Musculoskeletal News Roundup 19-May-17

May 19, 2017 | Blake Mossy

EARNINGS

ConforMIS reported financial results for 1Q:17. Total revenue was $20.5 million in 1Q:17, beating consensus estimates by 11% and representing an increase of 2% compared to $20.3 million in 1Q:16. Gross margin for 1Q:17 decreased to 31.8%, from 32.9% in 1Q:16. Domestic revenues increased by 9% and international revenues decreased by 12% respectively in 1Q:17. International sales represented 22% of total revenue in 1Q:17. All growth rates are on a constant currency basis.

DJO Global reported financial results for 1Q:17. Total revenue was $288.4 million in 1Q:17, increasing 5% compared to $278.9 million in 1Q:16. Adjusted EBITDA was $57.2 million in 1Q:17, increasing 15% from $48.9 million in 1Q:17. Adjusted EBITDA margin increased to 19.8% in 1Q:17 from 17.5% in 1Q:16. Gross margin for 1Q:17 increased to 58.5%, from 57.7% in 1Q:17. The company's segments grew by: Bracing & Vascular (0.2%), Recovery Sciences +7% and Surgical Implant +17% in 1Q:17 respectively. International revenues increased by 5% in 1Q:17 compared to 1Q:16 and represented 27% of total revenue in 1Q:17. All growth rates are on a constant currency basis.

Mazor Robotics reported financial results for 1Q:17. Total revenue was $11.7 million in 1Q:17, increasing 83% compared to $6.4 million in 1Q:17. Revenue generated in the U.S. increased from $5.6 million in 1Q:16 to $11.2 million in 1Q:17, selling twelve of its Mazor X systems. International non-U.S. revenue decreased from $0.8 million in 1Q:16 to $0.5 million in 1Q:17. Revenue from system kit sales, services & other was $5.2 million in 1Q:17, representing a 37% increase compared to $3.8 million in 1Q:16. Gross margin for 1Q:17 decreased to 64.6%, from 74.2% in 1Q:17. All growth rates are on a reported basis.

Seikagaku Corporation reported financial results for their 2016 fiscal year. Net sales YTD were ¥29.6 billion ($266.5 million), representing a decrease of 4% from ¥31.0 billion ($278.9 million) for the same period. Sales of the company's single-injection injectable treatment for osteoarthritis pain of the knee, Gel-One, in the U.S. and internationally both increased. Operating income decreased 40% due to drug price reductions and one-time selling, general and administrative (SGA) expenses, from ¥2.1 billion ($19.3 million) in 2015 to ¥1.3 billion ($11.5 million) in 2016. All growth rates are on a reported basis.

Vericel reported financial results for 1Q:17. Total revenue was $9.4 million (net of a $2.8 million revenue reserve related to an unresolved contractual dispute) in 1Q:17, missing consensus estimates by 35% and representing a decrease of 34% compared to $14.1 million in 1Q:17. Net revenue for the company's Total Carticel (autologous cultured chondrocytes) implants and surgical kits and Epicel (cultured epidermal autografts) product revenues were $5.0 million and $4.4 million in 1Q:17, decreasing from $8.8 million and $5.3 million respectively in 1Q:16. Gross margin for 1Q:17 decreased to 24.1% from 53.5% in 1Q:16. All growth rates are on a reported basis.

Xtant Medical reported financial results for 1Q:17. Total revenue was $22.1 million in 1Q:17, missing consensus estimates by 3% and representing an increase of 5% compared to $21.0 million in 1Q:16. Gross margin for 1Q:17 increased to 70.3%, from 67.2% in 1Q:17. EBITDA was $0.6 million in 1Q:17, increasing from ($0.2) million in 1Q:16. All growth rates are on a reported basis.

FUNDING

Amend Surgical entered into a funding agreement with The Florida Institute for the Commercialization of Public Research. The capital will be utilized to support company product development and expansion.

Orthonika Limited secured  £0.7 million ($0.9 million) in financing led by a group of undisclosed investors. The new capital will be used to accelerate progress on the company’s biomechanical testing and conduct a pre-clinical pilot trial.

REGULATORY

Exactech received clearance from the FDA for its ExactechGPS Shoulder Application system, which combines pre-operative planning with computer-assisted surgery for standard and challenging shoulder arthroplasty procedures. The system aims to provide greater visibility into the glenoid vault, retroversion inclination, reaming, drilling depth and screw placement in real-time.

