Braintree Laboratories, Inc.

The increasing global incidence of gastric cancer is a major factor driving the demand for gastric cancer diagnostics. The market is also being fueled by the rising prevalence of GERD and other stomach-related conditions, along with the growing number of stomach infections such as H. Pylori and gastroenteritis. Additionally, the surge in obesity and smoking, which are linked to the development of stomach cancer, are significant contributors to the market's growth during the forecast period from 2024 to 2030. LAS VEGAS, Sept. 3, 2024 /PRNewswire/ -- DelveInsight's Gastric Cancer Diagnostics Market Insights report provides the current and forecast market analysis, individual leading gastric cancer diagnostics companies' market shares, challenges, gastric cancer diagnostics market drivers, barriers, trends, and key market gastric cancer diagnostics companies in the market. Key Takeaways from the Gastric Cancer Diagnostics Market Report As per DelveInsight estimates, North America is anticipated to dominate the global gastric cancer diagnostics market during the forecast period. In the product type segment of the gastric cancer diagnostics market, the reagents & kits category generated a significant revenue share in the gastric cancer diagnostics market in 2023. Notable gastric cancer diagnostics companies such as Abbott, BD, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Thermo Fisher Scientific Inc., Pillar Biosciences Inc., Hologic, Inc., CD Genomics, Natera, Inc., Biodesix, Illumina, Inc., Quest Diagnostics, Agilent Technologies, Inc., FUJIFILM Holdings Corporation, NeoGenomics Laboratories, Guardant Health, Myriad Genetics, Inc., Invitae Corporation, Danaher, and several others, are currently operating in the gastric cancer diagnostics market. In March 2024, AI Medical Service Inc. announced that it had launched gastroAI-model G, an AI-based endoscopic diagnostic support device that operates within the stomach. The diagnostic device operates by scanning for potential lesions, utilizing images derived from the video processor of the endoscopy system. Upon determining that a lesion appears suspicious for early gastric cancer and requires additional evaluation, the program notifies the physician and offers diagnostic support by presenting a highlighted area within the endoscopic display. In November 2023, Dedalus Group in collaboration with Ibex Medical Analytics, announced the launch of a fully integrated AI-powered digital pathology solution for gastric cancer diagnosis. In August 2023, Mirxes Pte Ltd announced that its flagship product GASTROClear, a PCR-based in vitro diagnostic test for early detection of gastric (stomach) cancer, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). It is a molecular blood test for the early detection of gastric cancer that helps to cure cancer with affordable treatment. To read more about the latest highlights related to the gastric cancer diagnostics market, get a snapshot of the key highlights entailed in the Global Gastric Cancer Diagnostics Market Report Gastric Cancer Diagnostics Overview Gastric cancer, or stomach cancer, is typically diagnosed through a combination of clinical evaluation, imaging techniques, and tissue biopsy. The diagnostic process often begins with a patient's history and physical examination, focusing on symptoms like persistent indigestion, weight loss, and abdominal pain. Imaging studies, such as upper gastrointestinal endoscopy, are crucial as they allow direct visualization of the stomach lining. During an endoscopy, a flexible tube with a camera is inserted through the mouth into the stomach, enabling doctors to identify suspicious lesions or tumors. Additional imaging techniques, such as computed tomography (CT) scans or positron emission tomography (PET) scans, may be used to determine the extent of the cancer and to detect possible metastasis to other organs. Confirming a diagnosis of gastric cancer requires a biopsy, where tissue samples are taken during an endoscopy and examined under a microscope for cancerous cells. Histopathological analysis of the biopsy helps determine the type and grade of the cancer, which is critical for guiding treatment options. Molecular testing on the biopsy sample can also identify specific genetic mutations or protein expressions, such as HER2, which may influence targeted therapy decisions. Blood tests for tumor markers like carcinoembryonic antigen (CEA) and CA 19-9 are sometimes used to support diagnosis or monitor treatment response, although these markers are not specific to gastric cancer. Early and accurate diagnosis is essential in improving the prognosis and survival rates for patients with gastric cancer. Gastric Cancer Diagnostics Market Insights In 2023, North America held the largest share of the gastric cancer diagnostics market. This dominance is attributed to the increasing prevalence of gastric cancer and related stomach diseases, along with the region's growing geriatric population and advancements in early cancer