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PROTON FROM PAGE 1
Because of ProTom’s unspecified delays, Lane said, McLaren was forced to hire at least five subcontractors and several consultants to help it complete the project. Lane didn’t specify what caused the delays. “We hired the subcontractors before ProTom filed for bankruptcy,” said Lane, declining to name the subcontractors or consultants. He said they include a legal counsel to the Food and Drug Administration and software consultants. “We have made great progress since our team assumed project management” duties, Lane said. Proton beam therapy is a controversial form of megavoltage radiation that has been suggested by some to be effective in some prostate and pediatric cancers because it causes less damage to surrounding tissues while directing high dosages at tumors. Critics say the therapy is still unproven and that its high cost and similar effectiveness compared with existing treatments makes it an unnecessary and expensive technology. However, supporters contend patients are treated more effectively because proton therapy can more precisely target the tumor with lower radiation doses to surrounding nor-
PATHOGEN FROM PAGE 1
to radiation or nuclear materials. Having raised $200,000 in seed funding, including $100,000 from angel investor Paul Glantz, co-founder and chairman of Troy-based Emagine Entertainment Inc., company officials have begun approaching local venture capitalists for the $1.5 million they say they need to get to market. They say they would use the funding to make 20 hand-held prototypes to be used in beta testing at medical and veterinary facilities. The plan is to generate enough good data to win the business of beta testers and start producing revenue next year. The company was founded in 2011 by Greg Auner, director of the Smart Sensors and Integrated Microsystems program in the College of Engineering at Wayne State; Charles Shanley, M.D., a surgeon and professor at both the Wayne State’s medical school and the Oakland University William Beaumont School of Medicine; and Mark Trexler, the CEO for more than the last 20 years of Technical Enviro Ser vices, an environmental consulting firm based in West Bloomfield Township. Medical Engineering has been developing its sensor-based technology and algorithms since being founded, getting to the prototype stage before going out for equity capital. Shanley, who gave a presentation on the company’s technology at the TEDx Detroit event at the Fox Theatre in Detroit on Oct. 8, is the CEO; Auner is chief technology officer, and Trexler is COO. WSU’s board of governors approved a license for Medical Engineering in July. Medical Engineering’s devices are based on Raman spectroscopy,
MCLAREN HEALTH CARE
McLaren Health Care’s planned opening of a proton beam cancer treatment center in
Flint is expected to be delayed at least until next spring. mal tissues. The therapy has also has been used to treat lung cancer and cancers of the head and neck, although criticism has always centered on lack of peer-reviewed clinical trials. Lane said McLaren’s sub-vendors will provide all the parts and necessary software to keep the proton beam technology operational. “We were very disappointed. It’s unfortunate, and we can’t change what happened, but we are moving forward,” Lane said.
named for Chandrasekhara Venkata Raman, who won the Nobel Prize in physics in 1930 for his discovery that when light passes through a transparent material, some light deflects and changes wavelength. Medical Engineering’s prototypes target suspected pathogens or contaminants with laser beams. The company’s database compares the resulting fingerprint of scattered light against a cloud-based database of fingerprints it has stored from previous tests it conducted as it built up a large library of fingerprints. The result is in many cases being able to determine in 100 milliseconds what pathogen needs to be dealt with and how, whether it’s something causing an infection in a patient or has contaminated food or water. Current devices using Raman spectroscopy are table size, which prohibits them from going into the field or to a patient’s bedside. Fluid or tissue specimens taken from a patient must be cultured for several days, growing enough pathogens for an identification to be made. And it might take three to five more days to determine if detected bacteria are antibiotic resistant. There is no need for Medical Engineering to grow cultures from samples gathered bedside. The laser is aimed at a sample, and if there is a pathogen, it is generally identified almost instantaneously, say the company’s founders. Fingerprints available in Medical Engineering’s database include methicillin resistant staphylococcus aureus (MRSA), all flu types, rhinovirus, human papillomavirus, E. coli and various staph infections. And because the shape of bacteria are altered as they become disease resistant, Medical Engineering’s technology can tell if an illness is being caused by a bacterium that is resist-
McLaren officials said the center is expected to treat 100 patients per day at full capacity with its three rooms, including one for pediatrics. “We don’t envision any disadvantages with running the proton beam center” without ProTom and by using subcontractors and consultants, Lane said. “It is the same product.” McLaren’s proton beam machinery and Radiance 330 cyclotron was made in Russia and shipped to Michigan four years ago. But con-
struction and approval by the FDA took several years to complete. The road to opening Michigan’s first proton beam center has been arduous for McLaren, and Southfieldbased Beaumont Health, which was the first system in Michigan to propose a proton beam center, in 2008. In 2017, Beaumont plans to open a $40 million, single-room proton beam facility on its Royal Oak campus. Beaumont is developing its project with Proton International, an Atlanta-based proton therapy development group. When Beaumont completes its two-story building, the 17,000square-foot proton center will be on the first floor with an 8,000-squarefoot second floor that will house Beaumont Children’s Hospital’s pediatric oncology and hematology program. Nationally, there are 13 proton beam therapy centers operating and at least 12 more facilities are in development, according to the National Association for Proton Therapy. Depending on the size of the center, costs range from $30 million to more than $200 million. Joe Spallina, a consultant with Ann Arbor-based Arvina Group LLC, said many proton beam centers are seeing fewer patients than expected, leading some to speculate that new centers might have a rough go.
