Category: Knee deformation

Increases 2023 annual revenue guidance to $88 million – $91 million

BELGRADE, Mont., November 09, 2023 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal conditions, today reported financial and operating results for the third quarter ended September 30, 2023.

“Driven by strong organic growth of 18% and contributions from our recent acquisitions, we achieved record third quarter revenue of $25 million, up 73% year over year, and exceeded our 2023 revenue guidance for the second consecutive quarter increased. ” said Sean Browne, president and CEO of Xtant Medical. “I am extremely proud of our team’s efforts to integrate Surgalign’s hardware and biologics businesses while growing our core businesses. These results and execution are a testament to their steadfast commitment and dedication. With the integration with Surgalign running smoothly, we remain focused on optimizing our distribution network and further scaling our operations. We look forward to building on this momentum by providing comprehensive solutions to patients in need and maximizing value for our shareholders.”

Financial results third quarter 2023

Third quarter 2023 revenue grew 73% to $25.0 million, compared to $14.5 million for the same quarter in 2022. Revenue includes 18% organic growth plus a 55% increase from products added in the acquisition of the Coflex and CoFix lines and Surgalign hardware and products. biological matters. These sales increases are primarily attributed to increased sales from independent agents and private label brands, sales from the acquired Coflex and CoFix product lines, and sales from the Surgalign acquisition.

Gross margin for the third quarter of 2023 was 61.3%, compared to 54.6% for the same period in 2022. The increase is primarily due to greater production efficiencies, lower costs for excess and obsolete inventory and product mix, in part offset by higher product yields. cost.

Operating expenses for the third quarter of 2023 totaled $18.7 million, compared to $9.8 million for the third quarter of 2022. The increase was primarily due to additional independent agent sales commissions, higher personnel costs, legal fees and amortization of intangible assets related to the Coflex and CoFix product lines.

Net income in the third quarter of 2023 was $9.2 million, or $0.07 per share, compared to the net loss in the third quarter of 2022 of $2.4 million, or $0.03 per share.

Non-GAAP Adjusted EBITDA for the third quarter of 2023 was $0.5 million, compared to a Non-GAAP Adjusted EBITDA loss of $0.9 million in the prior year period. The Company defines Adjusted EBITDA as net income/loss from operations before depreciation, amortization and interest expense and provision for income taxes, and as further adjusted to add or exclude, as applicable, non-cash compensation, acquisition-related expenses, acquisition costs. -related fair value adjustments, gain on bargain purchase and dispute settlement reserve. A calculation and reconciliation of the Adjusted EBITDA with the net loss can be found in the attached financial tables.

Financial guidance 2023

Xtant Medical is raising its full-year 2023 revenue guidance to $88 million to $91 million, compared to the company’s previous guidance of $75 million to $77 million. The revised guidance represents annual revenue growth of approximately 52% to 57% compared to full-year 2022 revenue and includes contributions from the Surgalign transaction.

Conference call

Xtant Medical will host a webcast and conference call to discuss its third quarter 2023 financial results on Thursday, November 9, 2023 at 9:00 AM ET. To access the webcast, click here. To access the conference call, call 877-407-6184 within the US or 201-389-0877 outside the US. A replay of the call will be available at www.xtantmedical.com, under ‘Investor Info’.

About Xtant Medical Holdings, Inc.

Xtant Medical’s mission to honor the gift of donation so that our patients can live the fullest and most complete lives possible is the driving force behind our company. Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development and commercialization of a comprehensive portfolio of orthobiology spinal products and implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. ease . Xtant’s people are dedicated and talented and work with the highest integrity to serve our customers.

The symbols ™ and ® indicate trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States and other countries. All other trademarks and trade names referred to in this press release are the property of their respective owners.

