Shares of Smith & Nephew (NYSE:SNN) were on the rebound today after a downgrade by analysts at Citi sent them spinning down nearly 4 percent yesterday.

SNN shares closed Sept. 21 at $45.39, but opened at $43.88 the next morning, down 3.3 percent on news of the downgrade. The stock closed yesterday at $43.68, down 3.8 percent. Smith & Nephew closed out today at $44.57, up 3.0 percent from yesterday’s low-water mark of $43.28 but still 1.8 percent shy of Thursday’s close.

The Citi analysts cut their estimate of the stock by two notches, spurred by the slim chances of a buyout and declines in the markets for hip and knee implants. The bank shifted its rating on SNN shares from “Sell” to “Buy,” according to StreetInsider.com.

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“While both Stryker (NYSE:SYK) and Zimmer (NYSE:ZMH) could technically make a go for the company, Citi argues such a deal would see serious antitrust issues,” according to the website.

Another potential acquirer, Johnson and Johnson (NYSE:JNJ), has its hands full with a $21.3 billion acquisition of Synthes Inc., the Citi analysts noted. But even the size of that bite isn’t enough to rule out others, at least according to J&J’s CFO.

The bank cut its 2012 and 2013 sales estimates for Smith & Nephew’s orthopedic business by 4 percent and 8 percent, respectively. Citi also said the hip and knee markets won’t turn around in the near term and cast a dim view on the prospects for growth in emerging markets until at least 2014, the website reported.

NuVasive, BD rebound from 52-week lows

Becton, Dickinson &Co. (NYSE:BDX) and NuVasive Inc. (NSDQ:NUVA) each regained some of their losses today after posting 52-week lows.

BD’s stock has been volatile all year, hitting a high of $89.75 before plunging to yesterday’s low of $71.71 – a 25.2 percent spread. The stock closed today at $73.74, up half a percent on the day but still 2.3 percent off its Sept. 20 closing mark of $75.44.

As for NuVasive, a legal judgment that could wind up costing it more than $100 million in a patent infringement dispute with Medtronic Inc. (NYSE:MDT) sent its shares down the slide. NUVA shares plunged 12.1 percent, to $18.65 per share, after news of the adverse judgment broke late Sept. 20. Shares closed up a tad yesterday at $18.69 (after posting the 52-week low of $17.87) and regained 1.9 percent today, closing at $19.04.

A federal jury in San Diego awarded $101.2 million to Medtronic and $660,000 to its smaller rival Tuesday in a patent infringement lawsuit over spinal implant technology. The news prompted at least one analyst on The Street to lower his earnings estimate for NuVasive’s 2011 and 2012 fiscal years “to account for ongoing MDT royalty accruals.”

“In the near-term, uncertainty around the exact amount of royalties and/or the possibility that MDT will seek an injunction may keep NUVA shares under pressure – at least until a final judgment is issued,” Leerink Swann analyst Rick Wise wrote, noting that it’s only the first phase of a three-stage trial. “However, now that the financial impact of this first, and in our view more significant, phase of the trial has – at least partially – been framed, we think the stock is poised to move higher from currently depressed levels as: (1) we get increased clarity that royalties are not likely to be materially worse than the company’s initial estimates, and (2) investors begin to re-focus on the company’s above-average sales growth potential.”

Wise maintained the investment bank’s “Outperform” rating on the stock, but cut earnings-per-share estimates for 2011 to $1.06, from $1.11, and lowered the 2012 EPS forecast from $1.27 to $1.15.

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The top three medical device stories for September 23, 2011.

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with MassDevice +3.

Robert Palmisano, the incoming CEO of Wright Medical Group, stands to make $750,000 in base pay and could earn up to 200 percent of his salary in bonuses next year.

The health care industry is ill prepared to protect patients’ medical records as new uses for data arise, according to a report by PricewaterhouseCoopers LLC.

A federal judge in Minnesota orders Medtronic to produce documents detailing the safety profile of its controversial Infuse bone growth protein in a shareholders’ lawsuit against the world’s largest pure-play device maker.

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September 23, 2011 by MassDevice staff

Neoprobe Corp. (NYSE Amex:NEOP) are prepping to sell off about 500,000 shares of stock should the company’s new drug application get the green light from the FDA.

Senior vice president & CFO Brent Larson, regulatory affairs & quality assurance VP Rodger Brown and former president & CEO David Bupp revealed plans to sell substantial portions of their stakes at various times over up to one year.

