SAN CARLOS, Calif., May 30, 2024 (GLOBE NEWSWIRE) — Medical robotics innovator Noah Medical announced today that it has been named a finalist in the prestigious Surgical Robotics Industry Awards 2024 alongside its founder and CEO Dr. Jian Zhang. This joint recognition highlights Noah Medical’s groundbreaking work in endoluminal robotics and Dr. Zhang’s visionary leadership within the industry. Noah Medical is a finalist in the Innovative Start-up category, which honors companies under six years old that have demonstrated significant potential and introduced innovative solutions to enhance surgical procedures and patient outcomes. Dr. Zhang is a finalist in the Industry Leadership category, awarded to those who have demonstrated outstanding business or commercial success, highly effective management, and a track record as a thought leader. Since the beginning of 2023, Noah Medical has announced $150 million in Series B funding, secured FDA clearance for The Galaxy System™, its fully image-integrated solution for robotic navigated bronchoscopy, and launched the platform to commercial and industry acclaim. The company’s proprietary technology is transforming the early identification and diagnosis of lung cancer by making it possible for physicians to overcome traditional imaging and navigation limitations to confidently reach nodules in the outer periphery of the lung. New white paper data from partner hospitals has shown the Galaxy System’s ability to consistently achieve a diagnostic yield as high as 96% in the field, including the 75% or more that were found in the outer third of the lung. In addition to reaching early adoption milestones faster than any other robotic platform, the technology was named a “2023 Fierce 15 Company” by Fierce MedTech and the “2023 Best Healthcare Robotics Company” in the 7th Annual MedTech Breakthrough Awards Program. About Noah Medical Noah Medical is building the future of medical robotics. Our next-generation robotic platforms and technologies target early diagnosis and treatment of patients across multiple indications. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top robotics, medical device, and healthcare companies in the world. Learn more at noahmed.com. About the Galaxy SystemDesigned in collaboration with physicians, the Galaxy System features a groundbreaking combination of innovative new technologies and features, including proprietary integrated tomosynthesis (TiLT+ Technology™) with augmented fluoroscopy, a disposable single-use bronchoscope with always-on vision, and a small, compact footprint that allows for easy integration into most bronchoscopy suites. Recent results have shown Galaxy Systems’ ability to achieve 100% successful navigation to lesion, 100% diagnostic yield, and 95% tool-in-lesion accuracy in a preclinical trial, and 100% tool-in-lesion accuracy and 90-95% diagnostic yield in a human trial. Media Contact:Jennifer SipeNoah Medical513-313-1403press@noahmed.com
Financial
BioSig Announces Closing of $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Westport, CT, May 30, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share and concurrent private placement unregistered warrants to purchase up to 1,570,683 shares of common stock at an exercise price of $1.78 per share. The unregistered warrants are immediately exercisable and will expire five years from the date of issuance. H.C. Wainwright & Co. acted as exclusive placement agent for the offering. The gross proceeds to the Company from the offering were approximately $3 million, before deducting placement agent fees and other offering expenses payable by the Company. BioSig intends to use the net proceeds of this offering for working capital and general corporate purposes. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described were offered and sold by BioSig pursuant to a shelf registration statement on Form S-3 (File No. 333-251859) that was previously filed with the Securities and Exchange Commission (“SEC”) on December 31, 2020, and subsequently declared effective on January 12, 2021. The offering of the shares of common stock were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. The offer and sale of the unregistered warrants issued in the concurrent private placement were made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioSig Technologies, Inc. BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements include, but are not limited to, statements related to the intended use of proceeds from the offering. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates; and (ix) market and other conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see BioSig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Annual Report on Form 10-K, filed with the SEC on April 16, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
BioSig Announces $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Westport, CT, May 30, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, BioSig has also agreed to issue and sell to the same purchasers unregistered warrants to purchase up to 1,570,683 shares of common stock at an exercise price of $1.78 per share. The unregistered warrants will become immediately exercisable upon issuance and will expire five years from the date of issuance. The closing of the offering is expected to occur on or about May 30, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $3 million, before deducting placement agent fees and other offering expenses payable by the Company. BioSig intends to use the net proceeds of this offering for working capital and general corporate purposes. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described above are being offered by BioSig pursuant to a shelf registration statement on Form S-3 (File No. 333-251859) that was previously filed with the Securities and Exchange Commission (“SEC”) on December 31, 2020, and subsequently declared effective on January 12, 2021. The shares of common stock to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. The offer and sale of the unregistered warrants are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioSig Technologies, Inc. BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements include, but are not limited to, statements related to the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates; and (ix) market and other conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see BioSig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Annual Report on Form 10-K, filed with the SEC on April 16, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
Medtronic announces pricing of €3.0 billion of senior notes
DUBLIN, May 29, 2024 /PRNewswire/ — Medtronic plc (the “Company”) (NYSE: MDT) announced today that its wholly-owned indirect subsidiary, Medtronic, Inc., has priced an offering (the “Offering”) of €850,000,000 principal amount of 3.650% senior notes due 2029, €850,000,000 principal amount of 3.875% senior notes due 2036, €600,000,000 principal amount of 4.150% senior notes due 2043, and €700,000,000 principal amount of 4.150% senior notes due 2053 (collectively, the “Notes”). All of Medtronic, Inc.’s obligations under the Notes will be fully and unconditionally guaranteed by the Company and Medtronic Global Holdings S.C.A., a wholly-owned subsidiary of the Company and the indirect parent of Medtronic, Inc., on a senior unsecured basis.