Non-GAAP Financial Measures

To supplement the Company’s consolidated financial statements prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), the Company uses certain non-GAAP financial measures in this press release, including Adjusted EBITDA and Organic Sales Growth. Reconciliations of the non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures can help investors evaluate the Company’s operations from period to period. Management uses the non-GAAP measures in this release internally to evaluate the company’s performance, including resource allocation. Investors should consider non-GAAP financial measures only as a supplement to, and not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend on or refer to future events or circumstances, or that contain words such as “intends” , “expects”, “anticipates”, “plans”, “believes”, “estimates”, “continues”, “future”, “will”, “potential”, “moving forward”, “guidance”, similar expressions or the negative thereof, and the use of future data. Forward-looking statements in this press release include the Company’s 2023 financial guidance. The Company cautions that its forward-looking statements, by their nature, involve risks and uncertainties, and actual results could differ materially depending on a number of important factors, including among others other: the future operating results and financial performance of the Company; its ability to increase or maintain revenues; risks associated with the recent acquisitions and integration of these companies; expected stem cell shortages that will negatively impact future revenues; possible future impairments on long-lived assets and goodwill and write-downs on excess inventories; the ability to remain competitive; the ability to innovate, develop and introduce new products; the ability to attract and retain new and existing independent distributors and agents and qualified personnel and the Company’s dependence on key independent agents for a significant portion of its revenue; the effect of COVID-19, labor and hospital staff shortages on the Company’s business, results of operations and financial condition, particularly as they impact key markets; the company’s ability to successfully implement its future growth initiatives and the risks associated therewith; the effect of inflation, higher interest rates and other recessionary factors and supply chain disruptions; the effect of changes in product sales mix on the company’s financial results; government and third party coverage and reimbursement for company products; the ability to obtain and maintain regulatory approvals and comply with government regulations; the effects of product liability claims and other legal proceedings to which the Company may be subject; the effect of product recalls and defects; the ability to obtain and protect the Company’s intellectual property and proprietary rights and operate without violating the rights of others; risks associated with the Company’s clinical trials; international risks; the ability to service the company’s debt, comply with debt covenants and access additional debt; the ability to obtain additional financing on favorable terms or at all; and other factors. Additional risk factors are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC) on March 8, 2023 and subsequent SEC filings by the Company, including but not limited to the most recent quarterly report on Form 10-Q for the quarterly period ended September 30, 2023 is expected to be filed with the SEC. Investors are encouraged to read the company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.

Contact person for Investor Relations

David Carey
Lazar FIND
Phone: 212-867-1762
Email: david.carey@finnpartners.com

SEE FINANCES HERE

Recruiting a panel of leading KOL surgeons who believe Nociscan can improve the diagnosis and treatment of discogenic low back pain is a critical step in establishing Nociscan as the standard of care.

Aclarion’s KOL panel represents spine surgeons at some of the largest and most influential academic centers and private practices in the country, including leaders of national associations that advocate for protocols to improve clinical treatments.

The company plans to activate MRIs for every KOL surgeon to expand Nociscan access for their patients and demonstrate improvements in clinical outcomes to payers.

Aclarion will release initial scan volume data before the end of the year and begin reporting on quarterly scan volume in 2024, as increasing scan volume is a measure of increasing revenue and the likelihood of a coverage decision the local payer.

BROOMFIELD, CO, November 8, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced that they have successfully achieved their goal of enrolling ten leading spine surgery KOLs to join the company help bring Nociscan to the standard of care for identifying discogenic low back pain.

“Since executing our IPO last year, Aclarion has consistently delivered value creation catalysts that fall within a very concise framework of technology readiness, clinical evidence and surgeon advocacy and are proven to bring disruptive technological advances to the standard of care in the healthcare industry. said Brent Ness, Chief Executive Officer of Aclarion. “The steps we have taken in a short period of time demonstrate that our actions follow our stated intentions. We are incredibly proud of the KOL panel that has worked to bring Nociscan to the standard of care.”

A cornerstone of the company’s strategy is Key Opinion Leaders (KOL) advocacy. Aclarion has now achieved its goal of engaging 10 leading spine physicians who are deploying Nociscan in their practices to close a major gap with conventional lumbar MR imaging, which cannot distinguish between pain and aging. Our KOL advisors are focused on advancing value-based healthcare through improved outcomes while advocating for societies and payers that leverage patient data and peer-reviewed, published clinical evidence. “KOL’s interest in Nociscan directly reflects the challenge of diagnosing and treating low back pain, and we are pleased that these physicians are advancing spine care with Nociscan,” said Ryan Bond, Chief Strategy Officer of Aclarion.

