IRVINE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom (UK) have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and UK Conformity Assessment (UKCA), respectively. The EU MDR, which replaced the Medical Device ...

Core Insights - ReShape Lifesciences Inc. is progressing towards completing a merger with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, which are expected to enhance its market position and operational capabilities [3][4][6]. Financial Performance - For Q1 2025, ReShape reported revenue of $1.1 million, a decrease of 42.7% or $0.8 million compared to Q1 2024, primarily due to reduced sales volume influenced by GLP-1 pharmaceutical weight-loss alternatives and a pause in direct-to-consumer marketing [8]. - Gross profit for the same period was $0.7 million, with a gross profit margin of 61.2%, up from 59.9% in Q1 2024, attributed to lower overhead costs [9]. - Sales and marketing expenses decreased by 48.1% to $0.5 million, while general and administrative expenses fell by 13.1% to $1.6 million, reflecting cost-saving measures [10][11]. - Research and development expenses also decreased by 24.8% to $0.4 million [12]. - The company recorded a gain of $3.7 million on changes in the fair value of liability warrants during Q1 2025 [14]. Strategic Developments - The merger with Vyome will result in the combined entity being renamed Vyome Holdings, Inc., with a focus on advancing immuno-inflammatory assets and exploring opportunities between the U.S. and India [3][6]. - ReShape has expanded its product portfolio through a distribution agreement with Motion Informatics for neuromuscular rehabilitation devices and a new distribution agreement for the enhanced Lap-Band 2.0 FLEX in Canada [6][7]. - The company has received multiple Notices of Allowance from the USPTO for patents related to its Diabetes Neuromodulation technology, extending intellectual property protection through at least 2039 [7]. Asset Transactions - ReShape will sell substantially all of its assets, including the Obalon Gastric Balloon System, to Biorad, which will assume most of ReShape's liabilities [5]. - The cash purchase price from the asset sale will contribute to determining post-merger ownership allocation between ReShape and Vyome stockholders [5]. Market Position - ReShape aims to strengthen its leadership in diabetes innovation and expand access to its minimally invasive weight-loss solutions, positioning itself as a key player in the obesity and metabolic health market [6][7].

Financial Performance - Revenue for Q1 2025 was $1,113,000, a decrease of 42.6% compared to $1,944,000 in Q1 2024[106] - Gross profit margin improved to 61.2% in Q1 2025 from 59.9% in Q1 2024, despite a decrease in revenue[106] - Total operating expenses for Q1 2025 were $2,887,000, representing 259.4% of revenue, compared to $3,375,000 or 173.6% of revenue in Q1 2024[106] - The company reported a net income of $1,474,000 in Q1 2025, compared to a net loss of $2,193,000 in Q1 2024[106] - Adjusted EBITDA for Q1 2025 was $(1,778,000), an improvement from $(2,131,000) in Q1 2024[110] - Total revenue for the three months ended March 31, 2025, was $1.1 million, a decrease of 42.7% or $0.8 million compared to the same period in 2024[111] - Gross profit for the same period was $0.7 million, representing 61.2% of total revenue, an increase from 59.9% in 2024, attributed to reduced overhead costs[112] - Operating expenses totaled $2.9 million, a decrease of 14.5% from $3.4 million in 2024, with significant reductions in sales and marketing expenses by 48.1% to $0.5 million[114] - Net cash used in operating activities was $2.1 million for both the three months ended March 31, 2025, and 2024, primarily due to net income and changes in working capital[120] Mergers and Acquisitions - The company entered into a merger agreement with Vyome Therapeutics, focusing on advancing immune-inflammatory assets[95] - The company plans to merge with Vyome Therapeutics, Inc. and expand the Lap-Band product line domestically and internationally[127] - The company plans to sell substantially all assets to Biorad for a purchase price of $2.25 million, subject to adjustments[102] - Transaction costs for the three months ended March 31, 2025, were $0.4 million, related to the pending merger and asset sale[117] Product Development and Agreements - An exclusive distribution agreement was signed with Liaison Medical Ltd. for the Lap-Band® 2.0 FLEX system in Canada, effective until December 31, 2028[98] - A key international patent for Diabetes Neuromodulation technology was granted, providing protection until December 4, 2039[96] - Research and development expenses decreased by 24.8% to $0.4 million, primarily due to a pause in clinical trials[116] Financial Concerns - The company anticipates running out of cash by the fourth quarter of 2025, raising concerns about its ability to continue operations[128] - Future capital requirements for product development will depend on decisions made by Biorad after the pending asset sale[129] Stock and Shareholder Actions - A reverse stock split of 1-for-25 was executed on May 9, 2025, affecting the number of shares outstanding[104] - The company raised $4.8 million in February 2025 from a public offering, with $2.5 million in cash and cash equivalents as of March 31, 2025[118]

