Archives for August 2008
FDA Clears Stereotaxis Guidewire for Peripheral Chronic Total Occlusions
Conventional catheters are designed to be operated mechanically from their proximal or back end. They are necessarily stiff to allow for steering through a series of cables. In contrast, Stereotaxis’ proprietary catheters are controlled directly at their working end by a magnetic field and are extremely soft and flexible.
The company’s Magnetic Navigation System allows physicians to more effectively navigate catheters, guidewires and other magnetic interventional devices through the blood vessels and chambers of the heart to treatment sites and then to effect treatment.
This atraumatic design may reduce the risk of perforation or damage to heart tissue or vessel walls. Stereotaxis’ systems are currently used in the cardiac catheterization lab.
The System provides the physician with remote instrument control using a “point and click” or joystick-operated technology, which can be operated from beside the patient table, as in traditional interventional procedures, or
NexMed Gets Nailed, Stock Price Derails
On Tuesday, NexMed announced that it would shelve its previously filed NDA for an onychomycosis treatment (NM100060) following disappointing Phase III clinical results.
Onychomycosis, or toenail fungus, affects six to eight percent of the adult U.S. population. Because the infection is embedded within the nail and is difficult to reach, treatment remains a challenge. Most therapies require systemic antifungal medications delivered orally.
NexACT, NexMed’s transdermal drug delivery technology, offered an attractive solution. The technology was purported to overcome the nail’s natural barrier properties and enable rapid penetration of high concentrations of terbinafine (an antifungal) directly.
In September 2005, NexMed entered into an exclusive, worldwide agreement with Novartis, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.
NexMed had anticipated up to $51 million in upfront and milestone payments on the achievement of certain development and regulatory milestones. The bad news
[Video] Interview with Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado Hospital
San Diego Sexual Medicine at Alvarado Hospital, led by physician Irwin Goldstein, attempts to improve sexual health through the prevention, diagnosis, treatment, and rehabilitation of conditions or diseases that involve sexual function.
Current areas of research and exploration include:
Bicycle Riding: Cardiovascular exercise such as jogging, racket ball, running, swimming and tennis has been associated with decreased prevalence of erectile dysfunction. While bicycle riding is a form of cardiovascular exercise, bicycle riding is associated with an increased prevalence of erectile dysfunction.
Diabetes: Diabetes mellitus and metabolic syndrome are common health problems in our society. Men who have these conditions often have associated vascular, neurologic, hormonal and psychologic issues. Sexual health problems such as reduced interest, erectile function, ejaculation and orgasm intensity are reported far more frequently in men with diabetes and metabolic syndrome than in men without these conditions.
Birth Control: Over 100 million women worldwide have
[Video] POM Wonderful: Seriously Profitable Science-Backed Marketing
POM Wonderful was founded by Stewart and Lynda Rae Resnick, who purchased a 100-acre pomegranate orchard in 1987. The company launched its namesake juice in 2002.
From 2003 to 2006, annual sales climbed from $12 million to $91 million. The company is now the largest grower and distributor of pomegranates and pomegranate juice in the U.S. This must be some seriously profitable juice.
Since inception, POM has banked on its health benefits. The company has invested more than $23 million in scientific research to support marketing claims. Packaged in precious containers, the juice sells for +/- $4.50 per16-ounce bottle.
We ran into the marketing folks at POM Wonderful at the AUA conference. The privately owned company has one of the most aggressive physician marketing programs in the juice industry.
Pomegranates are high in polyphenols. Polyphenols, say some researchers, may reduce the risk of cardiovascular disease
Kensey Nash Q4: A Well Oiled Machine
Revenues at Kensey Nash grew to a record $22 million in the company’s latest quarter, a 29% increase over the same period last year. Net sales grew to $15.0 million, a 42% increase from the $10.5 million reported in Q4 2007.
- Orthopedic sales increased 39% to $8.4 million, primarily due to a strong showing in Kensey’s sports medicine and spine product portfolios.
- Cardiovascular sales increased 29% to $4.2 million, largely the result of vascular closure product component sales to St. Jude Medical.
Royalty income, though robust, grew at a slower pace. Royalties increased 8% to $7 million and included $5.7 million in Angio-Seal royalties, a 5% year-over-year increase.
