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New patent out and no PR? 1/21/2016
Chad Wayne Lewis also is named on a number of Stryker patents.
Application Number: 14801665 Application Date: 16.07.2015
Publication Number: 20160015523 Publication Date: 21.01.2016
"Using screws to fasten the disc spacer directly the to the bone."
1. (US20160015523) INTERVERTEBRAL SPACERS AND RELATED METHODS AND INSTRUMENTS
https://patentscope.wipo.int/search/en/detail.jsf?docId=US154280886&recNum=1&maxRec=244&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=amedica&tab=NationalBiblio
https://patentscope.wipo.int/search/en/detail.jsf?docId=US154280886&recNum=1&tab=Drawings&maxRec=244&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=amedica
The Board of Directors interviewed two of the three nominees at the request of VCM. The third nominee was not available for an interview by the Board of Directors.By unanimous decision, the Company’s Board of Directors decided not to include any of the individuals nominated by VCM as nominees of the Board of Directors at the Annual Meeting due to their lack of relevant experience and industry knowledge, to serve on the Company’s Board of Directors.
May 26th meeting
The annual meeting of the stockholders of Amedica Corporation, a Delaware corporation, will be held at 11:00 a.m., local time, on May 26, 2016, at 1885 West 2100 South, Salt Lake City, UT 84119, for the following purposes:
to elect two Class II directors to hold office for a three-year term expiring at the annual meeting of stockholders to be held in 2019 or until their respective successors are elected and qualified;
to approve an amendment to the Amedica 2012 Equity Incentive Plan increasing the number of common shares authorized for awards under the Plan by 800,000 to a total of 1,142,425 shares;
to ratify the Audit Committee’s appointment of Mantyla McReynolds LLC as Amedica’s independent registered public accounting firm for the year ending December 31, 2016; and,
to act upon such other matters as may properly come before the meeting or any adjournment or postponement of the meeting.
This year’s Annual Meeting is a particularly important one, and YOUR vote is essential. VCM Group LLC (“VCM”), a beneficial holder of 100 shares, or approximately 0.0009%, of our outstanding common stock acquired in February 2016, has notified the Company that it intends to nominate its own slate of Class II directors to our Board of Directors at the Annual Meeting.
In my mailbox at 9:16 am
Subscribe to it and receive news before its released
on their website.
http://www.amedica.com/
http://investors.amedica.com/releases.cfm
Amedica First to 3D Print Silicon Nitride for Medical Applications
Custom parts in 24 hours.
The process is essentially binder-less and a device can be completely sintered in less than 24 hours. With this advancement, Amedica can now progress toward commercializing 3D printed silicon nitride implants, with controllable porosity levels to address specific clinical needs.
Delafield Investments Limited should have been the big red flag.
Live and learn.
"Scientists surprised to find that amino acids, not sugar, supply most building blocks for tumor cells"
"Glucose-to-lactate conversion help cells use amino acids to build more cells."
http://medicalxpress.com/news/2016-03-team-approach-curbing-cancer-cell.html
Ttrypsinogen and Chymotrypsinogen may have an effect on this conversion as they have been shown to neutralize lactate.
Trypsin, Chymotrypsin and Amylase enzymes dissolve the protein and sugar coating of the cancer cell making it vulnerable to the attack of white blood cells.
10Q
Common stock, $0.001 par value; 2,000,000,000 shares authorized; 432,719,886 and 347,442,013 shares issued and outstanding as of
December 31, 2015 and June 30, 2015, respectively.
What kind of lawyer would agree to this?
On December 31, 2015, the Company entered into an agreement, effective on January 1, 2016, with a law firm to provide legal services. The Company agreed to issue the law firm 1,600,000
shares of common stock. The Company valued the 1,600,000 shares based on the market price on the effective date of the agreement of $0.0279 and will expense the $44,640. On January 4,
2016, the Company issued 1,600,000 shares of common stock related to this agreement.
"FDA Approval Process for Medical Devices"
Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the online FURLS system on the FDA website.
STEP 4:
FDA will review your submission. The FDA reviews most submissions within 90 days and will often follow up with requests for more information. If successful, you will receive a 510(k) clearance letter from FDA with your 510(k) number
STEP 5:
Go to the FDA Device Registration and Listing page and register your device and company with the FDA. Your 510(k) number will be required. If you are located outside the US, you must appoint a US Agent at this time as well.
