News Category: Portfolio

Proceeds will support clinical development of lead pipeline candidates: ENV-101 for fibrotic lung diseases including idiopathic pulmonary fibrosis, and ENV-501, a next-generation HER3-targeted antibody-drug conjugate, for solid tumors

Oversubscribed crossover financing from large, top-tier life sciences investor syndicate led by AyurMaya, an affiliate of Matrix Capital Management

Karan Takhar, Senior Managing Director at Matrix, will join Endeavor BioMedicines’ Board of Directors

SAN DIEGO—(BUSINESS WIRE)—Endeavor BioMedicines, Inc. (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument. The oversubscribed round was led by AyurMaya, an affiliate of Matrix Capital Management, with participation from new investors including Fidelity Management & Research Company, Invus, SymBiosis, Velosity Capital, and Woodline Partners; and strong support from existing investors including funds managed by abrdn Inc. (formerly Tekla Capital Management LLC), Ally Bridge Group, Avidity Partners, Eckuity Capital, Longitude Capital, Omega Funds, Perceptive Advisors, Piper Heartland Healthcare Capital, Silver Arch Bio, and T. Rowe Price Associates.

Endeavor will use the financing proceeds to advance the clinical development of ENV-101, its lead candidate for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF); and to advance ENV-501, a human epidermal growth factor 3 (HER3) antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors through clinical proof-of-concept studies.

“We appreciate the support from this group of leading life sciences investors, who recognize the tremendous progress we’ve made since our initial funding rounds as well as the life-changing potential of our therapeutic candidates to reverse the trajectory of relentless diseases,” said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor. “Endeavor BioMedicines has the momentum, coupled with the right team and the necessary financing, to advance our mission of delivering transformational medicines to patients who need them.”

Advancing Potential Groundbreaking Medicine for Fibrotic Lung Diseases

Endeavor’s lead investigational candidate, ENV-101, has the potential to improve lung function and reverse the fibrotic process in the lungs of individuals with IPF and PPF. ENV-101 blocks a cellular wound-healing pathway known as Hedgehog (Hh) that is abnormally activated in IPF and PPF and causes the buildup of scar tissue in the lungs. Current standard-of-care therapies do not address the underlying cause of IPF or PPF. They minimally slow the decline of lung function, but do not stop or reverse it, and have tolerability issues that limit their long-term use in most patients.

Preliminary results from the recently completed randomized, double-blind, placebo-controlled Phase 2a clinical trial of ENV-101 (NCT04968574) underscore its potential to modify disease and offer treatment outcomes that go beyond slowing disease progression for patients with IPF. Results will be presented at the American Thoracic Society (ATS) International Conference in May. Endeavor plans to initiate a Phase 2b trial in patients with IPF and in parallel a cohort of patients with PPF in 2024.

Pursuing a Validated Therapeutic Target in Solid Tumors

Endeavor’s second investigational candidate, ENV-501, is a next-generation anti-HER3 ADC that has been engineered to minimize off-target toxicity and has a clear path for differentiation against other HER3 ADCs in development. The HER3 protein is a growth factor receptor related to clinically validated oncology targets. HER3 is overexpressed in many solid tumors and those cancers that are HER3-positive are associated with poor prognosis and resistance to certain types of therapies. ENV-501 incorporates chemical and genetic features designed to improve the delivery of the drug to tumors and thereby increase its potency and reduce the toxicities commonly associated with ADCs. Endeavor intends to initiate a Phase 1/2 trial of ENV-501 in 2024.

“Endeavor BioMedicines’ novel drug candidates have the potential to disrupt the underlying mechanisms that cause serious, life-threatening diseases,” said Karan Takhar, Senior Managing Director at Matrix, who will join Endeavor BioMedicines’ Board of Directors as part of the Series C financing. “I look forward to collaborating with Endeavor BioMedicines’ executive team and other members of the board to support the company’s clinical execution as it pursues significant milestones in 2024 and beyond.”

About Endeavor BioMedicines

Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead candidate, ENV-101, is an inhibitor of the Hedgehog (Hh) signaling pathway in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Their second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X.

Enhances Johnson & Johnson’s Ability to Transform the Treatment Landscape for Cardiovascular Disease and Continue to Improve Patient Outcomes

Extends Johnson & Johnson MedTech’s Position in Highest-Growth, Innovation-Oriented Segments of Cardiovascular Intervention

Accelerates Sales Growth and Accretive to Operating Margin for Both Johnson & Johnson and Johnson & Johnson MedTech

NEW BRUNSWICK, N.J. & SANTA CLARA, Calif.–(BUSINESS WIRE)–Apr. 5, 2024– Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired. The transaction was approved by both companies’ boards of directors.

