United Health Products Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 12, 2024
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001477932-24-004723
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001477932-24-007039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 62 previous paragraphs and 68 current paragraphs.
31 unchanged; 29 reworded; 7 added; 2 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
OurCelluSTAT Gauze Products
Current report
On August 15, 2024, we submitted a Submission Issue Request (SIR) to the FDA outlining its plan to address and respond to the FDA Deficiencies Letter. On September 16, 2024, at the FDA’s request, the Company submitted a condensed list of questions relating to the prior SIR submission. On October 29. 2024, the Company and FDA conducted a virtual meeting to discuss the SIR and the condensed list of questions.
Current report
From September 23 through October 4, 2024, the FDA conducted a Bioresearch Monitoring Program (BIMO) Inspection of our records and procedures relating to our 2019 clinical study, following which the FDA delivered its Inspectional Observations on Form 483. On October 25, 2024, we submitted our response to the observations on the Form 483, which the FDA will consider in developing its final report on the BIMO Inspection.
Current report
On October 29, 2024, the Company and its regulatory consultant met with the FDA’s PMA application review committee. The purpose of the meeting was to present, discuss and seek feedback from the FDA on our proposed resolutions to the deficiencies. Topics discussed include our clinical testing (including the results of the human trial), biocompatibility, product sterilization and shelf life.
Current report
During the discussion, the Company noted the results of its clinical trial involving 232 patients (of whom 118 were treated with its hemostatic gauze) that showed both non-inferiority and superiority for time to hemostasis using CelluSTAT relative to the standard of care and showed no evidence of heterogeneity of results across procedure categories, surgeons, or clinical sites, indicating both poolability and generalizability of study results. The Company also noted that none of the adverse events that occurred during the study were attributable to its hemostatic gauze product.** **
Current report
The FDA requested more data to confirm the safety and effectiveness of CelluSTAT in surgical procedures in the intestinal and thoracic organ space, where organ movement can impact the post operative stability of a hemostat and where observation of post operative rebleeding is more difficult. To address this concern, we have proposed to enroll a limited number of human subjects in a multi-site study as an extension of the original pivotal study, with patients undergoing surgical procedures within the organ space. The supplemental study process will consist of submitting an Investigational Device Exemption (IDE) for FDA approval, identifying and contracting suitable surgical sites, enrolling patents, and data collection and analysis.
Current report
Nine Months ended September 30, 2024 versus Nine Months ended September 30, 2023
Removed paragraphs (2)
Previous report
Our HemoStyp Gauze Products
Previous report
Six Months ended June 30, 2024 versus Six Months ended June 30, 2023
Reworded paragraphs (29)
Previous wording
UHP develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, HemoStyp®, is 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 hemostatic gauze product line into the U.S. Class III and European CE Mark human surgical markets.
Current wording
UHP develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, CelluSTAT®, is 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 hemostatic gauze product line into the U.S. Class III and European CE Mark human surgical markets.
Previous wording
HemoStyp hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The HemoStyp hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into glucose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, HemoStyp does not impede the healing of body tissue as compared to certain competing hemostatic products. Laboratory testing has shown HemoStyp to be 100% absorbable in the human body within 24 hours, compared to days or weeks with competing organic regenerated cellulose products.
Current wording
CelluSTAT hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The CelluSTAT hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into cellulose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, CelluSTAT does not impede the healing of body tissue as compared to certain competing hemostatic products.
Previous wording
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.
Current wording
CelluSTAT (formerly branded as 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, CelluSTAT 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.
Previous wording
In 2012, the Company began marketing its HemoStyp hemostatic gauze for human topical and dental applications as well as for and veterinary surgical applications under an FDA 510k approval.
Current wording
In 2012, the Company began marketing its CelluSTAT hemostatic gauze for human topical and dental applications as well as for and veterinary surgical applications under an FDA 510k approval.
Previous wording
In 2018, the Company determined to pursue a Class III designation to market its hemostatic gauze under an FDA Premarket Approval as an adjunct product to achieve hemostasis in human surgical applications. In February 2018, the Company completed and submitted to the FDA all materials relevant for the pre-market approval (or PMA) for HemoStyp as a Class III application for internal surgical procedures. Since our initial PMA submission, we have conducted a human trial and have worked to address certain deficiencies in our PMA application that were identified by the FDA.
Current wording
In 2018, the Company determined to pursue a Class III designation to market its hemostatic gauze under an FDA Premarket Approval as an adjunct product to achieve hemostasis in human surgical applications. In February 2018, the Company completed and submitted to the FDA all materials relevant for the pre-market approval (or PMA) for CelluSTAT as a Class III application for internal surgical procedures. Since our initial PMA submission, we have conducted a human trial and have worked to address certain deficiencies in our PMA application that were identified by the FDA.
