Zimmer Biomet Announces U.S. Launch of Avenue® T TLIF Cage with Integrated VerteBRIDGE® Plating

WARSAW, Ind.Oct. 2, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it is officially launching in the United States the Avenue® T TLIF Cage. Avenue T advances posterior lumbar cage technology by incorporating VerteBRIDGE® plating, which facilitates simplified cage insertion and zero-profile, intradiscal fixation through a direct, minimally invasive surgical (MIS) approach. Avenue T is the first and only posteriorly implanted cage with integrated, anti-migration fixation, solidifying Zimmer Biomet as the first company to offer a suite of lumbar cages with integrated fixation for every fusion approach. Avenue T joins a family of cages with VerteBRIDGE plating, including ROI-C® Cervical Cage, Avenue® L Lateral Lumbar Cage and ROI-A® ALIF Cage.

Dr. Craig Chebuhar, a board-certified orthopaedic spine surgeon in Atlanta, Georgia, who implanted one of the first Avenue T cages in the U.S., commented, “I regularly use Zimmer Biomet’s ROI-C Cervical Cage featuring VerteBRIDGE plating in my practice.  Transforaminal lumbar surgery is another attractive application for integrated plating.  For my TLIF patients, I appreciate the additional fixation VerteBRIDGE provides to the construct, all via a minimally invasive approach.”

The Avenue T Cage is a prime example of Zimmer Biomet’s commitment to the advancement of MIS surgery. The Avenue T Cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a simplified technique. The VerteBRIDGE plates are sterile packaged and pre-assembled on a PEEK cartridge. The cartridge simplifies the technique, enabling the cage and plates to be loaded simultaneously on the Inserter. Once the cage is implanted, the Impactor advances both plates at the same time, reducing implantation steps. The unique anterior column fixation provided by the plating may permit the surgeon to select from a greater array of options for supplemental fixation.

Indications: The Avenue T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Vivorté announces the commercial availability of FORTERA™ and REGENTO™ bone grafting solutions for orthopedic surgery

LOUISVILLE, KY — (October 3, 2017) — Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, today announced the commercial availability of a complete line of bone grafting product solutions. Joining Trabexus EB, the company’s flagship bone grafting solution, Fortera is a completely synthetic calcium phosphate cement, capable of controlled delivery through a 16-gauge cannula.  REGENTO is a resorbable, particulate b-TCP bone void filler with engineered macroporosity to promote protein deposition and cell attachment.

These newly introduced products join Trabexus EB, which first received 510(k) clearance in 2015.  TRABEXUS EB is a self-setting, gradually resorbable, calcium phosphate matrix enhanced with partially demineralized allograft particles.  The engineered bone component is formed into “hourglass” shapes (TRABS®) using a proprietary manufacturing process.

This novel shape provides multiple benefits, including increased “interconnectivity” of adjacent particles, creation of channels for accelerated remodeling and greater overall surface area.  Further, the TRABS are partially demineralized, exposing key osteoinductive proteins, which are known to influence and direct the formation of new bone.  Trabexus EB is resorbed and remodeled by the body as new bone formation occurs during the healing process.

“With the introduction of Fortera and Regento to our product portfolio, Vivorté now offers a complete line of synthetic biomaterials possessing a wide range of clinical performance attributes” said Ruth Voor, CEO of Vivorté, Inc. “Vivorté is a unique, emerging company, with multiple 510(k) cleared technologies, vertically-integrated manufacturing capability and an R&D pipeline of orthopedic biomaterials and traditional metallic implants. To date, our products have been well-received in the marketplace by orthopedic surgeons and hospitals, and we continue to expand our distribution network to reach institutions across the United States.”

According to BioMedGPS, the current market for bone graft substitute products exceeds $1.7B annually in the United States alone.  Bone grafting procedures are necessary to fill defects or cavities in bone as the result of injury, reconstructive surgical procedures such as a joint replacement, or surgical excision following the removal of tumors or cysts.

Clinical considerations vary across these procedures, requiring biomaterials with differing handling characteristics, biological activity and mechanical performance.  Vivorté continually seeks to understand the surgical environment in order to design and develop products that best complement each surgeon’s unique operative technique.

