Musculoskeletal News Roundup 10-Feb-17
BY BLAKE MOSSY, FEBRUARY 10, 2017
Entellus Medical secured $37.2 million through a public offering of 2,353,530 shares of its common stock at $0.001 a share and 1,176,470 shares at $17.00 per share. Entellus develops minimally invasive medical device systems and instruments for the treatment of patients suffering from chronic and recurrent sinusitis. The company plans to use the proceeds for working capital purposes and to repay its outstanding credit facility.
Spinal Simplicity received its third 510(k) clearance from the FDA for its Minuteman G3-R spinal implant. The implant is designed to be implanted through a minimally invasive lateral approach and will have a lower profile upon placement of the device. Minuteman G3-R is a sterile packed, posterior, non-pedicle supplemental fusion and fixation device for use in the non-cervical spine. It is a plating system intended for supplemental fusion in patients with degenerative disc disease, as an alternative to traditional pedicle screws.
PRODUCT INTRODUCTION & UPDATE
ChoiceSpine launched its HARRIER, an anterior lumbar interbody fusion system. The company received 510(k) clearance from the FDA for its HARRIER in November 2016, and is the first of four new products from ChoiceSpine.
Zimmer Biomet launched its Subchondroplasty procedure (SCP) internationally. The SCP Procedure is a minimally invasive outpatient intervention that aims to address the defects associated with subchondral bone marrow lesions (BMLs). The system fills the chronic lesions with AccuFill Bone Substiture, a porous injectable calcium phosphate, which is resorbed and replaced with healthy bone. SCP was originally used only in bone defects of the knee but has performed successfully in other areas including bones of the foot, ankle and hip.
SpineGuard received a patent from the United States Patent and Trademark Office (USPTO) for its Dynamic Surgical Guidance (DSG) technology covering the application of bone quality measurement. DSG technology utilizes a bipolar sensor and a pedicle screw to allow the surgeon real-time guidance and the ability to insert the screw into vertebrae without drilling a pilot hole. Its recent application in bone quality measurement is indicated as an improvement over the use of the DEXA scan, focusing on a more precise anatomical area.
AxioMed announced the completion of a two-year U.S. Investigational Device Exemption clinical study of its Freedom viscoelastic lumbar disc. The device received CE Mark approval from the FDA in 2009 and has been used to treat over 500 patients. The study results concluded that the restoration at the center of rotation, mimics a healthy human disc and correlates in a clinically improvement in patient disability.
BioRestorative Therapies received clearance from the FDA to commence a Phase 2 clinical trial using its lead cell therapy candidate, BRTX-100, to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. The primary goal of the treatment is to reduce pain and increase function in patients with chronic back pain and whose pain is not responsive to conservative treatment measures.
Vertebral Technologies (VTI) entered into a contract agreement with Resource Optimization & Innovation (ROi), a provider-owned cost management and supply chain solutions organization, to expand availability of VTI's modular interbody fusion devices to surgeons in ROi member facilities. VTI aims to provide advantages to surgeons dealing with difficult patient anatomy and disc space access, such as at L5-S1 and L4-L5 levels.
RTI Surgical appointed Camille Farhat as company Chief Executive Officer (CEO), effective March 15, 2017. Mr. Farhat will succeed the current Interim CEO, Robert Jordheim, who will resume his role as Chief Financial Officer. Prior to RTI, Mr. Farhat served as President & CEO of American Medical Systems (AMS), an operating business of Endo International plc.