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It’s not magic; it’s science

Posted On March 17, 2017 By OrthoSpineNews In Extremities, Sports Medicine /  

Steve Collins, Contributor – CFO/COO Oska, Inc.

If you suffer from chronic pain, it’s likely you’ve chased rainbows, been let down by false marketing claims or – at worst – lost hope that anything will emerge to help manage your pain effectively. Additionally, you’ve probably spent considerable amounts purchasing items that just don’t perform as stated. Sadly, for those suffering, things are getting worse. Recent Centers for Disease Control policies have emphasized prescribing less opiate pain-killers and the Drug Enforcement Administration has announced it intends listing kratom, an herbal pain-relief supplement, as a “schedule I” substance. This means that whether you are currently using prescribed narcotic pain-killers, or an herbal substitute, you will have no choice but to identify and use other pain-relief options.

The human body is wondrous, and its capacity to heal itself is amazing. Think of a scraped knee, bruised heel or sprained ankle. The body’s own healing processes kick in automatically in response to injuries. Chronic pain, however, is more challenging to manage. Most times, because chronic pain exists in localized unstable body areas, the natural healing processes need a kick-start. TENs devices, creams, pharmaceuticals and even physical therapy tend to be effective, but only for short periods as they “interrupt” pain rather than actually addressing the source. Ask any doctor or physical therapist the key to recovery, and most will say “exercise”. But if you already experience pain, the mere thought of exercise may fill you with anxiety.

What if it was possible to exercise an injury without leaving your chair, touching your toes or wrestling with a physiotherapist? What if there was an alternative option to swallowing dangerous narcotic or analgesic pain-killers?

Have you ever heard of pulsed electromagnetic field therapy (PEMF)?

PEMF, as a science, has been used for over 60 years with no known adverse effects. NASA uses it as an effective means of countering bone-density loss and muscle atrophy in astronauts exposed to weightless environments for prolonged periods. In fact, it is so effective that the FDA has cleared PEMF to close bone fractures, for mitigating migraines and for orthodontic work. If you think an electromagnetic field sounds “wacky”, consider that Earth generates one and so does your body!

PEMF emits very low-frequency waves that are created many times each second. These waves push and pull on human cells causing them to squeeze and stretch. As a result, cells can breathe more easily, allowing important healing signals to be carried into the cell. These signals then activate its natural recovery response and cause it to exhale even more healing signals into the surrounding area, promoting intensive healing. An injured area is typically not functioning normally, and if the healing process is compromised, pain can become chronic. When PEMF is introduced into the injured area, it acts at the cellular level to kick-start the body’s natural healing process.

A PEMF device produces similar effects as physical exercise, but you won’t feel anything. Typically, PEMF devices deliver three things: reduced pain levels; reduced inflammation; and improved range of motion. Whereas a TENs unit merely interrupts a pain signal, PEMF actually works at the cellular level, allowing for natural healing. Significantly, a PEMF device does not cause the usual discomfort experienced via a TENs unit because it is noninvasive (lacking physical attachment requirements) and is portable (you can use it at home, at work, in the car).

PEMF is a lesser-known therapy amongst consumers, but it provides scientifically superior results. It seems miracles can happen! CDC: we are looking at you!

 

READ MORE ABOUT OSKA HERE

 

 

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Active Implants LLC Secures First Tranche of a $40 Million Equity Financing

Posted On March 17, 2017 By OrthoSpineNews In Financial /  

March 16, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, LLC, a company that develops orthopedic implant solutions, today announced that it completed the first $10 million tranche of a $40 million Class D Units financing. The financing is to be comprised of $30 million from first-time investor LS Health Science Partners, L.P., with another $10 million to be contributed by existing investors.

“This investment reflects our enthusiasm for the NUsurface technology and its potential to fill a large unmet need in the market,” said Haynes Morris, managing partner for LS Health Science Partners. “We are pleased to participate in this new infusion of capital to help carry the company through this important phase of product development.”

An initial investment of $10 million has been received from LS Health Science Partners, with the remaining $30 million to be funded in tranches. The company intends to use the proceeds to continue funding two clinical trials of the NUsurface® Meniscus Implant – an investigational treatment for patients with persistent knee pain following medial meniscus surgery.

