Category: Knee deformation

Dr. Hamid Abbasi conducted an educational Trans Kambin OLLIF Cadaver Lab while in India. Pictured here with the faculty and organizational staff. More than 30 employees and surgeons visited the laboratory.

BURNSVILLE, Minn., Nov. 15, 2023 /PRNewswire/ — Leading spine surgeon, Dr. Hamid Abbasi, CMO of Inspired Spine, was invited to India to demonstrate his groundbreaking Oblique Lateral Lumbar Interbody Fusion (OLLIF) technique at the prestigious Minimally Invasive Spine Conference of the Surgical Association of Bharat (India) (MISSABCON). Dr.’s visit Abbasi not only marks a significant contribution to the advancement of spine surgery in the country, but also signals his intention to expand his innovative approach to spine interventions in India.

The MISSABCON conference provides a unique platform for spine surgeons in India to witness Dr. OLLIF technique. Abbasi in action. Known for its minimally invasive nature and exceptional patient outcomes, the OLLIF technique has attracted the attention of the global medical community. Dr. Abbasi’s presentation and hands-on cadaver laboratory at MISSABCON aim to share valuable insights and expertise with Indian physicians, promoting collaboration and knowledge exchange.

Impressed by the rapid growth and evolution of the medical and technological landscape in India, Dr. Abbasi expresses his enthusiasm for his contribution to the country’s healthcare sector. “India is experiencing remarkable growth in the field of medicine, and I am thrilled to be part of this vibrant community. The invitation to present at MISSABCON reflects a shared commitment to advancing spine surgery techniques and improving patient care. Witnessing the dynamic developments in India has inspired me to explore opportunities for expansion and collaboration within this rapidly growing healthcare environment,” said Dr. Abbasi.

Known for its precision and effectiveness in the treatment of lumbar spine conditions, the OLLIF technique meets the evolving needs of patients seeking minimally invasive solutions for spine conditions. Dr. Abbasi is considering establishing a presence in India, with plans for partnerships, training programs and collaborations with local medical institutions.

“As a spine surgeon committed to pushing the boundaries of innovation, I see tremendous potential in contributing to the Indian healthcare landscape. My goal is to make advanced spine care more accessible to patients across the country, and I am exploring opportunities for long-term partnerships that will facilitate the integration of the OLLIF technique into the Indian healthcare system,” added Dr. Abbasi to.

Dr.’s visit Abbasi to India not only underlines his commitment to advancing global spine care, but also emphasizes the growing importance of international cooperation in the medical field. While sharing his expertise at MISSABCON, Dr. Abbasi looks forward to laying the foundation for a lasting impact on the practice of spine surgery in India.

For media inquiries, please contact Amanda Armagost at aarmagost@islife.us

SOURCE Inspired Spine

(PRNewsfoto/Inspired Spine)

WASHINGTON, Nov. 15, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics-focused clinical research organization (CRO) and consulting firm integrating seven core services [U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH)] is pleased to announce the recruitment of Dr. Carolyn Yong and Dr. Iris Marklein as Vice President and Senior Director of Regulatory Affairs for Regenerative Medicine and Biological Quality, respectively.

Dr. Yong and Dr. Marklein bring nearly two decades of FDA regulatory experience to MCRA, making them leading leaders in this rapidly growing field of medicine. Their experience and deep understanding of the operation of the Center for Biologics Evaluation and Research (CBER) policy and regulatory review will create tremendous opportunities for MCRA’s clients to effectively navigate this complex regulatory framework. In addition, Dr. Yong and Dr. Marklein brings diverse expertise from their previous roles at CBER and the Center for Devices and Radiological Health (CDRH), positioning them as experts in early regulatory strategies and combination products.

Carolyn Yong, Ph.D. has worked for more than 10 years as a biomedical engineer and Associate Director of Policy at the FDA. Dr. Yong participated in developing and advancing the policy positions of CBER and the Office of Therapeutic Products (OTP) as a key decision maker and expert on advanced manufacturing. Dr. Yong also oversaw product jurisdiction and compliance-related activities in the OTP space. As Vice President of Regenerative Medicine and Biologics Quality Regulatory Affairs at MCRA, Dr. Yong will work closely with MCRA’s existing team of regulatory experts to manage, develop and execute regulatory strategies and submissions for tissue institutions, regenerative medicine therapies and device companies.