KOLs, consultants and advisors now include:

• Chris Ames, MD; University of CA San Francisco
• Gregory Basil, MD MBA; University of Miami
• Sigurd Berven, MD; University of CA San Francisco
• George Frey, MD; Advent Health Colorado
• Roger Hartl, MD; Weill Cornell Brain and Spine Center, New York, NY
• Dean Karahalios, MD; Advocate for the Aroura Health System
• James Keller, MD; University of Michigan Health West
• Alpesh Patel, MD MBA; Northwest
• Eric Potts, MD; St. Vincent’s, Ascension Day
• Juan Uribe, MD; Barrow Neurological Institute
• Bob Eastlack, MD; Scripps (surgeon consultant)
• Timothy Ryken, MD; (Consultant)
• Lawrence Tannenbaum, MD; RadNet (MD advisor)
• Jeffrey Lotz, PhD; University of CA San Francisco (Scientific Advisor)

The company will announce expansion of MRI access for each KOL once their MRIs are onboard. Dr. Frey and Hartl already have access to Nociscan and have used it in their clinical practice. As access to MRI increases, so will the potential scan volume, peer-reviewed evidence, and revenue.

For more information about the BEST trial, please visit: www.besttrial.org
For information about BACPAC, please visit: https://heal.nih.gov/research/clinical-research/back-pain
For more information about REACH, please visit: www.bacpac-reach.org
For more information about our published evidence, please visit: www.aclarion.com
For information about accessing Nociscan, please visit: www.aclarion.com

About Aclarion, Inc.
Aclarion is a healthcare technology company that uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information please visit www.aclarion.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s April 21, 2022 Prospectus as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), as well as other disclosures. included in the Prospectus and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor contacts:
Kirin M. Smith
PCG Advice, Inc.
646.823.8656
ksmith@pcgadvisory.com

Media contacts:
Jodi Lamberti
SPRIG advice
612.812.7477
jodi@sprigconsulting.com

Survey available for download; podcast planned with further data analysis

WESTCHESTER, Ill., Nov. 8, 2023 /PRNewswire/ — Avanza Healthcare Strategies, a leading expert in ambulatory surgical centers (ASCs) and outpatient services, has released the results of the 5th Avanza Intelligence Hospital Leadership ASC Survey.

The 2023 results continue to illustrate the fluidity of the surgery center industry and how the overall outpatient market continues to mature. Key findings include:

• ASC investments are accelerating and becoming central to the overall health care system strategy. More than seven in 10 hospitals and health care systems plan to continue investing in and joining ASCs.
• Ownership dynamics and equity incentives remain fluid. Hospitals prefer to have an ownership stake of more than 50%, and a growing number prefer to own 100% of their ASC.
• The maturing market continues to impact operational strategies. Hospitals and healthcare systems are considering alternative approaches to external partnerships.

“Investments in ASCs continue to increase and we are seeing increasing attention to outpatient strategies as part of larger strategic planning,” said Avanza founder Joan Dentler, MBA. “The market is experiencing a confluence of events due to price pressure, government regulation and the acceleration of complex business conducted in ASCs. This is a dynamic market and many of our clients are working to stay ahead of these competitive forces by developing a comprehensive, long-term strategy around ASC development.”

The survey, which can be downloaded here, was conducted by HealthLeaders Media on behalf of Avanza, with input from C-suite and board members, as well as financial, operational and clinical leaders from across the country.

Digging deeper into ownership trends, approximately two-thirds of leaders surveyed indicated that when their hospital or healthcare system partners or is considering partnering with physicians for an ASC joint venture, their organization owns or prefers to own a majority stake in the operating room . Centre. The survey found that the number of hospitals owning 100% of their ASCs increased by 61% from the previous survey.

“There is a growing desire to have control over record migration for both clinical and financial reporting purposes,” said Erik Miller, president of Avanza and parent company MedHQ. “Physician partners are increasingly favoring larger equity stakes in hospitals and healthcare systems to leverage contract relationships between payers and clinical operations.”

Later this month, Joan Dentler will elaborate on the study’s findings in a podcast with industry leaders.

About Avanza care strategies

Avanza is an ASC and healthcare consulting organization that supports leading healthcare organizations in planning, developing, executing and executing their ASC and outpatient strategies. Over the past 20 years, Avanza has worked with more than 150 organizations and participated in more than 500 ASC projects, representing more than $200 million in customer revenue. Avanza Healthcare Strategies is a subsidiary of MedHQ, a leading technology-based services provider that leverages expertise in human resources, accounting, clinical staffing and revenue cycles to strengthen outpatient strategies.

