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Printable Weekly

Musculoskeletal News Roundup 26-May-16

EARNINGS
Titan Spine reported financial results for the 2015 fiscal year. Total revenue was $33.5 million in 2015, representing growth of 51% from the 2014 fiscal year.

FUNDING
S14 IMPLANTS launched its fundraising campaign. The capital will go towards increasing the company's production capacity, reducing manufacturing times and for regulatory processes. The company is developing a range of implants relieving the intervertebral disc and facet joints of the spine.

M&A
Wright Medical announced that TMG Holdings Coöperatief U.A., an affiliate of the private equity firm, Warburg Pincus, plans to sell 6,221,809 of its ordinary shares of the company in a secondary offering. Based on the Wright's last closing share price of $19.57, the offering could raise up to $122 million for the selling shareholder.

REGULATORY
Implanet received 510(k) clearance from the FDA and CE Mark in Europe approval for its Jazz Claw system, a hybrid-implant for the treatment of degenerative spinal pathologies in adults like kyphosis and in adolescents scoliosis. The system aims to replace traditional hook-and-screw fixation systems by providing autostable posterior fixation.

Interventional Spine received clearance from the FDA for its 8° Lumbar Lordotic Opticage Expandable Intervertebral Body Fusion Device, intended for degenerative disc disease (DDD) cases in which the patient is using an autogenous bone graft at one or two contiguous levels from L2-S2. The system aims to provide implantation options through the posterior, transforaminal or lateral approach.

Ortho Kinematics received product approval for its Vertebral Motion Analysis (VMA) in the Canadian marketplace. VMA is a diagnostic test that generates patient-specific graphs assessing spinal motion and radiographic instability for each vertebral level of the spine.

PRODUCT INTRODUCTION & UPDATE
Active Implants announced the first implantation of its NUsurface Meniscus Implant, a meniscus replacement system for patients with persistent knee pain due to injury or deterioration. NUsurface intends to mimic the function of the human meniscus by restoring its function to distribute loads transmitted across the knee joint.

Acumed launched its Ankle Plating System 3, comprised of a number of fracture-specific plating options that focus on distal tibia and fibula fractures. Moreover, the system incorporates seven solitary plate families that address the lateral, medial and posterior malleoli bones.

Centinel Spine launched its MIDLINE II-Ti product line in the U.S. and Australian marketplaces. MIDLINE-Ti is intended for anterior lumbar interbody fusion (ALIF) procedures, and integrates the company's sixth generation STALIF Integrated minimally invasive interbody implant and Ti-ACTIVE microporous titanium plasma coating.

Integra LifeSciences launched its Fin-Lock Glenoid implant designed to address glenoid component loosening and failure in total shoulder arthroplasty. The device serves as an addition to its Titan Modular Shoulder System and consists of a four fin central peg which increases diameter to help improve pull-out strength and three peripheral pegs to assist protect against component movement.

Johnson & Johnson revealed that the company anticipates its robot-assisted surgery business, Verb Surgical, to transition from the concept phase to product design by the end of 2016. Johnson & Johnson management disclosed that the system being developed by Verb is aiming to offer a smaller physical footprint than current robot-assisted surgery systems on the market.

Medtronic launched its Spine Essentials platform of spinal implants and instruments, designed to increase operating room (OR) hospital efficacy and reduce costs associated with standardized 1-level and 2-level cervical spine fusion procedures. The platform consists of sterile-packaged implants that necessitate smaller instrument sets, lessening hospitals required inventory and therefore reducing sterilization and storage cost.

NuVasive launched its AttraX Putty product, the company's next-generation synthetic bone graft technology indicated for use as an autograft extender in posterolateral spine procedures. The product utilizes a biotextured surface to help promote bone regeneration.

Vertebral Technologies launched its InterLink system, a minimally invasive pedicle screw line indicated for single or multiple level fixation. InterLink supports the company's InterFuse modular implant systems.

DISTRIBUTION
curasan AG entered into a marketing agreement with Silony Medical International. Under the terms of the agreement, Silony will receive the distribution rights for curasan's synthetic bone grafting material CERACELL Ortho in the orthopedic markets of Germany, Switzerland, Great Britain, Italy, Austria, Czech Republic and Benelux. Moreover, the agreement also grants Silony the rights to market CERACELL Ortho as a private label in the future.