“Recruitment for the SUN and VENUS clinical trials for our NUsurface Meniscus Implant is going extremely well, and we expect to complete enrollment by the end of the year,” said Ted Davis, president and CEO of Active Implants. “This additional investment will allow us to continue our research and clinical development programs as we progress in and work toward bringing the first artificial meniscus to market.”

About Meniscus Injuries

A damaged meniscus has a very limited ability to heal itself, which can eventually lead to knee replacement surgery. It has been estimated that from 700,000 to over 1 million arthroscopic partial meniscectomies are performed annually in the U.S., with annual direct medical costs estimated at $4 billion. Active Implants estimates that in the U.S. alone, more than 130,000 meniscectomy patients per year would be appropriate candidates for the NUsurface Meniscus Implant.

About the NUsurface Meniscus Implant

The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant, which has been used in Europe under CE Mark since 2008 and in Israel since 2011.

About Active Implants

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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Alphatec Holdings Announces Fourth Quarter and Full Year 2016 Financial Results

Posted On March 17, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., March 15, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today financial results for the fourth quarter and full year ended December 31, 2016.

  • Fourth quarter total net revenues of $27.1 million; revenue from the Company’s U.S. commercial business of $24.5 million.
  • Annual total net revenues of $120.2 million; revenue from the Company’s U.S. commercial business of $106.9 million.
  • Cash and cash equivalents of $19.6 million at the end of the fourth quarter.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2016

As a result of the sale of the Company’s international business in September 2016, the financial results and related assets and liabilities of such business have been excluded from continuing operations for all periods herein and reported as discontinued operations.

U.S. commercial revenues for the fourth quarter of 2016 were $24.5 million, down 16.9%, compared to $29.5 million reported for the fourth quarter of 2015.  For the full year ended December 31, 2016, U.S. commercial revenues were $106.9 million, representing a decrease of 6.7%, compared to $114.6 million reported for full year 2015.

For the fourth quarter 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business, lower U.S. hospital unit volume and pricing declines.

For the full year 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business and pricing declines, partially offset by higher hospital volumes.

U.S. gross profit and gross margin for the fourth quarter of 2016 were $15.2 million and 62.2%, respectively, compared to $21.4 million and 72.6%, respectively, for the fourth quarter of 2015. For the full year 2016, U.S. gross profit and gross margin were $71.7 million and 67.0%, respectively, compared to $79.5 million and 69.4%, respectively, for full year 2015.

For the fourth quarter and full year 2016, gross margins declined as compared to 2015, primarily as a result of: higher product costs driven by lower than planned sourcing volumes throughout 2016, obsolescence charges related to product portfolio management, and price declines, partially offset by the absence of one-time charges that occurred in 2015.

Total operating expenses for the fourth quarter of 2016 were $21.7 million, reflecting a decrease of $7.4 million, or approximately 25% improvement over the fourth quarter of 2015. For the full year 2016, total operating expenses were $91.5 million, reflecting a decrease of $172.4 million compared to the full year 2015, which included non-cash goodwill and intangible asset impairment charges totaling $164.3 million.

GAAP net loss for the fourth quarter of 2016 was $4.7 million or ($0.56) per share (basic and diluted), compared to a net loss of $9.9 million, or ($1.18) per share (basic and diluted) for the fourth quarter of 2015.  For the full year, 2016 GAAP net loss was $30.3 million or ($3.57) per share (basic and diluted), compared to a net loss of $178.7 million, or ($21.53) per share basic and diluted for full year 2015. GAAP net loss for full year 2015 was unfavorably impacted by $164.3 million of non-cash impairment charges.

Adjusted EBITDA in the fourth quarter of 2016 was $(2.2) million, compared to $3.4 million for the fourth quarter of 2015.  For the full year 2016, Adjusted EBITDA was $1.1 million, compared to $10.5 million for the full year 2015.  Please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows for more detailed information.

Total Current and Long-term debt, includes $34.8 million in term debt and $12.5 million outstanding under the Company’s revolving credit facility at December 31, 2016. This compares to $29.9 million in term debt and $12.2 million outstanding under the Company’s revolving credit facility at September 30, 2016.

