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On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.
Evicel is manufactured by OMRIX biopharmaceuticals LTD (located in Kiryat Ono, Israel) and marketed by .
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As covered in a story from Venture Beat and from their own press release, Cogentus Pharmaceuticals of Menlo Park, CA just received $62.5 million in third round funding for their combination drug of clopidogrel (an anti-platelet) and omeprazole (a proton pump inhibitor). The idea behind this combination is omeprazole will help with the gastro-intestinal side effects of clopidogrel, a “blood thinner.” Both of these drugs have recently gone off patent and can be reproduced cheaply.
Convention would suggest that a doctor would not prescribe a combo-drug when two generics are cheaper for the patient. However, the market proves otherwise. On the list of top 200 drugs prescribed, we find many combo-drugs such as Advair Diskus, Vytorin, Symbyax, etc. Combo drugs are convenient for patients, and if a company could get the doctor to be aware of their drug, they’ll probably prescribe it because taking one drug vastly improves a patient’s compliance to drug therapy as compared to taking two drugs. Unfortunately, there’s a large hurdle for Cogentus, and that is the third party payers.
The successful combination drugs on the market all contain one common characteristic - at least one of the drugs in the combo is still under patent and buying them in a combination form would save money for a patient/third party payer compared to buying the two drugs separately. If the third party payer does not put Cogentus’ drug onto their formulary, it may be written, but it’s not going to be dispensed. Making a drug attractive to a patient and prescriber is not good enough, Cogentus needs to make a drug attractive to the third party payer. If I was Congentus, I’d try to obtain really good pharmaco-economic models on how the drug would be saving money.
There is yet one last hurdle for Cogentus’ combination drug and that is other generic companies. The generic manufacturer is on a crowded list of companies who function on slim margins. If Cogentus is successful with their venture, what is to prevent a company like Teva from coming along and copying it?
This is from the pile of cool products you may not know existed. The GlucoWatch is made by Cygnus, Inc of Redwood City, CA and was approved by the FDA on March 22, 2001. In March of this year, Animas Corp of West Chester, PA bought out Cygnus for $10 million. As of July 31, 2007, Animas will no longer be marketing the GlucoWatch.
What is it?
The GlucoWatch Biographer is a glucose monitoring device that a patient wears like a wrist watch. Glucose measurements are taken non-invasively through the skin every 20 minutes for up to 12 hours at a time. The GlucoWatch measurements are not intended to replace finger-stick glucose measurements, but instead should be used to detect trends and patterns in glucose levels. It is only approved for use in adults age 18 and over.
How does it work?
After a 3-hour warm-up period, the patient calibrates (sets) the GlucoWatch Biographer using a finger-stick measurement. After calibration, the Biographer will begin monitoring glucose values. A low level electric current pulls fluid through the skin into gel discs in the Biographer. Electrodes in the Biographer measure glucose in the collected fluid for up to 12 hours at a time. The GlucoWatch Biographer also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low levels and above pre-set high levels.
Why is it used?
The GlucoWatch Biographer is not intended to replace fingerstick measurements but used to see the rise and falls of glucose throughout the day that intermittent fingerstick measurements cannot tell. This additional glucose information may help people with diabetes and their healthcare practitioners better manage their disease by providing more information on glucose trends.
So why was this product so successful?
There were many reason why the GlucoWatch didn’t succeed, but in my personal opinion as a healthcare practitioner, the primary reason is because it wasn’t accurate. The reason that the GlucoWatch wasn’t accurate is because the glucose that they measure was plasma glucose that had traveled through all the tissue of the skin, whereas fingerstick measurements take the glucose out of whole blood (a droplet of blood). A practioneer and a patient needs to count on the accuracy of any test measurements, the GlucoWatch just did not provide that stability. It’s a great idea, and one that is critically needed, but the execution needed some work.
Hologic, Inc. announced that the FDA Obstetrics and Gynecology Devices Advisory Panel recommended the pre-market application for Adiana Permanent Contraception for female sterilization as approvable in a panel vote of 10 to 3.
The FDA is not required to accept the panel’s decision, but traditionally follows their recommendations. The panel recommended approval of the device contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations.
Bilateral tubal ligation — commonly referred to as “getting your tubes tied” — is the most common form of contraception used throughout the world. The surgery is typically performed in a hospital operating room under general anesthesia and requires the physician to make one or two incisions in the abdomen. This usually requires approximately four to five days of recuperation.
In contrast, Adiana is a minimally-invasive, non-incisional alternative. This procedure uses hysteroscopy, generally requires only local anesthesia, and can be performed in a physician’s office. Patients are typically able to return to work or resume their everyday activities within a day.
Adiana is a novel, two-step approach to permanent contraception. First, a catheter is positioned immediately inside the opening of the patient’s fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers an implantable, soft polymer, called a “matrix,” which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. Healthy tissue will grow into the matrix, creating a complete blockage of each tube.
