Bioventus Announces Divestiture of its Advanced Rehabilitation Business to Accelmed Partners
DURHAM, N.C., Oct. 01, 2024 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has signed a definitive agreement to sell its Advanced Rehabilitation business of its subsidiary, Bioness, to Accelmed Partners (“Accelmed”), a private equity firm focused on acquiring and growing commercial-stage HealthTech companies. The transaction includes a total cash consideration of $45 million, including $25 million in cash at close (subject to a working capital adjustment) and up to $20 million in potential post-closing earn-out payments. At the time of closing, the Company expects to net approximately $20 million after fees and expenses, which will be used to repay existing debt.
“This agreement reflects our deep respect for the Advanced Rehabilitation business and the many patients who benefit from its life-changing technology. The business will now be positioned in an environment that enables higher focus moving forward. Simultaneously, this divestiture allows Bioventus to focus on execution within our core, while also enhancing our liquidity,” said Rob Claypoole, Bioventus’s President and Chief Executive Officer.
Dr. Uri Geiger, Managing Partner of Accelmed, said, “We are excited to welcome the Advanced Rehabilitation business of Bioness to our investment portfolio. We believe Bioness’ Advanced Rehabilitation products are critical for helping patients with stroke and other neuromuscular conditions in their rehabilitation journey. We believe that there is a significant opportunity for growth and intend to invest in developing and extending the product line to continue improving patients’ lives.”
The divestiture of the Advanced Rehabilitation business reduces the Company’s annual revenue by approximately $50 million and annual Adjusted EBITDA by approximately $6 million.
The transaction is subject to customary closing conditions and is expected to close in the fourth quarter of 2024.
Moelis & Company LLC is acting as financial advisor and Reed Smith LLP is acting as legal advisor to Bioventus in connection with the sale of its Advanced Rehabilitation business. Jones Day and Stevens & Lee are acting as legal advisors to Accelmed.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
About Accelmed Partners
Accelmed is a U.S.-based private equity firm focused on acquiring and investing in U.S. commercial stage, lower middle market HealthTech companies. Since 2009, Accelmed has deployed over $500 million into companies spanning medical devices, diagnostics, digital health and technology-enabled healthcare services. Accelmed seeks to accelerate value and scale innovation across the HealthTech field by bringing to bear the team’s industry experience, operational and financial expertise, and strong global relationships. For more information, please visit www.accelmed.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the Company’s future growth, operating margins, market leadership and strategy, the expected proceeds from the divestiture, and the use of such proceeds to repay existing debt. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “possible,” “predict,” “project,” “propose,” “potential,” “positioned,” “seek,” “should,” “strive,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, our ability to successfully complete the planned divestiture of the Rehabilitation Business, our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; the clinical studies of any of our future products that do not produce results necessary to support regulatory clearance or approval in the United States or elsewhere; we are subject to securities litigation and may be subject to similar or other litigation in the future, which will require significant management time and attention, result in significant legal expenses or costs not covered by our insurers, and may result in unfavorable outcomes; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the quarterly reports on Form 10-Q, and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor and Media Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus Enters into an Amendment with its Credit Agreement Lenders to Enhance Financial and Operational Flexibility
DURHAM, NC – January 18, 2023 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that it has entered into an Amendment No. 5 (the “Amendment”) to the Credit and Guaranty Agreement, between the Company, Wells Fargo Bank, National Association as Administrative Agent and Collateral Agent, and the Lenders from time to time party thereto, dated as of December 6, 2019 and as amended on August 29, 2021, October 29, 2021, July 11, 2022 and March 31, 2023 (the “Credit Agreement”).
Among other items, the Amendment provides for additional financial covenant relief through the Third Quarter of 2025, including the Company’s leverage maintenance covenant and interest coverage ratio. The amended covenant levels are expected to provide the Company with greater financial and operational flexibility relative to its operating plan in order to execute on key growth initiatives and enhance profitability. Financial covenant thresholds will revert to existing levels under the Credit Agreement for all covenants by the Fourth Quarter of 2025.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning our future financial results and profitability; our business strategy, position and operations; and expected growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause our actual results to differ materially from those contemplated in this press release include, but are not limited to, our ability to meet certain of our debt covenants under our Credit Agreement and the potential accelerated obligation to repay indebtedness; our ability to secure additional funding, if needed, on reasonable terms or at all; the risk that the material weakness we previously identified or a new material risk could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; we might not be able to continue to fund our operations for at least the next twelve months as a going concern; and the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2022, as updated by Bioventus' subsequent Quarterly Report on Form 10-Q for the quarters ended April 1, 2023 and September 30, 2023 and as may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at https://ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor and Media Inquiries:
Dave Crawford
919-474-6787
Robert Claypoole Named CEO
Seasoned Leader Brings More than Two Decades of Medical Device Experience and Proven Track Record of Driving Revenue and Operating Margin Growth
DURHAM, N.C., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that its Board of Directors has appointed Robert (Rob) Claypoole as Bioventus’ President and Chief Executive Officer and a member of its Board of Directors, effective January 10, 2024. Mr. Claypoole succeeds Mr. Anthony Bihl who has served as interim CEO and a director on the Board since April 2023.