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Larson will sell up to 125,000 shares, representing 12 percent of his holdings, over the course of the 12 months beginning Sept. 14, according to documents filed with the SEC.

Brown plans to unload 28,715 in the first month, beginning Sept. 14, and will sell a total of 73,715 shares over a year, representing 14 of his total shares. Bupp intends to sell 300,000 shares, representing 6 percent of his holdings, over six months beginning Sept. 13.

NEOP shares were up 2.5 percent to $2.87 in afternoon trading today.

The Dublin, Ohio-based cancer diagnostics firmfiled the NDA for its flagship Lymphoseek radiopharmaceutical, a diagnostic tracing agent for detecting and treating certain types of cancer, with the FDA in August.

The application came amid controversy around the company’s clinical trail for the NDA. Neoprobe weathered a storm of criticism, including a citizen’s petition filed by hedge fund MSMB Capital Management asking the FDA to block the application on the grounds that the drug’s pivotal trials suffered from vital mistakes, allegations that Neoprobe has officially rebutted.

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EXTON, Pa., Sept. 23, 2011 — (Healthcare Sales & Marketing Network) — Kensey Nash Corporation (Nasdaq:KNSY ) today announced that Lisa Earnhardt, President and Chief Executive Officer of Intersect ENT, has joined Kensey Nash’s Board of Directors.

Ms. Earnhardt has served as President and Chief Executive Officer of Intersect ENT since March 2008. Intersect ENT, a venture-backed medical device company, is an innovator in local drug delivery and recently gained FDA approval for a steroid-releasing bioabsorbable implant that improves surgical outcomes for chronic sinusitis patients.

Prior to joining Intersect ENT, Ms. Earnhardt served as President of Boston Scientific’s Cardiac Surgery division. Ms. Earnhardt holds a BS degree in Industrial Engineering from Stanford University, and an MBA from Northwestern’s Kellogg School of Management. In addition to Kensey Nash’s Board, Ms. Earnhardt serves on the boards of Intersect ENT and the Kellogg Alumni Council. Ms. Earnhardt also served on the board of Nerites Corporation.

“Lisa’s extensive medical device experience will be an asset to our Board and our company,” commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. “Her talents, skills and industry knowledge will be highly complementary to our future business objectives,” he concluded.

“Over the past twenty-five years Kensey Nash has developed a broad range of innovative products and technologies that have benefitted patients worldwide. I am pleased to have the opportunity to join the Board and look forward to working with the current Directors and accomplished management team to achieve the company’s strategic objectives,” Ms. Earnhardt commented.

About Kensey Nash Corporation. Kensey Nash Corporation is a medical device company primarily focused on regenerative medicine utilizing its proprietary collagen and synthetic polymer technology. The Company is recognized as a leader for innovative product development and unique technology in the field of resorbable biomaterials. The Company has an extensive range of products, which are sold through strategic partners in multiple medical markets, including the cardiology, orthopaedic, sports medicine, spine, endovascular and general surgery markets. For more information, visit www.kenseynash.com.

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ALBANY, N.Y.–(Healthcare Sales & Marketing Network)– AngioDynamics (NASDAQ:ANGO ), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced that Scott Solano, Senior Vice President and Chief Technology Officer, has resigned his position effective October 14, 2011, to pursue other interests. Mr. Solano joined AngioDynamics in September 2010.

“We are disappointed that Scott has decided to leave AngioDynamics,” said Joseph DeVivo, President & CEO. “During the past year, Scott contributed significantly to our technology direction and product pipeline. With Scott’s full cooperation, we are implementing an orderly transition of his responsibilities.”

“My decision to leave AngioDynamics is a personal one,” said Mr. Solano. “I believe the Company is well positioned for future growth and wish all of the employees great success in the years ahead.”

About AngioDynamics

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.AngioDynamics.com.

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MASSDEVICE ON CALL — Asthma patients using over-the-counter inhalers will no longer be able to buy them after the end of the year, as the FDA will pull them off the market for using a carbon gas that depletes the earth’s ozone layer.

Many non-prescription inhalers, including Primatene Mist, will be pulled off the market to comply with an international treat on the use of chlorofluorocarbons, or CFCs, that have a negative impact on the environment.

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Patients can use non-CFC epinephrine inhalers, but will need a prescription from a doctor, Businessweek reported.

CDC’s stricter organ donor testing may limit availability, doctors say

New guidelines requiring more stringent organ donor testing, which the Centers for Disease Control & Prevention issued yesterday, has surgeons concerned that fewer organs will be available, the Wall Street Journal’s Health Blog reported.

