Category: Knee deformation

Led by former FDA Imaging Experts, MCRA AI & Imaging Center is the first and only integrated solution covering the medical device lifecycle with 24/7 customer support

WASHINGTON , Nov. 27, 2023 /PRNewswire/ — MCRA, the leading private independent Clinical Research Organization (CRO) and medical device, diagnostics and biologics consulting firm, is pleased to announce the launch of its AI & Imaging Center, the first and only integrated solution, led by former FDA imaging experts, covering the entire medical device lifecycle.

MCRA’s AI & Imaging Center is designed to better meet the emerging and complex needs of imaging technologies. By combining innovation, expertise and speed, we accelerate customers’ AI/ML needs faster and more efficiently.

Led by former FDA regulatory and imaging experts, the Integrated AI & Imaging Center provides critical services to medical device customers developing AI/ML-enabled devices and new imaging technologies. The AI ​​& Imaging Center works with an extensive network of radiologists and specialists to provide world-class diagnostic and therapeutic imaging laboratory services.

MCRA’s AI & Imaging Center services address the entire lifecycle of medical device studies, including regulatory support, study design and design, data collection and aggregation, expert recruitment and training, statistical analyses, performance testing, and project and data management . MCRA’s AI & Imaging Center has already provided services ranging from protocol development to study execution and regulatory submissions for more than 50 imaging clients. As a fully integrated solution, MCRA AI & Imaging Center uses proven zero-print, advanced image analysis and data management software with 24/7 support for customers and network specialists.

Alex Cadotte, Ph.D., Senior Director, Digital Health and Imaging Regulatory Affairs, said: “As the only fully integrated AI & Imaging Center, our value lies in the expertise of our team, which consists of former FDA experts who have navigated the regulatory landscape to understand. and clinical processes. Our value proposition is to ensure that the study is designed and conducted in a manner that meets FDA expectations and ultimately reduces time to market by conducting the right study the first time.”

MCRA is excited to continue advancing imaging and digital health innovation in the medical device industry by helping customers navigate the evolving AI/ML imaging landscape. Read more about the MCRA AI & Imaging Center here.

MCRA customer Richie Christian, Head of Regulatory and Quality at Formus Labs says: “The MCRA AI & Imaging Center has provided our technologies with real insights into how the FDA thinks about best practices for AI MedTech. This deep insight allowed us to be more innovative and deliver a best-in-class product to the AI ​​marketplace.”

Anthony Viscogliosi, CEO of MCRA said: “The MCRA AI & Imaging Center truly integrates our deep regulatory experience with clinical trial execution, technology and performance testing. This new addition to MCRA will only allow us to improve our customers’ success throughout the entire product lifecycle, with a focus on the main goal: FDA approval.”

About MCRA, LLC: MCRA is the leading private, independent clinical research organization (CRO) and consulting firm for medical devices, diagnostics and biologics. MCRA delivers its client’s industry experience and integrates its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to deliver a dynamic, market-leading effort from concept of innovation to commercialization . MCRA’s integrated application of these key value-creating initiatives provides unparalleled value to its customers. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 customers worldwide. Key areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dentistry, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery. urology and in vitro diagnostic (IVD) devices. www.mcra.com

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. Headquartered in New York City, VB specializes in financing venture capital, private equity and investment banking activities for the neuromusculoskeletal industry. VB is committed to financing healthcare innovation. www.vbllc.com

For more information please contact:
Erinn Grable, business development manager
Phone: 202.552.5821 | Email: egrable@mcra.com

SOURCE MCRA, LLC

The use of 3D printing can improve outcomes by providing 3D modeling to physicians with real-world scenarios to practice and reference.

EDEN PRAIRIE, Minnesota & REHOVOT, Israel, November 27, 2023–(BUSINESS WIRE)–Stratasys Ltd. (NASDAQ: SSYS), a leader in polymer 3D printing and additive manufacturing solutions, today announced it is partnering with Siemens Healthineers to conduct a groundbreaking research project designed to develop new state-of-the-art solutions develop for the advancement of medical imaging phantoms for computed tomography (CT) imaging.