For more information:
Phone: 512.479.6700
Email: 368317@email4pr.com
Find Avanza on LinkedIn

SOURCE Avanza Healthcare Strategies

Pre-sutured fascia allograft designed for hip arthroscopy specialists to help the surgeon increase the efficiency of their procedures and return their patients to an active lifestyle

CENTENNIAL, Colo., Nov. 8, 2023 /PRNewswire/ — AlloSource®, one of the largest allograft providers creating innovative tissue products to help surgeons heal their patients, today announced the first implant of the AceConnex Pre-Sourd Fascia Device for hip-labral reconstruction announced and augmentation. The labral reconstruction procedure was performed by Dr. Winston Gwathmey of University of Virginia Health as part of AceConnex’s limited market launch, marking the next step in the advancement of AlloSource’s products to support hip arthroscopy.

“I appreciated having AceConnex Pre-Surtured Fascia for this labral reconstruction procedure because it made my process in the operating room more efficient compared to the extra time I spent suturing myself,” said Dr. Gwathmey. “I am honored to be the first surgeon in the United States to implant AceConnex. This device will be a true innovation for this procedure as it will allow the surgeon to suture an allograft preoperatively.”

AceConnex Pre-Sutured Fascia is a device intended for use as part of soft tissue surgical procedures where constructs, including those containing allograft tissue, are used for reconstruction, replacement or augmentation of the labrum. The off-the-shelf, sterile device will be available in multiple pre-sutured lengths and diameters, with trimmable areas that allow adjustments of the allograft to match the patient’s anatomy. Additionally, AceConnex Pre-Surtured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured intraoperatively. For many years, fascia allografts have been documented as an effective allograft for labral reconstruction. ^1,2

“The AceConnex Pre-Sutured Fascia allograft device represents a commitment to developing patient-specific solutions for the treatment of hip labral injuries as part of our comprehensive sports medicine and hip arthroscopy portfolio,” said Kevin Whitten, Chief Commercial Officer of AlloSource.

Surgeons have trusted and implanted AlloSource fascia for labral procedures since 2012.

For more information about the new AceConnex pre-bonded fascia, please email info@allosource.org.

About AlloSource
AlloSource, one of the largest suppliers of human tissue, honors tissue donors by creating innovative dermis, cartilage, tendon, fascia, bone and amnion allografts to help patients heal. Since 1994, the Colorado-based nonprofit organization has continued to develop its allografts to improve patient outcomes and serves as a trusted tissue partner to the medical community. AlloSource® is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks. Learn more at allosource.org.

References

1. Carreira DS, Kruchten MC, Emmons BR, et al. Arthroscopic labral reconstruction using fascia lata allograft: shuttle technique and results over at least two years. J Hip conservation surgeon. 2018;5(3):247-58.
2. Rathi R, Mazek J. Arthroscopic acetabular-labral reconstruction with fascia lata allograft: clinical results at a minimum one-year follow-up. Open Orthop J. 2017;11:554-61.

Media contact
Cindy Mason
AlloBron
720. 873. 4744
cmason@allosource.org

SOURCE AlloSource

MAGNOLIA, Texas, Nov. 8, 2023 /PRNewswire/ — Stratus^® Medical, a company focused on improving clinical outcomes for chronic pain patients by advancing radiofrequency (RF) technology for the treatment of pain, today announced the issuance of its fifth U.S. patent (U.S. Patent No. 11,806,070 ) and the first two Canadian patents (Canadian patent). Nos. 2,778,997 and 2,799,505) for the NIMBUS^® Electrosurgical RF multitine expandable electrode (“NIMBUS”).

These important patents further protect NIMBUS’ valuable intellectual property for its highly differentiated pain ablation technology. The company now holds 29 issued patents and 11 pending patent applications for its technology and will continue to file additional applications. NIMBUS is rapidly gaining market share in the US and other key markets around the world, where Stratus Medical distributes through both direct sales representatives and distributor partners.

Bret Boudousquie, CEO of Stratus Medical, said: “We continue to invest in our patents, trademark registrations and trade secrets for our valuable RF ablation technologies. We are committed to making NIMBUS the preferred ablation technology for the treatment of pain and are fortunate to work with many of the leading physicians and hospitals in the United States, United Kingdom, Australia, Brazil, Spain and other countries using NIMBUS to improve the quality of life. for patients.”