The Fortera and REGENTO products will be made available concurrent with the Orthopaedic Trauma Association (OTA) Annual Meeting, being held October 11-14, 2017 in Vancouver, B.C., Canada.  Representatives from Vivorté will be attending the OTA meeting to further address product requests and inquiries.

 

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky, is a privately-held, ISO-certified orthopedic biomaterials manufacturer, focused on developing innovative and cost-effective, surgical products for the benefit of surgeons, hospitals and patients.  The company’s products include TRABEXUS® EB Osteoinductive Bone Matrix, Fortera Injectable Bone Graft and Regento Bone Void Filler.  To learn more, please visit our website at www.vivorte.com.

Contact: Therese Montano / Vivorté, Inc. / 502-714-7234 / tmontano@vivorte.com

OrthoPediatrics Corp. Announces Launch of Initial Public Offering

WARSAW, Ind., Oct. 02, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”), an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market, announced today the launch of the initial public offering of 4,000,000 shares of its common stock. OrthoPediatrics will grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock. The proposed offering price is expected to be between $12.00 and $14.00 per share of common stock. OrthoPediatrics has applied to list its common stock on the NASDAQ Global Market under the ticker symbol “KIDS.”

OrthoPediatrics intends to use the net proceeds that it receives from the proposed offering to pay accumulated and unpaid dividends on its Series B preferred stock, to invest in implants and instrument sets for consignment to its customers, to fund research and development activities, to expand its sales and marketing programs, and for working capital and general corporate purposes.

Piper Jaffray and Stifel are acting as joint book-running managers, William Blair is acting as lead manager and BTIG is acting as co-manager, of the proposed offering.

The proposed offering will be made only by means of a prospectus. Copies of the prospectus related to the proposed offering may be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicole Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at prospectus@pjc.com; or from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, via telephone at (415) 364-2720 or via email at syndprospectus@stifel.com.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. All statements other than statements of historical facts included in this press release, including statements concerning OrthoPediatrics’ plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook and business trends, are forward-looking statements. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “budget,” “goals,” “potential,” “continue,” “design,” “objective,” “would” and other similar expressions. The forward-looking statements are not historical facts and are based upon OrthoPediatrics’ current expectations, beliefs, estimates, projections and assumptions, many of which, by their nature, are inherently uncertain and beyond OrthoPediatrics’ control. OrthoPediatrics’ expectations, beliefs, estimates and projections are expressed in good faith, and OrthoPediatrics believes there is a reasonable basis for them. However, there can be no assurance that such expectations, beliefs, estimates and projections will result or be achieved, and actual results may vary materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ registration statement on Form S-1. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

About OrthoPediatrics Corp.

Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States.

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

Taking MIS TLIF to the Next Level

Tracey Romero/9-29-2017

Photo: PROLIFT® and Dr. Zeshan Hyder/Courtesy of Life Spine

In an arena of rapid technological advancement, it takes an innovation powerhouse to design products that have the ability to disrupt the spine industry. Life Spine, a manufacturer of spinal implants that launched 27 products in 2016, has revolutionized the TLIF taking it from a 90+ minute minimally invasive procedure to a micro-invasive procedure that has been completed in as little as 25 minutes.

Surgeons like Zeshan Hyder, D.O. of the Bone and Joint Specialists of Northwest Indiana are executing up to six of these procedures in one day. The potential benefits of a drastic reduction in procedural time are directly realized by surgeons and their patients. The system is designed to offer the benefits of: less time in the hospital and OR, reduced incision size, a safer surgery and a more reproducible procedure that caters to an ambulatory surgery center (ASC) setting.

The main benefit of the micro-invasive TLIF is less time in the operating room which typically correlates to a faster recovery.

Traditional TLIF procedures can take up to six hours. Six hours of muscle retraction, anesthesia, blood loss and fatigue to the hospital staff. Additionally, the longer the operating time, the fewer the patients a surgeon can operate on and the higher the cost of surgery.

