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United Health Products Reports on FDA Application Status
MESQUITE, NV - (NewMediaWire) - October 03, 2023
United Health Products, Inc. (OTCPK: UEEC) today provided an update on the companys FDA Premarket Approval application process.
The company reports today that the packaging testing process is substantially completed with no non-conforming results. Testing completed to date includes assessment of labeling durability, Tyvek pouch packaging integrity, product stability under transport-related agitation, product stability under 6-month and 1-year accelerated aging treatment. The company is awaiting final reports on sterilization and bio burden testing.
In anticipation of re-submitting updated PMA information, UHP has engaged regularly with the FDA. Through this engagement the company was recently notified that it had been selected as the first medical device application for Premarket Approval (PMA) to be submitted and evaluated using the FDAs electronic Submission Template and Resource ("eSTAR") platform. The eSTAR is an interactive, automated PDF form that guides applicants through the process of preparing a comprehensive medical device submission. This template contains (i) content and structure that is complementary to FDA internal review templates, (ii) integration of multiple resources such as process guidance and databases, (iii) guided construction for each submission section and (iv) automatic verification of submitted files. With a standardized eSTAR format, submitters can ensure their submissions are complete, and the FDA can conduct premarket reviews more efficiently to help promote timely approval decisions on new medical devices. For example, the automatic verification process within eSTAR negates the need for a "Refuse to Accept" review, among other time-consuming administrative processes. The eSTAR has been used extensively in medical device applications for 510(k) approval and UHP is honored to have been selected as the first to submit its Premarket Approval application through this FDA resource.
In addition to a more streamlined FDA filing and review process, under a joint pilot program that will test the use of a single eSTAR submitted to both Health Canada and the FDA, the eSTAR will allow UHP to also seek approval from Health Canada which, if received, would allow the company to market its products for human surgical applications in this market.
There can be no assurance that the companys PMA or Health Canada applications will be approved.
About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
For more information on UHP visit the companys new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
United Health Products Provides Update on FDA PMA Application and Amendment to White Lion Agreement
Mesquite, NV - (NewMediaWire) - January 31, 2023 - United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the companys FDA Premarket Approval application process and the amendment of its Agreement with White Lion Capital.
UHP continues to advance its Premarket Approval application with the Food and Drug Administration. Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the companys human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the companys manufacturing process, which results will be included in its final PMA application.
There can be no assurance that the companys PMA application will be approved.
Separately, in September 2022 the company entered into a Common Stock Purchase Agreement with White Lion Capital, LLC under which the company has the right to sell shares of its common stock to White Lion at a price equal to 93% of the five-day volume weighted average trading price. The company has successfully raised over $350,000 to fund its operations under the Agreement. The Agreement contains a condition that the company share price must be above $0.25 per share (the Floor Price) in order to issue a share purchase notice, which White Lion can waive at its discretion. On January 25, 2023, the company and White Lion amended the Agreement such that if the company issues a purchase notice when its shares are trading below the Floor Price and White Lion waives the Floor Price condition, White Lions purchase price per share in that transaction will be 90% of the five-day volume weighted average trading price rather than 93%. All other terms of the Agreement remain unchanged.
About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
For more information on UHP visit the companys new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
Titan Medical Announces Appointment of Eric Heinz as Vice President, Market and Corporate Development
TORONTO, ON, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq:TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that Eric Heinz has been appointed as the companys Vice President, Market and Corporate Development. Mr. Heinz will be responsible for developing and executing on strategic business plans to expand and accelerate Titans Enos robotic single access surgical systems portfolio cadence. He will also lead existing partnerships and look to supplement those to maximize Titans reach and the utilization of the Enos system. Mr. Heinz will engage and collaborate with stakeholders in refining the companys value proposition, branding, product positioning and core messaging.
We are excited to have Eric join the senior leadership team. Eric brings a proven track record of leading efforts to grow businesses and augment markets in the dynamic surgical robotics industry. It was especially important for us to bring in a leader with extensive experience at leading successful negotiations while driving organic and inorganic growth in the medical technology industry, said Cary Vance, Titans President and CEO.
Mr. Heinz has more than 20 years of medical device experience across business strategy, corporate development, product development and marketing for companies ranging in size from small-cap to multi-nationals. He recently served as Director, Business Development (M&A) for Smith & Nephew, where he led teams responsible for executing upon the inorganic growth strategy via M&A, equity investments and co-development partnerships. Prior to joining Smith & Nephew, Mr. Heinz consulted to ZimmerBiomet, Medtech Surgical SA and a boutique investment bank, managing quality remediation, market development and private placement projects, respectively. He also served as senior marketing manager for the SYMBIS Surgical System MRI-compatible neurosurgical robotics business at IMRIS, and as a product manager over the $500m instruments, accessories and video system portfolio at Intuitive Surgical. Mr. Heinz holds a Master of Engineering Management from Christian Brothers University, a Bachelor of Science in Bioengineering from The University of Illinois, Urbana-Champaign, and is anticipated to graduate with an Executive MBA degree from the Kellogg School of Management at Northwestern University in December 2022.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with operations in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
Enos is a trademark of Titan Medical Inc.
For more information, visitwww.titanmedicalinc.comand follow@TitanMedicalon Twitter andLinkedIn.
Titan Medical Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule
TORONTO, June 29, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq:TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") has notified the company that it has been granted an additional 180 calendar day period, through December 26, 2022, to evidence compliance with the US$1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market.
If at any time before December 26, 2022, the bid price for the company's common shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaqs discretion), it is expected that Nasdaq would provide formal notice that the company has regained compliance with the bid price requirement.
In the event the company does not evidence compliance with the minimum bid price requirement during the 180-day grace period, it is expected that Nasdaq would notify the company that its shares are subject to delisting. At such time, the company may appeal such determination to a Nasdaq Hearings Panel (the Panel), and it is expected that the companys securities would continue to be listed and available to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful or that the company would be able to evidence compliance with the terms of any extension that may be granted by the Panel.
The Nasdaq notification letter does not impact the companys compliance or listing status on the Toronto Stock Exchange.
Titan Medical Provides Update to Enos Project TimelineDe Novo marketing authorization planned for early 2025 remains unchanged
TORONTO, June 28, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq:TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that multiple disruptions have resulted in an updated Investigational Device Exemption (IDE) submission timeline for the Enos robotic single access surgery system. The company now expects the IDE submission to occur mid-year 2023 instead of the first quarter of 2023. Pending successful regulatory review and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system remains on schedule for early 2025.
We have been fortunate to have avoided and mitigated against many of the issues facing almost all other technology companies over the last few months. However, we now expect our targeted IDE application date to be pushed out to the summer of 2023. Human clinical trials are still planned to start in 2023 and we expect to receive marketing authorization in the U.S. in early 2025, said Paul Cataford, Interim President and CEO.
The Enos project timeline has been impacted by several factors including:
Supply of certain key components and materials has affected the production of instruments and camera systems and the delivery of capital equipment resulting in delays for verification and validation testing.
Recruitment and resourcing of software engineers and developers has resulted in delays in unit testing procedures and certain documentation activities.
Delayed procurement of disposable and consumable components resulted in delays in cleaning and disinfection testing and the GLP study required for the IDE submission.
We continue to carefully monitor our project plan. With recent changes, we believe we have the right people, resources and partners in place to execute against our project delivery timeline. This team is committed, engaged and accountable, and were excited to bring our vision of single access robotic assisted surgery to the market, concluded Paul Cataford.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with operations in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
Enos is a trademark of Titan Medical Inc.
For more information, visitwww.titanmedicalinc.comand follow@TitanMedicalon Twitter andLinkedIn.
Litigation: SEC Vs. United Health Products, Douglas Beplate and Louis Schiliro
WASHINGTON, June 9 -- The Securities and Exchange Commission issued the following litigation release (No. 1:22-cv-03612; D.N.J. filed June 8, 2022) involving United Health Products Inc., Douglas Beplate and Louis Schiliro:
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SEC Charges Medical Supply Company and Executives for Accounting Fraud and Suspends Audit Professionals for Improper Professional Conduct
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The Securities and Exchange Commission today charged medical supply company United Health Products, Inc., its former CEO and Chairman, Douglas Beplate, and its former COO, Louis Schiliro, with allegedly defrauding investors by materially inflating the companys financial results in its 2017 and 2018 SEC filings.
The SECs complaint alleges that Beplate and Schiliro engineered two fraudulent sales transactions that they had UHP record and report in UHPs publicly-filed financial statements. As alleged in the complaint, in the first fraudulent sales transaction, in May 2017, Beplate and Schiliro procured a sham purchase order back-dated to March 2017 from a customer for product that was quickly cancelled and UHP never shipped. In the second allegedly fraudulent sale, Beplate and Schiliro orchestrated a purported December 2017 sale of a large amount of product to a customer who had never ordered it. The complaint alleges that Beplate and Schiliro took measures for UHP to report these fraudulent sales as revenue and receivables in UHPs 2017 and 2018 Forms 10-Q and 10-K, including repeatedly lying to and concealing the true facts from UHPs auditors.
The SECs complaint, filed in the U.S. District Court for the District of New Jersey, charges UHP, Beplate, and Schiliro with directly violating or aiding and abetting violations of the anti-fraud provisions of Section 17(a) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 thereunder, the reporting, books and records, and internal controls provisions of Exchange Act Sections 13(a), 13(b)(2)(A), and 13(b)(2)(B) and Rules 12b-20, 13a-1, and 13a-13 thereunder, and as to Beplate and Schiliro, the falsification or circumvention provisions of Section 13(b)(5) of the Exchange Act and Rule 13b2-1 thereunder. The SECs complaint also charges Beplate and Schiliro with lying to accountants in violation of Exchange Act Rule 13b2-2, and Beplate with violations of the certification provision of Rule 13a-14 and the insider security ownership filing requirements of Section 16(a) of the Exchange Act and Rule 16a-3 thereunder.
Without admitting or denying the complaints allegations, UHP, Beplate and Schiliro consented to the entry of final judgments, subject to court approval, which would: (i) permanently enjoin each of them from violating the charged provisions; (ii) order civil penalties of $450,000 against UHP, $240,000 against Beplate, and $225,000 against Schiliro; (iii) impose permanent officer-and-director bars against Beplate and Schiliro; and (iv) order Beplate to reimburse UHP $1,010,976.15, representing profits from his sales of UHP stock, pursuant to the clawback provisions of Section 304(a) of the Sarbanes-Oxley Act of 2002.
In separate settled administrative proceedings, the SEC charged Steven Avis, the audit engagement partner, and Steven Hurd, the audit manager, of Haynie & Co., which audited UHPs 2017 financial statements. According to the SECs order, Avis and Hurd failed to address numerous red flags in connection with UHPs fraudulent sales transactions when they signed off on the 2017 audit, and failed to, among other things, obtain sufficient appropriate audit evidence, exercise due professional care and skepticism, and investigate relevant information after Haynie issued its 2017 audit report.
The SECs order finds that Avis and Hurd engaged in improper professional conduct within the meaning of Sections 4C(a)(2) and 4C(b)(2)(A) of the Exchange Act and Rules 102(e)(1)(ii) and 102(e)(1)(iv)(B)(1) and (2) of the Commissions Rules of Practice and were a cause of certain violations by UHP of the reporting provisions of Section 13(a) of the Exchange Act and Rules 13a-1 and 13a-13 thereunder. Without admitting or denying the findings, Avis and Hurd agreed to the entry of the order, which suspends them from appearing or practicing before the Commission as an accountant, with permission to apply for reinstatement after three years for Avis and one year for Hurd, imposes a cease-and-desist order against them, and orders Avis to pay a $20,000 civil penalty.