The acquisition of Shockwave further extends Johnson & Johnson MedTech’s position in cardiovascular intervention and accelerates its shift into higher-growth markets. Cardiovascular intervention is one of the fastest-growing global medtech markets, with significant unmet patient need. With the addition of Shockwave, Johnson & Johnson will expand its MedTech cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease (CAD) and peripheral artery disease (PAD). The transaction follows Johnson & Johnson MedTech’s successful acquisitions of Abiomed, a leader in heart recovery, and more recently Laminar, an innovator in left atrial appendage elimination for patients with non-valvular atrial fibrillation (AFib). These acquisitions complement and build on Johnson & Johnson’s established global leadership position in electrophysiology through the Biosense Webster portfolio. Following the close of the transaction, Johnson & Johnson MedTech will be a category leader in four high-growth cardiovascular segments.

Shockwave is a leading, first-to-market provider of innovative intravascular lithotripsy (IVL) technology for the treatment of calcified CAD and PAD. IVL is a minimally invasive, catheter-based treatment for calcified arterial lesions, which can reduce blood flow and cause pain or heart attack. IVL helps restore blood flow by cracking calcium lesions using sonic pressure waves and is used in both CAD and PAD, often in combination with stenting. Shockwave offers the only commercially available IVL technology and has safely, simply, and effectively treated approximately 400,000 patients globally. In addition to its leading IVL platform, Shockwave also recently acquired Neovasc Inc., a company that has developed the Reducer System, a novel product focused on symptom relief of refractory angina. The Reducer System has a growing commercial presence. It is currently undergoing clinical studies in the U.S. and is CE marked in the European Union and the United Kingdom.

Joaquin Duato, Chairman and Chief Executive Officer of Johnson & Johnson, said, “With our focus on Innovative Medicine and MedTech, Johnson & Johnson has a long history of tackling cardiovascular disease – the leading cause of death globally. The acquisition of Shockwave and its leading IVL technology provides a unique opportunity to accelerate our impact in cardiovascular intervention and drive greater value for patients, shareholders and health systems.”

Tim Schmid, Executive Vice President and Worldwide Chairman of Johnson & Johnson MedTech, said, “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, and ultimately transform the future of cardiovascular treatment. Shockwave’s IVL technology for treating CAD and PAD, and its strong pipeline, are in a class of their own. We look forward to bringing Shockwave’s solutions into Johnson & Johnson MedTech and the hands of more physicians around the world.”

“Shockwave has transformed the treatment of complex calcified arterial disease through the pioneering development of intravascular lithotripsy, and it is our mission to make this remarkable technology available to patients worldwide,” said Doug Godshall, President and CEO of Shockwave. “As part of a larger, more diverse organization, with broad expertise and a core focus on improving patient outcomes, we are confident we will be able to further solidify IVL as the global standard of care for patients. I am deeply grateful to our team members and colleagues whose efforts have made today’s milestone possible; their accomplishments and passion have been extraordinary. I could not think of a better partner and home than Johnson & Johnson as the Shockwave team prepares to write its next exciting chapter.”

Transaction Benefits

• Solidifies Johnson & Johnson MedTech’s leadership in cardiovascular intervention: IVL is the only technology that can treat both intimal and medial calcification, and Shockwave offers the first and only commercially available IVL platform for CAD and PAD. This acquisition will complement Johnson & Johnson MedTech’s leadership positions in heart recovery (Abiomed) and electrophysiology (Biosense Webster) to make it a category leader in four of the largest and highest-growth medtech markets within cardiovascular intervention.
• Enhances opportunity to serve patients worldwide through complementary fit with Johnson & Johnson: Shockwave’s IVL and Abiomed’s Impella^® heart pump platform play a critical role in complex percutaneous coronary intervention (PCI) procedures. Specifically, IVL is used in approximately 30% of high-risk PCI cases that also use Impella^® today. This clinical compatibility, combined with Johnson & Johnson MedTech’s established global commercial infrastructure, provides numerous opportunities to accelerate the adoption of these segment-leading technologies to patients in need.
• Provides robust pipeline for future growth in underpenetrated markets: Shockwave benefits from a strong pipeline focused on continued innovation and expansion of its product portfolio in CAD and PAD, and the potential use of IVL in new indications, including carotid artery disease and structural heart disease, over the coming years. Shockwave is also evaluating its Reducer System technology in clinical studies to treat patients with refractory angina.
• Accelerates sales growth: The acquisition of Shockwave accelerates Johnson & Johnson MedTech’s ongoing efforts to increase its presence in high-growth markets with unmet need, while expanding its reach and scale globally. The proposed transaction adds a high-performing business in an underpenetrated category with a strong pipeline and an attractive growth and margin profile. The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech. Shockwave is ultimately expected to become Johnson & Johnson MedTech’s thirteenth priority platform, as defined by annual sales of at least $1 billion.
• Delivers immediate operational accretion: The transaction will be accretive to operating margin for both Johnson & Johnson and Johnson & Johnson MedTech. Johnson & Johnson expects the transaction to be operationally accretive upon closing, but considering the impact of financing costs, is expected to dilute adjusted earnings per share by approximately $0.10 in 2024 and approximately $0.17 in 2025.