Mr. Claypoole brings more than 20 years of global commercial leadership experience in the medical device industry, and a history of success in accelerating revenue growth and enhancing operational profitability. He most recently served as Executive Vice President at Mölnlycke Health Care AB, where he led Mölnlycke’s $1.2 billion global Wound Care business. Mr. Claypoole previously held senior positions at Medtronic, Covidien and Johnson & Johnson. Throughout his career, he has developed extensive expertise in transforming global medical device businesses to accelerate innovation, drive organizational efficiencies, and enhance go-to-market strategies to deliver above market revenue growth.
“We are excited to have Rob join Bioventus and build upon the significant improvements made this year to further elevate our execution and overall performance,” said William A. Hawkins, Bioventus’ executive chairman. “Throughout his career, Rob has demonstrated first-hand his ability at unlocking value opportunities across a global business. His track record is marked by consistently driving commercial and operational excellence, resulting in above-market sales growth and enhanced profitability. Moreover, Rob has a history of cultivating high-performing teams with a laser focus on execution.”
Mr. Claypoole said, “I am honored to join the talented team at Bioventus, a company with a strong foundation and a diverse, market-leading product portfolio across attractive markets. I was attracted to this unique and exciting opportunity given our important mission to return patients to active lives and due to the company’s positive momentum this year to solidify Bioventus’ financial position. I look forward to working with the Board and entire team to drive growth and innovation, generate operational efficiencies, and strengthen profitability as we unlock the full potential of our business and create value for patients and our shareholders.”
Mr. Hawkins added, “On behalf of the Board and the employees of Bioventus, I want to thank Tony for his valuable contributions and leadership. Tony has helped to rebuild our financial position, restore our credibility with stakeholders, enhance our execution and deliver on our financial plan, while stabilizing the organization.”
The Company reaffirms its full year financial guidance previously announced on November 7, 2023.
About Robert Claypoole
Mr. Claypoole joins Bioventus from Mölnlycke Health Care, a world-leading medical products and solutions company, where he served as Executive Vice President of Wound Care. In this role, Mr. Claypoole had full responsibility for a $1.2 billion business and rapidly accelerated growth from mid-single digit to consistent double-digit growth in sales and profitability, while also advancing Mölnlycke’s evolution as an innovative wound care solutions company across the continuum of care – from prevention to treatment in acute and post-acute settings. Before that, Mr. Claypoole was Executive Vice President and President, US for Mölnlycke where he turned around a declining business to strong growth and served as an Officer of Mölnlycke Health Care US, LLC and Mölnlycke Manufacturing US, LLC. In this role, Rob was responsible for over $.5B in revenue.
Prior to joining Mölnlycke in 2017, Mr. Claypoole served in various leadership roles at Medtronic and Covidien, before it was acquired by Medtronic. Mr. Claypoole was Global Vice President & General Manager, Obesity & Metabolic Health and led the effort to address one of the most significant healthcare challenges. Previously, he served as Global Vice President & General Manager of the Soft Tissue Repair & Hemostats business where he led a successful global turnaround from years of declining revenue to significant growth. Before that, he was the Vice President, Executive Operations after serving as Vice President, Global Marketing while located in Trevoux, France. Prior to his time in France, Mr. Claypoole was the Vice President, US Marketing for the company’s Endomechanical & Intelligent Device business. Before joining Covidien in 2007, Mr. Claypoole held various marketing roles with increasing responsibility at Johnson & Johnson’s Vision Care division.