Cash and cash equivalents were $19.6 million at December 31, 2016, compared to $25.6 million reported at September 30, 2016.

“Through our actions in 2016, we positioned the organization to be more responsive to today’s world-class spine surgeons, our employees and shareholders,” said Terry Rich, Chief Executive Officer of Alphatec.  “We look forward to providing you with a company update and more details on our plans in connection with the announcement of our first quarter 2017 results.”

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, in process research and development (IPR&D) expenses and other non-recurring income or expense items, such as impairments, restructuring expenses, severance expenses, litigation expenses, damages associated with ongoing litigation and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies.  The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the optimization of the Company’s product portfolio through active product lifecycle management and the Company positioning itself to be more responsive to surgeons, employees and shareholders.  In addition, the unaudited financial results for the fourth quarter and year ended December 31, 2016 included in this press release are preliminary and represent the most current information available to management. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  adjustments to the unaudited financial results reported for the fourth quarter and year ended December 31, 2016 in connection with the completion of the Company’s final closing process and procedures, final adjustments, completion of the audit by the Company’s independent registered public accounting firm and other developments that may arise during the preparation of the Company’s Annual Report on Form 10-K; the uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA clearance or approval or international regulatory approvals for new products, or unexpected or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Please refer to the risks detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Revenues $ 27,090 $ 34,791 $ 120,248 $ 134,388
Cost of revenues 12,463 11,192 44,114 46,366
Gross profit 14,627 23,599 76,134 88,022
54.0 % 67.8 % 63.3 % 65.5 %
Operating expenses:
Research and development 2,449 8,077 9,248 17,615
In-process research and development – – – 274
Sales and marketing 11,464 13,937 50,962 51,801
General and administrative 7,092 6,547 26,339 28,126
Amortization of intangible assets 172 304 934 1,200
Impairment of goodwill and intangibles – – 1,736 164,263
Restructuring expenses 514 246 2,292 597
Total operating expenses 21,691 29,111 91,511 263,876
Operating loss (7,064 ) (5,512 ) (15,377 ) (175,854 )
Interest and other income (expense), net (2,689 ) (769 ) (15,558 ) 3,455
Pretax loss (9,753 ) (6,281 ) (30,935 ) (172,399 )
Income tax provision (benefit) 474 182 (4,488 ) (1,146 )
Loss from continuing operations (10,227 ) (6,463 ) (26,447 ) (171,253 )
Income (loss) from discontinued operations 5,481 (3,440 ) (3,870 ) (7,423 )
Net loss $ (4,746 ) $ (9,903 ) $ (30,317 ) $ (178,676 )
Net loss per share continuing operations $ (1.21 ) $ (0.77 ) $ (3.11 ) $ (20.64 )
Net income (loss) per share discontinued operations 0.65 (0.41 ) (0.46 ) (0.89 )
Net loss per share  – basic and diluted $ (0.56 ) $ (1.18 ) $ (3.57 ) $ (21.53 )
Weighted-average shares – basic and diluted 8,465 8,376 8,495 8,298
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands – unaudited) 
December 31, December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents $ 19,593 $ 6,295
Restricted cash – 2,350
Accounts receivable, net 18,512 26,870
Inventories, net 30,093 32,632
Prepaid expenses and other current assets 4,262 3,138
Current assets of discontinued operations 364 30,210
Total current assets 72,824 101,495
Property and equipment, net 15,076 16,067
Intangibles, net 5,711 8,806
Other assets 516 502
Noncurrent assets of discontinued operations 61 19,471
Total assets $ 94,188 $ 146,341
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 8,701 $ 13,542
Accrued expenses 27,981 21,175
Common stock warrant liabilities – 687
Current portion of long-term debt 3,113 79,742
Current liabilities of discontinued operations 732 9,891
Total current liabilities 40,527 125,037
Total long-term liabilities 71,954 32,761
Long-term liabilities of discontinued operations – 1,516
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (41,896 ) (36,576 )
Total liabilities and stockholders’ deficit $ 94,188 $ 146,341

