PNLIP

The launch of the Catalyst® Pancreatic Lipase Test demonstrates IDEXX's Technology for Life strategy and will provide veterinarians with quantitative results at the point-of-care in less than 10 minutes WESTBROOK, Maine, June 4, 2024 /PRNewswire/ -- IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in pet healthcare innovation, announces the launch of the Catalyst® Pancreatic Lipase Test, a single-slide solution for canine and feline patients suspected of pancreatitis. With the innovative load-and-go workflow of the Catalyst analyzers, the test can run effortlessly alongside chemistry profiles, leading to a faster path to diagnosis and enhanced patient outcomes. The Catalyst Pancreatic Lipase Test will be available in the U.S. and Canada this September, with a global rollout to the over 70,000 Catalyst installed base planned to begin in the fourth quarter of 2024. Continue Reading IDEXX Laboratories, Inc. Pancreatitis is a common disease among cats and dogs, and while treatable, it can prove fatal if not caught early. Diagnosing pancreatitis can be difficult due to its nonspecific symptoms and subtle clinical signs, including vomiting and weight loss, which are among the 10 most frequently recorded clinical signs in primary care clinics.1 Now, with the Catalyst Pancreatic Lipase Test, veterinarians can receive quantitative results in under 10 minutes. By delivering quantitative diagnostic insights during the patient visit, the new test empowers veterinarians to confidently confirm or rule out pancreatitis and immediately begin treatment, saving crucial time and improving patient outcomes. "The Catalyst Pancreatic Lipase Test marks the tenth menu addition launched for the Catalyst platform since 2012, reinforcing our commitment to extend the clinical value and diagnostic capabilities of our technologies," said Jay Mazelsky, President and Chief Executive Officer of IDEXX. "We are pleased to deliver a highly requested test, which will streamline the diagnostic workflow and equip veterinarians with the necessary clinical insights for prompt action." The Catalyst Pancreatic Lipase Test, coupled with VetConnect® PLUS software, provides a critical solution for the long-term management of pancreatitis patients due to the chronic nature of the disease. VetConnect PLUS allows for seamless integration of historical data and test results, enabling efficient patient progress evaluation and treatment response. "The Catalyst Pancreatic Lipase Test is the first test to use dry chemistry slide technology that specifically measures pancreatic lipase and correlates with the IDEXX Reference Laboratories Spec cPL® and Spec fPL® tests* to provide the most accurate, quantitative results patient-side for dogs and cats," said Jörg M. Steiner, Dr.med.vet., PhD, DACVIM-SA, DECVIM-CA, AGAF, Texas A&M University.† New Catalyst SmartQC Control In the fourth quarter of 2024, the Catalyst platform will be further enhanced with the launch of the Catalyst® SmartQC® Control, a load-and-go quality control testing system that is 90% faster than current methods.2 The Catalyst SmartQC Control offers an intuitive workflow that takes less than 15 minutes, ensuring quality control is run consistently without compromising staff productivity. These enhancements will be delivered through IDEXX SmartService™ Solutions, a cloud-based software that supports in-house instruments and powers seamless upgrades for new tests and features. Please visit idexx.com for more information on the Catalyst Pancreatic Lipase Test and Catalyst SmartQC Control. About IDEXX IDEXX is a global leader in pet healthcare innovation. Our diagnostic and software products and services create clarity in the complex, constantly evolving world of veterinary medicine. We support longer, fuller lives for pets by delivering insights and solutions that help the veterinary community around the world make confident decisions—to advance medical care, improve efficiency, and build thriving practices. Our innovations also help ensure the safety of milk and water across the world and maintain the health and well-being of people and livestock. IDEXX Laboratories, Inc. is a member of the S&P 500® Index. Headquartered in Maine, IDEXX employs approximately 11,000 people and offers solutions and products to customers in more than 175 countries and territories. For more information about IDEXX, visit: . Note Regarding Forward-Looking Statements This news release contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "expects," "may," "anticipates," "intends," "would," "will," "plans," "believes," "estimates," "should," "project," and similar words and expressions. These forward-looking statements are intended to provide our current expectations or forecasts of future events; are based on current estimates, projections, beliefs, and assumptions; and are not guarantees of future performance. Actual events or results may differ materially from those described in the forward-looking statements. These statements are subject to risks, uncertainties, assumptions, and other important factors. Readers are cautioned not to put undue reliance on such forward-looking statements because actual results may vary materially from those expressed or implied. The reports filed by IDEXX pursuant to United States securities laws contain discussions of some of these risks and uncertainties. IDEXX assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are advised to review IDEXX's filings with the United States Securities and Exchange Commission (which are available from the SEC's EDGAR database at sec.gov and via IDEXX's website at idexx.com). 1Robinson NJ, Dean RS, Cobb M, Brennan ML. Investigating common clinical presentations in first opinion small animal consultations using direct observation. Vet Rec. 2015;176(18):463. doi:10.1136/vr.102751 *The Spec cPL Test for dogs and the Spec fPL Test for cats measure the level of pancreas-specific lipase in the blood: . †Dr. Steiner has received compensation from time to time for consulting services he has provided to IDEXX. 2Data on file at IDEXX Laboratories, Inc. Westbrook, Maine USA. SOURCE IDEXX Laboratories, Inc.

