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Aug 22- Aug 28

Aug 22nd: HealthpointCapital Announces Purchase of BioHorizons Implant Systems, Inc.

HealthpointCapital, LLC ("HealthpointCapital") announced today the purchase of BioHorizons Implant Systems, Inc. ("BioHorizons" or "Company"). BioHorizons designs, produces and distributes oral reconstructive devices including dental implants and tissue regeneration products. BioHorizons, located in Birmingham, Alabama, is one of the fastest-growing companies in the dental industry. Terms of the transaction were not disclosed.

"The dental implant market represents one of the fastest growing sectors in the medical technology industry," stated Mortimer Berkowitz III, President and Managing Director of HealthpointCapital. "Dental implants offer patients superior clinical outcomes and improved esthetics compared to traditional treatments such as bridges and dentures. BioHorizons has a legacy of providing superior product quality and unmatched clinical service."

Steve Boggan, President and CEO of BioHorizons, commented that, "We are extremely pleased with the outcome for our shareholders, employees and customers. Our management team is excited about the opportunity to partner with HealthpointCapital and expand our growth prospects in this attractive market."

Mr. Berkowitz becomes the Chairman of the Board and Mr. Boggan will continue as President, Chief Executive Officer and Director of the Company. BioHorizons plans to expand its headquarters in Birmingham and the management team will remain important shareholders.

First Albany Capital acted as exclusive financial advisor to BioHorizons in this transaction.

Aug 22nd: Possis Receives FDA Clearance for GuardDOG(R) Occlusion System

Possis Medical, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its GuardDOG® Occlusion System for use during the treatment of peripheral vascular disease. The GuardDOG System enables physicians to quickly and effectively manage local blood flow while employing interventional techniques and devices to treat vascular disease.

The GuardDOG Occlusion System is the first guidewire-based occlusion device designed and marketed with the specific challenges of the peripheral vasculature in mind. It features a 0.035" diameter guidewire, preferred for peripheral interventions, and a soft, compliant, CO2-filled balloon providing quick inflation and deflation. Designed to facilitate delivery of over-the-wire interventional tools, the GuardDOG System can be delivered through 0.038" diagnostic catheters to the treatment site. The GuardDOG System can be inflated, deflated and positioned up to three times during a single procedure, improving efficiencies in both routine and complicated procedures. These GuardDOG System features enable physicians to manage blood flow and achieve desired occlusion in peripheral vessels 3-6mm in size.

Possis is currently completing necessary production requirements in preparation for market evaluations at select medical sites to support full U.S. market release of the GuardDOG System by the end of the calendar year. Anticipated revenue from the GuardDOG System is reflected in the Company's current guidance for fiscal 2007.

In addition to the 0.0035" GuardDOG device, Possis is also developing a 0.014" version of the device. The Company expects 510(k) clearance for the 0.014" version later in fiscal 2007.

Aug 23rd: ICU Medical, Inc. Launches First Hemodialysis Catheter Protection Device

ICU Medical, Inc. the leader in needle-free intravenous connection devices for the healthcare industry has released the Tego Connector, the first catheter protection device designed specifically for use in hemodialysis treatments. The Tego protects the catheter from contamination during hemodialysis sessions, preventing bloodstream infections for patients and helping prevent revenue losses for dialysis clinics.

This needle-free product is uniquely designed to protect and defend the patient from bloodstream infection like no other product on the market today. The Tego enables dialysis clinics to provide a safer way to provide hemodialysis therapy, giving patients an added level of comfort when they need it most ... as they are faced with a very demanding and draining medical treatment.

In addition to protecting a patient from a bloodstream infection, Tego also helps clinics and hospitals maintain revenues. Last year, more than $40 million was spent on reimbursement for the treatment of bloodstream infections in dialysis patients. However, when dialysis patients get a bloodstream infection, they have to go to the hospital, requiring them to miss their regularly scheduled dialysis treatment. This results in lost revenues at dialysis treatment centers.

The fact is, about 10 percent of patients with a long-term central venous catheter for chronic hemodialysis will develop a bloodstream infection when using a traditional open hemodialysis delivery system. ICU Medical's Tego Connector creates a mechanically and microbiologically closed system when attached to the hub of the catheter. This closed system eliminates any manipulation of the catheter hub while attaching or removing blood lines, which helps prevent contamination and, consequently, bloodstream infections for the patient.

ICU Medical, Inc. is a leader in the development, manufacture and sale of proprietary, disposable medical connection systems for use in intravenous ("I.V.") therapy applications. Its devices are designed to protect patients from Catheter Related Bloodstream Infections and healthcare workers from exposure to infectious diseases through accidental needlesticks. ICU Medical is also a leader in the production of custom I.V. systems and is also a significant manufacturer of critical care medical devices, including catheters, angiography kits and cardiac monitoring systems.

Aug 24th: FDA Grants OTC Status to Barr's Plan B(R) Emergency Contraceptive

Barr Pharmaceuticals, Inc. today said that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr's wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B® (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription. In approving the sNDA, FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger. The Company's Plan B OTC product and the prescription product will be marketed as a single package, which will allow for a prescription label to be adhered to the package when dispensed to women age 17 and younger. Because Plan B will still remain a prescription product for women 17 and younger, it will be sold in retail pharmacy outlets from behind the counter. Duramed plans to introduce the dual status Rx/OTC version of the product before the end of the calendar year.