CT phantoms are a crucial tool in medical imaging and a nearly universal resource in hospitals around the world. They are specialized devices used to evaluate and ensure the performance of CT scanners. Phantoms are designed to simulate certain characteristics of the human body and enable the assessment of several key metrics, including radiation dose and image quality, facilitating calibration and ensuring consistent scanner performance. The joint development uses Stratasys’ PolyJet™ technology in combination with Siemens Healthineers’ unique RadioMatrix™ technology and advanced algorithm, aimed at translating scanned patient images into specific radiopacity material characteristics of the human anatomy. The solution enables custom phantom production and the creation of ultra-realistic human anatomy characteristics with complete radiographic accuracy of patient-specific pathology that was previously not possible.

This joint project will transform the way phantoms can be used in the medical field, and in some cases even allow device manufacturers and academic institutions to replace human cadavers with 3D printed structures. Having this capability enables critical efficiency and minimizes unavoidable human variability. This work will also generate a critical amount of research data, providing important insights for advancing CT system algorithms, driving materials development and unlocking potential new application areas – and identifying future research opportunities.

“The current limitations of phantoms have long been a challenge for the radiology community,” said Erez Ben Zvi, Vice President of Medical at Stratasys. “This collaboration with Siemens Healthineers will allow us to jointly explore the tremendous potential of our radiopaque materials and 3D printing technologies to overcome these barriers.”

Starting with the production of 3D printed phantoms for smaller scale anatomies of the head and neck region, the research will include the production of increasingly larger and more complex anatomies – leading to the Phase One endpoint of 3D printing a heart model and a complete human torso with full radiographic accuracy.

“The knowledge gained from this project represents a breakthrough in medical imaging that will open new possibilities for 3D printing and imaging applications,” said Lampros Theodorakis, Head of Computed Tomography Product & Clinical Marketing at Siemens Healthineers. “We are excited about the opportunities that await us as a result of this collaboration and believe it will have long-term implications for medical and academic applications.”

About Stratasys

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products, healthcare, fashion and education. Through smart and connected 3D printers, polymer materials, a software ecosystem and on-demand parts, Stratasys solutions deliver competitive advantages at every stage of the product value chain. The world’s leading organizations turn to Stratasys to transform product design, make manufacturing and supply chains more agile, and improve patient care.

For more information about Stratasys, visit www.stratasys.com, the Stratasys blog, X/Twitter, LinkedIn or Facebook. Stratasys reserves the right to use any of the foregoing social media platforms, including the Company’s websites, to share material, non-public information pursuant to the SEC’s Regulation FD. To the extent necessary and required by applicable law, Stratasys will also include such information in its public disclosure filings.

Note to editors: High-resolution images and additional information are available upon request from the appropriate media contacts listed.

Contacts

Investor and media contacts

Stratasys Business &
North America
Chris Reese
chris.reese@stratasys.com
+1 6651 357 0877

Investor Relations
Jonah Lloyd
Yonah.Lloyd@stratasys.com
+972 74 745 4919

Europe, the Middle East and Africa
Jonathan Wake / Samantha White,
Incus Media
stratasys@incus-media.com
+44 1737 215200

Brazil, Central America and South America
Erica Massini
Erica.Massini@stratasys.com
+55 (11) 2626-9229

Stratasys Corporate & Israel
Erik Snider
Erik.Snider@stratasys.com
+972 74 745 6053

Asia
Kalyani Dwivedi
Kalyani.Dwivedi@stratasys.com
+91 80 6746 2606

The pinnacle of minimally invasive surgical visualization, Summit™ is the first-of-its-kind 4K single-use surgical arthroscope designed to simplify endoscopy

MANCHESTER, NH, November 27, 2023–(BUSINESS WIRE)–Pristine Surgical, a medical device company committed to making endoscopy more efficient, consistent and safer, has accelerated the launch of its Summit™ 4K single-use surgical arthroscope – the first of its kind. After an overwhelmingly positive response during its limited market launch, Summit™ is now available to hospitals and ambulatory surgery centers across the United States.

“Summit™ is a fully integrated, single-use scope with 4K resolution that simplifies arthroscopic procedures and packs the latest in minimally invasive visualization technology into a sterile, cost-effective, ready-to-use package,” said Bryan Lord, CEO of Pristine Surgical. “I am pleased with the feedback we have received and we are excited to make this groundbreaking arthroscope available nationwide to help surgeons and their teams innovate their endoscopy suite.”

