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TransEnterix Provides Corporate Update

Posted On July 5, 2018 By OrthoSpineNews In Financial /  

July 02, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today provided a corporate update, including the announcement of the sale of an additional Senhance system as well as preliminary unaudited revenue for the second quarter ended June 30, 2018.

“We had a strong second quarter as we continued to drive sales of Senhance globally while at the same time making significant progress towards our 2018 goals, including the expansion of Senhance’s indications for use and portfolio of instruments,” said Todd M. Pope, President and CEO at TransEnterix. “We look forward to continuing to build upon the momentum we developed during the first half of the year to drive the widespread adoption of Senhance.”

Second Quarter Senhance System Sales

In June of 2018, the Company sold a Senhance System to an end user hospital through a distributor in the Company’s EMEA (Europe, Middle East, and Africa) region. This sale represents the fourth system sale during the second quarter of 2018, three of which (two in the EMEA region, one in the U.S.) have been previously announced.

Preliminary Second Quarter Revenue

Preliminary unaudited second quarter revenue is expected to be in the range of $6.0 million to $6.3 million, up from $1.5 million in the second quarter of 2017.

Indication Expansion

On May 29, 2018, the Company received FDA 510(k) clearance for expanded indications of its Senhance System for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System’s total addressable annual procedures in the U.S. has more than doubled to over three million.

Instrument Portfolio Expansion

On June 7, 2018, the Company announced that it had filed an FDA 510(k) submission for additional Senhance System instruments, including 3 millimeter diameter instruments.

Balance Sheet

On May 23, 2018, the Company entered into a loan and security agreement providing the company with up to $40.0 million in term loans. The initial tranche of the term loan, $20 million, was received at closing. The Company will be eligible to draw on the second tranche of $10 million upon achievement of certain Senhance System revenue-related milestones for its 2018 fiscal year, and a third tranche of $10 million upon achievement of designated trailing six months GAAP net revenue from Senhance sales. On the date of closing, the Company repaid all amounts owed under their previous loan provider.

Preliminary unaudited cash and cash equivalents as of June 30, 2018 was approximately $98 million.

About TransEnterix, Inc.

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the Senhance Surgical System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether we are making significant progress towards our 2018 goals and whether the preliminary unaudited 2018 second quarter revenue will be in the range of $6.0 million to $6.3 million. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, + 1-951-751-1858
joanna@greymattermarketing.com

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UnitedHealthcare’s New Positive Medical Policy in Favor of Lumbar Total Disc Replacement Reconfirms the Procedure’s Long-Term Effectiveness for Treatment of Degenerative Disc Disease

Posted On July 5, 2018 By OrthoSpineNews In Spine, Top Stories /  

CENTER VALLEY, Pa., July 3, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced that UnitedHealthcare® has issued a new, positive medical policy for Lumbar Total Disc Replacement (TDR). UnitedHealthcare will cover Lumbar TDR for single-level degenerative disc disease. This change means that millions of patients in virtually every state in the country will now have access to the procedure, taking total commercial insurance coverage in the United States to almost 65 percent.

“I like to think my case was part of the change,” said recent activL® Artificial Disc patient and UnitedHealthcare customer Carrie Guthrie, now of Washington state, who had her Lumbar TDR procedure in Atlanta with Dr. Tapan Daftari of the Resurgens group. Guthrie, who invested in the three-month external appeal process to fight UnitedHealthcare’s denial of her case, is now living pain free. “When the activL Patient Assistance Line helped to get the approval of the Lumbar Disc Replacement, I could not have predicted how the surgery would alter my life,” said Guthrie. “Living with severe daily pain year after year had changed my perception of life; it had dulled my ability to enjoy anything.”

Guthrie gained access to the activL Artificial Disc by leveraging her external review rights as afforded to her by the Affordable Care Act. By exercising her rights to the external review process, UnitedHealthcare had to send her case to an independent third party to determine if her case was medically necessary. Stakeholders believe that cases like Guthrie’s were an essential factor in UnitedHealthcare’s decision to overturn their negative policy.

“We are thankful for patients like Carrie Guthrie who are willing to put the evidence in front of non-covering payers and help them understand why Lumbar TDR should be an option,” said Kim Norton, who leads Aesculap’s payer policy and reimbursement efforts. “UnitedHealthcare will begin covering because patients have helped them to see that there is a demand for this procedure, and the patients do well after receiving it,” continued Norton.

