Musculoskeletal News Roundup 14-July-17

July 14, 2017 | Blake Mossy

FUNDING

Carmell Therapeutics secured $4 million in a series B financing. The new capital will be used to support the companies Phase III clinical development of its Bone Healing Accelerant, a Plasma-based Bioactive Material (PBM) product designed for the treatment of bone fractures while reducing complications and infections.

Xenco Medical announced the U.S. expansion of the Anterior Cervical Discectompy CerviKit delivery and storage platform for its Anterior Cervical Discectomy and Fusion systems. The kit comprised of a single0use, composite polymer cervical implant designed for ambulatory surgery centers.

PRODUCT INTRODUCTION & UPDATE

CrossRoads Extremity Systems launched its DynaFORCE, a hybrid fixation system. Comprised of a plate and nitinol clip fixation, the system aims to allow continuous adaptive compression, top loading insertion, and intraoperative placement flexibility during foot and ankle procedures.

DePuy Synthes launched its Distal Radius Sterile Kit, a pre-sterilized, single-use kit of instruments and implants for the treatment of wrist fractures. The kit consists of one Variable Angle LCP Two Column Volar Distal Radius Plate, a distribution of screws and the required fixation instrumentation, designed to provide repeatable and more consistent procedures.

MedShape launched its DynaFrame CF system, a carbon fiber-filled polyetheretherketone (PEEK) deployment system for implanting the DynaNail TTC Fusion System. The carbon fiber PEEK construction is designed to provide more rigidity than the original PEEK material and also includes accommodations for larger patient anatomies.

SeaSpine launched its Skipjack Expandable Interbody System, designed to provide continuous in-situ expansion in either height or lordosis for a patient-specific anatomical fit. The system aims to minimize tissue disruption, reduce endplate damage and improve patient outcomes with the use of in-situ expansion.

REGULATORY

Tyber Medical received 510(k) clearance from the FDA for its TyFix, an all-in-one extremity joint fixation system. TyFix is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction by integrating the implant and instruments.

Stryker received 510(k) clearance from the FDA for its MultiGen 2 RF Generator for radiofrequency ablation to treat facet joint pain. The minimally invasive procedure allows surgeons to create strip lesions without removing electrodes and resolve errors without stopping the procedure and is customizable based on patient need and physician preferences. The system is a part of the company’s Performance Platform, with Venom Cannula and Electrode System, designed to provide twice the industry standard for power to reach its target temperature faster and with fewer errors.

INTELLECTUAL PROPERTY

Pinnacle Spine received a patent from the United States Patent and Trademark Office (USPTO), covering its method of delivery of graft material to fill the internal chambers of a spinal fusion device, while allowing for graft material to be in flush contact with the endplates surfaces of the adjacent vertebral bodies. This is the company’s fourth patent covering its InFill fusion technology.

DISTRIBUTION

CTL entered into a distribution agreement with G-21, an Italian-based biomaterials company, to distribute D-21’s bone cement, kyphoplasty and vertebroplasty technologies in the United States. The kyphoplasty procedure involves the surgical filling of an injured or collapsed vertebra to relieve pain caused by spinal compression.

K2M entered into a distribution agreement with Japan Medicalnext, a Mitsubishi Corporation subsidiary, for the distribution of its spinal medical devices in Japan. Japan Medicalnext will utilize its 250 employees, including 50 orthopedic sales professions to cover the distribution.  

APPOINTMENTS

Zimmer Biomet appointed Dan Florin as interim Chief Executive Officer. Mr. Florin replaces David C. Dvorak, President and CRO for the past 10 years, he will serve in an advisory capacity to the company to assist with the transition. Prior to interim CEO, Mr. Florin served as Senior Vice President and Chief Financial Officer.