Sunday, January 19, 2014

5 Best Medical Stocks To Watch For 2014

On Thursday, small cap medical device stock Integra Lifesciences Holdings Corp (NASDAQ: IART) jumped 9.90% after the FDA completed its inspection of the company's manufacturing facility which led to positive comments from analysts, meaning it might be time to take a look at its performance verses that of medical device ETFs like iShares Dow Jones US Medical Device ETF (NYSEARCA: IHI) and SPDR S&P Health Care Equipment ETF (NYSEARCA: XHE).

What Is Integra Lifesciences Holdings?

Small cap medical device stock�Integra Lifesciences Holdings offers solutions in orthopedic extremity surgery, neurosurgery, spine surgery and reconstructive and general surgery. Specifically, Integra Lifesciences Holdings' orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair.�The company calls itself a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma and related critical care.

5 Best Medical Stocks To Watch For 2014: NeoStem Inc (NBS)

NeoStem, Inc., incorporated on September 18, 1980, operates in cellular therapy industry. Cellular therapy addresses the process by which new cells are introduced into a tissue to prevent or treat disease, or regenerate damaged or aged tissue, and consists of a separate therapeutic technology platform in addition to pharmaceuticals, biologics and medical devices. The Company�� business model includes the development of novel cell therapy products, as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. Progenitor Cell Therapy, LLC, the Company�� wholly owned subsidiary (PCT), is a CDMO in the cellular therapy industry. PCT has provided pre-clinical and clinical current Good Manufacturing Practice (cGMP) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing.

PCT has two cGMP, cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. The Company�� wholly-owned subsidiary, Amorcyte, LLC (Amorcyte) is developing its own cell therapy, AMR-001, for the treatment of cardiovascular disease. AMR-001 represents its clinically advanced therapeutic product candidate and enrollment for its Phase II PreSERVE clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post Acute Myocardial Infarction (AMI) patients.

Through the Company�� subsidiary, Athelos Corporation (Athelos), the Company is collaborating w! ith Becton-Dickinson in early stage clinical development of a therapy utilizing T-cells, collaborating for autoimmune and inflammatory conditions, including but not limited to, graft vs. host disease, type 1 diabetes, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection. The Company�� pre-clinical assets include its Very Small Embryonic Like (VSEL) Technology platform. The Company has basic research and development capabilities, manufacturing facilities on both the east and west coast of the United States.

Advisors' Opinion:
  • [By John Udovich]

    Summer and the slow news for the market that usually comes with it�is over with and both stem cell researchers or small� cap stem cell stocks like Advanced Cell Technology, Inc (OTCBB: ACTC), Neuralstem, Inc (NYSEMKT: CUR), NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO)�and BioRestorative Therapies (OTCBB: BRTX) having news for investors and traders alike. Consider the following:

5 Best Medical Stocks To Watch For 2014: Baxano Surgical Inc (BAXS)

Baxano Surgical Inc, formerly TranS1 Inc., incorporated in May 2000, is a medical device company focused on designing, developing and marketing products that implement its approach to treat degenerative conditions of the spine affecting the lower lumbar region. It develops its pre-sacral approach to allow spine surgeons to access and treat intervertebral spaces without compromising important surrounding soft tissue, nerves and bone structures. As of December 31, 2011, the Company was marketing the AxiaLIF family of products for single and multilevel lumbar fusion, the Vectre and Avatar lumbar posterior fixation systems and Bi-Ostetic bone void filler, a biologics product. All of the Company�� AxiaLIF products are delivered using its pre-sacral approach. It generates revenue from the sales of itsimplants and disposable surgical instruments. It has two distinct sales methods. The first method is when implants and/or disposable surgical instruments are sold directly to hospitals or surgical centers for the purpose of conducting a scheduled surgery. In November 2011, the Company launched its VEO Lateral Access and Interbody Fusion System.

The Company sells its products directly to hospitals and surgical centers in the United States and certain European countries, and to independent distributors elsewhere. The Company also markets its products at various industry conferences and through industry organized surgical training course. The Company has developed and markets two fusion products that are delivered using its pre-sacral approach include AxiaLIF 1L and AxiaLIF 2L+. Its products include surgical instruments for creating an access route to the L4/L5/S1 vertebral bodies, fusion implants, as well as supplemental stabilization products.

