The medical device industry can be a tricky field for those looking for investment advice. Between companies selling products in every category from drug-eluting stents to neuromodulation, where in the wide field of health care do you start? Fortunately, the ongoing earnings season has told us a few key trends every medical device investor can take advantage of. Here are three need-to-know points from the industry's earnings season that your portfolio can't afford to ignore.
This isn't a biotech-style growth industry
First off, the medical device industry as a whole is facing some tough times. Pricing pressures, maturing markets, and a tough European business climate have all contributed to slowing or declining sales among the top names in the industry.
Take a look around the top device companies reporting this week, and you'll see a picture of lackluster growth. Johnson & Johnson (NYSE: JNJ ) , one of the biggest names in health care, saw double-digit growth from its medical device department, but only because of its $12 billion acquisition of orthopedics powerhouse Synthes last year. Fellow diversified medical firm Abbott Labs' (NYSE: ABT ) medical device sales fell more than 4% despite its dominant position in the stent industry. St. Jude Medical (NYSE: STJ ) also saw sales decline 3% at a constant currency, even as the company managed to grow earnings by more than 5% by cutting costs.
Top Cheap Stocks To Invest In Right Now: Navidea Biopharmaceuticals Inc (NAVB)
Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.
Lymphoseek
Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.
AZD4694
AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.
RadioImmunoGuided Surgery
As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.
The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.
Advisors' Opinion:- [By Erin McCarthy]
Navidea Biopharmaceuticals Inc.(NAVB) said Chief Executive Mark Pykett would leave that post around the end of this month as the company restructures its biopharmaceutical product pipeline.
- [By Keith Speights]
3. Navidea Biopharmaceuticals (NYSEMKT: NAVB )
Some investors were likely befuddled by Navidea's stock action earlier this year. The company received FDA approval in March for Lymphoseek, its radiopharmaceutical agent used for imaging lymph nodes in patients with breast cancer or melanoma. That was great news, but shares dropped quickly and still haven't returned to previous levels.
Best Biotech Stocks For 2014: Alnylam Pharmaceuticals Inc.(ALNY)
Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and commercializing novel therapeutics based on RNA interference (RNAi). Its core product programs under clinical or pre-clinical development include ALN-TTR, a Phase I clinical trial program for the treatment of transthyretin-mediated amyloidosis; ALN-APC, a Phase I clinical trial program for the treatment of hemophilia; ALN-PCS for the treatment of severe hypercholesterolemia; ALN-HPN, a pre-clinical development for the treatment of refractory anemia; and ALN-TMP, a pre-clinical development for the treatment of hemoglobinopathies, including beta-thalassemia and sickle cell anemia. The company?s partner-based programs comprise ALN-RSV01, a Phase II clinical trial program for the treatment of respiratory syncytial virus infection; ALN-VSP, a Phase I clinical trial completed program for the treatment of liver cancers; and ALN-HTT, a pre-clinical development for the treatment of Huntington?s disease. It has strategic alliances with Novartis Pharma AG; F. Hoffmann-La Roche Ltd; Takeda Pharmaceutical Company Limited; Isis Pharmaceuticals, Inc.; Medtronic Inc.; Kyowa Hakko Kirin Co., Ltd.; and Cubist Pharmaceuticals, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.
Advisors' Opinion:- [By Sean Williams]
RNAi therapeutics expert Alnylam Phrmaceuticals (NASDAQ: ALNY ) also delivered big gains this week to the tune of 22% after reporting very encouraging mid-stage data for ALN-TTR02, its treatment targeting TTR-mediated amyloidosis. Its experimental drug ALN-TTR02 delivered a 93% reduction in TTR rates in patients, which is perfectly consistent with its early stage results that demonstrated a reduction in TTR rates of 94%. Peak sales estimates, should the drug be approved, range from $800 million to up to $2 billion, but I'd caution investors keep a level head on their shoulders in the meantime.
- [By Dan Carroll]
Yet no stock in biotech had a week like Alnylam Pharmaceuticals (NASDAQ: ALNY ) , whose stock shot up more than 32% over the past five days. Company shares rocketed up 19% on Thursday alone, after the company released early-stage clinical results that showed Alnylam's developmental therapy ALN-TTRsc, a treatment for a rare genetic disorder, reduced levels of the disease, transthyretin (or TTR) amyloidosis, by 80%. Alnylam also noted that the drug had been well received by clinical subjects, a critical key for investors cautious about the drug's safety.
Best Biotech Stocks For 2014: Prothena Corporation PLC (PRTA)
Prothena Corporation PLC, incorporated on September 26, 2012, is an Ireland-based, clinical-stage biotechnology company. The Company is engaged in discovering and developing monoclonal antibodies that are directed towards misfolded proteins or improper cell adhesion. Its pipeline includes NEOD001, PRX002 and PRX003. The Company�� work in protein misfolding could result in therapies to treat several neurodegenerative diseases, including AL (primary) and AA (secondary) forms of amyloidosis (NEOD001), Parkinson's disease and related synucleinopathies (PRX002). Its cell adhesion development activities could generate new therapies to treat inflammatory diseases and metastatic cancers (PRX003). The Company�� program, NEOD001, is in Phase 1. In addition to antibodies directed to neo-epitope targets, it is developing antibodies directed to other targets. The Company has generated antibodies against cell adhesion targets expressed on certain pathogenic Th17 immune cells and tumor cells.
