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Orthopedics News Roundup 9-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 10, 2006
Earnings: Tissue Grafting: Regeneration Technologies, Inc. announced revenues of $18.1 million for 3Q:06, compared to $22.5 million for 3Q:05. RTI said the decrease in revenues was due to fewer tissues available for processing demand and reduced orders from primary distributors. However, the loss has narrowed: the company reported a net loss of $1.5 million and net loss per diluted share of $0.05, compared to net loss of $1.6 million and net loss per diluted share of $0.06 for 3Q:05.
In their third consecutive profitable quarter, Osteotech reported net income of $0.4 million or $0.02 diluted earnings per share for the 3Q:06 compared to a net loss of $6.8 million or $.40 diluted net loss per share for 3Q:05. Gross margins increased to 49% in 3Q:06 from 31% in 3Q:05, which the Company attributes to improved inventory and processing productivity.
BioMimetics announced its 3Q:06 results. The Company reported a net loss of $4.2 million, or $0.27 per share. In 3Q:05, net loss attributable to common stockholders was $1.3 million, or $0.82 per share. Revenues for 3Q:06 reached $0.7 million, which includes $0.4 million of product sales of GEM 21S to Osteohealth Company and $0.2 million of sublicense fee income; 3Q:05 Revenues were $1.3 million.
Biomaterials: aap Implantate AG reported a 48% lift in sales revenues in 3Q:06, to EUR 4.9 million, up from 3Q:05's EUR 3.3 million. However, aap predicts they will finish out 2006 below prior estimates due to unscheduled expenses including new recruitments and projects in Biomaterials, stock option related personnel costs, and interrupting bone cement production to focus on automation.
Orthobiologics: Isotis reported 3Q:06 results of $10.2, a 25% increase over 3Q:05 revenues of $8.1 million. 3Q:06 operating loss reached $3.1 million, compared to $2.3 million in 3Q:05. Net loss for 3Q:06 totaled $1.9 million or $0.03 per diluted share (compared with a net loss of $1.5 million or $0.02 per diluted share 3Q:05.)
Spine: Alphatec Holdings, Inc. announced that revenue in 3Q:06 increased 51% to $17.4 million compared with $11.5 million in 3Q:05, representing an 11% decrease from the $19.4 million reported in 2Q:06. Gross profit for 3Q:06 was $10.8 million with a gross margin of 61.9%, compared with a gross profit of $6.5 million with a gross margin of 56.8% in 3Q:05. The net loss for 3Q:06 was $5.5 million, or $0.16 loss per share, compared to the $5.3 million, or $0.29 loss per share, 3Q:05.
Dental: National Dentex Corporation announced sales and earnings for 3Q:06. Sales for the quarter totaled $34.6 million, compared with $33.3 million in 3Q:05. Net income for the quarter was $925,000 or $.16 per diluted share, decreasing from $1.38 million or $.25 per diluted share in 3Q:05.
Acquisitions: The Blackstone Group has completed its $6.55 per coomon share buyout of Encore Medical Corp. That deal is valued at approximately $887 million. In other Encore news, the Company announced its acquisition of Cefar AB, a Swedish electrotherapy and rehabilitation device company. Financial terms were not disclosed.
Orthovita, Inc. announced that it had entered into a binding letter of intent to purchase the profit-sharing royalty rights for its VITAGEL™ Surgical Hemostat and CELLPAKER® Collection Device products under its license agreement with Angiotech Pharmaceuticals, Inc. Terms of the letter specify that Orthovita will pay $9.0 million in cash to Angiotech, subject to the satisfaction of financing and other closing conditions and the negotiation and execution of a definitive agreement.
Andover Medical, Inc. has entered into a letter of intent to acquire SRS Medical Systems, Inc. SRS Medical is a technology leader in the area of non-invasive devices for incontinence, and the proposed acquisition reflects Andover's plan to cater its business to aging populations.
Operations: IsoTis Inc., the orthobiologics company whose shares are currently listed on SWX Swiss Exchange (ISON), Euronext Amsterdam (ISON) and the Toronto Stock Exchange (ISO), announced its intention to become a U.S. company with a single listing on the NASDAQ Global Market during the first quarter of 2007. IsoTis expects that this will facilitate additional growth and a fair market valuation to its shareholders.
Regulatory: CMS has approved a pass-through payment for St. Francis Technologies, Inc®'s X STOP® Interspinous Process Decompression (IPD®) System for implantion in an outpatient setting. The pass-through code will include device costs for single- and double-level treatments. It is effective on January 1, 2007 and applicable nationally.
Cytori Therapeutics, Inc. was granted 510(k) clearance for the Celution™ Cell Concentration System, a cell saver device. The system is cleared for the collection, concentration, washing and re-infusion of a patient's own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular and urological surgeries and procedures.
Ascent Healthcare has received a 510k to reprocess Zimmer TransFx™ External Fixation devices, which are used to stabilize bone fractures. The Company claims the most extensive list of FDA-cleared reprocessed external fixation devices originally manufactured by industry leaders including Synthes, Smith & Nephew, Stryker Trauma and DePuy Orthopedics (a Johnson & Johnson company).
Clinical: Results from ReGen Biologics' multicenter clinical trial for CMI™, a collagen scaffold technology, show that four years post-surgery, CMI patients with previous meniscus injuries had a three times (3x) lower rate of re-operation on the affected knee than the control group. These new findings also support previously released results showing new tissue growth within the injured meniscus; significant improvements in patients' Tegner activity index scores for CMI; and greater patient satisfaction.
As we reported earlier this week, BioMimetics has announced interim results from its GEM OS1™ bone graft. So far, results show that the GEM OS1 is comparable to autograft without the pain and morbidity associated with harvesting the autograft material.
RTI announced the launch of a pre-shaped achilles tendon sterilized with their BioCleanse® System. The tendon can be used in anterior cruciate ligament (ACL) repair, posterior cruciate ligament (PCL) repair and shoulder reconstruction. The announcement came at the Arthroscopy Association of North America's fall meeting.
Service Agreements: Regeneration Technologies, Inc. and Tutogen have entered into mutual sourcing agreements, effective immediately: RTI will have first right of refusal to all soft tissue used in sports medicine surgeries recovered by Tutogen's recovery partners. Tutogen, in turn, will have first right of refusal to all dermis, fascia and pericardium recovered by RTI Donor Services agencies.
Nexa Orthopedics, Inc. announced a new multi-year distribution agreement with Smith & Nephew Endoscopy whereby Nexa has the exclusive right to distribute certain PolyGraft® products designed for use in forefoot surgery under Nexa's OsteoCure™ biologic products brand. Nexa will market and sell these products exclusively to Doctors of Podiatric Medicine in the United States and orthopedic surgeons specializing in foot and ankle surgery in certain countries outside of the United States.
Miscellaneous: LDR Medical reached a milestone 3,000 artificial discs implanted worldwide. This was largely due to the growing use of the Mobi-C® cervical artificial disc.