AngioDynamics ( ANGO) said a company it's set to acquire received regulatory clearance for a technology used in the surgical removal of certain types of body tissue. Shares of AngioDynamics edged up 0.4% to $22.10. The Food and Drug Administration granted Oncobionic approval to market irreversible electroporation technology, which uses needles and image guidance to target cells. The process is similar to existing thermal ablation technologies, but instead of "cooking" or "freezing" the targeted tissue, irreversible electroporation disrupts the cell membrane, thereby destroying the targeted cells. The impaired cells are then left in the body to be removed by the immune system. AngioDynamics has announced plans to buy Oncobionic for $5 million in cash, plus an additional $20 million to be paid over two years, pending the achievement of certain milestones. AngioDynamics expects to market a product using irreversible electroporation technology in mid-2008. The FDA approval "is an important step in achieving our goal of becoming the world leader in image-guided focal tumor therapy," said Eamonn Hobbs, president and chief executive of AngioDynamics. AngioDynamics also reiterated its expectation that research and development expenses in 2007 will be 8.3% of sales. Medical-imaging software developer Medicsight ( MGT) was lower despite getting U.S. clearance for a software tool used to detect colorectal polyps. The company's ColonCAR technology will help radiologists locate and measure polyps, which are abnormal growths that can lead to cancer. Once suspected polyps are found, the software can determine shape and features and automatically measure diameter and volume.
"We are really excited about bringing this innovative and leading product to market and the benefits it will mean for radiologists," says Etienne Vanderstokker, the company's CEO. Separately, the company announced the launch of Medicexchange.com, a portal where specialists in radiology can download medical-imaging software and related clinical research. Shares fell 3.5% to $4.20. Drug developer Genzyme ( GENZ) is beginning a mid-stage clinical trial on its blood cancer drug Clolar in older patients with acute myelogenous leukemia. The study, dubbed Classic II, is expected to enroll 109 patients age 60 or older. The study is designed to assess the rates of cancer recovery, the duration of remission, disease-free survival time, overall survival, safety and 30-day mortality rates. "Significant data from investigator-sponsored clinical trials have already been presented regarding the use of Clolar in adult AML and show very encouraging results," said Mark Enyedy, senior vice president and general manager of Genzyme Oncology. "The start of this new clinical study is another important step in our plan to broaden Clolar's label to benefit a larger patient population and address multiple lines of adult AML." The drug was first cleared in December 2004 to treat children with acute lymphoblastic leukemia. Shares of Genzyme were down 1.7% to $64.08. NxStage Medical ( NXTM) appointed former Boston Scientific ( BSX) vice president Robert Brown as chief financial officer, effective immediately.
Brown held a number of leadership positions in Boston Scientific's financial group, including vice president of corporate analysis and control. He also previously worked on financial reporting and special projects at United Technologies ( UTX) and was an accountant and consultant at Deloitte & Touche. Former NxStage CFO David Gill announced his intention to resign last spring, but agreed to stay with the company until his replacement could be found. Shares of NxStage fell 3.1% to $9.01. MannKind ( MNKD) received regulatory clearance in the U.S. to proceed with human trials of an experimental cancer treatment. The Food and Drug Administration's approval is associated with an investigational new drug application for an immunotherapy dubbed MKC1106-PP. Studies of immune response, safety and tolerability of the treatment are set to enroll patients before the end of the year. The clinical study is designed to target two tumor-specific antigens, preferential antigen of melanoma and prostate-specific membrane antigen, on the basis of their level of expression in commonly occurring adult malignancies, such as ovarian, prostate, renal, pancreatic, breast, colon carcinoma and melanoma. Shares dipped 1.2% to $17.23.