This corner of the market has been a good performer as well to start the year, as the sector has fought through Obamacare tax worries to post strong long term gains. In fact, top ETFs in the space have beaten out the S&P 500 over the past five years by a decent margin, suggesting a pretty good track record for the industry (see Medical Device ETFs: A Better Way to Play Health Care?).
However, the recent run may be coming to an end thanks to some weakness in one of the sector�� key components. Surgical device maker Intuitive Surgical (ISRG) gave a bad warning for its Q2 results, pushing its shares sharply lower by about 18% on the day (ISRG currently has a Zacks Rank #4- Sell).
Top 5 Medical Stocks For 2015: Impax Laboratories Inc.(IPXL)
Impax Laboratories, Inc., a specialty pharmaceutical company, engages in the development, manufacture, and marketing of bioequivalent pharmaceutical products. The company operates in two divisions, Global Pharmaceuticals and Impax Pharmaceuticals. The Global Pharmaceuticals division develops, manufactures, sells, and distributes generic pharmaceutical products. It provides its generic pharmaceutical prescription products directly to wholesalers and retail drug chains; and generic pharmaceutical over-the-counter and prescription products through unrelated third-party pharmaceutical entities. The Impax Pharmaceutical division develops proprietary brand pharmaceutical products that address central nervous system disorders, including Alzheimer?s disease, attention deficit hyperactivity disorder, depression, epilepsy, migraines, multiple sclerosis, Parkinson?s disease, and schizophrenia, as well as promotes third-party branded pharmaceutical products. As of May 2, 2011, the com pany marketed 101 generic pharmaceuticals, which represent dosage variations of 29 different pharmaceutical compounds; and another 16 of its generic pharmaceuticals representing dosage variations of 4 different pharmaceutical compounds. It markets and sells its generic pharmaceutical prescription drug products in the continental United States and the Commonwealth of Puerto Rico. The company has a strategic alliance agreement with Teva Pharmaceuticals Curacao N.V. Impax Laboratories, Inc. was founded in 1993 and is headquartered in Hayward, California.
Advisors' Opinion:- [By Eric Volkman]
Impax Laboratories (NASDAQ: IPXL ) �will soon hand out a raft of pink slips. As part of a move to slice costs, the company has announced a reduction in its headcount by roughly 110 employees. Most of these cuts will be effected at its manufacturing facility in Hayward, Calif.
- [By Keith Speights]
Impax Laboratories (NASDAQ: IPXL ) could be watching more closely than Sanofi. The two companies reached a deal last year that allows Impax to begin marketing a generic version of Renvela in 2014. If approved, Zerenex could take away some of the profits that Impax expected to gain.�
- [By Garrett Cook]
Shares of Impax Laboratories (NASDAQ: IPXL) were down 12.81 percent to $24.44 after the FDA issued a Form 483 with 10 inspectional observations for Impax Taiwan plant.
- [By Max Macaluso, Ph.D.]
RLS hasn't been a high-priority target for the pharma industry given the lackluster sales of Requip and Horizant, a third competitor of�UCB's Neupro, and a number of generic alternatives. Impax Laboratories (NASDAQ: IPXL ) was one of the few developing a new therapy, called IPX159, but Impax put the kibosh on the drug after it failed to meet its primary endpoint in a phase 2b study. According to its latest quarterly report, Impax has no other RLS drugs in development and seems to be focusing on getting its rejected Parkinson's disease drug Rytary back to the FDA for a second chance at approval.
Top 5 Medical Stocks For 2015: Bacterin International Holdings Inc (BONE)
Bacterin International Holdings, Inc. (Bacterin), formerly K-Kitz, Inc., develops, manufactures and markets biologics products to domestic and international markets through Bacterin's biologics division. Its products are used in a variety of applications, including enhancing fusion in spine surgery, relief of back pain with a facet joint stabilization, promotion of bone growth in foot and ankle surgery, promotion of skull healing following neurosurgery and subcondral bone defect repair in knee and other joint surgeries. The Company has developed and manufacture and sell several human tissue-based products, primarily allografts, into the medical marketplace through its biologics division. In addition, it also manufactures and sells, directly under its own name and indirectly through distributors, various coating and surgical drain products through its medical devices division.
