Musculoskeletal News Roundup 11-August-17

August 11, 2017 | Blake Mossy

EARNINGS

ConforMIS reported financial results for 2Q:17. Total revenue was $18.5 million in 2Q:17, missing consensus estimates by 4% and representing a decrease of 4% compared to $19.3 million in 2Q:16. Gross margin for 2Q:17 increased to 34%, from 31% in 2Q:16. Domestic revenues increased by 1.5% and international revenues decreased by 27.5% respectively in 2Q:17.

Exactech reported financial results for 2Q:17. Total revenue was $67.3 million in 2Q:17, missing consensus estimates by 1% and representing an increase of 2% compared to $66.1 million in 2Q:16. Gross margin for 2Q:17 decreased to 68.7%, from 69.3% in 2Q:16. The company’s segments grew by: Extremities +20%, Knee +1%, and Hip (7%) in 2Q:17. All growth rates are on a constant currency basis.

Orthofix International reported financial results for 2Q:17. Total revenue was $108.9 million in 2Q:17, beating consensus estimates by 6% and representing an increase of 5% compared to $104.1 million in 2Q:16. Adjusted EBITDA was $20.5 million in 2Q:17, increasing from $19.2 million in 2Q:16. Adjusted EBITDA margin decreased to 18.8% in 2Q:17 from 18.5% in 2Q:16. Gross margin for 2Q:17 increased to 78.7% compared to 78.4% in 2Q:16. The company's segments grew by: BioStim +5%, Biologics +10%, Extremity Fixation (6%) and Spine Fixation +17% in 2Q:17. All growth rates on a constant currency basis.

SeaSpine Holdings reported financial results for 2Q:17. Total revenue was $34.2 million in 2Q:17, representing an increase of 3% compared to $33.2 million in 2Q:16. Gross margin for 2Q:17 increased to 59.1%, from 58.0% in 2Q:16. The company's segments increased by: Orthobiologics +5% and Spinal Fusion Hardware +1% in 2Q:17 respectively. Overall, U.S. revenue increased 1.1% to $34.2 million in 2Q:17. All growth rates are on a reported basis.

Vericel reported financial results for 2Q:17. Total revenue was $17.0 million in 2Q:17, beating consensus estimates by 32% and representing a increase of 32% compared to $12.8 million in 2Q:16. Net revenue for the company's Total Carticel (autologous cultured chondrocytes) implants and surgical kits and Epicel (cultured epidermal autografts) product revenues were $12.9 million and $4.1 million in 2Q:17, increasing from $8.9 million and $3.8 million respectively in 2Q:16. Gross margin for 1Q:17 increased to 51% from 43% in 2Q:16. All growth rates are on a reported basis.

Wright Medical reported financial results for 2Q:17. Total revenue was $179.7 million in 2Q:17, beating consensus estimates by 1% and representing an increase of 6% compared to 170.7 million in 2Q:16. Adjusted EBITDA was $19.8 million in 2Q:17 increasing from $12.2 million in 2Q:16. The adjusted EBITDA margin in 2Q:17 was 11.0% increasing from 7.2% in 2Q:16. Gross margin for 2Q:17 was 78.8% increasing from 78.5% in 2Q:16. The company's segments grew by: Lower Extremities +2%, Upper Extremities +10%, Biologics +8% and Sports Medicine & Other (2%) in 2Q:17 respectively. All growth rates are on a pro forma, constant currency basis.

M&A

ConforMIS entered into an agreement to acquire the machining and polishing assets of Broad Peak Manufacturing. Under the terms of this transaction, ConforMIS will obtain supplies and equipment, and lease a fully operational manufacturing facility and office space in Wallingford, Connecticut. The transaction aims to allow ConforMIS to reduce costs, enhancing manufacturing of the company’s customized knee implants and improve operations.

Tissue Regenix (TRX) acquired CellRight Technologies, a U.S. based specialist in regenerative osteoinductive bone scaffolds.  TRX’s portfolio is comprised of soft tissue products for use in wound care, orthopedics and cardiac applications. This transaction supports the company’s plan to launch its OrthoPure HT, decellularized human tendon in 2018.

REGULATORY

ApiFix received regulatory approval for its ApiFix system in Australia, indicated for the treatment and correction of Adolescent Idiopathic Scoliosis (AIS). The minimally invasive, non-fusion spinal implant system is designed to maintain spinal flexibility and reduce hospitalization and operating room time.

In2Bones received 510(k) clearance from the FDA for its 5MS Fracture Repair and CoLag Locking Compression Screw system, indicated for the treatment of fractures and deformities of the 5th metatarsal bone of the foot. The system utilizes anatomically contoured plates and fracture-specific screws, single-use instruments and sterile-packaged in a disposable tray.

Renovis Surgical received 510(k) clearance from the FDA for its Tersea porous titanium interbody fusion systems. The systems include implants indicated for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options. The implants utilized the company’s Tesera Trabecular Technology, a porous structure that allows for bone attachment to implant surfaces and the potential for biologic fixation deep into the pore structure for long-term stability.

Xtant Medical received 510(k) clearance from the FDA for its Calix-C cervical interbody cages. The clearance allows for the addition of two larger footprints and for use with allograft. The system can now be used with the company’s 3Demin and OsteoSponge allografts and OsteoVive cellular allograft, this aims to allow increased stability against the vertebral endplates and allow for a larger area for bone graft.

PRODUCT INTRODUCTION & UPDATE

Nextremity Solutions launched its PiroVue Gastrocnemius Recession System for the treatment of equinus deformity, a condition that limits the bending motion of the ankle joint. The system is a disposable, single use, sterile packed instrument kit for gastrocnemius recession, consisting of an integrated cutting guide and retractor with a controlled recession knife.

Paragon 28 launched its Gorilla NC Fusion Plate, designed for the treatment of naviculocuneiform arthritis and flatfoot. The system is comprised of four plates with five screw options for compression across joint, and aims to be compatible with PRECISION Guide technology that provides three options for crossing screw trajectory to accommodate varying patient anatomies.

CLINCAL

Anika Therapeutics announced the publication of a study using its HYALOFAST biodegradable hyaluronic acid (HA) technology. The study results suggest that HYALOFAS, used in combination with autologous adult mesenchymal stem cells (MSCs), is a viable and effective option for the treatment of cartilage lesions of the knee joint.

FH Orthopedics announced the first total shoulder arthroplasty using its Arrow Prime cementless glenoid baseplate. The system’s cementless humeral and glenoid platform solutions address a variety of arthroplasty indications, including component loosening, and is accompanied by a universal instrument set.

Life Spine announced the first clinical use of its TiBOW, a minimally invasive, expandable, transforaminal lumbar interbody fusion system. The system allows for in-situ expansion for increased endplate coverage and stability, for minimally invasive TLIF and oblique approaches. TiBOW utilizes Osseo-Loc surface technology, which aims to create a geometric surface architecture that supports the recruitment of bone-building osteoblasts.