The SECs investigation was conducted by Teresa A. Rodriguez, Jonathan M. Grant, Kenneth Gottlieb, Nancy A. Brown, Desiree M. Marmita, and Wendy B. Tepperman of the New York Regional Office. The case is being supervised by Lara Shalov Mehraban and Sheldon L. Pollock. The investigative team appreciates the assistance of Margaret Cain of the Office of Market Intelligence.
United Health Products Provides Regulatory Update
Henderson, NV, May 18, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire-- United Health Products, Inc. (OTCPK: UEEC), (UHP)today provided an update on its FDA regulatory process.
Regulatory Review
As previously disclosed, on April 20, 2022, UHP delivered to the U.S. Food & Drug Administration (FDA) a supplemented and e-formatted Premarket Approval (PMA)response for its HemoStyp hemostatic gauze and, as is customary, requested a meeting with the committee responsible for reviewing its PMA application. UHP has accepted the FDAs offer to meet on July 6, 2022, and anticipates receiving feedback on its latest response in advance of this meeting. The company will continue to engage with members of the review committee to address any remaining requests and to ensure a productive interaction in July. There can be no assurance that the PMA application will be approved.
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
UNITED HEALTH PRODUCTS, INC. - 10-Q -
Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed financial statements and related notes appearing elsewhere in this quarterly report on Form 10-Q. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth under Risk Factors in our annual report on Form 10-K for the fiscal year ended December 31, 2021,filed with SEC on April 1, 2022.
Company Overview
UHP develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, HemoStyp, is a neutralized, oxidized, regenerated cellulose ("NORC") derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. We are in the process of seeking regulatory approval to sell our Hemostyp product line into the U.S. Class III and European CE Mark surgical markets.
Our HemoStyp Gauze Products
HemoStyp hemostatic gauze is a collagen-like 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 510k approval obtained in 2012 to help control bleeding from open wounds and body cavities. The HemoStyp hemostatic material contains no chemical additives, thrombin, collage nor 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 do 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 2020demonstrated the effectiveness of HemoStyp in vascular, thoracic and abdominal surgical procedures.
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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.
Potential Target Markets
Our HemoStyp material is currently cut to several sizes and configuration and marketed as HemoStyp Gauze. While we have paused our commercial activities to focus on our Class III PMA application, our potential customer base includes, without limitation, the following:
Hospitals and Surgery Centers for all Internal Surgical usage (in the event we obtain FDA Class III approval) Hospitals, Clinics and Physicians for external trauma EMS, Fire Departments and other First Responders Military Medical Care Providers Hemodialysis centers Nursing Homes and Assisted Living Facilities Dental and Oral & Maxillofacial Surgery Offices Veterinary hospitals Primary Strategy
Our HemoStyp technology received an FDA 510k approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for HemoStyp products to address unmet needs in several medical applications that represent attractive commercial opportunities. However, the Class III surgical markets, both domestic and international, represent the most attractive market for our products due to the smaller number of competitors offering Class III approved hemostatic agents and the resulting premium pricing for products that can meet the demanding requirements of the human surgical environment. Our extensive laboratory testing and our completed human trial indicate that the HemoStyp technology can successfully compete against established Class III market participants and allow us to gain a significant market share. There can be no assurance that an FDA PMA will be granted.
In 2018, we made the decision to focus our efforts and resources on accessing these Class III markets to maximize the value potential of our HemoStyp. The Class III PMA process required a substantial investment of time and resources so we made the strategic determination to pause our sales and marketing to non-Class III markets in order to devote our full attention to the FDA process. In the fourth quarter of 2021, with our PMA application largely complete and under review by the FDA, we re-engaged with certain consumers and distributors of 510-k hemostatic products with the objective of developing a revenue channe lin this market going forward. Our primary market focus for this initiative includes the first aid, hemodialysis and emergency medicine sectors.
In anticipation of receiving a Class III PMA (which cannot be assured), we are evaluating paths to rapidly grow our revenue and profits in all potential market segments, with the objective of maximizing shareholder value. Options under consideration include (i) a sale or merger of the Company with an industry leader in the wound care and surgical device sectors, which may include a pre-sale collaboration on commercialization and distribution, (ii) one or more ommercial partnerships with established market participants, without any specific, associated sale or merger transaction, and (iii) a capital raising program to establish and grow our own marketing and distribution capabilities and drive revenue and profits organically.
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The Company has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who have expressed an interest in the Companys products and business strategy. In response to these inbound contacts, we continue to engage in discussions to evaluate the potential commercial partnerships in anticipation of an FDA decision on our Class III PMA application. There can be no assurances that any specific transaction will occur as a result of these discussions. No assurances can be given that the Company will identify any commercialization candidate(s)or complete a transaction.
Manufacturing and Packaging of our Products
The Companys NORC products are manufactured largely in the United States to our specifications and using our equipment through a contract manufacturing arrangement with an FDA certified contract manufacturer that maintains stringent quality control protocols to assure the uniformity and quality of all of our gauze products. Information on our equipment, the manufacturing process and our manufacturers facility has been submitted as part of our PMA submission, which includes the FDA inspection records of the facility. Certain of our adhesive bandage formats designed for the 510k market are manufactured by a separate contractor based in China.
Patents and Trademarks
Our NORC technology is protected through patents filed with the U.S. Patent and Trademark Office, which protection currently runs through 2029. In 2020 and2021, we filed additional U.S. and International patents that protect the use of our NORC technology in a gel or hydrocolloid formulation.
On January 21, 2021, the U.S. Patent Office provided notification of publication of the Companys patent application for the method of forming and using a hemostatic hydrocolloid. This publication does not imply any assurance of the receipt of the patent but establishes an obligation of any party that seeks to use the applicable method to pay royalties for the right to do so. The patent application for this process remains pending as of the date of this filing.
On February 11, 2021, the Company was notified that its application to establish global patent protection for the process of creating and deploying a hydrocolloid (or gel) format of its HemoStyp technology was accepted for publication under the procedures of the Patent Cooperation Treaty ("PCT"), an international patent law treaty which provides a unified procedure for filing a patent application in most foreign countries. We previously filed provisional patent applications for our HemoStyp hydrocolloid process in 2020. In January2022 the Company initiated steps to register its hydrocolloid patent in the European common market and in additional foreign countries where we intend to commercialize any future HemoStypo gel formats. We can give no assurance that foreign registration of our patents will be granted in any of these jurisdictions.
The Company has registered trademarks for the following product formats:
Boo Boo Strips The Ultimate Bandage Hemostrips Nik Fix17 Table Of Contents
Results of Operations for the three months ending March 31, 2022 and 2021
The following table sets forth a summary of certain key financial information for the three months ended March 31, 2022 and 2021
Three Months ended March 31, 2022 versus Three Months ended March 31, 2021
During the first quarter of 2022 and 2021, the Company had $0 and $59 of revenues, respectively. The minimal revenues are due to the continued focus of the Companys capital and resources towards obtaining a Class III PMA.
Total operating expenses for the first quarter of 2022 and 2021 were $954,501and $26,705,225, respectively.
The decrease in operating expenses is due primarily to a decrease in stock for services and compensation expense of $26,271,221. The Company recorded a total$10,200 of stock for services and compensation during the three months ended March 31, 2022 compared to $26,281,421 during the three months ended March 31,2021.
The decrease in stock for services compensation is due to the Company issuing20,000 shares of common stock for services with a fair value of $10,200 during the three months ended March 31, 2022. Stock for services and compensation during the three months ended March 31, 2021 was primarily due to the vesting and amortization of RSUs. During the three months ended March 31, 2021, the Company amended the RSU agreement with its former Chief Executive Officer and Chairman. The amendment resulted in the vesting of 21,970,000 RSUs along with the issuance of an additional 2,000,000 shares of restricted stock as a bonus. The change in vesting and issuance of the bonus shares of common stock resulted in the immediate recognition of $26,127,300 in stock-based compensation expense. The Company also recognized $43,121 of stock-based compensation due to the amortization of the RSUs that vested on January 1, 2021 and issued 100,000shares of common stock for settlement of a consulting agreement valued at$111,000.
Other income (expense) for the first quarter of 2022 and 2021 was $(9,763) and$(341,947), respectively. The decrease in other expense was due to a decrease in total interest expense of $602,142, a decrease in loss on settlement of debt$34,415 and a decrease in other income of $304,273. The decrease in interest expense is primarily due to the Company only having total interest expense of$8,880 during the first quarter of 2022 compared to the Company having total interest expense of $611,030 primarily due to recording amortization of beneficial conversion features on convertible notes payable and convertible notes payable - related party to interest expense during the first quarter 2021totaling $604,521. The decrease in the loss on debt settlement is due to the Company issuing common stock with a fair value of $4,001 for the settlement of$3,126 of accrued liabilities during the first quarter of 2022 compared to the Company issuing common stock with a fair value of $188,713 for the settlement of$153,523 of various debts and accrued liabilities - related party. The Company did not have Other income during 2022 compared to the Company receiving $304,273as full and final payment for settlement of its December 2019 arbitration with Maxim during the first quarter of 2021.
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Our net loss for the quarter ended March 31, 2022 was $964,264 as compared to net loss of $27,047,138 for the comparable period of the prior year. The decrease in the net loss is due to the Company having a decrease in operating expenses of $25,750,724 and a decrease in other expenses of $332,184, as explained above.
Financial Condition, Liquidity and Capital Resources
As of March 31, 2022, the Company had a negative working capital of $2,054,153.The Company has not yet attained a level of operations which will allow it to meet its current overhead expense obligations. If we are not successful in our commercialization strategy, we cannot assure that we will be able to fund a standalone marketing and sale strategy, and if we do, we are unable to assure we will attain profitable operations within the next year or at all. The report of our independent registered public accounting firm on our 2021 financia statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. While the Company has funded its operations with private placements, and secured loans from related parties, there can be no assurance that adequate financing will continue to be available to the Company and, if available, on terms that are favorable to the Company. Our ability to continue as a going concern is also dependent on many events outside of our direct control, including, among other things, our ability to achieve our business goals and objectives.
Cash Flows
The Companys cash on hand at March 31, 2022 and December 31, 2021 was $32,955and $21,799, respectively.
The following table summarizes selected items from our statements of cash flows for the three months ended March 31, 2022 and 2021:
For the Three Months Ended March 31, 2022 2021
Net cash used in operating activities $ (195,716 ) $ (110,488 )Net cash used in investing activities (40,500 )
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Net cash provided by financing activities 247,372 235,000
Net increase in cash and cash equivalents $ 11,156 $ 124,512
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities for the three months ended March 31, 2022was $195,716. The Company had net loss of $964,264 offset by stock for services and compensation of $10,200, amortization expense of $1,012, a loss on debt settlement of $875, an increase in accounts payable and accrued expenses of$191,052, an increase in accrued liabilities - related party of $135,409 and an increase in accrued litigation settlement of $430,000.