The Company�� medical devices division develops medical devices intended for use in several diverse clinical areas, including orthopedic, plastic, and cardiovascular surgery. The medical devices division also develops custom surgical instrument kits for use with allografts processed by its biologics division. The medical devices division actively develops intellectual property associated with its devices and coating platforms, for the purposes of protecting its Bacterin-branded devices and for use in alliance projects. The manufacturing and operations of the biologics and medical devices divisions are organized separately while products from both are marketed through several channels, including independent distributors, joint development projects and its direct sales network.
Biologics Division
The Company�� biologics products include OsteoSponge, OsteoSponge SC, OsteoWrap, OsteoLock and BacFast, as well as certain other allograft products, such as OsteoSponge, OsteoWrap, OsteoLock and BacFast and hMatrix. OsteoSponge is a form of demineralized bone matrix made from 100% human bone. Ost! eoSponge provides a natural scaffold for cellular in-growth and exposes bone-forming proteins to the healing environment. The malleable properties of OsteoSponge enable it to conform to, and fill, defects. Upon compressing the allograft, OsteoSponge springs back to completely fill the void. Its mechanical and biological properties make OsteoSponge an bone graft for use in various orthopedic practices, including spine, neurology, cranial/maxillofacial, trauma, plastic/reconstruction and general procedures where new bone growth is needed.
OsteoSponge SC is a form of OsteoSponge designed to be used in joint surgery. Bacterin has shown, in goat studies, the ability to re-generate cartilage in joint repair and believes that this product has the potential to significantly change the standard of care in human joint surgery. OsteoWrap is 100% human cortical bone demineralized through a process to make the graft flexible while maintaining allograft integrity. This product has various applications in orthopedic, neurological, trauma, oral/maxillofacial and reconstructive procedures. OsteoWrap can wrap around non-union fractures to assist with fusion, can act as a biologic plate or can be used in conjunction with a hardware plate system. Additionally, this product provides the surgeon with superior handling characteristics as the allograft can be easily sized using surgical scissors or a scalpel, and will withhold sutures or staples for fixation.
OsteoLock and BacFast are dowels made from human bone. BacFast HD, having the same design as OsteoLock, is optimized through its demineralization technology. OsteoLock and BacFast can be used to augment spinal procedures for mild spinal conditions. hMatrix dermal scaffold is an extension of Bacterin's core biologics technology and its third human acellular biological scaffold. hMatrix is an acellular matrix made from donated human dermal tissue that is used to replace a patient's damaged tissue. hMatrix provides a natural collagen tissue scaffold! that pro! motes cellular ingrowth, tissue vascularization and regeneration. The Company makes and sells sports allografts which are processed specifically for anterior and posterior cruciate ligament repairs, anterior cruciate ligament reconstruction and meniscal repair; milled allografts, which are consists of cortical bone milled to desired shapes and dimensions, also called milled spinal allografts, and traditional allografts for multi-disciplinary applications, including orthopedics, neurology, podiatry, oral/maxillofacial, genitourinary and plastic/reconstructive.
Medical Device Products
The Company�� medical devices division researches, tests and develops coatings for medical devices, particularly antimicrobial-based coatings. This division produces and distributes OsteoSelect DBM putty, an osteoinductive product used by surgeons as bone void filler in the extremities and pelvis. OsteoSelect DBM putty is engineered with the surgeon in mind. OsteoSelect can be molded into any shape and compressed into bony voids. Its medical devices division also develops custom surgical instrument kits for use with allografts processed by its biologics division. The Company sells a surgical drain series called ViaTM, which is used to drain exudate from a surgical site. Building upon the ViaTM platform, Bacterin plans on releasing a second generation product called the Elutia surgical drains, which will be performance enhanced through an antimicrobial coating to help reduce the incidence of surgical site infection.
The Company competes with Medtronic, DePuy, Synthes, Arthrex, Smith & Nephew, Nuvasive, OrthoFix, Biomet, Osteotech, Orthovita, MTF, Stryker, RTI, AlloSource, Lifenet Health, Integra, ConMed/Linvatec, Wright, Exactech, ArthroCare, Harvest and Arteriocyte.
Advisors' Opinion:- [By James E. Brumley]
Traders may not want to get married for the long haul to any of them, but for speculators looking for a quick, profitable hit, Arca Biopharma Inc. (NASDAQ:ABIO), Pluristem Therapeutics Inc. (NASDAQ:PSTI), and Bacterin International Holdings Inc. (NYSEMKT:BONE) may be better-than-average bets. Here's why.