“We invested in a comprehensive evidence development and payer policy strategy at Aesculap because we know how strong our long-term activL Artificial Disc outcomes are. We saw the unmet need, and we wanted to focus our resources on important initiatives like helping patients with Degenerative Disc Disease,” said Chuck DiNardo, President of Aesculap Implant Systems. “We all knew that with the evidence and through the work of our Patient Assistance Line, US payers would want to extend access to Lumbar TDR to their customers, our patients. We are pleased that payers are giving the data consideration.”

This announcement comes weeks after the US Military’s TRICARE health plan also announced coverage and after numerous BlueCross BlueShield plans have decided to cover. The remaining patients with non-covering health plans include primarily a few BlueCross BlueShield plans, as well as Aetna, a large national insurer which had a positive coverage policy for Lumbar TDR and dissolved it as part of a merger with a different plan in 2012.

The activL Artificial Disc is a third generation motion preservation device designed to more closely mimic the natural biomechanics of the healthy human spine, thereby significantly reducing the impact on adjacent level anatomy. The five-year clinical outcomes were recently presented at the North American Spine Society (Orlando, FL, October 25-28, 2017) meeting and will be presented at EuroSpine 2018 (Barcelona, Spain, September 19-21, 2018). The radiographic outcomes were published in Spine(https://journals.lww.com/spinejournal/Abstract/publishahead/Progression_of_Adjacent_level_Degeneration_After.95075.aspx).

If you are a Degenerative Disc Disease sufferer interested in understanding your spinal fusion alternative options or if you need help navigating the Lumbar TDR insurance landscape, visit https://www.soactivesofast.com/low-back/activl-artificial-disc or call 1-844-245-1140.

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://www.aesculapimplantsystems.com

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Medicrea Announces Record Sales for the First Half of 2018

Posted On July 5, 2018 By OrthoSpineNews In Financial /  

July 05, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 -ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today sales for the first half of 2018.

Sales for the first half of 2018 amounted to € 16.9 million, up 22% at constant exchange rates compared to the first half of 2017. Second quarter sales reached € 8.8 million, a new historic performance following the previous record of € 8.2 million in the first quarter of 2018.

“We have resumed the path of sustained growth, with the expectation that recent US registrations for two key product families in our development strategy, the top-loading thoracolumbar fixation system PASS TULIP™ and our IB3D™ 3D-printed titanium interbody cages, will further contribute to the turnover from the second half of 2018,” stated Denys Sournac, President and CEO of Medicrea.

The month of June 2018 shows the best performance of the year with:

– Sales for an amount of € 3.4 million, reflecting the resumption of strong growth from the very beginning of 2018;

– Record number of 116 patient-specific UNiD® Rod surgeries performed for the month of June, confirming  the adoption of personalized UNID ASI™ services and implants by a growing number of surgeons. In total, 2,500 UNiD® patient-specific surgeries have been performed since the launch of this technology associated with service expertise delivered by the UNiD Lab™.

In the United States, patient-specific UNID® surgeries are reported to be up + 50% in the first half of 2018 compared to the same period in 2017. The reorganization of the sales force at the end of 2017 aimed at refocusing efforts on the UNiD ASI™ platform is starting to bear fruit. The UNiD ASI™ activity represents more than 60% of total sales for the US subsidiary.

Outside of the United States, sales with international distributors grew by 40% following the opening of new countries and the resumption of invoicing in Brazil. The new Belgian subsidiary, Medicrea Belgium, which was incorporated in February 2018, contributed significantly to the half-year turnover, as hospitals are now billed directly. In France, the Company is also continuing its market share gains with a + 3% growth in sales. Medicrea is now also active on the Australian market with a distribution subsidiary operating since June that is expected to represent a significant source of additional revenue in the medium term given the attractive pricing sustained by the local market for premium products.

“In 2018, we have started to see strong growth in the use of our UNiD ASI™ preoperative planning services and patient-specific implants, which confirms that surgeons are interested in this technology and moreover the relevance of our strategic positioning. We believe that this fully personalized approach to treating spinal pathologies will become the standard of care over the coming years as it improves patient outcomes while reducing costs to the healthcare system,” stated Denys Sournac, President and CEO of Medicrea.

