Angels invest in local medical device startup

By  – September 7, 2016

A Naples-based investment fund has bet its money on the success of a local orthopedic medical device startup.

The fund, Tamiami Angel Fund II, or T2 for short, has invested nearly $1 million in Catalyst OrthoScience to help the company ramp up the production of what it describes as a “breakthrough product” for shoulder-replacement surgery.

“The product we feel is revolutionary, not evolutionary. And we liked the progress that the management team had made,” said Tim Cartwright, chairman of Tamiami Angel Funds.

Steven Goldberg, chief of orthopedic surgery at Physicians Regional Healthcare System in Naples, founded Catalyst OrthoScience in December 2014. He started developing his product, called the Catalyst CSR Shoulder System, about four years ago. He has several patents for the device and others pending.

The device, which can fit in the palm of a hand, is made of two materials: a metal alloy, cobalt-chromium-molybdenum, and ultra-high molecular-weight polyethylene. It’s in the shape of a shoulder. Used with a new surgical approach, the implant requires less bone removal than other procedures for arthroplasty, or joint replacement.

T2 invested $930,000 in Catalyst OrthoScience. The fund was the lead investor in a $3.3 million Series A capital raise. Series A refers to the first significant round of capital raised from outside investors, and it’s the largest such raise in Southwest Florida this year, according to the MoneyTree Report from PricewaterhouseCoopers LLP.

Other investors in the new company include IrishAngels, a Chicago-based group whose members have ties to the University of Notre Dame.

Catalyst OrthoScience is one of two Naples-based companies T2 has invested in, and it’s one of the fund’s largest investments in a first round.

 

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Interventional Orthopedics Foundation Announces Fellowship Grants

BROOMFIELD, Colo., Sept. 2, 2016 /PRNewswire/ — As part of its commitment to furthering the quality of education in the field of interventional orthopedics, the Interventional Orthopedics Foundation is proud to announce that it has awarded two prestigious universities and medical centers in the United States for the 2016-2017 academic year. The grants were awarded through the Foundation and provided a total of $75,000 to recipients for the placement of clinical PM&R Fellows.

Award recipients are Emory University Department of Orthopedics and Sports Medicine in Atlanta, Georgia and Stanford University PM&R Sports Medicine Fellowship in Redwood City, California.

These programs demonstrate a comprehensive curriculum that fits well with the IOF’s mission to expand the reach of regenerative interventional orthopedics. Fellows in these programs have the opportunity to acquire significant hands-on spine and peripheral joint ultrasound and fluoroscopy training focused on Interventional Orthopedics—by utilizing more invasive and technically advanced stem cell therapies.” said Nancy Ho, Executive Director for Interventional Orthopedics Foundation.

About the Interventional Orthopedics Foundation

The Interventional Orthopedics Foundation (www.interventionalorthopedics.org) was created as a not-for-profit (501)C(3) organization on January 27, 2015.  The Foundation’s primary function is to educate and serve as a resource to physicians and the public who seek to understand the growing field of interventional orthopedics, which includes the development and availability of regenerative medicine therapies. 

Each application is reviewed by IOF’s Grant Review Committee. Two nationally recognized universities and medical centers were selected to receive one of the 2016 PM&R Clinical Fellowship grants based on a comprehensive application process, focusing on each institution’s specific clinical and research programs that target the specific needs of the local community.

Media contact:  
Dave Klein  
Email  
303-800-6467

SOURCE Interventional Orthopedics Foundation

Related Links

http://www.interventionalorthopedics.org

Should your ASC bundle? Dr. Randolph Bishop on navigating a spine program

Bundled payment programs are receiving a lot of buzz in the value-based arena, but developing a bundled product is no straightforward task.

Before surging ahead into a bundled payment program, ambulatory surgery centers should first decide whether its surgeons and facility can perform the desired service at a competitive market price. Consider whether the ASC has the ability to operate the business with the margin generated by government payers.