Once forms are submitted online and fees are paid, you are cleared to sell in the USA! Your company now becomes subject to inspection for compliance with the FDA Quality System Regulation (21 CFR Part 820) at any time.
http://www.fda510k.com/approval-process
Let the science speak for itself:
Of particular note was the surprising finding that the protease proenzymes were involved in differentiation of CaCo2 tumour cells (possible conversion of malignant cells to non-malignant cells) and in the up-regulation of the expression of E-cadherin and ß-catenin in all three cell lines.
They spend too much on advertisements like this.
Monthly sponsorship fees range from $1,000 to $3,000 per month. Streetwise Reports LLC does not accept stock for payment of sponsorship fees. Sponsor pages may be considered advertising for the purposes of 18 U.S.C. 1734.
The Si3N4 biomaterial experienced a surface toughness value independent of hydrothermal attack.
http://www.ncbi.nlm.nih.gov/pubmed/26437609
Ex wife finds Chin and settles the score
St. John’s Antigua- Jay Marie Chin has been found guilty of the murder of her ex-husband Raymond Chin and the prosecution is seeking the death penalty.
There goes my 8 million shares
http://antiguaobserver.com/court-hears-deceased-was-shot-13-times/
News on the improved design is out.
SALT LAKE CITY, Jan. 25, 2016 (GLOBE NEWSWIRE) -- Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce the release of its Valeo II™ C interbody fusion device system. The second generation cervical system will be commercially available mid-February 2016.
http://www.globenewswire.com/news-release/2016/01/25/804345/0/en/Amedica-Enhances-Valeo-II-Product-Family-With-the-Addition-of-Its-Second-Generation-Cervical-System.html
This is why Mayo is interested:
Todays release
Kevetrin down regulated expression of both HDAC2 and HDAC6 in MIA PaCa-2 cells.
Mayo study (pancreatic cell lines):
We conclude that HDAC6 inhibition alone is insufficient for disruption of cell growth, and that some degree of class 1 HDAC inhibition is required.
"Identification of HDAC6-Selective Inhibitors of Low Cancer Cell Cytotoxicity."
http://www.ncbi.nlm.nih.gov/pubmed/?term=pancreatic+cancer+mayo+clinic+HDAC
2016 Jan;11(1):81-92. doi: 10.1002/cmdc.201500456. Epub 2015 Nov 23
There is also a safer Doxorubicin (GPX-150) entering phase II trials with no cardiotoxicity.
Is it possible to combine 2 phase II trials into 1?
http://www.ncbi.nlm.nih.gov/pubmed/?term=GPX-150
The most frequent adverse events were neutropenia, anemia, fatigue, and nausea. No patients experienced cardiotoxicity while on the study. The best overall response was stable disease in four (20 %) patients.
http://www.cancernetwork.com/sarcoma/investigational-sarcoma-drug-gpx-150-gets-orphan-drug-designation
The new agent is modified in two locations on the molecule in an effort to reduce the cardiotoxicity commonly associated with doxorubicin. A phase I trial was conducted earlier and results were published in June 2015, in patients with different types of metastatic solid tumors. They received an infusion of GPX-150 at varying doses once every 21 days for up to 8 cycles.
Why Mayo?
Dr. Kumar commented, “The research began with trying to understand why Kevetrin™ was so effective against certain resistant cancers that other drugs can’t treat.
Grant payments are triggered by proof
of subject enrollment and trial participation. It is
anticipated that one RAN-2 Grant will be awarded.
At least two institutions must be involved in
the project, and the impact on pancreatic cancer
patients should be immediate, if not as soon as
possible.
Of all the phase II trials they picked CTIX
Nice!
1. Analysts expect the company to report revenue of $4.78 million for the quarter.
2. Amedica is expected to report earnings per share of $0.05.
3. During the last three quarters, Amedica has registered negative earnings with an average miss of 58.67 percent.
4. In the third quarter, Amedica reported earnings per share of $0.15.
5. Revenue for the third quarter reached $4.8 million.
http://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/29185-http-www-istreetwire-com-stocks-buzz-amedica-corporation-nasdaqamda-1426380.html
The cost reduction will benefit hospitals that use Oritavancin, saving 9.3-12.9 % per year. So using O as the comparator makes sense.