Rob received his Bachelor’s degree and his Master’s degree in Business Administration from Cornell University.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning our future financial results and liquidity; our ability to continue as a going concern; our business strategy, position and operations; expected sales trends, opportunities, market position and growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause our actual results to differ materially from those contemplated in this press release include, but are not limited to, our ability to attract, retain and motivate our senior management team and highly qualified personnel; the risk that the material weakness we previously identified or a new material risk could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; we might not be able to continue to fund our operations for at least the next twelve months as a going concern; pricing pressure and other competitive factors; we maintain cash at financial institutions, often in balances that exceed federally insured limits; we are subject to securities class action litigation and may be subject to similar or other litigation in the future, which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; legislative or regulatory reforms; our business may continue to experience adverse impacts of COVID-19 pandemic or similar epidemics; and the other risks identified our Annual Report on Form 10-K for the year ended December 31, 2022, as updated by Bioventus’ subsequent quarterly reports on Forms 10-Q for the quarters ended Apri1 1, 2023 and September 30, 2023 and as may be further updated from time to time in Bioventus' other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and the Investor Relations page of Bioventus’ website at https://ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor and Media Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus Agrees to Nationwide Contract with Aetna Medicare Advantage Plans for DUROLANE for Knee Osteoarthritis
DURHAM, NC – Dec. 5, 2023 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, has agreed to a nationwide contract with Aetna™ Medicare Advantage plans. Beginning January 1, 2024, over 3 million Aetna™ Medicare Advantage plan members will have access to DUROLANE to treat knee osteoarthritis (OA) pain. DUROLANE, is a single-injection hyaluronic acid (HA)-based joint-fluid treatment for patients. DUROLANE will be one of two single-injection HA products under contract.
OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues. Injection treatments of HA-based products, such as DUROLANE, help manage knee OA pain.
“We are pleased DUROLANE is among the preferred options available to both Aetna™ Medicare Advantage members and physicians,” said Anthony Doyle, General Manager, Pain Treatments and Restorative Therapies for Bioventus. “Both now have access to a safe HA product that is proven to provide relief from knee OA pain.”
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Investor and Media Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus Announces Divestiture of its Wound Business
DURHAM, N.C., May 10, 2023 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has signed a definitive agreement to sell its Wound business, including the skin substitutes TheraSkin and TheraGenesis, to LifeNet Health. The transaction includes a total cash consideration of $85 million, including $35 million in cash at close, a $5 million cash payment deferred 18 months, and $45 million in potential earn-out payments. At the time of close the Company expects to net approximately $30 million after fees and expenses which will be used to repay existing debt.
Bioventus and LifeNet Health have also signed a Sales Agent Agreement under which LifeNet Health will have exclusive rights to sell SonicOne ultrasonic wound debridement products in the US and Canada.
“The sale of our Wound business will enhance our liquidity and enable a greater focus on execution” said Tony Bihl, Bioventus’ interim chief executive officer.
The divestiture of the Wound business reduces the Company’s annual revenue by approximately $40 million and annual Adjusted EBITDA by approximately $5 million.
The transaction is expected to close in approximately one week before the end of May.
Jefferies LLC is acting as financial advisor and Reed Smith is acting as legal advisor in connection with this transaction.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the Company’s future growth, operating margins, market leadership and strategy. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, our ability to successfully complete planned divestures, the risk that the material weakness we identified in the third quarter of 2022 or a new material weakness could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner; we might not be able to continue to fund our operations for at least the next twelve months as a going concern; we might not meet certain of our debt covenants under our Credit Agreement and might be required to repay our indebtedness; restrictions on operations and other costs associated with our indebtedness; we maintain cash at financial institutions, often in balance that exceed federally insured limits; we are subject to securities class action litigation and may be subject to similar or other litigation in the future, which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes; we are highly dependent on a limited number of products; our long-term growth depends on our ability to develop, acquire and commercialize new products, line extensions or expanded indications; we may be unable to successfully commercialize newly developed or acquired products or therapies in the United States; demand for our existing portfolio of products and any new products, line extensions or expanded indications depends on the continued and future acceptance of our products by physicians, patients, third-party payers and others in the medical community; the proposed down classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (FDA) could increase future competition for bone growth stimulators and otherwise adversely affect the Company’s sales of Exogen; failure to achieve and maintain adequate levels of coverage and/or reimbursement for our products or future products, the procedures using our products, such as our hyaluronic acid (HA) viscosupplements, or future products we may seek to commercialize; pricing pressure and other competitive factors; governments outside the United States might not provide coverage or reimbursement of our products; our business may continue to experience adverse impacts as a result of the COVID-19 pandemic; risks related to intellectual property matters; legislative or regulatory reforms; risks related to intellectual property matters; and other important factors described in Part I. Item 1A. Risk Factors in our 2022 Annual Report on Form 10-K as updated by our subsequent Quarterly Reports on Form 10-Q, this Quarterly Report on Form 10-Q and as may be further updated from time to time in our other filings with the SEC. You are urged to consider these factors carefully in evaluating these forward-looking statements. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Actual results may differ materially from those set forth in the forward-looking statements.