Core Points - ReShape Lifesciences Inc. announced a 1-for-25 reverse stock split effective May 9, 2025, where every 25 shares will convert into one share [1] - The reverse stock split was approved by stockholders during a special meeting on April 1, 2025, and instructions for exchanging stock certificates will be provided by the transfer agent [2] - The company specializes in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band System and investigational Diabetes Bloc-Stim Neuromodulation™ system [3] Company Overview - ReShape Lifesciences is recognized as a leading provider of weight loss and metabolic health solutions in the U.S. [3] - The company offers a range of products aimed at managing obesity and metabolic diseases, including non-surgical options like the Obalon balloon technology [3] - The Lap-Band System provides a minimally invasive treatment alternative to more invasive surgical procedures [3]

Core Insights - ReShape Lifesciences is presenting pre-clinical data on its proprietary Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium, showcasing a novel approach to treating diabetes and hypoglycemia without cardiac side effects [1][4] Group 1: Technology and Mechanism - The Diabetes Neuromodulation technology employs Hypoglycemia Vagus Nerve Stimulation (HVNS) to stimulate the sub-diaphragmatic posterior vagus nerve, effectively increasing blood glucose levels during hypoglycemic episodes [3] - HVNS demonstrated the ability to raise blood glucose levels from a baseline of 45 mg/dL to 58 mg/dL and from 51 mg/dL to 68 mg/dL in a Type 1 diabetic swine model after 30 minutes of stimulation [3] - The technology avoids impacting heart rate, blood pressure, or respiration, addressing limitations of conventional vagal stimulation techniques [3][7] Group 2: Clinical Data and Efficacy - Pre-clinical results showed that HVNS increased glucagon levels from 4.1 pmol/L to 12.3 pmol/L and from 3.5 pmol/L to 7.6 pmol/L, indicating a significant physiological response [3] - The mean heart rate remained stable during stimulation, with vomiting only observed at higher amplitudes, suggesting a clear therapeutic window for effective treatment [3] Group 3: Future Development and Market Potential - The company plans to seek non-dilutive funding and collaborate with leading researchers and corporate partners to advance the commercialization of the Diabetes Neuromodulation device [4] - The ReShape Diabetes Neuromodulation system is positioned as a minimally invasive alternative to traditional diabetes management methods, potentially improving the quality of life for individuals with Type 1 or Type 2 diabetes [5][8]

Core Insights - ReShape Lifesciences has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to an intragastric balloon system, which includes a swallowable capsule and a degradable release valve designed for natural excretion after deflation [1][2] - The patent, once issued, will provide protection until at least January 2031, potentially extending further with a Patent Term Extension [1] - The company has secured over 50 patents related to its intragastric balloon system since its initial application in 2011, resulting in a total of more than 160 patents issued and pending [2] Company Overview - ReShape Lifesciences is a leading company in the weight loss and metabolic health solutions sector, offering a range of products and services aimed at managing obesity and metabolic diseases [3] - The company’s FDA-approved products include the Lap-Band and Lap-Band 2.0 Flex Systems, which provide minimally invasive treatments for obesity, and the Obalon balloon technology, a non-surgical, swallowable intra-gastric balloon [3] Recent Developments - ReShape Lifesciences has entered into an asset purchase agreement with Biorad Medisys, under which it will sell substantially all of its assets, including the Lap-Band System and Obalon Gastric Balloon System, to Biorad [4]

Core Insights - ReShape Lifesciences has received a Notice of Allowance for a patent on its Diabetes Neuromodulation system, which utilizes vagus nerve modulation to treat Type 2 diabetes and hypoglycemia, with patent protection extending until August 4, 2037 [1][2] - The technology is designed to regulate blood glucose levels through targeted vagal nerve modulation, using a unique energy-efficient algorithm that consumes approximately 10 times less energy than traditional methods, allowing for smaller devices and longer battery life [2][3] - The company has completed preclinical development, demonstrating the system's efficacy in boosting insulin production and managing blood glucose levels, while remaining compatible with standard implantable pulse generators [2][3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band systems and non-surgical options like the Obalon balloon technology [4] - The company is in the process of selling its assets, including the Lap-Band System and the Diabetes Neuromodulation system, to Biorad Medisys, which will take ownership of the DBSN™ system upon closing the transaction [5] Technology Details - The ReShape Diabetes Neuromodulation system is a minimally invasive implant that delivers bio-electronic neuromodulation to regulate plasma glucose by stimulating the pancreas and blocking signals to the liver [3] - The system is designed to be reversible and adjustable, potentially representing a significant advancement in personalized medicine compared to existing vagus nerve stimulation methods [3] Intellectual Property - The company holds a robust intellectual property portfolio with 63 issued or pending patents covering various aspects of its technology, including vagal neuromodulation and glucose regulation, which supports its commercialization efforts [2]

Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2024, totaled $8,000,000, representing a contraction of 8% or $700,000 compared to the same period in 2023 [14] - Gross profit for the year ended December 31, 2024, was $5,100,000, a decrease of $500,000 or 9% from $5,500,000 in 2023 [14] - Gross profit margin slightly decreased to 63.2% from 63.9% in the previous year [14] - Operating expenses were reduced by almost 42% compared to the previous year, excluding M&A related costs [3][12] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased by $4,600,000 or 60% to approximately $3,000,000 compared to $7,500,000 in 2023, primarily due to a reduction in advertising and marketing expenses [15] - General and administrative expenses decreased by approximately $3,400,000 or 33% to approximately $6,900,000 compared to $10,300,000 in 2023 [15] - Research and development expenses decreased by $500,000 or 22% to $1,800,000 compared to $2,300,000 in 2023 [16] Market Data and Key Metrics Changes - The introduction of GLP-1 pharmaceuticals impacted revenue negatively, contributing to the overall revenue contraction [14] Company Strategy and Development Direction - The company is focused on a disciplined approach to executing a cost reduction plan while pursuing growth initiatives [3] - A significant partnership was established with Motion Informatics to distribute next-generation neuromuscular rehabilitation devices, expanding the product portfolio [4][5] - The company aims to enhance its product offerings through both organic development and strategic partnerships [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the merger with Viome and the concurrent asset sale to BI RAD, viewing these transactions as beneficial for shareholder value [18] - The company is committed to improving the quality of life for patients through innovative products and therapies [5][8] Other Important Information - The company successfully closed a $6,000,000 public offering in February 2025 to strengthen its financial position [4] - A notice of allowance for patents related to the diabetes Neuromodulation System was received, reinforcing the company's leadership in innovative treatments [10] Q&A Session Summary Question: What are the expectations regarding the merger with Viome? - Management indicated that the merger with Viome and the asset sale to BI RAD are expected to generate significant value and growth for shareholders [18]

Core Insights - ReShape Lifesciences has entered an exclusive distribution agreement with Motion Informatics to import and distribute neuromuscular rehabilitation devices in the U.S. market [1][2] - The flagship product, Stimel-03, integrates Functional Electrical Stimulation (FES), Neuromuscular Electrical Stimulation (NMES), and real-time electromyographic (EMG) biofeedback [2] - This partnership aims to enhance patient outcomes and expand the market reach of both companies in the neuromuscular rehabilitation sector [2][3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band® System and investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [4] - Motion Informatics focuses on next-generation neuromuscular rehabilitation, utilizing AI-driven neuroinformatics and augmented reality to create adaptive therapeutic platforms [3] - The collaboration positions both companies at the forefront of the neuromuscular rehabilitation market, aiming for global expansion and improved clinical care [2][3]

Core Insights - ReShape Lifesciences Inc. reported a significant reduction in overall operating expenses of 41.9% in 2024, excluding M&A related expenses, compared to 2023 [1] - The company entered into a definitive merger agreement with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, both of which are on track [1][3] - A strategic business update call is scheduled for April 10, 2025, to discuss these developments [1] Financial Performance - For the year ended December 31, 2024, ReShape reported revenue of $8.0 million, a decrease of 7.7% or $0.7 million compared to 2023 [8] - Gross profit for the same period was $5.1 million, down from $5.5 million in 2023, representing a decrease of 8.9% [9] - Operating expenses totaled $12.8 million in 2024, down from $20.9 million in 2023, reflecting significant cost-cutting measures [30] Expense Breakdown - Sales and marketing expenses decreased by 60.4% to approximately $3.0 million in 2024, primarily due to reduced advertising and marketing efforts [10] - General and administrative expenses fell by 32.9% to approximately $6.9 million, driven by reductions in legal, audit, and professional fees [11] - Research and development expenses decreased by 22.1% to $1.8 million, attributed to halted clinical trials and reduced consulting [12] Merger and Asset Sale - The merger with Vyome will result in ReShape being renamed Vyome Holdings, Inc., and the combined company will focus on immuno-inflammatory assets [3] - The asset purchase agreement with Biorad involves the sale of ReShape's key products, including the Lap-Band® System and Obalon® Gastric Balloon System [4] - The cash from the asset sale will contribute to determining post-merger ownership allocation between ReShape and Vyome stockholders [4] Patent Developments - In March 2025, ReShape received a Notice of Allowance for a patent related to its Diabetes Neuromodulation system, which will provide protection until April 12, 2039 [5] - An international patent was granted in February 2025 for the same technology, extending protection until December 4, 2039 [5] Market Position and Strategy - The company aims to expand access to its next-generation Lap-Band® 2.0 FLEX through a distribution agreement in Canada [7] - The introduction of GLP-1 pharmaceuticals in the U.S. has impacted revenue, despite a slight growth in units sold of the Lap-Band [8] - The strategic moves, including the merger and asset sale, are expected to create significant value and growth for shareholders [7]