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Orthopedic and Dental Industry News Complete Archive »

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Integra Lifesciences to Acquire TEI Biosciences and TEI Medical for $312M

Integra LifeSciences entered into a definitive agreement to acquire all of the outstanding shares of TEI Biosciences and TEI Medical (TEI) for $312 million in cash, or 4.9x 2014 revenues, or approximately 19.7x 2014 EBITDA.

TEI is a biomedical company that offers regenerative technology-based products for soft tissue repair and regeneration applications including dura, hernia, tendon and abdominal wall repair and plastic and reconstructive surgery.

Under the terms of the transaction, Integra acquires a product portfolio that includes TEI's PriMatrix Dermal Repair Scaffold and SurgiMend collagen matrix platforms, which complement and broaden Integra's current reconstructive surgery and regenerative wound care product offerings. Additionally, the deal expands Intrega's sales force by 125 sales reps and managers and provides attractive operating margins that should help the company strengthen its future commercial channel and international priorities.

Integra expects to complete the transaction during 3Q:15.


Musculoskeletal News Roundup 25-Jun-15

FUNDING
ConforMIS filed an S-1 to raise between $126 million and $144 million through a previously announced initial public offering (IPO), by offering 9.0 million shares of common stock at a proposed price range of $14-$16 a share. At the midpoint of the proposed range, ConforMIS would have an enterprise value of approximately $632 million, valuing the company at 12.1x LTM revenues. The company intends to use the proceeds to expand the company's manufacturing capacity, sales, research and development, clinical activities, and to fund working capital and for general corporate purposes.

M&A
Amendia acquired from SpineSelect the assets and patents for its Minimally-Invasive Transforaminal Lumbar Interbody Fusion (MITLIF) system, which is comprised of the Marquis MIS Channel System and the Turbo MIS TLIF System. The Marquis MIS Channel system balances limiting muscle damage with providing adequate working access for procedures.

Wright Medical and Tornier shareholders both approved all proposals related to the merger of their companies, which was announced in October 2014. The remaining condition to closing is approval by the U.S. Federal Trade Commission (FTC). Assuming FTC approval is granted, the companies expect the transaction to close in 3Q:15.

Zimmer received clearance from the U.S. Federal Trade Commission (FTC) regarding its cash/stock acquisition of Biomet currently valued at approximately $14.0 billion. This effectively completes the transaction which was initially announced in April 2014. The transaction combines two product portfolios that are complementary in nature and will increase the combined company's diversity and scale across various geographies and product categories including Knee, Hip, Surgical, Spine, Dental, Sports Medicine, Extremities and Trauma.

Zimmer agreed to divest the U.S. rights and assets of its Unicompartmental High Flex Knee (ZUK) implant system to Smith & Nephew, and Biomet’s U.S. Discovery Total Elbow implant and Cobalt Bone Cement rights and assets to DJO Global. Under the terms of the transaction, Smith & Nephew will receive the U.S. intellectual property, manufacturing technology, and existing inventory relating to the ZUK system, and any transitional services to help them establish manufacturing capabilities and secure necessary FDA approvals.

REGULATORY
Anika Therapeutics submitted an Investigational Device Exemption (IDE) with the FDA to commence phase III clinical trials to support the expanded use of MONOVISC, a single injection product comprised of non-animal sourced hyaluronic acid, to include osteoarthritis of the hip. MONOVISC was previously approved by the FDA for the treatment of osteoarthritis of the knee pain. The IDE is designed as a prospective, double-blind, randomized, placebo-controlled, superiority study comparing WOMAC A1 pain scores over a 26 week period.

PRODUCT INTRODUCTION & UPDATE
Ellipse Technologies announced its PRECICE limb length system, an externally controllable internal limb lengthening device, has been utilized in 2,000 patients.

IlluminOss announced the first two U.S. treatments utilizing the IlluminOss System to treat fractures in the humerus due to metastatic carcinoma, using its light curable polymer contained within a balloon catheter for fracture fixation. The IlluminOss System has been in clinical use in Europe since 2010; observable benefits include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility.

Mazor Robotics announced its fiftieth purchase order in the U.S. for its Renaissance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain procedures.

INTELLECTUAL PROPERTY
InVivo Therapeutics received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) that broadens the allowed claims of its Neuro-Spinal Scaffold and Neuro-Spinal Scaffold Plus Stem Cells, both biodegradable, surgically implanted materials designed to act as a physical substrate for nerve sprouting.

CLINICAL
Bone Therapeutics reported results of the phase IIA trial of seven patients with severe osteopoorosis utilizing PREOB, its autologous osteoblastic cell therapy product derived from ex vivo cultured bone marrow cells of the patients. The patients, who did not respond to anti-osteoporotic therapy, received intravenous injections of radioactively-labeled PREOB. The cells were scanned and followed for 72 hours to determine the cells location in the body after injection. The patients showed a progressive accumulation of PREOB cells into the axial skeleton (i.e., vertebrae and pelvis). Bone Therapeutics aims to offer osteoporosis treatment with bone forming cell, in contrast to traditional, current treatments which inhibit bone resorption, but do not actively stimulate bone formation.

Wenzel Spine published in Medical Devices: Research and Evidence a study of over 700 patients treated with its VariLift Interbody Fusion System examining its design, functionality and retrospective clinical results.

