Like most medical device executives, Peter DeComo, chairman/CEO of ALung Technologies (Pittsburgh), a developer of respiratory assist devices, knows how difficult it can be to attract investors in the current environment. But with the right strategy and a differentiating technology, raising money is not impossible. ALung proved that with its recently closed $15.8 million Series B-1 financing round. The round is one of the largest this year in Pittsburgh's life sciences market, the company noted.

Guided Therapeutics (Norcross, Georgia) said it has received additional questions from the FDA regarding the company's pre-market approval application for the LuViva advanced cervical scan. FDA advised the company the PMA was not yet approvable in its current form and that the company will need to address these questions in order to place the PMA in approvable form.

C. R. Bard (Murray Hill, New Jersey) said it has agreed to acquire Rochester Medical (Stewartville, Minnesota) for $20 a share, or about $262 million in the aggregate to be paid at closing, expected to occur later this year. Rochester develops silicone urinary incontinence and urine drainage products.

Australian and U.S. researchers have developed a new approach to detecting unrecognized cases of celiac disease in the community, revealing this immune disorder is far more common than previously recognized. In a study of more than 2500 adults, the researchers combined traditional antibody testing (measuring the immune response to gluten) with an assessment of specific genetic risk markers. They found that more than half of the subjects had genetic risk factors for developing celiac disease. This newly developed testing strategy also showed that celiac disease potentially affected at least one in 60 women and one in 80 men. The research is published online in the journal BMC Medicine.

Spinal Modulation (Menlo Park, California) has enrolled the first patient in its U.S. pivotal trial to evaluate the safety and efficacy of the Axium Neurostimulator System for the treatment of chronic lower limb pain. The company said it announced the first enrollment in the ACCURATE study and presented data about the European experience with the Axium System last week at the 20th annual Napa Pain Conference in Napa, California.