Arthrex Announces Plans for Expansion of Global Headquarters

NAPLES, FL – November 9, 2017 – Arthrex announced details of its planned expansion for its North Naples global headquarters on Thursday in an event with Florida Governor Rick Scott and other state and local elected officials.

Construction is scheduled to begin next month with completion by the end of 2019.

“As Arthrex continues to experience unprecedented growth around the world, we remain committed to expanding in Southwest Florida,” said President and Founder Reinhold Schmieding. “This project was designed to accommodate our growth into the next decade, while maintaining the beautiful aesthetic of the Naples community.”

The project will demolish the Arthrex Manufacturing Inc. North building, located at 1250 Creekside Way, just east of the post office. Two grey office buildings located along Goodlette Road will also be demolished for the project.

Arthrex will construct three facilities for the project. The Arthrex Event and Administration Building will be a six-story, 300,000-square-foot modern office building with meeting space and will include a 15,000-square-foot cafeteria, a six-story parking garage with space for 1,400 vehicles and an outdoor terrace area overlooking a one-acre lake.

The INNovation Hotel, which will be located on the corner of Goodlette Road and Creekside Boulevard, will accommodate Arthrex guests and business travelers. The four-story, 170,000-square-foot full-service hotel will have approximately 160 rooms.

The third building, the Arthrex Wellness and Medical Center, will be located on the current site of the two office buildings along Goodlette Road. The two-story, 38,000-square-foot building will have a fitness center for employees with state-of-the-art equipment and group classes such as spinning and yoga. The building will also have a juice bar and lounge, a retail shop with Arthrex apparel and merchandise, and will be home to the Arthrex Medical Center, which provides free medical care to Arthrex employees and their families.

The campus expansion also includes a road project that will close the mid-section of Creekside Boulevard to create a university-style campus with abundant green space, interconnected walking and bicycle paths, a three-acre outdoor park area with a 1,000-square-foot pavilion for outdoor events and other activities.

Arthrex Boulevard, which is the street that runs between the post office and the Naples Daily News, will become the main entrance to Arthrex’s global headquarters and will undergo a renovation to expand the two-way street to include a median.

The expansion project is expected to create 560 jobs by 2021 and approximately 1,200 construction-related jobs through 2019.

About Arthrex

Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic product development and medical education for orthopedic surgeons. More than 11,000 products for arthroscopic and minimally invasive orthopedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.Arthrex.com.

DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

BALTIMORENov. 8, 2017 /PRNewswire/ — DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Hintermann Series H2™ is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2™ Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). The Hintermann Series H2™ is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2™ is protected by numerous patents with additional patents pending.

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters located in Raleigh, NC, and through specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2™ Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

DTM continues to market and distribute its Hintermann Series H3™ mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3™ is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.

Prof. Beat Hintermann, developer of the Hintermann Series™ Total Ankle Systems, stated, “I am looking forward to adding the H2 as a semi-constrained option for my patients alongside the H3* mobile-bearing prosthesis. With the addition of the new H2 prosthesis, I will be able to expand my indications and patient selection for total ankle replacements.”

DTM anticipates a limited release of the Hintermann Series H2™ in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2™ in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.

For additional DTM information inside the United States please email info@DTMedTech.com or call Ms. Jeannie Sardaat 410-427-0003; outside the United States, please email dtmedtech@healthlinkeurope.com or call +31 73 303 2537.

About DT MedTech, LLC

DT MedTech, LLC, is the parent company of DTMI and European Foot Platform, S.A.R.L. and DTM and its subsidiary companies maintain offices in Baltimore, MarylandDublin, IrelandSaint-LouisFrance; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, marketing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series™ Total Ankle Replacement Systems.*

*Hintermann Series H3™ is not available for sale within the United States and its territories.

SOURCE DT MedTech, LLC

Related Links

http://www.dtmedtech.com

Bone Therapeutics SA : Business Update for Third Quarter 2017

Gosselies, Belgium, 9 November 2017, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the third quarter ended 30 September 2017.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the Third Quarter, Bone Therapeutics has delivered several key milestones that further validated our unique, minimally invasive bone cell technology, bringing us closer to potentially game-changing treatments in the large and growing orthopaedic and bone disease markets. We were delighted to report the positive interim results for our allogeneic product ALLOB® in both spinal fusion and delayed-union fracture trials. Moreover, demonstrating the international appeal and potential of our unique bone cell therapy products, we are pleased to partner with Asahi Kasei for the development and commercialization of PREOB® in Japan, with the potential to expand to other countries in Asia.

