Awesome New Things

By Andrew Chow, JD at FindLaw.com

Tue Mar 27, 2012 4:39am EDT

Update: Three men accused of robbing medical marijuana home on Grand Rapids Northeast Side to be arraigned

GRAND RAPIDS, MI — After three armed men broke into a Northeast side home this morning where medical marijuana was being grown, residents there say they feel like suspects instead of victims.

Thats because in the hours after the robbery — a gun was held to the head of the lone person who was home at the time — police determined the marijuana growing operation violated the states Medical Marijuana Act and confiscated an estimated $6,000 in equipment and marijuana.

Its bad enough we got robbed and my step-son had a gun held to his head, but then the police do this, said a man who lives at the Foster Avenue NE home near Conger Street.

But Grand Rapids police say the violations appeared clear to them. No one at the home was arrested, but police plan to forward a report to Kent County prosecutors for review.

Grand Rapids Police Lt. Richard Nawrocki said investigators determined the grower had too many plants in the house and too many ounces of processed marijuana for the number of patients he served.

ST. JOHNSBURY – The Office of the Chief Medical Examiner of Vermont confirmed today that a body discovered off Comeford Dam Road in the Town of Barnet yesterday afternoon is that of Melissa Jenkins.

Jenkins, 33, of St. Johnsbury, was reported missing on Sunday night by a friend who found her car idling with only her 2-year -old child inside.

On Monday, her body was found during a search of the area.

The cause of Jenkins death is being withheld as to not inhibit the progress of the investigation.

In addition to numerous leads and interviews being conducted, the Vermont State Police Crime Scene Search Team returned to the scene this morning where the body was located and additional items of interest were collected. The

description of the items recovered at the scene will not be disclosed in an effort to preserve the integrity of the investigation.

Major Ed Ledo, Criminal Division Commander for the Vermont State Police said We are deeply saddened by the tragic death of Ms. Jenkins and our thoughts are with her family and friends. We remain committed to solving this case and to identify and bring to justice the person or persons responsible for the death of Ms. Jenkins.

Jenkins was a single parent who teaches science and coaches girls freshman basketball at St. Johnsbury Academy. She also waitressed part-time at The Creamery Restaurant in Danville. She graduated from Lyndon State College with a degree in natural science/geology.

Eric Berry

Hansen Medical, Inc. (NASDAQ: HNSN) announced William R. Rohn has been appointed as a Director and elected to chair the Compensation Committee, effective immediately. The appointment increases board membership to eight. Mr. Rohn brings to the board significant experience from his over 40 years of executive management in the healthcare industry.

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SANTA CLARA, Calif., March 27, 2012 /PRNewswire via COMTEX/ –
Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today over 250 patients have been enrolled in the landmark KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) clinical trial. KAST is evaluating Benvenue Medical’s Kiva VCF Treatment System in the largest randomized study to date versus the current standard of care, balloon kyphoplasty, in vertebral compression fractures (VCF) common to osteoporosis.

“We are excited at the level of response and participation in the KAST study, the largest prospective randomized trial to be undertaken for VCF treatment. Having achieved 250 enrolled patients in the study is a major milestone and we want to applaud the hard work and dedication to the KAST trial by our investigators and research coordinators,” said Sean Tutton, MD FSIR, co-principal investigator in the KAST study and associate professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee. The National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, yet 200,000 kyphoplasty procedures are done globally.

“We believe the progress we’re making with KAST is a result of the spine community’s desire to examine and validate the potential benefits of the Kiva System which potentially include cement containment, a reduced cement volume while utilizing a minimally invasive, unipedicular approach,” commented Robert Weigle, CEO of Benvenue Medical. The Kiva VCF Treatment System, commercially available in Europe, has now been used to treat more than 600 VCFs globally. Kiva is distributed by Zimmer Spine in Europe.

“Randomized clinical trials such as KAST are important in documenting not only patient outcomes but in providing evidence that might serve as guidance in clinical decision-making when physicians have a choice between multiple treatment options, as is the current case with VCFs, kyphoplasty, vertebroplasty and conservative therapies,” said Steven R. Garfin, M.D., co-principal investigator of the KAST study and professor and chairman of the Department of Orthopaedic Surgery at the University of California, San Diego Medical Center.

