RSLS: Hey, interesting NEWS spot there, Boss! OBESITY is (unfortunately) 'TRENDING' throughout the entire WESTERN HEMISPHERE!! And RSLS up a tiny pinch in the A.H., right now.
And yeah, the only thing poppin' today was that MEDS creature --- but, ya had to FLIP-IT in the after- and pre-markets, that's for sure. (Lastly, @WGS snuck-one-in just one minute after the Close today; nothing EPIC in their PR, per se, but a curious news spot.)
Hey! You didn't miss much today pretty dull. Yea man, you are stinking obese but hey you have great rhythm so that makes up for it. I like lol
RSLS: Monster THANKS, Capt. S-L, for the heads-up!!! (I was away all day today behind personal stuff!!) Hey, Boss, I myself want RSLS's Lap-Band-2.0 gadget!!! Heck, see MY joyous reaction, below, when I got your heads-up about it!!! Now ya know what a FAT PIG I am, Boss!!! I HATE when this happens to any of my fellow Human Beings, Homeboy --- let alone when it happens to my own stupid BIG FAT BUTT!!!
"I want that LAP-BAND-TWO-POINT-OH, two-point-oh, two-point-oh, BIG MAMA --- I said OH-OH-OH-OH, TWO=POINT-00000000000000000000000000, OH-YEAH --- BIG-BIG-BIG-BIG-BIG-BIG-FAT-&-GREASY-MAMA!!!!"
ReShape Lifesciences® Submits FDA PMA Supplement Application for the Next-Generation Lap-Band® 2.0
Enhanced Band Reservoir Technology Designed to Improve the Patient Experience
IRVINE, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced the submission of a Premarket Approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for the company’s next generation, enhanced Lap-Band® 2.0, utilizing a band reservoir technology.
“The PMA supplement submission is a significant milestone and is consistent with our second growth pillar to develop and, ultimately, commercialize new products and therapies,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “This next generation, enhanced Lap-Band® 2.0 was developed with physician feedback to improve the patient experience. Similar to our current Lap-Band, the Lap-Band 2.0 is adjustable postoperatively to increase or decrease the opening of the band in order to optimize an individual’s comfort, thereby improving therapy effectiveness. However, unique to the Lap-Band 2.0 is an enhanced band reservoir technology that serves as a relief valve, designed to alleviate discomfort from swallowing large pieces of food, that may require in-office band adjustments. We expect feedback from the FDA by year end. If approved, we believe that based on discussions with physicians, that there will be broad adoption by existing Lap-Band® surgeons and surgeons that newly adopt the Lap-Band® 2.0.”
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. ReShapeCare™ is a virtual weight-management program that supports lifestyle changes for all weight loss patients led by board-certified health coaches to help them keep the weight off over time. ReShape Marketplace™ is an online collection of quality wellness products curated for all consumers to help them achieve their health goals. 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 www.reshapelifesciences.com.
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 the statements that we expect feedback on the PMA submission from the FDA by year end, and, if approved, that we believe based on physician feedback that there will be broad adoption of the Lap-Band® 2.0 by existing Lap-Band® surgeons and surgeons that newly adopt the Lap-Band® 2.0. 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.
ReShape Lifesciences Investor Contact:
Chief Financial Officer
Investor Relations Contact:
Rx Communications Group
Source: ReShape Lifesciences Inc
© 2023 GlobeNewswire, Inc.
I think we have to wait years for that before we get to 50 .
Will this be followed by you, Tomorrow pre the numbers.
Little enthusiasm on this forum, what are your future estimates of this share ??
News Pre Market .???
Neus Pre Market .???
Seems like in ran already in one big short burst. Oh well...fun while it lasted. And now down :(
Going to break $7 momentarily $$$$
Got some will go up $$$$$
Glass sphere ??
8 R/S in 6 years. Yeah! Your right!
ReShape Lifesciences Shares Jump After FDA Clearance for GIBI Calibration Tube
12:25 pm ET August 10, 2022 (Dow Jones) Print
By Chris Wack
ReShape Lifesciences Inc. shares rose 33% to 64 cents a share after the company said it received U.S. Food and Drug Administration 510(k) clearance for its disposable gastro intestinal balloon indicator calibration tube for use in gastric and bariatric surgical procedures.
The company said it expects U.S. commercial sales to begin in September 2022.
The product includes three new sizes for bariatric procedures such as laparoscopic sleeve gastrectomy, gastric bypass and adjustable gastric banding.
The stock hit its 52-week low of 46 cents a share July 27.
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.
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.