http://www.healthpointcapital.com/research/ en Copyright 2012 HealthpointCapital LLC Thu, 02 Feb 2012 09:53:39 -0500 http://www.movabletype.org/?v=3.35 http://blogs.law.harvard.edu/tech/rss EXAC, KNSY, RTIX, SNN announce 4Q:11 ... CartiHeal raises $5M ... ConforMIS raises $89M ... FDA clears Eden Spine's GIZA device ... NLT announces 510(k) clearance for the PROW FUSION TLIF device ... ThermoGenesis announces "encouraging" study results http://www.healthpointcapital.com/research/2012/02/02/musculoskeletal_news_roundup_2feb12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/02/02/musculoskeletal_news_roundup_2feb12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Musculoskeletal News Roundup Thu, 02 Feb 2012 09:53:39 -0500 Reuters and others are reporting this morning that the FDA and industry have reached an agreement for the 2012 re-authorization of MDUFA, the legislation that allows the FDA to collect user fees from industry. User fees contribute about a third of the agency's budget. http://www.healthpointcapital.com/research/2012/02/01/industry_fda_reach_user_fee_agreement/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/02/01/industry_fda_reach_user_fee_agreement/?utm_source=rss&utm_medium=rss2&utm_campaign=feed FDA Wed, 01 Feb 2012 11:54:21 -0500 Earnings Align Technology announced 4Q:11 net revenues of $128.9 million, up 38.8% from the quarter a year ago and beating analyst estimates by $0.03 per share. Net profit for 4Q:11 was $20.4 million, or $0.25 per diluted share, compared to... http://www.healthpointcapital.com/research/2012/01/31/dental_news_roundup_january_2012/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/31/dental_news_roundup_january_2012/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Dental News Roundup Tue, 31 Jan 2012 15:26:29 -0500 Symmetry Medical announced after the close on Monday that the SEC has settled an investigation into accounting irregularities at the company's Sheffield, UK manufacturing site, which were first exposed in 2007. Four finance executives were implicated in the SEC's probe, and in a separate clawback action, Symmetry's former CEO and current CFO were ordered to repay compensation associated with the faulty accounting. http://www.healthpointcapital.com/research/2012/01/31/symmetry_resolves_sec_investigation/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/31/symmetry_resolves_sec_investigation/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Symmetry Tue, 31 Jan 2012 07:37:24 -0500 We're in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than is typical at these events, with commercial exhibits limited to single tables from the handful of sponsoring companies. The focus is instead clinical - surgical technique, treatment modalities and optimizing outcomes. http://www.healthpointcapital.com/research/2012/01/27/report_from_the_16th_annual_argospine_symposium/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/27/report_from_the_16th_annual_argospine_symposium/?utm_source=rss&utm_medium=rss2&utm_campaign=feed ArgoSpine Fri, 27 Jan 2012 07:18:16 -0500 DJO, JNJ, SYK, ZMH report 4Q sales ... FDA clears Interventional Spine's Opticage Expandable device ... Medtronic receives FDA clearance for newest Aquamantys device ... KFx Medical receives new patent ... Judge dismisses motions in MDT/NUVA case ... Pioneer Surgical announces grand opening of new N.C. manufacturing facility http://www.healthpointcapital.com/research/2012/01/26/musculoskeletal_news_roundup_26jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/26/musculoskeletal_news_roundup_26jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Musculoskeletal News Roundup Thu, 26 Jan 2012 17:29:00 -0500 We spoke with Paul Nichols, the current Executive Chairman of Bio2 Technologies who formerly worked with HealthpointCapital as President and CEO of Nexa Orthopedics. Learn what he has to say about the opportunities and challenges of the musculoskeletal and his advice for young companies. http://www.healthpointcapital.com/research/2012/01/25/an_inteview_with_paul_nichols/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/25/an_inteview_with_paul_nichols/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Interviews Wed, 25 Jan 2012 14:17:39 -0500