Summit™ is a brand new, 100% sterile 4K scope for every patient and is ready to use right out of the box, eliminating the time-consuming operating room set-up and tear-down process and device reprocessing required for reusable arthroscopes. It comes pre-installed with Pristine Connect™ software for seamless cloud-connected surgical image and video storage and automated inventory management.

“We developed Summit to address the challenges inherent in conventional surgical visualization – which relies on reusable arthroscopes that are becoming outdated, difficult and expensive to maintain, and prone to wear, damage and potential infections,” said Dr. Stephen J. Snyder, a pioneer in shoulder arthroscopy and Chief Medical Officer of Pristine Surgical. “It’s a major leap forward in an area that hasn’t changed much in my 40-plus years of practice, and when we saw the positive response and impact it had on our limited market launch, we were convinced that it was time to fully commercialize Summit.”

Summit integrates with a surgery center’s existing endoscopy tower, allowing ASCs to upgrade to 4K without major capital investments. It is delivered through a unique subscription scope business model and has transparent pricing to make this groundbreaking medical device cost-effective and practical. Through sustainability partnerships, Pristine Surgical will also offer recycling options to its customers.

Summit™ is available through select distributor partners in the United States. For more information or to learn how you can bring Summit to your facility, please contact info@pristinesurgical.com.

About pristine surgery

Pristine Surgical is a medical device company on a mission to simplify endoscopy. The company combines single-use endoscopes with cloud-based software to make minimally invasive visualization more efficient, consistent and safe. Pristine Surgical offers a subscription business model with transparent pricing and automated inventory management, delivering improved workflow and lower costs for the endoscopy suite. For more information, visit pristinesurgical.com or search for the company on LinkedIn.

Contacts

Dia Kalakonas
GM, Marketing Communications
Pristine surgical procedure
603-496-5493
dkalakonas@pristininesurgical.com

Photo: Business Wire

NAPLES, FL, November 20, 2023–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has appointed Amy Ables, Ph.D. as the organization’s Chief Strategy Officer, effective immediately.

“The board and I are pleased that an executive with the experience and leadership of Dr. Ables is joining our team at Catalyst OrthoScience,” said Carl O’Connell, CEO and president of Catalyst. “We are committed to building a world-class organization focused on the success of our customers and our impact in the marketplace. The leadership of Dr. Ables will help make that vision a reality and guide us as we build greater capabilities and organizational competence to accelerate growth and scale our operations.”

“I am grateful and excited to embrace this opportunity with the Catalyst team and return to my professional roots in shoulder orthopedics,” said Ables. “I look forward to contributing with strength and vision and driving our efforts toward growth and excellence with strategies that are both responsive to the present and aligned with the necessary investments for our future success.”

Ables brings nearly 20 years of medical device experience to Catalyst, including more than a decade in upper extremity orthopedics. She held leadership positions in sales, marketing, medical education and sales training at Tornier and Wright Medical before joining ATEC Spine.

Most recently, Ables served as Vice President of Customer Engagement and Sales Excellence at Cutera, a medical aesthetics organization. Before Cutera and during the peak of the COVID-19 pandemic, Ables served as Chief Learning Officer at Vyaire Medical, a global organization focused on respiratory care.

Throughout her career, Ables has built a reputation as a strong customer-focused leader with an incomparable energy for continuous learning, strategy development and execution. Ables is a highly skilled, relatable leader who is driven to deliver results through team performance. She is a culture bearer who believes credibility is key and always leads by example.

Ables earned a Bachelor of Science in Sports Medicine from the University of Charleston, a Masters in Biomechanics and a Ph.D. in human performance from Texas Woman’s University in 2003.

About Catalyst OrthoScience Inc.

Naples, Florida-based Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, MD, who saw the need to make shoulder replacements less invasive, with fewer complications and a more natural-feeling shoulder after surgery. Catalyst disrupts the traditional approach to shoulder replacement surgery. Our total shoulder systems provide precision and accuracy in shoulder restoration, while preserving the patient’s bone and soft tissue. Catalyst has a growing portfolio of patents and patents pending on its distinctive offerings, which are available in the US. For more information, visit www.catalysstortho.com.