Transaction Details and Path to Completion

Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash through a merger of Shockwave with a wholly owned Johnson & Johnson subsidiary. Johnson & Johnson expects to fund the transaction through a combination of cash on hand and debt.

Johnson & Johnson expects to maintain a strong balance sheet and to continue to support its stated capital allocation priorities of R&D investment, competitive dividends, value-creating acquisitions and strategic share repurchases.

Following the completion of the transaction, Shockwave will operate as a business unit within Johnson & Johnson MedTech, and financials will be reported within Johnson & Johnson MedTech’s Cardiovascular portfolio, which was previously referred to as Interventional Solutions. In addition to his current responsibilities for Abiomed as the Global Head of Heart Recovery, Michael Bodner will assume responsibility for the business upon close. Isaac Zacharias, who has 6 years with Shockwave, most recently serving as President and Chief Commercial Officer, will transition to become Worldwide President of Shockwave, reporting to Michael Bodner. Doug Godshall, Shockwave’s President and Chief Executive Officer, will advise through the transition.

The closing of the transaction is expected to occur by mid-year 2024 subject to the receipt of Shockwave’s shareholder approval, as well as the receipt of applicable regulatory approvals and other customary closing conditions. Following completion of the transaction, Shockwave’s common stock will no longer be listed for trading on the Nasdaq Global Select Market.

Advisors

J.P. Morgan Securities LLC is serving as financial advisor to Johnson & Johnson and Freshfields Bruckhaus Deringer LLP is serving as legal advisor.

Perella Weinberg Partners is serving as financial advisor to Shockwave and Fenwick & West LLP is serving as legal advisor.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

About Shockwave Medical, Inc.

Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave has also recently acquired the Reducer, which is under clinical investigation in the United States and is CE Marked in Europe. By redistributing blood flow within the heart, the Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at www.shockwavemedical.com.

Additional Information and Where to Find It

This communication may be deemed to be solicitation material in respect of the proposed acquisition of Shockwave Medical by Johnson & Johnson.

In connection with the proposed transaction, Shockwave intends to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including Shockwave’s proxy statement in preliminary and definitive form. Promptly after filing the definitive proxy statement, Shockwave will mail the definitive proxy statement and a proxy card to the security holders of Shockwave.

INVESTORS AND SECURITY HOLDERS OF SHOCKWAVE ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING SHOCKWAVE’S PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.

Investors and security holders of Shockwave are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at www.sec.gov or free of charge from Shockwave on Shockwave’s website at www.ir.shockwavemedical.com/.

Participants in the Solicitation

Johnson & Johnson and Shockwave and certain of their respective directors and executive officers, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from security holders of Shockwave in connection with the proposed transaction. Information about Johnson & Johnson’s directors and executive officers is set forth in Johnson & Johnson’s Proxy Statement on Schedule 14A for its 2024 Annual Meeting of Shareholders, which was filed with the SEC on March 13, 2024, and Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on February 16, 2024. Information about Shockwave’s directors and executive officers is set forth in Shockwave’s Proxy Statement on Schedule 14A for its 2023 Annual Meeting of Stockholders, which was filed with the SEC on April 21, 2023, and Shockwave’s Current Report on Form 8-K filed with the SEC on January 29, 2024. To the extent holdings of Johnson & Johnson’s or Shockwave’s securities by their respective directors or executive officers have changed since the amounts set forth in such 2024 or 2023 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. Investors and security holders of Shockwave are or will be able to obtain these documents free of charge from the SEC’s website at www.sec.gov, from Johnson & Johnson on Johnson & Johnson’s website at www.jnj.com, from Shockwave on Shockwave’s website at www.shockwavemedical.com/ or on request from Johnson & Johnson or Shockwave. Additional information concerning the interests of Shockwave’s participants in the solicitation, which may, in some cases, be different than those of Shockwave’s security holders generally, will be set forth in Shockwave’s proxy statement relating to the proposed transaction when it becomes available.

Cautions Concerning Forward-Looking Statements

• This communication contains “forward-looking statements” regarding the acquisition of Shockwave by Johnson & Johnson.
• The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.
• If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson or Shockwave. Risks and uncertainties include, but are not limited to: the risk that the closing conditions for the acquisition will not be satisfied, including the risk that clearance under the Hart-Scott-Rodino Antitrust Improvements Act or other applicable antitrust laws will not be obtained; uncertainty as to the percentage of Shockwave security holders that will vote to approve the proposed transaction at the Shockwave stockholder meeting; the possibility that the transaction will not be completed in the expected timeframe or at all; potential adverse effects to the businesses of Johnson & Johnson or Shockwave during the pendency of the transaction, such as employee departures or distraction of management from business operations; the risk of security holder litigation relating to the transaction, including resulting expense or delay; the potential that the expected benefits and opportunities of the acquisition, if completed, may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment.
• In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the programs, products, technologies and employees/operations and clinical work of Shockwave. A further list and description of these risks, uncertainties and other factors and the general risks associated with the respective businesses of Johnson & Johnson and Shockwave can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 16, 2024, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in Johnson & Johnson’s most recently filed Quarterly Report on Form 10-Q, in Johnson & Johnson’s subsequent filings with the SEC and in Shockwave’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 26, 2024, including in the sections captioned “Special Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Shockwave’s subsequent filings with the SEC. Copies of these filings, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com, www.shockwavemedical.com/ or on request from Johnson & Johnson or Shockwave. Neither Johnson & Johnson nor Shockwave undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law.

