Diabetic Neuropathies

Acquisition creates leading phage therapy company with an advanced pipeline that includes two Phase 2 assets, BX004 for the treatment of chronic pulmonary infections in cystic fibrosis (“CF”) patients and BX211for the treatment of diabetic foot osteomyelitis (“DFO”) Financing of $50 million will be used to advance the two lead product candidates through Phase 2 clinical readouts in 2025 CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the closing of its previously announced (March 6, 2024) acquisition (the “Acquisition”) of Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, and its previously announced $50 million private placement to certain institutional accredited investors, which was led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. “We are very pleased to announce the closing of the APT acquisition, which creates a leading phage company and an advanced pipeline that includes two Phase 2 assets each aimed at treating serious infections with unmet medical need,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We also appreciate the continued support of leading institutional healthcare investors. Through this financing, we expect to have sufficient capital to reach multiple data readouts in CF and DFO over the next 12-24 months.” RBC Capital Markets and Laidlaw & Company (UK) Ltd. acted as placement agents for the private placement. Haynes and Boone, LLP served as legal counsel to BiomX. Cooley LLP served as legal counsel to APT. McDermott Will & Emery LLP served as legal counsel to Deerfield Management. Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to the placement agents. About the Acquisition and the Private Placement The Acquisition was structured as a stock-for-stock transaction whereby all outstanding equity interests of APT were exchanged in a merger for 9,164,968 shares of BiomX common stock, 40,470 shares of Series X Preferred Stock convertible into 40,470,000 shares of BiomX common stock and warrants (“Merger Warrants”) exercisable for 2,166,497 shares of BiomX common stock. Upon the consummation of the Acquisition, a successor-in-interest of APT became a wholly-owned subsidiary of BiomX. The Merger Warrants will be exercisable at any time after the date of the receipt of BiomX stockholder approval at an exercise price of $5.00 per share and will expire on January 28, 2027. Concurrently with the consummation of the Acquisition, BiomX consummated its private placement financing with existing and new investors to raise $50 million, in which the investors purchased (i) an aggregate of 216,417 shares of Series X Preferred Stock and (ii) warrants (“Private Placement Warrants”) to purchase up to an aggregate of 108,208,500 shares of BiomX common stock, at a combined purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 500 shares of BiomX common stock. The Private Placement Warrants will be exercisable any time after the date of the receipt of BiomX stockholder approval, at an exercise price of $0.2311 per share, and will expire on the 24-month anniversary of the initial exercisability date. Subject to BiomX stockholder approval, each share of Series X Preferred Stock issued in the Acquisition and the private placement initially will be convertible into 1,000 shares of BiomX common stock, and subject to certain beneficial ownership limitations set by each holder not to exceed 19.99%. In connection with the execution of the definitive merger agreement, certain stockholders of BiomX (including its directors and officers), together holding on as converted basis over 50% of the outstanding shares of common stock of BiomX, have agreed to vote their shares in favor of the conversion of the Series X Preferred Stock. The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. BiomX has agreed to registration statement (the “Resale Registration Statement”) with the Securities and Exchange Commission (the “SEC”) registering the resale of (i) the shares of BiomX common stock issued pursuant to the Acquisition, (ii) the shares of BiomX common stock issuable upon conversion of the Series X Preferred Stock purchased in the private placement, (iii) the shares of common stock issuable upon exercise of all warrants issued in connection with the Acquisition and the private placement, (iv) the Series X Preferred Stock issued pursuant to the Acquisition and purchased in the private placement and (v) all warrants issued in connection with the Acquisition and the private placement (collectively, the ”Resale Securities”). Additional details regarding the private placement are contained in BiomX’s Current Report on Form 8-K filed with the SEC on March 6, 2024. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities of BiomX in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the Resale Securities under the Resale Registration Statement will only be by means of a prospectus. Additional details are available in an updated corporate presentation that can be found online at About BX004 BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a study where BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function1. BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections in the fourth quarter of 2024. The study is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Study results are expected in the third quarter 2025. The U.S. Food and Drug Administration (“FDA”) has granted BX004 Fast Track designation and Orphan Drug Designation. 1 Predefined subgroup of patients with baseline ppFEV1<70% About BX211 BX211 is a personalized phage treatment developed by APT for the treatment of DFO associated with S. aureus. The personalized phage treatment tailors a specific phage selected from a proprietary phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. The ongoing randomized, double-blind, placebo-controlled, multi-center Phase 2 study investigating the safety, tolerability, and efficacy of BX211 for subjects with DFO associated with S. aureus is expected to enroll approximately 45 subjects randomized at a 2:1 ratio to BX211 or placebo. BX211 or placebo is designed to be administered weekly, by topical and IV route at Week 1 and by the topical route only at each of Weeks 2-12. Over the 12-week treatment period, all subjects are expected to continue to be treated in accordance with standard of care which will include antibiotic treatment as appropriate. A first readout of study topline results is expected at Week 13 evaluating healing of the wound associated with