Clinicians from NewYork-Presbyterian Hospital/Weill Cornell Medical Center are studying the two-ring device to see its efficacy and applicability for the African population and beyond.

From the NewYork-Presbyterian Hospital/Weill Cornell Medical Center press release:

With the recent endorsement by the World Health Organization (WHO) and scientists worldwide of adult male circumcision as an important strategy for HIV prevention, there is increased urgency to develop safe and cost-effective circumcision services. This is especially the case in Africa where HIV/AIDS continues to spread at an epidemic rate.

Studying this method are Dr. Marc Goldstein and physician-scientists at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who are evaluating an innovative circumcision device developed in China and will initiate a study of the device in Africa in the coming months.

The device, named the ShangRing after its inventor, Mr. Jian-Zhong Shang, consists of two concentric plastic rings that sandwich the foreskin, allowing it to be cut away without suturing and with minimal bleeding. Performed in a clinic under local anesthesia, the procedure takes less than five minutes, compared with approximately 20 to 30 minutes for a traditional "free hands" circumcision that requires suturing. The patient returns in one week for device removal.

"Circumcision with this technique promises to be faster, safer and more acceptable to patients than conventional surgical circumcision methods," says Dr. Goldstein, the study's principal investigator. He is urologist and specialist in reproductive medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, the Matthew P. Hardy Distinguished Professor of Reproductive Medicine and Urology at Weill Cornell Medical College, and senior scientist at The Population Council, Center for Biomedical Research, located on the campus of The Rockefeller University.

The ShangRing has been used to circumcise several thousand Chinese men since 2005. Preliminary reports of 1,200 patients indicate good results with minimal complications. The ShangRing, with 15 patents pending in 85 countries, is currently available only in China. FDA evaluation is under way.

We tried to obtain images of this device, but unfortunately we failed. (Anyone out there can get them for us?)To further understand how the device works, attached is the United States Patent Application recently filed by Mr. Shang with USPTO.

Press release: New Male Circumcision Device for HIV Prevention Studied by NewYork-Presbyterian/Weill Cornell...

United States Patent Application # 20080154283:
Apparatus for circumcising a penis

UPDATE: Hurrah! Weill Cornell Medical College has kindly provided us with the picture of ShangRing device.

From the press release, titled "New IVF "lab in a box" increases clinical pregnancy rates by 50%":

The state-of-the-art gas controlled device mimics ‘inutero’ conditions for all IVF manipulations in a single workstation. According to Ruskinn, recent clinical trials in Denmark have demonstrated an increase in clinical pregnancy rates by up to 50% in an already successful IVF laboratory using the Ac-tive workstation.

According to the Human Fertilisation and Embryology Authority, the average IVF success rate (take home baby rate) for women under 35 years of age is 29.6%1. Using the Ac-tive IVF workstation, IVF clinics could potentially increase their “take home baby rate” by 50% - from a successful 29.6% to a possible 44.4%. Ac-tive results in the production of less stressed embryos, which suggests improved implantation in the uterus and ultimately increased pregnancy rates.

Replicating the entire in-utero environment in a single, controlled-atmosphere workstation, Ac-tive delivers a stable, optimal atmosphere which simulates the environment of the human body and creates optimal conditions for embryo
culture. This means all IVF procedures – from oocyte retrieval through to embryo transfer, and including embryo culture and selection - take place in a single, stable biological atmosphere.

The Ezee Sleeve™ Bare-hand System provides ‘hands in’ access to the workstation, enabling all processes to be carried out without disturbing the carefully controlled environment.

Press release (.pdf)...

Product page: Ac-tive® IVF System...

From the press release:

According to Claude Ranoux, M.D., President and Chief Scientist of BioXcell, "INVOcell allows conception and embryo development to take place inside the woman's body, making having a baby simpler and less expensive, while promoting more involvement by the woman. Our device, the INVOcell, and the INVO procedure, are less expensive and simpler to perform than conventional in vitro fertilization."

Dr. Ranoux added, "The INVO procedure uses a lower stimulation approach to produce eggs for fertilization. Eggs are combined with sperm in the INVOcell device and placed in the woman's vaginal cavity where it remains for 3 days. This step eliminates the need for a complex IVF laboratory and allows the woman's body to provide the nurturing environment in which conception and early embryo development take place."