Dr. Yong says, “I am thrilled to join MCRA at such a critical time for regenerative medicine. I look forward to working closely with leading and emerging regenerative medicine, therapeutics, human tissue and device companies to make these critical, innovative products available to people with unmet medical needs. I am also excited to help advanced manufacturing technology innovators navigate the evolving regulatory environment.”

After working at the FDA for more than 8 years, Dr. Marklein has extensive regulatory experience with regenerative medicine products, including cell and gene therapies, human tissues and combination products. Most recently, she served as Associate Director for Policy in the Office of Therapeutic Products at CBER, where she led the development of major guidance on gene therapies and human tissues. Dr. Marklein also served as Device and Combination Products team leader at CBER, focusing on delivery devices for cell and gene therapies and devices that produce biological outputs (e.g., platelet-rich plasma) at the point of care. At MCRA, Dr. Marklein works closely with cell and gene therapy, human tissue and device companies on regulatory strategies and proposals.

Dr. Marklein says, “Joining MCRA will allow me to leverage my regenerative medicine regulatory expertise to support our clients and drive meaningful change. I look forward to helping companies achieve their goals and ultimately advance patient care through the application of innovative technologies.”

Kevin McGowan, VP, Regulatory Affairs – Biologics, Tissues, and Combination Products states, “The addition of Dr. Yong and Dr. Marklein to the MCRA Regulatory team deepens MCRA’s expertise in regenerative medicine and biologics and will expand the scope of MCRA’s portfolio to include additional product types and therapeutic areas, as well as advanced manufacturing. We are pleased to welcome Carolyn and Iris to the MCRA team to further the expansion of MCRA’s focus in the field of regenerative medicine.”

Glenn Stiegman, SVP, Clinical & Regulatory Affairs said: “I am pleased that Dr. Yong and Dr. Marklein to join the MCRA team. The regenerative medicine space is a growing and exciting market that cuts across the entire medical industry. The skills and experience that Carolyn and Iris bring to the regulatory team will be a great addition to our current expertise and to the other therapy verticals.”

Anthony Viscogliosi, CEO of MCRA, said: “This strategic expansion of MCRA’s former FDA talent base underscores our commitment to providing our clients with the best regulatory guidance, and ultimately better serving patients around the world. Carolyn and Iris will not only strengthen MCRA’s knowledge of regenerative medicine, but also unlock new opportunities to serve customers in rapidly evolving areas such as advanced manufacturing.”

About MCRA, LLC: MCRA is the leading private, independent Clinical Research Organization (CRO) and advisory organization 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, United Kingdom, 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:
Alyssa Howard, vice president, business development
Phone: 215.870.3952 | Email: ahoward@mcra.com

SOURCE MCRA, LLC

HOPCo expands its East Coast footprint with one of the largest MSK platforms in the region

DANBURY, Conn. , Nov. 14, 2023 /PRNewswire/ — OrthoConnecticut, one of Connecticut’s largest MSK multi-specialty practices, announced they are partnering with Healthcare Outcomes Performance Company (HOPCo), the national leader in musculoskeletal practices and clinical results management solutions and the nation’s largest orthopedic value-based healthcare organization.

OrthoConnecticut is a leader in MSK care throughout the region and consists of 48 musculoskeletal providers with 9 locations in Connecticut. The practice’s Centers of Excellence provide integrated treatment by a team of orthopedic surgeons, physician assistants, imaging specialists and support staff. The practice helps patients regain their mobility, live an active life and achieve optimal health.

OrthoConnecticut was founded following the merger of Coastal Orthopedics, Danbury Orthopedics, New Milford Orthopedics and Connecticut Pain Care. “Our intent in joining forces and becoming OrthoConnecticut has always been to combine best practices to provide the best possible outcomes and experience for our patients,” said Dr. Michael Brand, president of OrthoConnecticut. “Now that we have consolidated into one platform, we knew we would benefit from an experienced partner who could provide proven infrastructure for continued growth and accelerated market transformation. We witnessed how HOPCo helped improve practices similar to ours with the value they bring, so we knew this was the best choice as a partner.”

The partnership between HOPCo and OrthoConnecticut will continue to develop unique clinically integrated partnerships with other leading musculoskeletal practices, physicians, healthcare systems and payers throughout Connecticut and the surrounding regions.