Net cash used in operating activities for the three months ended March 31, 2021was $110,488. The Company had net loss of $27,047,138 offset by stock-based compensation of $26,281,421, amortization of debt discount of $604,521 and a loss on settlement of debt of $35,190. The Company also had a decrease in inventory of $25, change in accounts payable and accrued expenses of $(46,312) and a change in accounts payable and accrued expenses related party of $116,805.The Company also had an increase in prepaid and other current assets of $5,000and an increase in subscription receivable of $50,000.
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Net Cash Used by Investing Activities
The Company paid $40,500 related to the patent application fees during the three months ended March 31, 2022.
The Company did not have any investing activities during the three months ended March 31, 2021.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities for the three months ended March 31,2022 was $247,372. This was due to the result of the Company receiving $77,292in proceeds from the sale of stock and receiving $185,000 from related party loans offset by making payments of $(14,920) on loan payable.
Net cash provided by financing activities for the three months ended March 31,2021 was $235,000. This was to the result of the Company receiving $20,000 in proceeds from a related party loan, $100,000 in proceeds from the sale of stock nd receiving $115,000 in proceeds from the issuance of convertible notes.
Off-Balance Sheet Arrangements
As of March 31, 2022, we have no off-balance sheet arrangements.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts o fassets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and revenues and expenses during the periods reported. Actual results could materially differ from those estimates. We have identified the following items as critical accounting policies.
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, the Company recognizes revenue from the sale of its HemoStyp product by applying the following steps: (1) identify the contract with a customer; (2) identify the performance obligations in thecontract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in the contract; and (5) recognize revenue when each performance obligation is satisfied.
The Company receives orders for its HemoStyp products directly from its customers. Revenues are recognized based on the agreed upon sales or transaction price with the customer when control of the promised goods are transferred to the customer. The transfer of goods to the customer and satisfaction of the Companys performance obligation will occur either at the time when products are shipped or when the products arrive and are received by the customer. No discounts were offered by the Company. The Company does not provide an estimate for returns as there is no anticipation for any returns in the normal course of business.
20 Table Of Contents Stock Based Compensation
The Company accounts for share-based compensation under the provisions of ASC718, Compensation-Stock Compensation. Under the fair value recognition provisions, stock-based compensation expense is measured at the fair value of the consideration received, or the fair value of the equity instruments issued, or liabilities incurred, whichever is more reliably measured. Share-based compensation for all stock-based awards to employees and directors is recognized as an expense over the requisite service period, which is generally the vesting period.
The Company accounts for stock compensation arrangements with non-employees in accordance with Accounting Standard Update (ASU) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which requires that such equity instruments are recorded at the value on the grant date.
UNITED HEALTH PRODUCTS, INC. FILES (8-K) Disclosing Other Events
In connection with the Securities and Exchange Commissions investigation against the Company, Douglas Beplate, the former Chief Executive Officer and Chairman and a former director of the Company, and Louis Schiliro, the former Chief Operating Officer and a former director of the Company, concerning possible violations of certain provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934, the Commissions Enforcement Division has presented proposed settlement terms which the Enforcement Division has indicated it would recommend to the Commission to resolve the matter as to the Company, if acceptable to the Company. The investigation was previously reported by the Company in its prior periodic reports including its Annual Report for the year ended December 31, 2021 under Item 1A "Risk Factors" which disclosure is incorporated into this report by reference.
The proposed resolution terms of the investigation presented by the Commission would include a consent judgment against the Company on the following terms, among others, without the Company admitting or denying the Commissions allegations:
The Company being permanently enjoined from violating: Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 under the Exchange Act; Section 17(a) of the Securities Act of 1933; Section 13(a) of the Exchange Act and Rules 12b-20, 13a-1 and 13a-13 under the Exchange Act; Section 13(b)(2)(A) of the Exchange Act; and Section 13(b)(2)(B) of the Exchange Act. The Company being required to pay a civil penalty of $450,000, payable in four installments as follows: $50,000 upon the entry of the judgment; $100,000 within 90 days of the entry of the judgment; $150,000 within 180 days of the entry of the judgment; and $150,000 within 270 days of the entry of the judgment, plus statutory interest on payments made after 30 days of the entry of the judgment pursuant to U.S.C. Section 1961.
Additionally, the Companys consent would include the Companys agreement not to take any action or make any public statement denying any allegations in the Commissions complaint or creating the impression that the complaint is without factual basis; and not to make any public statement to the effect that the Company does not admit the allegations in the complaint without also stating that the Company does not deny the allegations. This restriction would not affect the Companys right to take legal or factual positions in litigation or other legal proceedings in which the Securities Exchange Commission is not a party, nor would it affect the Companys testimonial obligations.
The Company has asked the Enforcement Division for clarification on certain points in the settlement relating to the proposed injunctive relief involving Section 13(b)(2)(B) of the Exchange Act, and for a draft of the allegations in the complaint on which the consent judgment would be based to review. Subject to the clarification on the injunctive relief and the complaint allegations not being unacceptable to the Company, the Company is predisposed to accepting the settlement terms presented.
Although the Commissions Enforcement Division has presented proposed terms of settlement to the Company, they have no obligation to recommend those terms to the Commission and they may withdraw or change the terms in their discretion. If the Enforcement Division decides to recommend the terms of settlement to the Commission, there can be no assurance that the Commission will proceed with the Enforcement Divisions recommendation. If this matter is not settled on the terms proposed, we cannot predict whether this matter will be settled without any enforcement action being taken. If this matter is not settled, the Commission may institute legal proceedings or enforcement actions against the Company to seek injunctive relief and monetary penalties in excess of the injunctions and civil penalties presented in the proposed settlement terms and we could not predict what the outcome, remedies or the duration of any legal proceedings or enforcement actions that may be brought will be.
The proposed settlement terms of the investigation presented to the Company do not include matters in the investigation pertaining to Mr. Beplate and Mr.Schiliro.
United Health Products Provides Regulatory and Business Update
Henderson, NV, April 27, 2022 (GLOBE NEWSWIRE) -- viaNewMediaWire --United Health Products, Inc. (OTCPK: UEEC), (UHP)today provided an update on its FDA regulatory process and other matters.
Regulatory Review
As previously disclosed in the companys Form 10-K, the U.S. Food & Drug Administration (FDA) requested in late January 2022 that i) the responses submitted by UHP to previous FDA questions be incorporated into its full Premarket Approval (PMA) application and ii) that the application be reformatted to conform to the FDAs eSubmitter online format. On April 20, 2022, UHP completed these tasks and there are currently no requests outstanding from the FDA. As is customary, the company and its regulatory consultant have requested a meeting within the next 30 days with the committee responsible for reviewing its PMA application. There can be no assurance that the PMA application will be approved.
Support for Ukraine
In an effort to support the people of Ukraine and those working to defend the country against the Russian invasion, UHP is donating 10,000 units of its HemoStyp hemostatic gauze to aid with much needed civilian and military medical care. UHP, with donations from certain of its existing shareholders, has partnered with a U.S. based charitable relief organization and will deliver an initial 4,000 units in the coming days and the remainder as the packaging and sterilization process is complete. UHP is proud to be able to bring some measure of comfort and relief to the victims of Russias brutal aggression, and continues to pursue commercial avenues to deliver its HemoStyp hemostatic products to this region.
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
UNITED HEALTH PRODUCTS, INC. FILES (8-K) Disclosing Change in Directors or Principal Officers, Other Events
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers, Compensatory arrangements of Certain Officers.
On February 18, 2022 Douglas Beplate submitted his resignation as a director of United Health Products, Inc., and Louis Schiliro submitted his resignation as a director and Chief Operating Officer of the Company, each effective on February 28, 2022, following their respective deliberations with the Companys other directors and in deference to the Companys ongoing efforts to resolve the previously reported Securities Exchange Commission investigation of the Company(discussed below under Item 8.01 "Other Events") and the Companys focus on its future business plans.
Neither Mr. Beplate nor Mr. Schiliro had any disagreements with the Company.
Mr. Beplate also ceases to be Chairman of the Board upon his resignation as director. Mr. Beplate previously stepped down as the Companys Chief Executive Officer effective on December 1, 2020 as part of the Companys management succession plan, being replaced in that role by Brian Thom as previously reported by the Company in its Current Report on Form 8-K filed with the Securities and Exchange Commission on December 2, 2020.
Mr. Schiliro remains in a non-officer position with the Company with a focus on the Companys FDA PMA application, new product and format development, R&D and manufacturing.
Item 8.01 Other Events.
As previously reported by the Company in its Quarterly Report for the period ended September 30, 2021 under Item 1A "Risk Factors" which disclosure is incorporated into this report by reference, the Securities and Exchange Commission has been conducting a private investigation concerning the Company since November 2018, in which the Company has been fully cooperating. The basis of the Commissions inquiry relates to the Companys original accounting revenue recognition treatment of two events in 2017. In order to reflect a correction to the revenue recognition treatment from the two events, the Company included restatements of its audited annual financial statements for 2017 and 2018 and unaudited financial statements for certain quarterly periods during 2017, 2018and 2019 in its 2019 Annual Report on Form 10-K which the Company filed with the Commission on July 9, 2020. The Commission has conveyed, among other things, the possibility that it could seek to enjoin the Company from violating the securities laws in the future and monetary remedies, and debarment and monetary remedies against Messrs. Beplate and Schiliro. The Company is engaged in dialogue with the Commission Staff to work toward a resolution of this matter, however we cannot predict whether this matter will be settled without any enforcement action being taken; or if it is not so settled, what the outcome, remedies or the duration of the investigation or any legal proceedings or enforcement actions that may be brought will be.
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Titan Medical Receives Final Milestone Payment and Retires Senior Secured Loan From Medtronic
TORONTO--(BUSINESS WIRE)--Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical technology company focused on the design and development of innovative surgical technologies for robotic single access surgery, announced today that it has received payment from Medtronic plc after successfully achieving the final milestone under the development and license agreement announced on January 4, 2022. In addition, the senior secured loan from Medtronic has been retired.
Titan received a net payment from Medtronic of $8.3 million. The payment is comprised of a $10.0 million milestone payment related to achieving the final milestone and a $0.6 million payment related to certain legal, transaction and intellectual property costs. A portion of the gross amount of $10.6 million was used to retire the $2.3 million senior secured loan with Medtronic to get to the net payment. The senior secured loan retirement included the original note of $1.5 million plus $0.6 million in legal, transaction and intellectual property costs and $0.2 million in interest.
On June 4, 2020, Titan announced it had entered into a license agreement as well as a development and license agreement with Medtronic to advance certain robotic-assisted surgical technologies for use by both Titan and Medtronic. As a result of this development activity, Titan has filed several new patent applications for which it retains world-wide rights to independently commercialize the technologies for use with its own Enos robotic single access surgical system. Additionally, the company was able to further attract and develop its team in Chapel Hill, North Carolina to further expand its knowledge base in robotic assisted surgery. The collaboration with Medtronic was possible without impact to the timeline for the development of the Enos system. The previously announced delay in the timeline of the Enos system are due, in part, to an uncertain and evolving regulatory pathway; certain resource gaps, particularly in the transfer to manufacturing and regulatory capability; and uncertainty and challenges relating to manufacturing (which may be offset with the engagement of an OEM manufacturer as announced on January 11, 2022). Additional details of the agreements with Medtronic may be viewed at www.sedar.com and at www.sec.gov.
