BELGRADE, Mont., Sept. 8/PRNewswire/ -- Bacterin International Holdings, Inc. (OTC Bulletin Board: BIHI) (“Bacterin”), a developer of anti-infective coatings for medical applications and processor of revolutionary tissue graft material, announced today its launch of a new product line, hMatrix, a dermal scaffold used in wound repair. The hMatrix dermal scaffold is an extension of Bacterin’s core biologics technology and the Company’s third human acellular biological scaffold. The Company is planning commercial release of hMatrix during first quarter of 2011.
Bacterin’s core technology designs and processes human acellular biological scaffolds that can incorporate the patients’ own stem cells or bioactive agents for accelerated regeneration of tissue. To date the Company has focused on bone, subchondral bone repair, and now has extended its technology to address dermal healing and repair. Bacterin’s hMatrix is an acellular matrix made from donated human dermal tissue that is used to replace a patient’s damaged tissue. hMatrix provides a natural collagen tissue scaffold that promotes cellular ingrowth, tissue vascularization and regeneration. The hMatrix scaffold tissue reabsorbs into the patient’s dermal tissue for a biocompatible, natural repair.
The Company initially intends to focus the new dermal product line on three indications: diabetic ulcers/wound repair, hernia repair and breast reconstruction an estimated market of approximately $2.5 billion, annually but plans to broaden its focus into other non-homologous uses such as rotator cuff and tendon augmentation as it receives FDA approval for these additional indications. Approximately half of the dermal repair market today utilizes allografts, which is used in primary repair for larger, more complicated defects. Given the high barriers to entry of the market, suppliers of dermal allografts are relatively few. Bacterin’s new entrance in the dermal allograft market provides a highly biocompatible scaffold that can support a patient’s own stem cells or bioactive agents.
“As an organization focused on responding to customer needs, our new dermal graft is addressing a supplemental product request by a number of surgeons currently using our Osteo product line. The extension of our proprietary core technology to dermal scaffolds is a natural progression of our existing capabilities, and a convenient leveraging of our operations and sales network,” commented Guy Cook, Bacterin’s president and CEO. “Our skilled technicians already facilitate the preservation of donor tissue in our five Class 100 Clean Rooms, processing bone and subchondral bone grafts. With the addition of several technicians, we are able to add the processing of a dermal scaffold within our current manufacturing protocol. We plan to source the new dermal scaffold product line from the same donors used to generate Bacterin’s bone and subchondral bone scaffold product lines, creating further processing synergies. In addition, the dermal scaffold will be marketed and distributed through our current sales force and independent distribution partners.”
About Bacterin International Holdings, Inc.
Bacterin International Holdings, Inc. (“Bacterin”) develops, manufactures and markets biologics products to domestic and international markets. Bacterin’s proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold and promote bone and other tissue growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain with a facet joint stabilization, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral bone defect repair in articulating joint surgeries.
Bacterin’s Medical Device division develops anti-microbial coatings based upon proprietary coating technologies. Bacterin develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin’s strategic coating initiatives include antimicrobial coatings designed to inhibit biofilm formation and microbial contamination on medical devices drug delivery, local (as opposed to systemic) pain management, and anti-thrombotic factors for medical device applications.
Headquartered in Belgrade, Montana, Bacterin operates a 32,000 square foot, state-of-the-art, fully compliant and FDA registered facility, equipped with four “Class 100" clean rooms. For further information please visit www.bacterin.com.
This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. These forward-looking statements are based on current expectations or beliefs and include, but are not limited to, statements about the Company’s earnings release and its expectations based on the results of second quarter of 2010, including reductions in expenses and increases in revenues due to among other things, the anticipated growth of its sales force. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s ability to meet its obligations under existing and anticipated contractual obligations; the Company’s ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability and willingness of third-party manufacturers to timely and cost-effectively fulfill orders from the Company; the ability of the Company’s customers to pay and the timeliness of such payments, particularly during recessionary periods; the Company’s ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company’s ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.
SOURCE Bacterin International Holdings, Inc.