Higher than expected end-user sales led to a 21% increase in royalties from Orthovita. That company launched a new Vistoss Bioactive Foam product; Vistoss foam is used in bone graft procedures to aid in the healing response.
Celleration Raises $30 Million to Accelerate Sales & Marketing
Ultrasound wound healing device developer Celleration has successfully completed a Series D financing, raising $30 million. Heron Capital, Venture Investors and Clarian Health led the round.
Celleration, founded in 1999, will use the proceeds to expand and accelerate its sales and marketing efforts. The company’s MIST technology is FDA cleared for sale in the U.S.; some 15,000 patients have been treated to date.
Commenting on Celleration, George Arida, managing director of Venture Investors said, “[It’s] not often that a company introduces a new treatment modality that can fundamentally change expectations in terms of clinical outcomes, especially in wound care.”
The company’s therapy creates ultrasound waves that produce and propel a mist of sterile saline to a wound. The non-contact therapy replaces the coupling gel that is required for in other forms of ultrasound such as fetal monitoring, sports medicine, and physical therapy.
The benefits of the
[Video Profile] Interview with Joseph Galli, President & CEO of Haemacure
Haemacure is developing human biological adhesives, hemostats and therapeutic proteins. The company’s research and development efforts are driven by a proprietary plasma protein extraction process.
Haemacure’s product development activities focus on surgical hemostats, wound management, drug delivery in select therapeutic areas, regenerative medicine, adhesion prevention and combination with biomaterials.
The company’s lead product candidate, Hemaseel HMN, is a human-derived fibrin sealant planned to enter pivotal Phase II/III clinical trials during Q1 2009. Haemacure’s second product candidate is an active hemostat now in preclinical stage, consisting of human thrombin, a component of its fibrin sealant.
Haemacure sells two fibrin sealant delivery devices that are cleared by the FDA. Second quarter revenues of $28,368 were derived from the sale of these legacy fibrin sealant application devices. In the most recent quarter, operating expenses were $2.5 million, compared to $1.3 million for the same quarter last year.
Thermage Considers Third Party Acquisition at Huge Premium
Thermage has received an unsolicited takeover bid from an as-yet-unnamed third party calling for the acquisition of all outstanding shares at $5.50 a piece. That bid, to be paid in cash or a combination of cash and stock (it appears to be a public company) represents an 82% premium over yesterday’s closing price.
Thermage, a company that has readily maintained its position in an otherwise weak aesthetics market, previously entered into a merger agreement with Reliant. That deal prohibits Thermage from initiating discussions with third parties concerning an alternative transaction unless the company’s Board of Directors determines that the proposal constitutes or is reasonably likely to lead to a superior offer and that the failure to take such action would be a breach of its fiduciary duties.
Needless to say, the company’s board will respond in due course. It should make for an
Medtronic Alleges Patent Infringement by NuVasive
Device giant Medtronic Sofamor Danek has filed a complaint against NuVasive, alleging patent infringement by certain NuVasive products.
Nuvasive is in the process of reviewing the complaint and assessing its defenses. Based on an initial review, Alex Lukianov, the company’s Chairman and CEO, does not expect operations to be “significantly disrupted” as the company responds to the lawsuit.
The two companies first sparred when NuVasive hired former Medtronic employees. That bad blood may have been behind Lukianov’s catty response. In a recent press release he said NuVasive represents “a growing threat to Medtronic’s spine business”.
Lukianov continued, “The timing of this lawsuit is strange given the fact the allegedly infringing products in some instances have been on the market for several years…Given the existing patents referenced by Medtronic in the complaint, we are also analyzing our potential counterclaims based on our own significant patent
Predicting the End of PreMD: FDA Rejects PREVU 510(k)
The FDA has upheld its decision regarding PreMD’s not substantially equivalent letter received in connection with the company’s 510(k) submission for an expanded regulatory claim on its skin cholesterol test.
PreMD submitted the 510(k) this June seeking to obtain broader clearance for the assessment of cardiovascular disease risk in individuals without known or suspected disease.
The company’s PREVU Skin Cholesterol Test is a non-invasive measure of skin tissue cholesterol. Skin cholesterol is believed to be a risk factor for heart disease and can be used an as adjunct to CAD risk assessment.
The expanded claim would have dramatically increased the market potential of PREVU. Skin contains over 11% of the body’s cholesterol and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so do the skin tissues. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation
