Healthcare Industry News: bone graft
News Release - May 5, 2006
Millenium Biologix provides update on ACTES(TM) Regulatory Strategy, withdraws Peptos(TM) IDE Submission, and announces senior management changeKINGSTON, ON, May 5 (Healthcare Sales & Marketing Network) - Millenium Biologix Corporation (TSX: MBC ; "Millenium" or the "Company") today provided an update on the regulatory strategy for its Autologous Clinical Tissue Engineering Systems (ACTES(TM)), and announced the formal withdrawal of its request to the U.S. Food and Drug Administration ("FDA") for an Investigational Device Exemption ("IDE") for its Peptos(TM) bone graft product.
The Company also announced the resignation, for personal reasons, of Ian W. Malone, Chief Financial Officer, effective June 23, 2006. A search for a replacement has commenced. "We thank Ian for his financial expertise and the insight that he brought to Millenium and wish him well in his future endeavours," said Brian Fielding, Millenium's interim Chief Executive Officer.
"The decision to withdraw the IDE submission for Peptos is consistent with our previously announced partnering strategy for our orthobiologics portfolio, as we consider clinical trial activity is best undertaken in concert with future commercial partners," added Mr. Fielding. "We believe that the Bone and Cartilage Stimulating Peptides (BCSP(TM)) program, which includes our Peptos bone graft product, has tremendous value and represents an exciting program with significant upside potential to attract world class partners, however, we have limited resources that we must focus on our lead ACTES program."
Following an extensive review of Millenium's regulatory strategy with respect to its ACTES program, the Company believes that a multi-phase regulatory approach will ensure the earliest introduction of the system into the marketplace.
The Company will pursue early approval of ACTES as a lab instrument for clinical use by centres currently providing cell therapy procedures for the treatment of cartilage damage. The Company expects to obtain this approval in the fourth quarter of calendar 2006. Clinical trials in support of expanded therapeutic labeling for cartilage repair indications (ACTES-C) will follow the initial equipment approval to broaden the commercial opportunities for the technology. Millenium expects ACTES-C to provide the first cartilage tissue engineering solution for the treatment of cartilage lesions.
Millenium also continues to progress its ACTES-B (Bone) technology, which the Company believes will offer an alternative to current autograft procedures, thus avoiding the second painful and invasive surgery associated with harvesting the graft from the patient.
Update on Financial Status
The Company's cash position at March 31 2006, the fiscal year end, was $4.6 million, compared with the $5.2 million reported for the end of February 2006. The Company is working towards ensuring that it has adequate financial resources to deliver on its technology development program. As previously indicated, the Company's ability to continue with this program is highly dependent on successfully securing the necessary financial resources. Millenium will keep shareholders fully informed of developments as appropriate.
ACTES is Millenium's proprietary closed bioreactor system for cell culture and tissue engineering, delivered through a modular clinical based workstation that provides automated end-to-end control over the full biological process from biopsy to tissue creation. Millenium believes that ACTES has the potential to be the first fully automated process that allows human cells to be cultivated outside a cGMP laboratory.
About Millenium Biologix Corporation
Millenium Biologix Corporation is focused on the development and commercialization of next generation cell culture and tissue engineering systems that will drive change from synthetic implants to more effective biologics-based solutions. For more information about Millenium, please visit www.millenium-biologix.com.
Note: Certain information contained in this press release is forward-looking and is subject to unknown risks or uncertainties. The actual results, performance or achievements of Millenium Biologix Corporation may differ materially from the results, performance or achievements of the Corporation expressed or implied by such forward-looking statements.
Source: Millenium Biologix
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.