Latest news with #DiabetesNeuromodulation
Yahoo
21-05-2025
- Business
- Yahoo
ReShape Lifesciences® Reports First Quarter Ended March 31, 2025 Financial Results and Provides Corporate Update
Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement with Biorad Medisys Progress Towards Completion IRVINE, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the first quarter ended March 31, 2025 and provided a corporate strategic update. First Quarter 2025 and Subsequent Highlights May 2025: Effected a 1-for-25 reverse stock split of the company's common stock, which was effective for trading purposes upon the commencement of trading on May 9, 2025. May 2025: Presented pre-clinical data on its proprietary Diabetes Neuromodulation device in a poster presentation at the 12th Annual Minnesota Neuromodulation Symposium. Jonathan J. Waataja, Ph.D., Director of Research at ReShape Lifesciences®, presented the data in a poster presentation entitled, Stimulation of the Posterior Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus. April 2025: Received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/241,151, entitled, 'Intragastric Device.' When issued, the patent will cover claims for an intragastric balloon system, comprising a swallowable capsule with a self-sealing fill valve and a degradable release valve designed to deflate and open the valve around three months after inflation with saline liquid, and configured for natural excretion after deflation, among other claim features. Once issued, the patent will provide protection into at least January 2031, without accounting for a potential Patent Term Extension (PTE). April 2025: Received a Notice of Allowance from the USPTO for patent application 18/069,689, entitled, 'High-Frequency Low Duty Cycle Patterns for Neural Regulation.' When issued, the patent will provide protection until August 4, 2037. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity. April 2025: Announced an agreement with Haifa, Israel-based Motion Informatics to exclusively import and distribute their next-generation neuromuscular rehabilitation devices in the U.S. The flagship product, the Stimel-03, was showcased at the American Occupational Therapy Association 2025 Annual Conference and Expo, held April 3-5, 2025, in Philadelphia, PA. March 2025: Received a Notice of Allowance from the USPTO for patent application 17/046,677, entitled, 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.' When issued, the patent will provide protection until April 12, 2039. February 2025: Signed a distribution agreement with Liaison Medical for ReShape's next generation, enhanced Lap-Band® 2.0 FLEX and Tubing Kit, in Canada. February 2025: Closed an upsized $6.0 million public offering. February 2025: Granted a key international patent from the State of Israel Patent Office for the company's Diabetes Neuromodulation technology. Patent Number 277949, entitled, 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control Systems and Methods,' will provide protection until December 4, 2039. January 2025: Provided an update on the definitive merger agreement under which ReShape and Vyome will combine in an all-stock transaction. The combined company will focus on advancing the development of Vyome's immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. ReShape also provided an update on the asset purchase agreement with Biorad Medisys. On July 8, 2024, ReShape Lifesciences Inc. entered into a definitive merger agreement with Vyome, under which ReShape and Vyome will combine in an all-stock transaction. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol "HIND," representing the company's alignment with the U.S.-India relationship. The board of directors of the combined company will be comprised of six directors designated by Vyome and one director designated by ReShape, and executive management of the combined company will consist of Vyome's executive officers. Simultaneously with the execution of the merger agreement, ReShape entered into an asset purchase agreement with Biorad, which was amended on April 25, 2025, which is party to a previously disclosed exclusive license agreement with ReShape for ReShape's Obalon® Gastric Balloon System. Pursuant to the asset purchase agreement, ReShape will sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the Diabetes Bloc-Stim Neuromodulation™ (DBSN™) System (but excluding cash), and Biorad will assume substantially all of ReShape's liabilities. The cash purchase price under the asset purchase agreement will count toward ReShape's net cash for purposes of determining the post-merger ownership allocation between ReShape and Vyome stockholders under the merger agreement. "The first quarter of 2025 and the months that followed have marked a period of strong momentum for ReShape, both operationally and strategically,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. 'We continued to expand access to our portfolio of physician-led, minimally invasive weight-loss solutions, highlighted by a new distribution agreement with Liaison Medical to launch our enhanced Lap-Band® 2.0 FLEX to the Canadian market. This partnership, following our Health Canada approval in late 2024, is a significant milestone in delivering effective, less-invasive alternatives to bariatric surgery to broader global patient base. We also expanded our product portfolio through an exclusive U.S. distribution agreement for Motion Informatics' next-generation neuromuscular rehabilitation devices, further broadening our portfolio of innovative medical devices. 