United Health Products Provides Regulatory Status Update
HENDERSON, Nev. - December 22, 2021 - (Newswire.com)
United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the status of its application to the Food & Drug Administration (FDA) for Pre-market Approval (PMA) of its HemoStyp hemostatic gauze. On Dec.21, the FDA informed UHP that its review of the PMA application is ongoing and at this time there were no additional information requests to UHP. The FDA reserves the right under its review process to request additional information at any time.
As previously disclosed, UHPs PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the companys ability to market its HemoStyp products for human surgical procedures in the United States. There can be no assurance that a PMA will be granted by the FDA.
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
Titan Medical completes Enos preclinical studies
Titan Medical Inc (2) (TSX:TMD)
Shares Issued 111,127,690
Last Close 10/25/2021 $2.10
Monday October 25 2021 - News Release
Mr. David McNally reports
TITAN MEDICAL ANNOUNCES COMPLETION OF PRE-CLINICAL GLP STUDIES
Titan Medical Inc. has completed its scheduled preclinical studies with its Enos robotic single-access surgical system, performed in accordance with Food and Drug Administrations good laboratory practice (GLP) regulations. GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support marketing permits for products regulated by government agencies.
Titans preclinical studies involved utilizing the Enos system to perform hysterectomies in porcine subjects. Initial testing has been successfully completed and in accordance with GLP principles, further tests on the subjects were run postsurgery and pathology results are expected over the next several months. The COVID-19 pandemic has impacted the processing time at laboratories, resulting in a longer-than-expected turnaround time for results. With the completion of these studies, surgeons have now performed over 70 preclinical procedures representing multiple subspecialties with Titans Enos system.
"We are pleased to report that the studies were completed on time, adding to the cadre of data supporting the Enos systems use in preclinical studies. These studies provide critical input toward the final steps of development in preparation for regulatory submissions. We look forward to finalizing product development of the Enos system and continuing with our plans for application for investigational device exemption with the FDA and, once approved, proceeding with clinical studies," stated David McNally, president and chief executive officer of Titan.
About Titan Medical Inc.
Titan Medical, a medical device company headquartered in Toronto, Ont., and with R&D (research and development) facilities in Chapel Hill, N.C., is focused on enhancing robotic-assisted surgery using innovative technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multiarticulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications. Certain of Titans robotic-assisted surgical technologies and related intellectual property have been licensed to Medtronic PLC, while retaining worldwide rights to commercialize the technologies for use with the Enos system.
Encode Ideas is initiating coverage on Titan Medical
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INSTANTGMP Announces new client: United Health Products
CARY, N.C. (PRWEB) October 26, 2021
InstantGMP™, innovators of the all-in-one manufacturing and quality system, is proud to now include United Health Products among its valued clients. The Nevada-based medical technology company has enlisted both InstantGMP™ PRO software and Learning Management System (LMS) to advance their manufacturing process and training programs.
Founded in 1997, United Health Products manufactures and distributes HemoStyp, a patented hemostatic gauze thats used in medical, dental and veterinary industries. This groundbreaking biocompatible (tissue compatible) gauze produces hemostasis within seconds of application to an open wound or cut. This allows the gauze to more effectively absorb emissions or drainage from a wound or cut to reduce bleeding. An all-natural, plant-based product, FDA-registered HemoStyp contains no harmful chemicals or additives.
"United Health Products is dedicated to improving patient outcomes and reducing health care costs across multiple healthcare sectors," said Lou Schiliro, Chief Operating Officer, United Health Products. "Were also dedicated to improving our own procedures and processes. Thats why we chose to invest in InstantGMP PRO software and Learning Management System. With these tools, not only can we improve efficiency and accuracy of our manufacturing processes, we can also save time and expenses when onboarding new employees and training our teams."
With InstantGMP™ PRO all-in-one manufacturing and quality system, United Health Products is able to achieve greater control over every step of its manufacturing workflows. From simplified Master Production Record (MPR) and Batch Production Record creation to inventory control and document management to equipment maintenance scheduling, this cutting-edge software solution ensures product quality, complete traceability and full compliance with all FDA and Good Manufacturing Practices (GMP) requirements.
At the same time, InstantGMPs Learning Management System (LMS) allows United Health Products to enhance its onboarding process and training programs. Developed in partnership with Entrenar.se, the leaders in cloud-based training platforms, the LMS maximizes the onboarding and training experiences while minimizing the related timeframes and expenses.
Using the LMS, managers can schedule and assign training courses to specific employees. This not only ensures that each team member is up-to-date with the latest procedures, it also confirms compliance with all FDA and GMP guidelines. The LMS tracks training progress, records completed courses in the training log and uploads any certifications directly to the team members personal file.
"Developing software that solves United Health Products manufacturing and training pain points is extremely gratifying," said Dr. Richard Soltero, President of InstantGMP. "With these two InstantGMP products, United Health Products can now successfully ramp-up productivity across its manufacturing, onboarding and training operations.
InstantGMP™ is delighted to welcome United Health Products as our newest client. We are eager to play a part in their continued success in the medical technology manufacturing industry."
To learn more about InstantGMP™ PRO software and the Learning Management System, please contact us today for a live demonstration.
About InstantGMP™, Inc.
Founded by pharmaceutical industry veteran Dr. Richard Soltero, InstantGMP, Inc., offers affordable all-in-one manufacturing and quality software. The company develops cloud-based electronic batch record software and standard operating procedures specific to industries that are required to follow FDA manufacturing regulations and Good Manufacturing Practices ("GMP").
As a manufacturing software company, InstantGMP™ pioneered accessible, easy-to-use electronic batch record software for products manufactured using GMPs. The Companys updated software simplifies the documentation and approval procedures for quality processes that keep all quality documentation organized in electronic format while providing for quality checks and workflow processes to make compliance with FDA requirements easy.
Gerard Abate Explains HemoStyp Benefits and Uses for Bleeding Control
PALM COAST, FL, UNITED STATES, September 10, 2021 /EINPresswire.com/ --
HemoStyp is an innovative hemostatic gauze. It's an all-natural product created from plant cellulose. It's used to control bleeding in a surgical setting. Gerard Abate, Chief Medical Director of HemoStyp manufacturer United Health Products, explains the benefits of the gauze.
Hemostyp Design
Hemostyp is made from neutralized oxidized regenerated cellulose, or NORC. In simpler terms, it's created using plant cellulose from cotton fibers. It contains no additives or animal by products.
One aspect of Hemostyp's innovation is its ability to be absorbed into the body. It maintains proper ph in the body and degrades rapidly into glucose and salts. These particles are safely and easily absorbed by the body.
Current and Future Uses
Gerard Abate states that Hemostyp is currently FDA approved for topical human use, dental procedures, and veterinary procedures. It can be used to control bleeding from cuts, abrasions, puncture wounds, and dental incisions.
United Health Products is currently in the approval process for Hemostyp as a Class 3 surgical device. This means that it can be used during surgical procedures to control bleeding.
The FDA has accepted the premarket approval application. They are now in the process of conducting a substantive review. In anticipation of FDA approval, United Health Products is creating other Hemostyp products, including a gel and powder.
How to Use Hemostyp
To use Hemostyp, it should be applied to a wound with pressure. As it gets wet, it sticks to the wound and expands. This creates pressure which helps control bleeding. It also promotes clotting.
It transforms into a gel substance. Excess gel can be wiped away, leaving the wound sealed and reducing the risk of bleeding recurring.
Hemostyp Vs. Traditional Gauze
Gerard Abate notes that traditional gauze functions similar to a scab. Continuous direct pressure is required to slow bleeding. Hemostyp begins to expand as soon as it comes into contact with blood or fluid. It unites with platelets and the clot, which allows it to stick to the wound and seal blood vessels. Converting to a gel allows it to seal small areas that are hard to contact with traditional gauze.
The removal of wound dressing is often painful for the patient. Hemostyp solves this issue by transforming into an easily removable gel and degrading quickly.
It leaves no residue in the wound and doesn't interfere with wound healing. It's alsobacteriostatic, which makes it ideal for contaminated wounds.
United Health Products Gerard Abate
Gerard Abate is the Chief Medical Director for United Health Products, the maker of HemoStyp. He's a cardiologist with 14 years of experience and 30 years of experience in the medical industry. Before he became a part of the United Health Products team, he was theExecutive Director of Medical Affairs for Quest Diagnostics.
Gerard Abate, MD
Vita-Scientia Consulting
+1 7865519491
email us here
United Health Products Provides Corporate Update and Announces Equity Financing
HENDERSON, Nev. - June 28, 2021 - (Newswire.com)
United Health Products, Inc. (OTCPK: UEEC), ("UHP"), developer, manufacturer and marketer of HemoStyp, a patented Neutralized Oxidized Regenerated Cellulose hemostatic agent, today provided a corporate update on its current product development and commercialization activities.
In anticipation of a successful outcome to its Class III Pre-market Approval (PMA) application, the UHP team is pursuing several initiatives that will maximize the addressable market for its HemoStyp gauze and additional formats which, if approved by the FDA, will allow UHP to offer a full suite of Class III hemostatic formats to the human surgical market.
"Our stated strategy has always been to deploy our patented HemoStyp technology in all applications and markets where its unique qualities can provide value to customers and patients and compete successfully with the leading alternatives," said Brian Thom, Chief Executive Officer. "To that end, we are advancing several clinical and commercial projects as we await FDA feedback on our PMA application."
UHP is working with the Western Institutional Review Board to design an 80-patient study to investigate the safety and efficacy of HemoStyp gauze in a variety of laparoscopic procedures. The study design and approval are complete and UHP expects to enroll the studys first patient within the next 60 days. Such minimally invasive procedures are a fast-growing segment of the surgical market and UHP believes that its products would be an excellent tool to address moderate bleeding due to its supple structure, neutral pH level and rapid breakdown and absorption in the body. The study will involve patients undergoing abdominal, thoracic, and orthopedic and gynecologic procedures at several facilities.
Separately, UHP continues to refine the design of its HemoStyp flowable gel format and recently completed additional animal testing for this potential product extension against the current market-leading gel product. The results of this latest test procedure support the commercial viability of a HemoStyp gel product that will have several unique attributes and offer surgeons an attractive alternative to existing gel options, if approved for Class III applications.
Consistent with the strategy to selectively target certain 510k markets where its HemoStyp technology offers a differentiated solution, UHP is in discussions with a leading U.S. provider of hemodialysis services to conduct a clinical study of a HemoStyp adhesive bandage format to address post-dialysis bleeding at the patients access site.
To fund these and other R&D initiatives, on June 25, UHP entered in a Common Stock Purchase Agreement with Triton Funds, LP, under which Triton Funds will invest $4,000,000 to purchase approximately 4,525,000 of UHPs common shares. In addition, Triton Fund will have the right to invest an additional $2,000,000 to purchase approximately 2,263,000 UHP common shares over the next two years. These investments are subject to the SEC approval of a Registration Statement which UHP is filing today.
Casey Barraza of Triton Funds commented: "UHP is poised to offer a disruptive technology to the human surgical market that, if FDA approved, we believe has the potential to capture significant market share in the hemostatic market. We are particularly excited about the potential to offer a variety of HemoStyp formats that will position UHP to successfully challenge the established market leaders."
