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eShape Lifesciences® Announces EU MDR Certification for Entire European and United Kingdom Product Portfolio
IRVINE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom (UK) have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and UK Conformity Assessment (UKCA), respectively.
The EU MDR, which replaced the Medical Device Directive (MDD) in May 2021, sets significantly more stringent requirements for clinical evaluation, post-market surveillance, and device traceability. Its goal is to improve patient safety, transparency, and product quality across all 30 countries within the European Economic Area (EEA). The UKCA has replaced the CE mark for certain goods placed on the market in Great Britain (England, Scotland, and Wales). It ensures that products meet the UK's regulatory requirements for safety, health, and environmental protection.
“Achieving MDR and UKCA certification well in advance of the December 31, 2027 regulatory deadline is a significant milestone that firmly establishes ReShape Lifesciences among a select group of medical device manufacturers capable of meeting the European Union’s rigorous new standards,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “We have invested in the infrastructure necessary not only to comply with the MDR’s demanding framework, but also to support ongoing innovation and maintain seamless access to all 30 countries within the EEA. We are proud to join the relatively small number of companies that have successfully navigated this rigorous process. As a result, ReShape Lifesciences is uniquely positioned to expand its product pipeline, knowing that the systems and infrastructure supporting its QMS align with the EU’s and UK’s highest standards. This certification not only secures our continued presence in the European market, but also reinforces our mission to deliver safe, effective, and innovative solutions to patients living with obesity worldwide.”
“Securing MDR and UKCA certification for our products and our QMS is a clear validation of our regulatory and quality systems,” said Dov Gal, Vice President of Regulatory, Quality, and Clinical Affairs at ReShape Lifesciences. “As of late 2023 and early 2024, many legacy devices that were previously approved under the older MDD framework were still awaiting MDR and UKCA certification. With only a small percentage of applications resulting in approved certificates at that time, the risk of device shortages across the EU market became increasingly apparent. ReShape’s early compliance ensures uninterrupted availability of our devices in Europe and demonstrates our commitment to meeting the highest standards of safety and performance under the new regulatory landscape.”
REshaping up nicely
ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium
Vagal Neuromodulation Offers a Novel Approach to Treating Diabetes and Hypoglycemia
Device Demonstrates the Ability to Modulate Glucose Levels Without Cardiac Side Effects, Overcoming a Key Limitation Of Conventional Vagal Stimulation Techniques
IRVINE, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced it will present pre-clinical data on its proprietary Diabetes Neuromodulation device in a poster presentation at the 12th Annual Minnesota Neuromodulation Symposium, being held in Minneapolis.
Poster Presentation Details:
Poster Title: Stimulation of the Posterior Sub-Diaphragmatic Vagal Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model of Type 1 Diabetes Mellitus
Poster Number: 3308
Author: Jonathan J. Waataja, Ph.D., Director of Research at ReShape Lifesciences®
Session: Session B
Date: May 2, 2025
Time: 10:45 am -1:00 pm CT
“Hypoglycemia remains a significant barrier to effective diabetes management, contributing to severe health risks and reduced quality of life,” stated Dr. Waataja. “Our Diabetes Neuromodulation technology utilizes Hypoglycemia Vagus Nerve Stimulation (HVNS), targeting stimulation of the sub-diaphragmatic posterior vagus nerve (PVN) to rapidly increase blood glucose (BG) during hypoglycemic episodes. The ability to avoid cardiac side effects while effectively mitigating BG is critical for clinical viability. Unlike conventional vagal stimulation techniques, our targeted HVNS approach alters glucose levels without impacting heart rate, blood pressure or respiration, overcoming a key limitation of conventional vagal stimulation techniques. Also, sub-diaphragmatic stimulation does not affect speech, which is an obstacle to increasing desired therapeutic levels with conventional vagal stimulation. The pre-clinical data presented today paves the way for the continued development of our proprietary technology aimed at reducing dependence on injections and wearable glucose monitors, with the potential to dramatically improve quality of life for people with Type 1 or Type 2 diabetes.”
Designed to evaluate HVNS efficacy and off-target systemic effects in a Type 1 diabetic swine model, laparoscopic placement of an electrode on the PVN successfully increased blood glucose levels and glucagon secretion without impacting cardiac output. Following insulin-induced hypoglycemia (blood glucose <55 mg/dL), HVNS elevated glucose from a baseline of 45 to 58 mg/dL in one swine and from 51 to 68 mg/dL in another after 30 minutes of stimulation. Correspondingly, blood glucagon levels rose from 4.1 to 12.3 pmol/L and from 3.5 to 7.6 pmol/L. Importantly, mean heart rate remained stable, with no significant changes observed during stimulation. Vomiting was only observed at current amplitudes (~6 mA) above those needed to elicit therapeutic glucose changes (~3 mA), underscoring a clear therapeutic window. Positive control tests using intramuscular glucagon produced similar blood glucose increases, further validating HVNS as an effective alternative.
“The presentation of this data at such an important industry conference is a testament to the strength of the pre-clinical evidence showing the potential effectiveness of our proprietary Diabetes Neuromodulation device,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “As demonstrated in this model, our technology offers a fast-acting, device-based intervention for insulin-induced hypoglycemia. Given the promise of this approach, we will continue to seek non-dilutive funding, while simultaneously working with top researchers and industry leading strategic corporate partners to potentially bring this novel therapeutic to market.”
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 www.reshapelifesciences.com.
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
but its trying to run. let’s see!
rsls has sudden …….
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buying volume but now they are dumping it again, as if not wanting it to run.
$UAMY: Sounds good................
I'll get some at $0.25................... at $2.20 today is too high.
