Orthopedic News Roundup 15-May-07
BY LAUREN UZDIENSKI, MAY 16, 2007
Earnings
BioMimetic Therapeutics reported a 1Q:07 net loss of $5.7 million or $(0.34) per share, beating estimates of $(0.37) and comparing to a net loss of $3.8 million, or $(2.22) per share, in 1Q:06. The company reported revenues of $0.25 million, missing estimates of $0.75 million, which included approximately $25,000 in GEM 21S sales by marketing partner Osteohealth Company.
IsoTis reported 1Q:07 revenue of $10.0 million, a 2% increase over 1Q:06's $9.8 million. 1Q:07 net loss was $5.0 million, or $0.79 per basic and diluted share, as compared with a net loss of $3.8 million, or $0.54 per basic and diluted share, in 1Q:06. Accell products showed 13% growth compared to 1Q:06 despite regulatory uncertainty.
Osiris reported 1Q:07 revenue of $2.3 million, an increase of nearly 63% over the comparable quarter. The company attributed the growth primarily to increased sales of Ostocel. 1Q:07 saw a net loss of $11.5 million, compared to a net loss of $5.1 million in 1Q:06. The company attributed the majority of the loss to the costs of five clinical trials.
Tutogen reported $13.0 million in revenues in the second fiscal quarter of 2007, up 43% from $9.1 million from the comparable quarter. Highlights include a 17% increase in international revenues over the comparable quarter; a 44% increase in dental revenues over 2Q:06; and an increase in spine revenues from $0.43 million in 2Q:06 to to $1.3 million in 2Q:07. Net income for the quarter was $930,000, or $0.05 per fully diluted share, compared to net income of $22,000 or $0.00 per fully diluted share, in the second quarter of fiscal year 2006.
Regulatory
Biomet received FDA clearance to market acetabular hip liners manufactured from E-Poly™ Highly Crosslinked Polyethylene. In their press release, Biomet stated that the liners are the world's first vitamin E-stabilized, highly-crosslinked polyethylene products to be introduced to the market. The vitamin E is expected to improve the longevity of the implant bearings used in total joint replacements by preventing oxidation.
Intellectual Property
Inion Oy has been granted a U.S. patent for a technology for bone-graft substitution for spine fusion, bone loss from emergency trauma and bone loss from cancer. The bone-grafting materials covered by the patent comprise porous ceramic or composite bone graft containing N-methyl-pyrrolidone (NMP).
Product Introduction
Globus Medical announced its "first foray into biomaterials" with the introduction of NuBone™ Osteoinductive Bone Graft product line. NuBone™ is a 100% allograft tissue product, composed of an osteoinductive demineralized bone matrix (DBM) combined with a cortical bone gelatin carrier. The first two products in the line to be released are NuBone DBM Putty and NuBone DBM Gel, developed for use in spinal fusion, trauma, and reconstructive bone grafting procedures.
Alphatec Holdings, Inc. announced the release of the CONNECT® II Cervical Structural Allograft spacer. The CONNECT II product is integrated with Alphatec's proprietary cervical fusion instrumentation for maximum ease of use, procedural efficiency and further completes Alphatec's cervical fusion product line.
Service Agreement
Regeneration Technologies, Inc. announced an exclusive 10-year agreement with Zimmer Holdings to distribute a new allograft paste implant. The bone paste implant is available in flowable and moldable formulations and composed of inductive and carrier elements derived from human bone. The moldable formulation includes additional bone chips for osteoconduction.
Osteotech entered into a single source agreement with Novation, LLC, whereby Novation's clients will have access to Osteotech's line of allograft products, including Grafton® DBM, Xpanse™ Bone Inserts and Graftech® Structural Allografts, as well as traditional allograft bone tissue grafts and Osteotech's PEEK-based GraftCage® Spacers. The term of the agreement is for 36 months and is effective July 2, with two one-year renewal options.
Additionally, Osteotech amended an agreement with Community Tissue Services. Osteotech first entered into an agreement with CTS in March 2006 whereby CTS would supply cortical bone tissues; the agreement has undergone several amendments since that time, and this week CTS agreed to supply Osteotech with an annual minimum number of whole donors. The initial five-year term of the agreement began in March 2006 and will automatically renew for successive two-year terms unless terminated by either party six months prior to renewal.
Appointment
Biomet Inc. appointed Daniel P. Florin Senior Vice President and Chief Financial Officer effective June 5. He replaces Greg Hartman, who resigned following concerns about options backdating. Florin's previous roles included Vice President and Corporate Controller for Boston Scientific Corp.
BioMimetic Therapeutics named Dr. Russ Pagano Vice President of Regulatory and Clinical Affairs effective May 23. Dr. Pagano has held posts as a scientific reviewer in the FDA's Office of Device Evaluation and has served as FDA Chief of the Restorative Devices Branch. Prior to announcing his intent to join BioMimetic Therapeutics, he was Executive Vice President and Regulatory Advisor at M Squared Associates, a consulting firm in Washington D.C.