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Operating loss, as reported $  (7,064 ) $  (5,512 ) $ (15,377 ) $ (175,854 )
Add back:
Depreciation 1,735 3,310 7,387 10,802
Amortization of intangible assets 693 327 1,608 2,968
Total EBITDA (4,636 ) (1,875 ) (6,382 ) (162,084 )
Add back significant items:
Stock-based compensation 1,931 5,004 3,441 7,444
In-process research and development – – – 274
Goodwill and intangible impairment – – 1,736 164,263
Restructuring and other charges 514 246 2,292 597
EBITDA, as adjusted for significant items $ (2,191 ) $ 3,375 $ 1,087 $ 10,494

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 24,487 $ 29,479 -16.9 %
Other 2,603 5,312 -51.0 %
Total revenues $ 27,090 $ 34,791         -22.1 %
Gross profit by source
U.S. $ 15,243 $ 21,396
Other (616 ) 2,203
Total gross profit $ 14,627 $ 23,599
Gross profit margin by source
U.S. 62.2 % 72.6 %
Other -23.7 % 41.5 %
Total gross profit margin 54.0 % 67.8 %
Year Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 106,932 $ 114,578 -6.7 %
Other 13,316 19,810 -32.8 %
Total revenues $   120,248 $   134,388 -10.5 %
Gross profit by source
U.S. $ 71,669 $ 79,501
Other 4,465 8,521
Total gross profit $ 76,134 $ 88,022
Gross profit margin by source
U.S. 67.0 % 69.4 %
Other 33.5 % 43.0 %
Total gross profit margin 63.3 % 65.5 % 
CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com
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Integra LifeSciences Launches Press-Fit Reverse Shoulder for Fracture for the Titan™ Modular Shoulder System

Posted On March 17, 2017 By OrthoSpineNews In Extremities /  

PLAINSBORO, N.J., March 15, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation  (Nasdaq:IART), a leading global medical technology company, announced the launch of the Titan™ Press-Fit Reverse Shoulder for Fracture.

The use of the reverse shoulder to treat humeral fractures has increased in recent years. However, heat from cement used to secure the prosthesis can hinder healing of the bone, which negatively impacts patient outcomes.1 The Titan reverse is one of the few prostheses that does not require cement, due to its unique two-piece stem that achieves a direct implant-to-bone press-fit fixation below the fracture line in the humeral canal.

Stems that fixate in the humeral canal have a strong clinical heritage, with published literature showing comparable or better functional results in fracture scenarios compared to published studies of other stem designs.2

Matt Ramsey, MD, of the Rothman Institute said, “This product has revolutionized my treatment of proximal humeral fractures. The Titan Press-Fit Reverse allows me to reliably obtain a solid fit in the canal without having to wait for the cement to dry, and the ability to adjust height and version independent of the stem means no fiddling with a jig or making sacrifices on the fit.”

The Titan Press-Fit Reverse for Fracture was developed in conjunction with Matthew Ramsey, MD; William Geissler, MD; Sanford Kunkel, MD; Jean-Marc Glasson, MD; Phillip Duke, MBBS, FRACS, FA(ORTH)A; and Mark Ross, MBBS, FRACS, FA(ORTH)A.

“The Titan Press-Fit Reverse for Fracture is a cornerstone of our shoulder portfolio.  At Integra, we’re committed to creating products that enhance patient care and enrich the surgeon experience.  Our shoulder franchise is poised to redefine expectations in shoulder arthroplasty with this and other products we have in the pipeline,” said Bob Davis, president of Integra’s Orthopedics & Tissue Technologies division.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

For additional information on the release of the Titan™ Modular Shoulder System Press-Fit Reverse for Fracture, please contact PressFit.Fx@integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

1 Formaini, NT, Everding, NG, Levy, JC, Rosas, S. Tuberosity healing after reverse shoulder arthroplasty for acute proximal humerus fractures: the “black and tan” technique. J Shoulder Elbow Surg 2015 Nov;24(11):e299-306. doi: 10.1016/j.jse.2015.04.014. Epub 2015 Jul 2.

