Key Developments For BioMimetic Therapeutics, Inc.
BioMimetic Therapeutics, Inc. (BMTI.O) (Consolidated Issue listed on NASDAQ Global Market)
BioMimetic Therapeutics, Inc. Reaffirms FY 2009 Earnings Outlook
BioMimetic Therapeutics, Inc. announced that for fiscal 2009 it expects loss before income taxes to be in the range of $31.0 to $38.0 million. According to Reuters Estimates, analysts on an average are expecting the Company to report operating loss of $35.6 million for the same period.
BioMimetic Therapeutics, Inc. Receives First Orthopedic Marketing Approval For Augment Bone Graft
BioMimetic Therapeutics, Inc. announced that it has received approval from Health Canada to begin the marketing of its lead orthopedic product, Augment Bone Graft, as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications in Canada.
BioMimetic Therapeutics, Inc. Announces Positive Data From Augment Bone Graft North American Pivotal Trial
BioMimetic Therapeutics, Inc. announced positive top-line results from its North American pivotal (Phase III) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft (Augment), to autograft for use in hindfoot and ankle fusion surgery. The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient's body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation. For the primary endpoint, the percent of subjects achieving fusion as defined by 50% or greater bone bridging on CT scans at 24 weeks, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%), which met non-inferiority (p=0.037; n=397 patients). Since many patients had multiple joints treated, analysis was also performed on a per joint basis. Non-inferiority was also established on a per joint basis, with 66.5% of joints treated with Augment fused on CT scans compared to 62.6% of joints treated with autograft (p=<0.001; n=597 joints). In the key clinical
BioMimetic Therapeutics, Inc. Reaffirms FY 2009 Earnings Outlook
BioMimetic Therapeutics, Inc. announced that for fiscal 2009 it expects loss before income taxes to be in the range of $31.0 to $38.0 million.
BioMimetic Therapeutics, Inc. Announces Completion of Rights Offering and Sale of Shares in Standby Purchase
BioMimetic Therapeutics, Inc. announced that it has closed its previously announced rights offering. The Company received valid subscriptions for all of shares purchasable in the rights offering, including shares subscribed for by certain of the Company`s stockholders in the exercise of their over-subscription rights, at a subscription price of $8.50 per share. The Company issued the shares purchased in the rights offering to the purchasers on June 25, 2009. After the closing of the rights offering, the Company sold 343,406 shares of its common stock to Novo A/S, a stockholder of the Company, in a private placement. The purchase price of such shares was $8.50 per share, the same purchase price of the shares sold in the rights offering. The Company received total gross proceeds of approximately $17.0 million from the rights offering and the transaction with Novo A/S. The Company intends to use the proceeds, after payment of fees and expenses incurred in connection therewith, for general corporate purposes, including to fund additional product development and potential commercialization activities. Subscription rights that were not exercised by June 22, 2009 have expired.
