ReShape Lifesciences (RSLS)
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ReShape Lifesciences® Announces Strategic Cost Reductions and Provides Update on the Merger Agreement with Vyome Therapeutics and Asset Purchase Agreement with Biorad Medisys
Globenewswire· 2025-06-26 12:31
Core Insights - ReShape Lifesciences Inc. announced a strategic headcount reduction aimed at saving over $750,000 annually, which represents approximately 23.4% of its payroll expenses [1][2] - The company is progressing towards finalizing a merger agreement with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, with a special shareholder meeting scheduled for July 24, 2025, to vote on these transactions [1][2] Company Overview - ReShape Lifesciences is a leading provider of weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band System, which provides a minimally invasive treatment for obesity [3] - The company also has investigational products such as a vagal neuromodulation system for type 2 diabetes and the Obalon balloon technology for non-surgical weight loss [3] Strategic Focus - The company aims to maintain its core capabilities while enhancing operational efficiency through workforce reduction, ensuring that its sales and marketing team remains intact to drive patient leads via digital marketing [2] - ReShape is also focusing on international expansion efforts in Canada through a distribution agreement with Liaison Medical to launch the enhanced Lap-Band 2.0 FLEX [2]
ReShape Lifesciences® Granted Key International Patent in Australia for Its Proprietary Diabetes Neuromodulation Technology
Globenewswire· 2025-06-25 12:31
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 technology utilizes a proprietary vagus nerve block (vBloc™) system combined with bioelectronic modulation to manage glucose levels effectively [2][3] - The patent protection extends until April 12, 2039, enhancing the company's intellectual property position and commercial prospects [1][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® systems and Obalon® balloon technology [4] - The company is focused on innovative approaches to treat obesity and metabolic diseases, with a strong emphasis on personalized medicine [3][4] Technology Details - The Diabetes Neuromodulation system is designed to deliver targeted electrical signals to regulate insulin release and glucose levels, showing promise in preclinical studies [2][3] - The system is considered superior to traditional vagus nerve stimulation methods, as it minimizes side effects and allows for adjustable treatment [3] Market Position - The granting of the Australian patent is seen as a significant milestone that underscores the global relevance of the company's technology and its potential to reduce reliance on daily medications for diabetes management [2] - ReShape Lifesciences holds a robust intellectual property portfolio with 63 issued or pending patents, covering various aspects of its technology [2]
ReShape Lifesciences (RSLS) Earnings Call Presentation
2025-06-17 08:37
Merger and Company Overview - Vyome Therapeutics intends to list on Nasdaq via reverse merger with $RSLS under the ticker $HIND[7] - The merger valuation is $120 million[42] - The company is building a 3-pillared healthcare platform in the US-India innovation corridor[7, 11] Market Opportunity and Assets - The immuno-inflammatory market is expected to reach $125 billion+ by 2028[8] - Vyome's assets include treatments for Malignant Fungating Wound (MFW), Uveitis, and Inflammatory acne[19] - The market size for Malignant Fungating Wound is estimated at $2.5 billion by 2032[19] - The total global acne market is forecasted to grow to $11.6 billion by 2028, with inflammatory acne comprising over 50% of the acne market[19] MFW Program - The MFW market represents a ~$1 billion/year unmet need with no approved drug[21, 26] - New data released in December 2024 shows a 75%+ reduction in odor and 50%+ increase in quality of life with Vyome's drug for MFW[27] Valuation and Comparables - Public comparables in the Inflammation & Immunology Market have an average market cap of $419 million[47] - Precedent M&A comparables in the Acquired Inflammation & Immunology Market have an average market cap of $2.8 billion and a transaction price of $482 million[51]
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]