Orthopedic News Roundup 14-Dec-06
BY LAUREN UZDIENSKI, DECEMBER 14, 2006
Regulatory
CryoLife received FDA 510(k) clearance for its ProPatch™ Soft Tissue Repair Matrix, an announcement that drove its stock up 9%. Among other applications, ProPatch can be used to reinforce tissues repaired by sutures or by suture anchors during tendon repair surgeries, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. The ProPatch is developed from bovine pericardial tissue.
Inion received FDA 510(k) clearance for the Inion ANCHRON™ Plus Suture Anchor for orthopedic and sports medicine applications. The anchor is designed for use in soft tissue to bone fixation (e.g. repairing a ligament/tendon rupture or detachment) and has particular application in the shoulder, such as for rotator cuff and instability repairs (such as Bankart and SLAP lesions). The system can also be used to repair injuries in the elbow, ankle and knee.
Tornier's Salto Talaris™ anatomic ankle prosthesis has been granted 510(k) approval. The device is intended for use as a total ankle replacement to relieve pain and significant disability in patients with ankle joints damaged by severe rheumatoid arthritis, post traumatic arthritis, degenerative arthritis, and/or failed previous ankle surgery.
Paradigm Spine received CE Mark approval for its Dynamic Cervical Implant. The device is a titanium implant designed for patients suffering from early-stage degenerative disc disease in the cervical spine.
Doctors Research Group received CE Mark approval for its proprietary Kryptonite Bone Cement™. The cement is a non-toxic, osteoconductive, calcified triglyceride.
M&A Activity
Biomet went up for grabs this week, with Smith & Nephew reportedly bidding ~£6 billion, or ~US $11 billion. Smith & Nephew admitted in November that they were in talks with Biomet, but Biomet is expected to garner bids from other companies and private equity firms as well.
aap Implantate signed an acquisition agreement with FAME Medical's stockholders, thereby acquiring a group of four operating companies by means of a pure stock transaction. The combined companies anticipate consolidated sales of around EUR 30 million in 2007.
Funding
HydroCision completed a $12.7 million venture financing round. The funding will support a clinical trial, expand sales and marketing and buy capital equipment. Triathlon Medical Ventures led the deal, and was joined by return backers Oxford Bioscience Partners, Newberry Ventures and Zero Stage Capital.
Private Placement
Langer received net proceeds of ~US $27.8 million following a private placement. Terms include: 5.0% Convertible Subordinated Notes due December 7, 2011. The Notes are convertible into shares of common stock of the Company at a conversion rate of 210.5263 shares per $1,000 initial principal amount of notes (equal to a conversion price of $4.75 per share), subject to certain adjustments. The Company plans to use the funds for capital expenditures, working capital needs and the funding of acquisitions.
Intellectual Property
HydroCision received its 25th patent this week (U.S. Patent 7,122,017) for use of fluidjet devices in open and minimally invasive surgery. The fluidjet products have been used in more than 15,000 spine, arthroscopic and wound debridement procedures.
Inion received U.S. Patent 7,135,025 for the use of color in its biodegradable surgical implants. Inion markets the Hexalon™ colored biodegradable screw for repair of cruciate ligament injuries; screws are typically translucent, and the dyed screws are more easily distinguished from surrounding tissue.
Service Agreement
Clearant signed an agreement with OR Specialties to distribute Clearant Process® Sterile Implants in New York, Northern New Jersey, Connecticut, Rhode Island and Western Massachusetts. The implants are used for allograft sport medicine surgeries. Through another agreement signed with with JPS Surgical, Clearant's sterile implants will be distributed throughout Oklahoma and Arkansas.
Osiris Therapeutics and AlloSource entered into a multi-year agreement for supplying orthopedic tissue. Under the agreement, AlloSource will provide bone matrix to Osiris for the production of Osteocel bone regenerating products.
ORTHOsoft has signed a non-exclusive distribution agreement with one its partners. The partner has committed to $2.5 million in minimum purchases of ORTHOsoft navigation systems for 2007. The partner will market the systems to orthopedic hospitals and surgeons, mainly in the U.S.
Clinical
BioMimetic Therapeutics released U.S. clinical trial data on its GEM OS1™ bone graft treatment, and the results suggest that it is as effective as autograft in the stimulation of bone healing. At 12 weeks, 63% of GEM OS1 and 50% of autograft patients had achieved >50% osseous bridging, and the GEM OS1 patients also reported lower pain scores, improved function and shorter OR times.
Male smokers with knee osteoarthritis may experience greater cartilage loss and more severe pain than men who do not smoke, according to a new study from the Mayo Clinic. In a study of 159 patients, men who were current smokers had 2.3-fold increased risk for cartilage loss at the medial tibiofemoral joint and a 2.5-fold increased risk at the patellofemoral joint, as well as pain scores that were 30% higher than in non-smokers
Appointments
AxioMed® Spine Corporation announced the addition of Neal Defibaugh has as Vice President for Clinical and Regulatory affairs. He joins AxioMed during the development of the Freedom™ Lumbar Disc (FLD) System, the first implant system in the Company's pipeline. Prior to joining AxioMed, Mr. Defibaugh served as Director of Clinical Affairs in Smith & Nephew, Inc.'s Orthopaedic Division.
Orthofix CEO Alan Milinazzo has been named to the Company's Board of Directors. Mr. Milinazzo replaces Robert Gaines-Cooper, one of Orthofix's founders and the Chairman of the Board from 1989 to 2004, who has retired from the company's Board.
Alphatec Holdings, Inc. announced that Ronald G. Hiscock, President and Chief Executive Officer, has left the Company. The Company also announced the departure of Vicky A. Romanoski, Senior Vice President, Chief Administrative Officer. John H. Foster, Executive Chairman, is assuming the position of President and Chief Executive Officer.
Miscellaneous
Dr. Andrew von Eschenbach was confirmed last week to head the FDA, following a vote of 80-11. Charles Grassley of Iowa and David Vitter of Louisiana were among the senators who attempted to have the vote delayed; it had been on hold for months due to legislators' concerns that the FDA wasn't doing enough to ensure drug safety, as well as concerns over Plan B.
The 109th Congress voted last week to reverse a previous CMS decision to cut physician reimbursement by 5.1%. The reprieve is temporary: physicians should see reimbursement rates dwindle by roughly 10% in 2008.
