Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Integra LifeSciences (NASDAQ: IART ) , a manufacturer of surgical instruments and medical implants, fell as much as 13% after the company announced a voluntary recall of certain products at its Anyasco manufacturing facility in Puerto Rico.
So what: The recall encompasses its DuraGen Dural Graft Matrix products that were manufactured between December 2010 and May 2011 and between November 2012 and March 2013. Integra noted that there "may have been deviations from approved processes in their production." On the bright side, there have no adverse events reported, and it appears to have remedied the manufacturing problem. However, the damage of the recall is done and will reduce its upcoming quarterly revenue by $8 million to $11 million to a range of $194 million to $197 million. Earnings will also be affected, with the company slated to now only earn an adjusted $0.30-$0.40 in the first quarter. Further, its second-quarter forecast was adjusted slightly lower to $205 million to $211 million because it may not be able to meet all necessary DuraGen Dural Graft Matrix product demand. As icing on the cake, Northland Capital downgraded Integra to "market perform" from "outperform."
Aethlon Medical, Inc. (Aethlon), incorporated on April 17, 1991, is a developmental-stage company. The Company is focused on creating medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions.
The Company's Aethlon ADAPT (Adaptive Dialysis-Like Affinity Platform Technology) system is a revenue-stage technology platform that provides the basis for a new class of devices that provide rapid, selective removal of disease promoting particles from the entire circulatory system. The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier to address infectious disease and cancer, and a medical device being developed under the Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers.
The Aethlon Hemopurifier
The Company's Hemopurifier is a medical device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation. Under the feasibility study protocol, the Company will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. In addition to augmenting the early viral kinetic response to SOC, the Company's Hemopurifier provides a candidate solution for viral rebound patients who traditionally are forced to discontinue therapy at the point HCV establishes resistance to drug regimens. Additionally, the Company's Hemopurifier represents a therapeutic strategy to address the population of HCV-infected dialysis patients for which SOC and all-antiviral strategies may be contraindicated or not cleared.
In design, the Company's Hemopurifier consists of the affinity lectin Galanthus nivalis agglutinin (GNA) immobilized in the outer-capillary space of advanced plasma membrane technology. The design allows for extracorporeal therapeutic delivery to occur on standard CRRT and dialysis instruments alre! ady located in hospitals and clinics worldwide. The mechanism of the Hemopurifier to rapidly eliminate a broad-spectrum disease targets is based on GNA�� ability to selectively bind high mannose signatures that are abundant on the surface of cancer-secreted exosomes and glycoproteins that reside on the outer membrane of infectious viral pathogens. The Company has also established a compassionate-use treatment program at the Medanta Medicity Institute in India that provides treatment access to HCV-infected individuals.
The Company's Hemopurifier has also been discovered to capture tumor-secreted exosomes underlying several forms of cancer. Tumor-derived exosomes have recently emerged to be a vital therapeutic target in cancer care. These microvesicular particles suppress the immune response in cancer patients through apoptosis of immune cells and their quantity in circulation correlates directly with disease progression. In addition to treating HCV-infected individuals, the Company has conducted a single proof of principal treatment study related to the treatment of HIV. In the study, Hemopurifier therapy reduced viral load by 93% in an HIV-AIDS infected individual without the administration of antiviral drug therapy. The study protocol provided for 12 Hemopurifier treatments, each four hours in duration, that were administered over the course of one month. Researchers at a university have since discovered that the Hemopurifier is able to capture exosomes that transport NEF protein, which is known to suppress the immune response in HIV-infected individuals.
The Company has been assigned all rights and title to and interests in an invention and related worldwide patent rights for a method to treat cancer under an assignment agreement with the London Health Science Center Research, Inc. (LHSCRI) The agreement provides that the Company is responsible for paying certain patent application and filing costs as well as a 2% royalty on any future net sales. The Company has als! o exercis! ed an option to license a pending patent entitled, Method to Inhibit Proliferation and Growth of Metastases from The Trustees of Boston University. The license provides a development strategy for new cancer therapies by uniting drug agents that inhibit the spread of cancer-related metastases with filtration techniques already in the Aethlon Hemopurifier(R). The resulting devices would inhibit tumor growth by reducing the presence of circulating growth factors without interfering with surgical wound healing or the recovery of tissue injured by radiation therapy.
