The FDA is co-sponsoring a public workshop, "Coronary Drug-Eluting Stent (DES) Guidance Document Workshop," with the Advanced Medical Technology Association (AdvaMed; Washington) on Tuesday.
The purpose of the workshop is to discuss the draft guidance titled "Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies" announced in the March 27 issue of the Federal Register and its companion document, "Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies."
The workshop is intended to solicit additional comments on the issues and questions presented in the draft guidance during the open comment period.
The workshop will be held from 8 a.m. to 6 p.m. Security screening will begin at 7 a.m., and registration will begin at 7:30 a.m.
The conference will be held at the FDA's White Oak Campus, Building 2, located at 10903 New Hampshire Ave., Silver Spring, MD.
For more information, contact Ashley Boam, Center for Devices and Radiological Health, 9200 Corporate Blvd. (HFZ-400), Rockville, MD 20850, call 240-276-3983 or e-mail email@example.com.----
CardioDynamics gets Nasdaq deficiency letter
CardioDynamics International (San Diego), a maker of impedance cardiography (ICG) technology, said that it received a Nasdaq staff deficiency letter from the listing qualifications department indicating that the company's common stock continues not to meet the $1 minimum bid requirement set forth in Marketplace Rule 4310(c)(4).
The latest Nasdaq letter follows the previously reported receipt of a letter from Nasdaq, on April 18, 2007, noting non-compliance with the minimum bid price requirement set forth in Marketplace Rule 4450(a)(5) and transfer of the company's common stock from the Nasdaq Global Market on Oct. 25, 2007. Upon transfer to the Nasdaq Capital Market, the company was provided a second 180 calendar days, until April 15, 2008, to regain compliance with the $1 minimum bid requirement while listed on the Nasdaq Capital Market.
CardioDynamics CEO Michael Perry said, "We look forward to completing the reverse split process and maintaining our Nasdaq listing. We are in the midst of a positive turnaround in the business with five consecutive quarters of revenue growth and most recently achieved 22% growth in our first quarter 2008. We believe that the capital structure, post-reverse split, will be more attractive to potential investors considering the revenue growth we are experiencing, international sales momentum, new partnership development and intense focus on achieving positive operating cash flow by the fourth quarter 2008."----
Report: CHF drug treatments to increase
The market for congestive heart failure (CHF) drug treatments was estimated at $18 billion in 2007, and is expected to reach $30 billion by 2017, according to a new report by Kalorama Information (New York). The report is titled, "Congestive Heart Failure: Major World Markets, Volume I: Pharmaceutical Management."
Growth is being driven by three factors: an increased incidence of CHF, the application of innovative technologies in search of targeted therapies which is creating opportunity for new entrants into this market, and physicians prescribing multi-drug regimens in response to the failure of traditional drugs to treat CHF.
"The future of CHF drug treatments lies in newer technologies such as biotechnology and genomics," said Kenneth Krul, the report's author. "The identification of fetal genes associated with CHF, new treatments that address the endothelium and cell therapy to regenerate damaged heart muscle tissue present some promising areas."----
SCA gains medical association interest
In an effort to boost public awareness of sudden cardiac arrest (SCA), the National Medical Association (NMA; Washington) convened medical professionals, government officials and patient advocacy organizations in Washington.
At the SCA Leadership Conference, held on April 15, health leaders addressed SCA risk factors, prevention measures, health disparities associated with the disease, and diagnosis and treatment options.
"More than 300,000 lives are lost every year due to the rising epidemic of sudden cardiac arrest. This public health crisis kills more people than lung cancer, breast cancer and HIV/AIDS combined," said Dr. Nelson Adams III, president of NMA. "Particularly alarming is that SCA disproportionately affects African-Americans and women, the majority of whom die before ever reaching emergency care and that adequate data is not available for Hispanics."