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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 1-May-08 BY LAUREN UZDIENSKI, MAY 1, 2008

Anika Therapeutics reported 1Q:08 total revenues of $8.55 million, an increase of 46% over the year-ago period, which the company attributed to strong domestic and international sales of ORTHOVISC. Revenues beat analysts' expectations by $0.2 million. Net income for the quarter was $0.62 million, or $0.05 per diluted share, missing estimates by $0.04 and down from $1.2 million, or $0.11 per diluted share, in 1Q:07. The decrease in net income was attributed to higher operating expenses, lower net interest income, a shift to U.S. Treasury securities and fewer dollars invested due to a facility project. During the quarter, the company began enrolling patients in U.S. pivotal trial for MONOVISC, which is expected to be launched in Europe mid-year.

CryoLife reported 1Q:08 revenues of $25.6 million, up 4% over 1Q:07 and missing estimates by $0.3 million. Net income for 1Q:08 was $2.8 million, or $0.10 per basic and fully diluted common share, beating estimates by $0.02 and up from a net income of $1.4 million, or $0.04 per basic and fully diluted common share, in 1Q:07. Orthopedic tissue processing revenues decreased 82% to $0.33 million, as the company discontinued procuring and processing orthopedic tissue in 1Q:07. BioGlue revenues were up 6% to $11.9 million.

Exactech reported 1Q:08 revenue of $39.8 million, up 34% over the year-ago period and beating estimates by $0.3 million. Net income for the quarter was $2.8 million, or $0.23 per diluted share, up 49% over 1Q:07 and beating estimates by $0.02. Among segments, knee increased 18% to $18.5 million; hip increased 16% to $6.4 million; biologics increased 34% to $4.7 million; shoulder increased 132% to $3.7 million; and spine sales from Altiva contributed $2.0 million.

Hanger Orthopedic Group reported 1Q:08 net sales of $157.7 million, up 10% over 1Q:07 and beating estimates by $3.7 million. Sales growth was attributed to an increase in same-center sales in the company's patient care business, an increase in outside sales in the distribution business and acquisitions. Net income for the quarter was $3.6 million, or $0.12 per diluted share, up 100% over 1Q:07 and beating estimates by $0.02.

Kensey Nash reported FQ3:08 revenues of $20.6 million, up 9% over the year-ago period and missing estimates by $3.0 million. Net sales of biomaterials products increased 8% to $12.6 million for the quarter, driven by orthopedic and cardiovascular sales. Orthopedic sales increased 8% to $7.7 million. The company reported earnings per share of $0.28, missing estimates by $0.04 and representing a 47% increase over FQ3:07.

MAKO Surgical reported 1Q:08 revenue of $0.5 million, beating estimates of $0.3 million and up from $0.1 million in 1Q:07. Revenue was attributed primarily to MAKOplasty procedures. Deferred revenue increased to $4.6 million during the quarter as a result of the sale and customer acceptance of two TGS units. Net loss for 1Q:08 was $9.1 million, or $0.95 per basic and diluted share, missing estimates of a loss of $0.60 per share. 102 MAKOplasty procedures were performed in 1Q:08, and a total 283 MAKOplasty procedures have been performed since June 2006.

Ossur reported 1Q:08 revenues of $89.75 million, up 12% over the year-ago period. The company reported net profit of $6.7 million, or $2.98 per share, improved from a net loss of $2.7 million in the year-ago period. President and CEO Jon Sigurdsson commented on the quarter, "Traditional Europe and Asia are showing excellent growth both in prosthetics and bracing and supports. Prosthetics sales continue to exceed market growth, confirming Ossur's strength in this market segment. Sales of bracing and support products in the US are still challenging. However, the company's management is confident that a turnaround is on the horizon."

Orthofix International N.V. reported 1Q:08 total revenue of $128.0 million, beating estimates by $5.3 million and representing an increase of 9% over the year-ago period. Adjusted net income was $0.21 per diluted share; analysts expected income of $0.10 per share. The company's spine division grew 11% over 1Q:07 to $62.5 million, with implant and biologic revenue contributing $29.0 million. This growth was attributed to biologics sales. Orthopedic revenue grew 8% to $29.8 million, with growth driven by sales of Physio-Stim bone growth stimulation devices, deformity correction devices and biologics.

Osteotech, Inc. reported 1Q:08 revenue of $27.6 million, beating estimates by $0.3 million and representing a 10% increase over 1Q:07. Net income was $0.8 million, or $0.05 per share, beating estimates by $0.03 and improved from a net loss of $0.6 million, or $0.04 per diluted share, for 1Q:07. DBM revenues were $16.97 million, up 10% from the year-ago period.