Prostate biopsies lead to more hospitalizations

Men who receive a prostate biopsy, where a need is passed through the rectal wall into the prostate gland, end up hospitalized in the next month twice and often as the average man on Medicare, the Wall Street Journal reported.

Telehealth market to top $6 billion by 2010

The global telehealth market, worth about $163 million in equipment shipments in 2010, may top $6 billion by 2020, MobiHealthNews reported.

Health reform’s benefits for the disabled put on hold

The White House asked Senators to hold funding for a controversial health care reform law aimed at providing benefits for the disabled, Healthwatch reported.

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The top three medical device stories for Sept. 22, 2011.

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with MassDevice +3.

Zoll Medical Corp. CEO Richard Packer says a change in the way Medicare pays for LifeVest would impact only 8 percent of the company’s total sales, calls the device critical for helping cardiologists stay within ICD guidelines.

The $10 million deal for Calypso Medical Technologies by Varian Medical Systems leaves a lot to be desired for Calypso’s legacy investors – namely, about $140 million.

It’s been a tough stretch in the courtroom for Johnson & Johnson’s Cordis Corp. The health care giant’s stent-making unit lost its bid for a new trial in the $482 million patent infringement lawsuit it lost to stent pioneer Dr. Bruce Saffran.

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Optos plc agreed to pay $17.5 million plus royalties for Opko Health Inc.’s ophthalmic diagnostic imaging device business.

Optos plc (LON:OPTS) agreed to pay $17.5 million plus royalties for Opko Health Inc.’s (NYSE:OPK) ophthalmic instruments operation.

Miami-based Opko Health said the deal is for its “worldwide activities for the development and commercialization of ophthalmic diagnostic imaging systems,” according to a press release. The plan is to integrate Opko’s OCT SLO device into Optos’ widefield technology, according to the release.

“We believe that the instrumentation business and OCT SLO technology have strong potential that will benefit greatly from the synergies provided as part of a large and successful ophthalmic focused instrumentation company,” Opko CEO Dr. Phillip Frost said in prepared remarks. “We have great confidence that our instrumentation business will grow and prosper as part of Optos.”

Last month Optos shares gained more than 6 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device. Shares closed at £1.44 today on the London Stock Exchange, down 6.2 percent.

In November, the company offered $15 million for Australia’s Opto Global Holdings Pty. Ltd.

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It’s been a tough stretch in the courtroom for Johnson & Johnson’s (NYSE:JNJ) Cordis Corp.

The health care giant’s stent-making unit lost its bid for a new trial in the $482 million patent infringement lawsuit it lost to stent pioneer Dr. Bruce Saffran Tuesday.

That loss followed the failure of its bid to overturn a pair of U.S. Patent Office rules.

A jury in the U.S. District Court for Eastern Texas awarded $482 million in damages to Saffran after finding that Cordis infringed one of his patents with its Cypher drug-eluting stent.

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Judge John Ward later tacked on another $111 million in pre-judgment interest, but ruled that the infringement was not willful – sparing Cordis the possibility of paying triple damages.

Cordis moved for a new trial, claiming that the jury never should have heard evidence of willfulness presented in the trial and that Saffran’s attorney violated a legal precept known as the “Golden Rule.”

Ward ruled Sept. 20 that the jury would have heard the evidence anyway during arguments about other claims in the suit, adding that in order for him to determine the infringement claims he needs to see the evidence of infringement, according to court documents.

“[T]he Court is not convinced a new trial is warranted because of any alleged prejudice suffered by defendants due to the willfulness claims in the trial (or evidence admitted due to the willfulness claims),” Ward wrote.

Ward also denied the claim of violation of the Golden Rule, which bars attorneys from appealing to jurors to put themselves in the plaintiff’s shoes, lest they judge the case from personal bias.

“[T]he Court holds that counsel for plaintiff did not violate the Golden Rule because counsel never asked the jury to step into the plaintiff’s shoes. Rather, counsel stated that, ‘I mean, just imagine how – it’s hard for me to imagine how that would feel, okay?’ Although counsel may have been in the process of starting to ask the jury to step in Dr. Saffran’s shoes (e.g., ‘just imagine how’), counsel quickly corrected himself when he paused (i.e., the dash in the quote) and changed directions,” Ward wrote. “Thus, counsel never asked the jury to step into the plaintiff’s shoes. Finally, even though the court does not hold that counsel for plaintiff violated the ‘Golden Rule,’ defendants never objected to the court and gave the court an opportunity to cure any potential prejudice.”