Financing led by Foresite Capital, Samsara BioCapital and venBio Partners with participation from additional new and existing investors

Proceeds will support ongoing comprehensive mid to late-stage clinical development program for ESK-001 in plaque psoriasis, systemic lupus erythematosus (SLE) and uveitis

Alumis will continue to explore ESK-001’s potential application in other immune-mediated diseases, as well as advance pipeline programs including A-005 for the treatment of neuroinflammatory and neurodegenerative diseases

SOUTH SAN FRANCISCO, Calif., March 6, 2024 – Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced an upsized $259M Series C financing. Alumis plans to use the proceeds of the financing to initiate pivotal Phase 3 clinical trials for its lead candidate ESK-001, a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate to severe plaque psoriasis in the second half of 2024, as well as support the two ongoing Phase 2 clinical trials for ESK-001 in systemic lupus erythematosus (SLE), and non-infectious uveitis. The financing will also support the further advancement of Alumis’ precision data analytics and multi-platform approach to explore ESK-001’s potential application in other autoimmune indications, as well as A-005, a TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases, and its earlier-stage internal pipeline programs.

The financing was co-led by existing investor, Foresite Capital, and new investors, Samsara BioCapital and venBio Partners, with additional participation from new investors Cormorant Asset Management, SR One, Lilly Asia Ventures, Nextech, Ally Bridge Group, HBM Healthcare Investments, Omega Funds, Piper Heartland Healthcare and existing investors AyurMaya, an affiliate of Matrix Capital Management and a U.S.-based healthcare-focused fund. Srinivas Akkaraju, M.D., Ph.D., Founder and Managing General Partner of Samsara BioCapital, and Richard Gaster, M.D., Ph.D., Managing Partner at venBio Partners, will join Alumis’ Board of Directors.

“We are pleased to announce our successful Series C financing and we are grateful for the support of our strong investor syndicate, a group that shares our commitment to transforming the treatment paradigm for patients living with immune-mediated diseases,” said Martin Babler, Alumis’ President and Chief Executive Officer. “This investment will support the continued clinical development of ESK-001, building on promising data that have demonstrated full, sustained target inhibition leading to a potentially best-in-class oral TYK2 inhibitor profile. It will also support continued advancement of additional pipeline programs powered by our proprietary precision immunology platform for target discovery and clinical development.”

“Led by a team with a proven track record in immunology and with whom we have successfully partnered previously, Alumis has advanced a strong immunology pipeline, including two oral allosteric TYK2 inhibitors, fueled by an innovative platform,” said Srinivas Akkaraju, M.D., Ph.D., Founder and Managing General Partner of Samsara BioCapital. “We are proud to invest in and work with this team again to support their continued growth and success as they explore both the full potential of their lead program, ESK-001, in immune-mediated diseases and the broad opportunity where the TYK2 pathway plays a key role.”

“There is a significant unmet need in immunology for oral therapies that can provide improved efficacy and safety,” said Richard Gaster, M.D., Ph.D., Managing Partner at venBio Partners. “Alumis’ precision approach in this field – focused on the application of data science and translational insights to validated targets that drive immune dysfunction – will ultimately lead to better outcomes for patients, and we look forward to supporting the team as they work to realize that goal.”

Jim Tananbaum, founder and CEO of Foresite Capital, added, “The partnership with Foresite Labs, which incubated Alumis, and its robust genetics and data analytics platform combined with Alumis’ expertise in the discovery and development of therapies for immune-mediated diseases has demonstrated powerful synergy. We are now starting to see how this will translate into outcomes for patients. We are proud of the company’s progress and happy to continue to support and work with the Alumis team and Board of Directors in this next stage of the company’s growth.”

About ESK-001

ESK-001 is a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor. The clinical program for ESK-001 includes the Phase 2 STRIDE trial and an open-label extension (OLE) study for the treatment of patients with moderate to severe plaque psoriasis, a Phase 2b clinical trial of ESK-001 for the treatment of patients with systemic lupus erythematosus (LUMUS), and a proof-of-concept Phase 2 clinical trial in non-infectious uveitis (OPTYK-1). In addition, Alumis continues to leverage its precision data analytics and a multi-platform approach to explore ESK-001’s potential application in other autoimmune indications.