2 Ross, M, Hope, B, Stokes, A, Peters, SE, McLeod, I, Duke, PFR. Reverse Shoulder Arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg 2015 Feb;24(2):215-22. doi: 10.1016/j.jse.2014.05.022. Epub 2014 Aug 29.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway                                              
609-936-2268                                                                    
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984 
laurene.isip@integralife.com
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Mitek Sports Medicine Introduces Comprehensive Knee Arthroscopy Platform for ACL and Meniscal Repair

Posted On March 17, 2017 By OrthoSpineNews In Sports Medicine /  

SAN DIEGO, March 16, 2017 /PRNewswire/ — DePuy Synthes Mitek Sports Medicine* has launched a new suite of knee arthroscopy solutions to help improve operating room efficiency, simplify ACL and meniscus repair, and make these surgeries more reproducible. The new platform expands the company’s leadership in products and instruments for knee arthroscopy by combining performance with an easy-to-use solution for every step of the procedure. The announcement was made here at the American Academy of Orthopaedic Surgeons Annual Meeting.

Meniscus and ACL surgery are two of the most common knee procedures performed worldwide. In 2016 580,000 meniscal repairs and more than 865,000 ACL surgeries were projected to be performed worldwide.1 With such a high-volume of surgeries, creating efficiency in the operating room through simple, versatile instruments and implants is critical for surgeons.

The new suite of products from Mitek Sports Medicine is designed to promote operating room efficiency and simplicity from the start to finish of the procedure, together with implants that may help promote stability:

  • The SPEEDTRAP™ Graft Prep System allows the surgeon to easily and quickly whipstitch, or suture, one tendon end without using a needle in about 20 seconds, which is at least 77 percent faster2 than traditional techniques and offers strong tension.
  • The TRUESPANTM Meniscal Repair System streamlines arthroscopic meniscal repair by offering a unique delivery system with an ergonomic handle, single trigger, and auto-reloading mechanism for quick, simple one-handed use. The TRUESPAN System also features the only 24-degree curved needle option on the market, which may provide better access to challenging tear locations.
  • The TWISTR™ Retrograde Reamer is used to drill the tunnels for graft placement during ACL reconstruction. The TWISTR Reamer can be set to drill 13 different tunnel diameters making it the only one-size-fits-all device of its kind on the market. The adjustable design simplifies inventory management by eliminating the need to stock multiple reamer sizes and help reduce cost during cases where more than one size reamer is needed. This product will be commercially available in the US in Q3 2017.
  • The RIGIDLOOP® Adjustable Cortical System, a titanium cortical button and adjustable loop implant, holds the graft in place in the femoral tunnel. The innovative design with adjustable loops eliminates need for multiple size implants. Simple one-handed tensioning technique allows surgeons to advance graft to completely fill the socket with stronger fixation and less graft displacement compared to similar adjustable loop devices.
  • The INTRAFIX® ADVANCE Tibial Fastener System provides rigid fixation of the graft in the tibial tunnel. The sheath and screw implant duo is designed to protect soft tissue grafts and promote integration with the surrounding bone to achieve a strong and stable fixation.

“The new products added to the Mitek Sports Medicine knee platform are well designed,” said Amir R. Moinfar, MD, orthopaedic surgeon at Elite Orthopaedic and Musculoskeletal Center in Glen Burnie, Md. “Either used individually or in concert with one another, their numerous features afford the opportunity to perform ACL reconstruction and meniscus repair safely, reproducibly and efficiently, ultimately assisting me in helping my patients.”

Matt Jewett, Platform Leader, Mitek Sports Medicine said, “We recognize that our customers need solutions for knee arthroscopy that deliver performance, reproducibility and operating room efficiency. We are very excited to be bringing these innovative knee products to our customers to address these needs at every step and help them treat patients with ACL and meniscal injuries.”