KAST is an IDE study in support of a future 510(k) market clearance application for the Kiva VCF Treatment System to the U.S. Food and Drug Administration (FDA). The KAST study is a non-inferiority, randomized controlled trial comparing Kiva to balloon kyphoplasty, which is the current standard of care in VCF treatment. The trial is enrolling patients at 25 medical centers in the United States, Canada, Belgium, France and Germany. Success will require non-inferiority on the primary endpoint, which is a composite of pain, function, and safety at one year of follow-up on patients treated on study. There is potential to demonstrate superiority on key secondary endpoints including PMMA cement volume, extravasation rate, and height restoration as well as other endpoints. (clinicaltrials.gov identifier:NCT01123512)

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides an innovative approach to the treatment of painful VCFs. The Kiva VCF Treatment System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva Implant is designed to function as a mechanical support structure and a reservoir to contain and direct the flow of bone cement.

The Implant is delivered percutaneously in a continuous loop fashion into the vertebral body with an all-in-one disposable device through a small diameter, single incision. The amount of the Kiva Implant delivered can be physician-customized during the procedure to adjust to various fracture types. Delivered over a removable guidewire, the Implant is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.

The minimally invasive Kiva System is designed to:

Reduce polymethyl methacrylate (PMMA) bone cement volume

Preserve cancellous (porous and mesh-like, as opposed to dense) bone structure

Potentially reduce adjacent level vertebral fractures

Reduce extravasation rate (leakage into surrounding tissue) versus comparable technologies

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. is advancing spine repair through the development of proprietary, minimally invasive surgical and interventional solutions. The company is privately held and funded by Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit
www.benvenuemedical.com .

MEDIA CONTACT:Betsy MerrymanMerryman Communicationsbetsy@merrymancommunications.com310-560-8176

ML2441.A

SOURCE Benvenue Medical, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

3 days ago 

CHICAGO (AP) — New research gives clear proof that weight-loss surgery can reverse and possibly cure diabetes, and doctors say the operation should be offered sooner to more people with the disease — not just as a last resort.

The two studies, released on Monday, are the first to compare stomach-reducing operations to medicines alone for “diabesity” — Type 2 diabetes brought on by obesity. Millions of Americans have this and can’t make enough insulin or use what they do make to process sugar from food.

Both studies found that surgery helped far more patients achieve normal blood-sugar levels than medicines alone did.

The results were dramatic: Some people were able to stop taking insulin as soon as three days after their operations. Cholesterol and other heart risk factors also greatly improved.

Doctors don’t like to say “cure” because they can’t promise a disease will never come back. But in one study, most surgery patients were able to stop all diabetes drugs and have their disease stay in remission for at least two years. None of those treated with medicines alone could do that.

“It is a major advance,” said Dr. John Buse of the University of North Carolina at Chapel Hill, a leading diabetes expert who had no role in the studies. Buse said he often recommends surgery to patients who are obese and can’t control their blood-sugar through medications, but many are leery of it. “This evidence will help convince them that this really is an important therapy to at least consider,” he said.

There were signs that the surgery itself — not just weight loss — helps reverse diabetes. Food makes the gut produce hormones to spur insulin, so trimming away part of it surgically may affect those hormones, doctors believe.

Weight-loss surgery “has proven to be a very appropriate and excellent treatment for diabetes,” said one study co-leader, Dr. Francesco Rubino, chief of diabetes surgery at New York-Presbyterian Hospital/Weill Cornell Medical Center. “The most proper name for the surgery would be diabetes surgery.”

The studies were published online by the New England Journal of Medicine, and the larger one was presented Monday at an American College of Cardiology conference in Chicago.

More than a third of American adults are obese, and more than 8 percent have diabetes, a major cause of heart disease, strokes and kidney failure. Between 5 million and 10 million are like the people in these studies, with both problems.