'At the same time, we strengthened our leadership in diabetes innovation by presenting promising pre-clinical data on our Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium, in a featured poster presentation, showcasing the potential of our proprietary vagus neuromodulation technology platform. Further strengthening our position, the Diabetes Neuromodulation system received significant intellectual property protection, including multiple Notices of Allowance from the USPTO and a pivotal international patent from the Israel Patent Office. These patents extend our intellectual property coverage through at least 2039, underscoring our leadership in addressing both Type 1 and Type 2 diabetes through neuromodulation and its close association with obesity. We also received a Notice of Allowance for our intragastric device patent, which covers a next-generation, self-deflating, swallowable balloon system—an important addition to our metabolic health platform. As our patent portfolio grows, we remain committed to protecting our position and, when appropriate, will pursue strategic, non-dilutive funding to support this objective.' Mr. Hickey concluded, 'The successful completion of our $6.0 million public offering in February strengthens our financial foundation as we continue to execute on our growth initiatives. Finally, we are making continued progress toward finalizing our merger with Vyome and the asset sale to Biorad Medisys. The S-4 was recently declared effective and we are working to set the record date in the near future. Our Board unanimously supports this transformative transaction, which we believe will unlock long-term value for shareholders and drive accelerated growth for the newly combined company." First Quarter Ended March 31, 2025, Financial and Operating Results Revenue $1.1 million for the three months ended March 31, 2025, which represents a contraction of 42.7%, or $0.8 million compared to the same period in 2024. This primarily resulted from a decrease in sales volume primarily due to GLP-1 pharmaceutical weight-loss alternatives as well as a temporary pause in DTC marketing programs. Gross Profit for the three months ended March 31, 2025 and 2024, was $0.7 million, and $1.2 million, respectively. Gross profit as a percentage of total revenue for the three months ended March 31, 2025, was 61.2% compared to 59.9% for the same period in 2024. The increase in gross profit percentage is due to the reduction in overhead related costs, primarily payroll. Sales and Marketing Expenses for the three months ended March 31, 2025, decreased by $0.5 million, or 48.1%, to $0.5 million, compared to $1.0 million for the same period in 2024. The decrease is primarily due to a decrease in advertising and marketing expenses, including consulting and professional marketing services. General and Administrative Expenses for the three months ended March 31, 2025, decreased by approximately $0.3 million, or 13.1%, to $1.6 million, compared to $1.9 million for the same period in 2024. The decrease is primarily due to a $0.4 million reduction in general legal, audit, and other professional fees, as the Company reduced its reliance on consultants and professional services to conserve cash. Research and Development Expenses for the three months ended March 31, 2025, decreased by $0.1 million, or 24.8% to $0.4 million, compared to approximately $0.5 million for the same period in the prior year. Transaction Costs for the three months ended March 31, 2025, were $0.4 million. These expenses primarily consisted of legal and audit-related fees incurred in connection with the Company's pending merger and asset sale. Gain on changes in fair value of liability warrants for the three months ended March 31, 2025 of $3.7 million is related to the change in fair value of liability-classified warrants issued in connection with the Company's February 2025 public offering. The gain recognized in the quarter reflects the decrease in the fair value of the warrants between the issuance date and March 31, 2025. Cash and Cash Equivalents as of March 31, 2025 were $2.6 million, including restricted cash. About ReShape Lifesciences® ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational vagal neuromodulation system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit Non-GAAP DisclosuresIn addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results. Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in this release have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies. Adjusted EBITDAManagement uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, and other one-time costs. Management uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies. Additional Information In connection with the proposed Merger and Asset Sale, ReShape plans to file with the Securities and Exchange Commission (the 'SEC') and mail or otherwise provide to its stockholders a joint proxy statement/prospectus and other relevant documents in connection with the proposed Merger and Asset Sale. Before making a voting decision, ReShape's stockholders are urged to read the joint proxy statement/prospectus and any other documents filed by ReShape with the SEC in connection with the proposed Merger and Asset Sale or incorporated by reference therein carefully and in their entirety when they become available because they will contain important information about ReShape, Vyome and the proposed transactions. Investors and stockholders may obtain a free copy of these materials (when they are available) and other documents filed by ReShape with the SEC at the SEC's website at at ReShape's website at or by sending a written request to ReShape at 18 Technology Drive, Suite 110, Irvine, California 92618, Attention: Corporate Secretary. Participants in the Solicitation This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities of ReShape and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed Merger and Asset Sale. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of ReShape's stockholders in connection with the proposed Merger and Asset Sale will be set forth in joint proxy statement/prospectus if and when it is filed with the SEC by ReShape and Vyome. Security holders may obtain information regarding the names, affiliations and interests of ReShape's directors and officers in ReShape's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on April 4, 2025. To the extent the holdings of ReShape securities by ReShape's directors and executive officers have changed since the amounts set forth in ReShape's proxy statement for its most recent annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed Merger and Asset Sale will be set forth in the joint proxy statement/prospectus when and if it is filed with the SEC in connection with the proposed Merger and Asset Sale, at ReShape's website at Forward-Looking Statements Certain statements contained in this filing may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Merger and Asset Sale and the ability to consummate the Merger and Asset Sale. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'believes,' 'plans,' 'anticipates,' 'projects,' 'estimates,' 'expects,' 'intends,' 'strategy,' 'future,' 'opportunity,' 'may,' 'will,' 'should,' 'could,' 'potential,' or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and ReShape undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) ReShape may be unable to obtain stockholder approval as required for the proposed Merger and Asset Sale; (2) conditions to the closing of the Merger or Asset Sale may not be satisfied; (3) the Merger and Asset Sale may involve unexpected costs, liabilities or delays; (4) ReShape's business may suffer as a result of uncertainty surrounding the Merger and Asset Sale; (5) the outcome of any legal proceedings related to the Merger or Asset Sale; (6) ReShape may be adversely affected by other economic, business, and/or competitive factors; (7) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement or Asset Purchase Agreement; (8) the effect of the announcement of the Merger and Asset Purchase Agreement on the ability of ReShape to retain key personnel and maintain relationships with customers, suppliers and others with whom ReShape does business, or on ReShape's operating results and business generally; and (9) other risks to consummation of the Merger and Asset Sale, including the risk that the Merger and Asset Sale will not be consummated within the expected time period or at all. Additional factors that may affect the future results of ReShape are set forth in its filings with the SEC, including ReShape's most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at specifically under the heading 'Risk Factors.' The risks and uncertainties described above and in ReShape's most recent Annual Report on Form 10-K are not exclusive and further information concerning ReShape and its business, including factors that potentially could materially affect its business, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that ReShape files from time to time with the SEC. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, ReShape assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. CONTACTS: ReShape Lifesciences Contact:Paul F. HickeyPresident and Chief Executive Officer949-276-7223ir@ Investor Relations Contact:Rx Communications GroupMichael Miller(917)-633-6086mmiller@ RESHAPE LIFESCIENCES Consolidated Balance Sheets (in thousands, except share amounts)(unaudited) March 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 2,515 $ 693 Restricted cash 100 100 Accounts and other receivables (net of allowance for doubtful accounts of $871 and $918 respectively) 734 987 Inventory 2,532 2,460 Prepaid expenses and other current assets 414 348 Total current assets 6,295 4,588 Property and equipment, net 34 38 Operating lease right-of-use assets 99 116 Deferred tax asset, net 26 22 Other assets 29 29 Total assets $ 6,483 $ 4,793 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $ 1,686 $ 2,208 Accrued and other liabilities 2,158 1,688 Warranty liability, current 163 163 Debt, current portion — 811 Operating lease liabilities, current 116 115 Total current liabilities 4,123 4,985 Operating lease liabilities, noncurrent 14 41 Common stock warrant liability 1,116 20 Total liabilities 5,253 5,046 Commitments and contingencies (Note 2 and Note 10) Stockholders' equity (deficit): Preferred stock, 10,000,000 shares authorized: Series C convertible preferred stock, $0.001 par value; 95,388 shares issued and outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $0.001 par value; 300,000,000 shares authorized at March 31, 2025 and December 31, 2024; 133,081 and 29,235 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively — — Additional paid-in capital 642,570 642,555 Accumulated deficit (641,230 ) (642,704 ) Accumulated other comprehensive loss (110 ) (104 ) Total stockholders' equity (deficit) 1,230 (253 ) Total liabilities and stockholders' equity (deficit) $ 6,483 $ 4,793 RESHAPE LIFESCIENCES INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts)(unaudited) Three Months Ended March 31, 2025 2024 Revenue $ 1,113 $ 1,944 Cost of revenue 432 779 Gross profit 681 1,165 Operating expenses: Sales and marketing 529 1,019 General and administrative 1,627 1,872 Research and development 364 484 Transaction costs 367 — Total operating expenses 2,887 3,375 Operating loss (2,206 ) (2,210 ) Other expense (income), net: Interest expense (income), net 40 (9 ) Gain on changes in fair value of liability warrants (3,661 ) (21 ) Gain on extinguishment of debt (24 ) — Loss on foreign currency exchange, net 12 24 Other income, net (54 ) (25 ) Income (loss) before income tax provision 1,481 (2,179 ) Income tax expense 7 14 Net income (loss) $ 1,474 $ (2,193 ) Net income (loss) per share - basic and diluted: Net income (loss) per share - basic and diluted $ 18.98 $ (135.37 ) Shares used to compute basic and diluted net income (loss) per share 77,668 16,200 The following table contains a reconciliation of GAAP net income (loss) to Adjusted EBITDA attributable to common stockholders for the three months ended March 31, 2025 and 2024 (in thousands): Three Months Ended March 31, 2025 2024 GAAP net income (loss) $ 1,474 $ (2,193 ) Adjustments: Interest expense (income), net 40 (9 ) Income tax expense 7 14 Depreciation and amortization 4 6 Stock-based compensation expense 15 72 Transaction costs 367 — Gain on changes in fair value of liability warrants (3,661 ) (21 ) Gain on extinguishment of debt (24 ) — Adjusted EBITDA $ (1,778 ) $ (2,131 )Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-04-2025