Amitabh Gulati, MD, a board-certified, interventional pain medicine physician based in New York City and president of the World Academy of Pain Medicine United (WAPMU), noted: “We have used NIMBUS RF ablation technology to treat spine and joint-related problems. to deal with. pain in our practice for the past four years and are satisfied with our clinical results. NIMBUS deployable teeth are unique and provide technical simplicity during placement, reducing overall procedure time. In addition, we are conducting ongoing research that will validate the improved lesion size and shape of the NIMBUS ablation zone compared to standard radiofrequency needling. We believe these qualities support NIMBUS as the preferred RF ablation technology for clinical and educational use.”

About Stratus^® Medical – Stratus Medical’s mission is to improve clinical outcomes for patients with chronic pain by advancing RF technology. The NIMBUS^® Electrosurgical RF Multitined Expandable Electrode (“NIMBUS”), in combination with a radio frequency (RF) generator and thermocouple probe, is intended for use in RF heat lesion procedures for pain relief. NIMBUS is FDA approved and CE marked. NIMBUS is easy to implement into the existing workflow, has demonstrated reduced procedure time and delivers significant savings for many of our customers. Stratus Medical continues to invest in the development of future technologies that align with our mission. Our headquarters are located in Magnolia, Texas.

Media contact
Cody Jorgensen
Director, Marketing
Stratus Medical
346-703-0642
cody@stratusmedical.com
https://stratusmedical.com

SOURCE Stratus Medical

LEWISVILLE, Texas, November 6, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch in the U.S. of the WaveForm^® L Lateral lumbar interbody system. Designed for lateral lumbar interbody fusion (LLIF) procedures, the 3D printed WaveForm L features a porous structure that prioritizes strength and stability to provide a robust fusion environment.

“Designed to safely and reproducibly treat the spine via indirect decompression and sagittal alignment restoration, the WaveForm L features a large core opening for the placement of bone graft material to optimize bone fusion throughout the body,” said Dr. Donald Blaskiewicz, director of Spinal Malformation at St. Luke’s Boise Medical Center in Boise, Idaho, and faculty at UCSD in San Diego, CA. “The WaveForm L also has enhanced imaging properties to assist with radiographic visualization during intra- and postoperative imaging. These combined features make it one of the best 3D printed interbodies available.”

WaveForm interbodies are uniquely created with a primary focus on structure, surface and stability. Constructed from a repeating wave-like structure, WaveForm L is designed to efficiently distribute compressive loads and provide high porosity for optimized stiffness without compromising strength.^1,2 With an 80 percent body porosity, WaveForm L provides improved imaging properties and greater graft packability, while the optimized 65 percent endplate porosity of the wave-like structure provides bone ingrowth and early mechanical stability.^3,4,5

“We are committed to delivering a comprehensive portfolio of innovative, procedurally focused products that are strategically designed to work together to drive fusion,” said Kevin Kenny, president of Orthofix Global Spine. “WaveForm L represents the latest developments in patented spinal implant technology, which is designed to address the many nuances of spinal pathology to meet the individual needs of patients, providing both clinical and economic value to patients, surgeons and hospital systems.”

Lateral lumbar interbody fusion (LLIF) procedures represent approximately 20 percent of the interbody device market. The number of these procedures is expected to continue to increase based on the rapid growth of titanium-coated PEEK devices and 3D printed metal devices. According to 2022 data, the LLIF market in the US is estimated at over $350 million.⁶

1. Data available, TM-0043-22
2. Kelly, Cambre N., et al. “Design and structure-function characterization of 3D printed synthetic porous biomaterials for tissue engineering.” Advanced Healthcare Materials 7.7 (2018): 1701095.
3. Data available, TM-0071-23
4. Data available, D0006845
5. Kelly, C.N., Wang, T., Crowley, J., Wills, D., Pelletier, M.H., Westrick, E.R., Adams, S.B., Gall, K., & Walsh, W.R. (2021). High-strength, porous, additively manufactured implants with optimized mechanical osseointegration. Biomaterials, 279, 121206. https://doi.org/10.1016/j.biomaterials.2021.121206
6. Data on file. Market estimates based on iData 2022 US Market Report Suite for Spinal Impants and MIS.

About Orthofix

Orthofix and SeaSpine merged in January 2023 to form a leading global spine and orthopedics company with an extensive portfolio of biologics, innovative spine hardware, bone growth therapies, specialty orthopedic solutions and a leading surgical navigation system. The products are distributed in approximately 68 countries around the world.