Investor and Media Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus to Showcase Full Orthobiologics and Ultrasonic Portfolio at NASS in Chicago
Bioventus to Showcase Full Orthobiologics and Ultrasonic Portfolio at NASS in Chicago
Full Launch of BoneScalpel Access® at NASS
DURHAM, NC – October 12, 2022 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, will present its spine procedural solutions portfolio at the North American Spine Society (NASS) meeting in Chicago, October 12 through 15.
By combining the power of the neXus® BoneScalpel® for decompression with OSTEOAMP® bone graft for fusions, Bioventus Procedural Solutions is the go-to portfolio for spine surgeons who demand the best. “One year post-acquisition, we are seeing cross-pollination from our combined customer base, ensuring more surgeons have access to these great technologies,” Andrew Hosmer, general manager at Bioventus said. “Legacy neXus users are rapidly adopting OSTEOAMP into their practices and our bone graft customers are expanding their neXus utilization.”
Bioventus continues to invest in the future of both portfolios with the newest product launch, expanding their reach in the rapidly growing minimally invasive spine segment. The BoneScalpel Access handpiece 20 mm blade and Micro Hook Shaver will be available throughout the U.S. on October 17. The BoneScalpel Access handpiece allows surgeons to leverage the many advantages of ultrasonic bone cutting in minimally invasive spinal procedures. Combined with OSTEOAMP Flowable, Bioventus now has a full portfolio for MIS spine procedures, the fastest growing segment of spine surgery.
“BoneScalpel Access is finally allowing ultrasonics to go into spaces and through tubes for spine surgery, allowing me to treat patients optimally with the safest and least invasive way possible. Line of sight down the slight ly angled shaft facilitates maximal visualization of the anatomy.” said Tiffany G. Perry, MD, Cedars Sinai Medical Center.
The Bioventus surgical solutions portfolio brings together innovative products that add value for surgical applications in decompression and fusion.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatment, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Summary for Indications of Use
The BoneScalpel Access handpiece is indicated for use in the fragmentation and aspiration of soft and hard (e.g., bone) tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecology, External Genitalia – condyloma – benign tumors – (lipomas, fibromas, and leiomyomas) malignant primary metastatic tumors of all types and the following cystic lesions: Bartholin’s cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts. Abdominal Area – any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. Thoracic Surgery – limited pulmonary reception such as segmetectomies, nonanatomical subsegmetectomies and metastatectomies.
OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects.
SIGNAFUSE Strip is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the Company’s future financial results, the benefits of the CartiHeal acquisition and the potential for the Company’s current portfolio to deliver sustained double-digit growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, the ability to obtain financing for and to make the deferred payments in connection with the CartiHeal acquisition on expected timelines or at all; our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the CartiHeal acquisition; risk related to the Company’s debt and payment obligations relating to the CartiHeal acquisition; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended April 2, 2022 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus Completes CartiHeal Acquisition
Bioventus Completes CartiHeal Acquisition
DURHAM, NC – July 12, 2022 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has completed its acquisition of CartiHeal.
“We are excited to add CartiHeal to our diverse portfolio of active healing solutions,” commented Ken Reali, Bioventus’ chief executive officer. “CartiHeal represents an important breakthrough for the treatment of osteoarthritis and osteochondral defects of the knee with significant medium- and long-term potential as evidenced by the robust data generated from its pivotal clinical trial showing superiority to current treatments. We believe that the addition of CartiHeal will complement our joint preservation technologies and specifically our HA business, further supporting our short- and mid-term growth drivers and helping us to deliver on our goal of sustained double-digit revenue growth. We welcome the CartiHeal team to Bioventus and look forward to bringing this life-improving technology to as many patients as possible.”
CartiHeal is an attractive alternative for the approximately 650,000 U.S. patients that receive microfracture or debridement annually and can potentially delay the need for a total knee replacement in patients with joint surface lesions of the knee. The acquisition of CartiHeal is directly aligned with Bioventus’ sports medicine and total joint reconstruction call point and extends the Company’s leadership position in joint preservation technologies. In a randomized controlled clinical trial, CartiHeal’s Agili-C implant demonstrated superiority to either microfracture or debridement.