Brian Thom commented further: "We are very pleased to welcome Triton Funds as an investor. Tritons successful history of investment in innovative, fast-growing companies lends credibility to our own technology and development strategy. This investment will provide sufficient capital to fund our R&D and commercialization budget and help us position our products favorably with potential distribution partners and acquirers."
As previously disclosed, UHPs Class III PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to market HemoStyp products for human surgical procedures. There can be no assurance that the PMA will be granted by the FDA.
UHP continues to engage in discussions with several industry participants and financial investors regarding potential commercial partnerships and strategic transactions, including a possible sale of the company. There can be no assurance that any such partnership or transaction will be identified and, if so, that it will be consummated.
Titan Medical Reports Year-End 2020 Financial Results
TORONTO--(BUSINESS WIRE)--Titan Medical Inc. (Titan or the Company) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, today announced the release of its annual financial results for the years ended December 31, 2020 and 2019. During the year ended December 31, 2020, the Company generated revenue of $20.0 million, resulting from development and license agreements with Medtronic plc, and raised aggregate net proceeds of approximately $22.0 million from equity financings and approximately $2.7 million from the exercise of warrants. The Company also received a $1.5 million 8% senior secured loan from an affiliate of Medtronic.
On December 31, 2020, the Company had cash and cash equivalents of approximately $25.5 million, compared to approximately $0.8 million on December 31, 2019. Since December 31, 2020, the Company has received approximately $10.0 million from the exercise of warrants and net proceeds of approximately $10.2 million from a financing which closed on January 26, 2021. The Companys cash position was $42.5 million on January 31, 2021. In addition, the Company has also announced another financing with aggregate gross proceeds of $20.0 million, which is expected to close by the end of February 2021.
The progress made in the second half of 2020 resulted in an incredible year of accomplishments to position Titan for success. Recently announced financing arrangements and warrant exercises add to that progress, further strengthening our cash position to support the development of the Enos robotic single access surgical system, as we prepare to commence human clinical studies. said David McNally, President and Chief Executive Officer of Titan.
During 2020, we also executed a license agreement and a separate development and license agreement with Medtronic, resulting in the Companys first revenue of $20.0 million, by way of license payments. We believe Titan is in an excellent position to validate our vision of providing an innovative single access robotic surgical system. We are proud of our progress and recognize that our success is a direct result of the commitment and hard work of our entire team.
Business highlights for the fourth quarter of 2020 and recent weeks include:
On October 7, 2020, the Company announced the election of Paul Cataford, Anthony J. Giovinazzo, and Cary G. Vance as independent members to its board of directors.
On October 26, 2020, the Company announced the achievement of a $10.0 million technical milestone under a development and license agreement with Medtronic.
David McNally, President and CEO of Titan, presented a corporate overview and the Enos surgical system to a live virtual audience at the Benzinga Global Small Cap conference on December 9, 2020.
On December 24, 2020, the Company received written notification from The Nasdaq Stock Market LLC that it had cured the bid price deficiency and regained full compliance with all applicable criteria for continued listing and trading on The Nasdaq Capital Market.
On December 30, 2020, the Company announced that it received a written response from the U.S. Food & Drug Administration to its Request for Information in accordance with Section 513(g) of the U.S. Federal Food, Drug and Cosmetic Act, indicating that while the FDAs response does not constitute a classification decision, based on information provided to the agency, the Enos system is appropriate for classification through the De Novo pathway.
On January 26, 2021, the Company announced the closing of an offering of 6,451,613 units of the Company sold on a "bought deal" basis whereby Bloom Burton Securities Inc. acted as underwriter for the offering and exercised its over-allotment option in full for an additional 967,741 units resulting in aggregate gross proceeds to the Company of approximately $11.5 million.
On February 2, 2021, the Company announced it had entered into an agreement with underwriters Bloom Burton Securities Inc. pursuant to which Bloom Burton agreed to purchase, on a "bought deal" basis, 6,250,000 units of the Company at a price of $2.40 per Unit for aggregate gross proceeds of $15.0 million.
On February 3, 2021, the Company announced it had entered into an agreement with Bloom Burton Securities Inc. to increase the amount of its previously announced offering of February 2, 2021, to 8,335,000 units of the Company at a price of $2.40 for aggregate gross proceeds of $20.0 million.
On February 16, 2021, the Company launched Titan Living Labs, a new media-rich addition to its website providing access to stories behind the design, engineering and innovative technologies employed by Titan Medicals engineering team for the Enos surgical system.
Financial results for the twelve months ended December 31, 2020 include:
Net and comprehensive loss for the year ended December 31, 2020, was $24.2 million or $0.36 per share, compared to a net and comprehensive loss of $41.9 million, or $1.37 per share, for the year ended December 31, 2019. These figures included research and development expenditures of $7.7 million for 2020 and $51.4 million for 2019, as well as a non-cash loss on change in the fair value of warrants of $27.9 million in 2020 and a non-cash gain on change in fair value of warrants of $19.8 million in 2019. The Company also had an aggregate gain on settlements with suppliers of $2.5 million in 2020.
The net and comprehensive loss for the three months ended December 31, 2020 was $20.6 million, compared with a net and comprehensive gain of $2.4 million, for the three months ended December 31, 2019. The comparative increase in comprehensive loss was primarily due to an increase in non-cash loss on the fair value of warrants of $29.8 million, and an increase of $3.4 million in research and development expenses after the Company secured additional financing, offset by $10.0 million in revenue from the development and license agreement with Medtronic, all in the three months ended December 31, 2020.
Cash and cash equivalents as of December 31, 2020 were $25.5 million, compared with cash and cash equivalents of $0.8 million as of December 31, 2019. At December 31, 2020, current liabilities, excluding warrant liability, were $6.6 million compared with $11.4 million as of December 31, 2019.
At December 31, 2020, the Company had working capital of $20.4 million compared to a working capital deficit of $9.7 million at December 31, 2019.
The Company has disclosed in its managements discussion and analysis in respect of the 2020 annual financial year (2020 MD&A) that during the preparation of its financial statements for the year ended December 31, 2020, management became aware of certain errors in the calculation of asset and liability balances and the appropriate IFRS application and disclosure required for an amendment to a contract with an external development firm. After adjusting the financial statements of the Company as at and for the year ended December 31, 2020, the Company has concluded that the audited consolidated financial statements as at and for the year ended December 31, 2020 present fairly, in all material respects, the Companys financial position, results of operations, changes in equity and cash flows in accordance with IFRS.
As the 2020 MD&A outlines, the Company identified a material weakness in its controls in 2020 and has developed a remediation plan which includes the following: i) engagement of one or more qualified and independent consulting firms with subject matter experts to assist with the Companys internal accounting and reporting over complex accounting issues; ii) implementation of business information systems to support the work associated with the valuation and reporting of the warrant liabilities and other equity-based securities; and iii) the hiring of additional resources.
The consolidated financial statements for the year ended December 31, 2020, and December 31, 2019, have been prepared in accordance with International Financial Reporting Standards and International Accounting Standards as issued by the International Accounting Standards Board (IASB) and interpretations (collectively IFRS) and may be viewed at www.sedar.com and at www.sec.gov.
Investor Audio Webcast Information
Titan Medical will host an investor audio webcast at 4:30 p.m. ET today (February 22, 2021) to discuss the Companys annual financial results for the years ended December 31, 2020 and 2019, and business highlights. The webcast can be accessed in the Investor Relations section on the Companys website at www.titanmedicalinc.com.
About Titan
Titan Medical Inc., a medical device company headquartered in Toronto, is focused on developing robotic assisted technologies for application in single access surgery. The Enos system, by Titan Medical, is being developed with dual 3D and 2D high-definition vision systems, multi-articulating instruments, and an ergonomic surgeon workstation. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
Certain of Titans robotic assisted surgical technologies and related intellectual property have been licensed to Medtronic plc, while retaining world-wide rights to commercialize the technologies for use with the Enos system.
Enos is a trademark of Titan Medical Inc.
Just cleaned up my board with the Ignore button
Titan Medical Announces Closing of US $11.5M Bought Deal Offering Including Full Exercise of Over-Allotment Option
TORONTO--(BUSINESS WIRE)--Titan Medical Inc. (Titan or the Company) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announced today that it closed its previously announced offering of 6,451,613 units of the Company (Units) sold on a bought deal basis for gross proceeds of approximately US $10,000,000.00 (the Offering). Bloom Burton Securities Inc. (the Underwriter) acted as underwriter for the Offering and exercised its over-allotment option in full on the date hereof for an additional 967,741 Units and additional gross proceeds to the Company of approximately US $1,500,000. The aggregate gross proceeds to the Company under the Offering were approximately US $11,500,000.
Each Unit was issued at a price of US $1.55 per Unit and consisted of one common share in the capital of the Company (each a Common Share) and one half (1/2) of one Common Share purchase warrant (each whole warrant, a Warrant). Each Warrant is exercisable to acquire one Common Share at an exercise price of US $2.00 per share until January 26, 2026.
The net proceeds of the Offering will be used to fund the development of the Companys robotic surgical technologies and for general working capital.
The Units were offered by way of a short form prospectus in each of the provinces of British Columbia, Alberta, and Ontario pursuant to National Instrument 44-101 Short Form Prospectus Distributions, and by way of private placement in the United States and to, or for the account or benefit of, U.S. persons (as defined in Regulation S under the United States Securities Act of 1933, as amended (the 1933 Act)) pursuant to exemptions from the registration requirements under the 1933 Act, and pursuant to the applicable securities laws of any state of the United States.
The securities referred to in this news release have not been, nor will they be, registered under the 1933 Act and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful.
Related Party Transaction
An aggregate of 39,500 Units were purchased by directors, officers and employees of the Company and its subsidiary under the Offering for gross proceeds of US $61,225. Each insider subscription constituted a "related party transaction" pursuant to Multilateral Instrument 61-101 -- Protection of Minority Security Holders in Special Transactions ("MI 61-101"). In completing the purchases of Units by the Companys personnel, the Company relied on the exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 set forth in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as the aggregate value of the purchases of Units did not exceed 25% of the market capitalization of the Company. The Company did not file a material change report more than 21 days before the expected closing of the Offering due to the limited time between the launch of the Offering and the Closing.
Titan medical provides regulatory update on its Enos Robotic Single Access System
January 13 -- Titan Medical (NASDAQ:TMDI) announces that it has received a written response from the FDA to its Request for Information regarding the regulatory requirements applicable to its robotically assisted surgical device (RASD), the Enos Robotic Single Access System.
While the FDAs response to the request does not constitute a classification decision, the regulator has indicated that, based on information provided to the agency, the Enos system is appropriate for classification through the De Novo pathway.
Should the FDA grant the De Novo classification request, the Class II device would be cleared to be marketed.
"During the first quarter of 2021, we plan on further communications with the FDA, including filing a Pre-Submission, with the intent of clarifying any requirements for our planned Investigational Device Exemption studies and any potential impact on previously established timelines and forecasted costs, CEO David McNally said.
Titan Medical Announces Filing of Preliminary Short Form Prospectus
TORONTO--(BUSINESS WIRE)--Titan Medical Inc. (Titan or the Company) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announced today that it has filed a preliminary short form prospectus with applicable securities regulators in Ontario, British Columbia and Alberta in connection with its previously announced offering of 6,451,613 units of the Company (Units) on a bought deal basis, at a price of US$1.55 per Unit (the Offering Price) for aggregate gross proceeds of US$10,000,000 (the Offering). Bloom Burton Securities Inc. (the Underwriter) will act as underwriter for the Offering.