Once an ASC understands its capabilities, it can build a bundled spine surgery product by calculating an accurate facility cost combined with the surgeon payment.

“The goal would be for the facility and surgeon to assume the risk of the episode of care and therefore should cover all aspects of the surgery with the exception of indirect complications,” says Randolph Bishop, MD, MBA, a neurosurgeon at Neurological Institute of Savannah (Ga.).

Certain ASCs pose as superb candidates for bundled payment programs. Surgeon-owned centers and centers specializing in spine are especially groomed for bundled payments.

 

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Stem cell company paid $443,500 to former head of state agency that funds research

By DAVID JENSEN – September 1, 2016

The former president of the $3 billion California stem cell agency received $443,500 in total compensation from the Bay Area stem cell company that appointed him to its board of directors only seven days after he left his state post.

The stock and cash were provided over a two-year period to Alan Trounson by Newark-based StemCells Inc., a firm that was awarded more than $40 million in funding while Trounson headed the California Institute for Regenerative Medicine, as the state stem cell agency is formally known.

In 2014, when Trounson served less than six months on the StemCells Inc. board, his total compensation was more than double that of any other board member.

The surprise appointment of Trounson almost immediately after he left CIRM in 2014 generated allegations of conflict of interest. The size of Trounson’s total compensation, however, was not available at that time.

Conflict-of-interest allegations have dogged the agency since it was created in 2004 by California voters to use state bond proceeds to finance stem cell research.

In 2008, the respected scientific journal Nature warned about “cronyism” at the agency. In 2012, the Institute of Medicine, a division of the National Academies of Sciences, recommended in a $700,000 study commissioned by CIRM that the stem cell agency make sweeping changes to reduce the possibility of such conflicts.

Speaking about the agency’s board, Harold Shapiro, chairman of the Institute of Medicine team, told the Los Angeles Times, “They make proposals to themselves, essentially, regarding what should be funded.”

The agency made some changes to deal with conflict questions but resisted the institute’s far-reaching proposals.

The latest news prompted John Simpson, who has followed the stem cell agency for Consumer Watchdog of Santa Monica, to say in an email, “Trounson’s joining the StemCells Inc. board a mere seven days after quitting as CIRM’s president at the time smacked of being a payback for a job well done on behalf of the company when he should have been looking out for the taxpayers’ money and interests. It was a blatant conflict that undermined the agency’s credibility. Now we know his price tag.”

In 2014, the stem cell agency said its “limited” investigation showed that no violation of law occurred. At the time, CIRM Chairman Jonathan Thomas described the issue as a “perception” problem.

 

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Vexim: Amendment of the financial agenda for 2016

Toulouse, September 2, 2016 –VEXIM (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, will announce its 2016 Half-Year Results on Tuesday, 20 September, 2016 – after the market close.

The other dates announced on the original schedule remain unchanged:

ANNOUNCEMENT                                                            DATE*

2016 Half-Year Results                                          Tuesday, September 20, 2016

Q3 2016 Sales                                                          Thursday, October 13, 2016

* Subject to modification. Press releases are distributed either before the financial markets opening, or after the closure

About VEXIM, the innovative back microsurgery specialist Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital1 and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 62 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® 2 , a revolutionary implant for treating Vertebral Fractures The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

MasterflowTM 2 , a high-performance orthopedic cement delivery system The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

 

1 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.

2 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

CONTACTS

VEXIM Vincent Gardès CEO investisseur@vexim.com Tél. : +33 5 61 48 48 38

PRESS

ALIZE RP Caroline Carmagnol / Wendy Rigal vexim@alizerp.com Tél. : +33 1 44 54 36 66 Tél. : +33 6 48 82 18 94

Zimmer Biomet Holdings to Present at INVESTIndiana Equity Conference

WARSAW, Ind., Sept. 1, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that it will be participating in the INVESTIndiana Equity Conference at the Indianapolis Marriott Downtown on Thursday, September 15, 2016 at 1:10 p.m. Eastern Time.