“In May of 2018, the Company achieved FDA 510(k) clearance for its 3D-printed patient-specific interbody devices. With this world-first clearance, Medicrea is able to digitally plan, manufacture in-house and supply a 3D-printed device in the United States that has been optimized to follow each patient’s unique spinal anatomy using the Company’s proprietary AI-driven UNiD technology,” Mr. Sournac continued.

“We are confident in pursuing this growth throughout the second half of the year, particularly in the United States, by deploying new services and products for the personalized treatment of spinal pathologies and should be on track to be EBITDA positive during 2018,” Mr. Sournac concluded.

Next publication: Results for the First Half of 2018: Tuesday, September 18, 2018, after-market.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 185 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:

FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on

EURONEXT Growth Paris

ISIN: FR 0004178572

Ticker: ALMED

LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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Hospitals’ can’t afford not to’ provide value-based care

Posted On July 3, 2018 By OrthoSpineNews In Financial /  

By Tara Bannow  | July 2, 2018

LAS VEGAS—The calls for health systems to ditch fee-for-service payment in favor of value-based models were downright urgent at this year’s Healthcare Financial Management Association conference in Las Vegas.

“We can’t afford not to make the change,” David Hammer, a principal in Healthcare Performance Management Consultants’ revenue cycle and managed-care practice in Fort Lauderdale, Fla., told attendees on the conference’s opening day.

It’s been a topic of discussion at the annual conference for years. But this year, conversations seemed to indicate a breaking point. Healthcare costs are unsustainable, and anyone not on the capitation train—or at least without a ticket in their hand—is part of the problem, presenters echoed.

Speakers also acknowledged the real fear C-suite leaders have about taking that leap. When margins are already squeezed, they offered, it can be hard to agree to a change that could decrease revenue further. Indeed, individual discussions with health system leaders revealed more caution than was present in thought leaders’ presentations.

“Honestly, there is too much fear,” said Christer Johnson, health analytics advisory leader with Ernst & Young. “They’re not clear on how they’re going to make money. And that’s why the bundled-payment programs are voluntary today.”

Nonetheless, the resounding theme of this year’s HFMA conference: It’s time to bite the bullet.

In his keynote speech June 25, HFMA President Joseph Fifer urged a packed audience to forge ahead into the value-based unknown, despite a recent study by the HFMA, Leavitt Partners and McManis Consulting that found such models didn’t lower the total cost of care. He attributed the finding to a lack of incentive in those programs to lower the cost of care and too little downside risk and upside opportunity.

The chief financial officers of the future have a different mindset, he said. They’re willing to implement payment models that truly share the risk and use metrics to assess the return on investment.

“If you invest, you’re part of the solution, even if your fee-for-service revenue goes down,” Fifer said. “But if you don’t invest, someone else will. And the revenue could still go down.”

A forward-thinking CFO will also formulate a value-based payment arrangement that fits within his or her specific health system and market, he said. Perhaps that’s why discussions about such programs can begin to sound nebulous, like when you’ve seen one, you’ve seen one.

Health systems at different levels of adoption

Only a very small proportion of the hip and knee replacements performed on commercially insured patients at Providence St. Joseph Health’s hospitals are paid for in bundles, or lump sums regardless of whether the total cost exceeds that amount. On the Medicare side, the Renton, Wash.-based system has seen its costs decrease significantly since it started participating in the CMS’ Comprehensive Care for Joint Replacement bundles, said Kevin Fleming, Providence St. Joseph’s vice president of orthopedics and sports medicine. Twenty of the system’s 50 hospitals are enrolled in the joint replacement program.

“Working with those government bundles really caused us to re-examine what we were doing and take a whole new approach—not being so laser-focused on what’s going on within the four walls of our own hospital and looking at what we’re doing for patients before they come to the hospital and then after discharge,” he said.

Even the system’s markets that aren’t enrolled in the CMS program have adopted some of those hospitals’ value-based strategies, such as using case managers to make sure patients get the right care once they leave the hospital, Fleming said.

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Globus Medical Adds Two Innovative Solutions to Growing Trauma Portfolio

Posted On July 3, 2018 By OrthoSpineNews In Extremities /  

AUDUBON, Pa., July 03, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today the expansion of its orthopedic trauma product portfolio with two new product offerings, the ANTHEM® Ankle Fracture System and the ANTHEM® Proximal Humerus Fracture System, marking the Trauma division’s fourth and fifth comprehensive product launches over the last 10 months.