- Health
- Yahoo
ReShape Lifesciences® Receives Notice of Allowance for Additional U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
Vagal Neuromodulation Offers a Novel Approach to Treating Type 2 Diabetes and Hypoglycemia Patent Enables Equivalent Efficacy with 10 times Lower Energy Consumption Than Current Device Fully Compatible with Standard Implantable Pulse Generators, Enabling Cost-Effective Development IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 18/069,689, entitled, 'High-Frequency Low Duty Cycle Patterns for Neural Regulation.' When issued, the patent will provide protection until August 4, 2037. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity. 'Type 2 diabetes remains a global health challenge and continues to be difficult to treat effectively, despite the range of available medications, surgical options, and dietary interventions,' stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences®. 'Our Diabetes Neuromodulation technology addresses this by regulating blood glucose through targeted vagal nerve modulation, specifically, blocking and stimulating signals to the liver and pancreas. This patent will cover discontinuous high-frequency signals with interwoven micro- and millisecond pauses, forming an energy-efficient algorithm that 'taps' the nerve with bursts of stimulation to achieve a blocking effect. By using approximately 10 times less energy than traditional continuous signals, the system enables the use of smaller batteries or devices and allows for longer intervals between charges. Preclinical testing on rat vagus nerves has demonstrated equivalent efficacy to continuous signals, while remaining fully compatible with standard implantable pulse generators, which will allow for cost-effective development. To date, our team has successfully completed preclinical development, harnessing bioelectronic technology to personalize treatment, boost insulin production, and manage blood glucose levels. This innovation shows strong promise for the treatment of both type 2 diabetes and hypoglycemia.' 'The recent allowance of this patent—coming shortly after the Notice of Allowance received in March—further reinforces the promise of our groundbreaking Neuromodulation technology. Designed to personalize diabetes management, this innovation has demonstrated the potential to reduce reliance on medications by optimizing glucose control. In doing so, it aims to lower overall treatment costs and decrease complications associated with poor blood sugar management and medication non-compliance,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. 'Similar to other patent families within ReShape, the Diabetes Neuromodulation technology is backed by a strong intellectual property portfolio, consisting of 63 issued or pending patents. These patents span key areas such as vagal neuromodulation, glucose regulation, artificial intelligence, and Bluetooth-enabled applications—collectively securing a clear path to commercialization and offering robust protection against competitive threats.' About The ReShape Diabetes Neuromodulation DeviceThe ReShape Diabetes Neuromodulation system (formerly, Diabetes Bloc-Stim Neuromodulation™) (DBSN™) is a novel minimally invasive therapeutic implant concept that delivers bio-electronic neuromodulation of vagus nerve branches that are innervating organs which regulate plasma glucose. The system stimulates vagus celiac fibers of the pancreas to release insulin during stimulation, while blocking the hepatic vagal branch, innervating the liver, to decrease glucose release and decrease insulin resistance following ligation. The system utilizes a proprietary, reversable and adjustable electrical blockade that may represent the future of personalized medicine. Reshape Lifesciences believes its system is superior to both standalone stimulation of the vagus nerve, and vagus nerve ligation which has undesirable side effects and causes irreversible damage to the nerve. About ReShape Lifesciences®ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® and Lap-Band® 2.0 Flex Systems provide minimally invasive, long-term treatment of obesity and are an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit As previously announced ReShape has entered into an asset purchase agreement with Biorad Medisys, Pvt. Ltd., pursuant to which ReShape has agreed to sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the DBSN™ system (but excluding cash). Therefore, at the closing of the transactions contemplated by the asset purchase agreement, the DBSN™ system will be owned by Biorad. Forward-Looking Safe Harbor Statement This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this press release include statements about the promise of the Diabetes Neuromodulation technology and the potential path to commercialization of the technology. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as "risk factors" in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law. CONTACTSReShape Lifesciences Investor Contact:Paul F. HickeyPresident and Chief Executive Officer949-276-7223ir@ Investor Relations Contact:Rx Communications GroupMichael Miller917-633-6086mmiller@ in to access your portfolio
Yahoo
07-04-2025
- Business
- Yahoo
