Archives for December 2007
[Video Profile] Interview with Terrance Gregg, President & CEO of DexCom
DexCom is developing a short term continuous glucose monitor for people with diabetes.
The Seven System’s probe-like sensor is inserted by the user under the skin and is held in place by an adhesive. Once inserted, the Sensor begins continuously monitoring glucose. The Transmitter sends the glucose signal from the Sensor and wirelessly transmits the data to the hand-held Receiver. The Receiver processes the glucose signal and, with the push of a button, displays the user’s current glucose value, as well as 1-hr, 3-hr, and 9-hr trends. The Receiver also sounds an alert when a high or low glucose excursion is detected.
Clinical research has demonstrated that users show statistically significant improvements in glycemic profiles with no guidance or therapeutic adjustments from physicians. Users were able to reduce time spent hyperglycemic and hypoglycemic, while simultaneously increasing time spent in their target glucose range.
In
One Small Step for Muscular Dystrophy Treatment Requires Giant Leap for FDA
Dr. Eric Hoffman of the Children’s National Medical Center predicts that individualized molecular therapies will be medicine’s next big innovation, but only if the FDA revises its regulatory processes.
In a recent edition of the New England Journal of Medicine, Dr. Hoffman shares the results of a clinical trial involving a new treatment for Duchenne muscular dystrophy (MD) which he believes provides a proof-of-concept for personalized molecular medicine.
The study involves application of a nucleic acid drug called PRO051. The drug shows promise in restoring the expression of dystrophin, a protein linked to healthy muscle tissue. PRO051 was shown to reactivate dystrophin protein production in small areas of muscle tissue at the injection site in MD patients.
“Dozens of specific sequences will be required for effectively treating the majority of patients with Duchenne muscular dystrophy,” says Hoffman. Implementation of the ‘exon-skipping’ approach described
[Video Profile] Interview with E. Kevin Hrusovsky, President & CEO of Caliper Life Sciences
Caliper Life Sciences combines microfluidics, liquid handling and laboratory automation to deliver research tools for drug discovery and development, and genomics and proteomics laboratories. The company uses direct, indirect distribution, and partnership channels to increase penetration of its products and technologies. Caliper’s partnership distribution channel is core to Caliper’s business strategy and complimentary to its direct sales and distribution network activities.
Using their partnership channel, Caliper has participated in the launch of many products, including lab systems with Agilent, Bio-Rad and Affymetrix. Recently, Affymetrix and Predicant Biosciences have licensed a portion of Caliper’s microfluidics patent estate for use in proteomics and GeneChip analysis.
Caliper’s in house products include the LabChip 3000 Drug Discovery system, used by 75% of the largest 15 pharmaceutical companies as a tool in their screening effort. The number one application of the system is kinase profiling. LabChip assays are
Biosphere-DuPont Collaboration May Create Higher-Margin Microspheres
BioSphere Medical, which has an FDA approved method to treat symptomatic uterine fibroids using microsphere technology, has signed an agreement with DuPont Applied BioSciences to evaluate potential peripheral vascular and embolotherapy research, development, and manufacturing projects.
The agreement establishes a “non-binding framework” for the parties to consider and evaluate potential projects that target and deliver leading edge solutions in embolotherapy.
Embolotherapy works by reducing blood flow to target areas of the body; the procedure is performed by injecting agents, usually particles, through a catheter and into the blood vessels that feed these target areas. By selectively blocking the target tissue’s blood supply, the deprived tissue will either be destroyed or become devitalized.
Biosphere’s Embosphere Microspheres and EmboGold Microspheres, have a number of beneficial properties that make them well suited for uterine embolotherapy. The uniform, spherical shape and soft, slippery surface, make the particles
Applied NeuroSolutions’ Test Predicts Disease Progression from Mild Cognitive Impairment to Alzheimer’s Disease
Mild cognitive impairment (MCI) affects many areas of cognition including language, attention, reasoning, and judgment. Many view MCI a transitional stage from the cognitive changes that accompany normal aging to the more serious complications brought on by Alzheimer’s disease.