“This is an exciting time for Globus Trauma as we continue to execute our product launch strategy and build a comprehensive Trauma product portfolio,” said Barclay Davis, Vice President, Orthopedic Trauma. “With each new product introduction, our goal is to design systems that help streamline the procedure, increase versatility, reduce operative time, and improve patient care.”

ANTHEM® Ankle Fracture Plating and other lower extremity systems will be exhibited at the annual American Orthopedic Foot and Ankle Society Meeting in Boston, Massachusetts July 11th-14th.  Globus Medical invites meeting attendees to Booth 206 to experience its recent product innovations and discuss trauma advancements with the company’s product development experts.

  • The ANTHEM® Ankle Fracture System is an extensive range of 7 unique plating options for treatment of virtually any ankle fracture. Over 25% thinner than the market leader’s plate, ANTHEM®’s low profile ankle fracture plates are designed to minimize soft tissue irritation from implant prominence. Anatomically contoured plates, extensive screw options and instruments specifically designed for ankle anatomy are rolled into one efficient and comprehensive system for treating ankle fractures.
  • The ANTHEM® Proximal Humerus Fracture System is designed to treat a wide variety of shoulder fractures and streamline procedural flow. The unique polyaxial screw technology allows for more accurate targeting of dense calcar bone to enhance fixation, independent of plate position. Large suture holes simplify suture attachment for soft tissue or rotator cuff repair. This comprehensive stand-alone system includes small fragment instruments and innovative retractors to help streamline the surgical procedure, aid in visibility of the fracture site, and optimize surgical time.

Indications

The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.

Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults.  Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

To learn more about the complete line of Globus Medical Trauma products visit www.globusmedical.com/trauma.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

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University Hospital Center of Grenoble Alpes (CHUGA) Becomes the 20th University Hospital Equipped with the EOS® System in France

Posted On July 3, 2018 By OrthoSpineNews In Extremities /  

July 03, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the installation of its EOS® system at the University Hospital Center of Grenoble Alps (CHUGA), a state-of-the-art hospital facility for osteoarticular surgery in children and adults. CHUGA is the 20th university hospital center to acquire an EOS® system, and the new system will be dedicated to the center’s clinic as well as to clinical research activities.

With more than 2,100 beds, CHUGA employs nearly 8,000 professionals, including 1,700 doctors. It has an advanced technical platform and provides highly specialized care. The center’s teams are recognized for their excellence in orthopedic surgery, particularly in the field of advanced surgical techniques assisted by navigation or robotics.

The new EOS system will be located in the pediatric radiology department within the pediatric section of the hospital. It will be used in the care of both pediatric and adult patients through a collaboration with two adult orthopedic services located in the North and South Poles of CHUGA.

“The EOS system will allow us to further develop the clinical care of our pediatric patients through imaging at low radiation dose. It will also significantly accelerate our collaborative research programs with EOS on the orthopedic treatment of scoliosis with braces,” commented Professor Aurélien Courvoisier, Pediatric Orthopedic Surgeon.

“We are very pleased to serve the Grenoble Hospital Center for clinical and research applications,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The patient has always been our main concern as we work to spread low-dose, 2D/3D imaging capabilities. EOS has changed the care of osteo-articular pathologies and has become a standard thanks to lower radiation, higher accuracy, and 3D imaging of the full body, all of them valuable in choosing the most effective treatments, preparing surgical intervention, as well as in post-operative follow-up. On the research side, we hope to open new perspectives on the treatment of spinal deformities with braces, and will also pursue collaborative programs on the integration of the EOS examination data in the operating room.”

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier, Ph: +33 (0)1 55 25 60 60
CEO
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman, Ph: 646-536-7006
The Ruth Group
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
Ph: 646-536-7008 / 7024
The Ruth Group
EOS-imagingIR@theruthgroup.com

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Woven Orthopedics raises $5m

Posted On July 3, 2018 By OrthoSpineNews In Financial /  

 By 

Woven Orthopedic Technologies has raised $5.4 million in a new round of equity and options financing, according to an SEC filing posted this week.

