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Shoondale is a stock broker shorting it. Go back to your vodka Frank you drunk.
"The U.S. government does not review or approve the safety and science of all studies listed on this website."
"certain deficiencies in its Premarket Approval (PMA) application that were identified by the FDA in 2021. These were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products."
Developments
During 2022 and 2023, the Company worked to address certain deficiencies in its Premarket Approval (PMA) application that were identified by the FDA in 2021. These were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products. As of the date of this report we have implemented procedures and Good Manufacturing Practices that are responsive to the deficiencies identified by the FDA.
On March 21, 2024, we submitted to the FDA a revised Premarket Approval application to market our absorbable hemostatic gauze for human surgical applications in the United States. The FDA is currently reviewing our application and there can be no assurance that our PMA application will be approved.
Our HemoStyp Gauze Products
HemoStyp hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The HemoStyp hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into glucose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, HemoStyp does not impede the healing of body tissue as compared to certain competing hemostatic products. Laboratory testing has shown HemoStyp to be 100% absorbable in the human body within 24 hours, compared to days or weeks with competing organic regenerated cellulose products. A human trial conducted in 2019 and 2020 demonstrated the effectiveness of HemoStyp in vascular, thoracic and abdominal surgical procedures.
HemoStyp hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. The gel maintains a neutral pH level, which avoids damaging the surrounding tissue. In superficial bleeding situations, HemoStyp can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a broad range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis.
Still waiting for clinical submission link...and waiting....
I have the feeling I will be waiting forever just like the wait for explanation of why all the past PMA's failed....
I have linked to that 10-K in numerous posts today. It answers none of the questions I have asked. It merely creates more questions I am asking. There is nothing about clinical trials or any explanation of 7 years worth of failed PMA's.
Let me return the favor. Here is a link that actually explains what is going on:
https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf
I post facts with links. Where's your link?
"Hey MORON, we have a full clinical submission on 3/20/24. You post nothing but BullShit!"
Hey MORON, we have a full clinical submission on 3/20/24. You post nothing but BullShit!
What has happened with UHP PMA's since 2017? Although we never hear about it, the reality of the situation is every time a PMA gets filed from United Con Artists, it gets summarily rejected. And, as always, the next time will be different. The reality we are dealing with is that the FDA never approves this product. We have no idea why.
"In response to the FDA’s comments and questions to our 2021 and 2022 PMA submissions, we have developed and incorporated several product design, manufacturing and quality assurance procedures into our production process. Upon completion of certain finished product testing that is being conducted by outside laboratories we will submit a revised application to the FDA. There can be no assurance that our revised application, once resubmitted, will lead to a successful FDA decision regarding a PMA"
"FDA Selects HemoStyp ® for CtQ Pilot Program
Henderson, Nevada – December 4, 2017 –United Health Products, Inc. (UHP) (OTC: UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that it is proceeding with its application for HemoStyp under the FDA’s new and innovative CtQ Pilot Program. The FDA selected UHP’s HemoStyp as only one of nine participants for the program. UHP management has scheduled its first face-to-face meeting with FDA experts for January 17, 2018 to provide the agency with whatever information it needs to advance the application for premarket approval (PMA).
The FDA has stated that it intends to work collaboratively with pilot program participants during the review of their PMA submission to define characteristics of the device that are critical to product quality, and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. For pilot program participants, the FDA would forego conducting the standard PMA preapproval inspection, and a postmarket inspection focusing on the PMA applicant’s implementation of the critical to quality characteristics would be conducted instead.
The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body –as evidenced by years of prior product usage and studies-- to be approved for Class III internal surgical use. The program’s intent is to allow products that have demonstrated repeated safe interaction to enter the market in a more efficient manner. This application will run simultaneously with the company’s prior Class II application for expanded indication. The market for 2017 internal surgical market for hemostatic products is estimated at in excess of seven billion dollars, and is expected to grow at 7.1% over the next few years, to reach more than $8.3 billion by 2022. (http://industryarc.com/Report/15189/hemostats-market.html)
Concurrent with its CtQ Pilot Program participation, UHP reaffirms that its current Class II application – Expanded Indication submission with the US FDA-- continues to progress, and is in an advanced stage of review
About Premarket Approval Application Critical to Quality (PMA CtQ) Pilot Program
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA’s medical devices center is a focus on quality.
More specifically, the FDA is working with stakeholders—industry, health care providers, patients, payers, and investors—to build a strong Case for Quality.
This program allows the FDA to identify device manufacturers that consistently produce high-quality devices. By doing so, we can better focus our resources helping other manufacturers raise their level of quality. This program also helps the FDA identify and promote practices that support consistent quality manufacturing, and align our regulatory, enforcement, compliance approaches with those practices.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. The FDA’s analysis flagged certain widespread or common manufacturing risks that impact product quality. The review also showed manufacturers that focus on and manage those risks often become more productive, receiving fewer complaints, needing to open fewer CAPAs and investigations, and having lower quality-related product costs than their competitors.
