Mega Review of Previously Posted DD: For newer
Post# of 1023
For newer investors/readers: Here's a bunch of DD from a number of weeks ago. The paragraphs are good to read, but the links probably will not work.
Note:
All of this DD is from previously posted DD. This DD was copy/pasted from older posts which means THE LINKS IN THIS POST MAY NOT WORK, but if you were to review the actual older posts, the links would probably work:
1.
From GAO: (Government Accountability Office)
441 G St. N.W. Washington, DC 20548
June 30, 2015 The Honorable Harry Reid Senate Minority Leader United States Senate Medical Device Companies: Trends in Reported Net Sales and Profits Before and After Implementation of the Patient Protection and Affordable Care Act
Dated June 30, 2015 - So this is relatively new:
http://www.gao.gov/assets/680/671094.pdf
Note : Read the article and then go to Page 12. Look at #29.
While reading this article, it is important to remember the following:
1. The Government Accountability Office (GAO) is a government agency that provides auditing, evaluation, and investigative services for the United States Congress. It is the supreme audit institution of the federal government of the United States. The fact that the GAO is investigating trends in the medical field and mentions Spectra Science, speaks volumes.
2.
From Aetna-
For anyone who does not know, Aetna is an American managed health care company, which sells traditional and consumer directed health care insurance plans and related services, such as medical, pharmaceutical, dental, behavioral health, long-term care, and disability plans. Aetna is a member of the Fortune 100 .
(Spectra Science mentioned on Page 2)
In Vivo Analysis of Colorectal Polyps and Inflammatory Bowel Disease
While reading this article, it is important to remember the following:
1. Aetna is a Fortune 100 company.
2. This Article was revised April 2014, which means Spectra Science has had 2 YEARS time to prove to the medical company that their product now has sufficient evidence of its effectiveness.
3. The fact that a Fortune 100 company would even consider writing an article which includes a penny stock company says volumes. They didn't have to write about Spectra Science, but they recognize the technology as having the potential to enhance detection of colorectal neoplasia. And now 2 YEARS has gone by from the time this article was written until today, SCIE is on the verge of finally being able to put all of their research and evidence into practice.
Disclaimer : Everything posted is opinion. Do your own DD.
I found the article:
Quote:
________________________________________
On Jun 30, 2009, the FDA received a filing from SPECTRA SCIENCE for a real-time process of change design/components/specifications/material. On Aug 27, 2009, the GU review committee issued the following statement with the approval order:
APPROVAL FOR MINOR DESIGN CHANGES DUE TO THE HARDWARE PARTS
________________________________________
Quote:
________________________________________
The review and decision took 58 days.
________________________________________
So as you can clearly see, it doesn't take long to get a new PMA approval.
http://fdazilla.com/devices/pma/P990050
The good thing about this is that SCIE is willing to spend the money to further enhance their product. They didn't have to modify the WavSTAT3. But they did because they want it to be the best product in its class
BOOM! WavSTAT4 is now viewable on PENTAX Medical's website!
Featured Products
https://pentaxmedical.com/pentax/en/101/1/Advanced-Imaging/
WavSTAT4 Optical Biopsy System
https://pentaxmedical.com/pentax/en/101/1/Wav...sy-System/
Side note:
Anyone read about this?
http://www.businesswire.com/news/home/2015091...Endoscopic
Reminder: SCIE is working with PENTAX and now PENTAX is working with Creo Medical Ltd which could ultimately help promote endoscopic technologies such as the WavSTAT in the UK.
Some interesting links for people who are interested in real DD and not Forum Fluff :
Remember, if you're serious about an investment, you'll want to know the history of the company and not just the daily PPS.
1.
Code of Federal Regulations Title 21 (PMA)
http://www.accessdata.fda.gov/scripts/cdrh/cf...?fr=814.39
2.
Premarket Approvals
http://www.accessdata.fda.gov/scripts/cdrh/cf...er=P990050
3.
FDA Registered Products:
http://www.medevnet.com/search/products/fda_a...%20(COLON)
(Notice SCIE is listed under 'Registered Products')
Some more DD for anyone serious about Spectra Science
1.