The Company�� pipeline also includes several late discovery stage programs for which it is testing antibodies in preclinical models of disease. It is also generating additional antibodies against other targets involved in protein misfolding and cell adhesion for characterization in vivo and in vitro.
NEOD001 for Amyloidosis
NEOD001 is a monoclonal antibody that targets the amyloid that accumulates in both AL and AA forms of amyloidosis. The antibody was designed to not react with normal serum amyloid A and only with the aberrant cleaved form of the protein (amyloid A).
PRX002 for Parkinson�� Disease
The Company has generated antibodies targeting alpha-synuclein that may slow or reduce the neurodegeneration associated with synuclein misfolding and/or transmission. It has tested these antibodies in various cellular and animal models of synuclein-related disease. In a transgenic mouse model of Parkinson�� disease, passive immunization with 9E4, a murine ver! sion of PRX002, reduced the appearance of synuclein pathology, protected synapses and improved performance by the mice in behavioral testing. The humanized antibody product candidate PRX002 has advanced into manufacturing and preclinical testing.
PRX003 for Inflammatory Diseases and Cancers
The Company is developing PRX003, a monoclonal antibody targeting MCAM for the potential treatment of inflammatory diseases and cancers. It has generated monoclonal antibodies that block MCAM-mediated cell adhesion and have been shown to delay relapse and severity of relapse in a mouse model of multiple sclerosis known as experimental autoimmune encephalomyelitis. The Company�� antibodies are being tested in animal models of inflammatory diseases and cancers. Based on early results from these studies, it has identified a clinical candidate, PRX003. It has advanced this antibody into manufacturing and intends to advance this antibody into preclinical testing.
Advisors' Opinion:- [By Michael Robinson]
CSD is also tapping into the biotech boom. Another firm that it holds, and we like, is Prothena Corporation PLC (PRTA), a clinical-stage biotechnology firm focused on Parkinson's disease and other neurodegenerative disorders.
- [By Jake L'Ecuyer]
Prothena Corporation (NASDAQ: PRTA) shares were down as well, falling 28.00 percent to $27.13 after the company released some materials from its coming symposium presentation.
- [By MONEYMORNING]
For its part, CSD also is tapping into the biotech boom. The second firm that it holds and we like is Prothena Corporation PLC (Nasdaq: PRTA), a clinical-stage biotechnology firm focused on Parkinson's disease and other neurodegenerative disorders.
- [By Lauren Pollock]
Roche Holding AG(ROG.VX) has entered a pact with Prothena Corp.(PRTA) PLC to develop and commercialize a treatment the clinical-stage biotechnology firm is developing for Parkinson’s disease. In after-hours trading, Prothena’s stock rose 8.6% to $29.75 premarket.
Best Biotech Stocks For 2014: Osiris Therapeutics Inc.(OSIR)
Osiris Therapeutics, Inc., a stem cell company, focuses on the development and marketing of therapeutic products to treat various medical conditions in the inflammatory, autoimmune, orthopedic, and cardiovascular areas. It operates in two business segments, Therapeutics and Biosurgery. The Therapeutics segment focuses on developing biologic stem cell drug candidates from a readily available and non-controversial source, adult bone marrow. The Biosurgery segment works to harness the ability of cells and novel constructs to promote the body's natural healing. This segment focuses on developing biologic products for use in surgical procedures. The company?s lead biologic drug candidate is Prochymal, which is in phase 2 and 3 clinical trails for various indications, including acute graft versus host disease (GvHD), Crohn's disease, acute myocardial infarction, type 1 diabetes, pulmonary disease, and gastrointestinal injury resulting from radiation exposure. Its biologic drug candidates also include Chondrogen, a preparation of adult mesenchymal stem cells that is in phase 2 clinical trials for osteoarthritis and cartilage protection. The company has collaboration agreements with Genzyme Corporation for the development and commercialization of Prochymal and Chondrogen in various countries except in the United States and Canada. It also has a partnership with Juvenile Diabetes Research Foundation for the development of Prochymal as a treatment for the preservation of insulin production in patients with newly diagnosed type 1 diabetes mellitus. Osiris Therapeutics, Inc. was founded in 1992 and is headquartered in Columbia, Maryland.
Advisors' Opinion:- [By Alexander Maxwell]
One of the companies attempting to develop a better treatment for chronic diabetic foot ulcers is Osiris Therapeutics� (NASDAQ: OSIR ) . Earlier this month, Osiris shares more than doubled as the company announced positive data for its CDFU drug Grafix. The study results were very impressive to say the least; the study was stopped early due to the overwhelming efficacy exhibited by the treatment. A main highlight is the fact that 62% of Grafix patients had their wound closed at 12 weeks, compared to only 21% of patients using conventional methods. Clearly, the efficacy in this endpoint was overwhelming. Grafix also achieved all of the secondary endpoints for the trial, and more importantly demonstrated a relatively benign safety record.�
Best Biotech Stocks For 2014: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
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