OrthoConnecticut will be equipped with HOPCo’s proven clinical, quality, outcomes, digital patient engagement and claims analytics infrastructure to drive performance, growth and value-driven market transformation in the musculoskeletal space. Leveraging HOPCo’s proprietary care management platform, software tools and analytics, the partnership will deliver value-based healthcare solutions that improve healthcare outcomes, patient access, healthcare equity and the patient experience.

“OrthoConnecticut is a shining example of a practice leading the transition to value-based care in their market,” said Dr. Wael Barsoum, President and Chief Transformation Officer at HOPCo. “Their decision to become OrthoConnecticut signaled to the community their commitment to expanding access to excellent care. As they partner with HOPCo, we want to help them accelerate their growth, improve outcomes and reduce costs for patients and payers, while still providing unparalleled patient access and personalized care.”

OrthoConnecticut is the latest addition to HOPCo’s growing national MSK market transformation platform. Over the past twelve months, HOPCo has entered into multiple partnerships in Philadelphia and five new partnerships in Florida, including a partnership to manage MSK spending for 2 million insured lives. HOPCo has also entered into multiple practice partnerships in Nevada and additional partnerships in Michigan and Arizona. HOPCo also partners with healthcare systems and physician practices in more than 30 states and continues to collaborate with payers across the U.S. on advanced value-based care programs.

About Healthcare Outcomes Performance Company (HOPCo)
Healthcare Outcomes Performance Company (HOPCo) is the national leader in integrated, value-based health outcomes management, practice management and service line management for healthcare systems. This includes extensive expertise in all MSK specialties including orthopedics, spine, neurosurgery, hand, pain management, rehabilitation and neurology. HOPCo’s integrated care, analytics, and facility development and management platforms are proven to increase the quality of patient care while reliably reducing the total cost of care across the care continuum for practices, healthcare systems and payers alike. HOPCo’s affiliated payers, practices and healthcare systems successfully participate in highly efficient, value-based contracting (bundled payments, chronic episodes of care initiatives, population health programs and other advanced risk-based arrangements), using HOPCo’s proprietary platforms, IT solutions, digital patient care, engagement platform, integrated analytics and evidence-based, comprehensive care pathways. Visit www.hopco.com for more information.

About OrthoConnecticut
OrthoConnecticut is a multispecialty practice staffed by leaders in orthopedics and pain care, and is the unified practice of Coastal Orthopedics, Danbury Orthopedics, New Milford Orthopedics and Connecticut Pain Care. The practice-trained physicians offer appointments at 9 office locations. The practice’s goal is to help patients regain their mobility, live active lives and achieve optimal health. Offices in Danbury, Darien, Litchfield, New Milford, Norwalk, Ridgefield, Sharon, Southbury and Westport. For my information, visit www.myorthoct.com

SOURCE Healthcare Results Performance Company

Tallahassee, Florida, November 14, 2023 – OrthoSpineNews – Vy Spine, a leader in spine innovation using differentiated materials and designs, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).

The new ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine. PEKK implants (as opposed to PEEK) implants exhibit bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time, and a significantly higher push-out force compared to standard PEEK.

Vy Spine’s patented OsteoVy lattice structure helps with bone integration and fluid drainage, because PEKK is a hydrophilic material, to provide even more benefits as an interbody implant.

“The ClariVy OsteoVy PEKK approval is the first in a long line of Vy Spine implants that will leverage the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, president of Product Development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we began to realize that its composition achieves what we as an industry had always hoped PEEK would achieve. But PEEK fell short. We are very excited about the OXPEKK material and our collaboration with Oxford Performance Materials to make this new device possible.”

“We are thrilled that Vy Spine has achieved this important milestone,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s new, 3D printed OsteoFab technology and Vy Spine’s innovative designs and experience in the spine market will drive substantial adoption of this best-in-class solution.”

About Vy Spine, LLC.

VySpine was created through active internal development and licensing of several proven technologies using innovative materials and designs. The company strives to outperform its competitors by partnering with key spine innovators while providing a flexible, cost-effective approach to spine care. More information can be found at www.vyspine.com.

About Oxford Performance Materials, Inc.

Oxford Performance Materials, Inc. was founded in 2000 to exploit and market the world’s highest performing thermoplastic plastic, PEKK (polyether-ketone-ketone). OPM’s Materials division has developed a range of proprietary technologies for the synthesis and modification of a range of PAEK polymers sold under the OXPEKK® brand, including coating technologies for a range of industrial and biomedical applications. The company is a pioneer in the field of 3D printing. OPM’s OsteoFab® technology is commercially produced in numerous orthopedic implant applications, including cranial, facial, spinal and sports medicine devices, and OPM’s OXFAB® production parts are designed for highly demanding industrial applications.