The Company competes with Asahi Kasei Kurary Medical.
Advisors' Opinion: - [By James E. Brumley]
Stocks as a whole haven't gotten the new year off on the best foot, but that's not to say every equity out there is in trouble. Indeed, some small cap stocks may actually be doing well - and poised to do well for a while - specifically because larger companies are seeing their stocks struggle. To that end, traders looking for a bullish bright spot to start the new year may want to take a closer look at Amedica Corporation (NASDAQ:AMDA), Threshold Pharmaceuticals, Inc. (NASDAQ:THLD), and Aethlon Medical, Inc. (OTCMKTS:AEMD).
Top 5 Medical Stocks To Own For 2015: Cambridge Heart Inc (CAMH)
Cambridge Heart, Inc., incorporated on January 16, 1990, is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. The Company's products incorporate its technology for the measurement of Microvolt T-Wave Alternans (MTWA). The MTWA Test is conducted by elevating the patient's heart rate through exercise as performed on a treadmill similar to a stress test, pharmacologic agents, or pacing with electrical pulses.
The Company's products, including its first generation HearTwave System and second generation HearTwave II System, CH 2000 Cardiac Stress Test System, MTWA original equipment manufacturer (OEM) Module (MTWA Module) and Micro-V Alternans Sensors have received 510(k) clearance from the United States Food and Drug Administration (FDA) for sale in the United States. The Company's products have also received the Conformite Europeenne (CE) mark for sale in Europe. The Company's first generation HearTwave System, CH 2000 Cardiac Stress Test System and the HearTwave II System have been approved for sale by the Japanese Ministry of Health Labor and Welfare.
The Company's 510(k) clearance allows the Company's MTWA Test to be used to test patients with known, suspected, or at risk of ventricular tachyarrhythmia and/or sudden cardiac arrest, and allows the claim that its MTWA Test is predictive of those events. The MTWA Module is designed to work with existing cardiac stress test platforms distributed by other manufacturers as an add-on module to enable MTWA testing to be performed using the Company's Micro-V Alternans Sensors.
The Company's HearTwave II System, which has replaced the Company's original HearTwave System, is used to perform both MTWA testing and standard cardiac stress testing. In addition to MTWA measurement, the Company's HearTwave II System is a cardiac diagnostic system designed to support a range of customized protocols for the conduct of cardiac exercise stress testing. The Comp! any's Micro-V Alternans Sensors are single patient use, multi-segment electrodes. The Company's CH2000 is a cardiac diagnostic system designed to support a range of customized protocols for the conduct and measurement of cardiac exercise stress testing.
The Company competes with GE Medical Systems.
Advisors' Opinion: - [By Peter Graham]
Last Friday, small cap stocks Cambridge Heart, Inc (OTCMKTS: CAMH), Abby Inc (OTCMKTS: ABBY) and Grillit Inc (OTCMKTS: GRLT) surged 176.92%, 71.2% and 24.07%, respectively. Of course, that was last week and today is a new trading week. So what should investors and traders alike be prepared for this week with these three small caps? Here is a closer look to help you decide on an investing or trading strategy:
Cambridge Heart, Inc (OTCMKTS: CAMH) Recently Changed Its Board Small cap Cambridge Heart, Inc is a healthcare company engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. On Friday, Cambridge Heart, Inc surged 176.92% to $0.018 for a market cap of $1.80 million plus CAMH is up 20% since the start of the year and down 86.1% over the past five years according to Google Finance.