APPOINTMENTS
Entellus Medical appointed Brent Moen as the company's Corporate Secretary and Chief Financial Officer, replacing Thomas Griffin, who will assume the newly created position of Vice President of Finance. Prior to Entellus, Mr. Moen served as Executive Vice President and CFO of ABRA Auto Body & Glass. The appointment is effective immediately.

Wright Medical announced that its Executive Vice President and Chief Operating Officer, David Mowry, stepped down from the company to pursue other opportunities. Before the merger of Wright Medical and Tornier, Mr. Mowry served as CEO at Tornier.


Johnson & Johnson Divulges a Few Details of its Developing Robot-assisted Surgical Platform

Along with outlining plans to accelerate the annual growth of its medical device business to 4%-6% through 2020, Johnson & Johnson revealed that the company anticipates its robot-assisted surgery business, Verb Surgical, to transition from the concept phase to product design by the end of 2016.

Johnson & Johnson management disclosed that the system being developed by Verb is aiming to offer a smaller physical footprint than current robot-assisted surgery systems on the market. Verb intends to target difficult to reach areas of the human anatomy, where minimally invasive surgical procedures are not prevalent.

The kind of deep, confined and inaccessible procedures under consideration by Verb include ones within the thoracic cavity, and low anterior resection.


Wright Medical Announces Secondary Offering of 6.2M Ordinary Shares

Wright Medical announced that TMG Holdings Coöperatief U.A., an affiliate of the private equity firm, Warburg Pincus, plans to sell 6,221,809 of its ordinary shares of the company in a secondary offering.

Based on the Wright's last closing share price of $19.57, the offering could raise up to $122 million for the selling shareholder. No proceeds will return to the company from the sale. Bank of America Merrill Lynch is acting as the lead bookrunner on the offering.

Last week, Wright raised an aggregate of $395 million through a private placement of cash convertible senior notes, which the company intends to use for general corporate purposes, and to cover the documented cost of the cash convertible note hedge transactions.


Musculoskeletal News Roundup 19-May-16

EARNINGS
Amedica Corporation reported financial results for 1Q:16. Total revenue was $4.2 million in 1Q:16, missing consensus estimates by 17% and representing a decrease of 12% compared to $4.7 million in 1Q:15. Adjusted EBITDA was ($1.9) million in 1Q:16, increasing from ($2.9) million in 1Q:15. Gross margin for 1Q:16 increased to 78.6%, from 67.9% in 1Q:15. All growth rates are on a reported basis.

ConforMIS reported financial results for 1Q:16. Total revenue was $20.3 million in 4Q:15, beating consensus estimates by 5% and representing an increase of 40% compared to $14.7 million in 1Q:15. Gross margin for 1Q:16 decreased to 34.7%, from 36.1% in 1Q:15. Domestic and international revenues increased by 43% and 28% respectively in 1Q:16. International sales represented 26% of total revenue in 1Q:16. All growth rates are on a constant currency basis.

DJO Global reported financial results for 1Q:16. Total revenue was $278.9 million in 1Q:16, increasing 14% compared to $247.5 million in 1Q:15. Adjusted EBITDA was $48.9 million in 1Q:16, increasing 6% on a reported basis from $46.3 million in 1Q:15. Adjusted EBITDA margin increased to 17.5% in 1Q:16 from 18.7% in 1Q:15. Gross margin for 1Q:16 decreased to 57.7%, from 58.8% in 1Q:15. The company's segments grew by: Bracing & Vascular +9%, Recovery Sciences +6% and Surgical Implant +60% in 1Q:16 respectively. International revenues decreased by 7% in 1Q:16 compared to 1Q:15 and represented 27% of total revenue in 1Q:16. All growth rates are on a constant currency basis.

LDR Holdings reported financial results for 1Q:16. Total revenue was $42.4 million in 1Q:16, missing consensus estimates by 1% and representing an increase of 10% compared to $39.1 million in 1Q:15. Adjusted EBITDA was ($4.8) million in 1Q:16, decreasing from ($1.4) million in 1Q:15. Gross margin for 1Q:16 decreased to 83.0% in 1Q:16 from 83.5% in 1Q:15. Domestic U.S. revenue increased 8% to $33.9 million in 1Q:16 from $31.3 million in 1Q:15. International revenue increased 9% to $8.5 million during 1Q:16, representing 20% of total revenue. All growth rates are on a constant currency basis.

