Musculoskeletal News Roundup 16-Aug-07
BY LAUREN UZDIENSKI, AUGUST 16, 2007
Earnings
BioMimetic Therapeutics reported a 2Q:07 net loss of $6.4 million, or $(0.35) per share, beating estimates of $(0.39) per share and improving from a net loss of $3.9 million, or $(0.42) per share, in 2Q:06. 2Q:07 Revenues were $0.5 million, in line with estimates and down from $1.1 million in 2Q:06. The decrease in revenues was attributed to seasonal variation in orders of GEM 21S from Osteohealth, BMTI's marketing partner.
Cytori Therapeutics reported product revenues of $0.51 million, up from $0.45 million in the comparable quarter. Net loss for 2Q:07 was $4.0 million, or $(0.17) per common share, improving from a net loss of $7.3 million, or $(0.47) for the comparable quarter.
Osiris Therapeutics reported $3.3 million in sales of Osteocel, up from $1.7 million in 2Q:06. Other revenues in both 2Q:07 and 2Q:06 were $0.3 million. Net loss for 2Q:07 was $10.5 million, improving from $11.6 million in 2Q:06. The loss was attributed to advancing the company's clinical trials.
Tutogen reported total FQ3:07 revenues of $14.2 million, beating estimates of $13.35 million and up 42% over the comparable quarter. Net income for FQ3:07 was $5.9 million, or $0.30 per fully diluted share, beating estimate of $0.04 per share and up from a loss of $1.1 million, or $(0.07) per fully diluted share, in FQ3:06. U.S. revenues for FQ3:07 increased by 55%, to $10.1 million, which the company attributed to demand for TUTOPLAST® bone products for dental applications sold by Zimmer Dental and Tutogen's machined graft spinal products and new hernia repair and breast reconstruction products.
LCBM LifeCore Biomedical reported FQ4:07 net sales of $19.2 million, missing estimates of $19.36 million and increasing 9% over net sales of $17.7 million in the FQ4:06. Dental revenues increased 6% to a record $12.9 million, with sales led by the Prima™ Implant System. The company reported net income of $2.88 million, or $0.21 per diluted share in FQ4:07, beating estimates by a penny. Income increased from from net income of $2.41 million, or $0.18 per diluted share, in FQ4:07.
Reimbursement
CMS released its final decision on lumbar artificial disc replacement (LADR) procedures this week, with CMS ruling that LADR is not reasonable and necessary for the Medicare population over 60. For the Medicare population under 60, coverage determinations will be made on a local basis. Private insurers may still cover the disc; Cigna, Aetna, Kaiser Permanente and Horizon Blue Cross Blue Shield are among the insurers who cover Depuy's Charite.
M&A
ReAble Therapeutics' planned acquisition of DJO passed a regulatory hurdle this week: DJO announced that the FTC granted early termination of a waiting period under antitrust regulations. The acquisition is still subject to satisfaction of several other conditions, including approval of the transaction by DJO's stockholders and the expiration or termination of the waiting period under an additional antitrust law.
Orchid Orthopedics announced the acquisition of Micro Precision Swiss, Anzon Company and Keller Engineering, all precision machining companies for orthopedic and other medical markets. Terms were not released.
Funding
KFx Medical closed a Series B financing. Investors in the $10 million Series B round included lead investor Alloy Ventures and returning investors Charter Life Sciences L.P, Arboretum Ventures, Montreux Equity Partners and MB Venture Partners.
Product Introductions
Innovative Spinal Technologies, Inc. announced the U.S. commercial launch of the Paramount™ VBR System for minimally invasive spine surgery. The system offers novel delivery instrumentation designed for precise implant placement.
Product Update
Smith & Nephew is recalling 185 of its Birmingham Hip Resurfacing System implants due to a packaging mistake. The company said the implants were packaged by a subcontractor and that different sizes of acetabular cup were mixed together. The packages were sent to a number of countries, including the U.K. and the U.S.
License Agreements
Cytori Therapeutics and Green Hospital Supply, Inc. have partnered to commercialize Cytori's StemSource™ cell bank, which includes Cytori's Celution™ System, to hospitals throughout Japan. The partnership marks the first commercial introduction of the Celution™ System. Under the agreement, Green Hospital Supply will be the exclusive Japanese provider of both the StemSource banking platform and the Celution System for stem and regenerative cell banking. Cytori retains exclusive rights for both products in other countries. Revenues from all related product sales will be shared equally between Cytori and Green Hospital Supply.
Altiva Corporation, a North Carolina-based manufacturer of spinal implants, announced the signing of an exclusive licensing agreement with NAS Medical Technologies, Inc. to distribute the Procyon® Pedicle Screw System. The Procyon System is a screw and rod system that offers a quarter-turn locking mechanism designed to reduce the risk of cross threading.
Clinical
Depuy Spine announced results from a 3-D finite element study showing that the mobile-core design of the CHARITE® Artificial Disc reduces facet loading by more than 50% when placed at or near the center of the disc space, while a fixed-core artificial disc increases facet loading when compared with an intact disc in axial rotation even when placed in an ideal position. The study will be published in the August 1 edition of Spine.