For a century, doctors have been treating diabetes with pills and insulin, and encouraging weight loss and exercise with limited success. Few very obese people can drop enough pounds without surgery, and many of the medicines used to treat diabetes can cause weight gain, making things worse.

Surgery offers hope for a long-term fix. It costs $15,000 to $25,000, and Medicare covers it for very obese people with diabetes. Gastric bypass is the most common type: Through “keyhole” surgery, doctors reduce the stomach to a small pouch and reconnect it to the small intestine.

One previous study tested stomach banding, a less drastic and reversible procedure for limiting the size of the stomach. This technique lowered blood sugar, but those patients had mild diabetes. The new studies tested permanent weight-loss surgery in people with longtime, severe diabetes.

At the Cleveland Clinic, Dr. Philip Schauer studied 150 people given one of two types of surgery plus standard medicines or a third group given medicines alone. Their A1c levels — the key blood-sugar measure — were over 9 on average at the start. A healthy A1c is 6 or below.

One year after treatment began, only 12 percent of those treated with medicines alone were at that healthy level, versus 42 percent and 37 percent of the two groups given surgery.

Use of medicines for high cholesterol and other heart risks dropped among those in the surgery groups but rose in the group on medicines alone.

“Every single one of the bypass patients who got to 6 or less got there without the need for any diabetes medicines. Almost half of them were on insulin at the start. That’s pretty amazing,” said a study co-leader, Dr. Steven Nissen, the Cleveland Clinic’s cardiovascular chief.

An obesity surgery equipment company sponsored the study, and some of the researchers are paid consultants; the federal government also contributed grant support.

The second study was led by Dr. Geltrude Mingrone at the Catholic University in Rome, with Rubino from New York. It involved 60 patients given one of two types of surgery or medicines alone. The researchers set as their goal an A1c under 6.5 — the level at which someone is considered to have diabetes.

Two years later, 95 percent and 75 percent of the two surgery groups achieved and maintained the target blood-sugar levels without any diabetes drugs. None of those in the medicine-alone group did.

There were no deaths from surgery and only a few complications. Four patients in the Cleveland study needed second surgeries, and two in the Italian study needed hernia operations. Doctors note that uncontrolled diabetes has complications, too — many patients wind up on dialysis when their kidneys fail, and some need transplants.

An adult who has a body mass index (a calculation based on height and weight) of 30 or more is considered obese. That’s 203 pounds or more for a 5-foot-9 man, for example.

The government recently lowered the criteria for use of gastric bands from a BMI of 35 down to 30 in diabetics or people with heart disease, opening the way for wider use of this and other procedures for obesity.

Dr. Alvin Powers, director of the Vanderbilt University diabetes center, said the results are very encouraging for people like those in these studies — very obese, with diabetes that can’t be controlled through less drastic means.

“We still don’t know the long-term outcomes of these surgeries” and whether the benefits will last for more than a few years, he said.

Others were more positive.

The studies “are likely to have a major effect on future diabetes treatment,” two diabetes experts from Australia, Dr. Paul Zimmet and George Alberti, wrote in an editorial in the medical journal. Surgery “should not be seen as a last resort” and should be considered earlier in treating obese people with diabetes, they wrote.

Jon Diat is a success story. Diat, 50, who works at Citigroup and lives in New York, had been piling on pounds and pills for cholesterol and high blood pressure. After he needed an artery-opening procedure he was diagnosed with diabetes, but medicines for that failed to keep his disease under control and worsened his obesity.

“I was maxed out on the medications. It was very grim,” he said. Two years ago, he had weight-loss surgery from Rubino.

“They told me, ‘You’re going to see rapid results,’ but it was amazing. I literally lost 70 pounds in the first three months,” he said. “I was off insulin within less than 72 hours of surgery. I am in complete, total remission of diabetes. My blood sugars are normal.”

Now he eats right, plays tennis and hockey, walks the two miles home from work and takes 12 flights of stairs to his apartment.

“I look at this as a second chance at life,” he said. “It’s been liberating.”