“Vy Spine”, “ClaiVy” and “OsteoVy” are registered trademarks of Vy Spine.

Media contact: Paul Williams, 310-569-0023, paul@medialinecommunications.com

ENGLEWOOD, Colo., November 14, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its BEAST™ Cortical Fibers which provide an osteoinductive porous structure for cellular adhesion and osteoinductive potential to aid in cellular differentiation and bone formation. Designed to complement specific surgical applications in the foot and ankle, these loose cortical fibers are flexible with hydration, allowing application even to extremely challenging fusion sites. The cortical matrix absorbs bioactive fluid, including bone marrow aspirate, and supports cellular infiltration to stimulate efficient bone remodeling. Powerful processing capacity enables the retention of natural bone morphological proteins (BMPs) and other growth factors necessary to promote bone formation.

The addition of the BEAST™ Cortical Fibers strengthens Paragon 28’s biological product offering, including the PRESERVE™ Bone Wedge System, V92™ and V92™-FC+ Cellular Bone Matrices, MgNum™ Bone Void Filler, Paraderm™ Dermal Matrix, BEAST™ Demineralized Bone Matrices and Pro3™ Placenta and Umbilical Cord Regenerative Tissue Matrices. With this extensive portfolio, Paragon 28® offers its customers innovative biological solutions for reconstruction and trauma.

About Paragon 28, Inc.

Based in Englewood, CO., Paragon 28 is a leading medical device company focused exclusively on the foot and ankle orthopedic market and committed to improving the lives of patients. Since its inception, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and devices covering a wide range of foot and ankle conditions, including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flat foot, Charcot foot and orthobiological agents . The company designs products with both the patient and surgeon in mind, with the goals of improving outcomes, reducing recurrences of disease and complications, and making procedures simpler, more consistent and reproducible.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates and assumptions, which speak only as of the date on which they are made, and are subject to risks and uncertainties, some of which we are not currently aware of. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at or at which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Paragon 28’s business generally, see the current and future reports from Paragon 28 filed with the Securities and Exchange Commission. Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements . except as required by law.

Disclaimer

Nothing in this material is intended to provide specific medical advice or take the place of written law or regulation.

Contacts

Contact person for investors

Matthew Brinckman
Senior Vice President, Strategy and Investor Relations
Phone: (720) 912-1332
mbrinckman@paragon28.com

MOVE®-C cervical artificial disc replacement

NONNWEILER, SAARLAND, GERMANY, November 14, 2023 /OrthoSpineNews/ — NGMedical GmbH, a medical device manufacturer focused exclusively on creating innovative technologies for spinal applications, announces the first implantation of its MOVE^®-C cervical artificial disc replacement in Taiwan.

MOVEMENT^®-C combines the features of a second-generation viscoelastic disc prosthesis with the simple implantation technique of a cervical cage. The prosthesis provides physiological movement in all six planes, including axial damping with progressive movement resistance. MOVEMENT^®-C is the first prosthesis with additively manufactured titanium end plates and avoids the use of PE.

“The first implantation of our MOVE^®-C cervical artificial disc replacement in Taiwan marks another important milestone for NGMedical. The market launch in Taiwan is the next step in the global commercialization of our MOVE^®-C artificial disc prosthesis. Taiwan is a very active spine market and we are proud to see how MOVE^®-C is even more widely used and accepted by experienced spine surgeons in many countries.” says Peter Weiland, CEO of NGMedical.

About NGMedical
We are an owner-managed company specializing in the development of innovative spinal implants. Many years of experience, combined with a high degree of creativity, give us the impetus to significantly advance the development of spine surgery.

The NGMedical team has been developing innovative product systems since 2001. NGMedical emerged from the company Advanced Medical Technologies AG, which was acquired by Medtronic Inc. in 2012. NGMedical exploits this many years of experience combined with a high degree of creativity and know-how for the development of further innovative product concepts. Both in the past and now, collaboration with a team of experienced surgeons and scientists forms the basis for the market-driven orientation. Many product solutions, which are accepted as standard and widely used today, come from our team.