Contacts

Nancy McCarroll, CAO
570.335.7417
nmccarroll@catalystortho.com

BURLINGTON, Mass., November 20, 2023–(BUSINESS WIRE)–Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiology products for the spine fusion markets, today announced the closing of its previously announced registered direct offering at market-based prices under Nasdaq rules of an aggregate of 1,139,063 shares of its common stock at a purchase price of $0.64 per share. In a concurrent private placement, the Company also issued and sold unregistered warrants to purchase an aggregate of 1,139,063 shares of common stock. The unregistered warrants have an exercise price of $0.52 per share and are exercisable upon issuance and have a term of five and a half years from the date of issuance.

HC Wainwright & Co. acted as exclusive placement agent for the offering.

The gross proceeds to Bone Biologics from the offering were approximately $729,000, before deducting placement agent fees and other offering expenses payable by the Company. Bone Biologics currently intends to use the net proceeds from the offering to fund clinical trials, maintain and expand its patent portfolio and for working capital and other general corporate purposes.

The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (Registration No. 333-265872), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on June 28, 2022 and declared effective by the SEC on 11 July 2022. The offering of the common shares issued in connection with the registered direct offering was made only by means of a prospectus supplement forming part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the registered direct offering have been filed with the SEC and are available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained by contacting HC Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or email to placements@hcwco.com.

The offer and sale of the unregistered warrants in the private placement were made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “ Securities Act “) and/or Rule 506(b) of Regulation D promulgated thereunder and, together with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or the applicable state securities laws. Accordingly, the unregistered warrants offered in the private placement and the underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable government bonds. securities laws.

This press release shall 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 the registration. or qualification under the securities laws of any such state or jurisdiction.

About bone biology

Bone Biologics was founded to pursue regenerative medicine for bones. The company is working with select strategic partners that will build on the preclinical research on the Nell-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft replacement product on bone regeneration in spinal fusion procedures, while also having rights to applications in trauma and osteoporosis. For more information, please visit www.bonebiologics.com.

Forward-Looking Statements

Certain statements in this press release, including but not limited to the expected use of proceeds from the offering, as well as statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements.” statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and factors including the Company’s ability to deliver our flagship product to develop NELL-1. and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain necessary financing to develop products and conduct necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval for commercialize any product it may develop in the United States and to obtain any other regulatory approval necessary to market a product in other countries, its ability to commercialize any product it may develop market, its ability to create, sustain, manage or predict its growth; the ability to attract and retain key personnel; changes in the company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized development company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the The Company’s Form S-1, Form 10-K for the year ended December 31, 2022, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contacts

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com

GAINESVILLE, Fla., Nov. 20, 2023–(BUSINESS WIRE)–Exactech, a developer and manufacturer of innovative implants, instrumentation and smart technologies for joint replacement surgery, today announced that its Active Intelligence® (AI) platform has a total of more than 100,000 exceeded joint replacement surgeries around the world.

“We are proud to reach this incredible milestone of more than 100,000 patients with the support of our surgeon partners worldwide,” said Darin Johnson, CEO of Exactech. “As a leader in orthopedic innovations, Exactech is focused on pushing technological boundaries to deliver a best-in-class platform of enabling technologies and smart solutions. With a commitment to research and transformative technologies, such as a first-to-market surgical guidance system, machine learning-based tools and personalized planning solutions, we are delivering on our vision to unlock data insights through platform-independent, economical innovations that improve clinical outcomes .”

Active Intelligence was launched in 2021 as a dynamic ecosystem of enabling technologies and smart solutions that provides unparalleled support to surgeons in and outside the operating room. With powerful scheduling software, prediction tools, disruptive surgical technologies and engagement capabilities, Exactech AI provides surgeons with data-rich, low-cost solutions that help improve patient outcomes.

Some notable achievements of Exactech AI include:

• Informed by the collective intelligence of thousands of surgeries, powerful tools have enabled more than 2,500 personalized patient predictions by more than 450 surgeons around the world.
• Personalized preoperative planning software, expanded globally this year, allows surgeons to plan the placement of shoulder components and select implants and sizes for the scapula and humerus based on each patient’s specific anatomy.
• At no capital cost, more than 500 GPS stations are used by thousands of surgeons in hospitals and ASC centers around the world, and in nearly half of Exactech shoulder cases.
• Modern alignment philosophies are supported by our ligament-controlled Newton Knee platform, now used in more than half of our guided, personalized knee surgeries.
• A unique clinical exchange app connects all Exactech surgeons worldwide.

