Best of the Week
Most Popular
1. Investing in a Bubble Mania Stock Market Trending Towards Financial Crisis 2.0 CRASH! - 9th Sep 21
2.Tech Stocks Bubble Valuations 2000 vs 2021 - 25th Sep 21
3.Stock Market FOMO Going into Crash Season - 8th Oct 21
4.Stock Market FOMO Hits September Brick Wall - Evergrande China's Lehman's Moment - 22nd Sep 21
5.Crypto Bubble BURSTS! BTC, ETH, XRP CRASH! NiceHash Seizes Funds on Account Halting ALL Withdrawals! - 19th May 21
6.How to Protect Your Self From a Stock Market CRASH / Bear Market? - 14th Oct 21
7.AI Stocks Portfolio Buying and Selling Levels Going Into Market Correction - 11th Oct 21
8.Why Silver Price Could Crash by 20%! - 5th Oct 21
9.Powell: Inflation Might Not Be Transitory, After All - 3rd Oct 21
10.Global Stock Markets Topped 60 Days Before the US Stocks Peaked - 23rd Sep 21
Last 7 days
Chinese Tech Stocks CCP Paranoia and Best AI Tech Stocks ETF - 26th Oct 21
Food Prices & Farm Inputs Getting Hard to Stomach - 26th Oct 21
Has Zillow’s Collapse Signaled A Warning For The Capital Markets? - 26th Oct 21
Dave Antrobus Welcomes Caribou to Award-Winning Group Inc & Co - 26th Oct 21
Stock Market New Intermediate uptrend - 26th Oct 21
Investing in Crypto Currencies With Both Eyes WIDE OPEN! - 25th Oct 21
Is Bitcoin a Better Inflation Hedge Than Gold? - 25th Oct 21
S&P 500 Stirs the Gold Pot - 25th Oct 21
Stock Market Against Bond Market Odds - 25th Oct 21
Inflation Consequences for the Stock Market, FED Balance Sheet - 24th Oct 21
To Be or Not to Be: How the Evergrande Crisis Can Affect Gold Price - 24th Oct 21
During a Market Mania, "no prudent professional is perceived to add value" - 24th Oct 21
Stock Market S&P500 Rallies Above $4400 – May Attempt To Advance To $4750~$4800 - 24th Oct 21
Inflation and the Crazy Crypto Markets - 23rd Oct 21
Easy PC Upgrades with Motherboard Combos - Overclockers UK Unboxing - MB, Memory and Ryzen 5600x CPU - 23rd Oct 21
Gold Mining Stocks Q3 2021 - 23rd Oct 21
Gold calmly continues cobbling its Handle, Miners lay in wait - 23rd Oct 21
US Economy Has Been in an Economic Depression Since 2008 - 22nd Oct 21
Extreme Ratios Point to Gold and Silver Price Readjustments - 22nd Oct 21
Bitcoin $100K or Ethereum $10K—which happens first? - 22nd Oct 21
This Isn’t Sci-Fi: How AI Is About To Disrupt This $11 Trillion Industry - 22nd Oct 21
Ravencoin RVN About to EXPLODE to NEW HIGHS! Last Chance to Buy Before it goes to the MOON! - 21st Oct 21
Stock Market Animal Spirits Returning - 21st Oct 21
Inflation Advances, and So Does Gold — Except That It Doesn’t - 21st Oct 21
Why A.I. Is About To Trigger The Next Great Medical Breakthrough - 21st Oct 21
Gold Price Slowly Going Nowhere - 20th Oct 21
Shocking Numbers Show Government Crowding Out Real Economy - 20th Oct 21
Crude Oil Is in the Fast Lane, But Where Is It Going? - 20th Oct 21
3 Tech Stocks That Could Change The World - 20th Oct 21
Best AI Tech Stocks ETF and Investment Trusts - 19th Oct 21
Gold Mining Stocks: Will Investors Dump the Laggards? - 19th Oct 21
The Most Exciting Medical Breakthrough Of The Decade? - 19th Oct 21
Prices Rising as New Dangers Point to Hard Assets - 19th Oct 21
It’s not just Copper; GYX indicated cyclical the whole time - 19th Oct 21
Chinese Tech Stocks CCP Paranoia, VIES - Variable Interest Entities - 19th Oct 21
Inflation Peaked Again, Right? - 19th Oct 21
Gold Stocks Bouncing Hard - 19th Oct 21
Stock Market New Intermediate Bottom Forming? - 19th Oct 21
Beware, Gold Bulls — That’s the Beginning of the End - 18th Oct 21
Gold Price Flag Suggests A Big Rally May Start Soon - 18th Oct 21
Inflation Or Deflation – End Result Is Still Depression - 18th Oct 21
A.I. Breakthrough Could Disrupt the $11 Trillion Medical Sector - 18th Oct 21
US Economy and Stock Market Addicted to Deficit Spending - 17th Oct 21
The Gold Price And Inflation - 17th Oct 21
Went Long the Crude Oil? Beware of the Headwinds Ahead… - 17th Oct 21
Watch These Next-gen Cloud Computing Stocks - 17th Oct 21
Overclockers UK Custom Built PC 1 YEAR Use Review Verdict - Does it Still Work? - 16th Oct 21
Altonville Mine Tours Maze at Alton Towers Scarefest 2021 - 16th Oct 21