ReShape Lifesciences® Reports Year Ended December 31, 2024 Financial Results and Provides Corporate Update
Significant Reduction in Overall Operating Expenses of 41.9% in 2024, Excluding M&A Related Expenses, Compared to 2023 Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement with Biorad Medisys Remain on Track Strategic Business Update Call to be Held Thursday, April 10, at 4:30 pm ET IRVINE, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the year ended December 31, 2024 and provided a corporate strategic update. Fourth Quarter 2024 and Subsequent Highlights March 2025: Received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 17/046,677, entitled, 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.' When issued, the patent will provide protection until April 12, 2039. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity. February 2025: Signed a distribution agreement with Liaison Medical for distribution of ReShape's next generation, enhanced Lap-Band® 2.0 FLEX and Tubing Kit, in Canada. February 2025: Closed an upsized $6.0 million public offering of 2,575,107 units at a price of $2.33 per unit. Each unit consisted of one common share and one warrant to purchase one common share. February 2025: Granted a key international patent from the State of Israel Patent Office for its Diabetes Neuromodulation technology. Patent Number 277949, entitled, 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control Systems and Methods,' which will provide protection until December 4, 2039. January 2025: Provided an update on the definitive merger agreement under which ReShape and Vyome will combine in an all-stock transaction. The combined company will focus on advancing the development of Vyome's immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. ReShape also provided an update on the asset purchase agreement with Biorad July 9, 2024, ReShape Lifesciences Inc. entered into a definitive merger agreement with Vyome, under which ReShape and Vyome will combine in an all-stock transaction. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol "HIND," representing the company's alignment with the U.S.-India relationship. The board of directors of the combined company will be comprised of six directors designated by Vyome and one director designated by ReShape, and executive management of the combined company will consist of Vyome's executive with the execution of the merger agreement, ReShape entered into an asset purchase agreement with Biorad, which is party to a previously disclosed exclusive license agreement with ReShape for ReShape's Obalon® Gastric Balloon System. Pursuant to the asset purchase agreement, ReShape will sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the Diabetes Bloc-Stim Neuromodulation™ (DBSN™) System (but excluding cash), and Biorad will assume substantially all of ReShape's liabilities. The cash purchase price under the asset purchase agreement will count toward ReShape's net cash for purposes of determining the post-merger ownership allocation between ReShape and Vyome stockholders under the merger agreement. November 2024: Received approval from Health Canada for the next-generation Lap-Band® 2.0 FLEX through an updated Medical Device License. November 2024: Awarded an approximately $241,000 supplementary grant from the National Institutes of Health (NIH), with the University of Southern California's Center for Autonomic Nerve Recording and Stimulation Systems (CARSS), for the development of the next-generation electrodes for ReShape's Diabetes Bloc-Stim Neuromodulation™ (DBSN™) device. October 2024: Entered into a securities purchase agreement (SPA) with an institutional investor. Pursuant to the SPA, ReShape agreed to issue the investor a senior secured convertible note in the aggregate original principal amount of $833,333. The convertible note has now been paid in full. "The fourth quarter and subsequent months have been a transformative period for ReShape, marked by the achievement of significant milestones for our suite of physician-led weight loss solutions, while also fully executing on our 2024 cost reduction plan leading to a 41.9% decrease in operating expenses, excluding M&A related expenses, compared to 2023,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. Our recent Notice of Allowance from the U.S. Patent and Trademark Office, along with the issuance of a key international patent from the State of Israel Patent Office, highlights our leadership in developing groundbreaking treatments for Type 2 diabetes. These patents provide long-term protection for our Diabetes Neuromodulation system, which leverages our proprietary vBloc™ technology platform and vagus nerve stimulation to address one of the most pressing global health challenges—diabetes and its close association with obesity. Additionally, we are excited to expand access to our next-generation, enhanced Lap-Band® 2.0 FLEX through a distribution agreement with Liaison Medical in Canada, coming closely on the heels of our approval from Health Canada, in November 2024. This partnership represents an important step in making effective, minimally invasive weight-loss solutions more widely available to patients seeking alternatives to traditional bariatric surgery. The successful closing of our $6.0 million public offering strengthened our financial position as we continue to drive growth. Finally, regarding our merger agreement with Vyome and the asset purchase agreement with Biorad Medisys, both the ReShape and Vyome teams have been diligently working to have it declared effective so we can set the date for the shareholder meeting. Our board has unanimously recommended merging with Vyome while simultaneously selling assets to Biorad, as we believe this strategic move will create significant value and growth for our shareholders in the newly combined entity." Year Ended December 