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ReShape Lifesciences® Receives Notice of Allowance for Key U.S. Patent Related to an Intragastric Balloon System
Globenewswire· 2025-04-28 12:31
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]
ReShape Lifesciences® Receives Notice of Allowance for Additional U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
Globenewswire· 2025-04-21 12:31
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]
ReShape Lifesciences (RSLS) - 2024 Q4 - Earnings Call Transcript
2025-04-11 02:09
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]
ReShape Lifesciences® Partners with Motion Informatics to Bring AI-Driven Neurorehabilitation Technology to the U.S. Market
Globenewswire· 2025-04-09 20:05
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]
ReShape Lifesciences® Reports Year Ended December 31, 2024 Financial Results and Provides Corporate Update
Globenewswire· 2025-04-07 20:05
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]
ReShape Lifesciences (RSLS) - 2024 Q4 - Annual Report
2025-04-04 20:10
Financial Performance - Revenue for the year ended December 31, 2024, was $8,006,000, a decrease of 7.7% compared to $8,678,000 in 2023[397] - Gross profit margin for 2024 was 63.2%, down from 63.9% in 2023, with gross profit amounting to $5,057,000[397] - The net loss for 2024 was $7,130,000, a reduction of 37.5% from the net loss of $11,387,000 in 2023[397] - Adjusted EBITDA for 2024 was $(6,320,000), an improvement from $(13,575,000) in 2023[402] - Total revenue for the year ended December 31, 2024, was $8.0 million, a decrease of 7.7% or $0.7 million compared to 2023[403] - Gross profit for 2024 was $5.1 million, down 8.9% from $5.5 million in 2023, with a gross profit margin of 63.2% compared to 63.9% in 2023[404] Operating Expenses - Total operating expenses for 2024 were $12,785,000, representing 159.7% of revenue, compared to $20,931,000 or 241.3% of revenue in 2023[397] - Operating expenses decreased by 38.9% to $12.8 million in 2024 from $20.9 million in 2023, primarily due to significant reductions in sales and marketing expenses[405] - Sales and marketing expenses dropped by 60.4% to approximately $3.0 million in 2024, down from $7.5 million in 2023[405] - General and administrative expenses decreased by 32.9% to approximately $6.9 million in 2024, compared to $10.3 million in 2023[406] - Research and development expenses fell by 22.1% to $1.8 million in 2024, down from $2.3 million in 2023[407] Cash Flow and Financing - Net cash used in operating activities was $4.4 million in 2024, a significant improvement from $17.0 million in 2023[415] - The company raised $0.7 million from financing activities in 2024, compared to $17.6 million in 2023[420] - In February 2025, the company raised $4.5 million in a public offering, which will be used for operations and transaction costs[422] Mergers and Agreements - The company entered into a merger agreement with Vyome Therapeutics, focusing on advancing immune-inflammatory assets[385] - The company plans to merge with Vyome Therapeutics, Inc. and expand the Lap-Band product line both domestically and internationally[421] - An exclusive distribution agreement was established with Liaison Medical Ltd. for the Lap-Band® 2.0 FLEX system in Canada, effective until December 31, 2028[388] Intellectual Property and Technology - The company was granted a key international patent for its Diabetes Neuromodulation technology, valid until December 4, 2039[386] Asset Management - The company plans to sell substantially all of its assets to Ninjour Health International Limited for a purchase price of $5.16 million[392] - A reverse stock split of 1-for-58 was executed on September 23, 2024, affecting the number of shares outstanding[396] Revenue Recognition and Accounting - Revenue is recorded net of taxes collected from customers, with amounts billed for shipping and handling included in revenue[430] - Customers of the Lap-Band product can return or exchange products within 30 days, subject to a 10% restocking fee, impacting revenue recognition[431] - Volume rebates or discounts for Lap-Band customers are treated as reductions in sales price and revenue at the point of sale[432] - The company is assessing the impact of competing products, clinical device costs, and regulatory approvals on future revenue generation[433] Reserves and Valuation - Warranty reserves are established based on specific assessments of claims related to product defects, with a five-year warranty provided for the vBloc product line[435][436] - Stock-based compensation expenses are measured based on estimated fair values using the Black-Scholes option valuation model[437] - Accounts receivable reserves are provided for estimated losses based on customer-specific analysis and current economic conditions[438] - Inventory reserves for obsolescence are established based on specific identification of expired or unusable units[439] - The fair value of warrants is analyzed to determine their classification as liability or equity, using various valuation models[440] - Recent accounting standards have been adopted and discussed in the financial statements[441]