Market Oracle FREE Newsletter

How to Protect your Wealth by Investing in AI Tech Stocks

This Bioscience Company Has "Nearly Limitless" Income Potential

Companies / BioTech Aug 07, 2015 - 02:45 PM GMT

By: ...

Companies

MoneyMorning.com Ernie Tremblay writes: Medical device companies can be profit-making machines – one manufacturer of magnetic resonance imaging (MRI) machines and other high-tech products is up more than 250% over the past 12 months, for instance.

Most of them make their living by staying on the leading edge of innovation, producing some of the coolest gadgets you can imagine.

And, even better, they can deliver some of the most impressive gains in the bioscience industry to their shareholders.


The good performance of these manufacturers gives you some idea of the potential we're dealing with here.

Just look at these soaring share prices…

These Three Companies Have Easily Beaten the Markets

Boston Scientific Corp. (NYSE: BSX) develops, manufactures, and markets medical devices for the cardiology markets, including stents, balloon catheters, wires, and peripheral embolization devices, among many, many other items. The company also makes products to treat diseases of the digestive, urinary, and pulmonary (lung) systems. Boston Scientific is up 40% over its price this time last year.

Hologic Inc. (Nasdaq: HOLX) makes a broad array of diagnostics products, medical imaging systems, and surgical products for women, such as digital and film-based mammography systems, computer-aided detection (CAD) for mammography, invasive breast biopsy devices, breast biopsy site markers, breast biopsy guidance systems, and breast brachytherapy products (radioactive inserts). Hologic shares are currently up 64% over their value one year ago.

IRadimed Corp. (Nasdaq: IRMD) develops, manufactures, markets, and distributes magnetic resonance imaging (MRI) compatible products in the United States and internationally. It offers non-magnetic intravenous (IV) infusion pump systems and accessories, wireless remote displays/controls under the mRidium name, sidecar pumps, and dose error reduction systems, among many other products. IRMD stock is up a whopping 250% over the past 12 months.

This Is a Big Market – and It's Getting Bigger

Although medical device companies and biotechs that develop new drugs play on similar fields, there are significant differences both in the markets they target and in the regulatory process they undergo. It's important for investors to understand these differences when choosing where to put their capital.

Because drugs require repeated dosing, sometimes over the course of a patient's life, biotechs and pharmaceutical companies concentrate their sales efforts on prescribers, and more recently, on the patients themselves. Manufacturers realize profits on every dose.

According to the IMS Institute for Healthcare Informatics, Americans filled 4.3 billion prescriptions last year, spending nearly $374 billion on medicine.

The marketing model for devices is a bit different and more complex. Medical gadgets may diagnose or treat disease, monitor health, or deliver medication. For the most part, they're sold to clinics or hospitals, although there is also a physicians' market, and some products, such as lancets and test strips for diabetics, are sold directly to patients.

Many devices, such as monitors and imaging machines, are one-time sales. Manufacturers will realize a profit only once, without much reordering. So innovation – coming up with new devices that improve upon and replace the old ones – drives this market.

Other devices, such as infectious disease diagnostic kits, are used once per patient and then discarded. This is a broader market, driven in part by innovation, but more by reordering. Seven billion lab tests are done in the United States every year.

In total, the size of the device market is comparable to that of the medication market. Analysts estimate current global sales at $361 billion and expect the market to grow to $427 billion by 2018.

Understand the Regulatory Track and Book Profits

The U.S Food and Drug Administration (FDA) classifies medical devices in three categories:

  • Class I devices, such as bandages, tongue depressors, and examination gloves, present a low risk of harm to the user and are usually exempt from the regulatory process.
  • Class II devices, such as CT scanners and contact lens care products, are more complicated and require special controls for labeling, guidance, tracking, design, performance standards, and post-market monitoring.
  • Class III devices, such as pacemakers and breast implants, present potential risk of illness or injury. They have the toughest regulatory controls.