Each Unit will consist of one common share in the capital of the Company (each a Common Share) and one half (1/2) of one Common Share purchase warrant (each whole warrant, a Warrant). Each Warrant will be exercisable to acquire one Common Share for a period of 60 months following the closing of the Offering at an exercise price of US$2.00 per share.
The Company has granted the Underwriter an option, exercisable in whole or in part and from time to time at any time until 30 days after the closing of the Offering, to purchase up to an additional number of Units equal to 15% of the number of Units sold pursuant to the Offering at the Offering Price.
The net proceeds of the Offering will be used to fund the development of the Companys robotic surgical technologies and for general working capital. The Offering is expected to close on or about January 29, 2021 or such other date as the Company and the Underwriter may agree, and is subject to certain closing conditions, including but not limited to, the receipt of all necessary regulatory, stock exchange and other approvals, including the approval of the Toronto Stock Exchange.
The Units will be offered by way of a short form prospectus to be filed in each of the provinces of British Columbia, Alberta, and Ontario pursuant to National Instrument 44-101 Short Form Prospectus Distributions, and by way of private placement in the United States and to, or for the account or benefit of U.S. persons (as defined in Regulation S under the United States Securities Act of 1933, as amended (the 1933 Act)) pursuant to exemptions from the registration requirements under the 1933 Act, and pursuant to the applicable securities laws of any state of the United States. The Units may also be sold in such other jurisdictions as the Company and the Underwriter may agree.
The securities referred to in this news release have not been, nor will they be, registered under the 1933 Act and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful.
Related Party Transaction
An aggregate of 39,500 Units will be purchased by directors, officers and employees of the Company and its subsidiary under the Offering for gross proceeds of $61,225. Each insider subscription constitutes a "related party transaction" pursuant to Multilateral Instrument 61-101 -- Protection of Minority Security Holders in Special Transactions ("MI 61-101"). In completing the purchases of Units by the Companys personnel, the Company will rely on the exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 set forth in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as the aggregate value of the purchases of Units does not exceed 25% of the market capitalization of the Company. The Company did not file a material change report more than 21 days before the expected closing of the Offering due to the limited time between the launch of the Offering and the Closing.
Titan Medical Announces US$10 Million Bought Deal Offering
TORONTO--(BUSINESS WIRE)--Titan Medical Inc. (Titan or the Company) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announced it has entered into an agreement with Bloom Burton Securities Inc. (the Underwriter) pursuant to which the Underwriter has agreed to purchase, on a bought deal basis, 6,451,613 units of the Company (the Units) at a price of US$1.55 per Unit (the Offering Price) for aggregate gross proceeds of US$10,000,000 (the Offering).
Each Unit shall consist of one common share in the capital of the Company (each a Common Share) and one half (1/2) of one Common Share purchase warrant (each whole warrant, a Warrant). Each Warrant will be exercisable to acquire one Common Share for a period of 60 months following the closing of the Offering at an exercise price of US$2.00 per share.
The Company has granted the Underwriters an option (the Over-Allotment Option), exercisable in whole or in part and from time to time, at any time until 30 days after the closing of the Offering, to purchase up to an additional number of Units equal to 15% of the number of Units sold pursuant to the Offering at the Offering Price.
The net proceeds of the offering will be used to fund the development of the Companys robotic surgical technologies and for general working capital. The Offering is expected to close on or about January 29, 2021 or such other date as the Company and the Underwriters may agree, and is subject to certain closing conditions, including but not limited to, the receipt of all necessary regulatory, stock exchange and other approvals, including the approval of the Toronto Stock Exchange.
In connection with the Offering the Underwriter will receive: (i) a cash fee equal to 7.0% of the gross proceeds of the Offering (including Units sold pursuant to the exercise of the Over-Allotment Option); and (ii) that number of broker warrants equal to 7.0% of the Units sold under the Offering (including Units sold pursuant to the exercise of the Over-Allotment Option), each entitling the holder to acquire one Common Share at US$1.9375 for a period of 24 months after the Closing Date.
The Units will be offered by way of a short form prospectus to be filed in each of the provinces of British Columbia, Alberta, and Ontario pursuant to National Instrument 44-101 Short Form Prospectus Distributions, and by way of private placement in the United States and to, or for the account or benefit of U.S. persons (as defined in Regulation S under the United States Securities Act of 1933, as amended (the "1933 Act")) pursuant to exemptions from the registration requirements under the 1933 Act, and pursuant to the applicable securities laws of any state of the United States. The Units may also be sold in such other jurisdictions as the Company and the Underwriters may agree.
The securities referred to in this news release have not been, nor will they be, registered under the 1933 Act and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful.
United Health Products Announces HemoStyp Human Trial Results to be Available on ClinicalTrials.gov
HENDERSON, Nev.--(BUSINESS WIRE)--United Health Products, Inc. (OTCPK: UEEC, UHP) today announced that it has uploaded the full results of its Human Trial study, Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting, to the ClinicalTrials.gov website; these results are expected to be made available to the public within 7-14 days. UHPs randomized study of 238 patients undergoing thoracic, cardiac, abdominal, and vascular surgical procedures compared hemostatic performance of its patented HemoStyp gauze to the industry standard of care. The results of this study demonstrate a statistically superior performance of HemoStyp over J&Js Ethicons SURGICEL Original product. UHP will be submitting final documents requested by the FDA in conjunction with its PMA (Class III) application to use HemoStyp in internal surgeries. The company expects the FDA to seek additional information or approve the file within 30 days following the submission of the final documents.
All details and updates regarding the Human Trial will be available to the public at:
https://www.clinicaltrials.gov/ct2/show/NCT03654560?term=hemostyp&rank=1
UHP is progressing in its R&D efforts to develop and seek FDA approval for a hydrocolloid (flowable) formulation of its HemoStyp product and has filed patent applications for this hemostatic technology.
UNITED HEALTH PRODUCTS, INC. FILES (8-K)
The Company has been following the recommendations of local health authorities to minimize exposure risk for its team members for the past several weeks,including the temporary closures of its offices and having team members work remotely, and, as a result, the annual report will not be completed by the filing deadline, due to insufficient time to facilitate the internal and external review process.
UNITED HEALTH PRODUCTS, INC. (the Company) will be relying on the Securities and Exchange Commissions Order under Section 36 of the Securities Exchange Act of1934 Granting Exemptions From Specified Provisions of the Exchange Act of 1934and Certain Rules Thereunder dated March 25, 2020 (Release No. 34-88318) (the Order) to delay the filing of its Annual Report on Form 10-K for the year ended December 31, 2019 (the Report) due to the circumstances related to COVID-19.
In light of the current COVID-19 pandemic, the Company will be including the following Risk Factor in its Report:
Impacts of COVID-19 to Business and the general economy
Covid -19 has recently caused a material and substantial adverse impact on our general economy. It has also caused there to be a hold on our FDA application for class III approval of our hemostyp product for internal surgical purposes while the FDA deals with the Covid-19 crises
The impacts of the global emergence of Coronavirus disease (COVID-19) on our business and the general economy, are currently not fully known. We are conducting business as usual with some modifications to, employee work locations, among other modifications We have observed other companies taking precautionary and preemptive actions to address COVID-19 and companies may take further actions that alter their normal business operations. We will continue to actively monitor the situation and may take further actions that alter our business operations as may be required by federal, state or local authorities or that we determine are in the best interests of our employees, potential partners, suppliers and stockholders. It is not clear what the potential effects any such alterations or modifications may have on our business, including the effects on our prospects, although we do anticipate it to negatively impact our financial results and the length of time needed to obtain FDA approval of our hemostyp product for internal surgical purposes during fiscal year 2020.
UNITED HEALTH PRODUCTS, INC. Files An 8-K Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review
UNITED HEALTH PRODUCTS, INC. (OTCMKTS:UEEC) Files An 8-K Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review
Item 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Audit Report.
(d) Exhibits
About UNITED HEALTH PRODUCTS, INC. (OTCMKTS:UEEC)
United Health Products, Inc. is a product development and solutions company. The Company develops, manufactures and markets hemostatic gauze for the healthcare and wound care sectors. The Companys product, HemoStyp, is derived from regenerated oxidized cellulose and designed to absorb exudate/drainage from wounds and to help control bleeding. The Company is focused on identifying new markets and applications for its product. The Company has received orders from the dental and medical markets and is pursuing various markets for HemoStyp, including the medical, sports and veterinary sectors. Its HemoStyp Hemostatic Gauze is a hemostatic agent that controls bleeding from open wounds and body cavities. Its hemostatic gauze product line includes various configurations. Its hemostatic gauze product line includes dental gauze for oral surgery, approximately four versions of Trauma Gauze for battlefield trauma and approximately two island dressings to support intravenous procedures.
It traded at .57 briefly last Thursday 3/19
11000 at 11:30
24000 at 11:33
Hasn’t traded below .63 since Friday.
Added info at the end of todays news
HemoStyp Human Trial Results Article Submitted to American Journal of Surgery
HENDERSON, Nev.--(BUSINESS WIRE)--United Health Products, Inc. (OTC: UEEC), (UHP or the Company), developer, manufacturer and marketer of HemoStyp, an Oxidized Regenerated Cellulose, today announced that four surgeons who participated in the recently completed human clinical trial for HemoStyp have prepared and submitted an article entitled Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting to the American Journal of Surgery for peer review. This article is authored by Raymond Schaerf, MD, Sasan Najibi, MD, John Conrad, MD and UHP medical director Gerard Abate MD. This journal submission will highlight the results of aforementioned study showing HemoStyps superiority to Surgicel. Assuming that it obtains peer review approval, the paper will be published and later presented at an upcoming medical conference.
Separately, UHP announced that it has added NikFix (for use in minor cuts when shaving for both men and women), to its existing Hemostrip and BooBoo Strip product lines. The products are currently offered via Walmart Marketplace and can be purchased via the link below:
https://www.walmart.com/search/?query=hemostyp
From December 20th Progress Report
In January 2020 the company expects to meet with the FDA as part of the normal PMA application process.
In addition, in February 2020 management members will travel to China to complete the relocation of the manufacturing operation to Maryland. The entire relocation process, including the installation and testing of production equipment, is expected to take approximately two months.
Lastly, UHP has advanced its discussions to negotiations with well positioned candidates interested in acquisition of the company or partnerships that allow penetration into the surgical markets.
UNITED HEALTH PRODUCTS, INC. FILES (8-K)
Disclosing Changes in Registrant's Certifying Accountant, Financial Statements and Exhibits
Change in Registrants Certifying Accountant
On December 17, 2019, Haynie & Company resigned as United Health Products independent registered accountant by delivering a letter to the Company stating that they were ceasing services as the Companys accountants effective that day.
Haynie & Company orally advised the Company that they were ceasing as the Company's accountant because they did not want to take on the additional work of performing the internal control audit of the Company in connection with its 2019 fiscal year audit. The internal control audit is now required due to the increased market capitalization of the Company.
Haynie & Companys audit reports on the Companys financial statements for the fiscal years ended December 31, 2018 and 2017 did not contain an adverse opinion or a disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles, except that, the audit reports included an explanatory paragraph with respect to the uncertainty as to the Companys ability to continue as agoing concern.