The company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and corporate offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy. with an emphasis on product innovation, production and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil. For more information, visit Orthofix.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects” , ‘intends’, ‘predicts’, ‘potential’, ‘continue’ or other similar terminology. Orthofix cautions you that statements in this press release that are not descriptions of historical facts are forward-looking statements based on the company’s current expectations and assumptions. Any forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including due to the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s annual report. on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6. , 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Orthofix does not intend to revise or update any forward-looking statement contained in this press release to reflect events or circumstances occurring after the date of this press release, except as may be required by law.

Contacts

Media relations
Denise Landry
DeniseLandry@orthofix.com
214.937.2529

Investor Relations
Louisa Smith, Gilmartin Group
IR@orthofix.com

Scientist, inventor, business expert and holder of more than 140 patents will advance PUR Biologics’ regenerative therapeutic patent portfolio to address unmet needs in the $200 billion osteoarthritis, pain and cartilage and spine regeneration markets.

IRVINE CA., November 7, 2023 – OrthoSpineNews – HippoFi, Inc. (OTCPK: ORHB) is proud to announce the appointment of the world’s foremost authority and pioneer in regenerative medicine, Gail Naughton, MBA, Ph.D, as the “Head of Regenerative Therapeutics and Commercialization.”

Recognized worldwide, Dr. Naughton was awarded the 27th annual National Inventor of the Year by the Intellectual Property Owners Association in honor of her groundbreaking work in tissue engineering and regenerative medicine. Dr. Naughton has been a driving force in regenerative medicine for more than 35 years and, as founder of Advanced Tissue Sciences and Histogen, has a proven track record in monetizing important cell-based therapies and bioengineered tissue technologies. Although it is known for taking four products from concept, through FDA approval, to market launch; and taken two companies to a NASDAQ stock exchange listing, she has had broad success in commercializing major brands that are still widely sold today by establishing partnerships and strategic business alliances with several industry giants, including: NYSE Company Allergan (recently purchased by AbbVie for $63B), NYSE company Smith & Nephew, NYSE company Medtronic, and Inamed Corporation (also owned by AbbVie).

“I am thrilled and honored to join the visionary HippoFi team and work together to transform healthcare by developing and commercializing life-changing regenerative medicine solutions for unmet medical needs,” said Gail Naughton, MBA, Ph.D – Head of Regenerative Therapeutics and Commercialization.

Dr. Naughton has served on the board of directors of several public and private companies since 1988. She currently serves as chair of the board of directors of the La Jolla Institute, executive chair of BioHIP, a member of the boards of NASDAQ, Therapeutics MD, and NYSE company CelSci, and serves on the boards of International Business and Fowler College of Business at SDSU. In addition to serving for eleven years on the board of the Toronto-based, publicly funded Center for the Commercialization of Regenerative Medicine (CCRM), she also served for several years on the bioengineering advisory board of John Hopkins, UCSD, MIT and Georgia Tech. Dr. Naughton served as dean of the College of Business Administration at SDSU from 2002 to 2011 and received her Ph.D. and MS from NYU Medical Center and an MBA from UCLA.

“Dr. Naughton is a globally recognized, accomplished entrepreneur with many proven track records, visionary talent and unparalleled experience that will be extremely valuable to HippoFi’s continued growth and success,” said CJ Wiggins, MBA – Founder, Executive Chairman and CEO of HippoFi. “As a pioneer in our industry, adding her expertise to our experienced team not only helps us quickly commercialize and monetize our patented technologies, but also validates the tremendous market value of our patent portfolio and strengthens HippoFi as a leader in the market for regenerative therapies. ”

About PUR Biologics
PUR Biologics, a wholly owned subsidiary of HippoFi, Inc. (OTCPK: ORHB), is a leading biologics company committed to supporting surgeons and hospitals in providing the best care to their patients. PUR Biologics’ full line of biological products currently includes: advanced allografts and demineralized extracellular matrices (dECM), innovative synthetic solutions, cellular-derived tissues and a future of next-generation regenerative stem cell and growth factor-driven therapies for the treatment of osteoarthritis and cartilage regeneration.