Preparations for further clinical development of ALLOB® in delayed union fractures are well under way, as well as a continued focus on process optimization and scale up to ensure a truly commercially viable product. We also look forward to announcing the completion of recruitment in our Phase IIA spinal fusion study at end of 2017 or early 2018.

Business highlights

  • In September, Bone Therapeutics reported strong interim efficacy and safety results for the Phase IIA lumbar spinal fusion study with its allogeneic cell therapy product, ALLOB®. In addition to evidence of successful fusion shown by radiological data collected over a 12-month follow-up period (absence of motion in all patients and continuous bone bridges in 9 out of 15 patients), the interim results revealed substantial clinical improvement in function (55% improvement on the Oswestry Disability Index) and a strong reduction in back and leg pain (59% and 90% respectively). From a safety perspective, treatment with ALLOB® was well tolerated in all patients. Further details are available in the press release of September 14, 2017.
  • The Company also announced positive interim efficacy data for its ALLOB® Phase I/IIA study for delayed-union fractures. At 6 months post administration, all patients treated met the primary endpoint. Radiological evaluation of fracture healing showed an improvement of, on average, 4 points on the TUS (Tomographic Union Score) scale, twice the required minimum of 2 points. The health status of patients, as measured by the Global Disease Evaluation (GDE) score, improved by, on average, 48%, compared to the predetermined minimum of 25%. Based on these interim efficacy results, the Data and Safety Monitoring Board (DSMB) has recommended stopping the trial early due to efficacy results. ALLOB® was shown to be well tolerated. Further details are available in the press release of September 20, 2017.
  • The Company signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation. The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB®, in Japan with the option to extend into additional Asian territories. Further details are available in the press release of September 22, 2017.
  • At the beginning of September, Jean-Luc Vandebroek was appointed Chief Financial Officer. With his extensive international finance experience from major public and privately-owned companies, he will oversee the Company’s financial planning needs as it continues to mature and bring its innovative cell therapy products closer to the market.

Financial highlights

  • Cash used in operating activities amounted to EUR 10.13 million for the first nine months of 2017, compared to EUR 8.95 million for the same period in 2016.
  • Operating loss amounted to EUR 8.76 million compared to EUR 8.87 million for the same period last year.
  • Net cash at the end of September 2017 amounted to EUR 9.11 million.

Outlook

  • Bone Therapeutics expects to complete recruitment of patients into the ALLOB® Phase IIA study in spinal fusion at the end of 2017 or early 2018.
  • The Company plans to initiate the Phase IIB trial with ALLOB® for delayed-union fractures in the second half of 2018.
  • Ongoing recruitment for the pivotal Phase III study in osteonecrosis for PREOB® with interim analysis expected in the second half of 2018. The interim analysis will determine whether the trial could be stopped at this stage.
  • Good cash management will remain a key priority, with a strong focus on net cash burn. Cash burn for the full year 2017 is expected to be approximately EUR 13-14 million, below the previous guidance of EUR 15 million. Based on its strategic priorities, the Company provides guidance that it has sufficient cash to carry out its strategic objectives into Q2 2018. In order to pursue the development of its promising bone-forming cell therapy platform the Company plans to raise funds with existing and new investors to strengthen its cash position.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

SpineGuard Demonstrates the Unique Potential of its DSG™ Technology in Surgical Robotics

November 09, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today the successful completion of an experimental feasibility study in collaboration with the Institut des Systèmes Intelligents et de Robotique (UPMC /CNRS), Paris, France.

The study demonstrates how DSG™ technology can stop a robot automatically when an impending bone breach is detected and thus can prevent serious surgical complications. Practically, during a vertebral drilling, a DSG™ drill bit mounted on a robot transmits in real time an alert signal to the control unit of the robot.