- [By Bryan Murphy]
It may not be as big as NuVasive, Inc. (NASDAQ:NUVA), and it might not be as sexy as MiMedx Group Inc. (NASDAQ:MDXG). But, Bacterin International Holdings Inc. (NYSEMKT:BONE) offers something to investors that MDXG and NUVA don't - can't - right now... a distinct opportunity for a lot of upside in a short amount of time.
Top 10 Industrial Disributor Stocks To Invest In Right Now: Oncolytics Biotech Inc (ONCY)
Oncolytics Biotech Inc. (Oncolytics), incorporated on April 2, 1998, is a development-stage company. The Company is focused on its research and development of REOLYSIN, which is its cancer therapeutic. REOLYSIN is developed from the reovirus. This virus has been demonstrated in tumour cells bearing an activated Ras pathway. Oncolytics is directing a clinical trial program with the focus of developing REOLYSIN as a human cancer therapeutic. The clinical program includes clinical trials, which it sponsors directly along with Third Party Clinical Trials. Third Party Clinical Trials are clinical trials that are being sponsored by other institutions. As of December 31, 2011, the United States National Cancer Institute (NCI), the University of Leeds and the Cancer Therapy & Research Center at the University of Texas Health Center in San Antonio (CTRC) were sponsoring part of its clinical trial program.
The Company�� clinical trial program has included human trials using REOLYSIN alone, and in combination with radiation and chemotherapy, and delivered via local administration and/or intravenous administration. Oncolytics uses contract toll manufacturers to produce REOLYSIN. On December 31, 2011, the Company had two wholly owned subsidiaries, Oncolytics Biotech (Barbados) Inc. (OBB) and Valens Pharma Ltd. Oncolytics Biotech (US) Inc. and Oncolytics Biotech (U.K.) are wholly owned subsidiaries of OBB.
Advisors' Opinion:- [By Maxx Chatsko]
T-VEC is not your traditional biologic drug. It is actually a bioengineered form of the herpes virus that, once injected into cancerous tumors, replicates, and produces an immune-stimulating protein that puts a bulls eye on cancer cells throughout the body. Despite its promise and intriguing mechanism of action, T-VEC is not in further development at Amgen. However, Oncolytics (NASDAQ: ONCY ) has shown promising results for its bioengineered form of reovirus called Reolysin. Initial phase 3 results showed that 86% of patients taking the drug had reduced tumor mass or growth after six weeks of treatment. �
- [By Sean Williams]
With this in mind, I feel it'd be prudent of biotech-savvy investors to give Oncolytics Biotech (NASDAQ: ONCY ) a closer look.
The big risks
I'm quite aware that there are a lot factors that'd raise a red flag with Oncolytics. Similar to Affymax, you could say that Oncolytics has put all of its eggs in one basket with its lead experimental drug, reolysin. According to Oncolytics' website, including its U.K., Canadian, and U.S. studies, reolysin as either a monotherapy or combination therapy is the basis for all 31 clinical trials! Obviously, if reolysin proves ineffective or unsafe, Oncolytics is going to be a world of hurt. - [By John Udovich]
The biotech sector along with small cap biotech stocks Cardiome Pharma Corp (NASDAQ: CRME), Oncolytics Biotech, Inc (NASDAQ: ONCY), Vital Therapies Inc (NASDAQ: VTL) and TNI BioTech (OTCMKTS: TNIB) have all been producing their share of news this week for investors and traders alike to trade on. Moreover and while some 42 ��ife sciences��companies have gone public raising about $3 billion from investors so far this year, there are a growing number of biotechs pulling the plug on upcoming IPOs who are citing market conditions. With that in mind, here is a look at important news from the biotech sector and small cap biotech stocks this week:
Top 5 Medical Stocks For 2015: Cytomedix Inc (CMXI)
Cytomedix, Inc. (Cytomedix), incorporated in April 29, 1998, is a regenerative therapies company marketing and developing products within the United States and internationally .The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The Company is a commercial operation, and a robust clinical pipeline representing a logical extension of its commercial technologies in the evolving field of regenerative medicine. Cytomedix primarily operates in the United States. Its commercial offerings are centered on its point of care platform technologies for the safe and efficient separation of blood and bone marrow to produce platelet based therapies or cell concentrates.
The Company markets and selsl two distinct platelet rich plasma (PRP) technologies, the AutoloGel System for wound care and the Angel concentrated Platelet Rich Plasma (cPRP) Sytem in orthopedic and cardiovascular markets. Its clinical pipeline includes the ALDH, which are cell-based therapies (Bright Cells). In February 2012, the Company acquired Aldagen, Inc.
