Archives for February 2008
SignaLife Seeks Solace in Signalcare
Leveraging the experience gained and relationships developed through the deployment of its Fidelity 100 Heart Monitor, SignaLife, a Greenville, SC firm specializing in biomedical signal monitoring, has established Singalcare, a division focused on developing, acquiring and testing therapies capable of treating cardiovascular disease.
The decision comes not long after the American Stock Exchange issued a deficiency […]
DelSite to Test Needle-Free Bird Flu Vaccine
DelSite Biotechnologies, a wholly owned subsidiary of Carrington Laboratories, received a shipment of clinical-grade bird flu antigen and will commence production of a nasal powder bird flu vaccine. The vaccine is scheduled to enter a Phase I human clinical trial later this year.
Avian Flu is one of many maladies that achieved celebrity status over the […]
Find and Treat Coronary Artery Disease with Bayer’s Medrad-Possis Posse
Bayer Healthcare affiliate Medrad and Minneapolis, MN-based Possis Medical have entered into a definitive merger agreement whereby Medrad will acquire Possis for $19.50 a share, or $361 million.
The merger will capitalize on each company’s strengths to create a synergistic cardiovascular portfolio and sales force.
The offer represents a premium of approximately 39% over Possis’ recent share […]
Allied HealthCare Reports Bleak Outlook
It’s rare to see a company come clean with the brutal accord found in Allied HealthCare Products’ recent press releases.
The company disclosed Friday that its second quarter net income fell almost 98%. The sharp decline resulted from gross margins that fell by about $960,000 compared to last year. Low production levels, caused by lower sales, […]
Biolase Turnaround Continues; New Indications for Dental Laser
Jake St. Philip, Chief Executive Officer of Biolase, continues to instill investor confidence as he draws the company out of an abysmal year.
Biolase, which traded over $10/share as late as April, hit a 52-week low of $2.20 in December. Shares opened at $3.47 today. A downturn in domestic and international sales caused the company to […]
CryoLife Gets FDA Approval for Heart Valve
CryoLife announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the Company’s proprietary SynerGraft technology. CryoLife’s proprietary SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen […]
[Video Profile] Interview with Mitchell Seyedin, President & CEO of ISTO Technologies
Within the sports medicine market, repair of cartilage injuries represents one of the greatest unmet medical needs. In the U.S., approximately 500,000 cartilage lesions are detected in knee joints each year. Because adult cartilage cells cannot fully regenerate and repair injuries, lesions left untreated cause damage that can progress to post-traumatic osteoarthritis. Arthritis and related […]
[Video Profile] Interview with Raymond W. Cohen, CEO of Symphony Medical
Postoperative Atrial Fibrillation is an abnormal, irregular heart rhythm where electrical signals are generated apparently randomly throughout the upper chambers (atria) of the heart. The condition is the most common and significant complication of the more than one million cardiothoracic surgery procedures performed each year. Postoperative Atrial Fibrillation occurs in 20-40% of coronary bypass and […]
Aesculap to Distribute Misonix BoneScalpel
An example of the precision afforded by Misonix ultrasound cutting technologies: an eggshell is cut and the membrane is left intact.
In an agreement finalized Tuesday, Aesculap announced it will distribute the FDA-cleared Misonix BoneScalpel, a new ultrasonic bone cutting device for use in orthopedic and neurological applications.
The agreement (which sets minimum purchase requirements) gives […]
Revenue Guidance Revised as ATS Medical Seeks to Placate the FDA
Last week, word came from the FDA that ATS Medical would need to provide additional information and clarification to support its PMA for the ATS 3f Aortic Bioprosthesis (3FAB).
The FDA’s request for additional information was related primarily to the in-vitro testing submitted in the original IDE application. According to Michael Dale, President and CEO of […]