Olivier Frézal, VP Technical Operations at SpineGuard declared: “We are very satisfied by this result which confirms the potential of our DSG™ technology in surgical robotics thanks to its ability to measure tissue electrical conductivity locally and in real time. A technology breakthrough is now possible, because the robot will be able to automatically drill into the human skeleton, and allow the direct insertion of DSG™ sensing “smart” implants.” I am also delighted by our collaboration with UPMC which again underlines French research excellence.”

Guillaume Morel, ISIR, Professor, Director of the team AGATHE at INSERM: “For years it has been apparent that a sensing technology that could provide robots with a feedback loop would be an indispensable component of the progress of automation of surgical procedures. When SpineGuard contacted us about this research project and presented their DSG technology, we were immediately committed to a collaboration that revealed fruitful.”

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, Tel: +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

NASS 2017 Best Paper Sessions Provide Significant Insights into the Long-Term Results of activL® Artificial Disc

CENTER VALLEY, Pa.Nov. 9, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the significance of the long-term data presented at the NASS 2017 podium during the NASS Annual Meeting in Orlando, FLOctober 25-27, 2017. At the meeting, three key presentations were made that greatly increase the body of evidence in support of lumbar total disc replacement (TDR) as a standard of care for a subpopulation of patients suffering from degenerative disc disease (DDD).

The five-year outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) Study, a 7-Year Multi-Center, Randomized Controlled Trial (RCT) which compares outcomes of the activL Artificial Disc and previous generation disc replacements such as ProDisc-L (DePuy Synthes) were presented by one of the co-investigators of the study, Jim Yue, MD (Quinnipiac UniversityNew Haven, CT). The data demonstrates that while both the activL device and the control were effective at addressing patient pain and disability at five years, the activL device was more likely to preserve segmental range of motion at five years (p = 0.03) and had a higher safety profile (p < 0.001).

Additionally, the outcomes of a landmark 5-Year Meta-Analysis of RCTs comparing lumbar disc replacement to fusion were presented by Jack Zigler, MD (Texas Back Institute, Plano, TX). The meta-analysis demonstrated that TDR was superior to fusion at addressing patient disability, reoperation and satisfaction at five years (p=0.05, p=0.002, p=0.01, respectively).

During the data presentations, one audience member posed to the panel, “Is it your opinion that lumbar disc replacement can now be considered a gold standard of care for DDD?” Dr. Zigler replied, “It’s hard to reconcile that insurers still label lumbar TDR as experimental given this five-year level 1a data.” Members of the panel concluded that the evidence supported lumbar TDR as a standard of care that spine surgeons should be offering a subpopulation of their patients and that payers need to make accessible.

Later in the week, Richard Guyer, MD (Texas Back Institute, Plano, TX) presented one of the 21 papers nominated for Best Paper at NASS detailing the outcomes of an ad hoc analysis from the activL IDE study looking at the adjacent segment disease (ASD) outcomes between disc replacement systems at five years. From the analysis conducted by an independent third party, Dr. Guyer presented a 9% ASD rate for the activL device and a 19% rate for the control. The investigators are currently conducting additional data analysis to compare these TDR device outcomes to previously reported fusion ASD rates. Dr. Guyer also presented evidence of a correlation between the protective effect that range of motion has on ASD. “Finally, for those of us that have dedicated our careers to motion preservation, there is holy grail evidence that our theories were correct,” concluded Dr. Guyer from the podium.

The NASS abstracts are indexed and available for reference in The Spine Journal. The presenters and their co-authors are finalizing the full manuscripts relative to this data with the plan to present these outcomes to U.S. payers. In 2017, 16 million additional privately-insured patients now have a positive coverage policy giving them access to lumbar TDR.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

Related Links

http://aesculapimplantsystems.com

OrthoPediatrics Corp. Reports Third Quarter 2017 Financial Results

WARSAW, Ind., Nov. 08, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its financial results for the third quarter ended September 30, 2017.