The net proceeds of the Offering are expected to be used for general corporate purposes, which may include repayment of outstanding commercial paper and other indebtedness. The Offering is expected to close on June 3, 2024, subject to customary closing conditions. The joint book-running managers for the Offering are Citigroup Global Markets Limited, J.P. Morgan Securities plc, Merrill Lynch International and Mizuho International plc.
The Offering is being made only by means of a prospectus dated March 3, 2023, and prospectus supplement (together, the “Prospectus”). You may get these documents for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus may be obtained by contacting Citigroup Global Markets Limited, toll-free at +1 800 831 9146, J.P. Morgan Securities plc at +44 20 7134 2468 (non-U.S. investors), or J.P. Morgan Securities LLC collect at +1 212 834 4533 (U.S. investors), Merrill Lynch International, toll free at +1 800 294 1322 and Mizuho International plc, at +44 20 7248 3920.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the Offering and the expected use of proceeds therefrom, and the expected closing date of the Offering.
You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectus related to the offering referenced above, as well as the risk factors and cautionary statements described in Medtronic plc’s filings with the SEC, including the risk factors contained in Medtronic plc’s most recent Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.
Contacts:
Erika Winkels
Ryan Weispfenning
Public Relations
Investor Relations
+1-763-526-8478
+1-763-505-4626
SOURCE Medtronic plc
Nordson Corporation Announces Agreement to Acquire Atrion Corporation, a Market Leader in Medical Infusion and Cardiovascular Technologies
WESTLAKE, Ohio–(BUSINESS WIRE)–Nordson Corporation (Nasdaq: NDSN) today announced that it has entered into a definitive agreement to acquire Atrion Corporation (Nasdaq: ATRI), a leader in proprietary medical infusion fluid delivery and niche cardiovascular solutions, for $460.00 per share in cash. This reflects a valuation of 15X Atrion’s 2024 full-year estimated […]
Semler Scientific® Announces Bitcoin Treasury Strategy
SANTA CLARA, Calif., May 28, 2024 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a pioneer in developing and marketing technology products and services to healthcare providers to combat chronic diseases, announced today that its board of directors has adopted bitcoin as its primary treasury reserve asset. In addition, Semler Scientific announced that it has purchased 581 bitcoins for an aggregate amount of $40 million, inclusive of fees and expenses.
“Our bitcoin treasury strategy and purchase of bitcoin underscore our belief that bitcoin is a reliable store of value and a compelling investment,” said Eric Semler, Semler Scientific’s chairman. “Bitcoin is now a major asset class with more than $1 trillion of market value. We believe it has unique characteristics as a scarce and finite asset that can serve as a reasonable inflation hedge and safe haven amid global instability. We also believe its digital, architectural resilience makes it preferable to gold, which has a market value of approximately 10 times that of bitcoin. Given the gap in value between gold and bitcoin, we believe that bitcoin has the potential to generate outsize returns as it gains increasing acceptance as digital gold.
“Furthermore, we are energized by the growing global acceptance and ‘institutionalization’ of bitcoin — reflected most recently by the Securities and Exchange Commission’s January 2024 approval of 11 bitcoin exchange-traded funds. These funds have reported more than $13 billion of net inflows, with investments from nearly 1,000 institutions, including global banks, pensions, endowments and registered investment advisors. It is estimated that more than 10% of all bitcoins are now held by institutions,” added Mr. Semler.
Semler Scientific’s board and senior management have spent substantial time examining potential uses of cash, including acquisitions. “After studying various alternatives, we decided that holding bitcoin would be the best use of our excess cash,” said Mr. Semler.