For more information, visit www.ExactechAI.com.

ExactechGPS, Equinoxe Planning App and Predict+ are developed by Blue Ortho, a subsidiary of Exactech, and distributed by Exactech, Inc.

About Exactech

Exactech is a global medical device company that develops and markets orthopedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies for hospitals and physicians. Headquartered in Gainesville, Florida, Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, Vumedi, YouTube, Instagram and Tweet. With Exactech by your side you have EXACTLY what you need.

Contacts

Courtney Adkins
Director of Marketing Communications
media@exac.com

Photo: Business Wire

The PathKeeper 3D optical navigation system is used to improve the clinical experience, increase surgical accuracy and eliminate radiation exposure during spine surgery.

KFAR SABA, Israel, Nov. 16, 2023 /PRNewswire/ — PathKeeper Surgical, a privately held, Israel-based medical technology company, is committed to improving the health of people around the world suffering from all spinal problems requiring surgery. As PathKeeper Surgical celebrates the first use of the PathKeeper 3D optical navigation system during spinal fusion surgery at Southcoast Health’s St. Luke’s Hospital in New Bedford, Massachusetts, PathKeeper Surgical is committed to making navigation-guided surgery available to every patient in all operating rooms.

The PathKeeper system was used to create a comprehensive surgical plan and accurately navigate the single-level lumbar degenerative spinal fusion surgery at Southcoast Health’s St. Luke’s Hospital.

“The PathKeeper system addresses many of the complexities of spine surgery and adapts to the patient’s individual needs with a high degree of accuracy and without radiation during a critical part of the surgical procedure,” said Matthew Philips, MD, chief of Brain & Spine Services, Southcoast Health Neurosurgery, Dartmouth, MA. “We have already experienced the clinical benefits of integrating the PathKeeper system into our spinal fusion surgeries at St. Luke’s Hospital.”

The PathKeeper system is designed to replace traditional navigation technology with a 3D optical navigation system that provides comprehensive surgical planning; active, independent submillimeter registration and tracking of patient anatomy and surgical instruments; establish precise accuracy of device implantation; more efficient surgical workflow; elimination of radiation exposure during the surgical procedure; and a more affordable price point so that both hospital operating rooms and ambulatory surgical center operating rooms can integrate this new technology.

“We are very pleased with the adoption of the PathKeeper system at Southcoast Health, which continues our expansion of the PathKeeper system to hospitals and surgery centers across the United States,” said Ryan LeBlanc, Chief Commercial Officer of PathKeeper Surgical. “The PathKeeper system is a game changer in driving improved clinical outcomes and economic value for patients and healthcare providers.”

PathKeeper Surgical received FDA 510k clearance for the PathKeeper System earlier this year. The name PathKeeper effectively describes the essence of the system: a 3D optical navigation system that ‘keeps’ the surgical ‘path’ on course throughout the operation.

About PathKeeper Surgical
PathKeeper Surgical is an Israel-based medical technology company that has developed a solution to combat the high failure rates in spine surgery. PathKeeper was founded in 2018 by Erez Lampert, a top expert in medical 3D imaging with more than 20 years of experience in the healthcare and aerospace industries, and a proven track record in 3D imaging. Erez previously served as R&D leader for the Itero Element Intraoral Scanner for Align Technology (Invisalign), the world’s leading 3D dental scanner. Josh Schroeder, MD, director of Spinal Deformities at Hadassah Medical Center and an HSS fellow, has been on board as a clinical advisor since the company’s founding. Erez and Josh’s combined knowledge enabled the company to develop an innovative navigation system that outperforms existing solutions. More information can be found at path-keeper.com.

About Southcoast Health
For more than 25 years, Southcoast Health has served communities in southeastern Massachusetts and Rhode Island as the region’s largest provider of primary and specialty care. The nonprofit charity system includes three acute care hospitals – Charlton Memorial in Fall River, St. Luke’s in New Bedford (a Level II Trauma Center) and Tobey in Wareham – as well as a network of more than 700 physicians, hospitalists and mid-level practitioners.