ReShape Lifesciences® Receives Notice of Allowance for U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
Globenewswire· 2025-03-10 12:31
Core Insights - ReShape Lifesciences has received a Notice of Allowance for a patent on a novel Diabetes Neuromodulation system, which aims to improve glycemic control and reduce medication dependence for Type 2 diabetes patients [1][2] - The patent will provide protection until April 12, 2039, and is part of a broader intellectual property portfolio that includes 62 issued or pending patents [2] - The Diabetes Neuromodulation technology utilizes proprietary vagus nerve block (vBloc™) technology to regulate blood glucose levels by modulating the vagus nerve's influence on the liver and pancreas [2][3] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band systems and Obalon balloon technology [4] - The company is transitioning its assets, including the DBSN™ system, to Biorad Medisys, which will own the system following the asset purchase agreement [5] Technology and Research - The Diabetes Neuromodulation system is a minimally invasive implant that delivers bio-electronic neuromodulation to regulate plasma glucose levels [3] - Pre-clinical studies have demonstrated improved glycemic control in animal models of Type 2 diabetes, indicating the potential effectiveness of the technology [2]
ReShape Lifesciences® Signs Distribution Agreement in Canada With Liaison Medical for its Next-Generation Lap-Band® 2.0 FLEX
Globenewswire· 2025-02-25 13:31
Core Insights - ReShape Lifesciences has signed a distribution agreement with Liaison Medical for the Lap-Band 2.0 FLEX and Tubing Kit in Canada, following Health Canada's approval in November 2024 [1][2] - The Lap-Band 2.0 FLEX features a relief valve technology that alleviates discomfort from swallowing large pieces of food, potentially reducing the need for in-office adjustments [2] - Liaison Medical is one of the largest surgical device distributors in Canada, leveraging its relationships with hospitals to promote the new device [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 the investigational Diabetes Bloc-Stim Neuromodulation™ system [4] - Liaison Medical, founded in 2012, focuses on delivering innovative surgical devices to hospitals and aims to provide exclusive products to customers while fostering growth for its suppliers [3]
ReShape Lifesciences® Announces Pricing of Upsized $6.0 Million Public Offering
Globenewswire· 2025-02-16 04:17
Core Viewpoint - ReShape Lifesciences has announced a public offering of 2,575,107 units at a price of $2.33 per unit, aiming to raise approximately $6.0 million before expenses [1][2]. Group 1: Offering Details - Each unit in the offering consists of one common share (or a pre-funded warrant) and one warrant to purchase one common share [1]. - The warrants are initially exercisable at $5.83 per share and are subject to adjustments for dividends and splits, with a one-time reset on a specified date [2]. - The offering is expected to close on or about February 18, 2025, pending customary closing conditions [2]. Group 2: Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band systems and the ReShape Diabetes Neuromodulation system [6]. - The company provides minimally invasive treatments for obesity and metabolic diseases, positioning itself as an alternative to more invasive surgical procedures [6].
ReShape Lifesciences® Granted Key International Patent in Israel for Its Proprietary Diabetes Neuromodulation Technology
Newsfilter· 2025-02-03 13:31
Core Insights - ReShape Lifesciences has been granted an international patent for its Diabetes Neuromodulation technology, which aims to improve glycemic control in Type 2 diabetes patients [1][2] - The patent, valid until December 4, 2039, supports the company's proprietary vBloc™ technology, which combines vagus nerve block and stimulation [1][2] - The technology has shown promise in reducing medication reliance for diabetics, potentially lowering treatment costs and complications [2] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band® and Obalon® systems [4] - The company has a strong intellectual property portfolio with 62 issued or pending patents related to vagal neuromodulation and glucose control [2] - ReShape is in the process of selling its assets, including the Lap-Band® and Obalon® systems, to Biorad Medisys, which will also acquire the DBSN™ system [5] Technology Details - The ReShape Diabetes Neuromodulation system is a minimally invasive implant that utilizes bio-electronic neuromodulation to regulate plasma glucose levels [3] - The system works by stimulating pancreatic vagus celiac fibers to release insulin while blocking the hepatic vagal branch to decrease glucose release [3] - Pre-clinical studies have demonstrated increased glycemic control in animal models of Type 2 diabetes [2][3]