 

READ THE REST HERE

 

Alphatec Announces Additional Spine-Experienced Leadership Appointments

CARLSBAD, Calif., Oct. 02, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced that Patrick Miles has been appointed as Executive Chairman and Quentin Blackford as a member of the Board, effective today.  Miles will lead the organization, and Terry Rich, Alphatec‘s Chief Executive Officer, will continue in his role, reporting to Miles. In conjunction with these appointments, Miles and Blackford are personally investing in Alphatec common stock in an aggregate amount in excess of $3.5 million.

“Today’s announcement marks continued execution of our vision to reposition Alphatec as the most respected, fastest-growing company in U.S. spine,” said Mr. Rich. “Pat and Quentin have decades of industry experience and well-deserved reputations that speak for themselves. Their personal financial commitments are a powerful testament to their personal commitments to increase shareholder value; a conviction that has been expressed by our entire leadership team.”

Rich continued, “Pat is a globally recognized spine visionary and a proven driver of market-share expansion.  His passionate belief that our most important business is in the operating room aligns absolutely with the Alphatec value system, and positions him extraordinarily well to lead the organization. I have great confidence that Pat’s influence on daily operations, product development decisions, and surgeon engagement will accelerate the business transformation that we are driving. I look forward to partnering with him to advance Alphatec’s growth trajectory by executing our mission to improve patient lives.”

Miles brings a wealth of orthopedics and innovation expertise, with over 25 years of industry experience, and as a named inventor on close to 100 industry patents. In his capacity as Executive Chairman, he will be fully engaged, focusing primarily on further defining and implementing Alphatec’s strategic initiatives, expanding and fortifying the Company’s relationships with surgeon customers, and leading Alphatec’s new technology development.  Miles joins Alphatec following a 17-year tenure at NuVasive, Inc., where he was a central figure in the company’s expansion from a start-up business to a global spine corporation with close to $1 billion in revenues.  He most recently served as NuVasive’s Vice Chairman; prior to that, he was its President and Chief Operating Officer, and President of Global Products and Services.  Before joining NuVasive, Mr. Miles held sales and marketing roles with Medtronic Sofamor Danek and Smith & Nephew.

“I am thrilled to work closely with Terry once again to reposition Alphatec as the next great growth story in spine. Together, we share roughly 50 years of spine and orthopedics expertise – a level unrivaled in spine leadership – which will guide us in determining how best to serve this market.  I look forward to driving toward improved surgical outcomes and market share expansion,” said Miles. “Alphatec has a broad and impressive product portfolio, improving surgeon engagement, and great access to hospitals; all of which position the Company exceptionally well to take market share in today’s environment. This is a high-caliber team driving an important mission, and I feel incredibly lucky to be a part of it.”

Blackford joins the Alphatec Board of Directors with 17 years of experience in the medical device industry.  He is currently Executive Vice President and Chief Financial Officer of DexCom, Inc. Prior to joining Dexcom, Blackford was Executive Vice President, Chief Financial Officer, Head of Strategy and Corporate Integrity for NuVasive.  In that role, he led the Finance, Strategy and Corporate Development, Compliance and Regulatory functions. Before joining NuVasive in 2009, Mr. Blackford held various leadership roles with Zimmer Holdings, Inc., including Director of Finance and Controller for Zimmer Dental.

“Alphatec has assembled an exceptional team of spine industry leaders who are already transforming the business.  I am excited to help shape the Company’s strategic direction as Alphatec evolves into a leading spine player,” said Blackford.

In connection with these appointments, Mortimer Berkowitz III, Alphatec’s Chairman since December 2016, will transition into the role of Lead Director. In addition, Stephen O’Neil has resigned from his position as a member of the Company’s Board of Directors, effective immediately.  Mr. Rich will also remain a key member of the Alphatec Board.

Mr. Berkowitz, said, “I would like to thank Steve for his 12 years of dedicated service to Alphatec, and for being a trusted colleague and counselor. I also enthusiastically welcome Pat and Quentin to the Alphatec family, and thank Terry for his efforts in bringing them aboard. They share the optimism and the vision that we have for the future of this Company, and I look forward to serving with them in the Lead Director role.”