DISTRIBUTION
Bacterin International resigned an agreement with Premier, Inc, a group purchasing organization (GPO) of 3,400 U.S. hospitals and 110,000 other providers, to distribute to Premier members products in the Bone Tissue Synthetic Implantable Products Category manufactured by Bacterin at pricing and terms pre-negotiated by Premier. The new agreement will be commence July 1, 2015. Bacterin International also signed an agreement with Yankee Alliance, a GPO of over 11,500 members for a three year agreement covering Bacterin’s complete line of biologic implants.

COLLABORATIONS
Blue Belt Technologies announced a partnership with SurgCenter Development, a leader in the launch and growth of physician owned Ambulatory Surgery Centers across the United States. The partnership will enable SurgCenter Development locations to build streamlined Orthopedic Robotics Programs with Blue Belt Technologies’ Navio Surgical System.

APPOINTMENTS
Histogenics Corporation appointed Jonathan Lieber as its Chief Financial Officer (CFO), effective July 2, 2015. Mr. Lieber most recently served as the CFO of Metamark Genetics, Inc., a privately held, urology-focused, molecular diagnostics company.


Zimmer Receives FTC Clearance for its Acquisition of Biomet and Divests Certain Product Lines

Zimmer received clearance from the U.S. Federal Trade Commission (FTC) regarding its cash/stock acquisition of Biomet currently valued at approximately $14.0 billion. This effectively completes the transaction which was initially announced in April 2014.

The transaction combines two product portfolios that are complementary in nature and will increase the combined company's diversity and scale across various geographies and product categories including Knee, Hip, Surgical, Spine, Dental, Sports Medicine, Extremities and Trauma.

Management highlighted that they believe the transaction will enhance the combined company's:
- Growth profile
- Cross-selling opportunities by leveraging complementary sales channels
- Presence in emerging markets
- Innovation program platform and scope
- Ability to offer a broader range of personalized solutions
- Capability to influence how healthcare solutions are developed and delivered

In connection with the merger, Zimmer agreed to divest the U.S. rights and assets of its Unicompartmental High Flex Knee (ZUK) implant system to Smith & Nephew, and Biomet’s U.S. Discovery Total Elbow implant and Cobalt Bone Cement rights and assets to DJO Global.

Under the terms of the transaction, Smith & Nephew will receive the U.S. intellectual property, manufacturing technology, and existing inventory relating to the ZUK system, and any transitional services to help them establish manufacturing capabilities and secure necessary FDA approvals. DJO will receive the U.S. intellectual property, manufacturing technology, and existing inventory relating to Biomet's total elbow implant and bone cement products, and the agreement facilitates DJO’s hiring of the Biomet sales representatives and other staff who work with these products. Each transaction respectively expands Smith & Nephew's and DJO's product offerings in joint reconstruction and will close within three business days after the merger between Zimmer and Biomet has closed.

Lastly, due to the merger, Zimmer has changed its corporate name to Zimmer Biomet Holdings, Inc., and will trade on the New York Stock Exchange (NYSE) and the SIX Swiss Exchange under the ticker symbol "ZBH" beginning June 29, 2015.


ConforMIS Proposes Terms for IPO

ConforMIS filed an S-1 to raise between $126 million and $144 million through a previously announced initial public offering (IPO), by offering 9.0 million shares of common stock at a proposed price range of $14-$16 a share. At the midpoint of the proposed range, ConforMIS would have an enterprise value of approximately $632 million, valuing the company at 12.1x LTM revenues.

The company intends to use the proceeds to expand the company's manufacturing capacity, sales, research and development, clinical activities, and to fund working capital and for general corporate purposes.

ConforMIS develops customized (individually sized and shaped) joint replacement implants through its proprietary iFit Image-to-Implant technology platform. The company's iFit platform contours each implant to the patient's unique anatomy and consists of three elements: 1) proprietary algorithms and computer software to design the implants and associated patient-specific instrumentation (iJigs), 2) 3-D printing technology to manufacture the iJigs (currently in process of extending capability to manufacture certain components of customized knee implants) and 3) delivery model. Presently ConforMIS offers a line of customized knee implants, however, management expects to submit an application for clearance of its iTotal Hip, the company's first customized hip replacement implant, to the FDA in 2015. The company is based in Bedford, MA, and as of April 30, 2015, had 344 full-time employees.

For the 2014 fiscal year, ConforMIS reported total revenue of $48.2 million, representing an increase of 39% on a reported basis compared to $34.6 in 2013. Gross margin increased to 36.4% in 2014 from 21.1% in 2013. As of March 31, 2015, ConforMIS' LTM revenues were $52.1 million. To date, the company has sold more than 30,000 knee implants in the United States and Europe.

Since 2004, ConforMIS has raised an aggregate of $330 million from the sale of preferred stock and the exercise of preferred stock warrants and common stock warrants and options. The company's largest shareholders include: Procific, Veron International, SGR Sagittarius, Aeris Capital, Tasik Temenggor Investments and Stanhope Investments.

The company plans to list on the NASDAQ Global Market (NasdaqGM) under the ticker symbol "CFMS". JP Morgan and Deutsche Bank are acting as Joint Lead Bookrunners on the deal, while Wells Fargo, Canaccord and Oppenheimer will serve as Co-managers.



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