Gregory P. Crawford
Vice President and Associate Provost
Professor of Physics
http://physics.nd.edu/people/faculty/gregory-p-crawford/
2.
Gregory P. Crawford Full Curriculum Vitae:
In case someone doesn't know, a Curriculum Vitae is a written overview of a person's experience and other qualifications.
http://physics.nd.edu/assets/19077/crawford_cv.pdf
Spectra Science mentioned in his Curriculum Vitae.
Also notice, Spectra Science is mentioned under the Synergistic Activities heading.
FYI: Synergistic activities include exploratory or synthesis workshops, proposal review panels, organization of symposia, guest editing, or special sessions at conferences, and other activities that serve to advance research and education.
It's nice to know that extremely knowledgeable individuals have had contact with the SCIE team.
Why does all of this matter? Because Gregory P. Crawford isn't just your average Joe. He's actually the VP of the University of Notre Dame. And for whatever reason (more DD might reveal this), he was involved in Sponsored Research with Spectra Science.
Quote:
________________________________________
Gregory P. Crawford, William K. Warren Foundation Dean of the College of Science and professor of physics at the University of Notre Dame, has been appointed associate provost and vice president of the University, effective July 1, 2015.
________________________________________
http://provost.nd.edu/about/associate-provost...e-provost/
Very important read for all serious investors:
1.
Crystal Research Associates, LLC Issues Executive Informational Overview (EIO) on SpectraScience, Inc.
Quote:
________________________________________
The Company's lead platform -- the WavSTAT® Optical Biopsy System -- is in the final stages of a multicenter, 1,200-patient European study and is poised to commence sales in Europe and potentially Saudi Arabia in 2016
________________________________________
http://finance.yahoo.com/news/crystal-researc...00095.html
This was written Aug 12, 2015; 5 months ago.
Quote:
________________________________________
is in the final stages of a multicenter
________________________________________
2
Slideshow:
http://www.slideshare.net/CrystalResearchAsso...erview-ppt
Be sure to read this:
3.
page 9 - The SCIE Patents
http://www.spectrascience.com/investors/pdf/S...5-2015.pdf
At times, in order to find information concerning a stock, a simple Google search wont cut it. Instead, you have to dig deep..
So.. let's dig deep.
Dig Dig Dig..
GOLD! Look what I found..
First, be sure to review posts #60 and #61 where I mentioned 'SIMMEDICA – Sistemas Integrales de Medicina, S.A.'
If you remember, at the bottom of the PENTAX brochure for the WavStat4, there are a bunch of addresses. One of them is for 'SIMMEDICA' in Spain. A little research shows that PENTAX owns 75% of 'SIMMEDICA'. As we know, SCIE is working with PENTAX, which means 'SIMMEDICA' has some sort of relationship (either direct or indirect) with SCIE.
Post #61 took it a little further and proved that the address for SIMMEDICA is the same as the PENTAX address in Spain:
http://imgur.com/tF6kQvB
Going to the SIMMEDICA website, it appears that the website loads but you cant do anything on it. Its pretty much stuck..
http://simmedica.com/
Pulling out 'www.isitdownrightnow.com', we can check to see if the website is down or if its the server:
http://www.isitdownrightnow.com/simmedica.com.html
Quote:
________________________________________
Simmedica.com is UP and reachable.
________________________________________
(You may have to click Search to refresh it from this link)
Results show the website is up, which means a number of possibilities:
1. Website was abandoned
2. Website is under construction
3. SIMMEDICA is making a new website
4. Other possibilities that aren't listed above
Whois.com lookup shows us the SIMMEDICA website will expire in 12 days..
Quote:
________________________________________
Updated Date: 02-mar-2015
Creation Date: 01-mar-2001
Expiration Date: 01-mar-2016
________________________________________
Here's where the digging deep with DD starts to get crazy..(put on your Digging DD caps)
Seeing the SIMMEDICA.com webpage is stuck, and noticing there isn't much information to go off of on the site..
http://simmedica.com/
..I figured, why not travel back in time with our DeLorean DD Time Machine to see what the SIMMEDICA website looked like years ago. Maybe that would give us some information..