Mazor Robotics reported financial results for 1Q:16. Total revenue was $6.4 million in 1Q:16, increasing 42% compared to $4.5 million in 1Q:16. Revenue generated in the U.S. increased from $2.7 million in 1Q:15 to $5.6 million in 1Q:16, selling four of its Renaissance systems. International non-U.S. revenue decreased from $1.8 million in 1Q:15 to $0.8 million in 1Q:16. Revenue from system kit sales, services & other was $3.8 million in 1Q:16, representing a 41% increase compared to $2.7 million in 1Q:15. Gross margin for 1Q:16 decreased to 74.2%, from 75.7% in 1Q:16. All growth rates are on a reported basis.

SeaSpine Holdings reported financial results for 1Q:16. Total revenue was $31.4 million in 1Q:16, missing consensus estimates by 2% and representing a decrease of 2% compared to $32.3 million in 1Q:16. Gross margin for 1Q:16 decreased to 54.5%, from 61.0% in 1Q:15. The company's U.S. segments grew by: Orthobiologics +5% and Spinal Fusion Hardware (10%) in 1Q:16 respectively. Overall, U.S. revenue decreased 3% to $28.5 million 1Q:16. All growth rates are on a reported basis.

Vericel reported financial results for 1Q:16. Total revenue was $14.1 million in 1Q:16, beating consensus estimates by 22% and increasing from $10.8 million in 1Q:15. Net revenue for the company's Carticel (autologous cultured chondrocytes) implants and surgical kits and Epicel (cultured epidermal autografts) product was $8.8 million and $5.3 million, increasing 24% and 46% respectively in 1Q:16. Gross margin for 1Q:16 increased to 53.5% from 48.7% in 1Q:15. All growth rates are on a reported basis.

FUNDING
Bone Solutions secured $1.7 million through a private placement that the company plans to use for the commercialization of its new magnesium-based bone void filler product, OsteoCrete. The company also announced that the company has secured an incremental $1.65 million in committed funding from Next Health.

Teleflex priced a $400.0 million offering of senior notes in which it plans to utilize to repay/refinance approximately $393 million in outstanding debt under its revolving credit facility (RCF). Teleflex develops single-use medical devices and equipment for common diagnostic and therapeutic procedures in critical care and surgical applications. Within orthopedics, the company offers its KMedic surgical instrument line for laminectomy procedures, Pilling surgical instrument line for general orthopedic and ENT (Ear, Nose & Throat) procedures, and its K-Point needle and Deklene suture systems.

Wright Medical raised an aggregate of $395 million through a private placement of cash convertible senior notes. The company expects to use approximately $241.3 million of the offering's net proceeds for general corporate purposes, and the remaining $45.2 million to cover the cost of the cash convertible note hedge transactions documented in the agreement.

M&A
aap Implantate AG (aap) completed its divestiture of its subsidiary, aap Biomaterials GmbH, to Keensight Capital, a European growth private equity firm. The enterprise value of the deal was €36.6 million ($41.2 million), which valued aap Biomaterials at 2.4x its 2015 revenues of €16.0 million ($17.5 million). The sale transforms aap into a pure play trauma company, which will allow it to focus on established growth segments and unmet medical needs in the trauma market.

Medtronic entered into an agreement to acquire Smith & Nephew's gynecology (GYN) portfolio for approximately $350 million. Under the terms of the transaction, Medtronic acquires Smith & Nephew's TRUCLEAR System, a platform used to remove abnormal uterine tissue like polyps and fibroids. The system utilizes a minimally invasive procedure that can be performed as an outpatient procedure. The deal expands and strengthens Medtronic's minimally invasive surgical offerings with a complementary portfolio of global GYN products.

Tecres, a developer of bone cements and bone substitutes, and Keensight Capital, a European growth private equity firm, have invested in creating Demetra Holding. The new entity bridges the businesses of Tecres S.p.A. and aap Biomaterials GmbH to create a pure play bone cement and biomaterials company. Both Tecres and aap Biomaterials will continue to act as separate entities with their own respective business strategies, however, Demetra allow them to share in numerous industrial and R&D synergies, including biomaterials know-how, in order to see an uptick in growth at both companies. Historically, aap has focused on a Contract Manufacturing (CMO) model, while Tecres has developed its own-branded product lines.