As part of the Plan B OTC approval, the Company has reached an agreement with FDA on its CARE(SM) (Convenient Access, Responsible Education) Program that supports efforts to ensure that Plan B is used responsibly and appropriately. The CARE program is designed to limit the availability of Plan B only to pharmacies and clinics with professional healthcare supervision, to educate healthcare professionals and consumers within the target age groups regarding the availability and responsible use of Plan B, and to monitor the effectiveness of the program. In addition, the Company intends to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA's prescription age requirement for the dispensing of the product.

Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.

There are nearly three million unintended pregnancies each year in the United States. Unintended pregnancy is a major public health issue, affecting women in all reproductive age groups and socio-economic backgrounds. Plan B has been well-studied and shown to reduce the pregnancy rate, after a single incident of unprotected intercourse, from 8% to 1%, an 89% reduction. Plan B should not be used as routine contraception and does not protect against HIV/AIDS and sexually transmitted diseases (STDs).

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

Aug 24th: RSB Spine Announces 510(k) Approval to Market the InterPlate(TM) Vertebral Body Replacement Implant System

RSB Spine, LLC, a privately held medical device company focused on developing innovative spinal implants, announced today that the U.S. Food and Drug Administration has conditionally approved its 510(k) application to permit marketing of the InterPlate(TM) Vertebral Body Replacement System. Submissions for cervical and lumbar interbody indications will follow.

The InterPlate(TM) is a unique spinal implant designed to facilitate rapid spinal fusion and is used in conjunction with graft material to fuse two or more spinal vertebrae together. Spinal fusion is one of the most common spinal procedures performed by neurosurgeons and orthopedic spine surgeons.

The InterPlate(TM) is a next- generation device incorporating the best features of plate and interbody designs without the drawbacks.

John A. Redmond, chief executive officer of RSB Spine, said: "Based on the overwhelmingly positive response from surgeons who have seen the InterPlate(TM), we believe it could rapidly become a major revenue generator and change how spinal fusions are viewed. The approval of the InterPlate(TM) is another step in a series of advances supporting our strategy of developing unique implants that are attractive acquisition candidates for spinal implant companies with good distribution muscle."

In 2004 and 2005, respectively, RSB Spine sold its surgical instrument line to Jarit, an Integra Lifesciences Holding Corp. company (IART), and its cervical plate system to Nuvasive (NUVA).

Aug 25th: Stryker(R) Receives FDA Clearance for LFIT(TM) Anatomic Femoral Heads with X3(R) Liners.

Stryker Corporation (NYSE: SYK ) announced today that its Orthopaedics division has received FDA 510(k) clearance for its advanced bearing system, LFIT Anatomic Femoral Heads with X3 Polyethylene liners. A significant advancement in hip bearing technology, the new implant system combines Stryker's Low Friction Ion Treatment (LFIT) technology with Stryker's X3 advanced bearing technology and is anatomically sized for more natural hip performance. The result is total hip replacement designed to help minimize dislocation and its associated healthcare costs, while providing an attractive alternative to metal on metal bearings.

LFIT Anatomic Femoral Heads with X3 liners provides a combination of two advanced technologies pioneered by Stryker. "Up until now, metal on metal options in larger sizes only met the needs of a subset of the total hip population. We are excited that Anatomic Heads with X3 liners will help post- operative orthopaedic patients achieve their lifestyle recovery objectives," said Mike Mogul, President, Stryker Orthopaedics.

Hip dislocation is a major complication in total hip replacement for patients, surgeons, hospitals and payers alike and is estimated to cost the U.S. Healthcare System $74 million per year. Three to four percent of Medicare patients receiving total hip replacements experience hip dislocation.(1)

Stryker plans to initiate the global launch of LFIT Anatomic Heads with X3 liners starting in September.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly-based range of products in orthopaedics and a significant presence in other medical specialties.

Aug 28th: FDA Seizes Alaris Pumps

At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August 25. The seized infusion pumps have a design defect called "key bounce" that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris' manufacturing facility are not distributed unless the problem is corrected.

The press release goes on to describe an August 15 recall letter in which Alaris told customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. In the letter, Alaris also provided recommendations to pump users on steps they can take to minimize key entry errors - which are also included in the FDA press release (linked above).

The U.S. Marshalls seized about 1,300 pumps in San Diego valued at more than $1.8 million. From a Reuters wire report:

Cardinal Health spokesman Jim Mazzola said the pumps account for less than 1 percent of revenue in the company's Clinical Technology & Services business, which had quarterly revenue of $649 million in fiscal fourth quarter reported on Aug. 3, 2006.

The company said it currently is testing a modification of the device that reduces sensitivity of the keypad. This modification would need to be validated on the product and approved by the FDA.

FDA said its inspections revealed that Alaris failed to follow the agency's medical device manufacturing regulations.

No products were seized from health-care facilities or individual users, and there are no plans to do so, the FDA said.

The agency said Alaris was issued warning letters in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but failed to take appropriate actions.

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