In conjunction with its bitcoin treasury strategy, Semler Scientific will continue to focus on its core medical products and services. “We remain dedicated to our customers and our goal of operating a growing and profitable healthcare company,” said Doug Murphy-Chutorian, MD, Semler Scientific’s chief executive officer. “We are focused on maintaining sales of QuantaFlo® for peripheral arterial disease testing, while seeking a new 510(k) clearance from the FDA with expanded labeling for use as an aid in the diagnosis of other cardiovascular diseases.”
As Semler Scientific continues to generate revenue and free cash flow from sales of QuantaFlo, it will proactively evaluate its use of excess cash. Bitcoin will serve as Semler Scientific’s principal treasury holding on an ongoing basis, subject to market conditions and the anticipated cash needs of Semler Scientific.
More information regarding Semler Scientific’s bitcoin treasury strategy will be posted on its website at www.semlerscientific.com.
About Semler Scientific, Inc:
Semler Scientific, Inc. develops, manufactures and markets innovative products and services to combat chronic diseases. Its flagship product, QuantaFlo®, which is patented and cleared by the U.S. Food and Drug Administration (FDA), is a rapid point-of-care test that measures arterial blood flow in the extremities. The QuantaFlo test aids in the diagnosis of cardiovascular diseases, such as peripheral arterial disease (PAD), and Semler Scientific is seeking a new 510(k) clearance for expanded indications. QuantaFlo is used by healthcare providers to evaluate their patient’s risk of mortality and major adverse cardiovascular events (MACE). Semler Scientific also invests in bitcoin and has adopted bitcoin as its primary treasury reserve asset. Additional information about Semler Scientific can be found at www.semlerscientific.com.
Forward-Looking Statements
This press release contains “forward-looking” statements. Such statements can be identified by, among other things, the use of forward-looking language such as the words “believe,” “goal,” “may,” “will,” “intend,” “expect,” “anticipate,” “estimate,” “project,” “would,” “could” or words with similar meaning or the negatives of these terms or by the discussion of strategy or intentions. The forward-looking statements in this release include express or implied statements regarding the new bitcoin strategy and its ability to generate outsize returns, Website posting of information regarding the bitcoin strategy, as well as seeking a new 510(k) clearance for QuantaFlo with expanded indications for use, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause Semler Scientific’s actual results to differ materially from those discussed here, such as risks inherent with investing in bitcoin, including bitcoin’s volatility; risk of implementing a new treasury strategy; risk that insurance plans and other customers will not continue to license its cardiovascular testing products; risk of changes in the reimbursement landscape for its customers including related to the CMS rate announcement; risk of obtaining a new 510(k) clearance for expanded indications; along with those other risk factors detailed in Semler Scientific’s filings with the Securities and Exchange Commission. These forward-looking statements involve assumptions, estimates, and uncertainties that reflect current internal projections, expectations or beliefs. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward-looking statements contained in this press release are qualified in their entirety by these cautionary statements and the risk factors described above. Furthermore, all such statements are made as of the date of this release and Semler Scientific assumes no obligation to update or revise these statements unless otherwise required by law.
INVESTOR CONTACT:
Renae CormierChief Financial Officer[email protected]
SOURCE Semler Scientific, Inc.
Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.
— Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular risk in statin-treated adult patients with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and other high-risk characteristics as studied in REDUCE-IT1 — — Approval marks seventh national reimbursement of VAZKEPA® in Europe — — Vianex S.A., one of the leading pharmaceutical companies in Greece, will commercialize VAZKEPA® as Amarin’s exclusive distributor in the country — DUBLIN, Ireland and BRIDGEWATER, N.J., May 28, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announces that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1. As in most European countries, cardiovascular diseases are the main cause of death in Greece2. Today’s approval – which marks the seventh national reimbursement of VAZKEPA® in Europe – provides eligible patients across Greece access to a new treatment option to reduce their cardiovascular risk and help improve their overall heart health. “We are very pleased with this seventh national reimbursement for VAZKEPA® supporting our continued growth opportunity in Europe which is a testament to the strength of our scientific data and the value of our product for patients at-risk for a cardiovascular event,” said Patrick Holt, President & CEO of Amarin. To support the commercialization of VAZKEPA® in Greece, Amarin has entered into an exclusive agreement with Vianex S.A., one of the leading pharmaceutical companies in Greece celebrating its 100-year anniversary this year. Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a transfer price paid to Amarin. Vianex will start commercializing VAZKEPA® in the course of the next weeks. Christos Papadopoulos, Senior Vice President and Head of Commercial Europe at Amarin, commented: “We look forward to working with Vianex in bringing our VAZKEPA® treatment to healthcare providers and patients across Greece. As one of the country’s leading pharmaceutical companies, Vianex has strong commercial capabilities and deep expertise in cardiology and cardiovascular risk management. Their capabilities and experience align well with the opportunity to successfully commercialize VAZKEPA® and its proven ability to reduce cardiovascular risk and improve outcomes for patients.” About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. About VIANEX S.A. VIANEX S.A. is a Greek pharmaceutical company, founded in 1971 by the Giannakopoulos’ family that has been involved with the pharmaceutical industry since 1924. Through its 100-year history, VIANEX produces, imports, markets, packages and distributes a large number of pharmaceuticals, covering various therapeutic classes. It has formed strategic partnerships and alliances with major pharmaceutical entities across the globe. VIANEX owns four state-of-the-art fully specialized Manufacturing Plants that guarantee outstanding production capabilities. It covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services by investing in technological equipment. VIANEX has also been exporting registered products for over 20 years in 114 countries worldwide and is an approved supplier of the World Health Organization. Strategic planning, focus to quality, operational excellence and long-term experience have contributed to a leading position in the Greek Pharmaceutical market, based on a long-term effort, that passes from generation to generation and constantly focuses to the future. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (https://amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com 1 https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/12338-entaksh-farmakwn-ston-katalogo-apozhmioymenwn-farmakwn?fdl=270532 European Commission – Greece Country Health Profile 2023 – access May 2024
Nanox Announces First Quarter of 2024 Financial Results and Provides Business Update
Accelerates Deployment of Nanox.ARC in United States Signed two commercial agreements for Nanox.AI Management to host conference call and webcast Tuesday, May 28, 2024 at 8:30 AM ET PETAH TIKVA, Israel, May 28, 2024 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2024 and provided a business update. First Quarter 2024 Highlights and Recent Developments: Generated $2.6 million in revenue in the first quarter of 2024, compared to $2.4 million in the first quarter of 2023.In the first quarter of 2024, we have continued to make strides in our U.S operational performance.Secured agreements for Nanox.AI with Dandelion Health and Covera Health.Hosted a live demonstration of the Nanox.ARC, scanning a patient at Dynamic Medical Imaging in New Jersey in early April, which showcased the clinical utility of the Nanox.ARC in real time.Entered into an agreement with US-based Swissray, a leading provider of radiology services, to further strengthen Nanox’s customer support infrastructure.Continued to generate clinical data supporting the use of Nanox.ARC for chest and other musculoskeletal indications. “The entire Nanox team performed at a high level in the first quarter of 2024, marking positive strides commercializing the full Nanox technology suite worldwide, while also strengthening our customer support network and building the clinical data to support the use of the Nanox.ARC for an expanded array of musculoskeletal indications,” said Erez Meltzer, Nanox Chief Executive Officer. “We have also strengthened the crucial Nanox.AI product suite, receiving a new FDA clearance for Health FLD in February, and securing agreements with leading healthcare AI data platforms Dandelion Health and Covera. Alongside our commercial efforts in the US, we are also advancing in other geographies. The entire Nanox team is focused on acceleration into the rest of 2024.” Financial results for three months ended March 31, 2024 For the three months ended March 31, 2024 (the “reported period”), the Company reported a net loss of $12.2 million, compared to a net loss of $11.8 million for the three months ended March 31, 2023 (which is referred as the “comparable period”), representing an increase of $0.4 million. The increase was largely due to onetime income that was recorded in the comparable period due to a decrease in the Company’s earn-out liabilities in the amount of $4.7 million and an increase in gross loss in the amount of $0.5 million, which was offset by a decrease of $1.1 million in the research and development expenses, a decrease of $0.4 million in the sales and marketing expenses, a decrease of $2.8 million in the general and administrative expenses and increase of $0.4 in the Company’s financial income. The Company reported revenue of $2.6 million in the reported period, compared to $2.4 million in the comparable period. During the reported period, the Company generated