Clinilabs (New York), a specialty contract research organization (CRO), has completed expansion of its Phase I unit. This expansion brings the company's Phase I facility to 68 beds, which includes two new large observation rooms that can accommodate up to four beds each, or up to 12 PK seats.
The company conducts Phase I studies in any therapeutic area, including pharmacokinetic (PK), pharmacodynamic (PD), bioavailability (BA), bioequivalence (BE), drug interaction, and food interaction studies. Additionally, Clinilabs offers specialty services for complex PD studies, such as those that involve the collection of mood, cognition, psychomotor functioning, EEG, quantitative EEG, evoked potential (EP), and imaging data.
"Phase I studies are becoming increasingly complex and sponsors depend on data from these studies to make crucial decisions about their development programs," said Gary Zammit, president/CEO of Clinilabs. "Clinilabs' state-of-the-art facility is an ideal location for pharmaceutical and biotechnology companies looking for outstanding service for their Phase I studies," he added.
ACOG: UAE is a hysterectomy alternative
BioSphere Medical (Rockland, Massachusetts) said that in its August Practice Bulletin, the American College of Obstetricians and Gynecologists (ACOG; Washington) recommended uterine artery embolization (UAE) as an alternative to hysterectomy in the management of leiomyomas (fibroids).
The bulletin cites the availability of Level A research, which is based on "good and consistent scientific evidence" that shows that UAE "is a safe and effective option for appropriately selected women who wish to retain their uteri." The recommendation is also based on both long- and short-term treatment outcomes.
BioSphere has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy.
Hernia device gets new reimbursement codes
Minnesota Medical Development (Minneapolis) said that the Centers for Medicare & Medicaid Services (CMS) has agreed to create seven new ICD-9-CM reimbursement procedure codes for its new Rebound HRD (Hernia Repair Device). The new coding will become effective Oct. 1.
The Rebound HRD was recently FDA 510(k)-cleared and is intended to assist in the repair and/or reinforcement of hernia or other soft-tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.
The new coding options will delineate from the existing codes to identify the Rebound HRD as an inguinal hernia repair device which can be used specifically for laparoscopic hernia repair. Previously, CMS coding did not recognize the surgical differences between "open incisional" and "laparoscopic" types of hernia repair.
The Rebound HRD is a self-expanding nitinol-framed/surgical mesh medical device designed for the laparoscopic repair of both inguinal and ventral hernias. The super-elastic nitinol frame allows the device to be folded and inserted laparoscopically. Once deployed, the device fully unfurls or "rebounds" back to its original shape – ready for quick and easy placement over the hernia defect.
Encorium Group not in Nasdaq compliance
Encorium Group (Wayne, Pennsylvania) said that it received a letter from Nasdaq Listing Qualifications stating that as a result of the resignation of Paul Schmidt from Encorium's board, effective as of June 16, Encorium was not currently in compliance with Nasdaq's independent director requirements as set forth in Marketplace Rule 4350.
The company said it expects its board to change following the completion of its previously announced non-binding letter of intent to combine with Fine Success Investments, a British Virgin Islands company doing business as Linkcon.
In the interim, Kenneth Borow, MD, Encorium Group's president/chief medical and strategic development officer, stepped down from the board in order for Encorium to remain compliant with Nasdaq's independent director requirement.
Encorium Group is a global clinical research organization specializing in clinical trials and patient registries for the pharmaceutical, biotechnology and medical device industries.
Exact not in Nasdaq securities compliance
Exact Sciences (Marlborough, Massachusetts) said it has received a letter from the listing qualifications staff of the Nasdaq stock market indicating that the company has not regained compliance with the $50 million market value of listed securities requirement set forth in Nasdaq Marketplace Rule 4450(b)(1)(A).
The staff has indicated that the company's common stock is subject to delisting from Nasdaq and trading in the company's shares would be suspended at the opening of business on August 21, 2008 unless the company requests a hearing before a Nasdaq listing qualifications panel.
Exact Sciences uses applied genomics to develop screening technologies for use in the detection of cancer.