Good thing theres a website called 'archive.org'
https://archive.org/web/
I wont get into it, but pretty much https://archive.org/web/ archives websites over the years. It pretty much takes a snapshot of websites and stores it so you can see what a specific website looked like years ago. Example: Yes, you can time travel with it and see what yahoo.com looked like in 2002. It's insane stuff.
Back on track..
I time traveled back to April 7, 2012 and got this result:
http://imgur.com/usZv0kd
(This is what SIMMEDICA.com looked like in 2012)
Notice the companies at the bottom of the screen, especially ERBE .
Google ERBE
About ERBE (French company):
Quote:
________________________________________
As a family-owned and operated business, we have been developing, manufacturing and marketing medical devices for professional use across a wide field of clinical applications for five generations .
________________________________________
http://www.erbe-med.com/us/medical-technology...te-Mission
In case you haven't been around with SCIE awhile, ERBE was mentioned in a SCIE PR..
Quote:
________________________________________
Michel Vaudry, SpectraScience's VP of Sales and Marketing, said, "We are pleased to add another distribution partner in Europe. SIM is a respected and well established medical distribution company and adding the WavSTAT Optical Biopsy System to their portfolio is a strong validation of the need for our technology. SIM was established in 2000 and distributes other leading gastroenterological diagnostic products from market leaders including PENTAX and ERBE ."
________________________________________
http://www.prnewswire.com/news-releases/spect...67057.html
The mention of ERBE on the SIMMEDICA website further strengthens SCIE's connection to the European market.
So, now we Google 'erbe wavstat4' and look what pops up:
..We're so deep down in our DD research right now that we ended up on a French Website..
http://www.etsad.fr/etsad/index.php?module=dm...i=Système
Click the 'Rapport complet' link:
http://www.etsad.fr/etsad/afficher_lien.php?id=5561
.. and we END UP IN THE UNITED KINGDOM where the WavSTAT4 is mentioned in an article only ONE YEAR OLD!!!!
This is the MOTHERLOAD of DD!
Quote:
________________________________________
Horizon Scanning Centre February 2015
________________________________________
The Horizon Scanning Centre isn't some 'mom and pop' shop. Read below:
Quote:
________________________________________
Welcome to the NIHR Horizon Scanning Research & Intelligence Centre , providing the latest news on emerging technologies in healthcare
________________________________________
This report is referring to the WavSTAT4 as an EMERGING TECHNOLOGY!
Does anyone realize the amount of DD that can be performed on this ONE ARTICLE ALONE???
1.
ONGOING STUDIES
http://clinicaltrials.gov/ct2/show/NCT01980134
2.
Quote:
________________________________________
This study is currently recruiting participants . (see Contacts and Locations) Verified April 2014 by SpectraScience Sponsor: SpectraScience
________________________________________
3.
Quote:
________________________________________
The MORDIS Study Clinical Investigational Plan
________________________________________
4.
LOOK AT THE LIST OF COMPANIES INVOLVED IN THIS ONGOING CLINICAL TRIAL WITH SPECTRA SCIENCE!!...
Quote:
________________________________________
Collaborators:
Policlinico Universitario Agostino Gemelli
European Institute of Oncology, Italy
Institut des Maladies de l'Appareil digestif, France
European Georges Pompidou Hospital
Catholic University Hospitals Leuven, Belgium
Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen, Germany
University of Erlangen-Nürnberg
Copenhagen University Hospital at Herlev
SKANE University Hospital Malmö, Sweden
Institute for Clinical and Experimental Medicine
________________________________________
Every single one of these is more possible DD which could open new doors of information about Spectra Science! MIND BLOWING INFORMAITON!!
There's a literal treasure trove of information that would take me days to go through all of this stuff! And all of this stuff DIRECTLY mentions the WavSTAT4.
Details of the WavSTAT study:
https://clinicaltrials.gov/archive/NCT01980134/2014_04_22
Remember, studies take time. They don't find volunteers and then write the report a week later. It can take years. Seeing this was last updated 2014, chances are the study is coming to completion/all ready done. Pathology results (which they compare to WavSTAT results) usually take one to two weeks alone.