Manchester, Conn.-based Woven Orthopedics is developing orthopedic products which aim to improve fixation, specifically for procedures using screws, according to the company’s website.

The company produces the OGmend implant system which uses biotextiles to enhance fixation. The first generation version of the device is designed from a biopolymer intended to increase surface area contact between bone and screw to distribute load transfer and aid in bone healing and remodeling, according to the company’s website.

A total of 64 unnamed investors have joined in the round so far, with the first sale date noted last August 9. The round has a minimum investment of $50,000, according to the filing.

Of the funds raised so far, $469,000 will be used to pay the CEO and six directors of the company for its calendar year 2018. The company is looking to raise an additional $12.6 million in the round, according to the filing.

 

READ THE REST HERE

 

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The bad news keeps coming for MiMedx and its new auditor EY

Posted On July 3, 2018 By OrthoSpineNews In Financial, Top Stories /  

July 3, 2018  – By Francine McKenna, Reporter

MiMedx Group, Inc. played a version of, “Can you top that?” on Monday, when the troubled biopharmaceutical company installed an interim CEO and a new board chairman following the latest wave of executive departures.

The company’s stock MDXG, -8.37%  tumbled 38% on the news, sending it to its lowest level since September, 2013.

The company appointed Charles R. Evans, previously the company’s lead independent director, as chairman of the board, replacing Parker H. “Pete” Petit who resigned as board chairman and chief executive. It named David Coles to serve as interim CEO, according to a press release.

Chief operating officer William C. “Bill” Taylor also resigned his role and left the board.

The news follows the dramatic announcement on June 7 that the company’s CFO and its controller/treasurer would exit after MiMedx said it would restate more than five years of financial statements, for the period stretching from 2012 through 2016, and the first three quarters of 2017. All communications and financial information, it said at the time, with respect to the fourth quarter of 2017 and the first quarter of 2018 “should no longer be relied upon,” the company said. It withdrew all prior guidance for 2018.

That’s four times more periods reviewed than the average, signaling a substantial and long-standing problem, research firm Audit Analytics wrote in its analysis of the announcement.

“A financial restatement of this magnitude is a significant red flag in respect to a company’s accounting quality,” Audit Analytics wrote in early June.

Coles is taking the assignment on an interim basis, while continuing to act as a Managing Director with Alvarez & Marsal, a global professional services firm that advises and provides turnaround and restructuring services to companies, including providing interim management.

Coles served as the CFO, principal accounting officer, treasurer and controller at Lehman Brothers Holdings, Inc. from September 2008 to February 2009. He worked for Arthur Andersen & Co. in the U.K. and New York before joining Alvarez & Marsal in 1996.

In describing the actions already taken to “promote accountability and strengthen oversight” MiMedx said it had retained “a leading, operationally focused finance and accounting consultancy firm to provide interim leadership for the chief accounting officer, corporate controller and other financial roles.”

Coles’ appointment seems to be part of a larger engagement for Alvarez & Marsal to provide interim staffing to a company that is suddenly bereft of senior management.

 

READ THE REST HERE

 

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Kuros Biosciences Reports First U.S. & UK sales of MagnetOs

Posted On July 2, 2018 By OrthoSpineNews In Biologics /  

SCHLIEREN (ZURICH), Switzerland, July 02, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX:KURN) announced today it recorded the first commercial use last week of MagnetOs in the U.S., and the company expects to ramp up its commercial activities in Europe and the U.S. in the second half of 2018.

Joshua M. Ammerman, M.D. of Washington Neurosurgical Associates in Washington DC, successfully performed minimally invasive spinal fusion using MagnetOs Putty, and was satisfied with the handling and performance of MagnetOs.  Dr. Ammerman is a nationally and internationally recognized expert in the application of minimally invasive surgical techniques to disorders of the brain and spine.

Prior to this, the first commercial European use of MagnetOs occurred in the UK. Mr. Stewart Tucker MBBS, FRCS (Eng), FRCS (Ortho), performed a scoliosis intervention using MagnetOs Granules at the Wellington Hospital in London.  Mr. Tucker is Consultant Spinal Surgeon at Great Ormond Street Hospital for Children, and his specialist interests include childhood and adult scoliosis/kyphosis, degenerative cervical and lumbar disease, spinal trauma and spinal tumors, and complex revision spinal surgery.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “After reporting successful case studies with MagnetOs at last week’s State of Spine Surgery Think Tank, we are delighted to now report the first commercial usage of MagnetOs in the U.S. and Europe.  We commend Dr. Ammerman and Mr. Tucker for pioneering the clinical use of MagnetOs and look forward to ramping up our commercial effort in the U.S. and selected geographies in Europe, as we continue to execute on our strategy to build a leading orthobiologics company.”