Press release: BioXcell's New INVOcell Receives CE Mark "Declaration of Conformity;" Allows Conception and Embryo Development to Take Place Inside the Woman's Body

Product page: INVOcell

Abstract: INVO: a simple, low cost effective assisted reproductive technology Human Reproduction, doi:10.1093/humrep/den163

Flashbacks: IVF Minus The Test Tube Goes On Trial

Anecova ...

Times Online: IVF trial gives embryos a natural start in life...

Flashback to refresh our memories: Anecova IVF Technology: Where IVF Means In Vivo

The device is placed inside the vas deferens -- the duct which carries sperm from each testicle to the penis. When closed, it blocks the flow of sperm cells, allowing them to pass again when it is opened via a remote control. The valve could be a switchable alternative to vasectomy, the researchers say.

Although women can choose from several long-term contraceptive methods, for men vasectomy is really the only option. With this procedure, the vasa deferentia are cut or blocked, a process that requires surgery and can require a week of recovery. The procedure cannot be reliably reversed, leaving some men to later regret their decision.

Now, a team from the University of Adelaide, Australia, may have come up with a more easily reversed alternative. They have designed a small radio-controlled valve that would "push-fit" snugly inside the vas deferens and block the passage of sperm.

The silicone-polymer valve can be flipped between open and closed positions with a pulse of radio waves. A set of conducting "fingers" on the valve act as antennae and convert the signal's energy into sound waves that travel through the polymer and create stresses inside the device.

"Since it is flexible, the polymer either contracts or expands as a result, and this movement allows the valve to be opened or closed as needed," explains team leader Said Al-Sarawi.

"It will be like turning a TV on and off with a remote control," added team founder Derek Abbott, "except that the remote will probably be locked away in your local doctor's office to safeguard against accidental pregnancy or potential misuse of the device."

To secure the device against accidental activation, the device works in a similar way to a car's remote key-fob. Each valve responds only to a radio-frequency signal with a unique code.

Another advantage of the microvalve is that would not require open surgery, unlike a vasectomy. The 800 micron-long device could simply be inserted using a hypodermic needle. "The procedure could be performed in a special clinic rather than in a hospital," says Abbott.

The researchers have finished the design of all parts of the valve, and are convinced it will work effectively. The next step is to test it in the lab with a tube of pressurized water. After that, trials could begin in live sheep and pigs, they say.

Just don't forget to close your vas deferens before you start partying this weekend!

New Scientist...

The image is from the Wellcome collection, presented under the Creative Commons License: Vas deferens muscles.

Here are details about the device taken from the FDA Executive Summary:

The Adiana Transcervical Sterilization System consists of three principal components:

silicone matrix (one per tube);

hysteroscopic delivery catheter; and

radio-frequency (RF) generator to deliver thermal dose to tube prior to implantation.

The Adiana Transcervical Sterilization System is used to place a silicone implant, called a matrix, into each fallopian tube of the female patient to effect tubal occlusion and permanent sterilization. The delivery catheter is introduced into the patient through a hysteroscope, transvaginally and transcervically. The physician will require a separate delivery catheter to place individual matrices in each of the two fallopian tubes (two delivery catheters are needed per patient since each delivery catheter contains a single matrix). A black mark on the catheter, proximal to the electrode array and matrix, is visualized to confirm correct catheter placement prior to silicone matrix delivery. Device position is confirmed by the RF generator via the position detection array.

Once placement inside the intramural section of the fallopian tube is confirmed, the distal tip of the catheter delivers RF energy to the electrode array. Thermocouples in the catheter tip are used to maintain a constant temperature of 64°C for 60 seconds (maximum of 120 seconds of treatment per tube during a single procedure in the event that a procedure is terminated due to loss of adequate tissue contact). This creates a lesion within the fallopian tube (including destruction of the endosalpinx).

After the thermal dose is delivered, the release mechanism in the catheter is then actuated to deploy the matrix in the region of the tube where the lesion was formed. The endothelial damage provided by the RF energy encourages a tissue ingrowth response (i.e., wound-healing response). The implanted matrices provide attachment sites for tissue ingrowth, which secures the matrices in place by filling the voids in the implant. The physician conducts a hysterosalpingogram (HSG) three months after matrix placement to confirm contraceptive tubal blockage.

Press release: FDA Advisory Panel Finds Hologic's Adian® Permanent Contraception Approvable ...

FDA Exec Summary (.pdf)...

More from the WSJ Health Blog...