During the years ended December 31, 2018 and 2017 and during thesubsequent interim period preceding the date of Haynie & Companys resignation, there were (i) no disagreements with Haynie & Company on any matter ofaccounting principles or practices, financial statement disclosure or auditing scope or procedure, and (ii) no reportable events (as that term is defined inItem 304(a)(1)(v) of Regulation S-K).
The Company requested Haynie & Company to furnish it with a letter addressed tothe SEC stating whether it agrees with the statements made above by the Company.The Company has filed this letter as an exhibit to this 8-K.
On December 20, 2019 the Board of Directors of Company engaged MAC Accounting Group, LLP, to serve as its independent registered accounting firm. Prior to engaging MAC Accounting Group, LLP, the Company did not consult with MAC Accounting Group, LLP regarding the application of accounting principles to aspecific completed or contemplated transaction, or the type of audit opinionthat might be rendered on the Companys financial statements.
United Health Products Completes Safety and Efficacy Animal Study for HemoStyp Hydrocolloid Product
HENDERSON, Nev.--(BUSINESS WIRE)--United Health Products (UHP) (OTC: UEEC) today announced that it had completed a safety and efficacy animal study for its HemoStyp hydrocolloid product, for which it filed a patent application in August 2019. The hemostatic hydrocolloid product is formed into a gel, foam or spray in order to control bleeding and oozing from a variety of wounds. If the patent is granted and FDA approval is obtained, HemoStyp could then be bundled as a suite of multiple products for surgical and wound care applications. UHP is also working on two other complementary HemoStyp-based products that could potentially be added to its surgical product suite.
The study, A Safety and Efficacy HemoStyp Hydrocolloid Test, was done by creating bilateral femoral arteriovenous fistulas in swine. HemoStyp thrombin hydrocolloid was applied to the anastomosis suture line on one side for the cessation of bleeding, while the market leading competitive product was applied to the anastomosis suture line on the opposite side for the cessation of bleeding. Time to cessation:
Animal 1: HemoStyp Hydrocolloid Product 35 Seconds; Competitive Product 1 Min 25 Seconds
Animal 2: HemoStyp Hydrocolloid Product 35 Seconds; Competitive Product 1 Min 55 Seconds
Animal 3: HemoStyp Hydrocolloid Product 25 Seconds; Competitive Product 2 Min 20 Seconds
After the completed hemostatic test, an autopsy with pathologic evaluation was performed three weeks following the procedures and showed no difference in scarring and inflammation between the two hemostatic agents. Pathology was completed by Thomas J. Baldwin, DVM, PhD, DACVP Director, Utah Veterinary Diagnostic Laboratory, an affiliate of Utah State University, on November 22, 2019.
The study indicated that the safety properties are equivalent to a previously approved Class III competitive product. These findings will be used to create an application for an additional format to the HemoStyp family of products and an additional Class III approved product.
About United Health Products
United Health Products develops technology, manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The product, HemoStyp, is derived from oxidized regenerated cellulose. HemoStyp is an all-natural product designed to control bleeding. UHP is focused on identifying new markets and applications for its products and expanding its current markets. UHP currently sells a suite of hemostatic products to the dental, veterinary and retail markets.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com
Yes.
Shares shorted increased by 18% from last reporting period. Went from 1,048,000 to 1,234,700
Pre-market .75
10-Q
Management's Discussion and Analysis of Financial Condition and Resultsof Operations.
You should read the following discussion and analysis of our financial conditionand results of operations together with our condensed financial statements andrelated notes appearing elsewhere in this quarterly report on Form 10-Q. Thisdiscussion and analysis contain forward-looking statements that involve risks,uncertainties and assumptions. The actual results may differ materially fromthose anticipated in these forward-looking statements as a result of certainfactors, including, but not limited to, those set forth under Risk Factors inour annual report on Form 10-K for the fiscal year ended December 31, 2018,filed with SEC on April 1, 2019.
Recent Developments
The following developments in the Companys business have occurred during 2019:
In August 2019, the Company successfully completed the surgeries for its Human Trial study "Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting" which finalized human trial enrollment. The Company is compiling and presenting all study data and human surgical results to an independent firm that will certify all data and finalize the Companys Class III PMA submission for FDA approval.
In August 2019, the Company filed a patent application covering methods of forming and using a hemostatic material, and more specifically, methods of forming and using a hemostatic hydrocolloid that is formed into a gel, foam or spray used to control bleeding and oozing from a variety of wounds. The approval of the new patent would allow for the HemoStyp hydrocolloid to act as a conduit to transfer other properties associated with the treatment of wounds within the hydrocolloid. This would enable HemoStyp to be bundled as a suite of multiple products for surgical and wound care applications. We cannot assure that our patent application will be granted.
Furthermore, in August 2019, the Company received the pathology results of a preclinical animal study to assess the effect of HemoStyp on bone tissue. The Company conducted the animal study to evaluate the suitability of HemoStyp in contact with bone in the chronic swine model, and to validate HemoStyp for this application. This study and indication are independent of the current PMA application and will potentially allow UHP to access new and significant market opportunities. The study results determined that there was no adverse pH effect on the bone and surrounding tissue, which UHP believes demonstrate the potential for safe application of HemoStyp in human orthopedic procedures.
Additionally, in August 2019, the final patient had completed their follow up study visit in the Companys HemoStyp Human Clinical Trial. This trial was conducted on 236 Western Institutional Review Board approved and consented patients. Comparative hemostatic product testing was conducted on Level 1 and Level 2 bleeds on the Lewis bleeding scale during abdominal, cardiovascular, thoracic and vascular surgeries. The study is a randomized trial with safety and efficacy endpoints for FDA PMA Class III submission.
In October 2019 the Company filed a defamation, trade libel and unlawful and deceptive practices lawsuit against White Diamond Research LLC, Adam Gefvert, Streetsweeper.org, Sonya Colberg and others in response to a stock manipulation scheme to injure UHP for illegitimate personal gain. The complaint alleges that in August 2019 the above defendants published false and defamatory statements about UHP in "short and distort" schemes to artificially drive down the market price of UHPs common stock while at the same time having a short position in UHPs stock, so they could obtain illicit profits on their short sale positions.
Also, in October 2019 the Company received a final report by an independent reviewer of the result of its Human Trial study, confirming the non-inferiority and superiority of HemoStyp over Surgicel ORIGINAL, the market leader for hemostatic agents. This report will be integrated into the Companys Class III PMA submission for FDA approval
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Our HemoStyp Gauze Products
HemoStyp Hemostatic Gauze is an innovative collagen-like natural substancecreated from chemically treated cellulose. It is an effective hemostatic agentregistered with the FDA to help control bleeding from open wounds and bodycavities. The HemoStyp hemostatic material contains no chemical additives,thrombin or collagen, and is hypoallergenic. When the product comes in contactwith blood it expands slightly and converts to an adhesive gel that subsequentlydissolves into glucose and saline. Because of its purity and the fact that itsimply degrades to non-toxic end products, HemoStyp does not cause significantdelay in healing as do certain other hemostatic materials. Additional testinghas shown HemoStyp to be 100% absorbable in 24 hours or less. Tests have alsobeen conducted to demonstrate the effectiveness of HemoStyp in thoracic andabdominal procedures. The Company continues to test for the effectiveness andthe IFU (Instructions for Use) for abdominal and thoracic procedures.
HemoStyp Hemostatic Gauze is a flexible cloth-like material that is applied byfolding the gauze as needed to fit the size of the wound or incision, and thenplacing the gauze onto the bleeding tissue. In surgical situations, the productconverts to a transparent gel with a neutral pH level that allows the surgeon tomonitor the coagulation process and also avoids damage to the surroundingtissue. In first responder or other non-surgical situations, putting a bandageon top of the gauze is optional and, in many cases, unnecessary. Since EMS(Emergency Medical Services) work is pre-hospital, rinsing the gauze out withsaline or water is not necessary, as a wound will be debrided and possiblyreopened prior to suturing at the hospital.
Our hemostatic gauze product line includes various configurations which havebeen developed to address the specific needs of our market segments and ourexisting customers, including the U.S. military. Our HemoStyp gauze products aresold in different sizes for use in superficial trauma cases, as a dental gauzeand as a nasal dressing, and in a range of formats for veterinary applications,among others uses. The Companys hemostatic gauze product line now includes thefollowing products:
Veterinary Market type Products; Dental gauze for oral surgery; Several formats of Trauma Gauze for battlefield trauma; Adhesive bandages for use by consumers on cuts and abrasions; and, Island dressings to support intravenous procedures such as kidney dialysis.
Existing and Potential Target Markets
Our technology is marketed as HemoStyp Gauze but is also available to customerswith customized private labeling. We are customer driven. We distribute bothnationally and internationally. We are servicing (or intend to service) ourcustomers through distributors, sales representatives, industry-specializedtelephone support, and the Internet. Our current and potential customer base forour HemoStyp includes, without limitation:
Hospitals and Surgery Centers for all Internal Surgical usage, post FDA Class III approval Hospitals, Clinics and Physicians - For external trauma EMS, Fire Departments and Other First Responders Public Safety, Police Departments and Military Correctional Facilities, Schools, Universities and Day Care Facilities, Nursing Homes and Assisted Living Environments, Home Care Providers, Dental offices, Sports Medicine Providers, Veterinarians, Municipalities and Government Agencies and Occupational and Industrial Healthcare Professionals
Consumers
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Plan of Operation
We believe that the Class III surgical markets, both domestic and international,represent the most attractive market for our products due to the limitedcompetition from other Class III approved ORC (Oxidized Regenerated Cellulose)products and the resulting premium pricing for hemostatic agents that can meetthe demanding requirements of the human surgical environment. In addition, ourpreliminary tests lead us to believe that the HemoStyp technology can competesuccessfully against established market participants and allow us to gain marketshare. Given this assessment, we have devoted considerable resources in 2018 andin 2019 to the date of this report to completing the FDA process.
Based on advice from the Companys Medical Board our management believes, butcannot assure, that HemoStyp will receive Class III approval. In anticipation ofthat, our strategy is to devote resources and seek partnerships that allow us topenetrate this market along with the other markets to which the Company alreadyhas access. We are evaluating all potential paths for the Company, which couldinclude commercial partnerships and licensing agreement with established marketparticipants, in addition or as an alternative to raising the necessary capitalto establish and grow our own marketing and distribution capabilities.
We believe that refocusing the Company to become a stronger, medical technologybusiness with a patented technology will enhance the Companys value and overallmarket strength and allows for revenue generation via organic growth.Nevertheless, we have engaged a financial advisor as described under "RecentDevelopments" to advise the Company on potential strategic alternativesincluding the possible sale of the Company and/or its intellectual assets. Inthe event that a transaction is not completed on terms satisfactory to theCompany, we will require substantial additional capital to execute an organicbusiness development strategy addressing all of our target markets.
Results of Operations
Three Months ended September 30, 2019 versus Three Months ended September 30,2018
During the three months ended September 30, 2019 and 2018, the Company had $0and $9,048 of revenues, respectively. The decrease in revenues is due to theCompany not pursuing sales in the current quarter compared to achieving minimalrevenues in the comparable quarter of the prior year.
Total operating expenses for the three months ended September 30, 2019 and 2018were $436,667 and $403,359, respectively. The increase in operating expenses isdue primarily to a decrease in bad debt expense of $100,000 offset by anincrease in research and development expenses of $141,820. The increase inresearch and development expenses is due to higher expenditures on the ongoingprocess to obtain FDA Class III approval during the current period.