In simple terms, the review identified that an investment in quality has long-term payoffs."
You ass! That statement is what EVERY company has to put in their pressers when going for an approval. Just standard legal jargon! God you’re an idiot!
"We can provide no assurances that our Class III application for internal surgical procedures in the U.S. market will be approved by the FDA."
"There will be no failure. Only epic morons think this."
WTF has been going on since 2017 with PMA bullshit? Epic morons, as you call them, should consider and understand this. I have not seen one bit of evidence suggesting anything has ever changed since then. Does anyone care to explain what has been going on since 2017 that will garner FDA approval (besides the fraud the SEC uncovered which seems to be the only activity)?
"There will be no failure. Only epic morons think this. Surgicrap is a total disgrace which was never approved by the FDA and was grandfathered in and has so many side effects that they’ve had multiple lawsuits against it. The FDA has been carrying us to the finish line, which I finally realized. They could’ve reset the clock on us 10 to 20 times but they never did because they realize Surgicrap is an embarrassment and they want that product out of there."
"FDA Selects HemoStyp ® for CtQ Pilot Program
Henderson, Nevada – December 4, 2017 –United Health Products, Inc. (UHP) (OTC: UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that it is proceeding with its application for HemoStyp under the FDA’s new and innovative CtQ Pilot Program. The FDA selected UHP’s HemoStyp as only one of nine participants for the program. UHP management has scheduled its first face-to-face meeting with FDA experts for January 17, 2018 to provide the agency with whatever information it needs to advance the application for premarket approval (PMA).
The FDA has stated that it intends to work collaboratively with pilot program participants during the review of their PMA submission to define characteristics of the device that are critical to product quality, and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. For pilot program participants, the FDA would forego conducting the standard PMA preapproval inspection, and a postmarket inspection focusing on the PMA applicant’s implementation of the critical to quality characteristics would be conducted instead.
The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body –as evidenced by years of prior product usage and studies-- to be approved for Class III internal surgical use. The program’s intent is to allow products that have demonstrated repeated safe interaction to enter the market in a more efficient manner. This application will run simultaneously with the company’s prior Class II application for expanded indication. The market for 2017 internal surgical market for hemostatic products is estimated at in excess of seven billion dollars, and is expected to grow at 7.1% over the next few years, to reach more than $8.3 billion by 2022. (http://industryarc.com/Report/15189/hemostats-market.html)
Concurrent with its CtQ Pilot Program participation, UHP reaffirms that its current Class II application – Expanded Indication submission with the US FDA-- continues to progress, and is in an advanced stage of review
About Premarket Approval Application Critical to Quality (PMA CtQ) Pilot Program
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA’s medical devices center is a focus on quality.
More specifically, the FDA is working with stakeholders—industry, health care providers, patients, payers, and investors—to build a strong Case for Quality.
This program allows the FDA to identify device manufacturers that consistently produce high-quality devices. By doing so, we can better focus our resources helping other manufacturers raise their level of quality. This program also helps the FDA identify and promote practices that support consistent quality manufacturing, and align our regulatory, enforcement, compliance approaches with those practices.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. The FDA’s analysis flagged certain widespread or common manufacturing risks that impact product quality. The review also showed manufacturers that focus on and manage those risks often become more productive, receiving fewer complaints, needing to open fewer CAPAs and investigations, and having lower quality-related product costs than their competitors.
In simple terms, the review identified that an investment in quality has long-term payoffs."
There will be no failure. Only epic morons think this. Surgicrap is a total disgrace which was never approved by the FDA and was grandfathered in and has so many side effects that they’ve had multiple lawsuits against it. The FDA has been carrying us to the finish line, which I finally realized. They could’ve reset the clock on us 10 to 20 times but they never did because they realize Surgicrap is an embarrassment and they want that product out of there.
blob:https://tdameritrade-researchcomponents.markitdigital.com/2299eaf2-28ad-4456-88e2-9dafaca75d60\
The annual report was posted.
Why doesn't Thom want his clients to know he is CEO of a stock scam? He does not list it on his write up with Waveny Partners.
https://www.butlercap.com/our-team-2
Brian Thom
Alternative Asset Sales for Butler Capital and Principal of Waveny Partners, Alternative Asset Management Firm
Previous Experience
Capital Placement Practitioner and Advisor to Corporate Clients for Butler Capital and Principal of Waveny Partners
Head of Corporate Finance for the Americas with Société Générale
Managing Director at FBR & Co. Leading M&A and equity capital raising transactions in the Energy sector
Global Mergers & Acquisitions group at JPMorgan
Meanwhile the CEO is employed at Butler Capital on the other side of the country:
https://brokercheck.finra.org/individual/summary/4231884
Does he do anything more than manipulate the unrealistically high price of this stock scam?
https://www.butlercap.com/our-team-2
Brian Thom
Alternative Asset Sales for Butler Capital and Principal of Waveny Partners, Alternative Asset Management Firm
Previous Experience
Capital Placement Practitioner and Advisor to Corporate Clients for Butler Capital and Principal of Waveny Partners
Head of Corporate Finance for the Americas with Société Générale
Managing Director at FBR & Co. Leading M&A and equity capital raising transactions in the Energy sector
Global Mergers & Acquisitions group at JPMorgan
Master in Business Administration from McMaster University
Confirmation of UHP headquarters: UHP headquarters map and photo
https://uhpcorp.com/contact-us/
Stop by and get a u-haul in the desert instead of bandages?