AxiaLIF Lumbar Fusion Implants

The Company markets AxiaLIF family of products for single and two level lumbar fusion, the VEO lateral access and interbody fusion system, the Vectre and Avatar posterior fixation systems and Bi-Ostet! ic bone void filler, a biologics product. The Company also market products that may be used with its AxiaLIF surgical approach, including bowel retractors, a bone graft harvesting system and additional discectomy tools. Its AxiaLIF implants and instruments, combined with facet screws or pedicle screws, provide surgeons with the tools necessary to perform a lumbar fusion.

The Company's AxiaLIF 1L and AxiaLIF 2L+ implants are threaded titanium rods, that come in varying lengths to enable one-level L5/S1 fusions and two-level L4/L5/S1 fusions. As they are implanted, its design allows for the separation of the vertebrae to restore disc height.

VEO Lateral Access and Interbody Fusion System

This system features a two-stage retraction method that focuses on nerve visualization followed by controlled retraction. The VEO Lateral System is designed for direct visualization of the psoas muscles and adjacent nerves prior to muscle dissection, and features a full range of PEEK lateral interbody implants and a variety of ergonomic instruments.

TranS1 Access and Disc Preparation Instruments

The Company�� pre-sacral approach requires the use of a sterile set of surgical instruments that are used to create a safe and reproducible working channel and to prepare the disc and vertebrae for its implant. The instrumentation contained in the set includes stainless steel navigation tools and tubular dissectors to create the working channel, as well as nitinol cutters and brushes to cut and remove the degenerated disc material and prepares the disc space for its implant and the bone graft material.

Vectre Facet Screw System

The Company's Vectre facet screw system offers a cannulated facet screw inserted over a guidewire to provide stability while reducing the muscle and tissue trauma associated with conventional pedicle screws. The Vectre system features offer a reproducible posterior fixation option in select patients.

A! VATAR Ped! icle Screw System

In January 2010, the Company entered into an agreement to distribute Avatar, a pedicle screw system. Avatar can be used with or without its implants to provide lumbar posterior fixation. The AVATAR MIS System offers cannulated pedicle screws inserted over a guidewire to reduce muscle and tissue trauma. Extended tabs integrated to the screws provide a pathway for implantation of the rod while minimizing tissue dissection.

Bi-Ostetic Bone Void Filler

In February 2010, TranS1 entered into an agreement to sell Bi-Ostetic, an osteoconductive bone substitute. Bi-Ostetic is an alternative to allografts or cadaver bone. The spongy granules are bioceramics with interconnected porosity that mimic the cancellous bone structure.

Iliac Crest Bone Graft Harvesting System

The Company�� Iliac Crest Bone Graft Harvesting System is developed to aid surgeons in harvesting iliac crest autograft via a minimally invasive approach. Use of autograft, which is osteogenic, osteoinductive and osteoconductive, further improves the chances of fusion success. It provides structural support as well as scaffolding for new bone growth.

The Company competes with Medtronic Sofamor Danek, Johnson & Johnson DePuy Spine, Stryker Spine, NuVasive, Zimmer Spine, Synthes, Orthofix International, Globus Medical and Alphatec Spine.

Top Gold Stocks To Watch For 2014: Inergetics Inc (NRTI)

Inergetics, Inc., formerly Millennium Biotechnologies Group, Inc., incorporated on November 9, 2000, is a holding company for its sole operating subsidiary, Millennium Biotechnologies, Inc. (Millennium). The Company through its subsidiary Millennium, engages in the research, development, and marketing of specialized nutritional supplements as an adjunct to medical treatments for select medical conditions, as well as for athletes seeking improved recovery and advanced performance. The Company markets products, which are targeted toward immuno-compromised individuals undergoing medical treatment for diseases, such as cancer, as well as wound healing and post-surgical healing and geriatric patients in long-term care facilities among other conditions. In January 2013, the Company acquired Bikini Ready and SlimTrim brands from Whole Products Group.

The Company�� product portfolio include, Resurgex Select, Ready-To Drink Resurgex Essential and Ready-To-Drink Resurgex Essential Plus. Resurgex Select is a whole foods-based, calorically dense, high-protein powdered nutritional formula developed for cancer patients undergoing chemotherapy or radiation treatments. Resurgex Essential and Resurgex Essential Plus represent Millennium�� Ready-to-Drink product line and are being sold into the Long-Term Care geriatric markets.