About Alumis

Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize outcomes and transform the lives of patients with immune-mediated diseases. Leveraging its precision data analytics and a multi-platform approach, Alumis is advancing a pipeline of oral therapies designed to address immune dysfunction. Alumis’ lead candidate ESK-001 is a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor that is currently being evaluated for the treatment of patients with moderate to severe plaque psoriasis, systemic lupus erythematosus (SLE), and non-infectious uveitis. Alumis is also developing A-005, a potential first-in-class brain-penetrant allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases that is anticipated to enter a Phase 1 clinical trial in the first half of 2024. Alumis also has discovery efforts in undisclosed immune-mediated diseases and targets identified by its data analytics platform. Incubated by Foresite Labs and led by a team of experts with deep experience and proven track records in drug discovery, development and immunology, Alumis is developing transformative therapies that aim to reimagine the lives of people with immune-mediated diseases. For more information, please visit alumis.com.

About Foresite Capital

Foresite Capital is a multi-stage healthcare and life sciences investment firm with approximately $3.5 billion in assets under management. The firm aims to address areas of great unmet need by funding promising healthcare and life sciences businesses at all stages of their life cycles. Foresite Capital uses a data science-driven approach to invest in companies that leverage biology and big data to transform healthcare, as well as companies developing next generation therapeutics. Founded in 2011, Foresite Capital is based in the San Francisco Bay Area, Los Angeles and New York City. For more information, please visit www.foresitecapital.com.

About Samsara BioCapital

Samsara BioCapital is a new breed of biotech investment firm focused on translating cutting-edge biology into new therapies to treat patients with unmet medical needs. Founded in 2016 by Srinivas Akkaraju, M.D., Ph.D., our team of scientists, investors and entrepreneurs takes a long-term view on value creation across all stages of public and private life science companies. We believe in a collaborative, hands-on approach, working closely with entrepreneurs to harness exciting scientific advances and build leading companies. Samsara actively manages assets on behalf of endowments, foundations and family offices. For more information, please visit www.samsaracap.com.

About venBio Partners

venBio Partners is a life sciences investment firm that partners with industry leaders to build and invest in innovative medicines and technologies, with a focus on novel therapeutics for unmet medical needs. For more information, please visit www.venbio.com.

Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8^® Restorative Neuromodulation™ System

DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8^® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.

The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors.

“A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical. “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”

“We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare, who also joins the Mainstay Medical Board of Directors. “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising.”

Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

About ReActiv8^®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Mainstay Forward-Looking Statements

All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s funding needs, strategies, alternatives and transactions, ability to fund its objectives moving forward, commercial efforts and performance, research studies and results, financial position, product design and development, intellectual property portfolio and its scope, regulatory applications and approvals, and reimbursement arrangements.

Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.

Proceeds to support development of ProfoundBio’s differentiated clinical-stage ADC pipeline, including the planned pivotal trial of rinatabart sesutecan (Rina-S)

Financing led by Ally Bridge Group, bolstered by contributions from world-class healthcare dedicated and mutual fund institutional investors, including Nextech Invest, T. Rowe Price, Janus Henderson Investors, RA Capital Management, and OrbiMed, among others

Andrew Lam, Eric Dobmeier and Enoch Kariuki to join ProfoundBio Board of Directors

SEATTLE — February 13, 2024 — ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for patients with cancer, today announced an oversubscribed $112 million Series B financing supported by a syndicate of top healthcare dedicated and mutual fund institutional investors. This financing underscores the new and existing investor confidence in ProfoundBio’s innovative approach to cancer treatment and is expected to accelerate the development of its comprehensive ADC portfolio, including the planned pivotal trial of rinatabart sesutecan (Rina-S) for the treatment of ovarian cancer.

The funding round was led by Ally Bridge Group, with substantial contributions from new investors including Nextech Invest, funds and accounts advised by T. Rowe Price Associates, Inc., Janus Henderson Investors, RA Capital Management, OrbiMed, Surveyor Capital (a Citadel company), Medicxi, Logos Capital, Octagon Capital, Piper Heartland Healthcare Capital and LifeSci Venture Partners, as well as continued support from existing investors Lilly Asia Ventures (LAV) and LYFE Capital.

“We are excited to welcome this premier group of life science investors. Their commitment is a testament to our progress and our mission to develop innovative ADCs with the potential for improved clinical outcomes for patients,” said Erin Lavelle, Chief Operating Officer and Chief Financial Officer of ProfoundBio. “This investment boosts our momentum, especially with three clinical-stage candidates in our portfolio and another poised for clinical trials in the next few months. It’s a pivotal step in enabling significant milestones and delivering key data readouts this year and through 2025. The addition of Andrew Lam, Eric Dobmeier, and Enoch Kariuki to our board brings invaluable expertise, strengthening our path to redefine patient care.”

