VasClip for Male Sterilization

Birth Control

• Women bear the burden of birth control in more than 80% of relationships.
• All birth control methods for women have varying levels of risks, complications, and associated costs.

Vasectomy

Vasectomy is one of the most effective, and reliable methods of birth control.

• More than 4 million vasectomies are performed worldwide each year.
• Men are increasingly more willing to accept the responsibility for birth control.
• Men's primary concern regarding vasectomy is the fear of pain and complications.

As shown in the table below, historical studies on vasectomy report a wide range of complications and varying degrees of patient pain.

Procedure	Clinically Significant Swelling (Hematoma)	Infection	Build-up of solidified sperm at ends of cut vas deferens (Sperm Granuloma)	Significant Pain	Infertility Rate
Vasectomy	0.1 - 15.0%	0.2 - 6.9%	15 - 40%	0.9 - 54.0%	87.1 - 100%t
t A review of (11) published vasectomy studies by leading urologists indicated a weighted average infertility rate of approximately 95%. The three most recently published papers on vasectomy cite infertility rates of 95.8%, 87.1%, and 95.1% (sources and references available at www.vasclip.com). This is equal to, or better than, the infertility rates of alternative methods of birth control.

The VASCLIP

The VASCLIP procedure is the less invasive alternative to vasectomy. The VASCLIP is a locking plastic band designed to close the vas deferens in a manner that reduces tissue damage.

• Eliminates all cutting, suturing and cauterizing (burning) of the vas deferens
• Reduces potential complications related to damage of the vas deferens

The VASCLIP design features ensure:

• Total encircling of the vas deferens
• No post-procedure movement

How the VASCLIP Works

VASCLIP Clinical Study

124 men were enrolled in a study on the VASCLIP. The complication rate and pain associated with the VASCLIP procedure was significantly lower compared to historical data on vasectomy.

Procedure	Clinically Significant Swelling (Hematoma)	Infection	Build-up of solidified sperm at ends of cut vas deferens (Sperm Granuloma)	Significant Pain	Infertility Rate
Vasectomy	0.1 - 15.0%	0.2 - 6.9%	15 - 40%	0.9 - 54.0%	95.0%*
Vasclip	0.8%	0%	0.8%	5.0%	97.5%
* Three subjects (3/124 or 2.5%) did not become infertile due to improper placement of the VASCLIP. 68 of the 124 patients (54.8%) participated in an extension of the clinical study. All of the 68 patients (100%) tested as infertile at an average of 372 days post-VASCLIP procedure.

110 of the 124 men who participated in the study responded to a post-procedure survey. Their feedback:

• 99% indicated satisfaction and would recommend the procedure to other men.
• 76% indicated that there was no pain at all or less than expected.
• 80% reported returning to normal activity one day after the VASCLIP procedure.

Benefits of the VASCLIP

The VASCLIP procedure significantly reduces pain and complications when compared to traditional vasectomy.

• Reduces recovery time.
• Increases patient satisfaction.
• Provides cost savings, compared to other birth control options.
• Increase the willingness of men to bear the responsibility of birth control.
• Avoids women bearing the burden of the complications and costs of birth control.

VASCLIP Procedure and Device Costs

• The cost of the Vasclip implant procedure is equivalent to the cost of a traditional vasectomy procedure.
• The $400 to $500 cost of the Vasclip device is in addition to the implant procedure.
• Check with your physician regarding cost, and your health insurer regarding procedure and device coverage.
• In the event that you insurer does not cover the cost of the Vasclip device you may choose to personally pay for the Vasclip device and its associated benefits.

Birth Control Product and Procedure Overview

(listed in increasing order of 5-Year Costs)

Method of birth control	% Failure Rates (Actual use)	% Users that Discontinue	Initial or per Use Costs	5-Year Costs (cost of method, unintended pregnancies, and treating of side-effects & complications)
Vasectomy	5.0	6	$353 - $1,200	$764
Vasclip	2.5	-	$753 -$1,600	$1,164 minus costs of reduced complications
IUD	2.0	20	$144 - $391	$1,815
Injectable Hormones	2.6	44	$375 - $750/yr.	$2,386
Implantable Hormones	1.4	16	$500 - $750/yr.	(similar to injectables)
Male Condoms	14.7	47	$0.33 to $1.04 / use	$2,424
Tubal Ligation	1.9	7	$1,190 - $2,467	$2,633
The Pill	8.1	32	$290 - $570/yr.	$2,949
The Patch	1.3	12	$342 - $510/yr.	(similar to The Pill)
Withdrawal	27.1	-	None	$3,278
Periodic Abstinence	25.3	-	None	$3,450
Diaphragm	20	44	$90 - 210	$3,993
Spermicide	26	60	$0.73 to $1.00 / use	$4,079
Sponge	20	44-58	$0.83 to $1.50 / use	(similar to spermicide)
Female Condoms	21	44	$3.00 / use	$4,214
Cervical Cap	20	44-58	$90 - $210	$5,455
No Method	85.0	-	None	$14,663

• The Vasclip procedure has been clinically proven to significantly reduce complications and pain when compared to published, vasectomy complication studies.
• Vasclip may reduce the costs associated with managing pain and complications resulting from vasectomy
• The Pill, patch, injectables and implants are not appropriate for all women, and extended use may cause various health problems. Additionally, not all health care insurance plans cover hormone-based contraception.
• Tubal ligation is a general anesthesia procedure with corresponding risks of complications and death, and increases the chances of a future hysterectomy by a factor of four. At a minimum, an insurance co-pay is typically required.
• Other birth control methods are not as effective as sterilization, and, in some cases, are uncomfortable and hamper spontaneity.
• The incremental cost of the Vasclip device should be compared to your current birth control costs, including birth control methods that are covered by your insurance company but require a co-pay.