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ReShape Lifesciences® Signs Exclusive Distribution Agreement with Recon Supply to Access the VA and DoD Markets
Globenewswire· 2025-06-12 12:25
Core Insights - ReShape Lifesciences has signed an exclusive U.S. distribution agreement with Recon Supply to distribute its medical products to U.S. veterans and active-duty service members [1][2] - The partnership aims to enhance access to innovative medical technologies, including the STIMEL-03 neuromuscular rehabilitation device and the Lap-Band® 2.0 FLEX [2] - Recon Supply has experienced significant growth, with a 113% year-over-year increase since its relaunch in 2022, and now distributes to 102 VA Medical Centers nationwide [2] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of FDA-approved products for obesity management [4] - The company’s portfolio includes the Lap-Band® System, a minimally invasive treatment for obesity, and other innovative technologies aimed at treating metabolic disorders [4] - Recon Supply is a Service-Disabled Veteran-Owned Small Business (SDVOSB) focused on delivering high-quality medical solutions while supporting the veteran community [3]
ReShape Lifesciences® Announces Pricing of $2.6 Million Public Offering
Globenewswire· 2025-06-09 13:00
Core Viewpoint - ReShape Lifesciences has announced a public offering of 1,054,604 shares of common stock at a price of $2.50 per share, expecting gross proceeds of approximately $2.6 million before expenses [1]. Group 1: Offering Details - The public offering is being conducted under an effective shelf registration statement filed with the SEC, which was declared effective on May 14, 2025 [3]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is expected to close on or about June 9, 2025, pending customary closing conditions [1]. Group 2: Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products and services for obesity and metabolic disease management [4]. - The company’s FDA-approved products include the Lap-Band® systems, which provide minimally invasive treatment options for obesity, and the ReShape Diabetes Neuromodulation system, which targets glucose regulation [4]. - The Obalon® balloon technology is another innovative product that offers a non-surgical method for weight loss [4].
ReShape Lifesciences® Announces EU MDR Certification for Entire European and United Kingdom Product Portfolio
Globenewswire· 2025-06-03 12:31
Core Insights - ReShape Lifesciences has achieved certification for its Quality Management System (QMS) and medical devices under the EU Medical Device Regulation (MDR) and UK Conformity Assessment (UKCA), ahead of the December 31, 2027 deadline [1][3] - The EU MDR, effective since May 2021, imposes stricter requirements for clinical evaluation, post-market surveillance, and device traceability to enhance patient safety and product quality across the European Economic Area [2] - The certification positions ReShape Lifesciences among a select group of manufacturers compliant with the EU's rigorous standards, enabling the company to expand its product pipeline and maintain market access in Europe [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] - The company’s offerings include non-surgical options like the Obalon balloon technology, designed for long-lasting weight loss [4]
ReShape Lifesciences® Reports First Quarter Ended March 31, 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-21 12:31
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].
ReShape Lifesciences (RSLS) - 2025 Q1 - Quarterly Report
2025-05-20 20:56
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]
ReShape Lifesciences Announces 1-for-25 Reverse Stock Split
Globenewswire· 2025-05-07 12:31
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]
ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium
Globenewswire· 2025-05-02 12:31
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]
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]