Peter Weiland
NGMedical GmbH
+49 6873 999970
email us here
Visit us on social media:
Facebook
LinkedIn
Instagram

JAWS Great White Staple System (includes 12, 15, 18, 20 and 25 mm staples)

ENGLEWOOD, Colo., November 14, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its JAWS™ Great White Staple System, which is designed to provide greater strength and stability to the osteotomy or fusion site compared to traditional stapling systems. The staples feature an ultra-low profile bridge with a larger surface area to improve stability and minimize soft tissue irritation. The newly designed staple has a 400 times longer fatigue life compared to a competitive nitinol staple subjected to the same loading parameters.¹ The shoulders of the staple work together with the inserter, allowing the staple to fully seat before compression is activated, limiting the need for tamping. The staples are designed to provide a uniform compression profile across the entire osteotomy and provide a 169% higher compressive force compared to the average of a competitive marketing-leading two-pin nitinol staple.¹

Paragon 28 CEO Albert DaCosta said: “We are excited to further expand our JAWS™ base offering, allowing surgeons to address the complexities of midfoot and hindfoot reconstruction. Our development team has designed implants that provide greater fatigue resistance and increased compression compared to leading nitinol stacking systems. We look forward to expanding our market position in the midfoot and rearfoot segments with this exciting offering.”

The addition of the JAWS™ Great White Staple System strengthens Paragon 28’s product offering of rearfoot solutions, including the Gorilla® Ankle Fracture Plating System, APEX 3D™ Total Ankle Replacement, Silverback™ Ankle Fusion Plating System, Phantom® TTC Nail System and Phantom ® ActivCore™ nail system. With this extensive portfolio, Paragon 28® offers its customers innovative ankle solutions for trauma, arthritis and limb rescue.

About Paragon 28, Inc.

Based in Englewood, CO., Paragon 28 is a leading medical device company focused exclusively on the foot and ankle orthopedic market and committed to improving the lives of patients. Since its inception, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and devices covering a wide range of foot and ankle conditions, including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flat foot, Charcot foot and orthobiological agents . The company designs products with both the patient and surgeon in mind, with the goals of improving outcomes, reducing recurrences of disease and complications, and making procedures simpler, more consistent and reproducible.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates and assumptions, which speak only as of the date on which they are made, and are subject to risks and uncertainties, some of which we are not currently aware of. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at or at which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Paragon 28’s business generally, see the current and future reports from Paragon 28 filed with the Securities and Exchange Commission. Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements . except as required by law.

Disclaimer

Nothing in this material is intended to provide specific medical advice or take the place of written law or regulation.

1. Internal test data saved

Contacts

Contact person for investors
Matthew Brinckman
Senior Vice President, Strategy and Investor Relations
Phone: (720) 912-1332
mbrinckman@paragon28.com

Photo: Business Wire

Three posters accepted, including a President’s Choice Award for new data from a randomized controlled trial of postoperative pain in total knee replacement

CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) — At the 22nd annual American Society of Regional Anesthesia (ASRA) Pain Medicine Meeting in New Orleans, three posters about the SPRINT^® PNS system was shared for the first time.

The first poster, “Percutaneous PNS relieves persistent postoperative pain and improves function after TKA: results from a placebo-controlled randomized controlled trial” was recognized with a President’s Choice Award from ASRA. This poster highlights the results of a prospective study evaluating the impact of SPRINT peripheral nerve stimulation (PNS) used for chronic knee pain after total knee arthroplasty (TKA). This study not only demonstrated that the majority (60 percent) of the SPRINT PNS treatment group (n=12/20) experienced ≥50 percent pain relief at the end of treatment compared to baseline, it also provided objective functional data, measured with a six-minute walk test. The SPRINT PNS treatment group (n=18) showed a 47 percent improvement in walking ability as measured by a six-minute walk test, while the placebo group (n=20) showed a nine percent decrease. This is an important finding for the large number of TKA patients who experience persistent postoperative neuropathic TKA pain (up to 20 percent of the 800,000 patients undergoing TKA surgery annually in the US). There were no study-related serious or unexpected adverse events.

The second poster, “60 Days PNS for Pain Management in a Medicare Eligible Population: Real-World Results from a Retrospective Analysis” is a review of outcomes in a subset of 1,763 Medicare-eligible patients from the recently published SPRINT PNS real-world retrospective data of more than 6,000 patients. The Medicare eligible population is important because it has been reported that 78 percent of Medicare beneficiaries may experience chronic pain, and this retrospective review supports the use of 60-day PNS as a safe and effective option for chronic pain management in the Medicare eligible upcoming population. In this retrospective analysis, 70 percent of patients (n=1,226/1,763) were defined as responders at end of treatment (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change) for all nerve targets . , consistent with recent prospective studies. The total rate of adverse events reported for this Medicare-eligible cohort was four percent, with skin irritation being the most common event, usually due to bandages or adhesives.