Previous wording
On March 21, 2024, we submitted results of the human clinical trial and other information, including our manufacturing, sterilization and shipping processes, to the FDA. On June 18, 2024, the FDA issued a customary "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application. The FDA's 180-day PMA application review period will be paused while the Company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted. There can be no assurance that our PMA application will be approved.
Current wording
On March 21, 2024, we submitted results of the human clinical trial and other information, including our manufacturing, sterilization and shipping processes, to the FDA. On June 18, 2024, the FDA issued a customary "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application. The FDA's 180-day PMA application review period will be paused while we develop responses to the deficiencies that were identified and will resume once all the responses have been submitted.
Previous wording
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:
Current wording
Our CelluSTAT material is currently cut to several sizes and configuration and marketed as CelluSTAT 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:
Previous wording
Our HemoStyp technology received an FDA 510(k) 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. We believe that our extensive laboratory testing and our completed human trial indicate that the HemoStyp technology could successfully compete against established Class III market participants, and could gain a significant market share. As discussed above, we are in the process of seeking FDA pre-market approval for our HemoStyp product. There can be no assurance that an FDA PMA will be granted.
Current wording
Our CelluSTAT technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for CelluSTAT products to address unmet needs in several medical applications that represent attractive commercial opportunities. However, the Class III human 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. We believe that our extensive laboratory testing and our completed human trial indicate that the CelluSTAT technology could successfully compete against established Class III market participants, and could gain a significant market share. As discussed above, we are in the process of seeking FDA pre-market approval for our CelluSTAT product. There can be no assurance that an FDA PMA will be granted.
Previous wording
Total operating expenses for the three months ended June 30, 2024 and 2023 were $405,177 and $475,456, respectively.
Current wording
Total operating expenses for the three months ended September 30, 2024 and 2023 were $391,903 and $450,451, respectively.
Previous wording
The decrease in operating expenses for the three months ended June 30, 2024 was primarily due to the Company having a decrease in legal and professional expenses of $59,575, a decrease in research and development expenses of $39,393 offset by an increase in write-off of inventory of $33,598.
Current wording
The decrease in operating expenses for the three months ended September 30, 2024 was primarily due to the Company having a decrease in research and development expenses of $55,876.
Previous wording
Other income (expense) for the three months ended June 30, 2024 and 2023 was $(26,844) and $(47,455), respectively. The decrease in other expense was primarily due to a decrease in loss on settlement of debt of $19,594.
Current wording
Other income (expense) for the three months ended September 30, 2024 and 2023 was $88,241 and $(35,281), respectively. The decrease in other expense was primarily due to the Company paying $55,532 to settle approximately $171,000 of accounts payable resulting in a $115,085 gain on settlement of debt.
Previous wording
Our net loss for the three months ended June 30, 2024 was $432,021 as compared to net loss of $522,911 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 $70,279 and a decrease in other expense of $20,611, as explained above.
Current wording
Our net loss for the three months ended September 30, 2024 was $303,662 as compared to net loss of $485,732 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 $58,548 and a decrease in other expense of $123,522, as explained above.
Previous wording
Results of Operations for the six months ending June 30, 2024 and 2023
Current wording
Results of Operations for the nine months ending September 30, 2024 and 2023
Previous wording
The following table sets forth a summary of certain key financial information for the six months ended June 30, 2024 and 2023:
Current wording
The following table sets forth a summary of certain key financial information for the nine months ended September 30, 2024 and 2023:
Previous wording
During the six months ended June 30, 2024 and 2023, the Company had $0 of revenues. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Current wording
During the nine months ended September 30, 2024 and 2023, the Company had $0 of revenues. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Previous wording
Total operating expenses for the six months ended June 30, 2024 and 2023 were $830,271 and $1,529,431, respectively.
Current wording
Total operating expenses for the nine months ended September 30, 2024 and 2023 were $1,222,174 and $1,979,882, respectively.
Previous wording
The decrease in operating expenses was primarily due to a decrease of $462,500 in litigation settlement expenses, a decrease of $124,472 in legal and professional expenses and research and development expenses decreasing $142,517 to $181,272 during the six months ended June 30, 2024 from $323,789 in the six months ended June 30, 2023.
Current wording
The decrease in operating expenses was primarily due to a decrease of $462,500 in litigation settlement expenses, a decrease of $132,015 in legal and professional expenses and research and development expenses decreasing $198,393 to $247,157 during the nine months ended September 30, 2024 from $445,550 in the nine months ended September 30, 2023.
Previous wording
Other income (expense) for the six months ended June 30, 2024 and 2023 was $(53,688) and $(136,186), respectively. The decrease in other expense was primarily due to a decrease in loss on settlement of debt of $80,532.
Current wording
Other income (expense) for the nine months ended September 30, 2024 and 2023 was $34,553 and $(171,467), respectively. The change in other income (expense) was primarily due to the Company having a $115,085 gain on settlement in the current period and having a loss on settlement of debt of $80,532 in the comparable period from the prior year.