31, 2024, Financial and Operating Results Revenue totaled $8.0 million for the year ended December 31,2024, which represents a contraction of 7.7%, or $0.7 million compared to the same period in 2023. The primary reason for the decrease is due to the introduction of GLP-1 pharmaceuticals within the U.S. With the introduction of Lap-Band 2.0, the Company did experience a slight growth in units sold of 6.5%, however, sales of the Lap-Band accessories units decreased by 26.4% within the U.S. Worldwide sales of Lap-Band units decreased by 8.5% and accessories decreased 25.9%. The Company did increase the price of Lap-Band systems including accessories, which helped revenues to not decrease at the same ratio as the decline in unit sales. Gross Profit for the year ended December 31, 2024, was $5.1 million, compared to $5.5 million for the year ended December 31, 2023, a decrease of $0.5 million or 8.9%. Gross profit as a percentage of revenue for the year ended December 31, 2024, was 63.2% compared to 63.9% for the same period in 2023. The slight reduction in gross profit margin is primarily due to the writeoff of certain inventories offset by the Company allocating resources to increase efficiencies and a slight increase in product pricing. Sales and Marketing Expenses for the year ended December 31, 2024, decreased by $4.6 million, or 60.4%, to approximately $3.0 million, compared to $7.5 million for the same period in 2023. The decrease is primarily due to a decrease of $2.2 million in advertising and marketing expenses, including consulting and professional marketing services, as the Company has continued to scale down its marketing efforts to a targeted digital marketing campaign. The Company also had reductions in payroll expenditure, including commissions, travel and stock-based compensation of $2.2 million, due to reductions in workforce during the year due to declining revenues. General and Administrative Expenses for the year ended December 31, 2024, decreased by approximately $3.4 million, or 32.9%, to approximately $6.9 million, compared to $10.3 million for the same period in 2023. This decrease was primarily driven by a $1.8 million reduction in general legal, audit, and other professional fees, as the Company reduced its reliance on consultants and professional services to conserve cash. In addition, payroll-related expenses, including stock-based compensation, decreased by $1.3 million due to changes in personnel and workforce reductions during the year. The Company also recorded a $0.2 million decrease in rent and insurance expense as a result of the lease expiration of its former Carlsbad, CA location in mid-2023. Lastly, there was a $0.2 million reduction in bad debt expense and other miscellaneous items. Research and Development Expenses for the year ended December 31, 2024, decreased by $0.5 million, or 22.1%, to $1.8 million, compared to $2.3 million for the same period in 2023. The decrease is primarily due to a decrease of $0.3 million in consulting and clinical trials, as the Company halted clinical trials during 2023 and reduced the use of consultants once Lap-Band 2.0 was released early 2024. The Company also had reductions in payroll expenditures, including stock-based compensation of $0.2 million, due to reductions in workforce during the year. Transaction Costs for the year ended December 31, 2024, were $1.0 million. These expenses primarily consisted of $0.7 million in legal fees and $0.2 million in audit-related fees incurred in connection with the Company's pending merger and asset sale. Cash and Cash Equivalents as of December 31, 2024 were $0.7 million. Noted above, the Company completed an upsized $6 million public offering on February 18, 2025. The Company has $0.8 million in a convertible note payable to an institutional investor at December 31, 2024, which was repaid on February 18, 2025. A full discussion of the Company's financials is available in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission. Conference Call Information Management will host a conference call to provide a strategic business update on Thursday, April 10 at 4:30 pm ET. To participate in the conference call please register with the following Registration Link, and dial-in details will be provided. Participants using this feature are requested to dial into the conference call fifteen minutes ahead of time to avoid delays. An archived replay will also be available on the 'Events and Presentations' section of ReShape's website at: About ReShape Lifesciences® ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit Non-GAAP DisclosuresIn addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results. Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in this release have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies. Adjusted EBITDAManagement uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, and other one-time costs. Management uses Adjusted EBITDA in its evaluation of the company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the company may be different from similarly named non-GAAP financial measures used by other companies. Additional InformationIn connection with the proposed Merger and Asset Sale, ReShape plans to file with the Securities and Exchange Commission (the 'SEC') and mail or otherwise provide to its stockholders a joint proxy statement/prospectus and other relevant documents in connection with the proposed Merger and Asset Sale. Before making a voting decision, ReShape's stockholders are urged to read the joint proxy statement/prospectus and any other documents filed by ReShape with the SEC in connection with the proposed Merger and Asset Sale or incorporated by reference therein carefully and in their entirety when they become available because they will contain important information about ReShape, Vyome and the proposed transactions. Investors and stockholders may obtain a free copy of these materials (when they are available) and other documents filed by ReShape with the SEC at the SEC's website at at ReShape's website at or by sending a written request to ReShape at 18 Technology Drive, Suite 110, Irvine, California 92618, Attention: Corporate Secretary. Participants in the SolicitationThis document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities of ReShape and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed Merger and Asset Sale. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of ReShape's stockholders in connection with the proposed Merger and Asset Sale will be set forth in joint proxy statement/prospectus if and when it is filed with the SEC by ReShape and Vyome. Security holders may obtain information regarding the names, affiliations and interests of ReShape's directors and officers in ReShape's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on April 4, 2025. To the extent the holdings of ReShape securities by ReShape's directors and executive officers have changed since the amounts set forth in ReShape's proxy statement for its most recent annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed Merger and Asset Sale will be set forth in the joint proxy statement/prospectus when and if it is filed with the SEC in connection with the proposed Merger and Asset Sale, at ReShape's website at Forward-Looking StatementsCertain statements contained in this filing may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Merger and Asset Sale and the ability to consummate the Merger and Asset Sale. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'believes,' 'plans,' 'anticipates,' 'projects,' 'estimates,' 'expects,' 'intends,' 'strategy,' 'future,' 'opportunity,' 'may,' 'will,' 'should,' 'could,' 'potential,' or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and ReShape undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) ReShape may be unable to obtain stockholder approval as required for the proposed Merger and Asset Sale; (2) conditions to the closing of the Merger or Asset Sale may not be satisfied; (3) the Merger and Asset Sale may involve unexpected costs, liabilities or delays; (4) ReShape's business may suffer as a result of uncertainty surrounding the Merger and Asset Sale; (5) the outcome of any legal proceedings related to the Merger or Asset Sale; (6) ReShape may be adversely affected by other economic, business, and/or competitive factors; (7) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement or Asset Purchase Agreement; (8) the effect of the announcement of the Merger and Asset Purchase Agreement on the ability of ReShape to retain key personnel and maintain relationships with customers, suppliers and others with whom ReShape does business, or on ReShape's operating results and business generally; and (9) other risks to consummation of the Merger and Asset Sale, including the risk that the Merger and Asset Sale will not be consummated within the expected time period or at all. Additional factors that may affect the future results of ReShape are set forth in its filings with the SEC, including ReShape's most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at specifically under the heading 'Risk Factors.' The risks and uncertainties described above and in ReShape's most recent Annual Report on Form 10-K are not exclusive and further information concerning ReShape and its business, including factors that potentially could materially affect its business, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that ReShape files from time to time with the SEC. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, ReShape assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. CONTACTS: ReShape Lifesciences Contact:Paul F. HickeyPresident and Chief Executive Officer949-276-7223ir@ Investor Relations Contact:Rx Communications GroupMichael Miller(917)-633-6086mmiller@ RESHAPE LIFESCIENCES Balance Sheets (in thousands, except share and per share amounts) December 31, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 693 $ 4,459 Restricted cash 100 100 Accounts and other receivables (net of allowance for doubtful accounts of $918 and $804 respectively) 987 1,659 Inventory 2,460 3,741 Prepaid expenses and other current assets 348 337 Total current assets 4,588 10,296 Property and equipment, net 38 60 Operating lease right-of-use assets 116 250 Deferred tax asset, net 22 28 Other assets 29 29 Total assets $ 4,793 $ 10,663 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $ 2,208 $ 1,689 Accrued and other liabilities 1,688 1,814 Warranty liability, current 163 163 Debt, current portion 811 — Operating lease liabilities, current 115 111 Total current liabilities 4,985 3,777 Operating lease liabilities, noncurrent 41 151 Common stock warrant liability 20 72 Total liabilities 5,046 4,000 Commitments and contingencies (Note 15) Stockholders' equity (deficit): Preferred stock, 10,000,000 shares authorized: Series C convertible preferred stock, $0.001 par value; 95,388 shares issued and outstanding at December 31, 2024 and December 31, 2023 — — Common stock, $0.001 par value — — Additional paid-in capital 642,555 642,325 Accumulated deficit (642,704 ) (635,574 ) Accumulated other comprehensive loss (104 ) (88 ) Total stockholders' equity (deficit) (253 ) 6,663 Total liabilities and stockholders' equity (deficit) $ 4,793 $ 10,663 RESHAPE LIFESCIENCES INC. Consolidated Statements of Operations (in thousands, except share and per share amounts) Year Ended December 31, 2024 2023 Revenue $ 8,006 $ 8,678 Cost of revenue 2,949 3,130 Gross profit 5,057 5,548 Operating expenses: Sales and marketing 2,991 7,548 General and administrative 6,967 10,324 Research and development 1,803 2,315 Transaction costs 1,024 — Impairment of long-lived assets 36 777 Gain