Musculoskeletal News Roundup 10-Mar-11
BY LAUREN UZDIENSKI, MARCH 10, 2011
Earnings
Anika reported 4Q:10 revenues of $14.2 million, up 43% over the year-ago period. Excluding revenues from Fidia, product revenue grew 17% in 4Q:10. The company added that sales growth was primarily driven by continued strong U.S. sales of ORTHOVISC and international sales of MONOVISC. Net income for 4Q:10 was $1.4 million, or $0.10 per diluted share, increasing from $0.7 million, or $0.06 per diluted share, in 4Q:09.
Biomimetic Therapeutics reported 4Q:10 revenues of $0.4 million, flat over the year-ago period and missing estimates by $0.1 million. In their press release, the company provided a regulatory and clinical update on Augment bone graft, for which there is an FDA panel meeting scheduled in May. The company anticipates that the panel will be positive and that Augment will receive FDA approval later this year. Net loss for 4Q:10 was $10.0 million, or $0.36 per diluted share, which compares to a net income of $1.1 million, or $0.05 per diluted share, in 4Q:09. Analysts had forecast a net loss of $0.35 per share.
Orthovita reported 4Q:10 product sales of $23.4 million, down 4% over the year-ago period and missing estimates by $0.4 million. Sales in the company's Vitoss Synthetic Bone Graft Substitute product line decreased by 6% during the quarter, while U.S. sales of Cortoss Bone Augmentation Material and the Aliquot Delivery System used with Cortoss increased by 19%. Biosurgery sales were flat in 4Q:10 compared to 4Q:09. Net loss for 4Q:10 was $3.7 million, or $0.05 per common share, widening from a net loss of $0.3 million, or less than $0.01 per common share, in 4Q:09. Analysts were expecting EPS to break even in 4Q:10.
Funding
BoneGrafix announced that Global Biotech Corporation signed a letter of intent to purchase a minority stake in BoneGrafix through an equity investment. Proceeds will support commercialization of the company's synthetic regenerative bone products.
ConforMIS intends to raise $1.8 million from an offering of Series D Preferred Stock or other equity securities. The company manufactures customized uni and bicompartmental implants for use in the treatment of knee OA.
Dallen Medical raised approximately $1.6 million of new capital, bringing total funds raised to nearly $3.4 million. The round was led by Pacific Health. The company plans to use the funds to further development of their first product, the Compressyn Band, which is designed to offer fixation with compression in sternal closure, small bone and sports medicine applications.
Regulatory
Medtronic disclosed in a regulatory filing that during the F3Q:11, the FDA notified the company that they were not able to approve AMPLIFY without additional information from Medtronic. The company said that they're working with the FDA to resolve the issues. Amplify consists of a BMP-2 matrix designed for single-level posterolateral lumbar fusions. The material has a different formulation and carrier than InFuse and is indicated as a treatment for degenerative disc disease.
Oxford Performance Materials Inc. announced that a spinal system manufactured by Manufacturas Solco S.A. de C.V. and made from the company's OXPEKK-IG PEKK material has received market clearance from COFEPRIS, Mexico's health regulator.
Tenex Health received 510(k) clearance for the TX1 Tissue Removal System, a portable, self-contained system that allows for soft tissue removal in the elbow, knee, ankle, foot and shoulder. The company plans to launch the product in 2Q:11.
Product Introduction and Update
Medtronic launched the ATLANTIS VISION ELITE Anterior Cervical Plate System in the U.S. The device features a quarter-turn locking mechanism designed to prevent screw back-out or loosening and a plate design that offers surgeons "visibility to better view the spine." The company also introduced the VERTEX SELECT CHROMALOY Plus Rods. The devices are indicated for use in the occipitocervical and upper-thoracic spine.
Wright Medical announced the full commercial release of the PRO-TOE VO Hammertoe Fixation System, which was designed to "offer a simple and efficient means to surgically repair the lesser toes following correction of a hammertoe deformity."
Legal
Orthofix received a subpoena from the Justice Department and the Securities and Exchange Commission over possible violations of the Foreign Corrupt Practices Act. The company says the subpoena is related to payments by Mexican subsidiary Promeca SA de CV to employees of "a Mexican governmental healthcare entity."
Clinical
Vertos Medical released clinical results from two studies of its mild system for the treatment of lumbar spinal stenosis. One study showed that at one year, mild patients "continued to experience a statistically significant and clinically relevant reduction in pain and improvement in mobility" as measured by the VAS, Zurich Claudication Questionnaire and SF-12v2 scales. A second randomized, controlled, double-blind comparison of mild versus epidural steroid injections showed that among 38 patients, mild demonstrated "superior durability over ESI with respect to pain relief and patient satisfaction."
Collaborations
GenOsteo and SpineSmith Partners announced an agreement to commercialize a bone graft substitute that consists of a synthetic scaffold that can be used with adult stem cells. Applications for the graft include spinal fusion, general orthopedic and CMF cases, and the press release states that GenOsteo plans to evaluate its scaffold for use in applications that "impose greater mechanical demands on the graft material." SpineSmith will focus on the marketing, sales and distribution of the product. The press release adds that the two partners are seeking growth funds to support commercialization.
License Agreements
RegeneCure has licensed a regenerative membrane implant from Yissum Research Development Company and Hadasit Medical Research Services & Development. According to the press release, the membrane synthetic microporous surface that "facilitates adherence of [mesenchymal stem cells] recruited to the injured site through a signaling mechanism known as chemotaxis." RegeneCure plans to develop and commercialize the technology for use in trauma, spine and reconstructive cranial and facial orthopedics. Under the terms of the agreement, Yissum and Hadasit will receive license fees, milestones and royalty payments from future sales of the final product.
Appointments
Orthofix promoted Brian McCollum to chief financial officer, effective March 1, 2011. He had been serving as interim chief financial officer since January 2011 and previously held the role of senior vice president of finance. Mr. McCollum has been with the company for close to 10 years.
Pioneer Surgical appointed Jim St. John to the position of Vice President International Sales. Prior to joining Pioneer, Mr. St. John was Vice President Worldwide Sales & Marketing at Benvenue Medical. He has also held positions at Zimmer Spine and Abbott Spine.
Miscellaneous
Bacterin began trading on the NYSE Amex on March 7 under the ticker symbol "BONE". Formerly, Bacterin traded under the symbol BIHI.OB on the OTC Bulletin Board.
