Medical Devices Today

Medical Device Deals Update, April 2012

Article preview from Medtech Insight - April, 2012

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

Haldor Advanced Technologies Ltd.

Article preview from Start-Up - April, 2012

Haldor Advanced Technologies Ltd.’s ORLocate surgical instrument tracking and asset management system uses RFID to automatically track, trace, monitor and manage the life cycle of instruments and consumables within the hospital – before, during and after a surgical procedure. In addition to managing the logistical chain and the specific location of an instrument at any point in time, ORLocate is designed to be a comprehensive workflow management system that provides statistical and processing data, par-level and inventory management and preventive maintenance.

Out Of The Blocks, April 2012

Article preview from IN VIVO - April, 2012

Brief profiles of these recently formed companies: 3D Biomatrix, ADC Therapeutics, GeneCentric Diagnostics, IDx, InControl Medical and Intrepid Therapeutics.

FDA User Fee Reauthorization Charges Along With Senate Passage

Article preview from "The Gray Sheet"-  May 28, 2012

FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.

Deals In Depth: February 2012

Article preview from IN VIVO - April, 2012

Pfizer and Zhejiang Hisun Pharmaceutical together invested $545 million to create a Chinese generics joint venture. Dainippon Sumitomo Pharma expanded its cancer pipeline though the acquisition of Boston Biomedical. Driven by a large amount of FOPOs, biopharma financing totaled $1.8 billion in February, while device companies raised $248 million.

Deep Brain Provides Stimulating Market

Article preview from Medtech Insight - April, 2012

There are signs that the field of deep brain stimulation (DBS) has gained a certain momentum of late: three start-ups raised venture rounds in 2011 and there have been two acquisitions in the space within the past year. DBS enables the giants in cardiac rhythm management – Medtronic, St. Jude Medical, and Boston Scientific –to leverage existing technology platforms from CRM to address a new area once served primarily by drugs, and start-ups can help them by validating new disease targets and increasing procedural accuracy and efficiency. The space is appealing because with a single platform, companies can address several diseases with large populations, such as depression and Alzheimer’s disease. But the opportunities remain far from certain with this highly complex technology.

Bluegrass Vascular Technologies Inc.

Article preview from Start-Up - April, 2012

Central venous catheters are commonly employed to deliver long-term dialysis, nutrition and chemotherapy, but nearly 10% of patients have an upper-extremity venous occlusion that renders the vein impenetrable by standard access techniques. When access is not possible through traditional “outside-in” routes, Bluegrass Vascular Technologies’ Surfacer system allows for central venous access through the femoral vein in the leg. The device features a bullet-shaped catheter tip with a proprietary side-exit needle that allows the physician to enter into the occlusion and create a new tissue channel, from the inside out.

New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting

Article preview from "The Gray Sheet"-  May 21, 2012

The Medicare Evidence Development & Coverage Advisory Committee was charged May 16 with helping CMS better define the evidence threshold under which the agency should or should not pursue a coverage- with-evidence-development policy.

LAA Closure Devices: Reaching Critical Mass?

Article preview from Medtech Insight - April, 2012

Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs. Regardless of how these issues are eventually resolved, industry leaders see a big opportunity for a successful device in the LAA closure space, with market estimates of $1 billion considered conservative by some.

CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices

Article preview from Start-Up - April, 2012

Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.