Commitment to Innovative Cancer Therapy

The capital raised will support ProfoundBio’s diverse array of clinical and preclinical ADC programs, primarily targeting solid tumor cancers. Key programs include:

• Rina-S, a folate receptor-alpha (FRα) targeted ADC, in Phase 2 trials for ovarian and endometrial cancers, with pivotal studies in ovarian cancer planned for later this year.
• PRO1160, a CD70 targeted ADC, in Phase 1 trials with initial results expected in 2024.
• PRO1107, a protein tyrosine kinase 7 (PTK7) targeted ADC, in Phase 1 trials with initial results anticipated in 2025.
• PRO1286, a bi-specific ADC, anticipated to enter the clinic in 2024.

Baiteng Zhao, Ph.D., Chairman of the Board and Chief Executive Officer of ProfoundBio stated, “This Series B financing is an important milestone in our mission to redefine cancer treatment. Our ADC pipeline programs, led by Rina-S, demonstrate our dedication to bringing groundbreaking therapies to patients with cancer. With this support, we are better positioned to advance our clinical trials and offer new differentiated approaches. We welcome our new board members and look forward to this next chapter of ProfoundBio.”

New Board of Directors Appointments

ProfoundBio strengthens its board of directors with the addition of Andrew Lam from Ally Bridge Group, alongside two independent directors, Eric Dobmeier and Enoch Kariuki, who bring a breadth of experience in biotechnology and investment.

• Andrew Lam, Pharm.D., Managing Director and Head of Biotech Private Equity at Ally Bridge Group, is known for his strategic and capital markets insights based on his extensive expertise in the life sciences sector.
• Eric Dobmeier brings over two decades of leadership, operating and business development experience in biotechnology companies, having led significant growth initiatives at Seagen and Chinook Therapeutics.
• Enoch Kariuki, Pharm.D., brings extensive background in healthcare strategy, investment banking, and venture capital, contributing valuable financial and strategic acumen.

Joining existing board members Baiteng Zhao, Ph.D. (co-founder), Lynn Yang (HongShan), and Josh Jin (LAV), these new members bring considerable experience and expertise to ProfoundBio.

“ProfoundBio is led by an experienced management team with a proven track record of global approvals of ADC therapeutics and decades of research and development experience focused on this modality,” said Dr. Lam. “We are proud to be supporting a great team that has advanced an exciting pipeline of differentiated and potentially best-in-class and first-in-class ADCs.”

ProfoundBio’s Cutting-Edge Investigational ADC Programs

Rinatabart sesutecan (Rina-S, PRO1184) is a FRα-targeted ADC being developed as a novel treatment option for patients with ovarian and endometrial cancer, and potentially other FRα-expressing cancers. Rina-S is comprised of a FRα-directed antibody conjugated to sesutecan, ProfoundBio’s novel, proprietary hydrophilic exatecan-based linker-drug, at a homogeneous drug-to-antibody ratio (DAR) of 8. Exatecan is a highly potent, membrane permeable topoisomerase-1 inhibitor with strong bystander effect. The linker component of sesutecan is a highly hydrophilic, stable, cleavable linker designed to mask the hydrophobicity of exatecan, enabling high DAR and efficient delivery of the exatecan payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC. Rina-S is currently being evaluated in a Phase 1/2 clinical trial (NCT05579366) and has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

PRO1160 is an ADC consisting of a CD70-targeted antibody conjugated to ProfoundBio’s novel, proprietary hydrophilic exatecan-based linker-drug, sesutecan. CD70 is a protein expressed on both solid tumors and hematological malignancies including renal cell carcinoma, nasopharyngeal carcinoma, and non-Hodgkin lymphoma, yet is largely absent in normal tissues. With preclinical results showcasing encouraging pharmacokinetics, efficacy, and tolerability, PRO1160 is emerging as a potential advancement in the treatment of these cancers and is currently being evaluated in a Phase 1/2 clinical trial (NCT05721222).

PRO1107 is an ADC consisting of a PTK7-targeted antibody conjugated to ProfoundBio’s novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous DAR of 8. MMAE is a potent, membrane-permeable microtubule inhibitor that has been clinically validated as an ADC payload by multiple marketed ADCs incorporating MMAE in the linker-drug vedotin at a DAR of 4. The linker component of LD343 is a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of MMAE, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC. PRO1107 is currently being evaluated in a Phase 1/2 clinical trial (NCT06171789).

PRO1286 is a bispecific ADC that has the potential to treat multiple tumor types. PRO1286 is built on the clinically validated sesutecan platform and is anticipated to begin clinical trials in 2024.

About ProfoundBio

ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple ADC drug candidates targeting solid tumors and hematological malignancies. The company’s disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting FRα; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens. ProfoundBio is headquartered in Seattle, Washington.

For more information, please visit www.profoundbio.com and follow us on LinkedIn.