revenue through teleradiology services, the sales and deployment of its imaging systems and the sale of its AI solutions. The Company’s gross loss during the reported period totaled $2.1 million (gross loss margin of (81%)) on a GAAP basis, as compared to $1.5 million (gross loss margin of (62%)) in the comparable period. Non-GAAP gross profit for the reported period was $0.6 million (gross profit margin of approximately 22%), as compared to $1.0 million (gross profit margin of approximately 43%) in the comparable period. The Company’s revenue from teleradiology services for the reported period was $2.4 million in the reported and comparable periods. The Company’s GAAP gross profit from teleradiology services for the reported period was $0.3 million (gross profit margin of approximately 14%), as compared to $0.5 million (gross profit margin of approximately 21%) in the comparable period. Non-GAAP gross profit of the Company’s teleradiology services for the reported period was $0.9 million (gross profit margin of approximately 37%) as compared to $1.1 million (gross profit margin of approximately 45%) in the comparable period. The decrease was attributable mainly to an increase in the cost of the engaged radiologists due to increases in reading rates. During the reported period the Company generated revenue through the sales and deployment of its imaging systems which amounted to $48 thousand for the reported period, with a gross loss of 0.4 million on a GAAP and non-GAAP basis. The revenue stems from the sale and deployment of our 2D systems in Africa and our ARC systems in the U.S. The Company’s revenue from its AI solutions for the reported period was $97 thousand with a gross loss of $2.0 million on a GAAP basis, as compared to revenue of $49 thousand with a gross loss of $2.0 million in the comparable period. Non-GAAP gross profit of the Company’s AI solutions for the reported period was $29 thousand, as compared to a loss of $20 thousand in the comparable period. During the reported period, Nanox AI continued to complete pilot programs with health organizations and other prospects in anticipation of full deployment of its products. Research and development expenses net for the reported period were $5.2 million, as compared to $6.3 million in the comparable period, reflecting a decrease of $1.1 million. The decrease was mainly due to a research grant of $0.9 million that was received as part of the NHSX project, decrease of $0.2 million in salaries and wages, decrease of $0.2 million in share-based compensation which was offset by an increase of $0.3 million in the expenses related to our research and development activities. Sales and marketing expenses for the reported period were $0.8 million, as compared to $1.2 million in the comparable period, reflecting a decrease of $0.4 million in the Company’s marketing expenses. General and administrative expenses for the reported period were $5.0 million, as compared to $7.8 million in the comparable period. The decrease of $2.8 million was mainly due to a decrease in our legal expenses in the amount of $2.2 million, largely as result of the finalization of the SEC investigation and the settlement of the class action and a decrease in the cost of the directors’ and officers’ liability insurance premium in the amount of $0.4 million. Non-GAAP net loss attributable to ordinary shares for the reported period was $8.1 million, as compared to $10.5 million in the comparable period. The decrease of $2.4 million was mainly due to a decrease in non-GAAP operating expenses of $2.4 million and an increase of $0.4 million in our non-GAAP interest income which was mitigated by a decrease of $0.6 million in our non-GAAP cost of goods sold. Non-GAAP gross profit for the reported period was $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP research and development expenses, net for the reported period, were $4.6 million, as compared to $5.5 million in the comparable period. Non-GAAP sales and marketing expenses for the reported period were $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP general and administrative expenses for the reported period were $4.3 million as compared to $5.4 million in the comparable period. The difference between the GAAP and non-GAAP financial measures above is mainly attributable to amortization of intangible assets, share-based compensation, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. A reconciliation between GAAP and non-GAAP financial measures for the three months periods ended March 31, 2024, and 2023 is provided in the financial results that are part of this press release. Liquidity and Capital Resources As of March 31, 2024, the Company had total cash, cash equivalents, restricted deposits and marketable securities of $73.3 million, compared to $82.8 million as of December 31, 2023. The decrease of $9.5 million during the reported period was primarily due to negative cash flow from operations of $9.4 million. Other Assets As of March 31, 2024 and December 31, 2023, the Company had property and equipment of $42.3 million. As of March 31, 2024, the Company had intangible assets of $78.0 million as compared to $80.6 million as of December 31, 2023. The decrease was attributable to the periodic amortization of intangible assets in the amount of $2.6 million. Shareholders’ Equity As of March 31, 2024, and December 31, 2023, the Company had approximately 57.8 million shares outstanding. Conference Call and Webcast Details Tuesday, May 28, 2024 @ 8:30am ET Individuals interested in listening to the conference call may do so by joining the live webcast on the Investors section of the Nanox website under Events and Presentations. Alternatively, individuals can register online to receive a dial-in number and personalized PIN to participate in the call. An archived webcast of the event will be available for replay following the event. About Nanox: Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Forward-Looking Statements: This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, those relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to continue to develop of the Nanox imaging system; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox imaging system and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; and (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces, including the continuation and escalation of the military conflicts in Israel and current war between Israel and Hamas; (x) the costs incurred with respect to and the outcome of litigation Nanox is currently subject to and any similar or other claims and potential litigation it may be subject to in the future; and (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with class-action litigation and the SEC investigation. The Company’s management and board of directors utilize these non-GAAP financial measures to evaluate the Company’s performance. The Company provides these non-GAAP measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, these non-GAAP measures should not be considered measures of the Company’s liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release. NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands except share and per share data) March 31,2024 December 31, 2023 U.S. Dollars in thousands Assets CURRENT ASSETS: Cash and cash equivalents 44,921 56,377 Restricted deposit 46 46 Marketable securities 28,043 26,006 Accounts receivables net of allowance for credit losses of $55 as of March 31, 2024 and December 31, 2023, respectively. 1,442 1,484 Inventories 2,952 2,356 Prepaid expenses 1,004 1,274 Other current assets 625 1,092 TOTAL CURRENT ASSETS 79,033 88,635 NON-CURRENT ASSETS: Restricted deposit 323 327 Property and equipment, net 42,328 42,343 Operating lease right-of-use asset 4,370 4,573 Intangible assets 77,954 80,607 Other non-current assets 1,869 2,163 TOTAL NON-CURRENT ASSETS 126,844 130,013 TOTAL ASSETS 205,877 218,648 Liabilities and Shareholders’ Equity CURRENT LIABILITIES: Current maturities of long term loan 3,341 3,490 Accounts payable 1,860 3,303 Accrued expenses 3,267 3,920 Deferred revenue 496 543 Current maturities of operating lease liabilities 883 861 Other current liabilities 3,762 3,407 TOTAL CURRENT LIABILITIES 13,609 15,524 NON-CURRENT LIABILITIES: Non-current operating lease liabilities 3,819 4,045 Deferred tax liability 2,859 2,953 Other long-term liabilities 629 612 TOTAL NON-CURRENT LIABILITIES 7,307 7,610 TOTAL LIABILITIES 20,916 23,134 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS’ EQUITY: Ordinary Shares, par value NIS 0.01 per share 100,000,000 authorized at March 31, 2024 and December 31 2023, 57,779,033 and 57,778,628 issued and outstanding at March 31, 2024 and December 31, 2023, respectively 165 165 Additional paid-in capital 517,388 515,887 Accumulated other comprehensive loss (118) (305)Accumulated deficit (332,474) (320,233)TOTAL SHAREHOLDERS’ EQUITY 184,961 195,514 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 205,877 218,648 NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ANDCOMPREHENSIVE LOSS(U.S. dollars in thousands except share and per share data) Three Months EndedMarch 31, 2024 2023 REVENUE 2,553 2,447 COST OF REVENUE 4,607 3,970 GROSS LOSS (2,054) (1,523) OPERATING EXPENSES: Research and development, net 5,220 6,286 Sales and marketing 800 1,153 General and administrative 5,042 7,808 Change in contingent earnout liability – (4,660)Other expense (income), net 9 (32)TOTAL OPERATING EXPENSES 11,071 10,555 OPERATING LOSS (13,125) (12,078) REALIZED LOSS FROM SALE OF MARKETABLE SECURITIES – (178)FINANCIAL INCOME, net 790 401 OPERATING LOSS BEFORE INCOME TAXES (12,335) (11,855) INCOME TAX BENEFIT 94 94 NET LOSS (12,241) (11,761) BASIC AND DILUTED LOSS PER SHARE (0.21) (0.21)Weighted average number of basic and diluted ordinary shares outstanding (in thousands) 57,901 55,157 Comprehensive Loss: Net loss (12,241) (11,761)Other comprehensive gain (loss): Reclassification of net losses realized in income statement – 178 Unrealized gain from available for-sale securities 187 414 Total comprehensive loss (12,054) (11,169) NANO-X IMAGING LTD.UNAUDITED CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY(U.S. dollars in thousands, except share and per share data) Ordinary shares Additional Accumulatedother Number ofshares Amount paid-incapital comprehensiveloss Accumulateddeficit Total BALANCE AT JANUARY 1, 2024 57,778,628 165 515,887 (305) (320,233) 195,514 Changes during the period: Issuance of ordinary shares upon exercise of options 405 * 24 – – 24 Share-based compensation – – 1,477 – – 1,477 Unrealized gain from marketable securities – – – 187 187 Net loss for the period – – – – (12,241) (12,241)BALANCE AT MARCH 31, 2024 57,779,033 165 517,388 (118) (332,474) 184,961 * Less than $1. Ordinary shares Additional Accumulatedother Number ofshares Amount paid-incapital comprehensivedeficit Accumulateddeficit Total U.S. Dollars in thousands BALANCE AT JANUARY 1, 2023 55,094,237 158 477,953 (1,974) (259,457) 216,680 Changes during the period: Issuance of ordinary shares upon exercise of options 56,108 – 176 – – 176 Unrealized gain from marketable securities, net – – – 592 592 Share-based compensation – – 1,043 – – 1,043 Net loss for the period – – – – (11,761) (11,761)BALANCE AT MARCH 31, 2023 55,150,345 158 479,172 (1,382) (271,218) 206,730 * Less than $1. NANO-X IMAGING LTD. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in thousands) Three Months EndedMarch 31, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss for the period (12,241) (11,761)Adjustments required to reconcile net loss to net cash used in operating activities: Share-based compensation 1,477 1,043 Amortization of intangible assets 2,653 2,653 Exchange rate differentials (174) (19)Change in contingent earnout liability – (4,660)Depreciation 286 255 Deferred tax liability, net (94) (94)Realized loss from sale of marketable securities – 178 Amortization of premium, discount and accrued interest on marketable securities 73 324 Impairment of property and equipment 25 145 Changes in Operating Assets and Liabilities: Inventories (676) – Accounts receivable 42 (331)Prepaid expenses and other current assets 737 1,404 Other non-current assets 219 142 Accounts payable (1,443) 706 Operating lease assets and liabilities (1) (7)Accrued expenses and other liabilities (298) (559)Deferred Revenue (47) (107)Other long-term liabilities 17 14 Net cash used in operating activities (9,445) (10,674) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment (141) (1,495)Proceeds from maturity of marketable securities 12,874 10,289 Purchase of marketable securities (14,797) – Proceeds from sale of marketable securities – 822 Net cash provided by (used in) investing activities (2,064) 9,616 CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from Issuance of ordinary shares upon exercise of options 24 176 Net cash provided by financing activities 24 176 EFFECT OF CHANGES IN EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS 29 (11)NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS (11,456) (893)CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT BEGINNING OF THE PERIOD 56,377 38,529 CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT END OF THE PERIOD 44,921 37,636 SUPPLEMENTARY INFORMATION ON ACTIVITIES INVOLVING CASH FLOWS Cash paid for interest 37 40 Cash paid for income taxes – – SUPPLEMENTARY INFORMATION ON ACTIVITIES NOT INVOLVING CASH FLOWS – Operating lease liabilities arising from obtaining operating right-of use assets – 572 UNAUDITED RECONCILIATION OF GAAP AND NON-GAAP RESULTS(U.S. dollars in thousands (except per share data)) Use of non-GAAP Financial Measures The unaudited condensed consolidated financial information is prepared in conformity with GAAP. The Company uses information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. The Company believes that separate analysis and exclusion of the one-off or non-cash impact of the above reconciling items (as applicable) adds clarity to the constituent parts of its performance. The Company reviews these non-GAAP financial measures together with GAAP financial measures to obtain a better understanding of its operating performance. It uses the non-GAAP financial measures for planning, forecasting, and measuring results against the forecast. The Company believes that the non-GAAP financial measures are useful supplemental information for investors and analysts to assess its operating performance. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Reconciliation of GAAP net loss attributable to ordinary shares to Non-GAAP net loss attributable to ordinary shares and Non-GAAP basic and diluted loss per share (U.S. dollars in thousands) Three Months Ended March 31, 2024 2023 GAAP net loss attributable to ordinary shares 12,241 11,761 Non-GAAP adjustments: Less: Class-action litigation and SEC investigation 32 2,236 Less: Amortization of intangible assets 2,653 2,653 Less (Add): Change in contingent earnout liability – (4,660)Less: Share-based compensation 1,477 1,043 Non-GAAP net loss attributable to ordinary shares 8,079 10,489 Non-GAAP BASIC AND DILUTED LOSS PER SHARE 0.14 0.19 WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands) 57,901 55,157 Reconciliation of GAAP cost of revenue to Non-GAAP cost of revenue (U.S. dollars in thousands) GAAP cost of revenue 4,607 3,970 Non-GAAP adjustments: Amortization of intangible assets 2,556 2,556 Share-based compensation 53 14 Non-GAAP cost of revenue 1,998 1,400 Reconciliation of GAAP gross loss to Non-GAAP gross profit (U.S. dollars in thousands) GAAP gross loss (2,054) (1,523)Non-GAAP adjustments: Amortization of intangible assets 2,556 2,556 Share-based compensation 53 14 Non-GAAP gross profit 555 1,047 Reconciliation of GAAP gross loss margin to Non-GAAP gross profit margin (in percentage of revenue) GAAP gross loss margin (80)% (62)%Non-GAAP adjustments: Amortization of intangible assets 100% 104%Share-based compensation 2% 1%Non-GAAP gross