Use of Oritavancin in Acute Bacterial Skin and Skin Structure Infections Patients Receiving Intravenous Antibiotics: A US Hospital Budget Impact Analysis.
http://www.ncbi.nlm.nih.gov/pubmed/26692006
Mean costs for inpatient treatment with vancomycin ranged from $5973 to $9885, depending on Charlson Comorbidity Index score and presence of systemic symptoms. Switching an individual patient from inpatient vancomycin treatment to outpatient oritavancin treatment was estimated to save $1752.46 to $6475.87 per patient
http://www.ncbi.nlm.nih.gov/pubmed/26708118
Multiple sites for research, not uncommon
another one
http://www.bocsci.com/kevetrin-cas-500863-50-3-item-84-462549.html?tm_source=bing&utm_medium=cpc&utm_campaign=Bocsci-Inhibitor&utm_term=Kevetrin%20for%20sale&utm_content=500863-50-3-(2)
Kevetrin - CAS 500863-50-3
and another
http://hudsonbiopharma.com/prod_details/HB0086.php
This one lists the patent at the bottom page
Certainly if we replace existing partners products with Si3N4
Convert existing partner’s metal or plastic device to Si3N4
Page 25
http://files.shareholder.com/downloads/AMDA-2JBRND/1293169212x0x853014/D4F9832D-5DDC-4996-A4B8-910DCDB410A8/AMDA_Investor_Presentation_Jan_2015.pdf
For example Kyocera Medical Corporation has their own line-
PASSMED is a spine fixation system of titanium.
http://kyocera-md.com/fields/medical.html
Consensus Price Target: $0.68 (410.98% upside)
http://www.marketbeat.com/stocks/NASDAQ/AMDA/
Out of 5 Australian patents 2 have lapsed and 1 was withdrawn
leaving 1 filed and 1 granted.
The lapsed and withdrawn are from the University of Bath
Filed 2015-11-12
Proenzyme composition
2015904678
(2) Si3N4 (Amedica) testing in Japan
Surface toughness of silicon nitride bioceramics: I, Raman spectroscopy-assisted micromechanics.
http://www.ncbi.nlm.nih.gov/pubmed/26522613
Surface toughness of silicon nitride bioceramics: II, Comparison with commercial oxide materials.
http://www.ncbi.nlm.nih.gov/pubmed/26437609
Conversely, the Si3N4 biomaterial experienced a surface toughness value independent of hydrothermal attack.
One plaintiff = one state
Why would they proceed with the suit?
"The court may limit recovery only to those who reside in states in which there is a named plaintiff. To ensure that you are eligible to receive any recovery, should the action be successful, you may seek to become a plaintiff in the class action. This will also enhance the likelihood that all other affected consumers from the state in which you live are able to participate in any recovery".
Rosen is estimated to have 80 class action suits in the works, one of the most recent is VTech
The Complaint was filed on December 3, 2015 in U.S. District Court for the Northern District of Illinois on behalf of a resident of the state of Washington. If you live in a state other than Washington, you may end up not receiving any recovery from the current class action against VTech because the current class action contains only a plaintiff from Washington.
The school in India is in the current Mako report with pictures.
What I find most disturbing is the early financing with White Star LLC
In 2011, Murray Huberfeld AND Mark Nordlicht, as well as both of their wives, Laura Huberfeld and Dahlia Kalter Nordlicht, were named in a lawsuit that made serious allegations about their involvement in Scott Rothstein's $1.2 billion Ponzi scheme. For these crimes, Scott Rothstein is currently serving a 50-year sentence in federal prison.
According to the SEC filing detailing several transactions between CTIX and White Star LLC, White Star LLC's address is 15 Manor Lane, Lawrence, New York, NY 11559, which happens to be an address registered to Murray Huberfeld.
http://seekingalpha.com/article/3406365-cellceutix-empty-office-unviable-science-misleading-disclosures-96-percent-downside?page=2
Mr. Zagami has a material interest. He bought 5,000
shares, lost over $6,000.
What was the timeframe of his purchase(s) was it a week before the Mako release?
$6,000 in alleged losses but $100,000 in lawyer fees, why?
Another killer could top cancer by 2050—and we're to blame
We've already been warned about an "antibiotic apocalypse." Now a new study says medicine-resistant infections will take more lives annually than cancer does by 2050 unless action is taken, CNBC reports.
http://www.foxnews.com/health/2015/12/29/another-killer-could-top-cancer-by-2050-and-were-to-blame.html
How many clinical managers do they need?
Kristine McGuigan
Manager Clinical Operations
Cellceutix
October 2013 – Present (2 years 3 months)|Pennsylvania
Executive Assistant - Clinical Operations/Regulatory Affairs
PolyMedix, Inc.