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
DSUS/MTK/0317/0939 03/17

1 Millennium Research Group Sports Medicine Device Market 2015 Analyses:  US, EMEA, ASPAC and LATAM Markets, September 2016.
2 DePuy Synthes Mitek Sports Medicine, Raynham, MA. Document 103304691 2016.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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Bioventus to Invest in New Clinical Research for EXOGEN®

Posted On March 16, 2017 By OrthoSpineNews In Biologics /  

March 15, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it will commission an innovative series of real-world evidence, direct-to-patient studies to further validate the ability of its EXOGEN Ultrasound Bone Healing System to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1

Recent publications analyzing data from a large registry of almost 8,000 fractures treated with EXOGEN suggest that the device supports healing fractures in patients despite the presence of associated comorbidities or medication use.2,3,4 This new clinical research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will build on this evidence and supplement the product’s broad body of clinical knowledge in a prospective population-based innovative clinical development program.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing the EXOGEN device with patients from a national health insurance claims database who received standard of care alone. The studies will include bones representative of long and small bones of upper and lower extremities. The unique design was discussed with FDA during its development.

“BONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of EXOGEN in fractures at risk, and to underscore the product’s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “It will build upon knowledge gained from extensive research conducted by Bioventus and recently published in JAMA Surgery, in over 700,000 fracture patients that has identified 40-plus factors which place a patient at an increased risk of progression to a nonunion.5”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

  1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.
  2. Nolte P, Anderson R, Strauss E, Hu L, J Jones, RG Steen. 2016. Heal rate of metatarsal fractures: A propensity-matching study of low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2017 47(11):2584-2590.
  3. Zura R, G Della Rocca, S Mehta, A Harrison, C Brodie, J Jones, RG Steen. 2015. Treatment of chronic (> 1 year) fracture nonunion: Heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). Injury 46:2036-2041.
  4. Zura R, S Mehta, G Della Rocca, J Jones, RG Steen. 2015. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): Findings in the elderly versus all patients. BMC Musculoskel. Dis. 16:45.
  5. Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones, JAMA Surgery. 2016: e162775. doi:10.1001/jamasurg.2016.2775.

EXOGEN – Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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Medacta International Expands Relationship With OREF to Advance Orthopedic Research and Innovation

Posted On March 16, 2017 By OrthoSpineNews In Financial, Recon, Spine /  

March 16, 2017

CHICAGO–(BUSINESS WIRE)–Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spine surgery products, today reaffirmed its partnership with the Orthopaedic Research and Education Foundation (OREF) to advance new frontiers of orthopedic discovery. Effective immediately, and building upon their work together over the past two years, Medacta has increased its support and will now match resident gifts two-to-one, up from its original commitment of one-to-one. Importantly, this program encourages residents to engage in charitable giving at an early state in their careers and prioritizes OREF as a beneficiary of their philanthropy.

Since the program started in 2015, the Medacta Challenge raised more than $150,000 for OREF. This includes contributions to OREF’s Research Fund from Francesco Siccardi, Executive Vice President of Medacta International, and Eric Dremel, President of Medacta USA, who each pledged $20,000 to kick off the partnership and demonstrate their commitment to the initiative. Mr. Siccardi and Mr. Dremel were recognized for their gifts as members of OREF’s Visionary Research Society.

“We believe the next big innovation is always just around the corner and are excited that our expanded partnership with OREF will make already generous resident contributions even more impactful,” said Siccardi. “This partnership drives Medacta and OREF’s shared goal of providing the best possible care to improve the lives of patients around the globe.”

All gifts made to OREF through the Medacta Challenge help OREF achieve its mission of funding new and seasoned investigators in the orthopedic field. This funding may be used to support research in orthopedic trauma, total joint arthroplasty, soft tissue repair and regeneration, among other important topics. With Medacta’s increased commitment, the impact of resident donations will be tripled to provide investigators with necessary resources to conduct these important studies.

“OREF relies on the generosity of organizations like Medacta to continue supporting research in orthopaedics,” said David Lewallen, MD, OREF Board President. “The grants we provide enable innovators to push the envelope and be bold, effectively creating change in the orthopaedic discipline – ultimately providing patients with safer, better options, and a higher quality of life. None of this would be possible without our committed partners such as Medacta.”

Richard Santore, MD, Trustee and Chair of OREF’s Individual Development Committee, added, “We are particularly excited that Medacta’s matching gift program will not only support our investigators, but will encourage other individuals and companies to consider establishing additional creative concepts for making gifts to OREF. Working together to promote new studies and drive creative solutions will benefit us all and, most importantly, the patients we serve together. Medacta is to be commended for their leadership and generosity for this multi-year commitment to OREF.”