profit margin 22% 43% Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses (U.S. dollars in thousands) GAAP research and development expenses, net 5,220 6,286 Non-GAAP adjustments: Share-based compensation 589 788 Non-GAAP research and development expenses, net 4,631 5,498 Reconciliation of GAAP sales and marketing expenses to Non-GAAP sales and marketing expenses (U.S. dollars in thousands) GAAP sales and marketing expenses 800 1,153 Non-GAAP adjustments: Amortization of intangible assets 97 97 Share-based compensation 146 78 Non-GAAP sales and marketing expenses 557 978 Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses (U.S. dollars in thousands) GAAP general and administrative expenses 5,042 7,808 Non-GAAP adjustments: Class-action litigation and SEC investigation 32 2,236 Share-based compensation 689 163 Non-GAAP general and administrative expenses 4,321 5,409 Contacts Media Contact:Ben ShannonICR WestwickeNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Westwickemike.cavanaugh@westwicke.com
HoneyNaps secures a $11.6 million Series B investment, becoming the No. 1 ranked A.I Sleep Technology Company
HoneyNaps secures $11.6 million in series B funding, propelling its entry into the American medical market.BOSTON, May 24, 2024 /PRNewswire/ — HoneyNaps, an industry-leading South Korean company in artificial intelligence (AI) sleep data analysis, announced on the 7th that it has closed its series B round of funding, securing $11.6 million.The series B funding is a successful achievement, nearly three times the $3.9 million raised through series A funding back in 2021. With the listing contract signed with Korea Investment & Securities Co., Ltd. in March 2024, the company is poised to become the no. 1 listed company in Sleep Technology (Sleep-Tech) that features an AI bio signal model.
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HoneyNaps Solutions
In this round, many institutions participated as new investors such as Korea Industrial Bank, Hi investment Partners and QUAD Investment Management. Despite a freeze-up in venture investment, this series B round achieved an early close due to overbooking, driven by overwhelming participation from prestigious domestic and foreign investors.
Founded in July 2015, HoneyNaps has amassed about $16.2 million to date, starting with seed funding for about $0.7 million, secured through success-share-funding from the Ministry of SMEs and Startups in 2019. This funding marks the largest scale among recent financings secured by domestic Sleep-Tech companies.HoneyNaps obtained FDA approval for its AI sleep diagnosis software SOMNUM in 2023, establishing partnerships with major university hospitals across the U.S. through its Boston-based American branch. The domestic sales growth coupled with the perceived potential for export to the American medical market are cited as key drivers to the company’s success in funding.SOMNUM is an algorithm that analyzes bio signal data during sleep and provides disease diagnoses under five minutes using its self-developed AI model. This AI diagnosis software is integrable into any medical and healthcare market using real-time large-scale bio signal.In particular, the company invested nine years to develop X.AI (eXplainable AI), a crucial component for the medical field. They have also registered 16 original patents and published SCIE-Level thesis, enhancing the technical value provided to its clients.HoneyNaps’ CFO states, “This successful funding amidst a challenging investment climate has validated our position as Korea’s leading Sleep-Tech company”, adding, “These resources will enable us to achieve results in the domestic and American medical market and earn recognition. Beyond the SOMNUM’s current use in sleep disease diagnosis, we plan to further advance the AI to expand its application to other critical areas such as cardiovascular disease, dementia, and Parkinson’s disease”.For additional information, please contact:HoneyNaps USA, Inc.Christine Kwon / Managing DirectorEmail: [email protected]Address: 6 Liberty SQ PMB 6202, Boston, MA 02109Website: www.honeynaps.comSOURCE HoneyNaps
Inari Medical Files Patent Infringement Lawsuit Against Imperative Care and Truvic Medical
IRVINE, Calif., May 23, 2024 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced today that it had filed a patent infringement lawsuit against Imperative Care, Inc. and Truvic Medical, Inc. (collectively, “Truvic”). The suit was filed in the United States District Court for the Northern District of California. Inari is seeking injunctive relief and damages for infringement. Inari believes Truvic is infringing eight of Inari Medical’s patents for the use of aspiration-based thrombectomy devices to treat pulmonary emboli and deep vein thrombosis. Truvic products named in the suit include the Symphony Thrombectomy System. “Inari was founded to improve patients’ lives using purpose-built innovation. Our mission depends on these innovations, and we are deeply committed to protecting our intellectual property rights,” said Drew Hykes, CEO of Inari Medical. About Inari Medical, Inc.Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous and other diseases. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram. Investor Contact:John Hsu, CFAVP, Investor Relations949-658-3889IR@inarimedical.com