Southcoast Health has established six urgent care centers, two cancer centers, a Visiting Nurse Association and numerous outpatient facilities that ensure convenient access to services for 725,000 residents in 33 communities covering 900 square miles. Additionally, the system has partnered with Acadia Healthcare to provide expanded resources at Southcoast Behavioral Health in Dartmouth.

Southcoast Health has been consecutively recognized as a Newsweeks World’s Best Hospital of 2019-2023, in addition to being ranked as a High Performing Hospital for Maternity Care during the calendar years 2021-2022 and 2022-2023 by American news and world report.

With more than 7,500 employees, Southcoast Health is the largest employer in southeastern Massachusetts and one of the largest employers in the Commonwealth, according to the Boston Business Journal. More information is available online at www.southcoast.org.

US Media Contact:
Ryan LeBlanc
head of marketing
ryan.leblanc@path-keeper.com

Photo – https://mma.prnewswire.com/media/2279117/PathKeeper.jpg

SOURCE PathKeeper

Recent coverage of Intracept in the healthcare plan^® system expands access to vertebrogenic pain treatment to tens of millions of patients

MARLBOROUGH, Mass., Nov. 17, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the completion of its acquisition of Relievant Medsystems Inc., a company offering the only U.S. Food and Drug Administration-approved Intracept system^® Intraosseous nerve ablation system, a therapy for the treatment of vertebrogenic pain, a form of chronic low back pain. The Intracept System, a basivertebral nerve ablation therapy, will complement Boston Scientific’s chronic pain portfolio, which includes spinal cord stimulation, radiofrequency ablation and an interspinous spacer procedure.

Relievant recently secured national coverage from Anthem Blue Cross Blue Shield and Humana, both of which are now effective and expanding access to the Intracept system. These national payers join Cigna Healthcare and local Medicare¹ plans that allow greater access to treatments for people with vertebrogenic pain. This policy expands access to more than 150 million lives.

“Relievant’s revolutionary therapy has tremendous potential to help even more people with chronic pain,” said Jim Cassidy, president, Neuromodulation, Boston Scientific. “The completion of this acquisition further differentiates our position in advanced interventional chronic pain, providing physicians with the broadest selection of evidence-based treatment options that address multiple pain targets and transform patients’ lives.”

The acquisition includes an upfront cash consideration of $850 million and undisclosed additional contingent payments based on sales performance over the next three years. On an adjusted basis, the transaction is not expected to be material to adjusted earnings per share in 2024, increasing slightly in 2025 and increasing thereafter. On a GAAP basis, the transaction is expected to have a greater dilutive effect due to depreciation and acquisition-related costs.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global leader in medical technology for more than 40 years, we advance science for life by providing a broad range of high-quality solutions that address patients’ unmet needs and reduce healthcare costs. To learn more, visit www.bostonscientific.com and get connected Tweet 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 can be identified by words such as “anticipate,” “expect,” “expect.” project”, “believe”, “plan”, “estimate”, “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates based on 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 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 prove incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied in our forward-looking statements. These factors have in some cases (along with other factors) affected our ability to implement our business strategy and could cause actual results in the future to differ materially from those contemplated by the statements contained in this press release. As a result, readers are cautioned not to place undue reliance on our forward-looking statements.

Factors that could cause such differences include: future economic, political, competitive, reimbursement and regulatory conditions; production, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other events related to climate change; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; demographic trends; concluding and integrating acquisitions; intellectual property rights; dispute; conditions in the financial markets; the execution and impact of our business strategy, including cost savings and growth initiatives; future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many 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 the Quarterly Reports on Form 10-Q that 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 applies to all forward-looking statements contained in this press release.

CONTACTS:
Jessica Sachariason
Media relations
+1 (415) 730-2310
jessica.sachariason@bsci.com

Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com

¹ Data on file. Local Medicare coverage includes Blue Cross Blue Shield Michigan and Palmetto GBA is a Medicare Administrative Contractor covering Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia and West Virginia.

