A Medical Device Daily
Bayer HealthCare Diagnostics (Tarrytown, New York) said it has been granted licenses under patent rights relating to free prostate specific antigen (PSA) and tacrolimus tests from Abbott Laboratories (Abbott Park, Illinois). Financial details were not disclosed.
Bayer said it intends to develop these two new tests for its Advia Centaur and Advia Centaur CP immunoassay systems immediately.
“By adding free PSA to the oncology portfolio, Bayer HealthCare Diagnostics will have a very comprehensive diagnostic menu for prostate cancer markers,“ said Samir Taneja, MD, director of urologic oncology, NYU Cancer Institute and School of Medicine (New York).
The company said the flexibility will allow physicians to select the tests they feel most appropriate to differentiate malignant and benign prostate disease within the individual patient.
“The addition of fPSA and tacrolimus to our assay offering will enhance the laboratories ability to increase their test offering while optimizing their overall efficiency,“ said Tom Warekois, senior vice president global strategic marketing, Bayer Diagnostics.
“This is another example of [our] commitment to expanding the test offering for immunosuppression drugs. Tacrolimus is complementary to cyclosporine, which is currently also in development and scheduled to release in 2006,“ he said.
The free PSA test is primarily ordered when a patient has a moderately elevated total PSA that does not appear to be caused by a non-cancer-related condition. The results give the doctor additional information about whether a patient is at an increased risk of having prostate cancer and helps with the decision of whether to biopsy the prostate.
The tacrolimus test is designed to determine the amount of immunosuppressant drug in the patient's system. Primarily, the drug tacrolimus is used as an immunosuppressant in liver transplant patients.
InforMedix Holdings (Rockville, Maryland) reported that it closed on the first tranche of a private placement financing of $1,380,000, which is a private investment in a public entity (PIPE) offering that will enable the company to expand its sales and marketing efforts nationally of its Med-eMonitor System, and general working capital purposes.
The offering will continue until an aggregate of $4.8 million of securities are sold or the offering is terminated.
“The Med-eMonitor System, InforMedix' patented solution for improving medication and plan adherence and reducing costs, has consistently achieved medication adherence rates of greater than 90% in a variety of clinical settings, as documented in peer-reviewed medical journals,“ said Dr. Bruce Kehr, chairman and CEO. “Average patient medication adherence rates of 50% cost the U.S healthcare system $100 billion annually in hospital expenses alone, and $300 billion in total annual costs.“
Company officials said each $10,000 investment unit consisted of 1 share of Series A preferred stock, convertible into 62,500 shares of the company's common stock at 16 cents a share, Series A-1 warrants to purchase 31,250 shares of common stock of InforMedix exercisable at 24 cents per share, and Series A-2 warrants to purchase 31,250 shares of common stock of InforMedix at 32 cents a share.
InforMedix said it has developed the Med-eMonitor System as the medication adherence solution for disease management and clinical drug trial markets.
Fresenius Medical Care North America (Lexington, Massachusetts) reported that, in connection with a previously disclosed tender offer and consent solicitation by Florence Acquisition, an indirect subsidiary of Freseni-us Medical Care (Bad Homburg, Germany), for any and all of the $159,685,000 in outstanding principal amount of 9% senior subordinated notes due 2011 of Renal Care Group (Nashville, Tennessee), Florence Acquisition is further extending the tender offer expiration date to 5 p.m., EST, on Feb. 27.
As of Jan. 27, 99.87% of the outstanding aggregate principal amount of the notes had been tendered.
Renal Care shareholders approved in August the agreement under which Fresenius will acquire that company for $48 per share of Renal Care Group common stock.
Renal Care serves some 31,900 patients at more than 450 outpatient dialysis facilities, and provides acute dialysis services at more than 210 hospitals. In all, it provides services in 34 states.
Fresenius has a network of about 1,670 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, providing treatment to some 130,400 patients. It also is the leading global provider of dialysis products, including hemodialysis machines, dialyzers and related disposable products.