The first part is simple DD, but it led elsewhere to a surprise..
1.
To reinforce the fact that real medical professionals are involved with Spectra Science:
Dr Venkat Subramanian
Clinical Associate Professor and Honorary Consultant Gastroenterologist
Quote:
________________________________________
d. I am the principal investigator in the UK for the international multicenter MORDIS trial (NCT01980134) which will evaluate the value of the WavStat 4 optical biopsy system for the characterization of colorectal polyps funded by Spectra Science (USA) and Colorectal HTC .
________________________________________
http://medhealth.leeds.ac.uk/profile/300/1295...ramanian/2
2.
The following part I actualy stumbled on by clicking random links after I read about Dr Venkat Subramanian, but man are you going to like this..
Check out the last sentence above talking about Colorectal HTC helping to fund the WavStat4 study . That's pretty big news; SCIE has companies aiding them in their studies! That's how much interest the market has in SCIE.
Quote:
________________________________________
What is a Healthcare Technology Co-operative?
The National Institute of Health Research (NIHR) has funded eight Healthcare Technology Co-operatives (HTCs) across England. Each HTC acts as a centre of expertise, which will focus on a clinical area of unmet need for NHS patients.
Working collaboratively with industry, each HTC is focused on developing new medical devices, healthcare technologies or technology-dependent interventions, which improve treatment and quality of life for patients.
________________________________________
http://colorectal.htc.nihr.ac.uk/about-the-htc/
3.
So, here we go. Look what I found:
This is from the HTC website in the UK..
Quote:
________________________________________
Our role SpectraScience was keen to find a UK centre to take part in a Europe-wide multi-centre trial to test the accuracy of the WavSTAT technology. The company approached the NIHR Office for Clinical Infrastructure, who put them in touch with the Colorectal HTC.
With our help, SpectraScience met with Dr Venkat Subramanian, Associate Professor and Consultant Gastroenterologist at St James University Hospital, who has a particular expertise and research interests in imaging technologies in endoscopy. As a result, Leeds became the trial’s only UK centre and has, to date, recruited over 60 patients and submitted close to 140 polyps as part of an overall Europe-wide target of 1200. Each polyp is diagnosed during endoscopy using WavSTAT, then sent to two separate pathologists for laboratory analysis – all three diagnoses being reached independently. If the two pathologists reach the same diagnosis, the polyp is submitted into the trial.
Next steps
The trial, now nearing completion , will provide data on the accuracy of diagnosis using WavSTAT, as compared to laboratory analysis. The American Society of Gastrointestinal Endoscopy guidelines require a negative predictive value of 90 per cent for the test to be clinically appropriate. A high negative predictive value means that if the test predicts that the polyp is benign then it is highly likely to diagnosed as benign by the histopathologist as well. This would reduce the risk of missing out any pre-cancerous polyps.
________________________________________
http://colorectal.htc.nihr.ac.uk/ongoing-proj...us-polyps/
..notice it says " The trial, now nearing completion " which as of today, theres a high chance it is completed.
4.
And here's the kicker...
Go here...
http://colorectal.htc.nihr.ac.uk/about-the-ht...nisations/
Scroll down and look at Industry Partners
http://i.imgur.com/jjLkAG0.jpg
Spectra Science is now considered an Industry Partner with another company!
Follow along:
1.
The WavSTAT4 mentioned at the Medical Technologies Advisory Committee:
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
Medical Technologies Advisory Committee (MTAC)
Minutes of the 49th meeting on 19 March 2015
https://www.google.com/url?sa=t&rct=j&...3917,d.dmo
Scroll down to Page 4 of 5..
Quote:
________________________________________
10. MT264 The WavSTAT 4 optical biopsy system for the real time histological assessment of colon polyps in vivo
Prof Venkataraman Subramanian declared a non-personal interest for this technology. Dr James East declared a personal pecuniary and non-personal interest for this technology.
The Committee was asked if there were any specific equality issues to consider in relation to this technology.