The AutoloGel System
The AutoloGel System is a point of care device for the production of a platelet based bioactive therapy derived from a small sample of the patient�� own blood. Using the patient�� own platelets as a therapeutic agent, AutoloGel harnesses the body�� natural healing processes to deliver growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and the formation of new tissue.
Angel Product Line
The Angel concentrated Platelet Rich Plasma (cPRP) System is a multi-functional cell separation device which produces concentrated platelet rich plasma for use in the operating room and clinic and is used in a range of orthopedic and cardiovascular indications. Similar to the AutoloGel System, the Angel System is a point of care device for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient�� own blood. The resulting cPRP is applied at the site of injury to promote healing. The Angel product line also includes ancillary products such as phlebotomy and applicator supplies and activAT. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products.
ALDHbr Cell Technology and Development Pipeline
The ALDHbr (Bright Cell) technology is an approach to cell-based regenerative medicine and a logical extension of its commercial technologies in the evolving regenerative medicine market, with potential clinical indications in markets with unmet medical needs such as peripheral arterial disease and ischemic stroke. The Bright Cell technology is in that it utilizes an intracellular enzyme marker to facilitate fractionation of essential regenerative cells from a patient�� bone marrow. The bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation.
The Company�� lead product candidate, ALD-401, is an autologous preparation of Bright Cells for the post-acute treatment of ischemic stroke. ALD-401 is being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase 2 study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of less than 22. An additional product candidate, ALD-301, is in clinical development for peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles in the leg. It has completed a Phase 1/2 study of autologous ALD-301 in critical limb ischemia (CLI), a late stage condition caused by PAD. The Phase 2 PACE! (Patient! s with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.
The Company competes with Harvest Technologies (a subsidiary of Terumo), Biomet, Arteriocyte, and Arthrex.
Advisors' Opinion:- [By Bryan Murphy]
When traders think of post-surgical wound management stocks, they may first think of names like Cytomedix, Inc. (OTCBB:CMXI) or Alliqua Inc. (OTCMKTS:ALQA). And well they should. Both companies have something of a history in the arena. ALQA is the purveyor of SilverSeal and Hydress antibiotic bandages, while CMXI is the developer of the AutoloGel system, which induces an affected patient's on body to do what it's supposed to do if there's a wound that won't heal. Cytomedix also makes the Angel platelet-rich plasma (PRP) delivery system. There's a relatively new name to add to the list of game-changing stocks in wound-management industry, however.... Arch Therapeutics Inc. (OTCBB:ARTH). The company is developing - well, has developed - a product called AC5 that nips post-surgical bleeding in the bud, largely negating the need for other post-surgical bleeding-control measures.
- [By James E. Brumley]
To give credit where it's due, Cytomedix, Inc. (OTCBB:CMXI) and Baxter International Inc. (NYSE:BAX) have both helped shape the landscape of the hemostasis (bleeding control) market with their products, AutoloGel and TISSELL, respectively. Arch Therapeutics Inc. (OTCBB:ARTH) has proverbially taken their concepts "up a notch", however, and its direct solution to a problem that CMXI and BAX can't quite solve may make ARTH the hottest trading candidate in the hemostasis space.
Top 5 Medical Stocks For 2015: Euromedis Groupe SA (EMG)
Euromedis Groupe SA is a France-based company that specializes in the design, manufacture, distribution, rental and export of medical and surgical equipment and products, and services for medical home care for hospitals, clinics, retirement homes, physicians, pharmacies, and individuals. The Company's product portfolio include products, such as syringes and needles; surgical equipment, such as catheters, instrumentation and compresses; gloves; hygiene products, comprising disposable clothing, masks and paper towel products, and pharmaceutical equipment, offering cotton wool and thermometers. Euromedis Groupe SA exports its products to Europe and Africa. Advisors' Opinion:- [By Sofia Horta e Costa]
Man Group Plc (EMG) jumped 6.8 percent to 104.3 pence. The world�� largest publicly traded hedge-fund manager said it no longer needs to hold a $300 million capital buffer after it confirmed with the U.K.�� Financial Conduct Authority a change in the company�� regulatory status.
- [By Inyoung Hwang]
Man Group Plc (EMG) advanced 3.6 percent to 85.85 pence. The world�� largest publicly traded hedge-fund manager posted its first quarterly net inflows in two years as clients added money to funds at its GLG Partners unit. Sales of Man Group�� funds totaled $4.1 billion in the third quarter, exceeding $3.4 billion of redemptions.
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