The $482 million jury award against Cordis, which is bailing out of the coronary stents business, is the largest patent infringement award so far this year, according to Bloomberg.

Cordis lost its legal challenge to the USPTO rules because it filed the lawsuit too late, according to a ruling by a federal judge in Virginia.

Cordis filed the suit in early February 2011, seeking to overturn two USPTO rules instituted in 2004 that it claimed interfered with its ability to subpoena witnesses during patent proceedings. But because the statute of limitations for suing the government is six years, Judge Gerald Lee of the U.S. District Court for Eastern Virginia granted the defendants’ motion to dismiss the case.

Read more medical device legal news from MassDevice.com

California bans DPL Therapy System

A California judge issued a preliminary injunction barring Suarez Corp. Industries from selling its DPL Therapy device after 10 California district attorneys’ offices sued the company.

“It’s a glorified heating pad that sells for $295 to over $300 with misleading advertising,” Kelly Walker, a spokeswoman for the Santa Cruz County DA’s office, told HealdsburgPatch.com.

The DPL device is a “LED deep penetrating light therapy,” according to Suarez Corp.’s website. It sells for $349, according to the site, which calls that price a 30.5 percent discount from $439.

“The DPL Rejuvenation Light Therapy System is widely used for both joint & muscle pain relief and for skin care. With the DPL, you can enjoy the benefits of photo rejuvenation infrared LED therapy in your own home,” according to the website.

Alameda Superior Court Judge Robert Freedman found that Suarez Corp. made unfounded advertising claims and banned the direct marketing company (dba BioTech Research) from selling, delivering or offering to sell the system in the Golden State unless they hew to FDA guidelines.

The lawsuit names 18 other Suarez Corp. products that it or executive Benjamin Suarez touted with “unsubstantiated, false and/or misleading claims,” according to the lawsuit.

It’s not the first legal action against Suarez Corp. or Suarez himself, according to Patch.com, including a 2006 sanction for deceptive marketing of the AbGone dietary supplement, which also contained lead levels above the allowed amount.

The latest lawsuit also seeks $6 million in civil penalties and restitution for Suarez Corp. customers.

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TEWKSBURY, Mass.–(Healthcare Sales & Marketing Network)– Cambridge Heart, Inc. (OTCBB:CAMH.ob ), a developer of non-invasive diagnostic tests for cardiac disease, today announced that it has executed an exclusive agreement with EO Medical Pte Ltd to distribute its HearTwave II System and proprietary Microvolt T-Wave Alternans™ (MTWA) software and Micro-V Alternans Sensors in Singapore upon regulatory approval.

EO Medical is a leading supplier of cutting-edge and innovative medical devices to healthcare providers. This addition is in-line with the Company’s strategy of partnering with companies that have established distribution networks, to make its technology readily available in cardiology and internal medicine physician practices and in hospitals.

“This is a great opportunity for the Company that will incrementally add to our global presence,” said Ali Haghighi-Mood, Cambridge Heart CEO. Mr. Haghighi-Mood added, “We look forward to gaining regulatory approval in Singapore, which we expect will occur within the next six to nine months, and begin marketing our MTWA technology.”

Sudden Cardiac Arrest (SCA) is the leading cause of death in the U.S. accounting for an estimated 300,000 deaths each year – more than lung cancer, breast cancer and HIV/AIDS combined. Out-of-hospital survival is less than 8 percent, making prediction and prevention critically important. It is estimated that there are approximately 10 to 12 million heart attack and heart failure patients in the U.S. who can benefit from annual MTWA testing. Microvolt T-Wave Alternans is a marker of SCA risk which is measured during a non-invasive treadmill test using Cambridge Heart’s proprietary technologies. The Company’s MTWA test is the only one of its kind that is reimbursed by Medicare under a National Coverage Policy.

About Cambridge Heart, Inc.

Cambridge Heart develops and commercializes non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The Company’s products incorporate proprietary Microvolt T-Wave Alternans measurement technologies, including the patented Analytic Spectral Method® and ultrasensitive disposable electrode sensors. The Company’s MTWA test, originally based on research conducted at the Massachusetts Institute of Technology, is reimbursed by Medicare under its National Coverage Policy.

Cambridge Heart, founded in 1990, is based in Tewksbury, MA. It is traded on the Over-The-Counter Bulletin Board (OTCBB) under the symbol CAMH.OB.

http://www.cambridgeheart.com.

Statements contained in this press release that are not purely historical are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences are identified in our most recent Annual Report on Form 10-K under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.

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