Since Medacta’s founding in 1999, the company has maintained a long tradition of prioritizing research and training, the foundations of orthopedics. Through training initiatives, such as the company’s M.O.R.E. Institute, Medacta promotes surgeon education and provides the tools for physicians to refine their skills. The company has trained over 5,000 surgeons at its learning centers, while its biennial M.O.R.E. International Symposium consistently attracts hundreds of renowned surgeons from across the world.

For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

About the Orthopaedic Research and Education Foundation

Founded in 1955, the Orthopaedic Research and Education Foundation is a charitable 501(c)(3) organization committed to improving lives by supporting excellence in orthopaedic research. OREF is dedicated to supporting new investigators and is the premiere orthopaedic organization funding research across all specialties. A list of research and funding priorities is available at oref.org/grants. To learn more about OREF, please visit www.oref.org or follow @OREFtoday on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com
or
For OREF
Karen Pubentz, 847-430-5113
pubentz@oref.org

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First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line

Posted On March 16, 2017 By OrthoSpineNews In Extremities, Regulatory /  

LOGAN, Utah, March 15, 2017 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Staple™ System product family.

Previously, the company received clearance for its “Standard” size implants in different lengths, manufactured from titanium alloy. The new FDA clearance includes: “Standard” size implants manufactured from PEEK, “Small” size implants manufactured from titanium alloy or PEEK, and “Mini” size implants manufactured from titanium alloy. Standard size implants are well suited for hindfoot fusions and first tarsometatarsal joint fusions. Small size implants are well suited for midfoot fusions, first metatarsophalangeal fusions and carpal fusions. Mini size implants are well suited for carpometacarpal joint fusions, lesser metatarsophalangeal fusions, and fixation of Akin osteotomies. Surgeons now have the choice for radiopaque and, for the Standard and Small sizes, radiolucent implants.

The Stealth Staple™ System, an intraosseous small bone fixation system, represents a significant advancement for the treatment of arthrodesis, osteotomies and bone fractures. Current standard-of-care devices used to treat these indications are primarily bone plates and bone screws, or bone staples. Due to the prominence above the bone surface associated with these standard-of-care devices, there are notable clinical rates of device related pain, soft tissue irritation, and second surgeries for hardware removal. Since the Stealth Staple™ is completely contained within the bone upon implantation, clinical complications related to prominent hardware may be substantially reduced.

Another significant advancement provided by the Stealth Staple™ is the creation of controlled and evenly distributed compression across the opposing bone surfaces of an osteotomy or fracture. Finite element analysis and biomechanical testing have demonstrated superior strength, superior bone compression and superior resistance to gap formation compared to bone plate and screw systems (data on file).

First Ray is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Lane Hale
Executive Vice President
150433@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE First Ray

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Soft Tissue Regeneration Raises Series C Financing and Rebrands to Biorez

Posted On March 16, 2017 By OrthoSpineNews In Biologics, Top Stories /  

NEW HAVEN, CONN. (PRWEB) MARCH 14, 2017

Biorez, Inc., formerly known as Soft Tissue Regeneration, Inc., today announced the close of a $1.5 million investment following preliminary results of the first in-human study of its novel implant for anterior cruciate ligament (ACL) reconstruction.

The breakthrough approach makes use of a proprietary tissue-engineered scaffold that stabilizes the knee, facilitates the body to regrow new ACL tissue, and then fully resorbs, leaving only new, functional tissue.

Connecticut Innovations, Connecticut’s leading source of financing and ongoing support for Connecticut’s innovative, growing companies, led the investment round. Vertical Group and KLP Ventures, an affiliate of Launch Capital, also participated in the round.

“Biorez has learned a great deal through their early stages of development and testing,” said Dan Wagner, managing director at Connecticut Innovations, and a Biorez board member. “With a new CEO at the helm and a new path ahead, we look forward to supporting the progress of this company and technology in the future.”

