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Printable Weekly

SeaSpine to Acquire NLT Spine for up to $52.5M

SeaSpine Holdings entered into an agreement to acquire NLT Spine Ltd. (NLT), an Israel-based developer of spine surgery instrumentation and implants for minimally invasive surgery (MIS) treatment of degenerative spinal conditions, for up to $52.5 million in aggregate.

Under the terms of the transaction, SeaSpine will acquire substantially all of the assets of NLT for an upfront cash payment of $1 million, and up to $43 million more in contingent payments. In addition to these contingency payments, SeaSpine could also pay $3.5 million in an issuance of common stock upon achievement of the near-term regulatory clearance of the company's Prow Fusion-L line, and $5.0 million in longer-term commercially-based milestone payments, as well as future revenue-based royalties. SeaSpine also has the option of making a one-time payment of $18 million after the transaction's close as opposed to any further contingent payouts.

NLT’s spinal platforms include vertical, lordotic and footprint expanding interbody technologies intended for lumbar fusion procedures. With its various technologies, the company aims to allow surgeons to place smaller, self-expanding interbody implants and screws designed for smaller incisions, easier insertion, less nerve retraction and potentially less tissue disruption. The company was formerly known as NonLinear Technologies Ltd. and was founded in 2006.

The deal provides SeaSpine with differentiated assets that will strengthen and broaden the company's portfolio of interbody product offerings. Additionally, NLT's intellectual property portfolio includes a robust pipeline of MIS interbody solutions that SeaSpine plans to evaluate and refine for additional product development opportunities.

Management expects the commercial launch of the first NLT product in 1H:17. This is SeaSpine's first strategic acquisition since it was spun-off of Integra Lifesciences as an independent, stand-alone company.


Musculoskeletal News Roundup 18-August-16

EARNINGS
aap Implantate AG reported financial results for 2Q:16. Total revenue was €5.1 million ($5.7 million) in 2Q:16, representing a decrease of 21% compared to €6.5 million ($7.2 million) in 2Q:15. The company's Trauma segment declined 8% from €3.3 million ($3.7 million) in 2Q:15 to €3.0 million ($3.3 million) in 2Q:16, driven by the company's LOQTEQ product family. EBITDA was (€1.4) million (($1.6) million) in 2Q:16, in-line with (€1.4) million (($1.6) million) in 2Q:15. All growth rates are on a constant currency basis unless stated otherwise.

Amedica Corporation reported financial results for 2Q:16. Total revenue was $4.0 million in 2Q:16, missing consensus estimates by 9% and representing a decrease of 16% compared to $4.8 million in 2Q:15. Adjusted EBITDA was ($1.9) million in 2Q:16, increasing from ($2.0) million in 2Q:15. Gross margin for 2Q:16 increased to 74.7%, from 71.5% in 2Q:15. All growth rates are on a reported basis.

FUNDING
Rotation Medical completed a $12 million Series B extension financing from New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. The financing is fundable in two tranches, $8 million initially (which was announced last week) and $4 million in 2017. The company plans to use the proceeds for U.S. commercialization activities for its Rotator Cuff Repair device, a proprietary bioinductive implant system that features disposable instruments and can be can be delivered arthroscopically.

M&A
Medtronic completed the second tranche of its equity investment in Mazor Robotics, an Israeli surgical robotics company. Pursuant to a previously executed agreement between the parties, Mazor issued new securities representing 3.40% percent of the company's issued and outstanding share capital, on a fully diluted basis, for $21.84 a share, equating to an aggregate purchase price of $20 million. The milestone that triggered this second tranche investment was the July unveiling of Mazor X, a transformative Surgical Assurance Platform for spine procedures.

Zimmer Biomet entered into an agreement to acquire CD Diagnostics, a U.S.-based fully-integrated diagnostics company. The financial terms of the deal were not disclosed. CD Diagnostics develops immunoassays and biomarker testing products that analyze various clinical conditions in a person's synovial fluid. The transaction provides Zimmer Biomet with a solution that can prevent or minimize costly complications, and personalize the course of treatment to shorten recovery time and optimize the patient experience.

REGULATORY
Centric Medical received 510(k) clearance from the FDA for its TARSA-LINK bunion correction system, indicated for the treatment of bunionectomies, opening base wedge osteotomies, bone fractures, fusions, and complications caused by trauma. The stand-alone, opening base wedge system features built-in fixation and aims to reduce procedure time and provide greater stabilization compared to traditional constructs.

Conventus Orthopaedics received 510(k) clearance from the FDA for its Conventus Cage DU (Distal Ulna) and PU (Proximal Ulna) systems, indicated for fracture fixtion procedures of the ulnar bone. These new self-expanding scaffolds feature the 3-dimensional memory shaping properties of nitinol, and are designed to prevent further collapse of fracture repairs.