Third Quarter and Recent Highlights

  • Total revenue of $12.4 million, up 22% as compared to the third quarter of fiscal year 2016
  • Launched PediFrag™ Pediatric Specific Clavicle Plate in August and Medial Patella Femoral Ligament Reconstruction System in October, expanding our product portfolio offering to 22 surgical systems
  • Secured exclusive distribution rights for FIREFLY® Pedicle Screw Navigation Guides in pediatric hospitals in the United States
  • Completed our initial public offering, raising $59.8 million in gross proceeds, primarily to fund commercial expansion
  • Signed a Letter of Intent to amend debt agreement with Squadron Capital LLC, which lowers interest rate and extends term until 2023

“We delivered strong results in the third quarter, highlighted by 22% total revenue growth and the expansion of gross margin to 77%. This included consistent growth in both the U.S. and international markets and across all of our product categories. We were particularly pleased with the performance of our U.S. spine business, which was our fastest growing domestic category this quarter, driven by increased demand for our RESPONSE and BandLoc products,” said Mark Throdahl, Chief Executive Operator of OrthoPediatrics. “We also continued to expand our product portfolio with the launch of two new products and the addition of innovative, 3D printed, patient-specific FIREFLY® Pedicle Screw Navigation Guides, expanding our offering to 22 systems that address the $2.5 billion global market for pediatric orthopedic products. In October, we completed our initial public offering, raising $59.8 million in gross proceeds that will allow us to invest in implant and instrument sets and research and development initiatives to support future growth.”

Third Quarter Financial Results
Total revenue for the third quarter of 2017 was $12.4 million, a 22.1% increase compared to $10.1 million for the same period last year. U.S. revenue for the third quarter of 2017 was $9.6 million, a 21.3% increase compared to $7.9 million for the same period last year, representing 77.2% of total revenue. International revenue for the third quarter of 2017 was $2.8 million, a 24.7% increase compared to $2.3 million for the same period last year, representing 22.8% of total revenue.

Trauma and deformity revenue for the third quarter of 2017 was $8.7 million, a 21.8% increase compared to $7.2 million for the same period last year. Spine revenue for the third quarter of 2017 was $3.3 million, a 20.9% increase compared to $2.7 million for the same period last year. ACL reconstruction/other revenue for the third quarter of 2017 was $0.3 million, a 45.4% increase compared to $0.2 million for the same period last year.

Gross profit for the third quarter of 2017 was $9.5 million, a 32.6% increase compared to $7.2 million for the same period last year. Gross margin percentage for the third quarter of 2017 was 76.7%, compared to 70.6% for the same period last year.

Total operating expenses for the third quarter of 2017 were $10.2 million, a 33.4% increase compared to $7.7 million for the same period last year. Within operating expenses, research and development expenses for the third quarter of 2017 were $1.1 million, a 125.0% increase compared to $0.5 million for the same period last year. Operating loss for the third quarter of 2017 was $(0.8) million, a 44.6% increase in loss realized compared to $(0.5) million for the same period last year.

Interest expense for the third quarter of 2017 was $0.8 million, a 90.7% increase compared to $0.4 million dollars for the same period last year due to incremental debt incurred.

Net loss for the third quarter of 2017 was $(1.5) million, compared to $(0.8) million for the same period last year. Net loss per share attributable to common stockholders for the third quarter of 2017 was $(1.70) per basic and diluted share, or $(1.38) per basic and diluted share, for the same period last year.

The weighted average number of diluted shares outstanding as of September 30, 2017 was 1,773,385 shares.

Purchases of property and equipment during the third quarter of 2017 were $1.1 million, a 34.4% increase compared to $0.8 million for the same period last year. The primary driver of this increase was the deployment of consigned sets, which include product specific instruments as well as cases and trays.

As of September 30, 2017, cash and cash equivalents were $2.2 million, compared to $2.3 million as of June 30, 2017.

Capitalization Update
In October, OrthoPediatrics completed its initial public offering of 4,600,000 shares of its common stock at a public offering price of $13.00 per share, raising $59.8 million in gross proceeds, before underwriting expenses and commissions and offering expenses.