Yes 1 Billion'$+ is my starting offer from the big pharms! Looking for RCA to make Brian Thoms some recommendations for a buyout plan!
https://www.rcainc.com/pharmaceutical/strategic-consulting/due-diligence-pharmaceutical-consulting-firm/
$5-$10+
"Another Green Day…….how nice!"
More groundless and unsubstantiated bullshit from rodman.
Sure you are. Amazing how many first time posters have shown up lately. How telling when you refer to facts and links from reputable sources like the SEC as noise.
"How does that work, how does UEEC get on everyone's radar assuming they get the PMA?" Good question?
JMO but third party consultants like RCA do not stop servicing clients upon the FDA submission. No they network with the intention of furthering their business and profits. For example RCA is reaching out to others soon with their pharmaceutical events where the big money may yet be made for UEEC and investors! (Shareholders) The party is just starting so jump in now at this ridiculous low pps.
https://www.rcainc.com/cphi-north-america/
$5-$10+
I'm long and first time poster. According to what I'm reading, everyone is now using the eStar program since 10/1/2023. Does this seem correct?
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
This seems to be the only active board on UEEC with anything insightful posted, as long as you filter out the noise. As long as we go north of $0.70/share then I'll finally be in the black. I'm riding this lotto ticket all the way to the finish line, be it a big payout or total loss. Not gonna make Tuscan villa money, but definitely luxury car money if it runs up.
Even if we get the PMA approval, I'm concerned that none of the big players know we exist. How does that work, how does UEEC get on everyone's radar assuming they get the PMA? Or is just getting it enough, and it's publicly noticed by the FDA and the interested acquiring parties show up at the door?
Getting old; wasn't there commentary that FDA was going to fast track this application as one of the early tests for the E Star application program? Maybe one or two PR's ago? If so; a 90 day window might be in play?
The banter is quite entertaining. One the one side there is speculation that this is going to be a big week. On the other side, it's going to be a complete failure and all of us longs are going to lose $$$ bigtime.
Here's the reality. It's in the FDA hands. They have up to 180 days to respond. They can respond as slow or as fast as they like. Until we get official word, we won't know what reality is. Based on this, we will know sometime this year.
Until there is news, we can't expect this stock to do anything other than hover around $0.20
Hard to get excited about up and down with no sustained growth in $SP.
Selling volume concerning.
Big week ahead! Looking for an update!
$5-$10++
Guess we would all be angry if I was unemployed and making penny's posting lies!
What a joke they are.
$5-$10+
Yo Shoony!
Why are you so angry? Keep that pipe up for Facebook - it’s politics season. Go hang with your side and fight on ✌🏼
Or alternatively hit up One Love at the theater and Relax Brah
Life’s too short and my guess is yours is shorter so have some supper and take a nap.
There is no company to contact. The whole thing is a dirty broker run scam and so are you. Only an idiot would contact dirty brokers running a sham.
Herd949
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Alias Born 02/12/2024
Who the eff are you bullshitting? A dirty broker threw $20 at the last minute to bullshit everyone. Dirty brokers are so desperate. They must have clients $$$$ tied up in this scam and trying desperately not to take heavy losses.
UEEC
United Health Products, Inc.
Common Stock
0.20115
0.00125
0.63%
0.1862 / 0.2092 (1 x 1)
TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/28/2024 15:56:59 0.20115 0.02 100
03/28/2024 14:56:07 0.1841 -0.03 749
Who the eff are you bullshitting? Throw $20 at the last minute to bullshit everyone corrupt clown. You jackasses are so desperate. Do you dirty brokers have your clients $$$$ tied up in this scam and trying not to take heavy losses?
UEEC
United Health Products, Inc.
Common Stock
0.20115
0.00125
0.63%
0.1862 / 0.2092 (1 x 1)
TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/28/2024 15:56:59 0.20115 0.02 100
03/28/2024 14:56:07 0.1841 -0.03 749
Looks like another nice Green Day !!
UEEC— On the verge of becoming a major player in the billion dollar surgical/triage arena.
UEEC— On the verge of becoming a major player in the billion dollar surgical/triage arena. Major upside coming to UEEC.
Yep. I think when they are approved things will conclude quickly.
We haven't seen anything yet! With the FDA approval the big pharms interest in the gel application of hemostyp will increase. How about
an announcement for a clinical trial using United Health Products Hemostyp Gel underway!
$5-$10+
"Means NOTHING"
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