, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three and twelve months ended December 31, 2011. For the three months ended December 31, 2011, the Company reported a net loss of $9.9 million, or $0.35 per diluted share, compared to a net loss of $10.0 million, or $0.36 per diluted share, for the same period in 2010. For the twelve months ended December 31, 2011, the Company reported a net loss of $33.2 million, or $1.19 per diluted share, compared to a net loss of $33.9 million, or $1.38 per diluted share, for the same period in 2010. The Company ended the year with $61.5 million of cash and cash equivalents and investments.
Recent and 2011 Product and Corporate Development Highlights
The Company made the following advancements in its product development programs and other critical business areas:
Augment® Bone Graft
- Since receiving a positive recommendation from the Food and Drug Administration’s (FDA) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee in May, the Company has been working with the FDA to obtain clarity regarding the regulatory approval pathway for Augment® Bone Graft. In January 2012, the Company announced the receipt of a comprehensive post-panel response letter from the FDA related to the PMA application for Augment Bone Graft. The letter listed the information the Company needs to submit for the PMA application to be approvable and outlined a pathway that could potentially lead to approval without additional clinical trials to support the safety and effectiveness of Augment Bone Graft.
- In January 2012, the Company met with the FDA review team regarding its PMA application for Augment Bone Graft. Following the meeting, the Company reiterated its previous guidance to submit an amendment to the PMA by the middle of 2012, which will include all of the requested additional information. If the submission is timely and satisfactorily addresses the FDA’s issues, product approval could occur between April 2013 and January 2014, which is consistent with the Company’s previous guidance of 15 to 24 months from January 2012. Although the Company is confident it can compile and submit the additional information requested by the FDA, there can be no assurance the FDA will be satisfied with the response. Additionally, if the new information submitted raises new concerns, a new clinical trial may be required.
“We continue to believe in the safety and effectiveness of Augment and remain optimistic about obtaining FDA approval of the product candidate,” said Dr.
, president and CEO of
. “The Company is diligently working through the action items listed in the post-panel letter, and we expect to have the PMA amendment submitted by the middle of 2012.”
Other Product Development Updates
- In February 2012, the Company began marketing a new bone graft substitute product line, Augmatrix™ BioComposite Bone Graft, in anticipation of its expected commercial launch in the second quarter of 2012. This product line is comprised of carbonate-apatite and bovine Type I collagen and is designed to be combined with bone marrow aspirate (BMA). The products are available in multiple forms to suit an array of bone grafting challenges, including fracture repair and general bone void filling procedures, for which Augment will not initially be indicated. The product line has been FDA cleared for use in orthopedic indications and will be sold by a portion of BioMimetic’s current distribution and sales network. Total U.S. sales of bone graft substitutes are estimated to reach $1.7 billion in 2012, according to Millennium Research.
- In February 2012, the Company announced results of its 30 patient Canadian Augment® Rotator Cuff Graft clinical trial. The goal of the randomized, controlled study was to assess the safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness rotator cuff tears as compared to standard surgical repair. The product achieved its safety endpoint, which was evaluated by a comparison of adverse events between the two treatment groups, and no device-related serious adverse events (SAEs) were reported. Although not designed as an efficacy study, the results also indicated improvement in the clinical outcome assessments on DASH (Disabilities of Arm, Shoulder and Hand) and WORC (Western Ontario Rotator Cuff) index scores. Additionally, Augment Rotator Cuff was found to be user-friendly for the surgeons and required no additional operating room or anesthesia time over the current standard of care.
- In the fourth quarter of 2011, the Company’s medical device application for Augment Bone Graft was cleared by the Australian Therapeutics Goods Administration (TGA) in Australia and was listed on the New Zealand Web-Assisted Notification of Devices (WAND), clearing the way for commercialization in these two countries. Augment will be sold through our exclusive medical device distributor throughout Australia and New Zealand. The Company anticipates Augment’s reimbursement level to be established in Australia during the second half of 2012 or early 2013, enabling a full launch at that time.
- In January 2012, the Company announced receipt of the CE Mark for GEM 21S ® in the European Union (EU). The Company believes this CE Mark, obtained on behalf of Luitpold, triggers a $10.0 million final milestone payment due to the Company from Luitpold based on the terms of the sale of GEM 21S to Luitpold in 2008. At the request of Luitpold, the EU regulatory authorities are re-evaluating the CE Mark. Given this re-evaluation, the EU regulatory authorities have suspended the GEM 21S CE Mark until the re-evaluation process is finalized. Luitpold has therefore notified the Company that it is evaluating whether the milestone conditions have been satisfied, and the Company is considering its options in the event Luitpold does not make the payment.
- Last year, the Company submitted a device application for the approval of Augment Bone Graft in the EU. The Company is seeking approval for Augment in the EU as a medical device under the CE Mark procedure. As a result of Luitpold’s request for a re-evaluation of the CE Mark for GEM 21S, the EU regulatory authorities have postponed their review of the Augment CE Mark application until their re-evaluation of the CE Mark for GEM 21S is completed. As a result, approval of the Augment CE Mark will be delayed. The Company is not able to provide updated guidance on the timing for potential approval of the Augment CE Mark until the GEM 21S re-evaluation is complete.
- In April 2011, the Company initiated patient enrollment in a North American pivotal trial evaluating Augment® Injectable Bone Graft in a hindfoot fusion indication. To date, the trial has been initiated at more than 20 hospitals, and 105 patients have been enrolled. After receipt of the Augment Bone Graft post-panel response letter in January, and based on the Company’s desire to focus its attention on addressing the FDA’s issues related to the Augment PMA and to conserve resources until there is further clarity from the FDA regarding Augment, the Company has voluntarily suspended additional screening and enrollment of patients in the Augment Injectable study. Once the Company has more clarity from the FDA regarding the study design and the regulatory prospects for Augment, it will make a final determination on whether to restart enrollment. It is important to note that the Company’s decision to temporarily suspend enrollment was in no way based on any safety concerns with Augment or Augment Injectable.
- Due to the Company’s immediate focus on the Augment PMA amendment, it expects to file the Device License Application (DLA) for approval of Augment Injectable in Canada and release top-line data from its 75 patient Canadian registration study around the middle of 2012, perhaps in conjunction with the American Orthopedic Foot and Ankle Society’s (AOFAS) summer meeting. The Augment Injectable study is a randomized, controlled study designed to demonstrate non-inferiority of the product to autograft in foot and ankle fusion surgeries.
- In early 2012, the U.S. Patent and Trademark Office allowed U.S. patent 8,106,008 titled “Compositions and Methods for Arthrodetic Procedures” and U.S. patent 8,114,841 titled “Maxillofacial Bone Augmentation Using rhPDGF-BB and a Biocompatible Matrix.” The former patent covers the use of Augment and Augment Injectable in foot and ankle fusion procedures and will remain in force until November 2027. The second patent covers methods of enhancing bone augmentation in a patient by applying PDGF compositions combined with matrix materials having defined characteristics, including Augment Injectable and will remain in force until August 2028.
“The submission of the PMA amendment for Augment remains our highest priority,” continued Dr. Lynch. “Additionally, we are preparing for entry into the large U.S. bone graft market with the launch of Augment outside the U.S. as well as the launch of Augmatrix in the U.S., and we continue to work towards additional marketing approvals for these products worldwide.”