On November 8, 2017, the Company signed a Letter of Intent to amend its current debt agreement with its largest shareholder, Squadron Capital LLC (“Squadron”), to modify and extend the terms of its existing term notes and revolving credit facility. The Letter of Intent consolidates a majority of the term note amounts into a $20.0 million term loan and reestablishes a $15.0 million revolver. Both facilities will have an interest rate equal to the three month LIBOR plus 8.61%, which in total equals 10.0%, compared to a previous interest rate of 10.0% for the term notes and 11.0% for the revolving credit facility. The Letter of Intent extends the loan period through January 31, 2023 (previously May 31, 2019 or May 31, 2020 based on revenue). As of September 30, 2017, the Company had approximately $27.6 million in total outstanding indebtedness, including $7.5 million outstanding under the revolving credit facility, of which the Company expects to convert $1.6 million to term notes plus pay back $2.5 million in the near term, leaving over $11.0 million in available capacity.

Fred Hite, Chief Financial Officer of OrthoPediatrics, commented, “We are pleased to have signed a Letter of Intent to amend our loan agreement with Squadron, which will provide for a more favorable interest rate and extend the length of the agreement. It demonstrates Squadron’s commitment and confidence in our business and its long-term dedication to supporting the Company.”

Conference Call
OrthoPediatrics will host a conference call on Thursday, November 9, 2017 at 8:00 a.m. ET to discuss its financial results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 9169647. A live webcast of the conference call will be available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com.

A replay of the webcast will remain available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com, until OrthoPediatrics releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the conference call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The replay conference ID number is 9169647.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share Data)
September 30, December 31,
2017 2016
ASSETS
Current assets:
Cash $ 2,238 $ 1,609
Accounts receivable – trade, less allowance for doubtful accounts of $148 and $152, respectively 5,686 4,098
Inventories, net 18,434 13,962
Inventories held by international distributors, net 579 924
Deferred charges 1,339
Prepaid expenses and other current assets 615 233
Total current assets 28,891 20,826
Property and equipment, net 9,749 8,592
Other assets:
Amortizable intangible assets, net 2,183 998
Other intangible assets 260 260
Total other assets 2,443 1,258
Total assets $ 41,083 $ 30,676
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable – trade 5,102 3,543
Accrued compensation and benefits 2,288 2,219
Current portion of long-term debt with affiliate 111 107
Other current liabilities 2,915 1,382
Total current liabilities 10,416 7,251
Long-term liabilities:
Long-term debt with affiliate, net of current portion 19,986 12,931
Revolving credit facility with affiliate 7,500 4,500
Total long-term liabilities 27,486 17,431
Total liabilities 37,902 24,682
Commitments and contingencies
Redeemable convertible preferred stock:
Series A preferred stock, $0.00025 par value; $8,874 cumulative preferred dividends, September 30, 2017 and $7,439 December 31, 2016; 1,000,000 shares authorized, issued and outstanding 24,874 23,439
Series B preferred stock, $0.00025 par value; $11,793 cumulative preferred dividends, September 30, 2017 and $8,864 December 31, 2016; 6,000,000 shares authorized; 4,446,978 shares issued and outstanding 50,793 47,864
Stockholders’ deficit:
Common stock, $0.00025 par value; 8,040,000 shares authorized; 2,487,589 shares and 2,421,599 shares issued and outstanding as of September 30, 2017 and December 31, 2016 1 1
Additional paid-in capital 9,541 12,824
Accumulated deficit (82,221 ) (78,134 )
Accumulated other comprehensive income 193
Total stockholders’ deficit (72,486 ) (65,309 )
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit $ 41,083 $ 30,676
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net revenue $ 12,375 $ 10,135 $ 33,939 $ 27,880
Cost of revenue 2,884 2,978 8,321 7,913
Gross profit 9,491 7,157 25,618 19,967
Operating expenses:
Sales and marketing 5,633 4,289 15,122 12,401
General and administrative 3,487 2,890 10,282 8,842
Research and development 1,127 501 2,482 1,599
Total operating expenses 10,247 7,680 27,886 22,842
Operating loss (756 ) (523 ) (2,268 ) (2,875 )
Other expenses:
Interest expense 761 399 1,857 1,056
Other expense (income) 20 (77 ) (38 ) (992 )
Total other expenses 781 322 1,819 64
Net loss $ (1,537 ) $ (845 ) $ (4,087 ) $ (2,939 )
Net loss attributable to common stockholders $ (3,021 ) $ (2,405 ) $ (8,451 ) $ (7,229 )
Weighted average common shares – basic and diluted 1,773,385 1,744,356 1,754,576 1,744,356
Net loss per share attributable to common stockholders – basic and diluted $ (1.70 ) $ (1.38 ) $ (4.82 ) $ (4.14 )
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
For the Nine Months Ended
September 30,
2017 2016
OPERATING ACTIVITIES
Net loss $ (4,087 ) $ (2,939 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 1,748 1,402
Stock-based compensation 1,081 951
Research and development fee obligation termination (889 )
Changes in certain current assets and liabilities:
Accounts receivable – trade (1,588 ) (74 )
Inventories (3,276 ) (2,834 )
Inventories held by international distributors 345 1,588
Prepaid expenses and other current assets (382 ) (232 )
Accounts payable – trade 1,559 1,798
Accrued expenses and other liabilities 513 (579 )
Research and development fee obligation (628 )
Other 193 0
Net cash used in operating activities (3,894 ) (2,436 )
INVESTING ACTIVITIES
Purchases of licenses (1,337 ) (406 )
Purchases of property and equipment (3,949 ) (2,617 )
Net cash used in investing activities (5,286 ) (3,023 )
FINANCING ACTIVITIES
Proceeds from issuance of debt with affiliate 10,139 3,500
Payments on mortgage notes (80 ) (77 )
Payments of deferred offering costs (250 ) (527 )
Net cash provided by financing activities 9,809 2,896
NET INCREASE (DECREASE) IN CASH 629 (2,563 )
Cash, beginning of year 1,609 3,878
Cash, end of period $ 2,238 $ 1,315
SUPPLEMENTAL DISCLOSURES
Cash paid for interest $ 1,856 $ 1,056
Accretion of redeemable convertible preferred stock $ 4,364 $ 4,290
Transfer of instruments from property and equipment to inventory $ 1,196 $ 196