In 2007, when Bradshaw arrived at DTI's flagship laboratory, MicroDental in Dublin, Calif., as the senior vice president for the dental services division, the situation was far from ideal. Many were not thrilled by her arrival. She came from a different industry and she spoke what seemed like a different language. She put a spotlight on things that most wanted left alone and her beginning to this new industry was off to a difficult start.]]> http://www.healthpointcapital.com/research/2012/01/23/journal_of_dental_technology_features_dti_president_and_ceo_kim_bradshaw/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/23/journal_of_dental_technology_features_dti_president_and_ceo_kim_bradshaw/?utm_source=rss&utm_medium=rss2&utm_campaign=feed DTI Dental Technologies Inc. Mon, 23 Jan 2012 06:30:23 -0500 Alphatec Spine announced today that Mark Francois has been named the Company's Senior Director of Investor Relations. http://www.healthpointcapital.com/research/2012/01/19/alphatec_spine_appoints_new_senior_director_of_investor_relations/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/19/alphatec_spine_appoints_new_senior_director_of_investor_relations/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Alphatec Spine, Inc. Thu, 19 Jan 2012 11:42:55 -0500 ZMH acquires Synvasive Technology ... Carticept, DiFusion announce funding rounds ... KFx announces ACL study results ... MedShape launches ExoShape Soft Tissue Fastener ... VG Innovations releases VerteLoc v2.5 ... Stryker settles OP-1 charges ... Zyga Technology appoints president and CEO http://www.healthpointcapital.com/research/2012/01/19/musculoskeletal_news_roundup_19jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/19/musculoskeletal_news_roundup_19jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Musculoskeletal News Roundup Thu, 19 Jan 2012 06:25:57 -0500 An FDA warning letter sent to DePuy in December alleges that the company has been manufacturing custom hip and knee components in violation of FDA regulations. Custom devices are intended to be manufactured for one patient, and such devices are generally exempt from market clearance. http://www.healthpointcapital.com/research/2012/01/18/fda_warns_depuy_over_custom_devices/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/18/fda_warns_depuy_over_custom_devices/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Johnson & Johnson Wed, 18 Jan 2012 14:51:13 -0500 Researchers in Finland have identified a 130-fold increase in incidence of total knee arthroplasty among Finnish patients younger than 59 years of age between 1980 and 2006. These data help to quantify the trend of younger patients undergoing knee replacement procedures while illustrating the need for more data on the long-term durability of knee devices. http://www.healthpointcapital.com/research/2012/01/17/rapid_growth_of_knee_replacement_in_younger_patients/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/17/rapid_growth_of_knee_replacement_in_younger_patients/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Knee Tue, 17 Jan 2012 08:18:47 -0500 Last Friday, the FDA announced agreements on user fee programs for drugs, generics and biosimilars, in time for a January 15th deadline for submitting the plans to Congress. The reauthorization for medical device user fees was not completed by the deadline and remains under negotiation. Bloomberg is now reporting that the FDA and device industry must come to a deal by February 15th, the date of a House Energy and Commerce health subcommittee meeting on the fees, or risk Congress taking over negotiations. http://www.healthpointcapital.com/research/2012/01/17/as_deadline_passes_user_fee_negotiations_continue/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/17/as_deadline_passes_user_fee_negotiations_continue/?utm_source=rss&utm_medium=rss2&utm_campaign=feed FDA Tue, 17 Jan 2012 07:14:36 -0500 MAKO, NUVA, OFIX, SYK, TRNX pre-announce ... FDA clears Biomet's E1 humeral bearing and Comprehensive Segmental Revision System ... Ortho Kinematics receives 510(k) clearance ... Lanx announces 100th implantation of Durango ... Mazor receives EU patent ... SNN announces VISIONAIRE study ... Arthrex to market ThermoGenesis PRP, bone marrow concentrate product ... Pioneer Surgical promotes Daniel Webber to CEO http://www.healthpointcapital.com/research/2012/01/12/musculoskeletal_news_roundup_12jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/12/musculoskeletal_news_roundup_12jan12/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Musculoskeletal News Roundup Thu, 12 Jan 2012 07:22:28 -0500 Medtronic CEO Omar Ishrak has spoken extensively about his vision for the company, a pillar of which is "accelerating globalization". At this week's JP Morgan Healthcare Conference in San Francisco, Mr. Ishrak addressed how M&A fit into the company's strategy. http://www.healthpointcapital.com/research/2012/01/11/medtronic_seeking_international_acquisitions/?utm_source=rss&utm_medium=rss2&utm_campaign=feed http://www.healthpointcapital.com/research/2012/01/11/medtronic_seeking_international_acquisitions/?utm_source=rss&utm_medium=rss2&utm_campaign=feed Medtronic/Sofamor Danek Wed, 11 Jan 2012 13:29:12 -0500