The Mayo Clinic estimates that 12% of those over 70 have MCI. People with MCI are three to four times more likely to develop Alzheimer’s than those without such impairment.
But some people with MCI don’t go on to develop any type of dementia. Some remain stable, and others revert to normal. Research indicates that approximately 16% of individuals with MCI develop Alzheimer’s each year.
For those living with MCI, a diagnostic that identifies Alzheimer’s disease before onset would offer the best opportunity for patients to take advantage of available treatment options.
A recent study led by Dr. Harald Hampel showed that Applied NeuroSolutions‘ p-tau
AngioDynamics Technology Not Responsible for Lung Tumor Treatment Deaths
In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with Radio Frequency ablation (RFA) of lung tumors.
Last week, the FDA released a Public Health Notification, specifically warning against lung tumor ablation using RFA.
Pointing to several studies, the statement noted,
“[The] FDA has received reports of patient deaths associated with lung tumor ablation using RF ablation devices…Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.”
“FDA has cleared many RF ablation devices as tools for general ablation of soft tissue by thermal coagulation necrosis. These devices have also been cleared for certain specific indications, including partial or complete ablation of non-resectable liver lesions and palliation of pain associated with
FDA Approves ATS’ AP360 Mechanical Heart Valve
The latest addition to ATS Medical’s suite of mechanical heart valve offerings, the AP360, has been approved for use in the U.S. The new design employs a supra-annular cuff that facilitates implantation and may appeal to a broader range of surgeons.
Michael Dale, President and CEO of ATS commented, “Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in a cuff that is well suited to their individual surgical techniques. When it comes to sewing cuffs, one style does not fit all tastes.”
In an interview with OneMedPlace this summer, Dale had indicated that a key growth driver would be the commercialization of its line of heart valves within the U.S.
“Because the
[Video] Interview with Charles Fleischman, Former President of Digene
In this interview, Charles Fleischman, former President, CFO, and COO of Digene, discusses building a company and taking a product from idea to market.
Says Fleischman of raising capital, “If you continually under promise and over deliver you get a very good reputation with those same financing vehicles that you have to continually return to.”
Last Spring, Digene was acquired by Netherlands-based Qiagen for $1.6 billion.
San Francisco Finance Forum Panels on Funding Growth
The OneMedPlace 2008 Finance Forum has organized panels focused on funding the growth of healthcare and life science companies. These panels will include:
Negotiating the Venture Term Sheet
This panel will examine the core principals of the term sheet and strategies for negotiating term sheets that make sense for both investors and the company. The law firm of Dorsey & Whitney will lead panel.
State Sponsored Venture Capital
Increasingly governments and regional economic development groups are hungry to attract the high wage jobs and are offering considerable incentives including venture Capital along with rich tax incentives and venture to attract healthcare and life science companies. A discussion of these opportunities will include a profile of programs in the State of Texas.
All about PIPES
Private Investments in Public Equities can play an important role in providing capital to the emerging healthcare or life science company. Recent regulatory
[Video Profile] Ray Krauss, CEO of GlucoLight
Blood glucose levels have been called the next vital sign in the surgical environment. Numerous studies show that aggressive management of glucose levels in ICU patients results in a measurable reduction in complications, including mortality, length of hospital stay, and infection.
Current testing methods, however, are labor-intensive, and tedious. As awareness and adoption of tight glycemic control expands, hospitals will require continuous, non-invasive glucose monitoring devices that provide a more cost-effective solution.
GlucoLight is focused on the development of non-invasive medical monitoring products using Optical Coherence Tomography (OCT). The company’s SENTRIS-100 is a novel, accurate, and cost-effective way to monitor blood glucose levels non-invasively in a hospital setting. In four years, GlucoLight has taken the SENTRIS-100 from an idea to a working prototype currently in clinical trials, with a pivotal FDA trial expected to begin in 2008.
Optical Coherence Tomography is a relatively new
