Medical Device Link.

Healthcare Reform:
Will Device Makers End Up in the Red or in the Pink?

David Nexon

Tracking the fate of U.S. healthcare reform is like watching a patient being wheeled into the operating room while the surgeons bicker in the corridor over the best way to save his life. Despite the current level of uncertainty surrounding the mid-summer debate, medical device makers should emerge from the legislative operation in relatively good health, according to several industry executives and at least one analyst. Given the focus on cost containment, obvious concerns have surfaced over the ultimate impact on device sales, company profits, product development, and investor confidence. But a quick roundup of industry opinions reveals both a commitment to the Obama administration’s reform push and the overall belief that most device makers will weather pricing pressures—and any attendant business fallout—as they always have. [MORE]

Managing Litigation Risk in Medical Device M&A

CEOs Need To Take the Reins of Software Development Strategy

$50 Million in Funding Strengthens ConforMIS's Business Strategy

Philipp Lang

In its largest equity round to date, ConforMIS Inc. has raised $50 million in U.S. and international funding. The milestone for the company provides a solid financial foundation for the company to not only build its commercial infrastructure, manufacturing base, and sales force, but it will boost ConforMIS as it prepares for the launch of its iTotal system. ConforMIS CEO Philipp Lang, MD, anticipates that iTotal, a total knee resurfacing system, will be the company's biggest product to date. [MORE]

MD&M Midwest · September 22–24, 2009 · Donald E. Stephens Convention Center, Rosemont, IL

Attend the Midwest’s new event for medical design and manufacturing—MD&M Midwest. See, compare, and evaluate the complete range of product and service resources for designing and manufacturing your current and next-generation medical devices and equipment. For complete event details including expo hall highlights, a current list of exhibitors, information on the co-located MD&M Midwest conference program, and easy online registration for free expo hall admission, visit www.MDMmidwest.com.

Cambridge Heart (Tewksbury, MA) has signed the first nonexclusive development and distribution agreement with an undisclosed U.S. stress test manufacturer to develop a Microvolt T-Wave Alternans (MTWA) module. The module will be integrated into cardiac stress testing equipment to better address sudden cardiac arrest (SCA) prevention. Development of the module is anticipated to take nine to 15 months, based on production and regulatory approval timelines. An announcement will be made at that time. The agreement marks a planned strategy shift to make Cambridge Heart’s technology available to a broad group of at-risk heart patients. Many heart attack and heart failure patients who might benefit from annual MTWA testing include those who routinely undergo cardiac evaluations, including stress testing, and those who may be under the care of a various specialists, including cardiologists and internists as well as heart rhythm specialists.

CareFusion Corp. (San Diego, CA) is the name of the company that will become public following the planned spinoff of Cardinal Health’s clinical and medical products businesses. According to a release, CareFusion’s brand signifies the fusion of proven technologies with actionable intelligence to measurably improve care. Print advertisements began appearing in healthcare trade journals and national media on July 15. David Schlotterbeck serves as CEO of CareFusion.

Johnson & Johnson (J&J) has acquired all assets and rights of Elan Corp. plc related to its Alzheimer's Immunotherapy Program (AIP), through a newly formed company. Through its affiliate, J&J will invest $1 billion in Elan in exchange for newly issued American Depositary Receipts (ADRs) of Elan, which will represent 18.4% of Elan's outstanding ordinary shares. The AIP represents Elan's interest in a collaboration with Wyeth to research, develop, and commercialize selective products for the treatment and prevention of neurodegenerative conditions. J&J will assume and continue Elan's activities with Wyeth under the AIP and plans to commit up to $500 million to development bapineuzumab, a potential treatment that is being evaluated for slowing the progression of Alzheimer's disease, as well as other compounds. The agreement provides for additional funding if needed. Elan will receive a 49.9% equity interest in the new company that will acquire the AIP. Elan is entitled to a 49.9% share of the profits and certain royalty payments upon the commercialization of products under the collaboration with Wyeth.

Medrad Inc. (Warrendale, PA) has launched Manage.Report, an informatics application that enables healthcare professionals to immediately access clinical and administrative information associated with radiology patients' contrast injections. This is the first in the company's series of informatics platform applications. Manage.Report automatically captures and logs in a secure database essential patient and radiology-management information concerning contrast injections delivered by the MEDRAD Stellant CT injector. In addition to meeting the needs of clinical teams through immediate access to patient-specific injection information, Manage.Report automates record keeping, increases data accuracy, simplifies the audit process, and facilitates compliance with the Joint Commission. Within moments after the scan, radiologists can log in and review details on the actual protocols administered to their patients and consider injection specifics associated with the procedure such as pressure rates and flow graphs. Administrators can track procedure volumes, contrast usage and injection events, and conduct detailed analysis using customized reporting capabilities.

eCardio’s CEO Larry Lawson has been named Ernst & Young 2009 Entrepreneur Of The Year in the Houston & Gulf Coast Area. eCardio Diagnostics, based in The Woodlands, TX, announced that Lawson was selected by an independent panel of judges and was awarded at a gala event at the InterContinental Houston Hotel. According to Ernst & Young LLP, the award recognizes outstanding entrepreneurs who are building and leading dynamic, growing businesses. Lawson is now eligible for the Ernst & Young LLP Entrepreneur Of The Year 2009 national program, the winners of which will be announced in Palm Springs, CA, on November 14, 2009.