Additional retrospective real-world data on the treatment of chronic low back pain in patients with lumbar spondylosis (a degenerative condition affecting the intervertebral discs, vertebrae and joints of the spine) are analyzed in the third poster, “Retrospective review of 60-day PNS targeting lumbar medial branches in subjects with spondylosis without radiculopathy.” In this study, 65 percent of patients with a suspected and/or confirmed diagnosis of spondylosis (n=173/265) were defined as responders (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change in function). Although safety was not directly evaluated in this analysis, previously published studies have shown that the most common adverse reactions are skin irritation due to dressings or adhesives and discomfort from the lead placement procedure.

“The addition of new functional data and SPRINT’s impressive, stable performance across multiple nerve targets and pain areas is exciting and confirms our belief that this treatment can have a tremendous impact on pain relief and quality of life improvement without opioids or the need for permanent implants,” said Maria Bennett, President, CEO and Founder of SPR Therapeutics.

About the SPRINT PNS system
The SPRINT^® PNS system, by SPR^® Therapeutics marks an innovative shift in the treatment of pain. Our breakthrough 60-day treatment is a first-line PNS^™ option uniquely proposed to repair the central nervous system to provide significant and long-lasting relief from chronic pain – without a permanent implant, nerve damage or the risk of addiction. The system has been extensively researched for low back pain, shoulder pain, post-amputation pain and chronic and acute postoperative pain, is approved for use up to 60 days and is recognized by leading pain management centers. Market research shows that this groundbreaking neuromodulation treatment is a patient-preferred alternative to more invasive options.

The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, postoperative and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended for placement in the area innervated by the cranial and facial nerves.

Clinicians should use common sense when deciding when to use the SPRINT PNS System. See the SPRINT PNS system instructions for use for more information. The most common side effects are skin irritation and erythema. Results may vary. Rx only.

For additional safety and efficacy information, please visit: SPR Safety Information.

About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical device company that offers patients a non-opioid, minimally invasive pain treatment option. Our SPRINT^® The PNS System fills a critical unmet need for a drug-free, surgery-free option for millions of people suffering from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and laid an incredibly strong foundation for commercial growth. Headquartered in Cleveland, Ohio with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s senior management team consists of experienced industry veterans with nearly 200 years of collective pain market and MedTech experience, all driven by our goal: improve the quality of patients. ‘ lives by offering them a minimally invasive, drug-free and surgery-free solution to manage their acute and chronic pain.

More information can be found at www.SPRTherapeutics.com.

Contact details

SPR contacts:
Michelle McDonald
Vice President – ​​​​Marketing
844-378-9108

Dave Folkens
Public relations
612-978-6547

ENGLEWOOD, CO, November 13, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) is pleased to announce the addition of a second trailer to its nationwide mobile laboratory training program, making it even easier for the company to facilitate on-site training and education of surgeons. Paragon 28’s new mobile laboratory is housed in a 40-foot tractor-trailer with a state-of-the-art cadaver training facility with 5 stations and space for up to 25 surgeons. The mobile laboratory will host more than 70 training sessions in approximately 65 U.S. cities in the fourth quarter of 2023. The mobile laboratory program launched in July 2022 and has been an incredible success for Paragon 28, allowing the company to efficiently train more than 350 surgeons.

“We are very excited to add a second laboratory to our mobile education program and increase our ability to bring education directly to surgeons. The mobile laboratory program has enabled Paragon 28 to find the most effective location for medical education to support our growing product portfolio and surgeon customers,” said Albert DaCosta, CEO and co-founder of Paragon 28. “The mobile laboratory program has proven to be an effective and versatile option to showcase P28’s broad and innovative product portfolio, which includes new solutions in the growing forefoot, HAV and rearfoot market segments.”

For more information about the Paragon 28 Surgeon Mobile Lab, visit the following site: Paragon 28 Mobile Lab

About Paragon 28, Inc.