Top 5 Medical Stocks To Own For 2015: Intrexon Corp (XON)
Intrexon Corporation, incorporated on April 19, 2004, is engaged in the business of synthetic biology. Using the Company�� suite of complementary technologies, it design, build and regulate gene programs, or sequences of deoxyribonucleic acid (DNA) that control cellular function, and cellular systems, or activities that take place within a cell and the interaction of those systems in the greater cellular environment, to enable the development of new and improved products and manufacturing processes across a variety of end markets, including healthcare, food, energy and environmental sciences. Its technologies include the UltraVector gene design and fabrication platform; Cell Systems Informatics; LEAP-cell identification and selection, and mAbLogix-antibody discovery.
The Company�� LEAP technology facilitates the automated identification of an individual cell with the highest levels of expression, quality and potency from a population of over 100,000 cells. Its mAbLogix platform complements UltraVector with a library of human antibodies that exceeds 500 million. By immortalizing human tonsils, which consists of lymphatic tissue containing B-cells, its mAbLogix platform creates a B-cell library that can generate antibodies against an almost infinite number of new antigens.
The UltraVector gene design and fabrication platform
The Company�� gene program design platform, which it refer to as UltraVector, is an integrated suite of tools comprising advanced DNA construction technology and components, cellular and protein engineering tools, computational models and statistical methods which facilitate the rapid design, build and testing of complex systems. The UltraVector platform allows the Company to translate gene programs into standard components that can be designed, manufactured and tested in an automated format. This technology enables it to engineer at the cellular level from biological sources.
UltraVector DNA design is computer-automated and ! utilizes a set of defined construction rules to assemble components that are stored in its DNA library. In addition to the number of gene components in its UltraVector library, it is designing and creating enzymatic and regulatory components that provide control over genome integration and gene regulation. Its RheoSwitch Therapeutic System is a three-component transcriptional regulator that provides inducible gene expression. The RheoSwitch Therapeutic System provides the ability to not only express proteins/enzymes of interest, but also the ability to control the level and timing of expression to achieve a biological outcome. Other ongoing programs include its Attsite recombinases, which mediate predictable gene exchange into host cells thereby eliminating many of the difficulties seen with traditional gene insertion.
Cell Systems Informatics
The Company�� Cell systems informatics permits design, as well as testing and learning about new gene targets or product pathways. Its bioinformatics software and database systems for mapping cellular pathways when combined with its genome-scale modeling and experimental data, including, gene expression profiling and protein engineering, enable the Company to optimize selection and development of gene programs and cellular systems for its collaborators. Its computational modeling and simulation platform enables the development of predictive computer models of organisms, from microbes to humans. This platform builds virtual cells from their basic molecular components, and can simulate the activity of the cell�� complete reaction network.
The Company is designing proteins with post-translational modifications. It is also working to develop enzyme inhibitors and fusion proteins for a variety of applications in human and animal therapeutics. Its protein engineering may utilize one or more of its technologies to obtain catalysis activitiesits component library, the generation of component variants sequence, evolutionary analy! sis and s! tructure-based sequence alignment, computer-aided drug discovery, de novo, or synthesized or generated, and comparative protein modeling, molecular dynamics simulation and free energy analysis, antibody design and humanization, antigenicity prediction, protein pharmacokinetics optimization, and/or in silico support of enzyme engineeringand quantitative structure-function relationships with machine learning algorithms to optimize, facilitate and prioritize protein variant libraries for the advancement of its collaborators.
LEAP-cell identification and selection
The Company�� Laser-Enabled Analysis and Processing technology (LEAP), is an instrument that merges semiconductor manufacturing technologies for cell processing applications to provide high levels of control and scale to cell purification and stem cell culture management. The LEAP platform can identify and purify cells of interest from large libraries of cells created by its UltraVector and bioinformatics technologies using a laser-based purification process, thereby providing a mechanism of testing the degree of protein expression in genetically modified cells, as well as means to learn from the genetic building process.
mAbLogix- antibody discovery
The Company�� mAbLogix antibody discovery platform, or mAbLogix platform, enables production of B-cell libraries for discovery of antibodies. The mAbLogix platform permits antigen targeting using fully human monoclonal and polyclonal antibodies. Its mAbLogix antibody discovery process consists of two major activities: the build of human B-cell libraries expressing a large number of antibodies, and the testing of these libraries based on an analysis of B-cells that express antibodies in response to a chosen antigen.