Net Revenue
The following tables set forth our net revenue by geography and product category for the three and nine months ended September 30, 2017 and 2016:

 Three Months Ended
September 30,
Nine Months Ended
September 30,
Product sales by geographic location: 2017 2016 2017 2016
U.S. $ 9,556 $ 7,875 $ 26,085 $ 21,565
International 2,819 2,260 7,854 6,315
Total $ 12,375 $ 10,135 $ 33,939 $ 27,880
 Three Months Ended
September 30,
Nine Months Ended
September 30,
Product sales by category: 2017 2016 2017 2016
Trauma and deformity $ 8,730 $ 7,168 $ 24,339 $ 20,184
Spine 3,299 2,729 8,652 6,940
ACL reconstruction/other 346 238 948 756
Total $ 12,375 $ 10,135 $ 33,939 $ 27,880

Patients sue B. Braun alleging defect in replacement knees

By Peter Hall of The Morning Call / November 7, 2017

Medical device maker B. Braun concealed from regulators problems with its line of ceramic-coated artificial knees and promoted the products to surgeons despite knowing they were prone to fail, a lawsuit filed in a California court alleges.

The Bethlehem-based company’s Aesculap Implant Systems subsidiary marketed the “advanced surface” ceramic coated knees as superior to standard bare metal implants, claiming they would last longer, the lawsuit says. But the ceramic joints were defective, the suit alleges, because they didn’t adhere properly to cement used to bond them with the patients’ bones.

As a result, the 25 knee replacement patients who are suing B. Braun and Aesculap in a California court were or will be required to undergo additional surgeries to correct problems with the joints or implant different devices, the suit says.

A spokesman for B. Braun, a German company with U.S. headquarters in Bethlehem, did not respond to messages Tuesday.

The lawsuit was filed last month in Los Angeles Superior Court by attorneys Christopher K. Johnston of Guaynabo, Puerto Rico, and Anthony Buzbee of Houston on behalf of the patients, who are from Louisiana, Florida and 10 other states.

According to the lawsuit, Aesculap sought and received permission from the U.S. Food and Drug Administration to sell its advanced surface replacement knees by demonstrating that the devices were as safe and effective as devices that had already been approved. The process is less rigorous than the FDA’s standard medical device approval process, the suit says.

 

READ THE REST HERE

 

Misonix Reports First Quarter Fiscal Year 2018 Financial Results

FARMINGDALE, N.Y.Nov. 7, 2017 /PRNewswire/ — Misonix, Inc. (Nasdaq: MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the first quarter of fiscal year 2018, ended September 30, 2017.