SOURCE Boston Scientific Corporation

BURLINGTON, Mass., Nov. 17, 2023–(BUSINESS WIRE)–Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiology products for the spine fusion markets, today announced that it has entered into a definitive agreement to issue and sell a aggregate of 1,139,063 shares of common stock at a purchase price of $0.64 per share in a registered direct offering that will be priced at the market under Nasdaq rules. In a concurrent private placement, the company also agreed to issue and sell unregistered warrants to purchase an aggregate of 1,139,063 shares of common stock. The offering is expected to close on or about November 20, 2023, subject to the satisfaction of customary closing conditions.

HC Wainwright & Co. is acting as the exclusive placement agent for the offering.

The unregistered warrants have an exercise price of $0.52 per share, become exercisable upon issuance and have a term of five and a half years from the date of issuance.

The gross proceeds to Bone Biologics from the offering are expected to be approximately $729,200, before deducting placement agent fees and other offering expenses payable by the Company. Bone Biologics currently intends to use the net proceeds from the offering to fund clinical trials, maintain and expand its patent portfolio and for working capital and other general corporate purposes.

The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a shelf registration statement. on Form S-3 (Registration No. 333-265872), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on June 28, 2022 and declared effective by the SEC on July 11, 2022. The offering of the common shares to be issued in the registered direct offering will be issued only by means of a prospectus supplement forming part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained by contacting HC Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856- 5711 or email placements@hcwco.com.

The offer and sale of the unregistered warrants in the private placement are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “ Securities Act”). Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, together with the common stock underlying such unregistered warrants, are not registered under the Securities Act or applicable state laws the field of effects. Accordingly, the unregistered warrants offered in the private placement and the underlying common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable government bonds. securities laws.

This press release shall 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 the registration. or qualification under the securities laws of any such state or jurisdiction.

About bone biology

Bone Biologics was founded to pursue regenerative medicine for bones. The company is working with select strategic partners that will build on the preclinical research on the Nell-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft replacement product on bone regeneration in spinal fusion procedures, while also having rights to applications in trauma and osteoporosis. For more information, please visit www.bonebiologics.com.

Forward-Looking Statements

Certain statements in this press release, including, but not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions relating to the offering and the anticipated use of proceeds therefrom, as well as statements containing the words “believes ” contain. “anticipates,” “expects” and words of similar meaning constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and factors including the Company’s ability to deliver our flagship product to develop NELL-1. and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain necessary financing to develop products and conduct necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval for to market any product it develops in the United States and to obtain any other regulatory approval necessary to market a product in other countries, its ability to market any product it develops to market, its ability to create, support, manage or predict its growth; the ability to attract and retain key personnel; changes in the company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized development company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the The Company’s Form S-1, Form 10-K for the year ended December 31, 2022, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contacts

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com

Curiteva, a privately held technology and manufacturing company based in Huntsville, Alabama, is proud to announce the commercial launch of its Prowess Laminoplasty System. The system is designed to provide surgeons with the tools they need to perform posterior decompression of the cervical spine with greater precision, accuracy and efficiency.

The Prowess system was designed based on feedback from surgeons and the first cases were performed by Dr. Joel Pickett at Huntsville Hospital in Huntsville, AL. “I am very pleased with the comprehensive, easy-to-use design of this system,” said Dr. Pickett. “This system is just a representation of Curiteva’s vision to maximize results while minimizing patient impact.”

The system consists of a variety of plate and spacer options, making it intraoperatively adjustable to treat different patient anatomies. The easy-to-use kit layout features streamlined tools such as a self-locking screwdriver, multiple plate insertion options and screw hole preparation choices, ensuring a consistent approach to the laminoplasty procedure.

“The feedback from distributors, scrub techs and surgeons has been overwhelmingly positive. They consistently tell us that our system is both reliable and efficient,” said Kevin Dill, director of strategic initiatives at Curiteva.

Curiteva strives to provide innovative solutions to improve patient outcomes. As the system grows, Curiteva plans to integrate the Inspire 3D printed trabecular PEEK technology into the laminoplasty spacer as an alternative to allograft.

About Curiteva:

Curiteva is a privately held technology and manufacturing company based in Huntsville, AL. Our company is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering new technology to meet the evolving needs of our customers and the patients they serve. operate. Curiteva is pioneering 3D printing of trabecular PEEK implants with a bioactive nanosurface to revolutionize how engineered structures and implant biomaterials accelerate immunomodulation, enhance healing and improve patient outcomes . For more information, please visit www.curiteva.com