Medical Device Link.

LEAD STORIES

McGarraugh

The old saw about necessity being the mother of invention holds special significance for Bhairavi Parikh. The founder of Apieron (Menlo Park, CA) is a wife and mother with two family members who suffer from asthma. Her company was born, if you will, of Parikh’s desire to help her husband and others, including her daughter, who are coping with the chronic lung disorder.

“The advent of the company was a personal experience for myself,” Parikh says. “My husband actually had severe asthma growing up, and I’ve known him since he was quite young.” Their daughter, 11, suffers from uncontrolled symptoms of the disorder as well.

As the leader of the instrumentation team for medical device clinical studies at the University of Massachusetts’ Division of Cardiothoracic Surgery, Parikh was in a position to bring some relief to her family. Her goal was to find a “better way to manage asthma by measuring inflammation in the airway.” She eventually designed and developed a biosensor that detects selected analytes such as exhaled nitric oxide (eNO), a common indicator of airway inflammation. Read on to learn how Parikh is taking her company into the future. [MORE]

Tong

Evaluating the market potential for a new medical technology requires an in-depth understanding of a product’s intellectual property, regulatory pathway, clinical application, and reimbursement potential. Performing due diligence and understanding strategic options along these four dimensions are critical to making go/no-go investment and development decisions. Consideration of how your product would be used if reimbursed or sold directly to consumers can determine its success or failure in the marketplace.

The growing role of direct consumer participation in the healthcare market captured the imagination of entrepreneurs and innovators. The poster child for the direct-to-consumer movement is likely Botox—an ongoing annuity stream that consumers readily pay for in cash. However, the economic downturn has threatened companies that focused their business strategy solely on consumers. It is important to understand the history and environment associated with various technologies that have been positioned in the CDHC space, especially if a manufacturer believes it is going to rely on a consumer-targeted strategy. The authors tell how to determine whether a consumer-directed strategy is the right path to take. [MORE]

Honeyman

As a business-savvy medical device executive, you likely are well versed on the value of utility patents. But are you aware that a design patent for your product can be an equally important component of your intellectual property portfolio? This article explains the differences between utility and design patents, and details why your company should consider diversifying its IP investment with design protection.

A utility patent is the most popular type of patent. It protects the structural or functional aspects of a new, or improved, product or system. A design patent, on the other hand, covers the unique look or appearance of a device. It embraces elements such as a specific product shape or a particular surface ornamentation. If you purchased a home blood-pressure monitor recently, for example, you may have noticed that the cuff is housed in a sleek-looking container. The shape of this container may be protected with a design patent. Two experts tell why it is essential that device firms also consider whether unique design elements are equally important to a product's identity and market share. [MORE]

Edwards Lifesciences Corp., a leader heart valves and hemodynamic monitoring, has entered into a definitive agreement with Baxter International Inc. to sell certain assets related to its hemofiltration product line, also known as continuous renal replacement therapy (CRRT). The transaction is expected to close in the third quarter of 2009, pending regulatory approvals.

Under the terms of the agreement, Edwards will receive an initial cash payment of approximately $56 million from Baxter upon the close of the transaction. Additionally, Edwards will provide transition services to Baxter and expects to receive up to an additional $9 million based on revenue objectives to be achieved over the next two years. Edwards is not revising its previous 2009 earnings guidance as a result of this transaction. [MORE]

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 .

A Breath of Fresh Air: Apieron

Is a Consumer-Directed Strategy Right for Your Technology?

Diversify Your Device Patent Portfolio with Design Patents

Edwards Lifesciences to Sell Its Hemofiltration Product Line to Baxter

INDUSTRY IN BRIEF

Stryker Corp. (Kalamazoo, MI) has won its case involving surgical plates used to fix broken wrist bones. The U.S. District Court for the Central District of California, Western Division, granted summary judgment of invalidity on behalf of Stryker concerning the patent infringement lawsuit brought by TriMed Inc.(Valencia, CA). TriMed had alleged that Stryker’s Universal Distal Radius and VariAx Distal Radius plate systems infringe TriMed’s U.S. Patent No. 5,931,839. The District Court ruled that the asserted claims of the patent are invalid because they would have been obvious in light of prior art.

ev3 Inc. (Plymouth, MN) has signed a definitive agreement to acquire Chestnut Medical Technologies Inc., a privately held, California-based company focused on minimally invasive therapies for interventional neuroradiology. The transaction broadens ev3's neurovascular product portfolio by adding the Pipeline Embolization device for treatment of cerebral aneurysms and the Alligator Retrieval Device for foreign body retrieval. Under the agreement, ev3 will acquire 100% of the equity interests of Chestnut for total upfront consideration of $75 million, 30–40% of which is payable in cash, with the remaining portion payable in ev3 common stock. An additional milestone-based contingent payment of up to $75 million is payable in a combination of cash and ev3 common stock upon receipt of premarket approval of the Pipeline device. Any contingent milestone payment is not expected to be paid until 2011.

Portland, OR–based Tiba Medical has launched an expansion effort that emphasizes distribution partnerships for its hypertension diagnostics products. The Ambulo 2400 system will be available in Canada, Western Europe, and Latin America. Tiba's systems will be available to customers throughout Canada exclusively from Roxon medi tech. In Europe, Tiba Medical has established distribution partnerships for the UK and Ireland, Spain, Greece, Cyprus, and Turkey. In Latin America, the company has a distribution partner in Argentina Tiba plans to continue its international expansion efforts in other parts of Europe, Latin America, and Asia over the next several months.

Irvine, Ca–based medical device maker Endocare Inc. is being acquired for $16 million by HealthTronics Inc. (Austin, TX). The deal comes 10 months after HealthTronics tried to buy Endocare, a maker of cancer treatment devices, for $27 million. HealthTronics dropped that bid in September. Although HealthTronics is offering a lot less this time around, its offer is 50% more than what Endocare was trading at on Friday. Endocare’s shares are down about 80% in the past year. They surged nearly 40% at the close of trading on Monday on HealthTronics’ offer. HealthTronics is offering cash and stock to buy Endocare. The deal is set to close in the third quarter of 2009. Endocare makes devices for cryoablation-based procedures that surgically freeze and destroy cells and tissues.

CALENDAR

July 29: Medtech Marketing Today, Webcast

August 10–12: Materials and Processes for Medical Devices, Minneapolis

August 10–11: Drive Business Performance through New Metrics and Incentives, Pasadena, CA

August 11–12: Tracking State Laws and Aggregate Spend, Arlington, VA