Smith & Nephew reported 1Q:08 revenue of $911.0 million, missing estimates by $13.0 million and representing a 22% increase (2% constant currency, 5% excluding Plus products) over 1Q:07. Adjusted earnings per share increased 14% to $0.13, in line with estimates. The company said that the quarter's performance was negatively impacted by "certain sales practices" that were uncovered during the integration of Plus Orthopedics and that an internal investigation into these practices is ongoing. SNN says this has impacted sales predominantly in Greece and "will continue to impact performance over the course of the year." Recon grew by 2% (constant currency: 8%, excluding all Plus products), with knee at 1% (7% excluding Plus products) and hip at 4% (9% excluding Plus products); fixation grew by 2% (6% excluding Plus products); and endoscopy grew by 4%.

TranS1 reported 1Q:08 revenues of $6.0 million, beating estimates by $0.7 million and representing a 92% increase over 1Q:07. Net loss was $2.4 million, or $0.12, compared to $1.7 million, or $0.69 per share, in 1Q:07. Analysts expected a loss of $0.21 per share. There were 673 TranS1 procedures performed during the quarter.

Paradigm Spine completed a $39.0 million financing round led by returning investor HealthCor Partners, who were joined by Trevi Health Ventures and a group of individual investors. Proceeds will be used to initiate U.S. sales operations, beginning with the recently FDA-cleared DSS system, fund the coflex interspinous spacer IDE trial and expand international operations.

TranS1 received 510(k) clearance to market its AxiaLIF 2L, a two-level percutaneous lumbar fusion system designed to treat degenerative disc disease at both the L5-S1 and L4-L5. The press release adds that the procedure requires a single, 1.5-inch incision.

Medtronic received FDA clearance to market two smaller kit sizes of INFUSE Bone Graft for use in certain spinal fusion and dental regenerative procedures. The new configurations are XX Small (0.7cc) kit and X Small (1.4cc) kit and will be available for clinical use this June.

Osteotech has received FDA clearance to market Plexur P Biocomposite for use in spinal applications as a bone void filler and bone graft extender. Plexur P was previously cleared for use in filling bony voids of the pelvis and extremities.

Mazor Surgical Technologies signed a strategic cooperation agreement with the Cleveland Clinic Foundation to develop spinal implants based on two patents. One product has undergone a feasibility study, and Mazor believes the product will be brought to market within a year. The company says it paid CCL an "insubstantial amount" for the licenses, and will pay additional insubstantial amounts when the product reaches certain milestones. Most of the payments will be from royalties.

Medtronic, Inc. and Scil Technology GmbH announced a development, licensing and supply agreement focused on the development of Scil’s rhGDF-5 dental regenerative technology. Under this agreement, Scil Technology is primarily responsible for all research and development activities with Medtronic responsible for clinical trials, regulatory approvals and commercialization. Financial terms were not disclosed.

Osteotech has signed an exclusive distribution agreement with BioHorizons, Inc., whereby BioHorizons will market Osteotech's bone regeneration products in countries in Europe, the Middle East, Latin America and Asia. Osteotech and BioHorizons previously entered into an agreement for BioHorizons to distribute Osteotech's products to the United States dental market in 2000. The agreement became effective April 1, 2008, and financial terms were not disclosed.

TiGenix released three-year data from its ongoing study comparing ChondroCelect to microfracture for the treatment of knee cartilage defects. The study has shown that the quality of the new tissue associated with ChondroCelect is higher than tissue quality following microfracture; additionally, ChondroCelect patients gained, on average, 22 percentage points (a 39% improvement from pre-treatment levels) on the Knee Injury and Osteoarthritis Outcome Score scale, compared to 15 percentage points (a 24% improvement from pre-treatment levels)in the microfracture group; ChondroCelect patients also showed a lower failure rate than the microfracture group, and a sub-analysis shows that patients who were treated within 2 or 3 years after symptom onset showed superior clinical improvement compared to microfracture.

Steve LaNeve has been named senior vice president and president of Medtronic's Spinal and Biologics business, replacing Pete Wehrly, who is leaving the company. LaNeve, the former president of Medtronic Japan, has responsibility for the continued integration of Kyphon, the biologics business and the core spine business. Concurrent with Wehrly's departure, Medtronic's COO, Michael DeMane, has also resigned. DeMane was Wehrly's predecessor at the Spinal business.

VertiFlex, Inc. appointed Earl R. Fender President and Chief Executive Officer and Member of the Board of Directors. Previously he served as Vice President of Sales, U.S. President and Worldwide President at DePuy Spine.

Facet Solutions, Inc. appointed Dr. Marc Peterman as Vice President of Research and Development. Prior to joining Facet Solutions, Dr. Peterman directed development activities at Abbott Spine.

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