LARRY PEPLIN
Greg Auner (seated) demonstrates the loading of a sample specimen into a prototype of the field unit device along with Mark Trexler (center) and Dr. Charles Shanley.
ant to a particular antibiotic, and what alternative antibiotic would be best to use instead. Tom Shehab, the former chief of staff at St. Joseph Mercy Hospital in Ann Arbor who is now a principal at Arboretum Ventures LLC, a venture capital firm in Arbor that invests in medical-device companies, has had a preliminary meeting with Medical Engineering officials. He said it is commonplace for a physician not to know what is causing a patient’s illness, and that there is no quick and easy way to find out. The result, he said, is often an overreliance on antibiotics that don’t work, which also worsens the growing problem of antibiotic resistance. “Both for severe infections and unusual epidemic infections, we often take a shotgun approach. We throw the kitchen sink at someone if they are sick and we don’t know what they have. The sooner we know the right bug and its resistance pattern, the better,” he said.
While acknowledging that Medical Engineering is still in the early stage, Shebab said: “The technology is intriguing. Hopefully, they’ll continue to make progress.” Martin Dober, vice president with Invest Detroit, which manages two early stage investment funds, has also met with Auner and Shanley. “The technology is interesting, and we’d be interested in taking a deeper look at it as things progress and they get closer to commercialization. We haven’t begun due diligence yet, but we’re interested in learning more,” he said. Trexler said the company has hired a consultant to plan a path toward approval by the U.S. Food and Drug Administration , which is required for use on humans. Since FDA approval is not needed for veterinary, food or environmental applications, those markets will be targeted first. He said he is negotiating with a company that has 300 veterinary practices in the U.S. to beta
“I view proton as a maturing market” with several major manufacturers and several smaller players competing for business, Spallina said. “Some startup manufacturers are running into capital and governance challenges. It is not surprising, because there has been a lot of promotional selling.” While Medicare pays for prostate cancer proton therapy, Spallina said, proton centers need to generate at least 50 percent of their business from commercial insurance or selfpay to cover their higher overhead costs. “The reality is payers are reluctant to pay higher rates for services that can be done less expensively by (traditional cancer centers),” he said. “Cancer centers are not going to give up that volume to proton beam.” In 2008, the Economic Alliance for Michigan began opposing plans for several proposed proton beam centers, primarily because of the high construction costs and lack of evidence of superior treatment over traditional cancer therapies. “We still feel the same. Proton beam technology is expensive and only increases health care costs without proving additional patient value,” Jackson said. 䡲 Jay Greene: (313) 446-0325 Twitter: @jaybgreene
test prototypes as they are made. He expects data from those tests to quickly lead to sales and revenue. “We think we’ll be selling devices to vets within a year,” he said. Robert Gougelet, who recently retired as an emergency physician at the Dartmouth-Hitchcock Medical Center in New Hampshire and was the longtime vice chairman of the National Advisory Council of the Federal Emergency Management Agency, has agreed to serve as liaison for Medical Engineering with various federal agencies. As a national expert in emergency preparedness, he said federal agencies he has worked with over the years include the National Institutes of Health, the National Institute of Allergy and Infectious Disease, the Naval Re search Laboratory, the Department of Homeland Security and the Depart ment of Defense. All are potential large customers for Medical Engineering. “I’ll help open doors for them,” said Gougelet. “What I like about their technology is it is so fast and so broad-based. It’s a very valuable platform that will have a major impact. The technology is fast and accurate, and there’s such a need for it.” Glantz said he met Auner about a year ago through his connection to Wayne State as a member of the business school’s board of visitors and chair of the Wayne State University Foundation investment committee. “I benefited from early stage funding in my career. My theater business was all started with an angel investment,” said Glantz, when asked why he became an angel investor in the company. “I see this as a truly disruptive technology. To immediately be able to detect the nature of a pathogen is a game-changer,” he said. 䡲 Tom Henderson: (313) 446-0337 Twitter: @TomHenderson2