“Typically, a torn ACL is surgically reconstructed using a tissue graft harvested from the patient or a cadaver,” said Kevin Rocco, CEO of Biorez. “Neither option is ideal for patients, but both biologic grafts remodel into new functional tissue over time. We have developed an off-the-shelf, synthetic scaffold constructed from biocompatible polymers that harnesses the same regenerative remodeling process.”

Biorez will be sharing the detailed results of the human trial in private meetings with key partners, surgeons, and researchers during the American Association of Orthopedic Surgeons (AAOS) meeting in San Diego, from March 14 through March 18, 2017. Biorez is the first company to clinically investigate a tissue-engineered scaffold for ACL reconstruction in a human trial.

“The clinical study has validated our unique approach, and given us a first-mover advantage to further optimize our technology,” said Rocco. “We look forward to publishing our results.”

About Biorez, Inc.
Biorez, Inc. is a privately-held, early-stage regenerative medicine company engaged in developing bioresorbable scaffold implants to regenerate functional tissue in vivo. Its lead product candidate is an off-the-shelf implant for ACL reconstruction that spares harvesting of patient donor-tissue, and provides a better alternative to cadaver-based materials. The company plans to commercialize its lead ACL technology, as well as expand its platform to develop new and innovative clinical solutions. To learn more, visit http://www.biorez.com.

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DePuy Synthes Companies Announces New ATTUNE® Revision Fixed Bearing Tibial Base and Cemented Stem

Posted On March 16, 2017 By OrthoSpineNews In Recon /  

SAN DIEGO, March 15, 2017 /PRNewswire/ — Today, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, announced the launch of the first ATTUNE® Knee revision options, the ATTUNE Revision Fixed Bearing Tibial Base and the 14×50 mm Cemented Stem. The Tibial Base is designed to address a range of patient needs, from complex primary to partial revision of ATTUNE Primary Knees. The announcement was made in San Diego, coinciding with the American Academy of Orthopaedic Surgeons Annual Meeting.

The ATTUNE Revision Fixed Bearing Tibial Base, which is compatible with either fixed bearing posterior stabilized or cruciate retaining tibial inserts, incorporates the proprietary technologies of the ATTUNE Knee such as the LOGICLOCK™ Tibial Base locking mechanism that is designed to enable enhanced kinematics, stability and wear reduction.1 The ATTUNE Revision Fixed Bearing Tibial Base can be used with a 14×50 mm Cemented Stem that can be added intra-operatively at the discretion of the surgeon for patients with clinical needs that require supplemental fixation.

According to Rajit Kamal, Global Knee Platform Leader, DePuy Synthes Joint Reconstruction, “DePuy Synthes worked with renowned experts around the world to develop the ATTUNE Knee System. The ATTUNE Revision Fixed Bearing Tibial Base and Cemented Stem were developed to address more complex clinical needs and expand treatment options for patients. It will also extend DePuy Synthes leadership in the category of revision solutions.”

DePuy Synthes Companies developed the ATTUNE Knee System to improve the stability and motion of knee replacement, which are important to patient satisfaction. The ATTUNE Knee System can help patients return to their normal activities sooner than anticipated2-3, while also enabling surgeons and health systems to improve clinical outcomes, reduce costs and increase patient satisfaction.

Implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirmed positive early results for the primary ATTUNE Knee.4 These data add to other recent registry evidence which has shown that survivorship for the primary ATTUNE Knee compares favorably to other knee systems in its class.5 In addition, one-year results from two worldwide studies have shown improved patient reported outcomes measures with the primary ATTUNE Knee compared to other leading knee systems.6

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the ATTUNE Knee System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes presents the products and service of DePuy Synthes, Inc. and its affiliates

The third-party trademarks used herein are trademarks of their respective owners
DSUS/JRC/0217/2035 March 2017

References:

1. Leisinger, S., Hazebrouck, S., Deffenbaugh, D., Heldreth, M. (2011) Advanced fixed bearing TKA locking mechanism minimizes backside micromotion. International Society for Technology in Arthroplasty (ISTA) Annual Meeting.

2. Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE® Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418.
In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE® Knees and 40 patients with SIGMA® CR150 knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent

3. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status.” Value in Health 19(3): A298.
Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon™.

4. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Retrieved from: https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty

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