Here's little bit more about the technology, that was co-developed with the Laboratoire d'Etude sur la Neurodégénérescence at the Ecole Polytechnique Fédérale de Lausanne (EPFL):

In the ANECOVA approach, the zygotes are placed in the maternal uterine cavity over all early development stages to get the benefits of a customized and adapted environment. The injected ovocytes are directly placed in the ANECOVA device which is then placed within the uterine cavity for the desired period. Formed embryos are then recovered and after the usual selection process, the required number is transferred as in the traditional embryo transfer procedure.

The first ANECOVA device thus restores the fertilization and early embryonic development phases back into the physiological environment of the maternal uterus instead of the laboratory incubator. This permits the development of the embryos in close communication and exchange with maternal factors from the very start of life.

A positive influence is expected on both the number and the individual quality of the embryos thus produced which should translate into better overall results of assisted reproduction.

Anecova ...

Press release: The World Economic Forum announces Technology Pioneers 2008 : The Swiss Anecova selected ...

World Economic Forum Technology Pioneers 2008 ...

The kits -- which will be distributed to oncology professionals nationwide starting this month -- contain the materials and instructions necessary for patients to produce a usable sperm sample at home or in the hospital. It includes a postage-paid package for fast delivery to Cryogenic Laboratories Inc., a Roseville, Minn., sperm bank, so no ice is needed for transport. Cryogenic Laboratories will charge $625 for processing and freezing the specimen for one year. The storage cost of each subsequent year -- frozen sperm can remain potent for decades -- is $280. In some cases, insurance will help defray that cost.

The kit, called Live:On, is also designed to eliminate a dilemma facing some men: whether to postpone treatment while pursuing sperm preservation. Gathering information about sperm preservation -- where and how to do it, how to ship off a specimen if no bank is nearby -- can take a few days. That could delay treatment of some fast-growing cancers. Armed with the kit soon to be available in oncologists' offices, however, a patient could preserve his child-bearing options in a matter of hours.

Cryogenic Laboratories will donate an unspecified percentage of its storage fees to its two partners in the effort, the Lance Armstrong Foundation and Fertile Hope, an organization dedicated to increasing fertility options for young cancer patients. Through Fertile Hope, financially strapped patients can apply for discounts.

Read on at the WSJ's Health Journal...

UPDATE: Press release from the Lance Armstrong Foundation ...

Product page: LIVE:ON ...

Enjoy!

(hat tip: Core77 Design Blog, Direct Daily)

At the ongoing 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, Starpharma Holdings Limited, an Australian company that has developed, and is now testing an STD-prevention gel, will report positive results from its most recent trial:

... 3% SPL7013 Gel (VivaGel™) was well-tolerated in men, and suitable for further development as a topical microbicide for the prevention of HIV and genital herpes...

The study compared 36 circumcised and uncircumcised men who applied VivaGel™ (24 men) or a placebo gel (12 men) topically to their penis once daily for seven days. The trial was double blinded so that the participants, principal investigator and study staff did not know who was receiving placebo or VivaGel™.

Overall, this study demonstrated that VivaGel(TM) was safe and well tolerated, and comparable with placebo when applied to the penis of both circumcised and uncircumcised healthy male volunteers once daily for seven days, and left in place for approximately 9 hours. As seen in a previous completed clinical trial in women, there was no evidence of absorption of the active ingredient of VivaGel™, SPL7013, into the blood after topical application.

According to the company, VivaGel™ is also being explored as a condom coating, as well as a vaginal gel.

The VivaGel™, that we reported on back in Nov. 2006, is a dendrimer-based nanoformulation, which is interesting enough to be revisited again:

Dendrimers are a kind of nanotechnology.

The specialised chemistry used to make dendrimers allows the chemist to control the physical and chemical properties of each dendrimer. Starpharma's synthesis of dendrimers begins with a core molecule with branching groups to which other molecules are added. Dendrimers are constructed by the successive addition of layers to the branching groups. Each new layer is called a generation. The final generation can incorporate additional active groups to tailor the functionality of the dendrimer.

The selection of core, branching and surface molecules gives the dendrimer the desired properties and functions for medical, electronic, chemical and materials applications.

In the picture above, one can see how SPL7013, the active dendrimer ingredient, binds to surface proteins on HIV, preventing the virus from infecting human T-cells.

Starpharma company page...

Press release: Starpharma Presents Positive Results of Clinical Study of VivaGel(TM) in Men at 4th International AIDS Society Conference ...