The Company competes with AbD SeroTec, Alexion Pharmaceuticals, Inc., XOMA Corporation, Genmab US, Inc., MorphoSys AG, NovImmune SA, Societe Des Systemes Biologiques, Adimab, LLC, ProMab Biotechnologies, Inc., Abpro, Inc.,! AIIM The! rapeutics and Open Monoclonal Technology, Inc.
Advisors' Opinion: - [By Ben Levisohn]
Overvalued companies include MWI Veterinary (MWIV) and�Stericycle (SRCL), while companies with attractive valuations include Cardinal Health (CAH), Selected Medical (SEM). He’s not a fan of Intrexon (XON) but calls�Aratana (PETX) a “hidden gem.”
- [By Jon C. Ogg]
Intrexon Corp. (NYSE: XON) was started as Buy at Mizuho Securities, started as Equal Weight at Barclays and started as Overweight at J.P. Morgan.
Nokia Corp. (NYSE: NOK) was raised to Hold from Sell at Deutsche Bank, raised to Neutral from Underperform at Credit Suisse and
Canaccord Genuity raised its price target to $5.50 from $3.30.
- [By John Udovich]
Bubble talk, biotech IPO setbacks plus news�about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
Top 5 Medical Stocks To Own For 2015: Intelligent Living Inc (ILIV)
Intelligent Living Inc., formerly Feel Golf Co., Inc., incorporated on February 14, 2000, is a developer of healthy aging software tracking systems and wellness centers, which will provide integrated services promoting optimal health and wellness programs. The services to be offered by the Company are personalized programs and regimens developed by nutritionists, fitness specialists and hormone replacement therapists. The Company focuses to offer the benefits of tailored nutritional programs and its products, combined with healthy-aging bio-identical hormone replacement therapies (BHRT). The Company provides services, such as Age Management Medicine, Excercise & Nutrition, MIND360.COM, Nutraceuticals, Hormone Therapy, and Business Solutions.
Age Management Medicine
The Company's Age Management Medicine is a proactive and preventative approach to healthcare for an aging population. The basic tenets of Age Management Medicine include medical history examination of the patient, a thorough lifestyle assessment, and physical and laboratory evaluations, which are used to establish personalized treatment plans.
Business Solutions
The Company is in the development stages of launching its own Electronic Medical Records software. The product will be a Web-based clinical application for the management of patients with hormone and other chronic conditions.
Excercise & Nutrition
The Company has on-site fitness specialists and nutritionists to help one attain goals. Depending on personal goals, personalized consultations are available at their request.
Hormone Therapy
The Company works directly with a pharmacy that compounds products for hormone replacement therapy (HRT). It serves both men and women.
MIND360.COM
Mind360 enhances and maintains people�� mental fitness through an online cognitive training platform. Its engaging brain training games are designed to help strengthen ke! y cognitive functions, including memory, attention, executive functions, thinking and reasoning, and visual perception. Mind360 has over 10,000 users in every continent with more than 40 games.
Nutraceuticals
The Company is focused on optimizing health goals through proper nutrition and dietary supplementation. Its Nutraceutical products support this proactive approach to healthy aging and helps reduce the negative effects of aging and improve quality of life. The Company's Nutraceutical line of products are formulated by both pharmacists and physicians.
Advisors' Opinion: - [By Peter Graham]
Small cap healthcare and lifestyle stocks Axxess Pharma Inc (OTCMKTS: AXXE), Medefile International Inc (OTCMKTS: MDFI) and Intelligent Living Inc (OTCMKTS: ILIV) have all been getting some extra attention lately thanks in part to a few disclosed paid promotions or investor relations type of activities. But just how healthy are these small cap stocks for investors and traders alike? Here is a quick reality check:
