nazarian said, because it takes advantage of some of the company's expertise in designing medical devices that circulate bodily fluids. The system may also be studied for treatments for other conditions like meningitis, complications from cancer, HIV infection and multiple sclerosis.
"We try to ... find areas of big need, and then bring solutions to bear. Our Neurapheresis Therapy is a great example of being able to leverage a technology that meets a need and fits right into a sweet spot for what Minnetronix does," said Matt Adams, general manager of the Minnetronix Neuro division.
And would Minnetronix Neuro follow SurModics' example and license or sell the Neurapheresis system to a larger med-tech company at some point? Nazarian said the company would evaluate good offers, but Minnetronix already has a strategy for developing and distributing the system on its own.
"If someone came along and said they were really excited about the technology and offered us a great deal to license it, it would be silly to say we wouldn't do that," he said. "But we are prepared to determine our own outcomes here."