Introduced by Brian Selman, Venkataraman Subramanian and James East.
The Committee then considered the technology for selection and routing
________________________________________
2.
The Medical Technologies Advisory Committee operates as a standing advisory committee of the Board of NICE .
This committee (MTAC) advised NICE on:
•Which new medical devices and diagnostics to evaluate
•Deciding which programme within NICE will evaluate each of the new medical devices and diagnostics.
3.
In the UK, The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.
Read more about NICE
https://www.nice.org.uk/Media/Default/About/W...harter.pdf
4.
It's great to see the wavSTAT4 being mentioned at such high level meetings; especially when these meetings are designed to improve the health and social care of the UK
DD Dr James East
Quote from post #99
Quote:
________________________________________
10. MT264 The WavSTAT 4 optical biopsy system for the real time histological assessment of colon polyps in vivo Prof Venkataraman Subramanian declared a non-personal interest for this technology. Dr James East declared a personal pecuniary and non-personal interest for this technology. The Committee was asked if there were any specific equality issues to consider in relation to this technology. Introduced by Brian Selman, Venkataraman Subramanian and James East. The Committee then considered the technology for selection and routing
________________________________________
Dr James East
Notice the above quote states the following about Dr james east:
Quote:
________________________________________
declared a personal pecuniary interest
________________________________________
Pecuniary = money / financial. Which means he has some sort of financial interest of some sort in this company. It doesnt say he has a personal interest. It says he has a financial interest.
Dr James East is an important person in the field of Gastroenterology.
1.
https://www.linkedin.com/in/james-east-6057aa...uthor_name
2.
Quote:
________________________________________
Cellular immunology, In vivo imaging and SNP typing
________________________________________
http://www.expmedndm.ox.ac.uk/tgu/principal-investigators
So, Dr. James East, the Honorary Senior Clinical Lecturer at the Translational Gastroenterology Unit, in John Radcliffe Hospital is interested, out of all the other competitors, in Spectra Science. That says a lot.
http://www.expmedndm.ox.ac.uk/tgu/home
WavSTAT4 shown on the PENTAX FRANCE WEBSITE NOW !!
and
WavSTAT4 shown on the PENTAX ITALY WEBSITE NOW !!
Go to the PENTAX FRANCE and ITALY webpage:
France
http://www.pentaxmedical.com/pentax/service/france?lang=fr
Then go to Menu » Produits » Imagerie avancée
Italy
http://pentaxmedical.com/pentax/service/italy
Then go to Home » Prodotti » Visualizzazione avanzata
So now, the WavSTAT4 shows up as an available product on the PENTAX websites for France, Italy, Germany, the UK, AND Spain!!
EXACTLY like SCIE said it would happen. First Europe, followed by America.
Despite nay-sayers trying to get us to believe that Spectra Science is 'going nowhere', it's obvious Spectra Science is making progress! Try to disprove the WavSTAT4 showing up on FIVE different countries PENTAX websites! YOU CANT! Furthermore, the WavSTAT4 is NOT shown on the USA PENTAX site yet! It PROVES Spectra Science and PENTAX are only showing the WavSTAT4 in countries where it is about to/already is available for purchase!
Remember..
Quote:
________________________________________
As previously announced in June 2012, SpectraScience entered into an exclusive five-year agreement with PENTAX Medical to distribute its WavSTAT Optical Biopsy System for the support of colorectal cancer screening and diagnosis . The agreement, which includes the company's new WavSTAT4 console and the disposable optical biopsy forceps, covers Europe as well as Turkey, Saudi Arabia and South Africa. PENTAX Medical is a leading provider of flexible endoscopes, which are used with the WavSTAT System during screening for colorectal cancer.
________________________________________
http://www.businesswire.com/news/home/2013041...n-WavSTAT4
This FIVE YEAR agreement started in 2012, which means we are almost at the END of this agreement! Which means this agreement has been going on SINCE 2012.
WavSTAT4 shown on the PENTAX SPAIN WEBSITE NOW !!