Neurosky and Emotiv Systems Inc. are two companies focused on creating games using brain wave activities. The companies hope that their development will:
- Boost mental abilities for users
- Enable paralyzed patients to move in a virtual world
- Boost mental focus of ADD patients
The core of both game technology is electroencephalography (EEG)
Neurosky uses a headset with one electrode sensor. A preview of the
game may be found in the video section on the left hand side of this page or here.
Emotiv Systems Inc., on the other hand, has developed a gel-free headset with 18 sensors that have the ability to monitor basic changes in mood, focus and detects brain waves correlating with blinks, laughter and as well as smiles. It is a development that may be applied in a game setting to help psychiatric patients deal with anger management
Brain activity associated with computers isn’t a new concept. Schools such as the University of California and Purdue have labs that focus upon correlating brain waves to moving cursors on the computer screen, which may useful for disabled individuals. However, the development of games via the use of brain waves is still in its infancy stage and has yet to penetrate the dura mater of the healthcare sector.
Neurosky and Emotiv Systems developments are potential alternative treatments for children and adults with attention deficit disorder/with and without hyperactivity (ADD/ADHD) or even Alzheimer’s patients . While there needs to be controlled studies on the effects of these types of games relating to psychiatric disorders or age-associated memory impairment, it is exciting to think of the possibilities and alternatives to patient care beyond pharmaceuticals.
Well, not exactly. In one of my wildest fantasy, we live in a world where humans can generate anatomical parts that stop working or have loss in accident or injuries. Norriton, PA, Tengion brings us one step closer to this fantasy. Tengion is a biotech firm focused in tissue regeneration in diseased or damaged organs. They’ve recently raised $33 million in third round funding with investors such as Deerfield Partners, Bain Capital, Johnson & Johnson Development, HealthCap, Quaker Bio Ventures, Oak Investment Partners, L Capital Partners, Horizon Technology Finance and Oxford Finance.
Currently, they’re working on regrowing bladder tissue to treat patients with spinal bifida or spinal-cord injuries. This technique was designed by Dr. Atala of Wake Forest University’s Institute for Regenerative Medicine (IRM). You can read more about Dr. Atala’s technique here. The above picture shows Dr. Atala and what the bladder tissue that he grows look like.
As many of you still remember, we’re able to grow “simple” tissue which doesn’t have complex biological functions as in the much publicized ear on a nude mouse. So what Tengion is attempting to do is to grow complex tissue of organs which are involved in complex biological functions such as the bladder.
Biologically speaking, we know that lizards and some other animals are able to regrow limbs after they are loss. If they are able to do it, theoretically, we should be able to do it as well (I know that does sound like something out of a Spiderman comic), but I really do believe that to be true someday. Cell growth are stimulated by the proper hormones and stimulant being released. Some examples have been seen in the regrowth nervous tissues in which cells know where they are suppose to be and they migrate there. It is not too far to see that if could potentially grow another arm if it is loss.
Read more about Tengion here.
Oriel Therapeutics is a lab out of Research Triangle Park, NC. They just went through third round funding for an undisclosed amount. They’re in works on a new inhaler technology that promises to be more efficacious than the current metered-dose-inhalers (MDI). [Reference: VentureBeat]
Inhalation drug is one of the best and most invasive ways of getting drugs into the body, that is, if we’re able to successfully get it to the site of absorption there at any accurate amount of the time.
Current MDI technology has an Achilles’ foot in that it does not deliver enough drug deep down enough to reach the alveoli. The alveoli is where all the air transfer and drug absorption takes place. The majority of the drug typically get caught in the bronchioles. There has been other advances where others have used another solution before the inhaler to coat the lining of the bronchioles so drugs don’t get caught there providing a free passage for the drug, but this technology is not perfect either. I am curious at what they’re doing and hope they they will be able to come up with something more successful.
My prediction is that inhalation drugs is the way of the future. Being with Exubera, the fast acting inhaled insulin from Pfizer, we’ll start to see more drugs being delivered this way, with a promise for at least two more insulins being delivered this way within the next two years.
Sorry for the pun. Bioheart, Inc is a biotech startup out of Sunrise, FL that specializes recovering dead heart tissue from adult stem cells. Bioheart now plans to offer 4.2 million shares at a price of $6 to $8 each (they previously had plans on a offer of $14 to $16 each). At the current price, the company would plan on making a much as $38.8 million, giving the company a value of $140 million. This is a bit slim for current standards.
Bioheart’s procedure is called MyoCell, a technique which harvest myoblasts (adult muscle stem cells) from a patient, and after a 21-day incubation period would inject them into dead myocardium (heart muscle tissue) causes by an MI/heart attack. A similar procedure was done on a small group of diabetic patients who received stem cells injected into their pancreas while made new insulin-producing beta-cells and helped with their disease (NOTE: Diabetes is more than a disease of insulin production, it also concerns the body’s non-response to insulin). On the face of it, the procedure seems like a great idea, but to date they have yet prove the procedure successful.