Based in Englewood, CO., Paragon 28 is a leading medical device company focused exclusively on the foot and ankle orthopedic market and committed to improving the lives of patients. Since its inception, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and devices covering a wide range of foot and ankle conditions, including fracture fixation, hallux valgus (bunions), hammer toe, ankle, progressive collapsible foot deformity (PCFD) or flat foot, Charcot foot and orthobiology. The company designs products with both the patient and surgeon in mind, with the goals of improving outcomes, reducing recurrences of disease and complications, and making procedures simpler, more consistent and reproducible.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates and assumptions, which speak only as of the date on which they are made, and are subject to risks and uncertainties, some of which we are not currently aware of. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at or at which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Paragon 28’s business generally, see the current and future reports from Paragon 28 filed with the Securities and Exchange Commission. Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements . except as required by law.

Contacts

Contact person for investors

Matthew Brinckman
Senior Vice President, Strategy and Investor Relations
Phone: (720) 912-1332
mbrinckman@paragon28.com

Image: Business Wire

WALTHAM, Mass., November 13, 2023–(BUSINESS WIRE)–Vicarious Surgical Inc. (“Vicarious Surgical” or the “Company”) (NYSE: RBOT, RBOT WS), a next-generation robotics technology company committed to improving patient outcomes, as well as both the cost and efficiency of surgical procedures, today announced financial results for the quarter ended September 30, 2023. Management will host a corresponding conference call today, November 13, 2023, at 4:30 PM ET.

“The third quarter brought several successes for our company, but also introduced new challenges as we focused on building and integrating our version 1.0 system,” said Adam Sachs, co-founder and Chief Executive Officer. “While we were pleased with our ability to expand our cash runway through a follow-on equity offering and make meaningful progress on our individual subsystem builds, the impact of recent market-driven cost savings initiatives coupled with certain integration challenges has forced us to adjust our development schedule revised. We now expect to complete build and integration of the Version 1.0 system in Fall 2024 and therefore anticipate a De Novo submission around early to mid 2026. While there is still work to be done, we remain confident that our differentiated technology will allow us to revolutionize surgical robotics and transform the standard of care.”

Financial results third quarter 2023

• Operating expenses were $21.4 million for the third quarter of 2023, compared to $22.2 million in the corresponding period last year, a decrease of 4%.
• R&D expenditures for the third quarter of 2023 were $13.0 million, compared to $12.1 million in the third quarter of 2022.
• General and administrative expenses for the third quarter of 2023 were $6.9 million, compared to $8.1 million in the third quarter of 2022.
• Sales and marketing expenses for the third quarter of 2023 were $1.4 million, compared to $1.9 million in the third quarter of 2022.
• GAAP net loss for the third quarter was $15.7 million, representing a net loss per share of $0.10, compared to a GAAP net loss of $24.7 million, representing a net loss per share of $0.20 for the same period of the previous year. Adjusted net loss for the third quarter was $20.4 million, representing a net loss of $0.12 per share, compared to an adjusted net loss of $21.7 million, or a net loss of $0.18 per share, for the same period of the previous year.
• The company had $110 million in cash, cash equivalents and short-term investments as of September 30, 2023, including $47 million in gross proceeds from the August follow-on equity offering. Excluding these gross revenues, cash burn for the third quarter of 2023 was $16.8 million.
• The company reduced fiscal 2023 cash burn guidance to $60-$65 million and initiated a preliminary fiscal 2024 cash burn guidance of $40-$55 million.

Conference call

Vicarious Surgical will hold a conference call to discuss its third quarter 2023 financial results on Monday, November 13, 2023 at 4:30 PM ET. Investors wishing to listen to the conference call can do so by dialing +1 (404) 975 4839 for domestic callers or +1 (929) 526 1599 for international callers and using the access code: 083118. A live and archived webcast of the event will be available at https://investor.vicarioussurgical.com.

About vicarious surgery

Founded in 2014, Vicarious Surgical is a next-generation robotics company developing a unique disruptive technology with multiple objectives: significantly increasing the efficiency of surgical procedures, improving patient outcomes and reducing healthcare costs. The company’s new surgical approach uses patented humanoid surgical robots to transport surgeons inside the patient to perform minimally invasive surgery. The company is led by an experienced team of technologists, medical device professionals and physicians, and is backed by technology luminaries including Bill Gates, Vinod Khosla’s Khosla Ventures, Innovation Endeavors, Jerry Yang’s AME Cloud Ventures, Sun Hung Kai & Co. Ltd and Philip Liang’s E15 VC. The company is headquartered in Waltham, Massachusetts. More information can be found at www.vicarioussurgical.com.