Tamikka McCray, 39, who also lives in New York and works for the city’s Human Resources Administration, also had success from her surgery a year and a half ago. When she left the hospital, her diabetes had disappeared before any major weight loss had a chance to occur.

“That was the crazy part,” she said. “I didn’t understand that when they came in and they checked it. My sugars were normal.” She added: “I left the hospital with no medication. And I haven’t been on anything since.”

AP video journalist Ted Shaffrey in New York contributed to this report.

On the Net:

VANCOUVER, BRITISH COLUMBIA, Mar 27, 2012 (MARKETWIRE via COMTEX) –
Pyng Medical Corp.

/quotes/zigman/187119 CA:PYT
+12.50%

today announced its financial
and operating results for the three months ended December 31, 2011.
All amounts are in Canadian dollars unless stated otherwise.

The Company reported total sales of $1,327,190 for the three months
ended December 31, 2011, down 35% compared with $2,041,737 for the
same quarter last year, due in part to the late approval of the US
Department of Defense budget. As a result, gross margin decreased to
$818,491, from $1,398,349 reported a year ago. The gross margin as a
percentage of revenue decreased from 69% to 62%, primarily due to
lower sales. Total operating expenses went down 24% to $708,194 from
$921,298 for the first quarter of last year as a result of lower
sales and cost reduction efforts that the Company has taken.

The Company also reported a net income of $105,641 for this quarter,
equal to earnings of $0.01 per share, compared to a net income of
$413,007 or $0.03 per share one year earlier. Earnings before
interest, depreciation, amortization and taxes (“EBITDA”) from
continuing operations were $264,700, which decreased 59% from
$647,588 reported for the first quarter of fiscal 2011.

As at December 31, 2011, the Company had a cash balance of $117,462,
a decrease of $77,952 compared with the balance of $195,414 as at
September 30, 2011. The working capital increased to $202,828 from
$113,710 due to the payout made to accounts payable and loans payable
during this quarter.

The Company continues to pursue debt and/or equity financing to help
fund its working capital needs. Management hopes to secure the
necessary financing through the combination of new credit facilities
and issuance of new equity or convertible debt instruments. There can
be no assurance that these initiatives will be successful.

Full audited financial results for fiscal year ended September 30,
2011 are available on SEDAR at
www.sedar.com .

About Pyng Medical Corp.

Pyng Medical Corp. commercializes award-winning trauma and
resuscitation products for front-line critical care personnel. Pyng’s
expanded product portfolio includes a variety of innovative,
lifesaving tools. With growing markets in North America, Europe and
Asia, Pyng offers user-preferred medical devices for use by hospital
staff, emergency medical services and military forces worldwide.

Safe Harbour Statement; Forward-Looking Statements: This release may
contain forward-looking statements based on management’s
expectations, estimates and projections. All statements that address
expectations or projections about the future, including statements
about the Company’s strategy for growth, product development, market
position, expected expenditures and financial results are
forward-looking statements. Some of the forward-looking statements
may be identified by words like “expects”, “anticipates”, “plans”,
“intends”, “projects”, “indicates”, and similar expressions. These
statements are not guarantees of future performance and involve a
number of risks, uncertainties and assumptions. Many factors,
including those discussed more fully elsewhere in this release and in
documents which may be filed with the British Columbia Securities
Commission, the Alberta Securities Commission, the Ontario Securities
Commission, the TSX Venture Exchange, as well as other USA
Commissions, could cause results to differ materially from those
stated. These factors include, but are not limited to changes in the
laws, regulations, policies and economic conditions, including
inflation, interest and foreign currency exchange rates, of countries
in which the Company does business; competitive pressures; successful
integration of structural changes, including restructuring plans,
acquisitions, divestitures and alliances; cost of raw material,
research and development of new products, including regulatory
approval and market acceptance; and seasonality of sales in some
products.

Neither the TSX Venture Exchange nor its Regulatory Service Provider
(as that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.

Contacts:
Pyng Medical Corp.
George Dorin
Chief Financial Officer
604-303-7964 ext. 219

www.pyng.com

SOURCE: Pyng Medical Corp.

http://www.pyng.com

Copyright 2012 Marketwire, Inc., All rights reserved.