detection technologies. Data from the American Cancer Society, published in January 2024, predicts approximately 26,890 new cases of stomach cancer in the United States for 2024, with 16,160 cases among men and 10,730 among women. Stomach cancer accounts for about 1.5% of all new cancer diagnoses annually in the country. The higher incidence of gastric cancer among older adults is linked to age-related risk factors such as stomach infections and gastroesophageal reflux disease (GERD). As a result, the expanding elderly population is expected to drive the growth of the gastric cancer diagnostics market in the region. In March 2024, Ibex Medical Analytics launched Galen, an AI-powered diagnostic platform that offers accurate cancer diagnoses, reduces manual tasks, and is used for diagnosing gastric cancer, H. pylori, and other gastric lesions like adenoma and low-grade dysplasia. This increase in R&D activities by major players to develop advanced diagnostic solutions is expected to further boost the North American gastric cancer diagnostics market. To know more about why North America is leading the market growth in the gastric cancer diagnostics market, get a snapshot of the Gastric Cancer Diagnostics Market Outlook Gastric Cancer Diagnostics Market Dynamics The gastric cancer diagnostics market is evolving rapidly, driven by technological advancements, increasing awareness, and a growing focus on early detection. Gastric cancer, which remains one of the leading causes of cancer-related mortality worldwide, particularly in Asia and Eastern Europe, has led to a pressing need for improved diagnostic methods. Traditional diagnostic techniques like endoscopy and biopsy are now being complemented and, in some cases, replaced by innovative, non-invasive technologies such as liquid biopsy, molecular diagnostics, and advanced imaging techniques. These new modalities offer the potential for earlier detection, more accurate staging, and better monitoring of disease progression, which is critical for improving patient outcomes. A significant dynamic in the market is the integration of molecular diagnostics, including next-generation sequencing (NGS), which allows for the detection of specific genetic mutations and biomarkers associated with gastric cancer. These advancements are not only enhancing the precision of diagnosis but also paving the way for personalized medicine, where treatment can be tailored based on an individual's genetic profile. The push towards personalized medicine is further fueling the demand for diagnostic tools that can provide comprehensive genomic data, leading to an increase in partnerships between diagnostic companies and pharmaceutical firms aiming to develop targeted therapies. Furthermore, the rise of artificial intelligence and machine learning in diagnostics is another key trend shaping the gastric cancer diagnostics market. AI and ML are being integrated into imaging and pathology tools to improve the accuracy of cancer detection and reduce the chances of human error. These technologies can analyze large datasets, identify patterns, and make predictions that can assist clinicians in making more informed decisions. The growing adoption of AI-driven diagnostic platforms is expected to enhance the efficiency of gastric cancer screening programs and reduce the time required for diagnosis. The market is also influenced by the increasing prevalence of gastric cancer in aging populations, particularly in regions with high incidence rates. This demographic shift is expected to drive the demand for more accessible and cost-effective diagnostic solutions. Governments and healthcare organizations in these regions are investing in public health initiatives aimed at improving cancer screening and early detection rates, which is likely to further boost the market for diagnostic products and services. However, the market faces challenges, such as high costs associated with advanced diagnostic technologies and the need for specialized expertise to interpret complex diagnostic results. Additionally, disparities in healthcare infrastructure and access to advanced diagnostics between developed and developing regions may limit market growth in certain areas. Despite these challenges, the overall outlook for the gastric cancer diagnostics market remains positive, with continuous innovations and increasing emphasis on early detection poised to significantly impact the landscape in the coming years. Get a sneak peek at the gastric cancer diagnostics market dynamics @ Gastric Cancer Diagnostics Market Dynamics Analysis Gastric Cancer Diagnostics Market Assessment Gastric Cancer Diagnostics Market Segmentation Gastric Cancer Diagnostics Market Segmentation By Product Type: Instruments, Reagents & Kits Gastric Cancer Diagnostics Market Segmentation By Test Test: Imaging Test [Upper Endoscopy, Barium Swallow/X-Rays, CT Scan, Laparoscopy, MRI, Stomach Ultrasound, and Others], Laboratory Test [Biopsy, Blood Test, and Others] Gastric Cancer Diagnostics Market Segmentation By End Users: Hospitals, Diagnostic Laboratories, Academic & Research Institutes, Diagnostic Centers, and Others Gastric Cancer Diagnostics Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the gastric cancer diagnostics market are set to emerge as the trendsetter explore @ Gastric Cancer Diagnostics Companies Table of Contents Interested in knowing the gastric cancer diagnostics market by 2030? Click to get a snapshot of the Gastric Cancer Diagnostics Market Trends Related Reports Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including Hanmi Pharmaceuticals, Merck, Minneamrita Therapeutics, Taiho Pharmaceuticals, Bayer, among others. Gastric Cancer Pipeline Gastric Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Gastroesophageal Reflux Disease Market Gastroesophageal Reflux Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key GERD companies, including Phathom Pharmaceuticals, Inc., Microbiome Health Sciences, Takeda, Braintree Laboratories, AstraZeneca, among others. Gastroesophageal Reflux Disease Pipeline Gastroesophageal Reflux Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GERD companies, including Cinclus Pharma, Onconic Therapeutics, Renexxion, Addpharma, Trio Medicines, Chong Kun Dang Pharmaceutical, HK inno.N Corporation, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Sub-analyses of the pivotal phase 3 data demonstrated that within three years following insertion of the novel, low-dose copper IUD: Bleeding and pain dramatically decreased after the first three months. IUD discontinuation rates due to AEs of bleeding and pain were infrequent and decreased over three years of use. Risk of pelvic infection was low regardless of past medical history or baseline infection. ROSWELL, Ga., Oct. 30, 2023 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced additional positive data from the pivotal Phase 3 open-label study of the investigational Copper 175 mm2 intra-uterine device (IUD). The data presented at three recent women's health scientific congresses provide further support for the investigational, next-generation, hormone-free IUD as exhibited in its pivotal phase 3 trial. Continue Reading "Sebela Women's Health remains encouraged by the additional analysis of the pivotal Phase 3 trial for what would be the first hormone-free IUD coming to market in almost 40 years." said Kelly Culwell, MD, Head of Research and Development at Sebela Women's Health. "In a study conducted by the non-profit group, HealthyWomen, 60% of the more than 5,000 respondents indicated they preferred a birth control without hormones, and effectiveness was the most important factor to both patients and their practitioners. This innovative investigational low-dose copper IUD clearly helps to fill a gap in the need for more than one hormone-free, long-acting, highly effective contraceptive option for women."1 Bleeding and pain dramatically decreased after the first three months. Post this About the Investigational Copper 175 mm 2 IUD The hormone-free Copper 175 mm2 IUD has a flexible frame made of nitinol, a material that has superelastic properties and allows for the copper to be strategically placed near the ostia of the fallopian tubes and the internal os of the cervix for proximal effect. 2-3 In the United States, the Copper 175 mm2 IUD utilizes the smallest hormone-free frame measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. The sterile IUD does not require loading; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm. According to guidelines from the American College of Obstetrics and Gynecology, long-acting reversible contraceptives (LARC), or intrauterine devices and contraceptive implants, are among the most effective contraceptive methods, have few contraindications, and almost all patients are appropriate candidates for them.4 While there are a variety of contraceptive methods available to women in the U.S., 45% of pregnancies are unplanned.5 "As both a researcher and practitioner in the field of women's health, analysis of these additional data from the pivotal Phase 3 study of the investigational low-dose copper IUD is not only encouraging, but also important," said Principal Investigator David K. Turok, MD, MPH, Associate Professor, Department of Obstetrics and Gynecology, University of Utah. "Clinicians tend to believe that IUDs increase the risk of pelvic infection, and that the bleeding and pain experienced with hormone-free IUDs is long-lasting and leads to discontinuation of use. These data suggest we may need to re-visit some of our common beliefs about IUDs with this product, as well as expand our thinking to the many women who may actually be appropriate hormone-free IUD candidates based on this new data." Bleeding and Pain Dramatically Decreased After First Three Months "Bleeding and pain over time with a novel low-dose copper intrauterine device with a flexible nitinol frame" Society of Family Planning (SFP) Annual Meeting in Seattle, WA Oral Presentation by Dr. David Turok, Associate Professor of Obstetrics and Gynecology, Chief of the Division of