PRODUCT INTRODUCTION & UPDATE
OrthoPediatrics launched its BandLoc 5.5/6.0 System, indicated for complex spinal pathologies, including scoliosis. BandLoc is a pedicle-sharing, band passing technique that incorporates a pre-assembled design, and is indicated for multiple rod diameters in cobalt chrome or titanium.

Spinal Simplicity launched its next generation Minuteman G3 interlaminar fusion device featuring a hydroxyapatite (HA) coating, indicated for the treatment of complex surgical problems in the spine through both Posterior MIS and Lateral MIS approaches. The company aims to decrease operating room (OR) time and costs through the system's sterile packaging.

Vertos Medical was named as a finalist in the 'Medical Technology' category of the Orange County Technology Alliance Annual High-Tech Innovation Award for its mild procedure, indicated for the treatment of lumbar spinal stenosis (LSS). The system provides long-term relief by utilizing specialized instruments and X-ray visualization through a small opening to remove small amounts of bone and tissue. The procedure is conducted in an outpatient setting and does not necessitate general anesthesia, implants or stitches.

CLINICAL
ConforMIS published results from two clinical studies evaluating its iTotal CR customized knee implant system. The independent, prospective, 62-patient study demonstrated superior results versus the traditional off-the-shelf implant in terms of length of stay and discharge, minimizes hospital and rehabilitation costs. The second, multicenter, prospective, 740-patient study, demonstrated that patients who received the company's implant showed success with functionality tests at quicker rates than patients who received off-the-shelf implants.

InVivo Therapeutics successfully treated its 9th spinal cord injury patient with its neuro-spinal scaffold in an ongoing clinical trial. The device is surgically implanted following acute spinal cord injuries, and acts as a physical substrate for nerve sprouting.

DISTRIBUTION
Titan Spine expanded its distribution agreement with MBA for the distribution of the company's Endoskeleton titanium implants into the Italian marketplace. Under the terms of the agreement, initially announced in September 2015, MBA distributes and Titan's spinal interbody fusion devices in Spain, Portugal, Luxembourg, Belgium, and the United Kingdom (UK).

APPOINTMENTS
RTI Surgical announced that Brian Hutchison will retire from his position as President and Chief Executive Officer, and as board member. Mr. Hutchinson has served as RTI President and CEO since 2001.


Medtronic Completes the $20M Second Tranche of its Equity Investment in Mazor Robotics

Medtronic completed the second tranche of its equity investment in Mazor Robotics, an Israeli surgical robotics company.

Pursuant to a previously executed agreement between the parties, Mazor issued new securities representing 3.40% percent of the company's issued and outstanding share capital, on a fully diluted basis, for $21.84 a share, equating to an aggregate purchase price of $20 million.

The milestone that triggered this second tranche investment was the July unveiling of Mazor X, a transformative Surgical Assurance Platform for spine procedures. The guidance platform is comprised of analytical tools, multiple-source data, precision guidance, optical tracking, intra-op verification, and connectivity technologies, and aims to reduce hospital costs and increase patient satisfaction.

Mazor is planning to launch Mazor X in October 2016.


Zimmer Biomet to Acquire CD Diagnostics

Zimmer Biomet entered into an agreement to acquire CD Diagnostics, a U.S.-based fully-integrated diagnostics company. The financial terms of the deal were not disclosed.

CD Diagnostics develops immunoassays and biomarker testing products that analyze various clinical conditions in a person's synovial fluid. The company offers the Synovasure Periprosthetic Joint Infection (PJI) test, a laboratory developed test that targets and identifies levels of alpha defensins for the detection of periprosthetic joint infection in the synovial fluid of patients experiencing pain and/or inflammation in the joint. Synovasure is able to inform a practitioner whether a patient has an infection within hours of testing.

Zimmer Biomet had initially partnered with CD Diagnostics in 2012 to co-develop diagnostics technologies in the field of musculoskeletal healthcare and marketed Synovasure. The transaction provides Zimmer Biomet with a solution that can prevent or minimize costly complications, and personalize the course of treatment to shorten recovery time and optimize the patient experience.

To date, this is the sixth acquisition for Zimmer in 2016. The company announced a 59% stake in Medtech Société Anonyme, a French-based company that develops surgical robotic technologies, the acquisition of Ortho Transmission, a Colorado-based developer of skeletal implant technology for limb amputee patients in March, the acquisition of Cayenne Medical, a company in the soft tissue repair and reconstruction segment of the sports medicine market in April, the $1.0 billion acquisition of LDR Holding, a developer of surgical implants, devices, and instrumentation for the treatment spinal disorders in June and the acquisition of Compression Therapy Concepts, a developer of medical devices and accessories for the prevention of deep vein thrombosis (DVT) in June.



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