Repairing myocardium is not as simple as putting in new tissue. The heart is specifically designed to a certain width. By adding in new tissue one needs to ask a few crucial questions: what is to be done with the old heart tissue? will the heart just get thicker? Where will the new tissue reside? I am the first one to endorse Bioheart if their procedure is shown successful. I lost a grandmother (the only grandparent that I ever knew) to said dead myocardium. After bypass surgery, she was fine, but her old weak that had the dead myocardium could not stand the extra pressure created by the increased pressure created in the heart. Believe me, this technology is very personal to me and anyone who has a love one who have had an MI.
Bioheart to date has raided $51 million in fuding from Dan Marino Investments (the answer to your question is yes), Ascent/Meredith Asset Management, Getz Medical, Guidant, Tyco Ventures, Getz Bros., St. Jude Medical, Advent-Morro-Guayacan Private Equity Fund, Astri Group, Minnesota Bio-Med Partners, New World Angels, Presidential Capital Partners and other individuals. I can assure you that there are at least some people in that group put money into Bioheart not because they hope to make money, but rather they hope that this technology would work purely on humanitarian/personal resolve.
The FDA have recently announced that it will make it mandatory to stop the use of CFC (ChloroFluoroCarbons) in epinephrine MDIs (metered dose inhalers). This product is most commonly seen as Primatene. CFCs are used as propellants in many canned devices such as inhalers and most recently hairspray and things of similar nature. The Clean Air Act have banned their use in just about everything because CFCs destroy the ozone. In that language they’ve giving a exception to medical devices that the FDA has deemed necessary to use.
Well, today, they just thought that epinephrine does need it anymore. What I think is wrong about this is that by stopping its use, we’re limiting another tool for researchers to find the best device to deliver medicine.
I personally have never seen any numbers regarding how much CFCs used in medical devices have affected the environment.
May 02, 2007. The FDA gives green light to Perlane (Medicis Aesthetics Holdings Inc.) to sell their anti-wrinkle therapy here in the states. Perlane has been used for years in Europe (and even illegally here in the US as doctors import it over for use in their patients). Perlane is comparable to collagen and Botox injection.
Botox is widely used today, becoming a household name and even have Botox parties reminiscent of the old Tupperware parties of the past. Along the way, it’s made tons of money for Allergan, the maker of Botox.
Perlane is similar to Cosmetic Tissue Augmentation Product (CTAP) by Anika Therapeutics, Inc. which is another hyaluronic acid product for wrinkle reduction which was passed by the FDA in December of 2006.
What is it? Perlane is composed of transparent, viscous gel particles of hyaluronic acid that are implanted into facial tissue to provide volume in or just under the skin to smooth wrinkles and folds, especially around the nose, mouth and under the edges of the mouth (nasolabial folds and oral commissures). Hyaluronic acid is a protective, lubricating and water-binding substance that is produced naturally by the body. Hyaluronic acid has been used in the past in a brand name product called Synvisc which injects hyaluronic acid into the joints to act as a viscous layer to treat osteoarthritis.
How does it work? Perlane works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face
When is it used? Perlane is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur as a result of loss of underlying volume. The gel particles temporarily add volume in and under the skin to restore surface contour and give the skin a smoother and more youthful appearance.
What will it accomplish? Perlane will help smooth moderate to severe facial wrinkles and folds. In two clinical studies, 89% of the Perlane patients achieved optimal correction of midface volume loss that caused their wrinkles and fold (nasolabial folds and oral commissures). The surface contour improvement lasted for at least 6 months.
Patients who have used both Perlane and Collagen see that Perlane lasts about twice as long as the latter. With the success of Botox, multiple other pharmaceutical companies have outpatient cosmetic devices to help make the decision a bit more difficult for doctors. As we talk three more products in are final review with the FDA and with baby boomers getting older plus the advent of twenty-something youths using products like Botox, it looks like there will be plenty of consumers to go around.
June 2007, the FDA approved a device by INRange called the Remote Medication Management System.
What is it? The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to remotely deliver, manage, assess, alter dosing schedules, and/or monitor a patient’s therapeutic medication regimens and adherence to those regimens in an outpatient setting.
How does it work? The INRange Remote Medication Management System provides a means:
- to store the patient’s prescribed medications in a delivery unit
- for a healthcare professional to remotely schedule the patient’s prescribed medications
- to notify the patient when the prescribed medications are due to be taken
- to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient’s command, and
- to record a history of the event for the healthcare professional
When is it used? The INRange Remote Medication Management System is used by healthcare professionals to aid in the control of the delivery of prescription drugs to patients in an outpatient setting.
What will it accomplish? The INRange Remote Medication Management System could help with outpatient adherence to complex medication regimens.
When should it not be used? There are no contraindications for this device.
Why should you care? Life Science Greenhouse of PA invested a mere $250k into INRange in 2006 and the device promises to be a huge hit for the care of the elderly. As more baby boomers start to retire, their care will be more complicated as they start to pill on the large amounts of drugs that they’re taking from 3-4 to an average of 12-18 different medications. A machine such as this allows for accurate dosing of drugs and promises to save countless lives in medication error as well as make lots of money for the manufacturer.
The downfall? It’s not as versitle as it needs to be. When a person can bring home a bottle and drop it into the machine and it’ll take care of the rest. This machine needs blister pack medications.
This device is approved by the FDA and is under patent.
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