Venous Insufficiency

Merakris Therapeutics to present poster at CAMPs Wound Care Summit in Miami, FloridaRESEARCH TRIANGLE PARK, N.C., March 12, 2024 (GLOBE NEWSWIRE) -- A recent multicenter study has demonstrated encouraging effectiveness and safety of Merakris Therapeutics’ Dermacyte® Amniotic Wound Care Matrix in treating hard-to-heal diabetic and venous leg ulcers (VLUs). Wounds with an average size of 20 cm2 showed a significant reduction in volume after a single application and a 50% reduction in wound size was observed after approximately two applications of Dermacyte Matrix, the study reported. The study, a real-world, multicenter, retrospective clinical study, analyzed 18 hard-to-heal wounds in 11 patients who received Dermacyte Matrix between August 2022 and August 2023. Thirteen of the wounds were diabetic ulcers and five were chronic venous insufficiency (CVI)-related VLUs. All the patients in the study had failed to respond favorably to prior standard of care wound treatment. The results suggest that Dermacyte Matrix – a human amniotic membrane allograft that protects soft tissue and wounds from the external environment – may improve treatment outcomes for diabetic and venous leg ulcers and help reduce a major healthcare and economic burden on society. The findings from this multicenter clinical study have been published in the March addition of the peer reviewed Journal of Wound Care (JWC). Merakris also will present a poster at the JWC- sponsored CAMPs (Cellular Acellular and Matrix-Like Products) Wound Care Summit in Miami, Florida, March 13-14. “We are delighted to share the results of this study, which provides positive evidence of Dermacyte Matrix use in addressing hard-to-treat wounds that were not resolved through standard-of-care wound treatment,” said Merakris CEO Chris Broderick. “A growing body of evidence indicates that amnionic membranes like Dermacyte Matrix offer a better option for protecting serious wounds that have not responded well to other treatments.” Overall, treatment with Dermacyte Matrix resulted in significantly decreased wound size over time. “Together, these findings suggest that placental biologics, including amniotic membranes, drive wounds through the productive phases of wound healing and can ultimately reduce wound duration and potentially scarring,” the study reported. “A likely indirect effect of these is the salvage of limbs that may otherwise face amputation as a last resort intervention.” The research was supported, in part, by Merakris. About Merakris Research Triangle Park-headquartered Merakris Therapeutics, founded in 2016, is at the forefront of scientific advancement in regenerative medicine. Dedicated to championing a precision medicine approach to wound care, the company seeks to improve global patient care and outcomes with cell-free regenerative therapies. In addition to Dermacyte® Matrix, its products include: Dermacyte® Amniotic Wound Care Liquid, a cell-free amniotic injection developed under Merakris’ Investigational New Drug (IND) clearance that is being evaluated for the treatment of non-healing venous stasis ulcers.Opticyte® Matrix, which provides an ophthalmic barrier to the corneal surface of the eye for use with various ocular procedures.Opticyte® Serum Tears, which can be used for the treatment of dry eye and corneal epithelial (outer layer) defects, and as an adjunct therapy to support optimization of the ocular surface before and after various clinical and surgical procedures. Merakris Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole. Bryant HaskinsOtter Creek Communicationsbryanthaskins@gmail.com(c) 973 590 9537

OAKLAND, Calif. and TAMPA, Fla., March 6, 2024 /PRNewswire/ -- Koya Medical, today announces topline results from its TEAYS trial. TEAYS (NCT05507346) is a prospective multi-center, randomized cross-over study comparing lower extremity lymphedema treatment effectiveness of Dayspring®, Koya's non-pneumatic compression device (NPCD) with a traditional advanced pneumatic compression device (APCD). Continue Reading Dayspring by Koya Medical The study met its primary endpoints, achieving statistically significant differences in limb volume reduction, improvement of quality of life, and treatment adherence, all favoring the Dayspring treatment arm over the APCD treatment arm. In limb volume reduction, the Dayspring arm achieved a mean reduction of 369.9mL from baseline compared to that of 83.1mL for the APCD arm. In quality of life, the Dayspring arm achieved 1.01 point improvement on the LYMQOL survey compared to 0.17 point improvement for APCD. In treatment adherence, rate of adherence was reported to be 81% for the Dayspring arm compared with 56% for the APCD. No adverse events were related to either treatment arm. Full study results are not yet available. "Koya is committed to continuing its innovation in this disease space. We are pleased with these topline results and will be conducting sub-analyses of the full data set," said Thomas Maldonado, MD, Chief Medical Officer. The latest TEAYS trial results add to the growing body of evidence for Dayspring, which has had 7 prior publications to date. In 2021, Koya Medical became the first company to receive FDA clearance for its non-pneumatic active compression system Dayspring, which provides patients with gradient sequential compression, mobility and ambulation during treatment. About Lymphedema An estimated 20 million Americans live with lymphedema, a progressive, incurable condition where a buildup of protein rich fluid causes painful swelling in the arm, leg, and/or other regions of the body. For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain. Lymphedema can result from a variety of factors, including cancer, chronic venous disease, infection, and surgery. About Dayspring The Dayspring compression system, available for upper and lower extremity care, is a non-pneumatic treatment that integrates compression, muscle pump activation, and mobility in one easy-to-use solution. The Dayspring system includes a low-profile active garment made of soft, breathable mesh using proprietary Flexframe® technology; a rechargeable controller that can be worn on a lanyard; and a mobile app. Dayspring is indicated to treat lymphedema, primary lymphedema, post mastectomy edema, edema following trauma and sports injuries, post immobilization edema, venous insufficiency, venous stasis ulcers, or arterial and diabetic leg ulcers, lipedema and phlebolymphedema and other similar conditions that impact lymphatic flow in the upper and lower extremities. Dayspring is also indicated to reduce wound healing time and treatment and assist in healing stasis dermatitis. About Koya Medical Koya Medical, a privately held company founded in 2018, is a transformative healthcare company developing breakthrough treatments for venous diseases and lymphedema and personalized care that is unavailable with traditional treatments. Visit Koya Medical LinkedIn at SOURCE Koya Medical