About HippoFi, Inc.
HippoFi, Inc. delivers its breakthrough healthcare innovations through an extensive sales channel network while deploying first-to-market solutions in the multi-billion dollar biotech, fintech and artificial intelligence (AI) markets. HippoFi consists of three segments: Regenerative Therapeutics, Digital Payments and AI, which use the same customer channels to commercialize solutions, increase revenue and improve patient outcomes.

HippoFi, Inc. is publicly traded under the symbol: ORHB and is headquartered in Irvine, California. For more information, please visit: www.HippoFi.com and www.PURbiologics.com.

Contact
HippoFi, Inc.
949-323-2330
info@hippofi.com

ENGLEWOOD, CO, November 7, 2023–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) (“Paragon 28” or “Company”), a leading medical device company focused exclusively on the foot and ankle orthopedic market, today announced that it has received a new $150 million credit facility from Ares Capital Corporation (“the Facility”) to replace the existing $90 million senior credit facility. The facility consists of up to $100 million in term loans, with $75 million drawn at closing, and a $50 million revolving credit facility, with $25 million drawn at closing. The facility has no dilutive effect without warrants or other equity-based instruments. The Company’s pro forma liquidity as of September 30, 2023 is $147.0 million, including $97.0 million of pro forma cash and $50 million of available borrowings under the facility.

“We expect continued improvements in our earnings and cash flow in 2024 and beyond, and the non-dilutive liquidity provided by Ares strengthens P28’s path to breakeven cash flow,” said Steve Deitsch, Chief Financial Officer.

“We are excited to partner with Paragon 28, a truly innovative and fast-growing company,” said Doug Dieter, partner at Ares’ Credit Group. “P28’s growth and leadership in the global foot and ankle market has been impressive, and we are pleased to support its continued mission to improve patient outcomes.”

Further details regarding the credit agreement are included in the Company’s Form 8-K filed with the U.S. Securities and Exchange Commission on November 7, 2023.

About Paragon 28, Inc.

Based in Englewood, Colo., 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.

About Ares Management Corporation

Ares Management Corporation (NYSE: ARES) is a leading global alternative investment manager offering clients complementary primary and secondary investment solutions across the credit, private equity, real estate and infrastructure asset classes. We strive to provide flexible capital to support businesses and create value for our stakeholders and within our communities. By working with all our investment groups, we aim to generate consistent and attractive investment returns throughout market cycles. As of September 30, 2023, Ares Management Corporation’s global platform had approximately $395 billion in assets under management, with approximately 2,800 employees operating in North America, Europe, Asia Pacific and the Middle East. For more information, please visit www.aresmgmt.com.

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 and estimated net revenues for the full year 2023. 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 an accurate indication 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. As a result of these risks and uncertainties, actual results and the timing of events may differ materially from those anticipated in such forward-looking statements. These risks and uncertainties are more fully described in the section entitled “Risk Factors” in Paragon 28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s Annual Report on Form 10-K filed on filed with the SEC on March 2. , 2023. Paragon 28 undertakes no obligation to update any forward-looking statements and expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the views of Paragon 28 as of any date subsequent to the date of this press release. Paragon 28’s results for the quarter ended September 30, 2023 are not necessarily indicative of our results of operations for future periods.

Contacts

Contact person for investors:
Matt Brinckman
Senior Vice President, Strategy and Investor Relations
mbrinckman@paragon28.com

Appointment of Sandrine Carle
as deputy general manager

Ecully, November 7, 2023-The Spineway Group, specialists in innovative implants for the treatment of serious spinal disorders, announces the appointment of Sandrine Carle as Deputy Chief Executive Officer. Ms. Carle joined Spineway in July 2022, at the time of the acquisition of Spine Innovations, where she was CEO. She was instrumental in the successful integration of Spine Innovations into the Spineway Group.

After obtaining a degree in biomedical engineering (UT Compiègne) and an Executive MBA at HEC in Paris, Sandrine Carle worked for more than 20 years in the orthopedic surgery sector, and more specifically in the spine surgery sector at Medtronic (Europe), Kyphon (USA) and Vexim (France). She held marketing and management positions in France and the US before being appointed CEO of Spine Innovations in 2020.

Ms. Carle led the creation of this entity following a spin-off in 2020¹ and the development of this activity between 2020 and 2022. She led the recruitment and management of about fifteen employees, set up the functional and operational organization of the team and also obtained the company’s certification from the notified body G-MED (France ).

