Physiometrix provided a plan of compliance to Nasdaq on April 20 to achieve and maintain compliance with all the listing requirements, but Nasdaq notified the company on May 18 that the plan submitted did not provide “a definitive plan evidencing its ability to achieve near-term compliance or maintain such compliance over an extended period of time.” Nasdaq therefore advised the company that its securities were subject to delisting as of May 27. Physiometrix filed an appeal on May 23, delaying any delisting until the hearing date. The company said it intends to continue activities designed to achieve compliance with the continued listing requirements in time to avoid delisting.
Physiometrix manufactures non-invasive medical products for use in anesthesia monitoring during surgical procedures.
Baxa moves to direct marketing in Canada
Baxa (Englewood, Colorado) reported that it would move to direct marketing and sales in Canada as of June 1. For the past 10 years, Baxa products have been sold through a distributor under the name of Baxa Canada. In that time, product marketing and technical support activities were done through the company’s corporate offices in Colorado.
With its distributor contract expiring, Baxa decided to begin direct sales and marketing operations for all of North America from its U.S. headquarters. It said that most product orders for Canadian customers originate in the company’s manufacturing headquarters.
With the change, customer support and contract management will be handled out of the corporate offices as well. Baxa Canada will maintain a distribution center in Toronto to support shipment of back-up equipment and supplies and manage product returns.
Baxa is a manufacturer of medical devices and systems for preparing, handling, packaging and administering liquid medications. Its products are used in hospitals, critical care units and alternate-site pharmacies.
UTEK, VisiJet in alliance
VisiJet (San Clemente, California) and UTEK (Plant City, Florida), a technology transfer company, reported the signing of a strategic alliance agreement. Randy Bailey, president and CEO of VisiJet, said, “We are enthusiastic about this strategic alliance with UTEK Corporation, which will enable us to identify ophthalmic technologies for acquisition.”
UTEK assists companies in enhancing their new product pipeline with the acquisition of proprietary intellectual capital from universities and laboratory research centers. Strategic alliance agreements are generally cancelable by either party with 30 days’ advance written notice.
VisiJet is focused on the development of ophthalmic applications. The company recently received FDA approval for its EpiLift system, a next-generation, ophthalmic surgical device designed for separating corneal tissue. The EpiLift system is the cornerstone of a new improvement in Lasik surgery called Epi-LASIK. VisiJet said the EpiLift systems improve upon existing technologies with new separating methods that can eliminate many postoperative problems.
The EpiLift system is manufactured in Germany by Gebauer Medizintechnik.
AzheimAlert kit to go before FDA panel
Nymox Pharmaceutical (Maywood, New Jersey) said it has been informed that its premarket approval (PMA) application to the FDA for a kit version of its AlzheimAlert urine test will be go before a panel of the Medical Devices Ad-visory Committee in July.
That step follows the submission to the FDA of further data and analyses by the company. In the PMA, the company is seeking approval to sell kit versions of its Alzheim-Alert test to laboratories and hospitals.
AlzheimAlert is Nymox’s urine test intended to aid in the diagnosis of Alzheimer’s disease. The test measures levels of a brain protein called neural thread protein known to be elevated in the brain tissue, cerebrospinal fluid and urine of patients with Alzheimer’s.
AlzheimAlert is certified as a laboratory testing service in the U.S. through the company’s CLIA-certified reference lab in Maywood. A kit version of AlzheimAlert is CE-marked.
Baylor board approves Texas Heart Hospital
The Baylor Health Care System (Dallas) board of trustees has approved the development of the Texas Heart Hospital of the Southwest, a hospital offering cardiology and vascular procedures, treatment and care in a centralized, accessible location.
The full-service heart center, to be built in Plano, Texas, will be a partnership between Baylor Health Care System and 86 cardiovascular physicians and surgeons who practice in North Texas. It is Baylor Health Care System’s second dedicated heart hospital, and the only dedicated heart hospital in Collin County. Baylor said it would break ground on the new facility on June 7.
Plans call for the construction of a 180,000-square-foot, 68-bed facility with a dedicated cardiac emergency department and heliport. The $106 million venture is scheduled to open in January 2007.
Texas Heart Hospital of the Southwest will be licensed as a general acute-care hospital providing inpatient and outpatient cardiovascular care. The facility will provide cardiovascular outpatient, interventional and surgical services, including non-invasive cardiovascular testing, cardiac catheterization, open-heart surgery, peripheral angiography, cardiac and vascular interventions, electrophysiology testing, arrhythmia management and treatment, vascular surgery and 24-hour emergency care.
bioMerieux launches Innovation in Motion
bioMerieux (Durham, North Carolina), which focuses on the field of in vitro diagnostics, launched its Innovation in Motion tour, a high-tech, bus-board presentation theater and mobile laboratory.
The luxury bus is equipped with the bioMerieux Inte-grated Solution, including BacT/Alert 3D, Vitek 2 Compact and Stellara, both diagnostic and IT equipment. The purpose of the 50-city tour is to bring a demonstration of the latest diagnostic technologies to cutting-edge hospital laboratory technicians, pharmacists and physicians across the country.
The Innovation in Motion Tour’s goal is to demonstrate how laboratory data can be transformed into clinician advisory. The audience will include laboratory professionals, pharmacy and other key administrative roles such as risk management, hospital administrators, clinicians and practitioners.
bioMerieux is the U.S. subsidiary of bioMerieux SA, headquartered in France. bioMerieux is an international diagnostics group that specializes in the field of in vitro diagnostics for clinical and industrial applications. bioMerieux manufactures systems (i.e., reagents, instruments and software) used in clinical and industrial applications.