Myoscience received 510(k) clearance from the FDA for its Lovera device, designed to relieve pain and symptoms associated with knee osteoarthritis (OA). The system uses the body’s natural response to cold to treat peripheral nerves, causing a sensory nerve to stop sending pain signals after receiving targeted cold therapy that is part of the treatment.

OrthoAlign received approval from the Japanese Ministry of Health, Labour and Welfare (JMHLW) for its Direct Anterior HipAlign for use in supine position Total Hip Arthroplasty (THA) and for its UniAlign product used in Unicompartmental Knee Arthroplasty (UKA) procedures. HipAlign is designed to provide accurate cup placement positioning and does not require pre-operative imaging, intraoperative fluoroscopy, or additional personnel in the operating room (OR). UniAlign aims to establish the mechanical axis of the tibia and determine the varus/valgus and posterior slope angles of the cutting block relative to the transverse resection. The products will be distributed by Zimmer Biomet Japan.

XpandOrtho received 510(k) clearance from the FDA for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device utilizes multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range motion. With the system in place, soft tissues can be released, enabling real-time feedback to the surgeon. The device also preserves an electronic record of the entire 3D balance of the knee at the end of the surgical procedure.

PRODUCT INTRODUCTION & UPDATE

Curasan launched its CERASORB Ortho Foam bone graft product, which allows for specific graft placement and is designed to prevent large gaps during bone graft procedures. The company gains entry to the U.S. orthopedic bone graft substitute market with this launch.

DePuy Synthes announced a national contract with the U.S. Department of Defense (DoD) for the supply of $260 million worth of its orthopedic products.  The company will supply the Defense Logistics Agency’s electronic catalog (ECAT) to create a more efficient online purchasing system and help ECAT improve overall care and patient satisfaction with the delivered products.

Life Spine launched its PROLIFT Lordotic expandable interbody solution system with OSSEO-LOC technology. The system aims to allow for in-situ disc height restoration for minimally invasive, posterior lumbar interbody fusion and transforaminal lumber interbody fusion oblique approaches. The system incorporates OSSEO-LOC surface technology which allows for the restoration of normal spinal pelvic parameters with multiple lordotic options.

Lima Corporate launched its SMR Bone Graft Instruments and Lima Personalized Surgical Instruments (LPSI) systems with pre-operative planning software. The SMR system aims to provide surgeons with a full platform that allows intraoperative flexibility and conversion from anatomic to reverse replacement, without the removal of the humeral stem or the Metal Back glenoid implant.

INTELLECTUAL PROPERTY

Zimmer Biomet entered into an agreement to license intellectual property from Bonutti Research. The newly licensed patents will be used by Zimmer to strengthen its knee systems and support the development of the company’s Rosa robotic knee application.

CLINICAL

Life Spine received approval from the Western Institutional Review Board to conduct a study utilizing Electrodiagnostic Functional Assessment (EFA) to determine whether open PLIF or MIDLIF, using Life Spine’s NAUTILUS Thoracolumbar Pedicle Screw System and CENTERLINE Thoracolumbar Cortical Screw System hardware, is less traumatic to the patient. The study will also evaluate if a patient type is better suited for a particular surgery and determine which procedure leads to faster muscular recovery and better functional outcomes.  

Rotation Medical announced interim study results of its Rotation Medical Bioinductive Implant Database (REBULID) Registry. The prospective, non-randomized, multicenter registry is designed to collect patient outcomes, including shoulder function, pain and quality of life after receiving the Bioinductive Implant. The results indicate that patients in the REBULIT registry report feel better within six months after receiving the Bioinductive Implant, and two years for those who received standard treatment.

DISTRIBUTION

Stryker entered into a distribution agreement with AlloSource for the distribution of AlloSource’s  biologic products in the U. S. for use in a number of different sports medicine procedures.

Xtant Medical entered into a licensing agreement with Sites Medical to use Sites’ OsteoSync Ti porous titanium scaffold technology for spinal fusion procedures. OsteoSync Ti is a highly porous titanium scaffold that aims to reduce the potential of absorb debris as the implant is delivered.  

COLLABORATION

Seikagaku entered into a collaboration agreement with Ono Pharmaceutical for Seikagaku’s SI-613 product, an injectable hyaluronic acid (HA) and a non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis (OA) in the country of Japan. SI-613 is currently in Phase III clinical development for use in the knee, and the company is planning for clinical studies for hip, ankle, elbow and shoulder applications.