Inducement Award 
As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has also approved an award to Mr. Miles of 1,000,000 restricted stock units (RSUs).

The RSUs will be granted following registration of the common stock underlying the RSUs and will vest in equal annual installments on each of the first three anniversaries of Mr. Miles’ date of employment if he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The Board approved an amendment to Alphatec’s 2016 Employment Inducement Award Plan to increase the shares reserved for issuance thereunder by 1 million shares, effective October 2, 2017.

Equity Investments in Alphatec Common Shares
Mr. Miles has agreed to purchase 1.3 million shares of common stock and Mr. Blackford has agreed to purchase at least 220,000 shares of common stock and up to 440,000 shares of common stock, all at a purchase price of $2.26 per share (the consolidated closing bid price of Alphatec common shares on September 29, 2017), for gross proceeds to the Company of between $3.5 million and $4 million. The share purchases are expected to close on or before January 1, 2018. In connection with his purchase of Alphatec common stock, at the closing, Mr. Miles will also receive a five-year warrant to purchase up to 1.3 million shares of common stock at a purchase price of $5.00 per share which, if exercised, will generate additional gross proceeds to the Company of $6.6 million.

About Alphatec Holdings, Inc.
Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, 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 providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. 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 contains “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. The Company 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 Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  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:  the uncertainty of success in developing new products or products currently in the Company’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 the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party 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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. 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.

Investor/Media Contact:
Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

Ortho Sales Partners Announces the Addition of Kevin McGann as Senior Vice President and General Manager

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Kevin McGann as Senior Vice President and General Manager. Mr. McGann joins the Ortho Sales Partners leadership team after a successful tenure with Stryker Spine as its Vice President of North American Sales where he was responsible for all US and Canadian sales, market development, commercial operations and medical education for all spine and biologics products in the US and Canada. Under his leadership, Stryker Spine saw consistent positive growth in revenue and share gain.

Prior to his role with Stryker Spine, Mr. McGann served as President, Americas Region for Lumenis Incorporated where he was responsible for all North and South American sales, marketing and operations overseeing $110M in revenue as well as a $40M annual operating budget. Lumenis Incorporated’s products serve the Urology, ENT, GYN, Ophthalmic and Aesthetic verticals. One of his more notable contributions was his involvement in taking the company public (NASDAQ) in the first quarter of 2014.

Mr. McGann started his Orthopedic career with US Surgical for over 15 years. He was later recruited to Kyphon which was acquired by Medtronic Spine and Biologics in 2008 for $4.2 Billion. After the integration, he was promoted to Area Vice President of Sales for the Eastern Division and he spent the last 3 years of his tenure with Medtronic as the Vice President of Sales, US Spine, Biologics and Operations where he had responsibility for an organization with over $1.5 Billion in annual revenue.

In his new role, Mr. McGann will be focused on utilizing his experience in creating and managing high caliber sales teams with a focus on scalability for the benefit of Ortho Sales Partners clients. In addition, Mr. McGann will bring insights in the areas of mergers and acquisitions, licensing, field operations, marketing and product messaging.

“I am very proud to be joining Ortho Sales Partners and the team of dedicated healthcare professionals and executives” said McGann. “The business model and access to experts in all areas of commercializing medical device platforms and products is unique and a key differentiator of Ortho Sales Partners. I look forward to helping the business continue to grow.”

“I am excited for what today’s announcement means for our clients” said Josh Sandberg President, Ortho Sales Partners. “Kevin McGann and his experience checks all the boxes we could hope for in adding a key executive to our management team. Our team offers unparalleled access and insights to the orthopedic, spine and orthobiologic industries. This addition allows us to further advance and assist companies avoid the impact of stalled growth.”

About Ortho Sales Partners

About Ortho Sales Partners – Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

  • A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
  • OUS companies looking to establish or enhance their presence in the United States.
  • Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
  • Established companies looking for marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis rather than surgery volumes from over 4 years ago.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US (http://www.orthosalespartners.com).