Updated 4:40 p.m.
CLEVELAND, Ohio — Medical imaging technology company Imalux Corp. has named a new president and chief executive: Michael Burke.
Burke, a veteran health care industry entrepreneur, left TREK Diagnostic Systems in Independence, Ohio, as its founding chief executive in November after selling the company to Magellan Biosciences in late 2006.
“We are very pleased to have Mike assume the leadership role at Imalux,” said Bill Sanford, the company’s chairman, in a written statement. “He has a track record of success in all phases of commercialization of medical technologies on a worldwide basis.”
Burke’s 30 years in the industry include 10 years in domestic and international management positions at Scientific Products and American Hospital Supply Corp., now Cardinal Health in Columbus, Ohio, according to the Imalux statement. In 1995, Burke joined a private company, AccuMed International, and later took AccuMed public.
Three years later, he led the acquisition of the microbiology assets of AccuMed, founding TREK Diagnostic Systems. TREK makes microbiology test kits used by clinical, pharmaceutical and veterinary diagnostic laboratories. In 2006, Burke sold TREK to Magellan Biosciences, remaining CEO until November.
“I kicked the tires on this one really hard,” Burke said during a telephone interview. He was impressed with the strength and commitment of the Imalux team, as well as the company’s promising technology, but it had been having trouble raising more investor money to finish product development and launch the product into the market.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Imalux is developing Niris, which uses near-infrared light to create real-time images of surface layers of tissue in the human body. The process is called optical coherence tomography, or  OCT, for short. Developed by Russian scientists, OCT creates cross-sectional images that are up to 100 times greater than those produced by ultrasound, a medical imaging technology based on sound waves.
Though Niris has broad applications, Imalux has been aiming its technology at urologists, gynecologists and ear, nose and throat doctors, mostly for cancer diagnoses without the need for biopsies, Burke said during a telephone interview. In February, Imalux released the latest results from its clinical validation studies – its medical imaging technology could be used to quickly diagnose pre-cancer and cancer of the cervix — at low cost and without doing a biopsy.
Started in 1996, Imalux has attracted four rounds of venture capital – more than $14 million-worth — and some research and development grants. The company won final U.S. Food and Drug Administration approval to sell its device in January 2005, but had to go back to the drawing board in 2007, working with doctors to figure out the best ways to use its technology.
The initial Niris system missed the mark on some of the things doctors needed most, like the ability to scan an entire organ rather than just one small spot of it at a time, Burke said. “They can scan the entire cervix in a minute-and-a-half now,” he said. Imalux also has developed a side-viewing probe, which enables doctors to produce images of tubular organs.
Multi-doctor practices – the target market for Imalux — also couldn’t afford to buy a Niris system. So the company developed a pay-by-the-scan plan for doctors who would rather lease the technology and buy disposable supplies, Burke said. “That makes it affordable to them, and to us as well.”
Now that Imalux has gained the clinical validation it needs, it is working on the second generation of its technology, which should be ready for market next year, he said.
Sanford, retired chairman and chief executive of STERIS Corp. of Mentor, Ohio, and an early Imalux investor, stepped in as the company’s chief executive officer in 2007 after its second CEO left. Though Sanford has passed the chief executive’s job to Burke, he remains Imalux chairman.
