Earnings
Artimplant announced 1Q:08 revenues of SEK 2.1 million ($0.35 million), down from SEK 3.9 million ($0.66 million) in 1Q:07. Net loss for the quarter was SEK 6.2 million ($1.04 million), or SEK 10 ($1.68) per share, a deterioration from a net loss of SEK 2.9 million ($0.49 million) in the year-ago period. The company adds that during the quarter, sales of the Artelon Spacer declined to approximately 800 units from 1,300 units in the year-ago period.
BioMimetic Therapeutics, Inc. reported 1Q:08 net income of $31.3 million, or $1.62 per diluted share, compared to a net loss of $5.7 million, or $0.34 per diluted share, in 1Q:07. Earnings beat estimates of $1.41 per share. In January 2008, the company closed the sale of GEM 21S to Luitpold, generating $33.4 million in cash. Other highlights for the quarter include progress toward full enrollment for GEM OS1 clinical trials in the U.S. and EU; the acceptance of the marketing application for GEM 21S by the EU; and confirmation from the FDA that the company's U.S. GEM OS1 pivotal study can continue as designed following concerns over JNJ's Regranex.
DJO (formerly ReAble Therapeutics) reported 1Q:08 net sales of $239.7 million, which represented a 125% increase over 1Q:07. The sales growth was attributed to acquisitions as well as continued growth across business segments. Adjusting for these acquisitions, year-over-year growth was 6%. The company reported a net loss for 1Q:08 of $24.2 million, compared to a net loss of $11.1 million for the year-ago period; losses in both periods were attributed to significant purchase accounting adjustments, non-recurring charges and other adjustments related to the DJO merger and other acquisitions. Highlights for the first quarter included the hiring of key personnel, beginning to implement the lean manufacturing principles associated with the legacy DJO and initiating other cost-cutting operations measures.
RTI Biologics announced 1Q:08 revenues of $29.9 million, beating revenues by $0.2 million and up from $22.0 million in 1Q:07. Net income was $0.65 million, or $0.02 per share, beating estimates by a penny and up from a net income of $0.13 million in 1Q:07. Sports medicine revenues were $9.2 million, an increase of 71% over 1Q:08; spinal revenues were $8.7 million, down 8% over 1Q:07. Revenues from bone graft substitutes were $4.8 million, up from $4.5 million in 1Q:07. General orthopedic revenues were $0.6 million, up from $0.2 million in 1Q:07, an increase that was attributed to the acquisition of Tutogen.
Orthovita, Inc. reported 1Q:08 product sales of $16.2 million, up 23% over 1Q:07 and beating estimates by $0.3 million. VITOSS FOAM platform products contributed approximately 61% of sales, and VITAGEL contributed approximately 26% of sales. The net loss for the quarter increased to $4.2 million, or $0.06 per share, from $2.9 million for 1Q:07. Analysts were expecting a net loss of $0.04 per share. The company attributed the widening loss to an increase in selling and marketing expenses, which were partially offset by increased gross profit. The company also announced FDA clearance for CORTOSS would be delayed by approximately six months while it collects additional followup data.
M&A
ArthroCare Corp. announced the acquisition of OrtoConcept Scandinavia, a distributor of sports medicine and spine devices throughout Denmark, Norway and Sweden. ArthroCare says the acquisition will "boost long term revenue growth potential and get direct representation in markets outside the U.S." Financial terms were not disclosed.
Sandvik Materials Technology has acquired Eurocut Ltd. for an undisclosed sum. Sandvik President Peter Gossas says, "The addition of Eurocut Ltd. broadens our product program, expands our capacity and strengthens our expertise within machining and production of medical instruments and implants." Eurocut's annual sales were reported to be SEK 60 million ($9.95 million), and the Sheffield, U.K. company has 60 employees.
Funding
Tissue Regeneration Systems closed a $2 million round of financing led by Madison, WI-based Venture Investors. The company, which was spun off from the Universities of Wisconsin and Michigan, will use the proceeds to "continue development of bioactive implants for bone and soft-tissue regeneration," with a particular focus on spinal applications. The company's current technologies include a bio-resorbable scaffold and bioactive coatings.
Regulatory
Scient'x received FDA 510(k) clearance to market their new Isobar DUO Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL Rod which received FDA 510(k) clearance in 1998. The Isobar Duo has been cleared to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; degenerative spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion.
Stryker's Biotech division received an FDA warning letter related to quality systems and compliance issues at its Hopkinton, Massachusetts location. The warning letter concerns issues from a past clinical study that were raised during an inspection initiated in September 2007. The company noted in the press release that corrective actions have been taken and further changes will be made as needed as Stryker continues to cooperate with the FDA.
Licensing Agreements
Alphatec Holdings, Inc. has reached a successful settlement and release agreement to license pedicle screw technology from DePuy Spine, Inc. and Biedermann Motech GmbH. Pursuant to the settlement and release agreement among Alphatec and DePuy & Biedermann, Alphatec has obtained a license to intellectual property rights contained in U.S. Patent Number 5,207,678, which is owned by Biedermann and licensed to DePuy. The agreement dismisses the lawsuit between Alphatec and the above-mentioned parties and grants Alphatec the right to continue to manufacture, market and sell its Zodiac and Solanas products. Terms of the agreements include a one-time payment of $11.0 million and an ongoing royalty payable upon future net sales of licensed products.
Product Introduction and Update
LDR launched the verteBRIDGE anchoring technology, which the company describes as zero-profile, self-locking anchoring plates that will be incorporated into LDR’s new stand-alone partial vertebral body replacement devices. The verteBRIDGE is implanted with a minimally-invasive direct anterior approach.
Pioneer Surgical Technology announced the completion of the first human implantation of its next generation cervical total disc replacement, the NuNec Cervical Arthroplasty Device. Drs. Hansen Yuan, Dewei Zou and Wenwen Wu performed the surgeries in Beijing on patients with degenerative disc disease otherwise indicated for fusion. The NuNec features the company's PEEK-on-PEEK technology, which Pioneer says is less susceptible to accelerated aging.
Clinical
ArthroCare Corp. reported five-year outcomes in its TOPAZ MicroDebrider study, finding that patients who had the procedure, which is a minimally-invasive treatment for tendon disorders, were "highly satisfied" and "continue to experience pain relief." The results were announced at the Arthroscopy Association of North America (AANA) Annual Meeting last month.
Operations
Medtronic plans to cut about 3% of its workforce during the current fiscal year as part of a global restructuring plan. The cuts will be company-wide and occur in divisions where growth is decelerating. Additionally, new jobs will be added in faster-growing segments. Medtronic currently has about 39,500 employees worldwide.