Our net loss for the three months ended September 30, 2019 and 2018 was $436,667and $397,791, respectively. The increase in the net loss is due to reducedrevenue and increased spending on research and development, offset by a decreasein bad debt expense as mentioned above.
Nine Months ended September 30, 2019 versus Nine Months ended September 30, 2018
During the nine months ended September 30, 2019 and 2018, the Company had$25,009 and $40,826 of revenues, respectively. The decrease in revenues is dueto the reduced sales effort in 2019 as we focus on FDA Class III productapproval.
Total operating expenses for the nine months ended September 30, 2019 and 2018were $3,993,796 and $1,700,442, respectively. The increase in operating expensesis due primarily to an increase in consulting/professional fees and an increasein research and development expenses. The increase in consulting/professionalfees include the issuance of 400,000 shares of our common stock for servicesvalued at $380,000 and 2,150,000 shares of common stock valued at $2,343,500vested during the nine months ended September 30, 2019 compared to the Companyissuing 850,000 shares of common stock valued at $674,500 to various medicaladvisors during the nine month period ended September 30, 2018. The increase inresearch and development of $384,088 is due to higher expenses related to theFDA Class III approval process during the current period relative to the prioryear.
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Our net loss for the nine months ended September 30, 2019 was $4,135,564 ascompared to net loss of $5,302,377 for the comparable period of the prior year.The decrease in the net loss is due to the Company having an increase inselling, general and administrative expenses of $1,909,266 as described above,an increase of $384,088 in research and development expenses along with anincrease of $156,890 of interest expense related to amortization of debtdiscount related to beneficial conversion feature on notes payable - relatedparty offset by a decrease of $3,632,500 in loss on settlement of debt.
Financial Condition, Liquidity and Capital Resources
As of September 30, 2019, the Company had working capital deficit of $292,124and stockholders deficit of $292,124. The Company has not as yet attained alevel of operations which allows it to meet its current overhead and may notattain profitable operations within the next few business operating cycles, noris there any assurance that such an operating level can ever be achieved. Thereport of our independent registered public accounting firm on our 2018financial statements includes a reference to going concern which indicatedsubstantial doubt about our ability to continue as a going concern. While theCompany has in the past funded its initial operations with private placements,and loans from related parties, there can be no assurance that adequatefinancing will continue to be available to the Company and, if available, onterms that are favorable to the Company. Our ability to continue as a goingconcern is also dependent on many events outside of our direct control,including, among other things, our ability to achieve our business goals andobjectives, as well as improvement in the economic climate.
Cash Flows
The Companys cash on hand at September 30, 2019 and December 31, 2018 was$88,219 and $31,273, respectively.
Net cash used in operating activities for the nine months ended September 30,2019 was $1,245,804. The Company had a net loss of $4,135,564 offset by stockissued for services of $2,723,500 and amortization of debt discount of $156,890.The Company also had an increase in accounts receivable of $25,009, an increasein inventory of $25,933, an increase in accounts payable and accrued expenses of$63,182 and a decrease in accrued liabilities - related party of $2,870. Netcash provided by financing activities was $1,302,750. This was due to theCompany receiving $1,110,750 in proceeds from the sale of stock and receivingnet proceeds of $192,000 from a related party.
Net cash used in operating activities for the nine months ended September 30,2018 was $900,754. The Company had net loss of $5,302,377 offset by stock issuedfor services of $674,500, bad debt expense of $100,000, expenses paid by anofficer of $30,000 and loss on settlement of debt of $3,632,500. The Companyalso had an increase in accounts receivable of $8,429, a decrease in inventoryof $2,701, a decrease in prepaids and other current assets of $12,114 and adecrease in accounts payable and accrued expenses of $41,763. Net cash providedby financing activities was $841,700. This was due to the Company receiving$980,200 in proceeds from the sale of stock and repaying a net amount of$128,500 in related party advances and $10,000 in notes payable.
Off-Balance Sheet Arrangements
As of September 30, 2019, we have no off-balance sheet arrangements.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformitywith generally accepted accounting principles in the United States requiresmanagement to make estimates and assumptions that affect the reported amounts ofassets and liabilities, disclosure of contingent assets and liabilities at thedate of the financial statements, and revenues and expenses during the periodsreported. Actual results could materially differ from those estimates. We haveidentified the following items as critical accounting policies.
17 Table of ContentsRevenue Recognition
The Company recognizes revenues in accordance with ASC 606 - Revenue fromContracts with Customers. Under ASC 606, the Company recognizes revenue from thesale of its HemoStyp product by applying the following steps: (1) identify thecontract with a customer; (2) identify the performance obligations in thecontract; (3) determine the transaction price; (4) allocate the transactionprice to each performance obligation in the contract; and (5) recognize revenuewhen each performance obligation is satisfied.
Stock Based Compensation
The Company issues restricted stock to consultants and employees for variousservices. Cost for these transactions are measured at the fair value of theconsideration received or the fair value of the equity instruments issued,whichever is more reliably measurable. The value of the common stock fornon-employees is measured at the date at which a firm commitment for performanceby the counterparty to earn the equity instruments is reached and expense isrecognized during the term at which the counterpartys performance is earned orat the date the shares are considered non-forfeitable. The Company recognizedconsulting expenses and a corresponding increase to additional paid-in-capitalrelated to stock issued for services.
6 message gap. Ignore list is a beautiful thing.
HemoStyp Human Trial Results Journal Article to be Submitted for Peer Review
HENDERSON, Nev., Oct. 23, 2019 (GLOBE NEWSWIRE) --
United Health Products, Inc. (OTC: UEEC), (UHP), developer, manufacturer and marketer of HemoStyp, an Oxidized Regenerated Cellulose, today announced that four surgeons who participated in the recently completed human clinical trial for HemoStyp are preparing and submitting a journal article entitled Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting for peer review. This article is being authored by: Raymond Schaerf, MD, Sasan Najibi, MD, Gerard Abate MD and John Conrad, MD. This journal submission will also highlight the results of the aforementioned clinical trial showing HemoStyps superiority to Surgicel (the current standard of care). Furthermore; a presentationat an upcoming surgical conferenceof the proposed journal article is being prepared by the study investigators.
About United Health Products
United Health Products develops technology; manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The product, HemoStyp, is derived from oxidized regenerated cellulose. HemoStyp is an all-natural product designed to control bleeding. UHP is focused on identifying new markets and applications for its products and expanding its current markets. UHP currently sells a suite of hemostatic products to the dental, veterinary and retail markets.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
Company Contact:
United Health Products, Inc.
877-358-3444
IR Contact :
PAN Consultants Ltd.
Philippe Niemetz 212-344-6464 p.niemetz@panconsultants.com
Source: United Health Products Inc.
United Health Products Announces Positive Results from HemoStyp Human Clinical Trial
HENDERSON, Nev., Oct. 18, 2019 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTC: UEEC), (UHP or the Company), manufacturer and marketer of HemoStyp, an Oxidized Regenerated Cellulose that is patented through Oct 2029 (US Patent 8,557,874 Oct 15, 2013), for the healthcare and wound care sectors, today announced that it has received the final report from an independent review of the results of its human clinical trial. The review confirmed the non-inferiority and superiority of HemoStyp over Surgicel, the market leader for hemostatic agents.
In summary the independent statistical reviewer (http://www.stat4ward.com/who_we_are) stated:
For the primary analysis comparing HemoStyp versus Surgicel for hemostasis in 10 minutes, both non-inferiority and superiority were satisfied in both ITT population and PP population. For the secondary analysis, HemoStyp was significantly better than Surgicel with respect to the percentage achieving hemostasis at 2 minutes, 5 minutes, and 10 minutes.
The website https://www.clinicaltrials.gov/ct2/show/NCT03654560?term=hemostyp&rank=1 is being updated with all relevant data and supporting documents and will be continuously updated over the next several weeks.
This trial was conducted on 236 WIRB (Western Institutional Review Board) approved and consented patients. Surgeries consisted of Level 1 and Level 2 bleeds on the Lewis bleeding scale for abdominal, cardiovascular, thoracic and vascular surgeries.
UHP is continuing its discussions with well positioned candidates interested in acquisition of the Company or partnerships that allow penetration into the surgical markets.
About United Health Products
United Health Products develops technology, manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The product, HemoStyp, is derived from regenerated oxidized cellulose. HemoStyp is an all-natural product designed to control bleeding. UHP is focused on identifying new markets and applications for its products and expanding its current markets. UHP currently sells a suite of hemostatic products to the dental, veterinary and retail markets.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
Company Contact:
United Health Products, Inc.
877-358-3444
IR Contact :
PAN Consultants Ltd.
Philippe Niemetz 212-344-6464 p.niemetz@panconsultants.com
Source: United Health Products Inc.
United Health Products to Move Manufacturing to U.S.
HENDERSON, Nev., Oct. 17, 2019 (GLOBE NEWSWIRE) --
United Health Products, Inc. (OTC: UEEC), (UHP or the Company), developer, manufacturer and marketer of HemoStyp, an Oxidized Regenerated Cellulose gauze, today announced that it will relocate the majority of its manufacturing operations to a United States facility. UHP is recently partnering with an established contract manufacturing company and is leasing clean room space at the partners state-of-the-art facility in the Baltimore suburb of Westminster, Maryland. The facility is ISO 9001 and 13485 certified, and offers certain engineering and technical services that will help UHP rapidly increase production of existing and new HemoStyp formats, in anticipation of a successful FDA Class III PMA application approval, the potential acquisition of the Company or a strategic partnership. Once fully operational, the facility will be capable of manufacturing up to 20 million square inches of HemoStyp gauze monthly. Additional formulations of the HemoStyp product designed for the specialized human surgical market will also be produced at this facility. UHP is onshoring its production operations to improve its order response time, reduce freight costs and improve scalability.
UHP has been working to relocate manufacturing to the United States since the beginning of the year. The Company has enjoyed a successful relationship with its Chinese associates who are providing support and technical assistance to UHPs effort to commission its U.S. manufacturing operation. They will continue to supply the raw material for HemoStyp and produce certain finished, adhesive based products for non-surgical markets. The Companys Chinese associates will continue to be an intricate part of the companys retail product process and provide UHP with continuous manufacturing expertise.
About United Health Products
United Health Products develops technology; manufactures and markets patented hemostatic products for the healthcare and wound care sectors. The product, HemoStyp, is derived from oxidized regenerated cellulose. HemoStyp is an all-natural product designed to control bleeding. UHP is focused on identifying new markets and applications for its products and expanding its current markets. UHP currently sells a suite of hemostatic products to the dental, veterinary and retail markets.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
Curious if Chop found those UEEC shares to short on 8//29?
In his original post on 8/29 stating “the party is over”, chop wanted to find some shares to short when the stock was around $1.50. Hopefully for his sake he was unsuccessful, just like his passive aggressive posting strategy has been on here.
Keep it up champ!! I’m sure you’re making someone proud, just not your boss. Down 21% in 2 weeks is not a good start. But maybe if you mention China, PO boxes and Walmart sales some more you can turn that frown upside down!!!
And like you, we are just here to have a conversation about UEEC. What a tired act it is.
GLTA!!!! Right Champ?