The next-generation RELiZORB digestive enzyme cartridge is intended to meet the enteral nutrition needs of a larger group of patients with short bowel syndrome and other rare diseases US FDA has approved next-generation RELiZORB device. (Credit: Marcelo Leal on Unsplash) The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted 510(k) clearance to Alcresta Therapeutics for next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge. RELiZORB is said to be the first-of-its-kind digestive enzyme cartridge designed to resemble pancreatic lipase’s function. It is based on Alcresta’s proprietary enzyme immobilisation technology, iLipase. It is indicated to break down fats in enteral formula and address fat malabsorption related to tube feeding in different disease states. The next-generation RELiZORB cartridge is intended to meet the enteral nutrition needs of a larger group of patients with short bowel syndrome (SBS) and other rare diseases. According to Alcresta, the cartridge widens the use of the device for use with several enteral nutrition formulas. It will be used with both continuous and bolus feeding and to increase the maximum number of cartridges a patient uses every day from two to six. The expanded RELiZORB indication consists of new findings from two published pre-clinical studies conducted at Boston Children’s Hospital. The trials assessed the safety and effectiveness of digestive enzyme cartridge use with both continuous and bolus enteral feeding in paediatric porcine models of SBS. Additionally, the Boston Children’s Hospital team is conducting ongoing RELiZORB clinical studies, which are recruiting SBS patients. Alcresta CEO Dan Orlando said: “Tube-fed patients have a wide range of enteral nutrition needs and feeding approaches and this 510(k) clearance represents an important expansion of the use of RELiZORB, enabling more patients to get more out of their enteral nutrition regimens.” The FDA approved the cartridge in 2015 for use in adult patients. In 2017, the cartridge was authorised for use in children as young as five. In August 2023, the label was extended to paediatric patients as young as two years. The device is anticipated to go on sale in Q2 of 2024 and the existing patients will be switching to the newer RELiZORB by the end of the summer.

Next-generation RELiZORB technology expands device utility to support more patients including many living with SBS and other rare diseases. WALTHAM, Mass., Dec. 21, 2023 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced 510(k) clearance of its next-generation RELiZORB® (iMMOBILIZED LIPASE) cartridge by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The next-generation RELiZORB device was developed to address the enteral nutrition needs of a wider population of patients living with rare diseases. "Tube-fed patients have a wide range of enteral nutrition needs and feeding approaches and this 510(k) clearance represents an important expansion of the use of RELiZORB, enabling more patients to get more out of their enteral nutrition regimens," said Dan Orlando, Chief Executive Officer at Alcresta. RELiZORB is the only FDA-cleared product indicated to break down fats in enteral formula and is intended to address fat malabsorption associated with tube feeding across a variety of disease states. The next-generation RELiZORB expands on Alcresta's novel digestive enzyme technology and broadens the utility of the device to be compatible with an increased number of enteral nutrition formulas (including many commonly used by patients with short bowel syndrome [SBS]), to allow for use with both continuous and bolus feeding, and to increase the maximum number of cartridges a patient can use per day from two to six. These improvements were developed to allow more enterally fed patients to benefit from the device, including those with SBS, for whom bolus feeding is a common enteral nutrition feeding approach. The expanded RELiZORB label includes new data from two published pre-clinical studies conducted at Boston Children's Hospital, led by Mark Puder, M.D., PhD and the pediatric surgical research team, that evaluated the safety and efficacy of RELiZORB use with both continuous and bolus enteral feeding in pediatric porcine models of SBS. Dr. Puder and the team at Boston Children's Hospital are conducting ongoing RELiZORB clinical trials, which are currently enrolling for patients with SBS. "People requiring tube feeding and suffering from fat malabsorption can experience significant consequences ranging from life-affecting gastrointestinal symptoms to an impact on growth and development for pediatric patients," stated Dave Recker, M.D., Acting Chief Medical Officer at Alcresta. "Since its initial clearance in 2015, RELiZORB has supported enterally fed patients by breaking down fats in their enteral formula, making them readily absorbable. The clearance of this next-generation device represents a significant milestone that will allow more patients to benefit from the unique role RELiZORB plays in enteral feeding." The next-generation RELiZORB is expected to become commercially available in the second quarter of 2024, with existing patients transitioning to the newer device by the end of summer. For more information about RELiZORB clinical trials now enrolling patients, visit ClinicalTrials.gov NCT03530852 and NCT05635747. About RELiZORB® (iMMOBILIZED LIPASE) CARTRIDGE RELiZORB is indicated for use in pediatric patients (ages 2 and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB is a first-of-its kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is developed using Alcresta's proprietary enzyme immobilization technology, iLipase®, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. Use was expanded to pediatric patients as young as two years old in August 2023. About Alcresta Therapeutics, Inc. Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and is developing platform applications for patients with short bowel syndrome (SBS) and prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by top-tier investors: Athyrium Capital Management, Bessemer Venture Partners, HealthQuest Capital, and Frazier Healthcare Partners. More information can be found at . Internal Media Contact: Natalie Bronfin Alcresta Therapeutics, Inc. [email protected] 617-431-3600 SOURCE Alcresta Therapeutics, Inc.