Zimmer completed its acquisition Cayenne Medical, a company in the soft tissue repair and reconstruction segment of the sports medicine market. This transaction expands Zimmer's arthroscopy and sports medicine portfolios and strengthens the company's capabilities in these segments. Additionally, Cayenne's product portfolio complements Zimmer's joint reconstruction offerings.

REGULATORY
First Ray received 510(k) clearance from the FDA for its CortiClamp System, a two-part bone screw system for small bone fixation. The system includes a second "screw head" that is attached to the distal end of the screw, which aims to enhance the device's bi-cortical clamping force. The system also incorporates an all-in-one instrument comprised of a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide.

Orthofix received 510(k) clearance from the FDA for its FORZA PTC (PEEK Titanium Composite) Spacer, designed to restore normal disc height for patients suffering from degenerative disc disease (DDD). The system combines PEEK and 3-D printed titanium end plates into a single porous interbody solution intended for fusion procedures at one of two contiguous levels in the lumbar spine (L2-S1).

OrthoPediatrics received product clearance from the Japanese regulatory body for its RESPONSE Spine System, indicated for use in pediatric and adult patients. The system aims to improve operating room (OR) efficacy by featuring low profile screws, simple rod reduction and de-rotation instrumentation. RESPONSE will be distributed regionally through Japan-based Robert Reid Inc.

Xtant Medical received 510(k) clearance from the FDA for a posterior cervical screw indication for its Certex Spinal Fixation System. The indication expands the use of the system's screws into the posterior cervical spine.

PRODUCT INTRODUCTION & UPDATE
Anika Therapeutics launched its CINGAL product in the Canadian marketplace. CINGAL is the company's third-generation viscosupplement injection therapy designed to treat pain associated with osteoarthritis (OA) of the knee by replenishing the joint's natural cushioning. The product will be marketed by Pendopharm, which is also Anika’s sole commercialization partner for its ORTHOVISC and MONOVISC products in Canada.

Misonix launched its BoneScalpel MIS, a minimally invasive spinal solution for cutting bone.The system aims to require less space when incising or removing bone than an osteotome or a Kerrison rongeur.

COLLABORATION
Johnson & Johnson entered into a collaboration agreement with a subsidiary of HP Inc. The collaboration is focused on using 3-D printing technologies to develop patient-customized products that can be quickly manufactured to provide better health care outcomes at reduced costs. Through the agreement, both companies anticipate to innovate in the orthopedic, eye health and consumer product sectors.

Mazor Robotics entered into two strategic agreements with Medtronic. The first being a co-development and distribution agreement, and the second being an equity investment of up to $52 million, which could see Medtronic own up to a 15% stake in Mazor. Under the commercial aspect of the accord, Mazor enters into a two-stage, multi-faceted, commercial agreement with Medtronic for the co-promotion, co-development of robotic-based spine systems and applications.

Novastep entered into an agreement with Vivex Biomedical, in which, Novastep will gain access to Vivex's allograft materials allowing the company to offer amniotic membranes and liquid alongside its bioSTART Tissue Repair products. Novastep also plans to make demineralized bone matrices (DBMs) available in its product portfolio.

ReWalk Robotics partnered with Harvard University’s Wyss Institute to develop a lightweight exoskeleton system for individuals with lower limb disabilities. Through the collaboration, both entities intend to develop "soft suit" systems for patients who suffer from stroke or multiple sclerosis (MS) and for older individuals with limited mobility. The first application of the suit will be intended for stroke sufferers.

CLINICAL
Bone Therapeutics published clinical results for its ALLOB allogeneic bone cell therapy product trial for the treatment of delayed-union fractures. Eight patients have now been treated in the Phase I/IIA study and of these, seven patients have met the primary endpoints of the trial within the six-month follow-up period. ALLOB is an osteoblastic cell therapy indicated for bone fracture repair, fracture prevention and spinal fusion.

Bone Therapeutics commenced its Phase II trial for its ALLOB allogenic bone cell therapy, indicated for the treatment of severe osteoporosis. Preparation for the trial has begun and it is expected to commence in early 2017.

