Uterine fibroids affect more than 25 million women in the US and nearly 6 million of these women seek treatment each year for this condition. Of these, more than 200,000 undergo invasive hysterectomies for fibroids and many others have fibroids removed surgically. BioSphere Medical (BSMD) is the first company to have a product under clinical testing for FDA approval to address this medical condition and offer a treatment method that will avoid the major surgical procedures than many women currently undergo.
BSMD’s is focusing on embolotherapy, the treatment of tumors and vascular malformations by stopping their blood supply. They are taking the lead with a patented and proprietary bioengineered microspheres…Embosphere. The product is an acrylic microsphere and can be easily delivered to tumors via minimally invasive catheterization techniques.
Several articles have been published in major medical journals as to the postive results that BSMD has obtained in their clinical trials. Dr. James Spies, Associate Professor of Radiology at Georgetown University is a lead investigator in the clinical trials. At the upcoming (Early April) Society for Cardiovascular and Interventional Radiology Conference (SCVIR), several new abstracts will be presented, including the Phase II results.
It is expected that BSMD will submit a 510(k) to the FDA for the approval of this new treatment method in early Q2(02) and approval should be expected by year end. Launch of this new treatment method should begin in Q1(03).
As with most new medical products, the transition to new treatment methods can be a slow process for doctors. And with the new Embosphere method it also faces the hurdle that confronts the issue of this method being conduct by the non-surgical doctor and rather done by interventional radiologist. Bottom-line…surgeons and the complicated surgery procedure will be bypassed. This will require a huge public awareness campaign and the training of radiologist to accomplish this transition. Also, it will require the radiologist to cultivate their relationships with gynecologists to enhance the referral network.
It appears from what I’ve read the SCVIR organization has developed a campaign to accomplish this goal. It will be of great interest as to what comes out of the upcoming SCVIR conference in April. From one analyst report that I’ve read, the SCVIR organization is projecting that 75% of their 4,000 members will adopt this new UFE procedure, once it receives final FDA approval.
There are several informative websites with information on this condition. The following are just a few and I would suggest doing a web search for others:
drkoop.com
fibroidcorner.com
fibroiduae.com
fibroids.com
BSMD is trading for under $7.00. It currently has a small revenue stream, but IMO when and if the Embosphere Microspheres are approved by the FDA…there is a market for this product. I own a small position in this stock and would welcome to discuss it with others. |