Before a manufacturer can test a new device to collect safety and effectiveness data, it must receive an investigational device exemption (IDE) for the product. Both the FDA and an independent institutional review board (IRB) must approve an IDE for Class III products before any study can begin. Class II products must gain approval only from an IRB. The 30-day review is intended to determine that the device is safe enough to test on humans and the proposed clinical study protocol is adequate to demonstrate safety and effectiveness.

Following clinical studies, a device can take one of three regulatory paths:

  • Pre-Market Notification (510(k)). Required when demonstrating substantial equivalence to a legally marketed device, when making significant modifications to a marketed device, and when a person required to register with the FDA introduces a device for the first time.
  • Pre-Market Approval Application (PMA). Required to evaluate the safety and effectiveness of Class III devices or devices that were found not substantially equivalent to a Class I or II predicate through the 510(k) process. This is both a scientific and regulatory review, evaluating benefit versus risk. Reviewable evidence includes controlled or partially controlled studies, historical controls, well-documented case, and clinical experience. Data about one device cannot be used as evidence to support another.
  • Humanitarian Device Exemption (HDE). This designation is given to devices that benefit patients by treating or diagnosing a disease or condition affecting fewer than 4,000 individuals in the United States per year. It is the equivalent of orphan status in drug development. HDEs are exempt from requirements to demonstrate effectiveness but must pose no unreasonable risks. The device must be used at a facility with an IRB.

As with medications, news of positive data releases, approvals, and favorable FDA classification can make stock prices soar.

One Very Cool Device Bound to Make Big Gains

Of all the exciting new gadgets now on the market, one of the most impressive – and coolest – is the Argus II Retinal Prosthesis System, the world's first bionic eye approved by both the FDA and the European Union. It can restore some functional vision to people suffering from blindness.

The device is manufactured and sold by Second Sight Medical Products Inc. (Nasdaq: EYES).

Argus II has an HDE classification in the United States to provide electrical stimulation of the retina to induce visual perception in blind patients with severe to profound retinitis pigmentosa (RP) and little or no light perception in both eyes, though the effectiveness of this device for this indication has yet to be proven.

Here's how it works.

Some types of blindness are caused by damage to cells in the back of the eye called photoreceptors, which come in two types: cones for perceiving visual color images in bright light, and rods, which are not receptive to color, for seeing in dimmer light and for peripheral vision.

Argus II bypasses these damaged cells via interplay between a miniature camera, a patient-worn visual processing unit (VPU), and an implant in the eye. The camera, housed in the patient's glasses, passes an image to the VPU, which translates it into a set of instructions that are then transmitted, via the camera, to an antenna in the implant. The implant, in turn, follows the instructions by sending certain electrical impulses to remaining healthy photoreceptors in the eye, which then pass along the message through the optic nerve to be decoded as an image in the brain.

EYES is also exploring use of the device in people with blindness due to a condition called wet macular degeneration (WMD).

There Is Nearly Limitless Income Potential with EYES

About 1.5 million people around the world suffer from RP, and about 2 million from WMD. Cost for one system is about $150,000, excluding surgery and the cost of learning how to use the system.

The potential income for Second Sight is staggering.

And the company is living up to its promise. On Aug. 4, 2015, the company reported it had grown net revenue by 335% to $2.7 million in the second quarter of 2015, compared to $0.6 million in the prior-year period.

With a market cap of $492 million and shares selling for around $13, this is an affordable stock poised to take off like a rocket.

Action to Take: Buy Second Sight Medical Products Inc. (Nasdaq: EYES) at market and set a 35% trailing stop to protect your investment.

Source :http://moneymorning.com/2015/08/06/the-best-way-to-buy-gold-today/

Money Morning/The Money Map Report

©2015 Monument Street Publishing. All Rights Reserved. Protected by copyright laws of the United States and international treaties. Any reproduction, copying, or redistribution (electronic or otherwise, including on the world wide web), of content from this website, in whole or in part, is strictly prohibited without the express written permission of Monument Street Publishing. 105 West Monument Street, Baltimore MD 21201, Email: customerservice@moneymorning.com

Disclaimer: Nothing published by Money Morning should be considered personalized investment advice. Although our employees may answer your general customer service questions, they are not licensed under securities laws to address your particular investment situation. No communication by our employees to you should be deemed as personalized investent advice. We expressly forbid our writers from having a financial interest in any security recommended to our readers. All of our employees and agents must wait 24 hours after on-line publication, or after the mailing of printed-only publication prior to following an initial recommendation. Any investments recommended by Money Morning should be made only after consulting with your investment advisor and only after reviewing the prospectus or financial statements of the company.


© 2005-2019 http://www.MarketOracle.co.uk - The Market Oracle is a FREE Daily Financial Markets Analysis & Forecasting online publication.


Post Comment

Only logged in users are allowed to post comments. Register/ Log in