Musculoskeletal News Roundup 29-Sept-17

September 29, 2017 | Blake Mossy

FUNDING

DiscGenics secured a $14 million Series B financing. The funding was led by the company’s Board of Directors, existing long-term investors and new investment partner Mitsubishi UFJ Capital Co. Ltd.  The new capital will be used to support the manufacturing, regulatory approval and commercial production of its IDCT product candidate, an injectable cell therapy to treat degenerative disc disease.

OrthAlign secured a $10 million Series D financing. The funding was led by River Cities Capital Fund, California Technology Ventures, Research Corporation Technologies and Mutual Capital Partners. The new proceeds will be used to support the expansion of the company’s computer-assisted navigation platform from total knee into partial knee and total hip applications.

Viseon Spine secured a $5 million Series A financing. The financing was led by HBM-MedFocus, Invus Opportunities, and Wexford Capital LP. The new funding will be used to support product development of its single-use, disposable visualization and illumination technologies for minimally invasive spine surgery.

REGULATORY

Expanding Orthopedics received 510(k) clearance from the FDA for its FLXfit 15 interbody cage that expands and enables controlled lordosis correction for spine surgery. The system intends to support restoration of the lordosis angle up to 15 degrees, while available in a shorter length to address smaller anatomies.

HD LifeSciences received 510(k) clearance from the FDA for its NanoHive, a system of interbody devices for ALIF, PLIF, and TLIF procedures. The system utilizes the company’s Soft Titanium technology, which is a honeycomb lattice designed to provide optimal stiffness, imaging and osteogenic nano-surfacing to support fusion.

K2M received 510(k) clearance from the FA for its YUKON OCT system indicated to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine and achieve 3D spinal balance. The system utilizes a top-loading, high angulation, polyaxial screw design to provide up to 105 degrees of polyaxial angulation and cobalt chrome and titanium screw heads to accommodate construct rigidity based on degenerative or deformative corrections.

Mortise Medical received 510(k) clearance from the FDA for its LigaMetrics Suture Anchor, designed for ankle injury repair. The system is a knotless suture anchor designed for connecting to and locking suture tape that is attached either to soft tissue or to a conventional suture anchor. The goal of the device is to achieve optimal tension, then allow for stability and range of motion assessment before final adjustments.  

Providence Medical Technology (PMT) received 510(k) clearance from the FDA for its ALLY Posterior Fixation system as an alternative to fusion in the cervical spine. The system is comprised of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 7,000 cases worldwide.

THINK surgical received clearance from the Korean Ministry of Food and Drug Safety for its TSolution One robotic surgical arm system, designed for total hip arthroplasty (THA) and total knee arthroplasty (TKA).  The system utilized CT based 3D pre-surgical planning using an open implant library combined with a surgical robot that aims to execute the patient specific plan and prepares the bone cavity and joint surface with sub-millimeter dimensional accuracy.

PRODUCT INTRODUCTION & UPDATE

Flower Orthopedics launched its Flower Efficiency (E-kit) Advanced system; FlowerGraft, a foot reconstruction platform with pre-shaped, bi-cortical allografts packaged in saline; and the expansion of Headless Compression Screws to the Ready-for-Surgery cannulated screw set. FlowerGraft’s saline-packaged implants and single-use instruments aim to reduce operation room time and its low-profile plates are designed to provide fixation without disrupting soft tissue near the surgical site.

Paragon 28 introduced posterior plates to its Gorilla Ankle Fracture system, which is now comprised of 44 total plates in seven families to address distal fractures of the fibula and tibia. The posterior plates are offered across four families and provide surgeons 20 options to address fractures of the tibia and fibula from a posterior approach.

SeaSpine launched  its Shoreline, an anterior cervical system designed for the treatment of spinal disorders.  The system offers a zero- and low-profile plating options, with two, three and four hole variations, as well as 10 and 15 degree lordotic implants, allowing surgeons to intraoperatively address a range of anatomy, surgical situations or bone.

VirtaMed launched its ArthroS Ankle, a high-fidelity simulator for ankle arthroscopy. The systems module allows surgeons to practice anterior and posterior access and replicate prone and supine positions. The joint is able to be manipulated in dorsiflexion and plantar flexion, and the model enables distraction. The simulator also includes modules for knee, shoulder, and hip arthroscopy, as well as the FAST module for basic skills training.

 

REIMBURSEMENT

Paradigm Spine announced coverage from Blue Cross Blue Shield of Michigan Medical Policy for its coflex Interlaminar Stabilization, which brings coverage of the coflex Interlaminar Stabilization implant procedure to 8.6 million patients in Michigan. The system is a non-fusion, motion-preserving implant for treatment of lumbar spinal stenosis.

COLLABORATION

LifeLink Tissue Bank entered into a partnership with HCT Regenerative, to distribute allografts for patients suffering from sports, orthopedic and spine injuries. HCT Regenerative, a Taiwan based company, processes human tissue into regenerative biomaterials for clinical use. LifeLink will provide bone and tissue to HCT, while both companies collaborate on the development of HCT’s operations.