Resurgex Select

Resurgex Select is a whole foods-based nutritional product that is designed to be used throughout the course of cancer treatment (chemotherapy, radiation, etc.), as many times patients lose weight and cannot consume adequate nutrition. This product combines dietary fiber (3 g), low sugar (5 g), and high protein (15 g) with no added antioxidants to be a high-calorie (350 calorie) supplement. It is available in three flavors (Vanilla Bean, Chocolate Fudge, and Fruit Smoothie) and each can be mixed with water, milk, juices, or in soft cold foods, such as yogurt, apple sauce or pudding.

Surgex

Surgex (www.surgexspor! ts.com), is a nutritional support formula that aims to address the concerns of many elite athletes who suffer from symptoms, such as fatigue, lean muscle loss, lactic acid buildup, oxidative stress, and stressed immune systems. This formula is designed to improve recovery parameters in efforts to enhance the performance of professional and collegiate athletes.

Resurgex Essential

The Essential line is a ready-to-drink alternative to Ensure and Boost designed to be marketed into the long-term care channel. Resurgex Essential has 250 whole food calories containing no corn syrup or corn oil. The product also contains fruit and vegetable extracts, and FOS Fiber to provide calories and taste.

The Company competes with Nestle and Abbott Laboratories Inc.

5 Best Medical Stocks To Watch For 2014: Telik Inc (TELK)

Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.

Clinical Product Development

TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tolerated. In June 2011, the Company initiated a Phase II clinical ! trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '

The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transfusions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.

TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolerability of the combinations was similar to that expected of each! drug alo! ne.

Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.

Preclinical Drug Product Development

The Company has a small molecule compound, TLK60404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.

The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multiple, standard preclinical models of cancer. TLK60596, a potent VG! FR kinase! inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.

5 Best Medical Stocks To Watch For 2014: Autoimmune Inc (AIMM)

AutoImmune Inc., incorporated in September 1988, is a healthcare company. The Company�� products are based on the principles of mucosal tolerance. The Company�� product is sold by Colloral LLC, the Company�� joint venture with Deseret, under the brand name Colloral, The Collagen Solution and Vital 3, and by Futurebiotics LLC under the brand name Vital 3. The other products which are in the development stage include MBP8298 (dirucotide), Oral Copaxone and AI 401.

The Company completed ten human clinical trials involving over 1,900 patients to investigate the use of Colloral as a pharmaceutical for treating symptoms of rheumatoid arthritis. The Company holds a joint venture with Deseret by forming Colloral LLC to manufacture market and sell Colloral as a dietary supplement. Colloral LLC holds a distributing agreement with Futurebiotics LLC for Colloral. Futurebiotics LLC markets the product under the brand name Vital 3. Colloral LLC also markets the product under the Vital 3 brand through The Shopping Channel of Canada via on air segments and their Website.

The Company�� other products in the development stage include MBP8298 (dirucotide) for multiple sclerosis, which is in Phase III trials for secondary progressive multiple sclerosis; Oral Copaxone is in the research stage for multiple sclerosis, and AI 401 is in Phase III trials for Type 1 diabetes. The development of MBP8298 (dirucotide) is conducted by BioMS Medical Corporation (BioMS). In August 2000, BioMS tested patients in a Phase II/III (MAESTRO-01) clinical trial of its MBP8298 treatment for secondary progressive multiple sclerosis. It was conducted at 47 sites across Canada and Europe. In November 2006, BioMS enrolled in a Phase II clinical trial (MINDSET-01) of MBP8298 for treatment of relapsing remitting multiple sclerosis. It enrolled 218 patients at 24 sites in six countries for a 15 month trial.

The Company collaborated with Eli Lilly, which supports clinical testing of orally administered a! utoimmune-mediated (Type 1) diabetes product, AI 401. Eli Lilly completed three different Phase II clinical trials to demonstrate human proof of principle for AI 401. The United States study was a one-year, double-blind, placebo-controlled trial with more than 200 patients, designed to measure immunological changes, preservation of pancreatic function and time to insulin dependence. Its second Phase II trial, involving approximately 150 patients, was conducted in France. The third trial was conducted in Italy with approximately 80 patients. In addition, Eli Lilly provided AI 401 for the Diabetes Prevention Trial (DPT-1) conducted by the National Institutes of Health (NIH). During the year ended December 31, 2008, the clinical trial of intranasal insulin to delay or prevent the clinical onset of Type I diabetes, called the Diabetes Prediction and Prevention Project was conducted in Finland. As of January 1, 2009, 115 had been enrolled in this trial.

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