Musculoskeletal News Roundup 12-May-17

May 12, 2017 | Blake Mossy

EARNINGS

Anika Therapeutics reported financial results for 1Q:17. Total revenue was $23.4 million in 1Q:17, missing consensus estimates by 2% and representing an increase of 5% compared to $22.3 million in 1Q:16. Product gross margin decreased to 74.0% in 1Q:17 from 75.6% in 1Q:17. The company's segments grew by: Orthobiologics +3.3%, Surgical (2%), Dermal +12% and Other +45% in 1Q:17 respectively. The company grew geographically: Domestic +5%, European +10% and ROW (5%) in 4Q:16. All growth rates are on a reported basis.

Orthofix International reported financial results for 1Q:17. Total revenue was $102.7 million in 1Q:17, beating consensus estimates by 6% and representing an increase of 5% compared to $98.7 million in 1Q:16. Adjusted EBITDA was $15.7 million in 1Q:17, increasing from $15.5 million in 1Q:16. Adjusted EBITDA margin decreased to 15.3% in 1Q:17 from 15.7% in 1Q:16. Gross margin for 1Q:17 increased to 78.0% compared to 77.6% in 1Q:16. The company's segments grew by: Biostim +9%, Biologics +6%, Extremity Fixation (1%) and Spine Fixation +2% in 1Q:17. All growth rates on a constant currency basis.

SeaSpine Holdings reported financial results for 1Q:17. Total revenue was $31.9 million in 1Q:17, representing an increase of 2% compared to $31.4 million in 1Q:16. Gross margin for 1Q:17 increased to 58.7%, from 54.5% in 1Q:16. The company's segments increased by: Orthobiologics +3% and Spinal Fusion Hardware +0.2% in 1Q:17 respectively. Overall, U.S. revenue increased 0.2% to $28.6 million in 1Q:17. All growth rates are on a reported basis.

Smith & Nephew reported financial results for 1Q:17. Total revenue was $1,142 million in 1Q:17, in-line consensus estimates and representing an increase of 1% compared to $1,137 million in 1Q:17. The company's segments grew at: Knee +5%, Hip +0%, Sports Medicine / Joint Repair +7%, Arthroscopic Enabling Technologies (1%), Trauma & Extremities +5% and Other Surgical +7% respectively in 1Q:17. All growth rates are on a constant currency basis.

Wright Medical reported financial results for 1Q:17. Total revenue was $177.2 million in 1Q:17, missing consensus estimates by 2% and representing an increase of 6% compared to 169.3 million in 1Q:16. Adjusted EBITDA was $18.2 million in 1Q:17 increasing from $13.0 million in 1Q:16. The adjusted EBITDA margin in 1Q:17 was 10.3% increasing 7.7% in 1Q:16. Gross margin for 1Q:17 was 79.0% increasing from 72.4% in 1Q:16. The company's segments grew by: Lower Extremities (2%), Upper Extremities +11%, Biologics +12% and Sports Medicine & Other 0% in 1Q:17 respectively. All growth rates are on a pro forma, constant currency basis.

 

FUNDING

CartiHeal secured $18.3 million financing led by aMoon, Johnson& Johnson Innovation, Peregrine Ventures and Elron. The new capital will be used to support CartiHeal’s Agili-C implant, a single-step implantation procedure indicated for the regeneration of bone and cartilage due to degenerative and non-degenerative joint conditions.

Conventus Orthopaedics competed a $20 million equity financing led by Deerfield Management, and funded entirely by the existing ownership Group. The new capital will be used for the commercialization of the company’s proximal humerus fracture repair therapy and develop future Cage extremity fracture repair indications.  

Intrinsic Therapeutics completed a $49 million round of financing co-led by New Enterprise Associates (NEA), Delos Capital, CG, Greenspring Associates, and Quadrille Capital. The new funding will be used to support the FDA approval process and the commercialization of the company’s Barricaid Anular Closure Device, which is designed to prevent repeat herniation in patients undergoing lumbar discectomy surgery to treat sciatic pain caused by a herniated disc.

Providence Medical Technology (PMT) secured a $10.5 million debt agreement with Bridge Bank. The new capital will support the commercialization and expand the distribution network of the company’s tissue-sparing cervical fusion portfolio.

M&A

Cook Medical divested its vertebroplasty product line to IZI Medical Products. The sale includes the Duro-Ject Osteo-Site, Osteo-Force and Vertefix brands in addition to other needles, injectors and cements used for the treatment of vertebral compression fractures (VCFs).  

REGULATORY

CurveBeam received 510(k) clearance from the FDA for its InReach, a Cone Beam CT imaging system designed for the hand, wrist, elbow and lower extremities applications in non-weight bearing positions. The system is comprised of on a ultra-compact scanner which provides high-contrast 3D datasets of bony anatomy that could potentially replace radiographs as a first line of diagnosis. InReach utilizes a small footprint, and self-shielded design.

Life Spine received 510(k) clearance from the FDA for its CRANIAL FUSION system, a multiple component titanium alloy based system comprised of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods and locking caps. The expanded clearance covers indications for use of SOLSTICE Polyaxial Screws into the cervical spine.  

Premia Spine received approval from the FDA for its pivotal study of its TOPS System, a posterior arthroplasty device for the treatment of degenerative grade I spondylolisthesis and stenosis. The study aims to establish the superiority of TOPS vs. traditional lumbar spinal fusion. The study will take place in 30 institutions and enroll 330 subjects.

ZipLine Medical received approval from the Indian Central Drugs Standard Control Organization for its Zip Surgical Skin Closure device in India. The system is a non-invasive skin closure device that replaces sutures, staples and glue for surgical incisions and lacerations. The clearance will allow ZipLine access to the medical device market in India.

INTELLECTUAL PROPERTY

Episurf Medical received a patent from the United States Patent and Trademark Office (USPTO) for its surgical drill guide with a functionality for depth adjustment, a part of the Episealer joint implant system. The company received EU patent protection for the drill guide in 3Q:16.

Vertebral Technologies received a patent from the USPTO covering its methods and apparatus for minimally invasive modular interbody fusion devices. The company currently has 28 patents and patent pending assets.

Vericel Corporation entered into an agreement with Innovation Cellular Therapeutics (ICT) for the licensing of the Vericel product portfolio. ICT will manufacture and distribute Vericel products in China, Singapore, South Korea and other countries in the region. Under the terms of the license agreement, Vericel will receive an upfront payment of $6.0 million, and will be eligible to receive approximately $8.0 million in development and commercial milestones.

LEGAL

Stryker Orthopedics announced that its subsidiary, Howmedica Osteonics, informed counts in New Jersey Multicounty and Federal Multidistrict litigations that 95% of additional registered eligible patients have enrolled in its Settlement Program under the Master Settlement Agreement. The company will proceed with the 2016 Settlement Program that provides for compensation to additional eligible U.S. patients who had revision surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem prior to December 19, 2016.

CLINICAL

Inspired Spine announced results from a study of its Oblique Lateral Lumber Interbody Fusion (OLLIF) procedure. The study results indicated that the surgery time of 124 patients was twice as fast and reduced blood loss compared to open TLIF. The OLLIF procedures were performed through a biplanar fluoroscopy approach.  

REIMBURSEMENT

SI-BONE received coverage from TRICARE, a regionally managed health care program for active duty and retired members of the uniformed services, for minimally invasive sacroiliac (SI) joint fusion using its iFuse Implant System. The written coverage policy provides access to over 9.4 million service members and their families, with access to 55 military hospitals and 373 military clinics.