Previous wording
Our net loss for the six months ended June 30, 2024 was $883,959 compared to net loss of $1,665,617 for the comparable period of the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $699,160 and a decrease in other expenses of $82,498 as explained above.
Current wording
Our net loss for the nine months ended September 30, 2024 was $1,187,621 compared to net loss of $2,151,349 for the comparable period of the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $757,708 and a decrease in other expenses of $206,020 as explained above.
Previous wording
As of June 30, 2024, the Company had a negative working capital of $2,064,538. The Company has not yet attained a level of operations, which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 2023 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company has been focusing its capital and resources towards seeking a Class III PMA for its HemoStyp technology, and has funded its initial operations with private placements, and unsecured 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, as well as improvement in the economic climate.
Current wording
As of September 30, 2024, the Company had a negative working capital of $2,171,720. The Company has not yet attained a level of operations which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 2023 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company has been focusing its capital and resources towards seeking a Class III PMA for its CelluSTAT technology, and has funded its initial operations with private placements, and unsecured 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, as well as improvement in the economic climate.
Previous wording
The Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gives the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. As of the date of this filing, the Company has received approximately $3.0 million in proceeds from White Lion to pay for its operations and finalization of its Class III PMA application. The sale of additional equity or convertible debt securities would be dilutive to our shareholders. In addition, economic conditions and actions by policymaking bodies are contributing to rising interest rates and significant capital market volatility, which, along with increases in our borrowing levels, could increase our future borrowing costs.
Current wording
The Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gives the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. As of the date of this filing, the Company has received approximately $3.2 million in proceeds from White Lion to pay for its operations and finalization of its Class III PMA application. The sale of additional equity or convertible debt securities would be dilutive to our shareholders. In addition, economic conditions and actions by policymaking bodies are contributing to rising interest rates and significant capital market volatility, which, along with increases in our borrowing levels, could increase our future borrowing costs.
Previous wording
The Company’s cash on hand at June 30, 2024 and December 31, 2023 was $18,574 and $95,420, respectively.
Current wording
The Company’s cash on hand at September 30, 2024 and December 31, 2023 was $43,783 and $95,420, respectively.
Previous wording
The following table summarizes selected items from our statements of cash flows for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes selected items from our statements of cash flows for the nine months ended September 30, 2024 and 2023:
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was $693,481. The Company had a net loss of $883,959 offset by amortization expense of $2,025, write-off of inventory of $33,598, amortization of right-of-use asset of $578, a decrease in prepaid and other current assets of $15,264, an increase in accrued liabilities - related party of $98,962 and an increase in accounts payable and accrued expenses of $40,051.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $1,013,278. The Company had a net loss of $1,187,621 and a gain on settlement of debt of $115,085 offset by amortization expense of $3,038, write-off of inventory of $33,598, amortization of right-of-use asset of $582, a decrease in prepaid and other current assets of $2,896, an increase in accrued liabilities - related party of $195,193 and an increase in accounts payable and accrued expenses of $54,121.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2023 was $1,019,370. The Company had net loss of $1,665,617 offset by amortization expense of $2,025, amortization of debt discount of $17,648, stock issued for litigation settlement of $462,500 and a loss on debt settlement of $80,532, a decrease in inventory of $1,132, a decrease in prepaid and other current assets of $15,369 and an increase in accrued liabilities - related party of $229,711. The Company also had a decrease in accounts payable and accrued expenses of $12,670 and a decrease in accrued litigation settlement of $150,000.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2023 was $1,624,145. The Company had net loss of $2,151,349 offset by amortization expense of $3,038, amortization of right-of-use asset of $346, amortization of debt discount of $26,502, stock issued for litigation settlement of $462,500, a loss on debt settlement of $80,532, a decrease in inventory of $1,132, an increase in prepaid and other current assets of $7,504 and an increase in accrued liabilities - related party of $224,698. The Company also had a decrease in accounts payable and accrued expenses of $14,040 and a decrease in accrued litigation settlement of $250,000.
Previous wording
The Company did not have any investing activities during the six months ended June 30, 2024.
Current wording
The Company did not have any investing activities during the nine months ended September 30, 2024.
Previous wording
The Company paid $2,850 related to a security deposit during the six months ended June 30, 2023.
Current wording
The Company paid $2,850 related to a security deposit during the nine months ended September 30, 2023.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $616,815. This was due to the result of the Company receiving net proceeds of $616,815 from the sale of common stock.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $961,641. This was due to the result of the Company receiving net proceeds of $811,641 from the sale of common stock and $150,000 in proceeds from a note payable.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2023 was $1,142,444. This was due to the result of the Company receiving $1,151,580 in proceeds from the sale of common stock offset by making payments of $9,136 on a loan payable.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $1,687,657. This was due to the result of the Company receiving net proceeds of $1,710,793 from the sale of stock offset by making payments of $19,136 on a loan payable and $4,000 on a loan payable – related party.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
There can be no assurance that our PMA application will be approved.