/quotes/zigman/187119

Add to portfolio

CA:PYT

Pyng Medical Corp.

$
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+0.01
+12.50%

Volume: 19,500
March 28, 2012 12:00a

SAN ANTONIO, March 27, 2012 /PRNewswire via COMTEX/ –
BiO2 Medical, Inc., a Texas based medical device manufacturer with manufacturing operations in Golden, Colorado, is proud to announce the first in man clinical study for the Angel(TM) Catheter. The clinical study is being conducted under IRB approval at two medical centers in Medellin, Colombia, Clinica Las Americas, and Hospital Pablo Tobon Uribe. As of today, eight critically ill patients have been enrolled in the study.

Dr. Cadavid and Dr. Gil, the principal investigators in the first in man clinical study, commented on the ease of bedside insertion of the Angel(TM) Catheter in a procedure that resembles a routine central venous catheter placement. Both principal investigators feel that the Angel (TM) Catheter fills an important clinical need for an Inferior Vena Cava filter designed for use in critically ill patients at high risk of pulmonary embolism (PE).

Dr. John A. Kaufman from the Dotter Interventional Institute and a member of BiO2 Medical’s clinical advisory board said, “This marks an important advance in the management of critically ill patients everywhere. The ability to protect from pulmonary embolism and resuscitate with one device is unique.”

This important milestone for the company will provide vital data regarding the safety of the Angel(TM) Catheter in a clinical setting, which will be instrumental in facilitating clinical adoption of the device. BiO2 Medical has been working closely with Pharmaceutical Product Development, Inc. (PPD), a contract research organization (CRO) that provides expertise in clinical development, management, and post approval services, in the design and execution of this first in man clinical study.

BiO2 Medical’s Chairman and Chief Executive Officer, Christopher E. Banas, commented on the initiation of the clinical study, “We are proud to be providing a lifesaving technology for critically ill patients at risk of PE, and this study demonstrates that this device is safe for use.” For more information regarding BiO2 Medical, and the Angel(TM) Catheter please visit
www.bio2medical.com .

SOURCE BiO2 Medical, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

21 hours ago 

KISSIMMEE, Fla. (AP) — Detroit Tigers star Miguel Cabrera was cleared Tuesday to play again, more than a week after a bad-hop grounder broke a bone beneath his right eye.

The third baseman is expected to return to the lineup within a couple of days, although manager Jim Leyland hasn’t committed to the exact date the AL batting champion will play.

“That’s not good news. That’s great news,” Leyland said before the Tigers played the Houston Astros.

The Tigers open their season April 5 at home against Boston. Leyland emphatically said that if Cabrera is healthy, he will start at third base and bat third.

Cabrera has been out since being hit in the face on March 19. The ball off the bat of Philadelphia’s Hunter Pence caused a gash that needed eight stitches and left some discoloring under Cabrera’s eye.

Cabrera was examined early Tuesday at Watson Clinic in Lakeland, Fla., and it was determined there was no structural damage that would hamper him.

“The nice part about it is I don’t have to worry about the medical part of it,” Leyland said. “I saw him this morning and had a nice conversation with him. I think he felt comfortable the whole time. I don’t think he was worried like everybody else was.”

Cabrera led the majors last year with a .344 batting average. He also hit 30 home runs and had 105 RBIs for the AL Central champions.

Cabrera was hitting .433 in 13 games this spring before he was hurt.

The 28-year-old Cabrera is making the switch back to third base this spring after playing first base for the Tigers for four years. Cabrera shifted across the diamond this spring to make room for new first baseman Prince Fielder.

Copyright © 2012 The Associated Press. All rights reserved.

8 hours ago 

TOPEKA, Kan. (AP) — A former Kansas abortion provider isn’t likely to face criminal charges for discarding hundreds of patients’ private medical records in a recycling bin outside an elementary school, but anti-abortion lawmakers called Tuesday for the state Legislature to investigate.