osteomyelitis, followed by a second readout at Week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments, and established biomarkers (ESR and CRP). These readouts are expected in the first quarter of 2025 and the first quarter of 2026, respectively. About BiomX BiomX is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. For more information, please visit , the content of which does not form a part of this press release. Safe Harbor This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995 concerning BiomX, APT, the private placement, the Acquisition and other matters. These forward-looking statements include, but are not limited to: future expectations, plans and prospects for BiomX following the consummation of the Acquisition; the use of proceeds from the private placement and the sufficiency of BiomX cash resources; stockholder approval of the conversion of the Series X Preferred Stock and the exercise of the warrants; the milestones of BiomX; the projected cash runway of BiomX; the status and plans for clinical trials, including the timing of data; future product development; the potential market for phage therapies; and the potential commercial opportunity of BX004 and BX211. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX discusses the safety, tolerability and efficacy of BX004 and its potential ability to treat CF patients, as well as the potential to advance the BX004 program to a larger, pivotal Phase 2b/3 trial, if such trial is initiated, including, among other things, timing, design, enrollment, regulatory approvals and funding of such trial, BiomX is making forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements, as a result of various important factors, including risks and uncertainties related to the ability to recognize the anticipated benefits of the Acquisition; the outcome of any legal proceedings that may be instituted against BiomX in connection with the Acquisition and related transactions; the ability to obtain or maintain the listing of the common stock of BiomX on the NYSE American; costs related to the Acquisition; changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; our potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2023, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements. BiomX Contacts: Investor Relations: LifeSci Advisors, LLC Managing Director John Fraunces (917) 355-2395 jfraunces@lifesciadvisors.com, or LifeSci Advisors, LLC Brian Mullen (203) 461-1175 bmullen@lifesciadvisors.com BiomX, Inc. Anat Primovich Corporate Project Manager +972 (50) 697-7228 anatp@biomx.com Source: BiomX Inc.

Fiscal year 2023 net product sales from prescriptions totaled approximately $5.2M, a 107% increase from 2022 Company projects $14M in net revenue for 2024 SOLANA BEACH, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the fourth quarter and full year ended December 31, 2023, and recent corporate developments. "In 2023, we focused on operational excellence to expand GIMOTI’s market share and ensure its availability for patients requiring an improved gastroparesis treatment. Our commercial team’s dedicated efforts yielded a 107% increase in year-over-year revenue,” stated Dave Gonyer, R.Ph., CEO of Evoke Pharma. “The new Healthcare Resource Utilization (HCRU) data has only been available to our commercial team since near the end of the year. We believe it is just starting to drive growth beginning with the addition of new prescribers, a rise in prescription fills, and an uptick in patient enrollments, solidifying 2023 as an important year for our product’s market presence. As of December 31, 2023, we’ve seen a 66% rise in cumulative prescribers from the previous year, totaling 1,689. Prescription fills and patient enrollments also climbed significantly by 100% and 88% respectively, year-over-year,” Mr. Gonyer added. Fourth Quarter and Full Year 2023 Developments and Recent Highlights: Continued Advocacy for GIMOTI as the Standard of Care for Diabetic Gastroparesis Treatment Healthcare resource utilization data presented at DDW 2023 revealed that there is statistically signficantly less burden on healthcare resources and facilities such as hospitical admissions, emergency department and physician office visits with patients who are being prescirbed GIMOTI versus those on oral metoclopramide.Based on the reduced utilization data, additional compelling cost data presented in a distinguished plenary session at ACG 2023 demonstrated financial savings benefits of GIMOTI for patients and payors compared to oral metoclopramide.Abstract focused on the HCRU of diabetic gastroparesis care in women using nasal metoclopramide to be presented at DDW 2024. Transitioned Pharmacy Service Partnership to ASPN Pharmacies Aiming to enhance patient prescription process and enhance revenues through ASPN’s extensive network of partners with broader PBM agreements. Fortified Patent Estate for GIMOTI Two patents issued in 2023 covering the methods of use for GIMOTI including two Orange Book listings.Teva Pharmaceuticals determination not to pursue a paragraph 4 certification against Gimoti without financial or other consideration further enhanced Evoke’s intellectual property position and eliminated 180-day exclusivity opportunity for later possible generic seeking entities for the future. Improved Cash Position In February 2024, the Company closed a $7.5M public offering with fundamental, healthcare-oriented institutional investors providing the company runway into the fourth quarter of 2024 with up to an additional $22.5M available if common stock warrants are exercised in full. Mr. Gonyer concluded, “2023 was a milestone year for GIMOTI with new real-world evidence demonstrating its superiority over traditional treatments and data showing a marked decrease in hospitalization and ER visits for GIMOTI over oral metoclopramide which translated into savings of over $15,000 per patient in only six months. Our results at major gastroenterology conferences including Digestive Disease Week 2023 have strengthened market trust in GIMOTI, bolstering our goal to make it the standard treatment for diabetic gastroparesis. Current and new IP protections, coupled with new inquiries about the prevalence GLP-1 associated diabetic gastroparesis, and the recent capital boost from our public offering further position us to scale our operations and achieve sustained business growth.” Fourth Quarter and Full Year 2023 Financial Review and Outlook For the fourth quarter of 2023, net