Financial Highlights for the First Quarter:

  • Revenue for the first quarter of fiscal year 2018 was $7.3 million, an increase of 18% compared with $6.2 million in the previous year’s first quarter.
  • Consumables sales in the United States increased 25% to $4.1 million in the first quarter of the new fiscal year compared to $3.3 million in the comparable quarter of fiscal 2017.
  • The gross profit percentage for the quarter was 70.1% primarily from a strong mix of higher margin consumables, compared to 69.0% in last year’s first quarter.
  • For the first quarter of fiscal year 2018, the Company reported a net loss of $(1.2) million, or $(0.14) per diluted share, compared to a net loss of $(0.5) million, or $(0.07) per diluted share, in the first quarter of fiscal year 2017.
  • At September 30, 2017, the Company maintained cash of $10.5 million with no long-term debt.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “Sales orders continued to be strong in the first quarter of fiscal year 2018, with double-digit revenue growth, picking up where we left off in fiscal 2017. Total revenue increased 18% in the first quarter of the new year primarily attributable to a 25% increase in domestic consumables sales. A significant contribution to the increase in domestic sales was made by the addition of new clinical sales specialists to support the sales activities of our distribution channel. The channel, coupled with our team of 28 clinical sales specialists, was successful in driving a 35% increase in BoneScalpel revenue in the U.S. over the prior year. We are making steady progress with the surgical community, and the hospitals where they practice, to further embed our technology in their respective surgical suites.”

“At the recent 32nd Annual Meeting of the North American Spine Society,” Mr. Vizirgianakis continued, “Dr. Wade Jensenof the Center for Neurosciences, Orthopaedics & Spine (“CNOS”) presented data showing a significant reduction in the use of bone grafting material when the Misonix BoneScalpel is employed compared to the use of standard power drill instruments. An estimated $1.9 billion is spent annually on bone graft substitutes. This is valuable data as we are able to show that our products contribute significant value to the overall healthcare system by reducing costs in spinal fusion procedures.”

The Company also recently entered into its most significant license, royalty and manufacturing agreement with Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd., a Chinese corporation, where Misonix will receive at least $11 million in revenue and royalties over the next four years, and further strengthen its balance sheet.

Conference Call
The Company has scheduled a conference call for Tuesday, November 7, 2017, at 4:30 pm ET to review the results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10113569. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX INC. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

For the three months ended

September 30,

2017

2016

Net sales

$    7,280,723

$   6,171,625

Cost of goods sold

2,177,355

1,912,007

Gross profit

5,103,368

4,259,618

Operating expenses:

 Selling expenses

3,570,713

3,325,687

 General and administrative expenses

2,573,131

1,931,821

 Research and development expenses

901,274

492,084

Total operating expenses

7,045,118

5,749,592

Loss from operations

(1,941,750)

(1,489,974)

Other income (expense):

 Interest income

13

19

 Royalty income and license fees

452,971

944,068

 Other

(4,458)

(1,996)

Total other income

448,526

942,091

Loss from operations before income taxes

(1,493,224)

(547,883)

Income tax benefit

(281,000)

(26,000)

Net loss

$   (1,212,224)

$    (521,883)

Net loss per share – Basic

$            (0.14)

$          (0.07)

Net loss per share – Diluted

$            (0.14)

$          (0.07)

Weighted average shares – Basic

8,958,405

7,809,385

Weighted average shares – Diluted

8,958,405

7,809,385

MISONIX INC. and Subsidiaries

Consolidated Balance Sheets

September 30,

June 30,

2017

2017

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$    10,528,041

$ 11,557,071

Accounts receivable, less allowance for doubtful accounts of $96,868 and $96,868, respectively

4,153,511

5,133,389

Inventories, net

5,206,025

4,992,434

Prepaid expenses and other current assets

504,653

918,899

Total current assets

20,392,230

22,601,793

Property, plant and equipment, net of accumulated amortization and depreciation of $8,134,134 and $7,794,580, respectively

3,842,419

3,730,203

Patents, net of accumulated amortization of $1,025,930 and $995,568, respectively