Johnson County District Attorney Steve Howe said he doesn’t expect to pursue a criminal case against Krishna Rajanna, who confirmed that he left records from Affordable Medical and Surgical Services in a school recycling bin blocks from his home in the Kansas City suburb of Overland Park. The Kansas City, Kan., clinic closed in 2005, shortly after the State Board of Healing Arts, which regulates physicians, revoked Rajanna’s Kansas medical license.

Howe said his office will examine whether Rajanna’s actions violated state consumer protection laws, which are enforced through civil lawsuits, and it may contact federal officials about potential violations of patient privacy laws.

Meanwhile, the Board of Healing Arts’ general counsel said it will consider going to court to have an outside custodian take possession of any remaining records from the clinic. Rajanna told The Associated Press he still has documents stored in his home.

Several lawmakers who oppose abortion said the Legislature should investigate to determine whether Kansas law, which requires providers to keep patients’ records for at least 10 years, adequately protects privacy when patient records are discarded or adequately punishes providers who dispose of documents improperly.

“It definitely needs to be investigated,” said House Majority Leader Arlen Siegfreid, an Olathe Republican.

Rajanna said when he discarded the documents Friday in the recycling bin, he expected it to be emptied quickly.

“We could burn them up, I suppose, but that just puts more carbon into the air,” he said. “Recycling would be the better way.”

The documents were discovered Saturday by a woman who was dumping materials for recycling. She contacted local police, who initially didn’t respond, then her daughter, a nurse. The daughter contacted The Kansas City Star, which reported their discovery (http://bit.ly/GVUz7Z ).

The Star reported that the woman found more than 1,000 records, and Rajanna confirmed that he left about that number in the bin. The Star said the records contained names, birth dates, telephone numbers, Social Security numbers and the patients’ health histories, including whether any abortions were performed, for patients from almost every county in the Kansas City area and beyond, from Topeka to Freeman, Mo.

Rajanna’s actions were condemned by advocates on both sides of the abortion debate. In recent years, Kansas has seen intense legal and political disputes over whether giving authorities access to information in medical records for investigations of providers would violate patients’ privacy.

But Howe said, “We don’t believe at this point, based on the information that we have, any criminal charges will be filed.”

Rajanna did not return a telephone message left at his home Tuesday afternoon, seeking a response to Howe’s statements and legislators’ comments.

The Star reported that after editors consulted with an attorney, one of its reporters gathered up the documents from the recycling bin and transported them by car to the newspaper’s offices in downtown Kansas City, Mo., where they were kept in a locked cabinet, with access limited to reporters and editors working on its story.

The Star said it collected and secured the records to protect patients’ privacy and recorded no personal information. It later turned the documents over to the Board of Healing Arts.

Hundreds of the records were dated after March 2002, The Star reported. Rajanna said he has been keeping his files for 10 years, as required by law, and was discarding ones older than that. He also suggested the materials should have remained in the recycling bin for disposal.

“This was the first time that I’d used it,” Rajanna said.

The Board of Healing Arts revoked Rajanna’s license in 2005 after fining or disciplining him four times since 2000. An inspector who made two surprise visits to his clinic in 2005 reported the facility was unclean and that it kept syringes of medications in an unlocked refrigerator. The inspector also reported finding a dead mouse.

Kelli Stevens, the board’s general counsel, said because Rajanna is no longer a licensed physician, the board’s jurisdiction over him is limited, though he still has legal obligations to keep medical records confidential. She said the board’s main concern now is the proper disposal of older records and the security of records less than 10 years old.

“It’s a very odd position to be in,” she said. “There’s a little bit of a gap in the law.”

Sen. Pete Brungardt, a Salina Republican and abortion rights supporter, was skeptical of the need for legislators to step in, but Siegfreid said they need to consider whether Kansas laws should be strengthened.

House Judiciary Committee Chairman Lance Kinzer, an Olathe Republican who opposes abortion, said, “On its face, it’s concerning.”

Information from: The Kansas City Star, http://www.kcstar.com

Copyright © 2012 The Associated Press. All rights reserved.