Go to the PENTAX SPAIN webpage:
http://www.pentaxmedical.com/pentax/service/spain
Then go to Pagina principal » Productos » Imagen avanzada
Notice the WavSTAT4 now shows up as an available product!! JUST LIKE SPECTRASCIENCE SAID IT WOULD! They said they would commercialize the WavSTAT4 first in Europe, Spain, and the UK and the Middle East, and then the USA!! And its happening!
How to know when the WavSTAT4 becomes available for purchase in the USA and globally:
1.
go to the PENTAX USA webpage:
http://pentaxmedical.com/pentax/service/usa?lang=en
Then go to Products > Advanced Imaging
Notice the WavSTAT4 is NOT a product shown here because the WavSTAT4 is not available commercially in the USA, yet .
If we were to check this website weekly (or daily depending on your interest level), and one day you see the WavSTAT4 show up as an available product, we'll know something big has happened with SCIE and that the product is available for purchase.
2.
go to the PENTAX Global webpage:
https://pentaxmedical.com/pentax/service/global?lang=en
Then go to Products > Advanced Imaging
Notice the WavSTAT4 is NOT a product shown here because the WavSTAT is not available globally, yet.
If we were to check this website weekly, (or daily depending on your interest level), and one day you see the WavSTAT4 show up as an available product, we'll know we've made it because the WavSTAT4 has become commercially available for the world. This is what we are all hoping for.
Notice the WavSTAT4 is shown on the PENTAX UK website:
http://pentaxmedical.com/pentax/service/unitedkingdom
..and on PENTAX Germany:
(Home » Produkte » Moderne Bildgebung)
http://www.pentaxmedical.com/pentax/service/germany
So keep your eyes peeled and let's keep each other informed for any changes on these two websites!
bet you've never read this before
1.
The link below takes you to a MASSIVE resource written by filip jelinek of the Netherlands.
http://www.google.com/url?sa=t&rct=j&...3917,d.eWE
Quote:
________________________________________
Filip Jelinek, PhD
Delft University of Technology
Faculty of Mechanical Engineering
BioMechanical Engineering
________________________________________
2.
Interesting. Mechanical Engineering? What could that have to do with the WavSTAT4?
Scroll to the bottom of Page 17 . Ah.. look what that is! The last diagram is the WavSTAT4's endoscope! (letter C)
3.
Now read the description on Page 18 (image below shows it)
So what's the point of this? The point is, how many people prior to reading this have actually read this before? That's the point. There is so much information out there about the WavSTAT4 it's overwhelming. 1. The fact alone that it was mentioned in this article is incredible. 2. The fact that it was written in the Netherlands is even more amazing because hospitals in the Netherlands are actively working to get the WavSTAT4 in their facilities. 3. And the best part is that Filip Jelinek describes the WavSTAT4 openly in this reading. He didn't have to. He could have said, "..but this technology will not work because..".
This is just more evidence that shows very intelligent professionals, many of them the leaders in their field, know of the WavSTAT4 and its potential.
Do you think that Filip Jelinek, a PhD, just randomly discovered the WavSTAT4 and randomly wrote about it because he had nothing better to do? No way! Michael Oliver and everyone behind Spectra Science WORKED day in and day out to set up appointments and meetings in order to showcase their product to countless facilities around the world. This is clear evidence that the CEO and staff are actively working to get their product into as many hospitals as possible.
WavSTAT mentioned AGAIN . This time in a 36-page Getinge pamphlet / PENTAX from 2014. Not only that, but its mentioned in a picture chart on page TWO . Page two? Not hidden all the way in the back? Nice. Not only that, but it's mentioned under the title:
Quote:
________________________________________
Supporting the pillars of Quality in Colonoscopy
________________________________________
..and subheading
Quote:
________________________________________
Lowest rate of complications
________________________________________
Check it out..
http://www.gastroenterologytoday.com/wp-conte..._V2_LR.pdf
This one chart is pretty much saying, " Gone are the days where the medical field has one generic endoscope to shove up your butt. Now, we have many, specialty endoscopes (including the WavSTAT) to shove up there ".
SpectraSCIENCE Inc. (SCIE) Stock Research Links
http://investorshangout.com/Joeys-Investment-Board-91611/
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