THANKS for the HEADSUP
GO $UAMY
here we go!
hopped back in since they have….
…
up to a year to r/s, i think the news was to temp drop this. lets see if im right.
grabbed 40’s.
HEPA Low Float Bio Tech under cash heavy short like RSLS ICCT
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ReShape Lifesciences™
https://www.reshapelifesciences.com/
ReShape Lifesciences™ is a medical device company focused on technologies to treat obesity and metabolic diseases. The FDA-approved ReShape Balloon™ System involves a non-surgical weight loss procedure that uses advanced balloon technology designed to take up room in the stomach to help people with a 30-40 kg/m2 Body Mass Index (BMI) and at least one co-morbidity lose weight. ReShape vBloc™ Therapy, delivered by an FDA-approved pacemaker-like device called the ReShape vBloc System, is designed to help patients with a 40-45 kg/m2, or a 35-39.9 kg/m2 BMI and at least one co-morbidity feel full and eat less by intermittently blocking hunger signals on the vagus nerve. The ReShape Vest™ System is an investigational, minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery, and is intended to enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy.
ReShape Lifesciences was incorporated in Minnesota in December 2002 under the name Beta Medical, Inc. In 2003, the Company changed its name to EnteroMedics Inc. and in 2004 reincorporated in Delaware. EnteroMedics began trading on the NASDAQ Stock Market on November 15, 2007. The Company acquired ReShape Medical, Inc. in October 2017 and subsequently changed its name to ReShape Lifesciences, Inc.
Financials http://ir.reshapelifesciences.com/static-files/cefa86e6-3998-4cb2-b8d8-c5447d7383b5
PART I – FINANCIAL INFORMATION ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS RESHAPE LIFESCIENCES INC. Condensed Consolidated Balance Sheets (Unaudited) June 30, December 31, 2018 2017 ASSETS Current assets: Cash and cash equivalents $ 1,863,217 $ 10,163,208 Accounts receivable (net of allowance for bad debts of $228,165 and $155,872 at June 30, 2018 and December 31, 2017) 446,027 488,613 Inventory 2,101,017 2,817,112 Prepaid expenses and other current assets 919,543 467,783 Total current assets 5,329,804 13,936,716 Property and equipment, net 303,206 438,621 Goodwill — 27,186,620 Other intangible assets, net 44,802,230 46,152,577 Other assets 76,827 990,015 Total assets $ 50,512,067 $ 88,704,549 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 4,201,239 $ 1,088,271 Accrued expenses 4,499,875 5,955,518 Total current liabilities 8,701,114 7,043,789 Deferred income taxes 2,700,681 5,292,291 Common stock warrant liability 74 1,600 Total liabilities 11,401,869 12,337,680 Commitments and contingencies (Note 7) Stockholders’ equity: Preferred stock, 5,000,000 shares authorized: Series B convertible preferred stock, $0.01 par value; 20,000 shares issued and 2,957 and 6,055 shares outstanding at June 30, 2018 and December 31, 2017, respectively 30 61 Series C convertible preferred stock, $0.01 par value; 187,772 shares issued and 95,388 shares outstanding at June 30, 2018 and December 31, 2017 954 954 Series D convertible preferred stock, $0.01 par value; 6,000 shares issued and 4,750 and zero shares outstanding at June 30, 2018 and December 31, 2017 48 — Common stock, $0.01 par value; 275,000,000 shares authorized at June 30, 2018 and December 31, 2017; 3,610,009 and 2,063,808 shares issued and outstanding at June 30, 2018 and December 31, 2017 36,100 20,640 Additional paid-in capital 424,158,496 411,104,568 Accumulated deficit (385,085,430) (334,759,354) Total stockholders’ equity 39,110,198 76,366,869 Total liabilities and stockholders’ equity $ 50,512,067 $ 88,704,549 See accompanying notes to condensed consolidated financial statements.
RESHAPE LIFESCIENCES INC. Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Product sales $ 633,554 $ 93,060 $ 1,574,985 $ 133,100 Other revenue 19,815 — 28,382 — Total revenue 653,369 93,060 1,603,367 133,100 Cost of revenue 634,774 54,472 1,463,731 83,995 Gross profit 18,595 38,588 139,636 49,105 Operating expenses: Selling, general and administrative 6,710,518 5,560,787 16,756,075 11,489,773 Research and development 2,439,337 1,352,075 5,126,856 2,476,488 Goodwill impairment 27,186,620 — 27,186,620 — Total operating expenses 36,336,475 6,912,862 49,069,551 13,966,261 Operating loss (36,317,880) (6,874,274) (48,929,915) (13,917,156) Other income (expense): Interest income 263 — 674 100 Interest expense — — (2,735) — Change in value of warrant liability 369 34,395 1,494 (288,735) Other, net (142,145) (298) (144,416) (1,198) Loss before income taxes (36,459,393) (6,840,177) (49,074,898) (14,206,989) Income tax benefit 1,208,560 — 2,590,613 — Net loss $ (35,250,833) $ (6,840,177) $ (46,484,285) $ (14,206,989) Adjustment for convertible preferred stock and warrants (3,841,790) — (3,841,790) — Net loss attributable to common shareholders (39,092,623) (6,840,177) (50,326,075) (14,206,989) Net loss per share—basic and diluted $ (15.78) $ (13.68) $ (22.14) $ (32.13) Shares used to compute basic and diluted net loss per share 2,477,910 500,114 2,273,160 442,191
The Company trades on the NASDAQ under the ticker symbol RSLS.http://ir.reshapelifesciences.com/financial-information/sec-filings
As of August 10, 2018, 9,013,421 shares of the registrant’s Common Stock were outstanding.
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