A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website athttp://investor.zimmerbiomet.com.

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; spine, bone healing, 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.

About INVESTIndiana
Since 2008, the INVESTIndiana Equity Conference has given professional investors and fund managers an opportunity to interact with leading Indiana public companies.  The event features CEOs, CFOs and corporate leaders discussing important trends and their strategies to grow their companies.

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SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

Stryker’s Endoscopy division acquires Ivy Sports Medicine

KALAMAZOO, Michigan, USA, Sept. 1, 2016 /PRNewswire/ — Stryker’s Endoscopy division announced today it has acquired Ivy Sports Medicine, LLC, whose portfolio is comprised of a comprehensive minimally invasive meniscal repair platform. The addition of Ivy Sports Medicine’s portfolio enables Stryker to provide customers with a complete meniscal platform to better serve their patients.

The portfolio includes the only FDA-approved collagen meniscus implant (CMI®) on the market, a reliable and innovative all-inside repair device, as well as an inside-out meniscal suturing platform.  Ivy’s history and sole focus on advancing the treatment of meniscal injuries is also highly complementary to Stryker’s current portfolio of visualization, resection, fluid management, and ACL reconstruction platforms.

“The acquisition of Ivy Sports Medicine strengthens our capabilities and fits strategically with our current portfolio. Ivy’s complete meniscal platform, coupled with their clinical history, will allow us to provide our customers with multiple solutions to address meniscal repair,” said Matt Moreau, Vice President and General Manager of Stryker’s Sports Medicine business.  “This is an area of sports medicine where there is continued opportunity to address unmet customer needs. The Ivy portfolio provides a unique platform for us to build upon as we seek to continue advancing the treatment of meniscal injuries.”

“Ivy Sports Medicine was formed to capitalize on the unmet opportunity in meniscal repair, which we view as one of the more attractive growth opportunities in all of orthopaedics,” said Robert Pangia, CEO of Ivy Sports Medicine. “Our products provide surgeons with a complete set of tools to treat a large spectrum of meniscal repairs. We are excited about the prospects of combining these products with Stryker’s distribution channels and complementary portfolio of sports medicine products.”

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Media Contact
Jenny Braga, Senior Communications Manager
jenny.braga@stryker.com

Logo – http://photos.prnewswire.com/prnh/20140106/PH40722LOGO

SOURCE Stryker

Related Links

http://www.stryker.com

Alphatec Holdings Completes Sale of International Business to Globus Medical

CARLSBAD, Calif., Sept. 01, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq: ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced the completion of the previously announced sale of its international operations and distribution channel to Globus Medical (NYSE: GMED), a leading musculoskeletal implant manufacturer.

With the closing of the transaction, the Company is now focused solely on the U.S. market, which Alphatec believes constitutes nearly 65% of the world’s spinal fusion market.

Over the past several years, the Company has focused its R&D programs and invested in the development of a leading, robust suite of products that are available to surgeons in the U.S. today—including Arsenal™ Degenerative, Arsenal Deformity and Battalion™ Universal Interbody.  In addition, the Company has recently obtained U.S. clearance for its new XYcor® Expandable Spinal Spacer System, which the Company plans to launch later this year.  The Company also made significant progress through its initiative to outsource its manufacturing operations—reducing capital investment in equipment, partnering with valued suppliers to provide flexible capacity, while achieving unit level cost reductions and margin improvements. As a result, Alphatec believes it is now better positioned to compete more effectively in the marketplace, accelerate growth and continue to improve profitability.

“Today marks the beginning of a new chapter for Alphatec,” said Jim Corbett, President and Chief Executive Officer of Alphatec Spine. “I am excited about the long-term prospects for the company as we pursue the U.S. spinal market with the resources we need to support continued investment in the commercialization of our robust product line. We have the right products, an exceptional team and a newly streamlined balance sheet to support our growth across the country, and we look forward to executing on our vision.”