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

LifeSci Advisors
Hans Herklots
Media & Investors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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Medovex Corporation’s DenerveX System Demonstrates Clinical Benefits in Patients Suffering from Low Back Facet Joint Pain

Posted On July 2, 2018 By OrthoSpineNews In Spine /  

ATLANTA, July 02, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced the release of patient data that demonstrates clinical benefits of its DenerveX System in patients suffering from low back facet joint pain at 6 months post-treatment.

Facet Joint Syndrome (FJS) is among the leading causes of low back pain and affects millions globally. Typically manifesting from spinal osteoarthritis (OA), FJS is a painful, chronic condition whose treatment options, often temporary in nature, have remained unchanged in the past four decades.

Medovex’s DenerveX is a novel, minimally invasive system developed to provide potential long-term relief via a combination of controlled thermal energy and rotational capsular tissue shaving of the bony structure to disrupt nociceptive signals and receptors. The Company hypothesized that use of this novel system would result in sustained pain relief and improved health metrics associated with mobility.

Methods

This prospective multicenter European cohort included patients with chronic intractable pain of the low back resulting from FJS who had failed conservative treatments for pain. Patients who were treated between July 2017 and February 2018 were evaluated for joint groupings treated, pain and quality of life as measured by the visual analog score (VAS), medication log, Oswestry Disability Index (ODI) and EQ-5D-5L. Follow-up was conducted at 1, 3, and 6 months post-treatment; data reported correspond to these time points.

Results

Results from 61 patients (60.7% females; average age 55.1±11.5 years) were evaluated. Prior to treatment, 47 patients regularly used one or more prescribed analgesics and had predominately undergone either physiotherapy (81.4%), spinal injections (86.4%), or both to help alleviate pain. A total of seven joint groupings were treated, with L3 – S1 (45.6%) and L4 – L5 (17.5%) being the most common. Baseline average VASback prior to treatment was 74.7±14.2mm, a 42.0±16.6 ODI score with a EQ-5D-5L score of 3 (out of 5). At 1, 3, and 6 months post-treatment, VASback decreased to 31.7±17.5mm (-57.5%), 25.5±22.9mm (-65.8%), and 17.7±18.3mm (-76.3%). Similarly, ODI 1, 3, and 6 months post-treatment decreased to 19.9±14.4 (-52.7%), 20.1±15.0 (-52.3%), and 14.1±9.9 (-66.4%). These decreases from baseline were consistently observed in more than half of the population. EQ-5D-5L scores post-treatment remained, on average 32% below baseline values.

Conclusions

Review of real world cases from five independent sites across Europe demonstrated reduction in pain scores and general improvement of health metrics up to 6 months following treatment as evidenced by VASBACK, ODI and EQ-5D-5L.

Jill Schweiger, Medovex Senior Vice President of Regulatory, Clinical and Quality stated, “We are pleased to present these initial results which affirm our belief that the DenerveX System provides significant quality of life improvement and relief from pain associated with facet joint syndrome. We look forward to releasing one-year data as soon as it is available.”

The Company also plans in upcoming months to attend EuroSpine 2018 in Barcelona, Spain, NASS 2018 In Los Angeles, California and the annual DWG Meeting in Wiesbaden, Germany to support further sales and marketing activities. It also presented its DenerveX in Adelaide, Australia during the SSA (Spine Society of Australia) with sizeable audience interest, followed by ten successful first cases.

After successful INVIMA product approval in Colombia, first DenerveX cases are scheduled for July 14, 2018 in Medellin followed by additional cases in Bogota and other areas throughout Colombia.

In April, the Company was issued two US patents and a trademark covering the EU for “Rotacapsulation”.

  • Patent No: US D810,290S Surgical Portal Driver
  • Patent No: US 9,883,882 Minimally Invasive Methods for Spinal Facet Therapy to alleviate pain and associated surgical tools, kits and instructional media

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with facet joint syndrome. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement                                                     

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

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