Family Planning, University of Utah, Saturday, Oct. 28, 1:15 pm This post-hoc analysis of the Phase 3 study assessed participant bleeding and pain with use of the investigational hormone-free, low-dose copper (175mm2) IUD with a flexible nitinol frame. Treatment-emergent adverse events (TEAEs) related to bleeding or pain, their frequency over time, and the number resulting in study discontinuation at three years were assessed. In total, 1601 of 1620 (98.8%) enrolled participants had a successful IUD insertion. Heavy menstrual bleeding among participants decreased over time and was reported at months 0-3; 69.0%, >3-6; 25.0%, >6-12; 23.1%, >12-24; 8.9%, and >24-36; 4.7%. During this same timeframe, dysmenorrhea reports decreased similarly from 63.8% to 5.2%. Over three years of observation, bleeding or pain-related TEAEs (>1.0%) reported as the primary reason for study discontinuation were heavy menstrual bleeding (6.1%), dysmenorrhea (3.9%), pelvic discomfort (1.7%), and pelvic pain (1.3%). Similarly, IUD discontinuations due to bleeding and pain decreased over time. Phase 3 Pivotal Data "A Novel Low-Dose Copper Intrauterine Contraceptive with a Flexible Nitinol Frame (Copper 175mm2): Clinical Trials Overview" (Encore Data) Nurse Practitioners in Women's Health (NPWH) Annual Meeting in San Diego, CA Poster presentation by Dr. Anita Nelson, Essential Access Health, Monday, Oct. 30, 11:45 am This encore presentation reaffirmed the positive results of the pivotal Phase 3 study demonstrating the efficacy of the investigational Copper 175 mm2 IUD with a cumulative 3-year Pearl Index (number of pregnancies per 100 women over 1 year) of 0.96 (95% CI, 0.59-1.48) or 99% efficacy. This prospective study, which enrolled women of child-bearing potential from 42 centers across the United States, following the U.S. Food and Drug Administration's rigorous clinical trial standards of Good Clinical Practice, demonstrated the Copper 175 mm2 IUD was well tolerated. Both clinicians and study participants also reported positive experiences with placement of the IUD, with an overall placement success rate 98.8%. The intent-to-treat population included 1,620 women aged 17-45, 60.1 % nulliparous and 39.9% parous. The primary outcome for the study was contraceptive efficacy through 3 years of use, as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). The study remains ongoing to assess use beyond 3 years. In the efficacy cohort (n=1397) representing subjects 35 years and younger, the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 0.96 (95% CI, 0.59-1.48). The most common adverse events were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding, with rates decreasing over time. Over three years, 15.4% discontinued for bleeding or pain adverse events (8.6% in the first year). Expulsion rates were low throughout the study, ranging from 2.4% in year 1 to 1.1% in year 3. Risk of Pelvic Infection Low Regardless of Past Medical History or Baseline Infection "Pelvic infection risk after insertion of a novel low-dose copper IUD with a flexible nitinol frame in participants with a history of chlamydia trachomatis (CT) or Neisseria Gonorrhoeae (NG)" American Society of Reproductive Medicine (ASRM) Scientific Congress in New Orleans, LA Oral presentation by David Turok, MD on Monday, Oct. 16, 1:30 pm CST This post-hoc analysis of the Phase 3 study assessed the risk for pelvic infection over three years after insertion of investigational Copper 175 mm2 IUD with a flexible nitinol frame. Data demonstrated that of the 1601 total study participants, only 1.2% developed an on-study pelvic infection overall. Of the 131 study participants with a past medical history or positive for CT/NG at screening, only 2.3% developed an on study pelvic infection. The majority of infections occurred more than a year into the study, most infections were treated as outpatient, and no infections resulted in IUD removal. About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 300 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References 1. Jacquelyne Froeber. HealthyWomen. Taking Control: Our Recent Survey Says Women Want Regular Periods, No Hormones and More Communication About Contraceptives. Issued May10, 2023. Accessed October 11, 2023. 2. ClinicalTrials.gov. Evaluation of the Efficacy, Safety and Tolerability of VeraCept IUD. Updated June 23, 2022. Accessed September 23, 2022. 3. Turok DK, Nelson AL, Dart C, et al. Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: phase 2 data to 36 months. Obstet Gynecol. 2020;135(4):840-847. doi:10.1097/AOG.0000000000003756 4. ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on April 18, 2023: and 5. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med 2016;374(9):843-52, doi:10.1056/NEJMsa1506575 SOURCE Sebela Pharmaceuticals Inc