Terms of the Transaction

Globus acquired Alphatec’s international operations and distribution channel for a purchase price of $80 million in cash. Globus will also provide Alphatec a five-year senior secured credit facility of up to $30 million. In addition, Alphatec has entered into a supply agreement through which Alphatec will supply its products to Globus for up to five years.

New Capital Structure

With the closing of this transaction, Alphatec believes that it can now establish a new capital structure that appropriately reflects the capital needs of its U.S.-focused business and positions the company for achieving future profitability. As part of the closing, Alphatec implemented the following related to this new capital structure:

  • Drew down $25M of the $30M credit facility from Globus upon closing;
  • Paid off the existing Deerfield credit facility balance and retired the credit facility;
  • Reduced the MidCap Financial term loan to a $5M balance; and
  • Reduced the MidCap Financial revolver commitment to $22.5M.

With this, Alphatec expects to have paid down approximately $66 million of existing debt and debt-related expenses.

Concurrent with this transaction, Deerfield Management Company, L.P. has utilized its cashless exercise provision under its warrant agreements, converting its warrants to purchase up to 11.45 million shares of common stock to approximately 3.2 million shares on a pre-reverse split basis. This will constitute approximately 269 thousand shares on a post-reverse split basis.  As a reminder, on August 25, 2016 the Company completed a one-for-twelve reverse stock split.

“As a result of this transaction, we are able to improve Alphatec’s forward-looking balance sheet by reducing our overall debt while providing the liquidity and reserves needed to invest in commercializing our robust product portfolio,” said Mike O’Neill, Alphatec’s Chief Financial Officer.  “The new term loan from Globus, in conjunction with a planned revolving line of credit from MidCap Financial, provides the company with credit facilities of up to $57.5 million, which will offer sufficient liquidity and appropriate financing to successfully support Alphatec’s transition to a U.S. market based company.  Upon closing, we estimate our total debt drawn will be approximately $45 million. I would like to thank Deerfield who has been an excellent partner and we appreciate the support that they have provided to the company through the years. I am also pleased that MidCap will remain as a lender and provide funding for the company going forward. I want to thank them for their continued commitment and support to Alphatec.”

The Company expects that its stronger financial foundation coupled with its strong product portfolio will support future investments in its capital instrument base each year. These investments will be used to drive the commercial expansion of its new product lines, which are expected to contribute substantially to its planned growth profile. In addition, the Company has already made substantial headway towards its goal of reducing its operating expenses by $20 million. The Company expects this to continue for the remainder of 2016 and into 2017, translating to positive cash flow and profitability in the back half of 2017.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops, manufactures 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 and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.

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

About Globus Medical

Globus Medical, Inc. is a leading musculoskeletal implant 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 www.globusmedical.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.  The Company cautions you 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 ability to compete in the U.S. marketplace, accelerate growth and continue to improve profitability, continued investment in the commercialization of the U.S. product lines and in its capital instrument base, expected capital re-structuring and expected reductions in operating expenses and the timing and likelihood of cash flow and profitability. 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 Company’s ability to execute on its business plan and effectively compete in the U.S. marketplace; the Company not realizing the full economic benefit from the transaction, including as a result of indemnification claims under the definitive purchase agreement and the retention by the Company of certain liabilities associated with the international business; the Company’s ability to meet its obligations under the supply agreement and its credit facilities; the uncertainty of success in developing new products or commercializing products currently in the Company’s pipeline, including the products discussed in this press release; the Company’s ability to successfully reduce and control its costs, improve its margins and improve its profitability; claims related to the Company’s intellectual property; product liability exposure; and other risks detailed in the Company’s public periodic filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement.

CONTACT: Investor/Media Contact:

Christine Zedelmayer

Investor Relations

Alphatec Spine, Inc.

(760) 494-6610

czedelmayer@alphatecspine.com

Source: Alphatec Holdings, Inc.