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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 22-Dec-15 BY ANDREW VAHRADIAN, DECEMBER 22, 2015

FUNDING
Checkpoint Surgical secured $7.5 million in its first round of institutional financing, led by First Analysis, which was joined by existing backers NDI Healthcare, JumpStart NEXT Fund and several individual investors. The funds will enable the company to continue growing in its core market of orthopedic and head and neck procedures and expand into new markets with new products. The company's handheld nerve monitor stimulates motor nerves in order to help surgeons avoid damaging them during surgical procedures and gauge nerve and muscle health.

M&A
Orchid Orthopedic Solutions completed its acquisition of Cam Bioceramics' coating facility and operations in Suzhou, China. The transaction creates a base for Orchid to further expand its capabilities in China and strengthens its position in the global coating market. The sale allows Cam to focus on its core engineering, development and contract manufacturing of orthobiologic calcium compositions.

REGULATORY
The House of Representatives and the Senate have both passed the Omnibus Appropriations Act, a $1.1 trillion funding bill that will negate another government "shut down" and keep the U.S. federal government functioning until September 30, 2016. Within this legislation is a provision to suspend the Affordable Care Act's 2.3% medical device excise tax for 2016 and 2017. This two-year postponement of the tax should provide further financial flexibility to medical device manufacturers and research analysts predict that the median upside potential to public medtech companies' EPS (Earnings per Share) would be nearly 3.0% in 2016 and 2017. President Obama signed the bill into law on Friday, December 18th.

ChoiceSpine received 510(k) clearance from the FDA for its TOMCAT stand-alone cervical device. TOMCAT utilizes PEEK-OPTIMA HA Enhanced, a new material that aims to allow early bone apposition and superior bone quality formation compared to PEEK-OPTIMA.

DeGen Medical received 510(k) clearance from the FDA for its Latitude-C Cervical Interbody Spacer System. Latitude-C utilizes a trapezoidal shape that takes into account the uncinate process (a hook-shaped projection or protuberance) of the cervical vertebra. The system can be made from a variety of materials based on patient needs including, PEEK-OPTIMA, Porous Titanium with PEEK, PEEK-OPTIMA HA Enhanced, and Titanium and Carbon fiber-reinforced (CFR) PEEK-OPTIMA. Commercial launch is expected for 1Q:16.

Histogenics announced that the FDA has accepted the company’s amendment filed in November 2015 to the NeoCart Phase 3 clinical trial protocol to expand the eligible patient population. The company believes this approval will enhance its ability to attract qualified patient candidates to the clinical trial. NeoCart is a regenerative collagen scaffold intended to repair knee cartilage damage.

Life Spine received 510(k) clearance from the FDA for its GRUVE Anterior Cervical Plate System, designed to allow extreme bone screw angulation and features large graft windows and a tactile and visual confirmation of the locking mechanism. The system is scheduled for limited release at the beginning of 2016 with full product release expected in 2Q:16.

INTELLECTUAL PROPERTY
AlloSource received a patent from the U.S. Patent & Trademark Office (USPTO) for its AlloStem Cellular Bone Allograft. AlloStem is a demineralized allograft bone that is combined with adipose derived mesenchymal stem cells (MSCs) and is indicated for general bone grafting applications.

LEGAL
The Department of Justice (DOJ) reached settlements with thirty-two hospitals located throughout 15 states over allegations that the health care facilities submitted false claims to Medicare for minimally-invasive kyphoplasty procedures. The group of hospitals have agreed to pay the United States a total of more than $28 million. Kyphoplasty is a minimally-invasive procedure used to treat certain spinal fractures that often are due to osteoporosis. In many cases, the procedure can be performed as an outpatient procedure without any need for a more costly inpatient hospital admission. The settlements announced resolve allegations that the 32 settling hospitals frequently billed Medicare for kyphoplasty procedures on a more costly inpatient basis, rather than an outpatient basis, in order to increase their Medicare billings.

REIMBURSEMENT
The Medicare Administrative Contractor (MAC) covering the states of Kentucky and Ohio issued a positive local coverage determination (LCD) for MIS SI joint fusion that will become effective on February 1st, 2016.

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