SUFLAVE™ offers the same efficacy as SUPREP® Bowel Prep Kit BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy preparation in adults. SUFLAVE, a low-volume, safe and effective colonoscopy preparation – with a taste similar to a lemon-lime sports drink – was developed and will be marketed by Braintree Laboratories, a leader in gastroenterology and part of Sebela Pharmaceuticals. The current active screening rate in the United States for colorectal cancer (CRC) is 72%, leaving 28% unscreened, which contributes to 153,000 CRC diagnoses and more than 52,000 deaths annually.i,ii Colonoscopy is the most common detection method for colorectal cancer, a leading cause of cancer-related deaths that can be managed more effectively through screening and early detection.iii Successful colonoscopy screening is dependent upon adequate cleansing of the colon.iv Despite this, available methods of liquid preparation are not widely accepted by patients due to large volumes of poor-tasting solutions, resulting in low patient compliance and the need for repeat screenings. Additionally, colonoscopy preparation products and processes are commonly cited as a significant patient barrier to colon cancer screening,v reinforcing an unmet need among patients for better bowel preparation options. Tolerance of bowel preparation remains the largest deterrent for patients considering screening colonoscopy with 71% of patients saying it's the worst part of colonoscopy and 55% indicating it was the greatest deterrent to a future colonoscopy.vi Prep volume, palatability and patient education are three key factors in reducing prep hesitancy. "Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively impact patient willingness to undergo follow-up colonoscopy if it is indicated," said Douglas K. Rex, M.D., Distinguished Professor Emeritus at Indiana University School of Medicine and a full time practicing clinical gastroenterologist. "I believe the palatable lemon-lime flavor of SUFLAVE will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure." In a head-to-head pivotal study versus SUPREP® Bowel Prep Kit, (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution, 94% of patients achieved successful bowel cleansing with SUFLAVE. The majority of patients reported that SUFLAVE tastes like a sports drink, and 79% of patients found the taste neutral to very pleasant compared to SUPREP (54%). Additionally, 87% of patients found SUFLAVE tolerable to very easy to consume, and 80% of patients reported that they would ask for SUFLAVE for a subsequent colonoscopy. Rates of gastrointestinal adverse events with SUFLAVE were low (<8%).vii "We believe in patient choice and are committed to improving the colon preparation process for patients. We are delighted with the FDA's approval of SUFLAVE – which has efficacy equivalent to SUPREP, but with taste similar to a sports drink," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "We are proud of the hard work and dedication of the Braintree team and the phase 3 trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening." SUFLAVE is the latest innovation in colonoscopy preparation from Braintree Laboratories. In November 2020, the FDA approved the company's tablet preparation, SUTAB®, which has had an excellent adoption record with use by over 2 million patients. SUFLAVE will be available by prescription to patients in the U.S. in early August. IMPORTANT SAFETY INFORMATION SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor-enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: Gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUFLAVE. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common adverse reactions (> 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. See Full Prescribing Information and Medication Guide About Sebela Pharmaceuticals Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). In addition, Sebela Women's Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 800-874-6756. Forward-looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of SUFLAVE™; growth and opportunity, including peak sales and the potential demand for SUFLAVE™, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Pharmaceuticals does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. For further information, contact: Logan Campbell, Red Havas [email protected] 1-724-987-2781 ______________ i Centers for Disease Control and Prevention. (2023, March 22). Colorectal (colon) cancer statistics. Center for Disease Control and Prevention. Retrieved June 12, 2023, from ii Colorectal cancer – statistics. Cancer.net (2023, February). Retrieved June 12, 2023, from iii Doubeni CA, Corley DA, Quinn VP, et al. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut. 2018;67(2):291-298 iv Harrison, N. M., & Hjelkrem, M. C. (2016). Bowel cleansing before colonoscopy: Balancing efficacy, safety, cost and patient tolerance. World journal of gastrointestinal endoscopy, 8(1), 4–12. v Romero, R. V., & Mahadeva, S. (2013). Factors influencing quality of bowel preparation for colonoscopy. World journal of gastrointestinal endoscopy, 5(2), 39–46. vi emulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689. PMID: 35324481. vii Data on File, Braintree, MA: Braintree Laboratories, Inc. SOURCE Sebela Pharmaceuticals