on disposal of assets, net — (33 ) Total operating expenses 12,785 20,931 Operating loss (7,728 ) (15,383 ) Other expense (income), net: Interest income, net (14 ) (26 ) Gain on changes in fair value of liability warrants (52 ) (3,878 ) Gain on extinguishment of debt (429 ) — Loss (gain) on foreign currency exchange, net 51 (22 ) Other (193 ) (122 ) Loss before income tax provision (7,091 ) (11,335 ) Income tax expense 39 52 Net loss $ (7,130 ) $ (11,387 ) Net loss per share - basic and diluted: Net loss per share - basic and diluted $ (13.83 ) $ (110.87 ) Shares used to compute basic and diluted net loss per share 515,566 102,707 The following table contains a reconciliation of GAAP net loss to non-GAAP net loss attributable to common stockholders for the years ended December 31, 2024 and 2023 (in thousands).: Year Ended December 31, 2024 2023 GAAP net loss $ (7,130 ) $ (11,387 ) Adjustments: Interest income, net (14 ) (26 ) Income tax expense 39 52 Depreciation and amortization 22 154 Stock-based compensation expense 184 766 Transaction costs 1,024 — Impairment of long-lived assets 36 777 Gain on disposal of assets, net — (33 ) Gain on changes in fair value of liability warrants (52 ) (3,878 ) Gain on extinguishment of debt (429 ) — Adjusted EBITDA $ (6,320 ) $ (13,575 ) Sign in to access your portfolio


Associated Press
10-03-2025
- Health
- Associated Press
ReShape Lifesciences® Receives Notice of Allowance for U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
IRVINE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application 17/046,677, entitled, 'Simultaneous Multi-Site Vagus Nerve Modulation for Improved Glycemic Control System and Methods.' When issued, the patent will provide protection until April 12, 2039. The Diabetes Neuromodulation system leverages its proprietary vagus nerve block (vBloc™) technology platform, along with vagus nerve stimulation, to treat Type 2 diabetes, a prominent disorder linked with obesity. 'Allowance for this newest patent, on the heels of the recently announced Israeli patent, serves as strong evidence of the promise of this groundbreaking technology, which has shown the potential to reduce dependence on medications for diabetics through a personalized approach. By optimizing glucose control, the technology aims to lower treatment costs and minimize complications related to poorly managed blood sugar and medication non-compliance,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. 'Like other patent families within ReShape, the Diabetes Neuromodulation technology is supported by a robust intellectual property portfolio, comprising 62 issued or pending patents. These cover vagal neuromodulation, glucose control, AI, and Bluetooth applications, ensuring a clear path to commercialization while providing strong protection against competitive threats.' 'Type 2 diabetes is a worldwide issue and continues to be difficult to treat effectively, despite the availability of medication, surgery, and dietary interventions,' stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences. 'ReShape's Diabetes Neuromodulation technology regulates blood glucose by selectively modulating vagal block and stimulation to the liver and pancreas. Studies have shown improved glycemic control in both a Zucker rat model of Type 2 Diabetes Mellitus (T2DM) and an alloxan-treated swine model of T2DM. To date, our team has successfully completed the pre-clinical development of the device, employing bioelectronics to optimize insulin production and manage blood glucose levels in a personalized manner, with the potential to treat Type 2 diabetes and hypoglycemia.' About The ReShape Diabetes Neuromodulation Device The ReShape Diabetes Neuromodulation system (formerly, Diabetes Bloc-Stim Neuromodulation™ (DBSN™) is a novel minimally invasive therapeutic implant concept that delivers bio-electronic neuromodulation of vagus nerve branches that are innervating organs which regulate plasma glucose. The system stimulates vagus celiac fibers of the pancreas to release insulin during stimulation, while blocking the hepatic vagal branch, innervating the liver, to decrease glucose release and decrease insulin resistance following ligation. The system utilizes a proprietary, reversable and adjustable electrical blockade that may represent the future of personalized medicine. Reshape Lifesciences believes its system is superior to both standalone stimulation of the vagus nerve, and vagus nerve ligation which has undesirable side effects and causes irreversible damage to the nerve. About ReShape Lifesciences® ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® and Lap-Band® 2.0 Flex Systems provide minimally invasive, long-term treatment of obesity and are an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit As previously announced ReShape has entered into an asset purchase agreement with Biorad Medisys, Pvt. Ltd., pursuant to which ReShape has agreed to sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the DBSN™ system (but excluding cash). Therefore, at the closing of the transactions contemplated by the asset purchase agreement, the DBSN™ system will be owned by Biorad. Forward-Looking Safe Harbor Statement This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as 'expect,' 'plan,' 'anticipate,' 'could,' 'may,' 'intend,' 'will,' 'continue,' 'future,' other words of similar meaning and the use of future dates. Forward-looking statements in this press release include statements about the promise of the Diabetes Neuromodulation technology and the potential path to commercialization of the technology. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as 'risk factors' in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law. CONTACTS Paul F. Hickey 949-276-7223 [email protected] Investor Relations Contact: Rx Communications Group Michael Miller 917-633-6086