On March 29, 2022, CartiHeal received premarket approval (PMA) of its Agili-CTM implant from the U.S. Food and Drug Administration. Agili-C was granted Breakthrough Device Designation by the FDA in 2020 and is indicated for the treatment of International Cartilage Repair Society (ICRS) grade III or above knee–joint surface lesions, with a total treatable area of 1-7 cm2 for patients without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
The Company will provide adjusted earnings per share guidance reflecting the acquisition of CartiHeal on its upcoming second quarter earnings call.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatment, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the Company’s future financial results, the benefits of the CartiHeal acquisition and the potential for the Company’s current portfolio to deliver sustained double-digit growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, the ability to obtain financing for and to make the deferred payments in connection with the CartiHeal acquisition on expected timelines or at all; our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the CartiHeal acquisition; risk related to the Company’s debt and payment obligations relating to the CartiHeal acquisition; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended April 2, 2022 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor Inquiries:
Dave Crawford
919-474-6787
[email protected]
Bioventus Amends CartiHeal Acquisition Structure
Bioventus Amends CartiHeal Acquisition Structure
DURHAM, NC – June 21, 2022 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has entered into an amendment to the Option and Equity Purchase Agreement for its pending acquisition of CartiHeal (“Amended Acquisition Agreement”).
“CartiHeal represents an important breakthrough for the treatment of osteoarthritis and osteochondral defects of the knee with significant long-term potential, and we are excited to have reached an amendment that we believe will be favorable to our stakeholders and enable us to complete the acquisition,” commented Ken Reali, Bioventus’ chief executive officer. “The ability to defer payments allows us to continue investing in our near-term strategy for growth while maintaining financial flexibility. Bioventus possesses multiple short- and mid-term growth drivers that are further enhanced by CartiHeal, and we continue to work towards realizing the potential of our portfolio to deliver sustained double-digit growth and margin expansion.”
The Amended Acquisition Agreement reduces the closing payment to $50 million (in addition to $50 million deposited into escrow last year) from the original $315 million that was previously agreed. The remaining $215 million of the purchase price (the “Deferred Amount”) will instead be paid to CartiHeal stockholders upon the earlier of the achievement of certain milestones or the occurrence of certain installment payment dates. The Deferred Amount will be paid in five tranches commencing in 2023 and ending no later than 2027.
Bioventus will pay interest on each tranche of the Deferred Amount, at a rate of at 8% annually, until such tranche is paid. Additionally, the approximately $135 million payable to CartiHeal’s stockholders upon the achievement of $100 million in trailing twelve-month sales will now be payable upon the achievement of $75 million in trailing twelve-month sales.
Bioventus expects the acquisition to close by the end of July 2022, subject to closing conditions, with an up-front payment to CartiHeal’s stockholders of approximately $108 million (inclusive of the $50 million previously deposited into escrow by Bioventus and in addition to approximately
$8 million of CartiHeal’s transaction-related fees and expenses that Bioventus has agreed to pay). The Company intends to finance the payment due at closing with additional debt. The Company is finalizing an amendment to its existing Credit and Guaranty Agreement to increase its current Term Loan to facilitate the closing of the acquisition. The payments of the Deferred
Amount are anticipated to be made through the Company’s free cash flow and expansion of its existing credit facility.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatment, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence- based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the timing and closing of the CartiHeal acquisition, the expected amendment to the Company’s Credit and Guaranty Agreement, the benefits of the CartiHeal acquisition and the potential for the Company’s current portfolio to deliver sustained double-digit growth and margin expansion. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, risk of litigation related to the Option and Equity Purchase Agreement to acquire CartiHeal; the ability to obtain financing for and to complete the CartiHeal Acquisition on expected timelines or at all; our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts of any termination of the CartiHeal acquisition on our business, financial condition and results of operations; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; risk related to the Company’s debt; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended April 2, 2022 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor Inquiries:
Dave Crawford 919-474-6787
Bioventus Exercises Call Option to Acquire CartiHeal
DURHAM, NC – April 4, 2022 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that it has exercised its call option to acquire CartiHeal Ltd., excluding the ownership interest already owned by Bioventus, for approximately $315 million, with an additional approximately $135 million payable contingent upon the achievement of $100 million in trailing twelve month sales. Bioventus plans to finance the acquisition with additional debt. The Company’s decision to exercise this option follows the U.S. Food and Drug Administration’s (FDA) March 29, 2022, premarket approval (PMA) of CartiHeal’s Agili-C™ implant.