product sales were approximately $1.7 million compared with $0.8 million during the fourth quarter of 2022, and the net loss was approximately $2.0 million, or $0.59 per share compared with $1.8 million, or $0.54 per share, for the fourth quarter of 2022. For the year ended December 31, 2023, net product sales were approximately $5.2 million compared with approximately $2.5 million for the year ended December 31, 2022, and the net loss was approximately $7.8 million, or $2.33 per share, compared with a net loss of $8.2 million, or $2.62 per share, for the year ended December 31, 2022. The year-over-year increase in revenue was due to higher net product sales in 2023, resulting from: Prescription sales through pharmacy service partnership with ASPN Pharmacy;Recapture of prescriptions sent to retail pharmacies without ability to order product; andMarketing of head-to-head real-world data comparing Gimoti to oral metoclopramide showing improvements in fewer hospitalizations and ER visits with GIMOTI. Research and development expenses totaled approximately $23,000 for the fourth quarter of 2023 compared with $27,000 for the fourth quarter of 2022. For the full year of 2023, research and development expenses were approximately $0.2 million compared with approximately $0.3 million for the prior year. For the fourth quarter of 2023 selling, general and administrative (SG&A) expenses were approximately $3.5 million compared with $2.3 million for the fourth quarter of 2022. For the year ended December 31, 2023, selling, general and administrative expenses were approximately $12.2 million versus approximately $9.6 million for the year ended December 31, 2022. The increase in SG&A costs year-over-year resulted primarily from higher marketing and Eversana profit sharing costs. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of GIMOTI. Total operating expenses for the fourth quarter of 2023 were approximately $3.6 million compared with $2.3 million for the same period of 2022. For the year ended December 31, 2023, total operating expenses were approximately $12.6 million compared with approximately $10.3 million for the full year of 2022. As of December 31, 2023, cash and cash equivalents were approximately $4.7 million. We believe, based on our current operating plan, that our existing cash and cash equivalents, including the proceeds of approximately $6.1 million from the public offering closed in February 2024, as well as future cash flows from net product sales of Gimoti, will be sufficient to fund our operations into the fourth quarter of 2024. Evoke projects net revenue in 2024 of approximately $14 million. Evoke’s 2024 guidance is dependent on its current business and expectations, including recent growth rates in net sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.Follow GIMOTI on FacebookFollow Evoke Pharma on FacebookFollow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety InformationWARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage. Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped. Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor. In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures. In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve it’s guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor & Media Contact:Daniel Kontoh-Boateng DKB PartnersTel: 862-213-1398dboateng@dkbpartners.net Financial Statements to Follow Evoke Pharma, Inc.Balance Sheet Evoke Pharma, Inc.Statement of Operations The Financial Statements accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/1505239a-5694-4a7e-99c2-8d96e50a84a3 https://www.globenewswire.com/NewsRoom/AttachmentNg/b26e2618-665c-4966-acc6-c45d683cb7e0

SARASOTA, Fla., March 14, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today presented positive interim data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 91 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 63 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1 The interim data are being presented at the Cellular, Acellular, and Matrix-Like Products Wound Care Summit (CAMPs) March 13-14 in Miami, and the completed data set demonstrating even stronger results is being submitted for publication in a peer-reviewed wound journal. "Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. Promedica conducted the DFU clinical trial. "In evaluating Omeza®'s platform, the first twelve patients treated in the study demonstrated significant healing—and in some cases, complete closure—of their diabetic wounds in twelve weeks or less, which is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the Promedica clinical trial site. In the study, patients with DFUs were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also received standard of care, which included offloading—no weight-bearing by the foot—to support healing. By week four of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week twelve, the average PAR was 91 percent, with two additional patients achieving complete closure of their DFUs. Both of these cases were of ≥1 year duration prior to treatment with OCM™ and off-loading. No adverse events related to treatment were reported during the study. "We continue to be encouraged by the high rates of wound closure experienced by patients in our three studies that are currently underway, and we look forward to obtaining further confirmation of OCM's™ ability to treat advanced wounds from day one, as well as to transition chronic wounds from a stalled state to a healing state more quickly and completely than other products on the market," said Desmond Bell, DPM, Chief Medical Officer at Omeza®. "All of the components in our platform are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting." Reference: 1 (22)02154-1/fulltext About OMEZA Omeza is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising essential omega fatty acids and hydrolyzed fish collagen infused with cod liver oil. Founded in 2014, the company currently markets Omeza Complete Matrix (OCM™) designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Omeza is currently conducting three clinical trials in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other etiologies to evaluate the effects of Omeza Combination Therapy versus standard of care on wound healing, pain reduction, quality of life, and additional secondary endpoints. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida. Media Contact: Bernadette Cupit [email protected] 908-334-4554 SOURCE Omeza LLC