SI-BONE published clinical results from its iFuse Implant System Minimally Invasive Arthrodesis. The randomized, controlled trial evaluated the safety and effectiveness iFuse triangular titanium implants, and compared it to conservative management (CM) in patients with chronic SI joint dysfunction. The study demonstrated superior improvement in pain, disability, function and quality of life for iFuse patients compared to patients utilizing CM.

RESEARCH
Each June, the AADSM Research Committee recognizes outstanding research in dental sleep medicine. This year, Dr. John Remmers, Zephyr Sleep Technologies’ Chief Medical Officer has been selected as a recipient of the AADSM Clinical Research Award and the AADSM Clinical Excellence Award based on the scientific merit and research excellence demonstrated in the abstract “A Mandibular Positioning Home Sleep Test Prospectively Predicts Outcome of Oral Appliance Therapy for OSA Using Retrospectively Derived Decision Criteria”. In addition, Dr. Nikola Vranjes, principal dental investigator in this clinical trial using the auto-titrating mandibular positioner (AMP) technology, has been selected as a recipient of the AADSM Clinical Research Award for the scientific merit of the abstract “A New Oral Appliance Titration Protocol using the MicrO2 Sleep Device and Mandibular Positioning Home Sleep Test”.


Mazor Enters into Co-development and Equity Purchase Agreements with Medtronic

Mazor Robotics entered into two strategic agreements with Medtronic. The first being a co-development and distribution agreement, and the second being an equity investment of up to $52 million, which could see Medtronic own up to a 15% stake in Mazor.

Under the commercial aspect of the accord, Mazor enters into a two-stage, multi-faceted, commercial agreement with Medtronic for the co-promotion, co-development of robotic-based spine systems and applications. The deal has an initial U.S.-based co-promotion phase, and if both parties achieve their respective milestones by the end of 2017, then the companies will enter the second phase of the agreement.

In the second stage, Medtronic will assume exclusive global sales and distribution rights for Mazor’s future spine products and incorporates annual quotas with a cumulative potential of hundreds of next-generation systems over a four-year period. At this point, Medtronic has placed a commitment to purchase 15 of these future systems during 2016.

Moreover, the accord stipulates that Mazor will be Medtronic’s only strategic partner for the development and commercialization of solutions. Both companies have already commenced on co-development activities of synergistic products and applications for spine.

Regarding the investment aspect of the agreement, Medtronic will make a three-step equity investment in Mazor.

In the first tranche, Medtronic will purchase newly issued securities representing 4% of Mazor's outstanding shares on a fully diluted basis, at the trailing 20-day volume weighted average price, which equates to approximately $11.9 million.

In the second tranche, Medtronic will purchase newly issued securities representing 6% of Mazor's outstanding securities on a fully diluted basis, however, this is conditional to Mazor achieving certain operational milestones. The cap of the second tranche is up to $20 million.

Lastly, in the potential third tranche, Mazor has the right to issue up to 5% (on a fully diluted basis) of primary shares to Medtronic. The third tranche is dependent of the consummation of the second tranche as well as the commencement of the Global Distribution Agreement, and, provided certain other conditions are met, will be solely at Mazor’s discretion. Medtronic may cap this tranche at $20 million as well.

The two agreements maintain that Mazor will remain an independent company that will continue to sell and fully support the Renaissance System through its own sales team and distribution partners.


Medtronic to Acquire Smith & Nephew's Gynecology Portfolio for $350M

Medtronic entered into an agreement to acquire Smith & Nephew's gynecology (GYN) portfolio for approximately $350 million.

Under the terms of the transaction, Medtronic acquires Smith & Nephew's TRUCLEAR System, a platform used to remove abnormal uterine tissue like polyps and fibroids. The system utilizes a minimally invasive procedure that can be performed as an outpatient procedure. TRUCLEAR serves as a less invasive treatment than other surgical procedures like hysterectomies and therefore aims to improve options for women with abnormal uterine bleeding (AUB).

The deal expands and strengthens Medtronic's minimally invasive surgical offerings with a complementary portfolio of global GYN products. Management feels this acquisition will help the company innovate in the marketplace and develop further therapies and solutions that enhance gynecology care.

The acquisition is anticipated to close 2Q:16 - 3Q:16.



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