Agili-C was granted Breakthrough Device Designation by the FDA in 2020 and is indicated for the treatment of International Cartilage Repair Society (ICRS) grade III or above knee–joint surface lesions, with a total treatable area of 1-7 cm2 for patients without severe osteoarthritis (Kellgren-Lawrence (KOOS) grade 0-3). The Agili-C implant is expected to be a cost-effective solution for cartilage regeneration and bone remodeling designed to delay total knee replacement in patients with joint surface lesions of the knee.
“CartiHeal represents an important breakthrough for the treatment of osteoarthritis, and we are excited to bring this complementary product into our growing portfolio of medical devices. CartiHeal addresses an unmet need in joint preservation and cartilage regeneration for approximately 675,000 U.S. patients annually, representing an estimated $1.3 billion market opportunity for Bioventus. The CartiHeal team has done a tremendous job developing the implant, as evidenced by strong clinical data demonstrating clinical superiority over microfracture or debridement,” said Ken Reali, CEO of Bioventus. “We look forward to leveraging our strong existing commercial infrastructure to begin commercializing CartiHeal in the coming months.”
The transaction is expected to close during the second quarter subject to certain customary closing conditions, and Bioventus plans a limited market release (LMR) of CartiHeal in the U.S. during the third quarter of 2022.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. Agili-C is a trademark of CartiHeal.
Legal Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the expected timing of the closing of the Company’s acquisition of CartiHeal and related conditions to closing, the benefits of an acquisition of CartiHeal, market opportunity for CartiHeal and the Company’s expected timeline for commercialization of CartiHeal. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, our ability to complete the CartiHeal acquisition on expected timelines or at all; our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; including the potential CartiHeal acquisition; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of the Company’s website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.
Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
Bioventus Receives 510(k) Clearance for StimRouter Pain Management Device
Industry Leading Peripheral Nerve Stimulator Upgraded to Improve Patient User Experience with Control of their Unique Chronic Pain Condition, Longer Battery Life
DURHAM, NC – March 1, 2022 – Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced that the US Food and Drug Administration (FDA) has awarded 510(k) clearance to the next generation StimRouter® Neuromodulation System for the treatment of chronic pain of peripheral nerve origin, excluding craniofacial pain. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external electric field conductor (E-EFC), and StimRouter Plus Mobile Application. Electrical signals are transmitted transcutaneously from the E-EFC and conducted to the target nerve by the implanted lead.
Thousands of patients have successfully used the StimRouter Neuromodulation system, and the newly cleared StimRouter system provides the same clinically proven, long-term pain relief while significantly improving the patient’s control and user experience. The next generation system includes a smartphone application and a new state of the art external electric field conductor, allowing patients greater freedom to return to active lives.
“The impact of chronic, debilitating pain is more than just managing the impacted anatomy, it is also about helping return the individual back to a life pre-pain,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The emotional and psychological damage from living with pain is horrific and we are pleased to support all the physicians who are committed to improving patient lives, in particular with alternatives to opioids when possible. The next generation StimRouter will support patients and physicians to meet their pain treatment goals as the previous generation of peripheral nerve stimulation has done for many years.”
Every day, individuals attempt to live their lives while suffering from debilitating pain that prevents each from working, enjoying their personal time and maintaining relationships with family and friends. Respecting the long-term and potentially negative consequences of opioids, patients have successfully undergone the minimally invasive StimRouter implant procedure and are now living a productive and comfortable life. Peripheral nerve stimulation (PNS) is the future of pain management. With over 50 million Americans living with daily chronic pain, PNS technology provides a focal, non-opioid treatment option and adoption is growing rapidly amongst clinicians and patients due to PNS’ proven effectiveness at reducing chronic pain.
The upgraded StimRouter technology and associated mobile application will help improve the experiences of patients who find pain relief through this innovative technology.
About Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. StimRouter, Bioness, are trademarks of Bioness Inc.
Individual results may vary. Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information and Risks: For Indications for Use, Warnings, Precautions, and other safety information please refer to www.stimrouter.com/safety-information/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning Bioventus’s future growth, operating margins, market leadership and strategy. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to recognize the benefits of our investments; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ Annual Report on Form 10-K for the period ended December 31, 2020, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended October 2, 2021, and as such factors may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.
Investor Inquiries:
Dave Crawford
Bioventus
919-474-6787
[email protected]