Use of Non-GAAP Financial Measures

In addition to providing financial measures prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), Vicarious Surgical provides additional financial measures not prepared in accordance with US GAAP (“non-GAAP ”). ”). The non-GAAP financial measures included in this press release are adjusted net loss and adjusted net loss per share (“adjusted earnings per share,” and together with adjusted net loss “non-GAAP financial measures”). The company presents non-GAAP financial measures to help readers of its consolidated financial statements understand key operating results that management uses to evaluate the business and for financial planning purposes. Vicarious Surgical’s non-GAAP financial measures provide investors with an additional tool to compare financial performance over multiple periods.

Adjusted net loss and adjusted earnings per share are key performance measures that Vicarious Surgical management uses to assess operating performance. These non-GAAP financial measures facilitate internal comparisons of Vicarious Surgical’s operating performance on a more consistent basis. Vicarious Surgical uses these performance measures for business planning purposes and forecasting. Vicarious Surgical believes that the non-GAAP financial measures enhance an investor’s understanding of Vicarious Surgical’s financial performance as it is useful in assessing its operating performance from period to period by excluding certain items from which Vicarious Surgical believes they are not representative of its core business. .

The non-GAAP financial measures may not be comparable to similar measures of other companies because they may not calculate this measure in the same way. Adjusted net loss and adjusted earnings per share are not prepared in accordance with US GAAP and should not be considered separately from, or as an alternative to, measures prepared in accordance with US GAAP. When evaluating Vicarious Surgical’s performance, you should consider its non-GAAP financial measures in addition to other financial performance measures prepared in accordance with US GAAP, including net loss.

The non-GAAP financial measures do not replace the presentation of Vicarious Surgical’s financial results in accordance with US GAAP and should only be used in addition to, and not as a substitute for, Vicarious Surgical’s financial results presented in accordance with US GAAP. In this press release, Vicarious Surgical has provided a reconciliation between adjusted net loss and net loss, the most directly comparable financial measure under US GAAP, and the adjusted earnings per share calculation.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The Company’s actual results may differ from expectations, estimates and projections and, accordingly, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical fact contained herein, including but not limited to quotes from our Chief Executive Officer regarding, among other things, Vicarious Surgical’s opportunities, are forward-looking statements that reflect management’s current beliefs and expectations. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are beyond Vicarious Surgical’s control and are difficult to predict. Factors that could cause such differences include, but are not limited to: changes in applicable laws or regulations; Vicarious Surgical’s ability to obtain future financing; the success, cost and timing of Vicarious Surgical’s product and service development activities; the potential features and benefits of Vicarious Surgical’s product candidates and services; Vicarious Surgical’s ability to obtain and maintain regulatory approval for the Vicarious System within the expected timeline, and any related restrictions and limitations of any approved product; the size and duration of human clinical trials for replacement surgery; Vicarious Surgical’s ability to identify, license or acquire additional technology; Vicarious Surgical’s ability to maintain its existing licensing, manufacturing, supply and distribution agreements and scale production of the Vicarious Surgical System and any future product candidates to commercial quantities; Vicarious Surgical’s ability to compete with other companies that currently market or engage in products and services that Vicarious Surgical currently markets or develops, as well as the use of open operations; the size and growth potential of the markets for Vicarious Surgical’s product candidates and services, and its ability to serve those markets, alone or in collaboration with others; the pricing of Vicarious Surgical’s product candidates and services and reimbursement for medical procedures performed using the product candidates and services; the company’s ability to meet its estimates regarding expenses, revenues, capital requirements, cash runway and additional financing needs; Vicarious Surgical’s financial performance; Vicarious Surgical’s intellectual property rights, its ability to protect or enforce those rights, and the impact on its business, results of operations and financial condition if it fails to do so; economic downturn, political and market conditions and their potential to adversely affect Vicarious Surgical’s business, financial condition and results of operations; the impact of COVID-19 on Vicarious Surgical’s operations; and other risks and uncertainties identified from time to time in Vicarious Surgical’s filings with the SEC. Vicarious Surgical cautions that the foregoing list of factors is not exclusive. The Company cautions readers not to place undue reliance on forward-looking statements, which speak only as of the date hereof. Vicarious Surgical disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

SEE FINANCES HERE