SAN MATEO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) — CARGO Therapeutics, Inc. (“CARGO”), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today announced the pricing of its initial public offering of 18,750,000 shares of its common stock at a public offering price of $15.00 per share. All of the shares of common stock are being offered by CARGO. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by CARGO, are expected to be approximately $281.3 million. In addition, CARGO has granted the underwriters a 30-day option to purchase up to 2,812,500 additional shares of common stock at the initial public offering price, less the underwriting discounts and commissions. CARGO’s common stock is expected to begin trading on the Nasdaq Global Select Market on November 10, 2023 under the ticker symbol “CRGX.” The offering is expected to close on November 14, 2023, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Jefferies, TD Cowen and Truist Securities are acting as joint book-running managers for the offering.

A registration statement relating to the shares of common stock being sold in the initial public offering has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on November 9, 2023. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (212) 284-2300; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926, or by email at Prospectus_ECM@cowen.com; or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, GA 30326, by telephone at (800) 685-4786, or by email at TruistSecurities.prospectus@Truist.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or that jurisdiction.

About CARGO

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and CARGO’s team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products.

The Company continues to deliver on its mission of bringing the benefits of Minimal Access Surgery (MAS) to more patients globally.

The Versius^® Surgical Robotic System has now been used to perform over 15,000 surgical cases globally in more than 20 countries and across a wide range of surgical specialties including general, urological, gynaecological and thoracic.

The company has recently closed an upsized $165 million (£133 million) fundraising to support continued product innovation and commercial growth in existing and key new markets around the world.

CAMBRIDGE, UNITED KINGDOM — 20 September 2023 07:00 (BST) — CMR Surgical (CMR or ‘the Company’) — the global surgical robotics business — has today announced that its next-generation Versius^® Surgical Robotic System has been used to perform more than 15,000 surgeries globally. The surgical cases span more than 130 complex and benign procedure types including colectomies, hernia repairs, hysterectomies, sacrocolpopexies, and lobectomies across seven surgical specialties.

CMR was established in 2014 with a mission to transform lives by making minimal access surgery (MAS) more accessible and affordable with Versius, a small, modular, and versatile surgical robotic system. Versius gained CE approval in 2019, and today, more than 140 Versius systems have been installed in hospitals around the world across the UK, Europe, Latin America, the Middle East, Asia and Africa.

The 15,000 procedures have been performed using Versius in a range of differently sized hospitals, including globally-renowned research hospitals such as Royal Papworth Hospital NHS Foundation Trust (UK), Institute Curie (France), Policlinico di Milano (Italy), Max Super Specialty Hospital (India), the Sindh Institute of Urology and Transplantation (SIUT) (Pakistan), Hospital Moinhos de Vento (Brazil), Gleneagles Hospital (Hong Kong) and Klinikum Chemnitz GmbH (Germany).

The funding round of $165 million (£133m), which was increased from the initial base size due to strong internal demand, was led by all of its major existing investors, including Ally Bridge Group, Cambridge Innovation Capital, Escala Capital, LGT, Lightrock, RPMI Railpen, SoftBank Vision Fund 2, Tencent and Watrium. The funds are to be used to drive continued product innovation, including new technological developments, and to support the further commercialisation of the system in key existing, and new, geographies. CMR’s vision is to make MAS universally accessible, rapidly increasing the number of robotic-assisted procedures that take place globally. Today, the global soft-tissue robotic-assisted MAS market is estimated to be worth over $7bn per annum and is growing at over 15% per annum.

Mr Adam Peryt, Consultant Thoracic Surgeon at Royal Papworth Hospital commented: “Versius is very well suited to our needs as a world-leading thoracic surgery department. We have successfully helped patients get the benefit of robotic assisted surgery and we look forward to developing our robotics programme working with CMR and other centres around the world as the adoption of Versius continues.”

Supratim Bose, Chief Executive Officer at CMR Surgical, said: “I am incredibly proud of our teams and what CMR stands for as we pass this latest milestone and work towards our vision of making minimal access surgery available to everyone. The benefits of MAS for patients are enormous and I am excited to see the continued adoption of Versius around the world, and the positive impact it is having on hospitals, surgeons, and, ultimately, their patients.
“More and more surgeons and patients are benefiting from Versius and our latest funding round will allow us to serve even more customers, supporting our continued growth in existing markets, as well as expansion into new key markets. Versius’ unique versatility and differentiated offering, enabled by its patented V-wrist technology, continues to receive positive feedback from hospitals and surgical teams. We are inspired by its potential to change the way the world receives surgical care.”

Umur Hursever, Partner at Lightrock and Chairman at CMR Surgical commented: “At Lightrock, we are committed to supporting innovators who make a positive contribution to humanity and the planet. We have always been impressed by not only CMR’s product, Versius, but also its exceptional people. CMR is one of those innovators who are blazing its own trail with Versius, a differentiated robotic experience that democratises robotic surgery both procedurally and geographically. With this latest raise, we are delighted to be supporting CMR in its mission to make robotic keyhole surgery available to everyone.”
The company’s latest clinical milestone and financing announcement follows the recent news that it has received the Royal College of Surgeons of England (RCS England) accreditation for its global professional education portfolio. The accreditation by RCS England is an internationally recognised hallmark of quality and serves as a recognition of excellence for the Versius surgical training programme. This recognition follows the company being awarded a King’s Award for Enterprise for Innovation for Versius, its small and modular next-generation surgical robotic system.

The Versius^® Surgical Robotic System

Versius^® resets expectations of robotic surgery. Versius fits into virtually any operating room set-up and integrates seamlessly into existing workflows, increasing the likelihood of robotic minimal access surgery (MAS). The small, portable and modular design of Versius allows the surgeon to only use the number of arms needed for a given procedure.

Biomimicking the human arm, Versius gives surgeons the choice of optimised port placement alongside the dexterity and accuracy of small fully-wristed instruments. With 3D HD vision, easy-to adopt instrument control and a choice of ergonomic working positions, the open surgeon console has the potential to reduce stress and fatigue and allows for clear communication with the surgical team. By thinking laparoscopically and operating robotically with Versius, patients, surgeons and healthcare professionals can all benefit from the value that robotic MAS brings.

But it’s more than just a robot. Versius captures meaningful data with its wider digital ecosystem to support a surgeon’s continuous learning. Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

About CMR Surgical Limited

CMR Surgical (CMR) is a global medical devices company dedicated to transforming surgery with Versius^®, a next-generation surgical robot.

Headquartered in Cambridge, United Kingdom, CMR is committed to working with surgeons, surgical teams and hospital partners, to provide an optimal tool to make robotic minimal access surgery universally accessible and affordable. With Versius, we are on a mission to redefine the surgical robotics market with practical, innovative technology and data that can improve surgical care.

Founded in 2014, CMR Surgical is private limited company backed by an international shareholder base.

Acquisition intended to expand neuromodulation portfolio to provide more treatment options for people living with chronic low back pain

MARLBOROUGH, Mass., Sept. 19, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the Intracept^® Intraosseous Nerve Ablation System to treat vertebrogenic pain, a form of chronic low back pain. The transaction includes an upfront cash payment of $850 million and undisclosed additional contingent payments based on sales performance over the next three years.

As the only U.S. Food and Drug Administration-cleared system for vertebrogenic pain, the Intracept system is a minimally invasive, implant-free outpatient procedure. The therapy uses targeted radiofrequency energy to stop the basivertebral nerve from transmitting pain signals to the brain and is designed to improve function and provide long-term relief. In the U.S., there is an estimated population of approximately 5.3 million people living with vertebrogenic pain.¹

″We anticipate this novel, clinically-backed technology can support our category leadership strategy while expanding access to care for individuals who need personalized treatment,″ said Jim Cassidy, president, Neuromodulation, Boston Scientific. ″Upon close, we look forward to working with the Relievant team to explore opportunities to bring this high-growth therapy to a wider population of people living with chronic low back pain.″

Boston Scientific expects to close the transaction in the first half of 2024, subject to satisfaction of customary closing conditions. Relievant is expected to generate sales in excess of $70 million in 2023 and to deliver year-over-year growth in excess of 50% in 2024. On an adjusted basis, the transaction is expected to be immaterial to adjusted earnings per share (EPS) in 2024, slightly accretive in 2025, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges.

“Today is an exciting step forward to shaping the future of chronic low back pain with Boston Scientific as a leader in the interventional chronic pain space,″ said Tyler Binney, president and CEO of Relievant. ″This is a testament to the exceptionally talented Relievant team and the innovative engine behind the Intracept system. Together with Boston Scientific, we can accelerate our journey to provide life-changing relief to patients by transforming the diagnosis and treatment of vertebrogenic pain.″

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding closing of the transaction and the timing thereof, the financial and business impact of the transaction, expected net sales and related growth rates, product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other climate change-related events; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; demographic trends; the closing and integration of acquisitions; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including cost savings and growth initiatives; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied; and closing of the proposed transaction may not occur or may be delayed. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this press release.

¹ Hoy D, March L, Brooks P, et al. The global burden of low back pain; estimates from the Global Burden of Disease 2010 study. Annals of the Rheumatic Diseases 2014;73:968-974. https://ard.bmj.com/content/73/6/968;The global point prevalence of LBP was 9.4% (95% CI 9.0 to 9.8), (333M U.S. pop * 9.4% = 31M); Lorio et al. International Journal of Spine Surgery December 2022, 16 (6) 1084-1094; DOI: https://doi.org/10.14444/8362;http://www.ijssurgery.com/content/16/6/1084; estimated that 15% of CLBP patients suffer from primary vertebrogenic pain.