715,177

719,136

Goodwill

1,701,094

1,701,094

Intangible and other assets

280,684

282,876

Deferred income tax 

5,524,422

4,334,547

Total assets

$    32,456,026

$ 33,369,649

Liabilities and shareholders’ equity

Current liabilities:

Accounts payable

$      2,106,506

$  1,861,228

Accrued expenses and other current liabilities

1,815,527

3,346,138

Total current liabilities

3,922,033

5,207,366

Deferred lease liability

7,016

9,354

Deferred income

8,989

13,087

Total liabilities

3,938,038

5,229,807

Commitments and contingencies 

Shareholders’ equity:

Common stock, $.01 par value-shares authorized 20,000,000; 9,365,666 and 9,357,166 shares issued and outstanding in each period, respectively

93,657

93,572

Additional paid-in capital

37,490,220

36,808,810

Accumulated deficit

(9,065,889)

(8,762,540)

Total shareholders’ equity

28,517,988

28,139,842

Total liabilities and shareholders’ equity

$    32,456,026

$ 33,369,649

Corporate Contact

Investor Contact

Joe Dwyer

Joe Diaz

Misonix, Inc.

Lytham Partners

631-927-9113

602-889-9700

jdwyer@misonix.com

mson@lythampartners.com

 

SOURCE Misonix, Inc.

Related Links

http://www.misonix.com

SPINEWAY: Joseph Brigneaud nominated to Spineway’s Board of Directors

    Ecully, 7 November 2017

The Board of Directors of Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), has co-opted Mr. Joseph Brigneaud as an independent Board member.

Joseph Brigneaud, a partner at MAELO Capital – a private-equity investment firm, has over 15 years’ experience in supporting and financing companies. Having opened and headed Euronext’s regional office in Lyon for three years, he has considerable expertise in listed SMEs and mid-cap companies.

As from 23 October 2017, the composition of Spineway’s Board of Directors is as follows:

  • Stéphane Le Roux, Chairman of the Board – Chairman and CEO of Spineway.
  • Philippe Laurito, Board member – Managing Director of Spineway, President of Spineway USA, Inc.
  • Bérangère Boggio, Independent Board member – Director of Legal Affairs and HR at MEDAC since 2013 after seven years with the MYLAN pharmaceutical group.
  • Joseph Brigneaud, Independent Board member.

Stéphane Le Roux, Chairman and CEO of Spineway, said, “We are thrilled to welcome Joseph Brigneaud as a member of our Board of Directors. His perfect understanding of the stock markets and his expertise in growing SMEs will help us increase our development and successfully pursue our geographic expansion.”

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

SPINEWAY will be attending the SFAF Mid-Caps conference on 14 November 2017

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015). 
ISIN code: FR0011398874 – Euronext Growth

This press release is entered into in both English and French languages. In case of discrepancies, French language shall prevail.

Contacts:           

Investor Relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com
 

 

 

 

 

 

 

 

 

Financial Communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/cba803a0-08bf-446d-b4fd-a2179bf35d7

AlloSource Announces Bob Lay As Chief Operating Officer

CENTENNIAL, Colo.Nov. 7, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Bob Lay as Chief Operating Officer.

With over 20 years of experience in both finance and operations, Bob has a broad-based understanding of how each department within an organization impacts another. He has an extensive background working with businesses and medical device companies to conduct operational audits, improve processes and systems, and balance the needs of many departments to drive company growth and success.

“The Chief Operating Officer role at AlloSource is critical to creating the cellular and tissue products surgeons need to help restore mobility in more patients,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Bob’s background, as well as his open-minded approach to driving improvements, will help us identify new opportunities to advance the work we do.”

In addition to his role as Chief Operating Officer, Bob also served AlloSource as the Director of Cost Accounting and Vice President, Operations. Prior to his time at AlloSource, he held leadership roles at both startups and large companies. Bob received his Bachelor’s and Master’s degrees in Accounting from the University of Denver.

“I am honored to lead the dedicated and passionate Operations team at AlloSource,” said Lay. “AlloSource’s commitment to donors and patients inspires me every day, and I look forward to contributing to the organization’s continued growth.”

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

 

SOURCE AlloSource