March 2010 – April 2013 (3 years 2 months)|Radnor, PA
Edward J. Walters, MPH
Head of Clinical Operations at Cellceutix
Allentown, New JerseyPharmaceuticals
Akesis is a CRO that handles the following:
Dermatology & Topical Contract Research Expertise
Phase I, II, III, and IV Trials
Medical Devices
Program & Project Management
Feasibility
Protocol Development
Site Selection
Patient Recruitment
Study Monitoring
Data Management
Biostatistics and Report Writing
Akesis is a quality-driven global contract research organization whose focus is clinical research services and regulatory affairs consulting. Complementing our dermatology and ophthalmology focus, we offer a broad spectrum of expertise in several therapeutic areas that round out our dynamic portfolio.
Cellceutix is not listed yet but Dana Farber is:
http://events.jspargo.com/ASCO16/Public/eBooth.aspx?IndexInList=2&FromPage=Exhibitors.aspx&ParentBoothID=&ListByBooth=true&BoothID=406974
Interesting new patent
COMPOSITION AND METHOD FOR THE TREATMENT OF NEUROLOGICAL DISEASES AND CEREBRAL INJURY
Publication Date:
December 17, 2015
UNIVERSITY OF NOTRE DAME DU LAC
2. The method of claim 1, wherein the hydrophobic drug is an HDAC inhibitor. Kevetrin is listed in their many HDAC inhibitors selection.
Using a triple combination formulation to cross the blood brain barrier.
http://www.sumobrain.com/patents/wipo/Composition-method-treatment-neurological-diseases/WO2015191931A1.html
where is this new patent they filed?
http://www.ipaustralia.com.au/applicant/propanc-pty-ltd/patents/
K has a lot of competition (21)in its class
http://www.medchemexpress.com/Targets/MDM-2,%20p53.html
Clinical website fixed back to not recruiting for K
Sure would like to see an update to K
Mostly how the first patients dosed survival/recurrence rates are, and if they seeing any resistance long term.
"we will be making a decision in the coming weeks about concluding the trial. We have ample data, and very compelling data for that matter, to end the trial, but we don't want to miss any opportunity for expanded research by an exceptional PI (Principal Investigator) team, so we have some important decisions to make"
I would like to see the University of L'Aquila - Italy Department of Life, Health & Environmental Sciences jump in and study K with HPV.
Association between p53 status, human papillomavirus infection, and overall survival in advanced oral cancer after resection and combination systemic treatment.
The incidence of HPV-16 infection decreased with increasing immune p53 expression (p=0.005), whereas that of the HPV16+p53mutation combination increased with increasing immune p53 expression (p=0.000). The results show the importance of the investigation of HPV and p53 expression to define prognosis in oral SCC.
Dec 5 2015
http://www.ncbi.nlm.nih.gov/pubmed/26669794
Is treatment of large B-cell lymphoma on the horizon?
Dana Farber may be looking into new targets.
Dec.9 2015
IMPLICATIONS:
The direct collaboration between EZH2 and Rb/E2F1 pathway provides an innovative mechanism underlying the cascade of tumor progression, and lays the foundation for the development of new anticancer targets/strategies.
http://www.ncbi.nlm.nih.gov/pubmed/26659825
Abstract 2874: Kevetrin targets both MDM2-p53 and Rb-E2F pathways in tumor suppression
http://cancerres.aacrjournals.org/content/72/8_Supplement/2874.abstract?cited-by=yes;72/8_Supplement/2874
ZURICH (Reuters) - Pharmaceuticals giant Novartis is pinning its hopes on a 43-year-old Harvard cancer research star to help fill gaps in its immuno-oncology arsenal after "missing the boat" on some promising therapies.
But the Basel-based company also failed to keep pace with Merck, Bristol-Myers and archrival Roche on "checkpoint inhibitors" against slippery tumors that hide from the immune system, a market worth tens of billions.
"They completely missed the boat," said Michael Nawrath, a Zuercher Kantonalbank analyst. "Jay Bradner may come from Dana-Farber, but his pedigree is that of somebody who knows how you take new scientific developments and commercialize them, and how you collaborate."
Still, it lags rivals armed with PD-1 and PD-L1 checkpoint inhibitors to fight tumors that evade the body's natural defenses. Merck's Keytruda is on the market, as is Bristol-Myers' Opdivo, while Roche aims for approval in 2016. Pfizer and AstraZeneca are also pursuing compounds.
http://news.yahoo.com/novartis-hires-harvard-star-plug-gaps-cancer-drug-120905496--finance.html