Together with Stéphane Le Roux, CEO of Spineway, Sandrine Carle is responsible for executing the Group’s overall roadmap, in particular the business development plan aimed at returning to operational break-even,² as well as all R&D projects (short, medium and long term).

Stéphane Le Roux said: “I am pleased that Sandrine is joining me as Deputy Chief Executive Officer of Spineway. I am confident that her leadership, strategic insight and deep market knowledge will help shape our future. She will strengthen our highly experienced management team. Sandrine will also lead the Group’s development plan as we remain committed to our core values ​​of quality and innovation. She will work closely with me, our management team and all our employees to achieve our goal: to become an innovative player in France and internationally, a leader in less invasive spine treatments.”

Next event:
November 10, 2023: Extraordinary General Meeting

SPINEWAY ELIGIBLE FOR PEA-SME (Small and Medium Business Equity Savings Plans)
Find out all about Spineway at www.spineway.com

This press release has been drawn up in both English and French. In case of contradictions, the French version shall prevail.

Spineway designs, produces and sells innovative implants and surgical instruments for the treatment of serious spinal conditions.
Spineway has an international network of more than 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specialized in innovation), has received the OSEO Excellence Award since 2011 and the Deloitte Fast 50 Award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent Award (2015).
ISIN: FR001400BVK2 – ALSPW

Contacts:

SPINEWAY Shareholder services line Available from Tuesday to Thursday +33 (0)806 706 060

Suitable PEA/PME ALSPW Euonext growth

HEAVEN Office & Communications Relations with investors Solène Kennis Spineway@aelium.fr

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1 Spine Innovations was a spin-off born in 2020 from the sale of Groupe FH Orthopedics (France) to the Spineway Group.
² Positive operating result

• Third quarter net sales of $1.754 billion increased 5.0% and 4.7% at constant exchange rates¹ base
• Third quarter diluted earnings per share were $0.77; adjusted¹ diluted earnings per share were $1.65
• The company updates reported 2023 revenue expectations due to currency expectations and reaffirms consistent 2023 foreign exchange revenue growth and adjusted¹ financial guidelines for earnings per share

WARSAW, Ind., Nov. 7, 2023 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended September 30, 2023. The company reported third quarter net sales of $1.754 billion, up 5.0% from the same period last year, and an increase of 4.7% at constant exchange rates¹ base. Net income for the third quarter was $162.7 million, or $346.5 million adjusted¹ base.

Diluted earnings per share were $0.77 for the third quarter and were adjusted¹ diluted earnings per share were $1.65.

1.	Reconciliations of these measures to the corresponding US generally accepted accounting principles are included in this press release.

“We are very pleased to report another Zimmer Biomet quarter of strong revenue growth and earnings per share. Our team continues to successfully drive execution and growth with a focus on innovation to create value for the stakeholders we serve,” said Ivan Tornos, President and Chief Executive Officer of Zimmer Biomet. “As the new CEO of ZB, I am more confident than ever in our team, our full-year expectations for 2023 and that our solid growth – both top and bottom line – will continue in 2024.”

Recent Highlights

In line with the ongoing transformation of Zimmer Biomet’s business, key recent highlights include:

• Appointment of Ivan Tornos as President and Chief Executive Officer and expansion of Chief Financial Officer Suketu (Suky) Upadhyay’s role to CFO and EVP, Finance, Operations & Supply Chain as part of Zimmer Biomet’s increased focus on innovation and commercial execution
• Major updates to the Zimmer Biomet Executive Leadership Team, including the promotion of Wilfred van Zuilen to Group President, EMEA and Mark Bezjak to President of the Americas, as well as the appointment of Chief Science, Technology and Innovation Officer Nitin Goyal, MD to the Executive Leadership team
• Registration of 100,000 patients since the launch of mymobility® care management platform, which provides a guided orthopedic patient experience, with automation, data and insights for physicians
• Continued recognition for our Environmental, Social and Governance (ESG) programs with inclusion on the Newsweek Americas Greenest Companies 2024 and Sustainability Magazine Top 10: Sustainable Healthcare Device Companies lists

Geographic and product category sales

The following sales tables provide results by geography and product category for the three- and nine-month periods ended September 30, 2023, as well as the percentage change compared to the applicable prior year period, both on a reported and constant currency basis.

SEE FINANCES HERE