$46.4 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025 Topline efficacy data for VenoValve® U.S. pivotal trial to be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024 Continued progress toward launch of GLP study for enVVe® transcatheter-based replacement venous valve IRVINE, CA / ACCESSWIRE / February 29, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2023. "We made significant progress over the course of the past year and are poised to reach multiple value driving milestones in 2024. We look forward to reporting topline efficacy results from the SAVVE pivotal trial on March 6th. Additionally, we are executing on our plans to launch the pre-clinical GLP study for enVVe which is on track to begin in the first quarter of this year," commented Robert Berman, CEO of enVVeno Medical. "In addition to the progress with our development programs, we have significantly bolstered our strong financial position and moving forward, have the capital that we need to focus our efforts towards our expected PMA approval for the VenoValve." Corporate Highlights Closed $28 million private placement led by Perceptive Advisors with participation from Nantahala Capital, Kingdon Capital Management, Velan Capital, L1 Capital and other new and existing institutional investors. Clinical Program Highlights VenoValve: Surgical Replacement Venous Valve Achieved completion of enrollment in the SAVVE U.S. pivotal trial. Positive preliminary device-related Material Adverse Event (MAE) safety data from the SAVVE U.S. pivotal trial for the VenoValve was presented at the 50th Annual VEITH symposium. The preliminary device related MAE rate for the fully enrolled 75 subject study is reported to be eight percent (8%). Topline efficacy data from SAVVE to be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024. PMA eligibility to FDA approval of the VenoValve is expected to occur in Q3 of 2024. enVVe®:Non-surgical Transcatheter Based Replacement Venous Valve Ongoing progress toward expedited development plan including six (6) month pre-clinical GLP study of enVVe, which the Company expects to begin in Q1 2024 and which is an FDA prerequisite and final step before seeking approval for the enVVe pivotal trial. Investigational Device Exemption (IDE) seeking approval for the enVVe pivotal trial expected to be filed in Q4 2024. Approval of enVVe pivotal trial expected in early 2025. Summary of Financial Results for the Full Year 2023 The Company ended the year with $46.4 million in cash and investments. Based on management's current expectations, this capital is expected to fund operations through late 2025, including the release of initial topline efficacy data from SAVVE, anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and accelerated plans for the pivotal trial for enVVe. Cash burn for the quarter was $5 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025. The Company reported net losses of $23.5 million and $24.7 million for the years ended December 31, 2023 and 2022, respectively, representing a decrease in net loss of $1.2 million or 5%, resulting from, as described in further detail below, an increase in operating expenses of $0.3 million, and an increase in other income of $1.4 million. For the year ended December 31, 2023, selling, general and administrative expenses decreased by $3.3 million or 22%, to $11.7 million from $15.0 million for the year ended December 31, 2022. This decrease is primarily driven by share-based compensation. Expense related to grants made in 2021 was $4.2 million lower in 2023 than in 2022. This decrease was partially offset by the expense from grants made in 2022, resulting in a net reduction of $3.6 million in share-based compensation from 2022 to 2023. Selling, general and administrative expenses also decreased $0.2 million from warrants issued to a vendor in 2022 with no similar warrants issued in 2023, and $0.1 million from lower insurance cost in 2023. These decreases were partially offset by $0.6 million of higher cash compensation related to management bonuses paid during 2023 compared to 2022 when no bonus was paid. For the year ended December 31, 2023, research and development expenses increased by $3.7 million or 37%, to $13.6 million from $9.9 million for the year ended December 31, 2022. The increase is due to an increase of $2.7 million in costs for the SAVVE trial from $3.5 million in 2022 to $6.2 million in 2023, and $1.1 million in compensation from the increases in staffing also to support the SAVVE trial, partially offset by a decrease of $0.1 million in other lab costs for development and other preparation for the enVVe trials. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe™. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC NVNO@jtcir.com (833) 475-8247 SOURCE: enVVeno Medical Corporation View the original press release on accesswire.com